[Federal Register: November 17, 1999 (Volume 64, Number 221)]
[Proposed Rules]
[Page 62745-62825]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17no99-28]
 
 
[[Page 62745]]
 
_______________________________________________________________________
 
Part II
 
 
Department of Health and Human Services
 
 
_______________________________________________________________________
 
 
Food and Drug Administration
 
_______________________________________________________________________
 
21 CFR Part 101
 
Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient
Content Claims, and Health Claims; Proposed Rule
 
 
[[Page 62746]]
 
 
 
DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
Food and Drug Administration
 
21 CFR Part 101
 
[Docket No. 94P-0036]
 
RIN 0910-AB66
 
 
Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient
Content Claims, and Health Claims
 
AGENCY: Food and Drug Administration, HHS.
 
ACTION: Proposed rule.
 
-----------------------------------------------------------------------
 
SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its regulations on nutrition labeling to require that the amount of
trans fatty acids present in a food, including dietary supplements, be
included in the amount and percent Daily Value (%DV) declared for
saturated fatty acids. FDA is proposing that when trans fatty acids are
present, the declaration of saturated fatty acids shall bear a symbol
that refers to a footnote at the bottom of the nutrition label that
states the number of grams of trans fatty acids present in a serving of
the product. FDA also is proposing that, wherever saturated fat limits
are placed on nutrient content claims, health claims, or disclosure and
disqualifying levels, the amount of trans fatty acids be limited as
well. In addition, the agency is proposing to define the nutrient
content claim for ``trans fat free.'' This proposal responds, in part,
to a citizen petition on trans fatty acids in food labeling from the
Center for Science in the Public Interest (CSPI). This action also is
being taken to prevent misleading claims and to provide information to
assist consumers in maintaining healthy dietary practices.
DATES: Written comments on the proposed rule should be submitted by
February 15, 2000. See section XI of this document for the proposed
effective date of a final rule based on this document. Written comments
on the information collection requirements should be submitted by
December 17, 1999.
 
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document. Submit
written comments on the information collection requirements to the
Office of Information and Regulatory Affairs, Office of Management and
Budget (OMB), New Executive Office Bldg., 725 17th St. NW., rm. 10235,
Washington, DC 20503, Attn: Desk Officer for FDA.
 
FOR FURTHER INFORMATION CONTACT: Susan Thompson, Center for Food Safety
and Applied Nutrition (HFS-165), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-205-5587.
 
SUPPLEMENTARY INFORMATION:
 
I. Background
 
A. Nutrition Labeling
 
    In the Federal Register of July 19, 1990 (55 FR 29847), FDA
published a proposed rule entitled ``Food Labeling; Mandatory Status of
Nutrition Labeling and Nutrient Content Revision'' (hereinafter
referred to as ``the July 19, 1990, proposal'') to amend its food
labeling regulations to require nutrition labeling on most food
products that are meaningful sources of nutrients. Among other things,
FDA proposed to revise the list of nutrients and food components that
must be included in nutrition labeling by adding to that list saturated
fatty acids, cholesterol, dietary fiber, and calories from fat.
    During the comment period for the July 19, 1990 proposal, Congress
passed, and the President signed into law, the Nutrition Labeling and
Education Act of 1990 (the 1990 amendments) (Public Law 101-535).
Section 403(q) (21 U.S.C. 343(q)) of the Federal Food, Drug, and
Cosmetic Act (the act), which was added by the 1990 amendments,
specifies, in part, that certain nutrients and food components are to
be included in nutrition labeling. Section 403(q)(2)(A) and (q)(2)(B)
of the act state that the Secretary of Health and Human Services (the
Secretary) (and, by delegation, FDA) can, by regulation, add or delete
nutrients to be included in the food label or labeling if he or she
finds such action necessary to assist consumers in maintaining healthy
dietary practices. In response to this provision, in the Federal
Register of November 27, 1991 (56 FR 60366), FDA published a proposed
rule entitled ``Food Labeling; Reference Daily Intakes and Daily
Reference Values; Mandatory Status of Nutrition Labeling and Nutrient
Content Revision'' (hereinafter referred to as ``the November 27, 1991,
proposal'') to modify the July 19, 1990, proposal. In the November 27,
1991, proposal, the agency proposed to require that foods bear
nutrition labeling listing certain nutrients and the amount of those
nutrients in a serving of the food.
    In the November 27, 1991 (56 FR 60366 at 60371) proposal, FDA also
addressed the conditions under which other nutrients could voluntarily
be included in nutrition labeling. FDA did not propose to include trans
fatty acids (throughout this preamble FDA has used the terms ``trans
fatty acids'' and ``trans fat'' interchangeably; likewise, for the
terms ``saturated fatty acids'' and ``saturated fat'') among the
nutrients that could voluntarily be listed on the nutrition label, but
requested comments on this position.
    In the Federal Register of January 6, 1993 (58 FR 2079), FDA issued
a final rule entitled ``Food Labeling: Mandatory Status of Nutrition
Labeling and Nutrient Content Revision, Format for Nutrition Label''
(hereinafter referred to as ``the nutrition labeling final rule'') that
prescribes how nutrition labeling is to be provided on the foods that
are regulated by the agency. The new regulations required the
declaration of total fat and of saturated fat, with the declaration of
monounsaturated fat and polyunsaturated fat (both defined as the cis
isomers only) required only when claims are made about fatty acids and
cholesterol. Based on its review of the comments, the agency stated
that it was premature to require the presence of trans fatty acids on
the nutrition label because of a lack of consensus on the dietary
implications of trans fatty acids intake. However, the agency
acknowledged that it might be necessary to revisit the labeling of
trans fatty acids in the future (58 FR 2079 at 2090 to 2092).
 
B. Nutrient Content Claims
 
    Section 403(r)(1)(A) of the act, which also was added by the 1990
amendments, provides that a product is misbranded if it bears a claim
on its label or labeling that either expressly or implicitly
characterizes the level of any nutrient of the type required to be
declared as part of nutrition labeling, unless such claim has been
specifically defined by regulation under section 403(r)(2)(A) of the
act (or the product is otherwise exempted under the act). In response
to this provision, FDA published two proposed rules in the Federal
Register of November 27, 1991 (56 FR 60421 and 56 FR 60478). The first
document entitled ``Food Labeling: Nutrient Content Claims, General
Principles, Petitions, Definition of Terms,'' covered general
principles for nutrient content claims and proposed, in part, to define
certain nutrient content claims, to provide for their use on food
labels, and to establish procedures for the submission and review of
petitions regarding the use of specific nutrient content claims. In the
other document entitled ``Food
 
[[Page 62747]]
 
Labeling: Definitions of Nutrient Content Claims for the Fat, Fatty
Acid, and Cholesterol Content of Food'' (hereinafter referred to as the
``fat, fatty acid, and cholesterol proposed rule''), the agency
proposed definitions for fat, fatty acid, and cholesterol nutrient
content claims, but not for ``saturated fat free.''
    A number of comments in response to the fat, fatty acid, and
cholesterol proposed rule strongly recommended that FDA define the term
``saturated fat free.'' In the Federal Register of January 6, 1993 (58
FR 2302 at 2419), FDA issued a final rule entitled ``Food Labeling:
Nutrient Content Claims, General Principles, Petitions, Definition of
Terms; Definitions of Nutrient Content Claims for the Fat, Fatty Acid,
and Cholesterol Content of Food,'' (hereinafter referred to as the
``nutrient content claims final rule'') (58 FR 2302 at 2419), that
defined ``saturated fat free'' to mean that the food contains less than
0.5 gram (g) of saturated fat per reference amount customarily consumed
(``reference amount'') and that the level of trans fatty acids in the
food does not exceed 1 percent of the total fat in the food
(Sec. 101.62(c)(1)(i) (21 CFR 101.62(c)(1)(i))). FDA included the
latter criterion because scientific evidence suggested that trans fatty
acids act in a similar manner to saturated fat with respect to raising
serum cholesterol and, therefore, should be present at insignificant
levels when claims are made about saturated fats. The agency stated
that it would be misleading for products that were labeled ``saturated
fat free'' to contain measurable amounts of trans fatty acids because
consumers would expect such products to be ``free'' of other components
that significantly raise serum cholesterol. The agency stated that 1
percent was the appropriate threshold because analytical methods for
measuring trans fatty acids below that level were not reliable (58 FR
2302 at 2332).
    Technical comments that FDA received after publication of the
nutrient content claims final rule objected to the 1 percent criterion
for trans fatty acids in the definition of ``saturated fat free.'' A
comment pointed out that a cookie containing 1.5 g of total fat would
be allowed to have only 0.015 g of trans fatty acids, an amount that
could not be accurately measured (58 FR 44020 at 44027). These comments
persuaded FDA to revise the trans fatty acids criterion for the
definition of ``saturated fat free'' in Sec. 101.62(c)(1)(i) to require
that a food contain less than 0.5 g trans fatty acids per reference
amount and per labeled serving to be eligible to bear the claim. The
agency selected this amount because of the reliable limit of detection
of trans fatty acids and because it corresponds to the amount of
saturated fat and total fat selected for the claims ``saturated fat
free'' and ``fat free,'' respectively. FDA incorporated this change in
technical amendments to the nutrient content claims final rule that it
published in the Federal Register on August 18, 1993 (58 FR 44020 at
44032).
 
C. Disqualification/Disclosure Levels
 
    The 1990 amendments addressed health claims by amending the act to
specify, in part, that a food is misbranded if it bears a claim that
expressly or by implication characterizes the relationship of any
nutrient that is of the type required in section 403(q)(1) or (q)(2) of
the act to be in the label or labeling of the food to a disease or
health-related condition unless the claim meets the requirements of a
regulation authorizing its use. Section 403(r)(3)(A)(ii) of the act
provides that a health claim may only be made for a food that does not
contain, as determined by regulation, a nutrient in an amount that
increases to persons in the general population the risk of a disease or
health-related condition that is diet related. FDA describes these
levels as ``disqualifying'' levels.
    In the case of certain nutrient content claims, section
403(r)(2)(B) of the act, as amended, requires that the label or
labeling of any food that contains a nutrient at a level that increases
to persons in the general population the risk of a disease or health-
related condition that is diet related shall contain, prominently and
in immediate proximity to such claim, the following statement: ``See
nutrition information for ________ content.'' The blank shall identify
the nutrient associated with the increased risk of disease or health-
related condition. FDA refers to these levels as ``disclosure levels.''
    FDA established disqualifying levels in Sec. 101.14(a)(5) (21 CFR
101.14(a)(5)) for fat, saturated fat, cholesterol, and sodium in the
health claims final rule (58 FR 2478, January 6, 1993). It also
established disclosure levels for these nutrients in Sec. 101.13(h) (21
CFR 101.13(h)) in the nutrient content claims final rule (58 FR 2302).
The nutrient levels are the same for both disqualification and
disclosure. During that rulemaking, the agency did not consider
disqualifying or disclosure levels for trans fatty acids due to the
inconclusiveness of scientific evidence concerning their impact on
public health.
 
II. The Petition From the Center for Science in the Public Interest
(CSPI)
 
    CSPI submitted a citizen petition dated February 14, 1994, which
was assigned FDA Docket No. 94P-0036/CP1. In the petition, CSPI stated
that an increasing body of evidence suggests that dietary trans fatty
acids raise blood cholesterol levels, thereby increasing the risk of
coronary heart disease (CHD). The petitioner argued that the food
labeling rules issued to implement the 1990 amendments do not
adequately reflect the effect of dietary trans fatty acids on CHD. The
petitioner stated that consumers expect the number of grams of
saturated fat listed on the nutrition label to represent all the
``heart-unhealthy'' fat in the product, and that, in many foods, the
number of grams of saturated fat underestimates the total amount of
``heart-unhealthy'' fats because trans fatty acids are not included in
the declared value. The petition included examples of products in which
the declared amount of saturated fat accounted for only half of the
``heart-unhealthy'' fat. Accordingly, CSPI requested that FDA amend the
definition of saturated fatty acids in Sec. 101.9(c)(2)(i) (21 CFR
101.9(c)(2)(i)) to include trans fatty acids so that the declaration of
saturated fat on the nutrition label would provide consumers with
complete information on all ``heart-unhealthy'' fatty acids.
    CSPI also requested that all saturated fat claims in Sec. 101.62(c)
be based on the combined level of saturated and trans fatty acids. The
petitioner requested that these claims be prohibited unless the levels
of saturated and trans fat combined meet FDA's saturated fat criteria
for such claims. The petitioner contended that consumers may assume
that the level of saturated fat allowed for these claims includes all
of the ``heart-unhealthy'' fat in a product. The petitioner stated that
the level allowed should include trans fatty acids because of the
substantial and growing amount of evidence demonstrating that trans
fatty acids increase the risk of CHD.
    Further, the petitioner maintained that without a limit on the
trans fatty acid content in foods with the previously mentioned claims,
manufacturers could replace saturated fat with trans fatty acids. To
support its position, the petitioner provided numerous product labels
bearing nutrient content claims for the content of saturated fat or
cholesterol. These products appear to contain trans fatty acids
(calculated by subtracting the sum of saturated, polyunsaturated, and
monounsaturated fat from total fat) in
 
[[Page 62748]]
 
higher amounts than saturated fatty acids.
    The petitioner stated that FDA has already taken a positive step in
this area by imposing a 0.5 g limit on trans fat allowed in foods that
have the claim ``saturated fat free.'' However, the petitioner
requested that the criteria for saturated fat of 0.5 g should refer to
the level of saturated and trans fat combined. The petitioner pointed
out that without this change, the level of ``heart-unhealthy'' fat can
be almost 1.0 g, which is the limit for ``low'' in saturates. The
petitioner stated that consumers expect foods that have the claim
``saturated fat free'' to be free of components that significantly
raise serum cholesterol. Thus, it would be misleading for such products
to contain significant amounts of ``heart-unhealthy'' fat.
    With respect to ``low in saturated fat,'' this claim is currently
defined in Sec. 101.62(c)(2)(i) as 1 g or less of saturated fat per
reference amount and 15 percent or less of calories from saturated fat.
The petitioner requested that this definition should read ``1 g or less
total of saturated fatty acids and trans fatty acids combined per
reference amount customarily consumed and not more than 15 percent of
calories from saturated fatty acids and trans fatty acids combined.''
    Similarly, the petitioner requested that the definition for
``reduced saturated fat'' in Sec. 101.62(c)(4)(i) of at least a 25
percent reduction in saturated fat should be amended to be a 25 percent
reduction in saturated and trans fat combined.
    The petitioner also requested that all saturated fat claims for
meal products and main dishes (i.e., ``saturated fat free'' in
Sec. 101.62(c)(1)(i), ``low in saturated fat'' in Sec. 101.62(c)(3)(i),
and ``reduced saturated fat'' in Sec. 101.62(c)(5)(i)) be amended to
reflect the combined level of saturated and trans fatty acids. The
petitioner made a similar request regarding ``lean'' and ``extra lean''
claims (Sec. 101.62(e)).
    In addition, the petitioner requested that the saturated fat
threshold on all cholesterol claims for foods, meal products, and main
dishes (i.e., ``cholesterol free'' (Sec. 101.62(d)(1)(i)(C) and
(d)(1)(ii)(C)), ``low cholesterol'' (Sec. 101.62(d)(2)(i)(B),
(d)(2)(ii)(B), (d)(2)(iii)(B), (d)(2)(iv)(B), and (d)(3)), and
``reduced cholesterol'' (Sec. 101.62(d)(4)(i)(B), (d)(4)(ii)(B),
(d)(5)(i)(B), and (d)(5)(ii)(B))) be amended to reflect the combined
level of saturated and trans fatty acids.
    CSPI also requested that the disqualification and disclosure levels
for health and nutrient content claims be amended to reflect combined
levels of saturated fat and trans fatty acids. For example, CSPI
requested that the disqualifying nutrient level for health claims in
Sec. 101.14(a)(5) and the disclosure level for nutrient content claims
in Sec. 101.13(h)(1) be changed from 4 g saturated fat to 4 g of
saturated and trans fatty acids combined.
    Further, CSPI requested that FDA limit ``vegetable oil'' claims
(e.g., ``made with vegetable oil,'' ``cooked in 100 percent vegetable
oil'') to foods that are low in both saturated and trans fatty acids.
Finally, the petitioner requested that FDA require that ``partially
hydrogenated'' fat be listed on food labels as ``partially saturated''
fat.
    On July 13, 1998, CSPI amended its petition in a way that would
maintain the definition of saturated fat in Sec. 101.9(c)(2)(i), yet
provide consumers with information on the trans fatty acid content of
the food. The amended petition continued to request that the number of
grams of trans fatty acids in a food be added to the number declared
for saturated fatty acids. However, in its amendment, the petitioner
suggested two methods that would alert the consumer to the presence of
trans fatty acids. In the first method, an asterisk would be used after
``Saturated fat'' when trans fatty acids are present. The asterisk
would refer to an asterisk at the bottom of the nutrition label
followed by a footnote explaining that the declaration of saturated
fatty acids ``Contains ______ g oftrans fat.'' Alternatively, CSPI
suggested that the terminology on the nutrition label be changed from
``Saturated fat'' to ``Saturated + trans fat.''
    The agency's tentative response to the petition and to the comments
on the petition follows.
 
III. Statutory Authority
 
    FDA is proposing to amend its regulations governing nutrient
content claims and nutrition labeling to include provisions on trans
fatty acids. FDA is proposing to take these actions under sections
201(n) 403(a)(1), 403(q), 403(r), and 701(a) of the act (21 U.S.C.
321(n), 343(a)(1), 343(q), 343(r), and 371(a)). Under section 201(n) of
the act, labeling is misleading if it fails to reveal facts that are
material in the light of representations made in the labeling or that
are material with respect to the consequences that may result from the
use of the food under the conditions of use prescribed in the labeling
or under such conditions of use as are customary or usual. Section
403(a)(1) of the act prohibits labeling that is false or misleading.
Section 403(q) of the act allows the Secretary, in section 403(q)(2)(A)
of the act, to require by regulation nutrition information about
nutrients other than those specified in section 403(q)(1) of the act to
assist consumers in maintaining healthy dietary practices. Under
section 403(r) of the act, a food is misbranded if its labeling uses
terms that have not been defined by regulation issued under section
403(r)(2)(A)(i) to characterize the level of any nutrient in a food, or
if, in violation of section 403(r)(2)(A)(iv), cholesterol levels are
not specified in immediate proximity to saturated fat claims. In
addition, under section 403(r)(2)(A)(vi) of the act, the Secretary by
regulation may prohibit a claim about the level of a nutrient because
it is misleading in light of the level of another nutrient in the food.
Section 403(r)(2)(B) of the act requires that the labeling of any food
bearing a nutrient content claim that contains a nutrient at a level
that increases to persons in the general population the risk of a
disease or health-related condition that is diet related must contain,
prominently and in immediate proximity to such nutrient content claim,
a disclosure statement specified by that section of the act. Moreover,
section 403(r)(3)(A)(ii) of the act provides that FDA establish by
regulation disqualifying levels for health claims to ensure that health
claims cannot be made for products that contain nutrients in amounts
that increase to persons in the general population the risk of a
disease or health-related condition that is diet related. Finally,
section 701(a) of the act gives the Secretary the authority to issue
regulations for the efficient enforcement of the act.
 
IV. Trans Fatty Acids
 
A. Definitions
 
1. Fats
    Fats are energy-yielding nutrients that are found in most foods.
Dietary fats are composed of fatty acids and glycerol. Dietary fatty
acids consist of carbon chains of various lengths and a terminal
carboxyl group. The carbon atoms in these chains are connected by
single or double bonds. Hydrogen atoms are attached to the noncarboxyl
carbons.
2. Fatty Acid Nomenclature
    A saturated fatty acid has no double bonds between the carbon atoms
in the chain. Therefore, a maximum number of hydrogens (i.e., 2) are
attached to each carbon atom, except for the end carbons, and
``saturate'' the carbon chain. An ``unsaturated'' fatty acid may
contain one or more double bonds between carbon atoms and, therefore,
two fewer hydrogen atoms per double bond. A
 
[[Page 62749]]
 
fatty acid with a single double bond is called a ``monounsaturated
fatty acid.'' A fatty acid with two or more double bonds is called a
``polyunsaturated fatty acid.''
    Fatty acids are identified by the number of carbons and the number
of the carbon-carbon double bonds. For example, stearic acid, a
saturated fatty acid, has 18 carbons and no double bonds. The shorthand
notation for this fatty acid is ``C18:0.'' Some examples of other
saturated fatty acids are lauric (C12:0), myristic (C14:0), and
palmitic (C16:0) acids. The most common dietary monounsaturated fatty
acid is oleic acid, C18:1, which has 18 carbons and one double bond.
The most common dietary polyunsaturated fatty acid is linoleic acid,
C18:2, which has 18 carbons and 2 double bonds.
3. Cis and Trans Isomers
    Most naturally-occurring dietary unsaturated fatty acids are in a
``cis'' configuration, i.e., the two hydrogen bonds attached to two
carbons are on the same side of the molecule at the double bond which
gives the molecule a ``bend'' at the site of the double bond. These
bent molecules cannot pack easily together, so fats of these molecules
are more often in a liquid form. In a ``trans'' configuration, the
hydrogen atoms attached to the carbon atoms at a double bond are not on
the same side of the double bond (``trans'' means ``across'' in Latin).
This arrangement of hydrogen atoms stabilizes the molecule in a
relatively straight contour. Trans isomers are primarily the result of
the hydrogenation process. One common trans fatty acid is
monounsaturated trans-C18:1.
4. Hydrogenation
    Chemical hydrogenation is the process by which hydrogen atoms are
added to unsaturated sites on the carbon chains of fatty acids in the
presence of catalysts, thereby reducing the number of double bonds.
``Partial hydrogenation'' describes an incomplete saturation of the
double bonds, in which some double bonds remain but may be moved in
their positions on the carbon chain and changed from a cis to trans
configuration or isomer.
    Hydrogenation increases the melting point, shelf life, and flavor
stability of unsaturated fatty acids. Through hydrogenation, oils
(i.e., fats in liquid form), such as soybean, safflower, and cottonseed
oil, which are rich in unsaturated fatty acids, are converted to semi-
solids and solids that are useful in margarines and vegetable
shortenings.
    Hydrogenation also occurs in the digestive tract of ruminant
animals and results in some trans isomers in the fat components of
dairy and meat products from these animals. These isomers usually make
up only a small percent of the total fatty acids of such products.
    The partial hydrogenation process was developed in the 1930's and
has been in widespread commercial use since the 1940's. Dietary fats
containing hydrogenated fatty acids, such as those used in margarine,
have gradually displaced animal fats, such as butter and lard (Refs. 1
and 2). About two-thirds of the dietary fat consumed in the 1940's was
of animal origin. The balance was reversed by the 1960's, with two-
thirds coming from fats of vegetable origin. This trend resulted in a
decrease in the intake of saturated fat and an increase in the intake
of polyunsaturated and trans fatty acids (Ref. 1).
 
B. Review of the Science
 
    In support of its petition, CSPI cited a number of scientific
publications that related consumption of trans fatty acids to increased
risk of CHD, as well as statements by government and professional
bodies about trans fatty acids. FDA has reviewed both the scientific
evidence cited in the petition and available human study evidence
published since receipt of the petition. There are two recent reviews
of findings from animal studies on the effects of feeding animals trans
fatty acids (Refs. 1 and 3). These reviews indicate that results from
animal feeding studies do not parallel findings from human intervention
and epidemiological studies. Although the results from the animal and
human studies differ, FDA considers the findings from human studies
more directly relevant and, as explained below, persuasive evidence
with which to evaluate the influence of trans fatty acid consumption on
CHD in humans.
 1. Reviews by the Federal Government and the National Academy of
Sciences (NAS)
    A review of reports published by the Federal Government and the NAS
between the late 1980's and the present time on dietary trans fatty
acids shows that conclusions and recommendations are evolving as
results from significant new studies become available. For example, a
report by the Surgeon General in 1988 (Ref. 2) concluded that trans
fatty acids appeared to be neutral in their effects on serum lipids
predictive of CHD risk. Based on a limited number of animal and
observational studies, the Food and Nutrition Board of the NAS
concluded in 1989 that trans fatty acids appeared to have no
deleterious health effects (Ref. 4).
    More recently, the 1993 publication from the National Cholesterol
Education Program (NCEP) entitled ``Second Report of the Expert Panel
on Detection, Evaluation and Treatment of High Blood Cholesterol in
Adults'' (Ref. 5) stated:
    Recent research indicates that trans fatty acids raise LDL-
cholesterol levels nearly as much as do cholesterol-raising
saturated fatty acids. Trans fatty acids account for about 3 percent
of total calories in the American diet; this amount causes a
definite increase in LDL-cholesterol levels, but of course less than
the more abundant cholesterol-raising saturated fatty acids.
Improvements in food technology in the future may reduce the trans
fatty acid content of the American diet. In the meantime patients
with high cholesterol should limit their intake of foods high in
trans fatty acids such as hydrogenated shortenings, some margarines
and foods containing these fats.
    The fourth edition of Dietary Guidelines for Americans (Ref. 6), a
joint 1995 publication from the U.S. Department of Agriculture (USDA)
and the U.S. Department of Health and Human Services (DHHS), stated:
    Partially hydrogenated vegetable oils, such as those used in
many margarines and shortenings, contain a particular form of
unsaturated fat known as trans-fatty acids that may raise blood
cholesterol levels, although not as much as saturated fat.
2. Published Human Research Studies
    FDA previously reviewed studies on trans fatty acids in the Federal
Register of November 27, 1991 (56 FR 60366 at 60371) proposal on
nutrition labeling and in its 1993 final rule for a health claim for
dietary saturated fat and cholesterol and CHD (58 FR 2739 at 2744). The
latter document included a review of studies considered in that health
claim evaluation. As a result of its review, the agency concluded that
the available scientific evidence was insufficient to make a policy
decision regarding dietary trans fatty acids and risk of CHD, noting
that the ``low fat'' eligibility requirement gave little room for
products to contain high levels of trans fatty acids. The agency has
focused its current review on studies cited in the petitioner's
submission plus recent studies in humans identified by a supplemental
literature search.
    To target its review of the available evidence on trans fatty acids
and CHD risk, the agency focused on the physiological measures that
were identified as valid predictors of increased risk for CHD, which
were published in the Second Report of the Expert Panel on Detection,
Evaluation, and Treatment of High Cholesterol in
 
[[Page 62750]]
 
Adults (Ref. 5). That Expert Panel identified a high blood cholesterol
level in adults as a major risk factor for CHD. In particular, that
study reported that a direct relationship had been demonstrated between
serum low-density lipoprotein cholesterol (LDL-C) concentrations and
rate of CHD. Intervention studies had shown that lowering plasma LDL-C
by dietary means and drug therapy can reduce this risk, and
recommendations for dietary interventions were made relative to their
effect on serum LDL-C concentrations.
    Based on the findings of the NCEP Expert Panel (Ref. 5), FDA has
concluded that an examination of the effects of trans fatty acids on
serum LDL-C would provide the strongest evidence, and should be the
primary criterion, to evaluate whether trans fatty acids influence the
risk of CHD. The agency also compiled changes in serum total and high
density lipoprotein cholesterol (HDL-C) and serum lipoproteins to
present a more complete picture of serum lipid changes.
    FDA reviewed findings from intervention and observational studies
to evaluate the evidence that dietary trans fatty acids influence blood
lipid levels in humans and increase their risk of CHD. In the present
review, FDA gave greater weight to results from dietary intervention
studies because of the ability of intervention studies to provide
evidence for a cause-effect relationship (Ref. 4). FDA regarded results
from observational (epidemiologic) studies, which can identify
associations between dietary intake and risk of CHD but which do not
provide direct evidence for cause and effect (Ref. 4), as indirect
evidence for a relationship between trans fatty acids intake and risk
of CHD. Because ``repeated and consistent findings of an association
between certain dietary factors and diseases are likely to be real and
indicative of a cause-effect relationship'' (Ref. 4), FDA heavily
weighted the consistency of results among studies.
    Results of the intervention and observational studies are shown in
Tables 1 and 2 of Appendix A of this document, respectively. A summary
of the effects of trans fatty acids on serum LDL-C, shown in the
dietary intervention studies detailed in Table 1 of Appendix A is
presented in Table 3 of Appendix A.
    a. Intervention studies. Controlled dietary intervention studies
(feeding trials) using test fats containing trans fatty acids have been
conducted in the Netherlands (Refs. 7 and 8), Norway (Ref. 9), Finland
(Ref. 10), Australia (Refs. 11 and 36), and the United States (Refs.
12, 13, 14, 15, 34, and 82). As detailed in Table 1 of this document,
test products consisted of partially hydrogenated vegetable and fish
oils commercially available in the study country or products especially
prepared for the study and similar to the partially hydrogenated oil
products used in the country.
    Serum LDL-C levels measured after consumption of diets containing
low levels of trans fatty acids were compared with serum LDL-C levels
measured after consumption of diets in which trans fatty acids replaced
cis-polyunsaturated fatty acids (PUFA's) (mainly linoleic acid), cis-
monounsaturated fatty acids (MUFA's) (mainly oleic acid), or saturated
fatty acids (varying combinations of lauric, myristic, palmitic, and
stearic acids). Within studies, the saturated fatty acid content of
diets was not increased, and in some studies was decreased, by the
inclusion of trans fat sources. See Table 1 of this document for
details about fatty acids composition of diets.
    In these studies, partially hydrogenated oils were incorporated
into diets fed to adult men and women for experimental periods of 3-
week (Refs. 7, 8, 9, 11, and 36), 4.5-week (Ref. 13), 5-week (Refs. 10,
34, and 82), or 6-week (Refs. 12, 14, and 15) intervals at levels
providing 2.4 to 10.9 percent of energy intake as trans fatty acids. At
the levels of dietary energy consumed, study participants consumed from
2.1 g/day to 38.3 g/day of trans fatty acids (see Table 1 of Appendix A
of this document for details).
    Overall, consumption of diets containing higher levels of trans
fatty acids resulted in significantly higher LDL-C levels when trans
fatty acids sources replaced fats high in cis-PUFA (mainly linoleic
acid) or cis-MUFA (mainly oleic acid). With respect to studies
comparing diets containing trans fatty acids to diets containing higher
levels of cis-PUFA, Lichtenstein et al. (1993) found that LDL-C levels
were 8.4 percent higher in 14 mildly hypercholesterolemic subjects
after consumption of NCEP Step 2 diets containing 12.5 g/day of trans
fatty acids for 3 weeks compared to a linoleic acid diet providing a
daily intake of only 1.2 g/day of trans fatty acids (Ref. 13). (The
Step 2 diet is an intensive dietary therapy for high blood cholesterol
recommended by the NCEP when less restrictive dietary intervention has
not resulted in serum LDL-C reduction (Ref. 5).) In a second study,
Lichtenstein et al., (1999) (Ref. 82) found that serum LDL-C
concentrations increased in a stepwise manner when 36 subjects consumed
NCEP Step 2 diets containing four hydrogenated soybean oil products
(semiliquid margarine, soft margarine, shortening, and stick margarine)
compared to a Step 2 diet containing unhydrogenated soybean oil. Trans
fatty acids intakes of subjects consuming hydrogenated products ranged
from 2.9 g/day for men and 2.1g/day for women consuming the semiliquid
margarine diet to 20.8 g/day for men and 15.8 g/day for women consuming
the stick margarine diet. Trans fatty acids intakes of subjects
consuming the soybean oil diet were 1.7 g/day for men and 1.3 g/day for
women (Ref. 82).
    Zock and Katan (1992) also reported LDL-C levels 8.5 percent higher
in 56 normolipidemic subjects after consumption of a diet containing
24.5 g/day of trans fatty acids compared to a linoleic acid diet
providing less than 0.05 g/day of trans fatty acids (Ref. 8). In a less
rigorously controlled study, Wood et al. (Ref. 15) reported that serum
LDL-C levels were increased 6.1 percent in 38 healthy men after
consumption of a hard margarine diet containing at least 15.8 g/day of
trans fatty acids compared to a soft margarine diet with unspecified,
but presumably lower, levels of trans fatty acids (Ref. 14).
    Other studies compared trans diets to diets containing oleic acid.
Compared to an oleic acid diet providing about 2 g/day trans fatty
acids, LDL-C levels in 58 healthy men and women were 6.0 percent higher
after consumption of diets containing moderate levels of trans fatty
acids (7.6 g/day in an 1,800 kilocalories (kcal)/day diet or 11.8 g/day
in a 2,800 kcal/day diet) and 7.8 percent higher after consumption of
diets containing higher levels of trans fatty acids (13.2 g/day for the
1,800 kcal diet or 20.5 g/day for the 2,800 kcal diet) (Ref. 12).
Mensink and Katan (1990) had earlier reported 13.9 percent higher
levels of LDL-C in 59 healthy men and women after consumption of a diet
containing 33.6 g/day of trans fatty acids compared to an oleic acid
diet providing no trans fatty acids (Ref. 7). Nestel et al. (1992) also
reported LDL-C levels 9.2 percent higher in 27 mildly
hypercholesterolemic men after consumption of a diet providing 15.6 g/
day of trans fatty acids compared to an oleic acid diet providing
intakes of 3.8 g/day trans fatty acids (Ref. 11). It should be noted
that changes in serum total cholesterol concentrations tended to
parallel changes in LDL-C in these studies; HDL-C levels either did not
differ significantly between treatment groups or were lower after
consumption of trans fatty acid diets than after cis-MUFA or PUFA diets
(see Table 1 of Appendix A of this document).
 
[[Page 62751]]
 
    Consumption of diets in which trans fatty acids replaced some
dietary saturated fatty acids resulted in LDL-C levels that were not
significantly different or were lower than LDL-C levels after
consumption of diets containing saturated fatty acids, although
generally not as low as the reduction in saturated fatty acids would
suggest. Aro et al. (Ref. 10), Zock and Katan (Ref. 8), and Nestel et
al. (Ref. 11) reported that LDL-C levels following consumption of diets
containing 24.9, 24.5, or 15.6 g/day, respectively, of trans fatty
acids were not significantly different from LDL-C levels following
consumption of saturated fatty acid diets providing mainly stearic acid
or palmitic acid and providing 1 to 3 g/day of trans fatty acids. Judd
et al. (1994) reported no significant difference in LDL-C in 58
apparently healthy subjects after consumption of a diet containing a
high level of trans fatty acids (13.2 or 20.5 g/day) compared to a
saturated fatty acid diet providing about 2 g/day of trans fatty acids
(Ref. 12). Although, at a moderate level of trans fatty acid intake
(7.6 or 11.8 g/day), LDL-C levels were 2.7 percent lower compared to
the saturated fatty acid diet, these LDL-C levels were still
significantly higher than after consumption of the cis-MUFA (oleic
acid) diet (Ref. 12). In these diets, trans fatty acids replaced
lauric, myristic, and palmitic acids; stearic acid levels provided 3
percent of energy in all diets.
    In a 1998 study, Judd et al. (Ref. 34) reported that LDL-C
decreased 4.9 percent after consumption of a diet containing a trans
fatty acids margarine and providing 13 and 9 g/day of trans fatty acids
to men and women, respectively, compared to a diet containing butter
and foods providing 9 and 7 g/day of trans fatty acids for men and
women (Ref. 34). At trans fatty acids intakes of 6.4 g/day or 6.8 g/day
(Ref. 36) and 12.5 g/day (Ref. 13), LDL-C levels were lower in mildly
hypercholesterolemic subjects after replacement of some saturated fatty
acids by trans fatty acids. Almendingen et al. (Ref. 9) also reported
6.0 percent lower LDL-C levels in 30 healthy men after consumption of
diets containing 22.6 to 38.3 g/day of trans fatty acids from partially
hydrogenated soy oil than after a saturated fat (butter) diet providing
only 2 to 4 g/day of trans fatty acids but no difference after
consumption of a diet containing 21.6 to 36.1 g/day of trans fatty
acids from partially hydrogenated fish oil compared to the saturated
fat diet. Mensink and Katan (Ref. 7) reported LDL-C levels 3.2 percent
lower in 59 healthy men and women after consumption of a diet
containing 33.6 g/day of trans fatty acids than after a saturated fatty
acid diet high in lauric and palmitic acids and containing 2.4 g/day
trans fatty acids.
    In a 1999 study, Lichtenstein et al. (Ref. 82), found that serum
LDL-C concentrations decreased in a stepwise manner when 36 subjects
consumed NCEP Step 2 diets containing four hydrogenated soybean oil
products (stick margarine, shortening, soft margarine, and semiliquid
margarine) compared to a butter diet containing the same amount of
total fat and 3.9 g/day and 2.9 g/day of trans fatty acids for men and
women, respectively. Trans fatty acids intakes of men and women
consuming stick margarine were 20.8 and 15.8 g/day, shortening 9.7 and
12.9 g/day, soft margarine 10.2 and 7.8 g/day, and semiliquid margarine
1.7 and 1.3 g/day (Ref. 82).
    Results from Mensink and Katan (Ref. 7), Judd et al. (1994 and
1998) (Refs. 12 and 34), and Lichtenstein et al. (1993 and 1999) (Refs.
13 and 82) indicate that consumption of diets containing trans fatty
acids results in LDL-C levels between those observed after consumption
of saturated fatty acid diets and cis-MUFA and PUFA diets; i.e., lower
than after consumption of saturated fatty acid diets but higher than
after cis-MUFA or PUFA diets. As noted previously in comparisons with
cis-MUFA and PUFA diets, changes in total cholesterol concentrations
also tended to parallel changes in LDL-C levels after consumption of
trans fatty acid diets compared to saturated fatty acid diets; HDL-C
levels either did not differ significantly between treatment groups or
were lower after consumption of trans fatty acid diets than after
saturated fatty acid diets.
    Interpretation of these intervention studies described previously
is complicated because trans fatty acids replace other dietary fatty
acids that also affect serum cholesterol levels. However, comparing
fatty acid composition of the test and control diets, these studies
consistently indicate that consumption of diets containing fats with
higher levels of trans fatty acids results in increased serum LDL-C,
the major dietary risk factor for CHD, compared with diets containing
cis-MUFA or PUFA fat sources and lower levels of trans fatty acids. The
studies that compare a saturated fat diet with a diet in which some of
the saturated fat has been replaced with trans fat also indicate that
trans fatty acids, like saturated fatty acids, increase serum LDL-C.
However, these studies do not conclusively show whether, on a gram-for-
gram basis, the rise in LDL-C from trans fatty acids is as great as the
rise that results from saturated fatty acids.
    b. Observational (epidemiologic) studies. The observational studies
included in FDA's review in this proposed rule used two approximations
of trans fatty acids intake (adipose tissue concentrations and dietary
data) to examine associations between trans fatty acids intake and CHD
risk. Details of the observational studies are provided in Table 2 of
Appendix A of this document.
    One case-control study of 1,388 men in 9 countries (the ``EURAMIC
Study'') found no association between trans fatty acid concentrations
in adipose tissue and the risk of acute myocardial infarction (MI)
(Ref. 16). A second case-control study of 250 men in the United Kingdom
found that the mean concentration of trans fatty acids in adipose
tissue was lower in cases of sudden cardiac death (2.68 percent of
total fatty acids) than in healthy controls (2.86 percent of total
fatty acids) and that multivariate odds ratios for trans fatty acids
were not independently related to the risk of sudden cardiac death
(Ref. 17). Although trans fatty acid concentrations in adipose tissue
have been reported to reflect dietary intake, for example, London et
al. (Ref. 37), the relationship of differences in adipose tissue
concentrations of fatty acids to CHD risk remains uncertain.
    Other observational studies have reported positive associations
between estimated dietary intakes of trans fatty acids and incidence of
CHD manifested as risk of MI or acute MI (Refs. 16 and 18), risk of
nonfatal MI (Refs. 19, 38, 20, and 21), risk of mortality from CHD
(Refs. 17, 19, 20, 21, and 22), or increased risk of CHD predicted by
higher levels of serum total cholesterol and LDL-C (Refs. 18, 22, 23,
and 38). In a Massachusetts case-control study of the risk of MI in 239
men and women diagnosed with a first MI and in an age- and sex-matched
control group (n=282), relative risk of MI was 2.03 in the highest
quintile of trans fatty acids intake (about 6.7 g/day) compared to the
lowest quintile of intake (about 3.0 g/day) (Ref. 18). These estimates
took into account adjustments for standard risk factors for CHD as well
as intakes of saturated fat, monounsaturated fat, linoleic acid, and
cholesterol.
    Trans fatty acids intake showed a statistical association with
serum LDL-C (r = 0.09) in a multiple linear regression analysis in 748
men in the Normative Aging Study, conducted between 1987 and 1990 (Ref.
23). The mean trans fatty acids intake was determined to be 1.6 percent
of energy
 
[[Page 62752]]
 
intake and did not differ between groups who did or did not have high
serum total cholesterol concentrations 3 to 5 years earlier.
Associations between trans fatty acids intake and serum LDL-C were
stronger in the group who previously had high serum total cholesterol
concentrations.
    In an univariate intercohort analysis of 16 cohorts of men in the
Seven Countries Study, Kromhout et al. (Ref. 22) reported that mean
intakes of trans fatty acids of cohorts ranging from 0.05 percent to
1.84 percent of energy were associated with serum total cholesterol (r
= 0.70) and with 25-year mortality rates from CHD (r = 0.78). In this
study, estimated intakes of trans fatty acids were based on composites
of foods retrospectively collected and analyzed in 1987 to approximate
average food intakes of each cohort reported during the baseline period
1958-1964. Independent effects of individual fatty acids and dietary
cholesterol on serum total cholesterol and CHD mortality could not be
analyzed in multivariate models because mean intakes of individual
saturated fatty acids, trans fatty acids, and dietary cholesterol were
highly correlated among the cohorts.
    One prospective cohort study in Finland (Ref. 20) and three in the
United States (Refs. 19, 21, and 38) have reported higher CHD risk in
population quintiles with the highest intakes of trans fatty acids
compared to the quintiles with the lowest trans fatty acid intakes. In
21,930 male smokers, who were participants in the Finnish Alpha-
Tocopherol, Beta-Carotene Cancer Prevention Study, higher trans fatty
acid intakes were associated with higher risk of major coronary event
and risk of CHD death. Relative risk (RR) of a major coronary event was
1.19 in the highest intake quintile (median intake 5.6 g/day) compared
to the lowest quintile (median intake 1.3 g/day) when the estimate was
adjusted for age and supplement group. An RR of an event associated
with trans fatty acid ingestion that is greater than 1 would be a risk
that is more likely to be associated with ingestion of trans fatty
acids. Additional adjustment for cardiovascular risk factors reduced
the RR to 1.14. With adjustments for age and supplement group, the RR
of CHD death was 1.38 in the highest intake quintile compared to the
lowest quintile. The association was also significant (RR = 1.39) after
adjustment for cardiovascular risk factors and dietary fiber. The
multivariate RR of coronary death for intakes of trans isomers from
hydrogenated vegetable fats was 1.23 (Ref. 20).
    In a cohort of 43,757 male health professionals followed for 6
years, median intakes of trans fatty acids were 1.5 g/day and 4.3 g/day
for the lowest and highest quintiles. Between these intake quintiles,
the RR of total MI (chi square for trend) was 1.27 after adjustment for
age, cardiovascular risk factors, and dietary fiber intake. The RR of
fatal CHD was similar to that for total MI (Ref. 19). In a cohort of
69,181 female nurses who reported that they had not changed their
margarine consumption over a 10-year period, the RR of CHD (nonfatal MI
or death from CHD) in relation to energy-adjusted trans fatty acids
intake was 1.67 for the highest intake quintile (mean intake 5.7 g/day)
compared to the lowest intake quintile (mean intake 2.4 g/day) after 8
years of followup (Ref. 21). Because intake of trans fatty acids was
strongly associated with intake of MUFA and linoleic acid, the RR value
reported here includes adjustments for dietary lipids. After 14 years
of followup in this study, the RR of CHD in relation to energy-adjusted
trans fat intake was 1.53 (Ref. 38).
    These epidemiologic investigations of associations between dietary
trans fatty acids and risk of CHD must be interpreted with caution
because of the imprecision associated with the dietary collection
methodologies used, the difficulty of eliminating confounding factors,
and because no dose-response relationship has been demonstrated in the
epidemiologic studies. However, despite these generally recognized
deficiencies in the observational studies, the repeated and consistent
findings from the observational studies suggest that consumption of
trans fatty acids is associated with adverse effects on CHD risk in
humans, which supports the findings from intervention studies.
    c. Estimates of dietary intake of trans fatty acids in the U.S.
population. Estimates of mean consumption of dietary trans fatty acids
in the United States range from about 3 g/day to about 13 g/day. Values
have been estimated from national food disappearance data (Refs. 24,
25, and 39), from dietary intakes reported in a national food
consumption survey (Ref. 26), and from food frequency data collected in
observational studies of trans fatty acids intakes and risk of CHD
(Refs. 18, 19, 21, and 23).
    Based on national food disappearance data, estimated mean values
for the daily per capita consumption of total trans fatty acids were
variable: 12.8 g/day (Ref. 24), 10.2 g/day (Ref. 39), and 8.1 g/day
(Ref. 25). Values estimated from food disappearance data tend to be
high because the data are collected before subtraction of losses that
occur during processing, marketing, cooking, and plate waste. However,
each of these three estimates did apply corrections for these types of
losses to varying degrees.
    One estimate of mean intake of trans fatty acids in the U.S.
population has been made based on dietary intake data reported by a
nationally representative sample of individuals in the 1989 through
1991 Continuing Survey of Food Intakes of Individuals (CSFII) (Ref.
26). For this estimate, a food composition database with more extensive
data on the trans fatty acids contents of foods than those used for
many previous estimates was developed incorporating data released by
USDA in 1995. The estimated mean intake of trans fatty acids derived by
this approach was 5.3 g/day (2.6 percent of calories) and the 90th
percentile intake was 9.4 g/day for individuals 3 years of age and
older in the U.S. population. In comparison, the total saturated fatty
acid intake was 25.0 g/day and the 90th percentile intake was 40.6 g/
day for this population.
    The previous estimates are somewhat higher than estimates made from
observational studies of trans fatty acids intake and risk of CHD in
the United States (Ref. 18, 19, 21, and 23). Estimates of mean trans
fatty acids intake based on food frequency data were 4.4 g/day for men
and 3.6 g/day for women in one observational study in the United States
(Ref. 18) and 3.4 g/day for men in another (Ref. 23). These estimates
included groups of participants who had MI or previous detection of
elevated serum cholesterol levels and subjects without those
characteristics. Some studies presented mean or median intakes for
quintiles of the population studied. Median intakes were 3.1 g/day for
men and 3.0 g/day for women in the lowest intake quintile and 6.7 g/day
for men and 6.8 g/day for women in the highest quintile (Ref. 18).
Another study reported intakes of 1.5 g/day and 5.3 g/day,
respectively, for the lowest and highest quintiles of male health
professionals (Ref. 19). For female nurses in the United States, mean
energy-adjusted intakes of trans fatty acids were 2.4 and 5.7 g/day,
respectively, for the lowest and highest quintiles of trans fatty acids
intake (Ref. 21). Because data on trans fatty acids contents of food in
food composition data bases were considered less than adequate for most
foods except fats and oils at the times these estimates were made (Ref.
28) and because some commonly consumed foods such as cookies, crackers,
and some salad dressings contain substantial amounts of trans fatty
acids (Refs. 29 and 30), the
 
[[Page 62753]]
 
food composition data component of these estimates may not have
included trans fatty acids content of all foods consumed. In addition,
these estimates, as well as all estimates of intakes based on food
frequency data (Ref. 27), may be subject to systematic bias toward
either over- or underestimation of quantities consumed, depending on
the design of the food frequency questionnaire.
    Overall, these estimates of mean trans fatty acids intakes are
similar to amounts of trans fatty acids provided in intervention
studies in the United States in which trans fatty acids contents were
determined by chemical analysis of duplicate portions of the diets and
in which statistically significant increases in serum LDL-C were
reported compared to diets containing cis-PUFA (Refs. 13, 34, and 82)
or cis-MUFA (Ref. 12). The intakes of trans fatty acids in these
intervention studies were 9 and 13 g/day (Ref. 34), 9.7 and 12.9 g/day
(Ref. 82), 12.5 g/day (Ref. 13), and as low as 7.6 g/day (Ref. 12).
Levels in these intervention studies are very similar to the estimated
intakes of the many individuals in the United States whose trans fatty
acids consumption is in the upper half of the intake distribution
(i.e., greater than the mean of 5.3 g/day) derived from food
consumption reported by a nationally representative sample of
individuals.
    d. Summary. Controlled intervention (feeding) studies in different
population groups in the United States and other countries consistently
indicate that consumption of diets containing trans fatty acids results
in elevations of serum LDL-C (the major dietary risk factor for CHD)
compared with consumption of diets containing cis-monounsaturated or
polyunsaturated fat sources. Although these studies are too short in
duration to provide direct evidence on the incidence of CHD, they
provide evidence for an effect of dietary trans fatty acids on LDL-C, a
biomarker and major risk factor for CHD. In addition, positive
statistical associations are consistently reported in observational
studies between estimated dietary intake of trans fatty acids in free-
living populations and incidence of CHD manifested as first acute MI,
mortality from CHD, or increased risk of CHD predicted by higher levels
of serum total cholesterol and LDL-C.
    The available studies do not provide a definitive answer to the
question of whether trans fatty acids have an effect on LDL-C and CHD
risk equivalent to saturated fats on a gram-for-gram basis. They also
do not provide information about mechanisms responsible for the
observed increases in LDL-C. However, the repeated and consistent
findings under a variety of conditions that consumption of trans fatty
acids (1) results in increases in serum LDL-C when dietary saturated
fatty acids are not increased in intervention studies, and (2) is
associated in observational studies with increased risk of CHD are
strong evidence of a relationship between consumption of higher levels
of trans fatty acids and increased risk of CHD.
     Estimates of mean dietary intake of trans fatty acids by the U.S.
population are similar to the levels of trans fatty acids consumed in
three intervention trials in the United States in which serum LDL-C was
adversely affected and in which dietary content of trans fatty acids
was determined by chemical analysis (9 and 13 g/day, 12.5 g/day, and as
low as 7.6 g/day) (Refs. 34, 12, and 13). In addition, statistically
significant associations between trans fatty acids intakes and
increases in serum LDL-C concentrations among free-living populations
were seen in observational studies with intakes of 5.7 and 6.7 g/day
(Refs. 18 and 21).
 
C. International Recommendations and Regulatory Initiatives
 
    Several national and international government bodies have recently
made recommendations or taken regulatory initiatives on trans fatty
acids. Internationally, a joint Food and Agriculture Organization/World
Health Organization (FAO/WHO) consultation recently addressed trans
fatty acids. In 1993, they recommended (Ref. 31):
    Governments should limit claims concerning the saturated fatty
acid content of foods which contain appreciable amounts of trans
fatty acids and should not allow foods that are high in trans fatty
acids to be labeled as being low in saturated fatty acids.
    The Department of Health, United Kingdom (UK) wrote in 1994 (Ref.
32):
    We recommend that, on average, trans fatty acids should provide
no more than the current average of about 2% of dietary energy and
that consideration should be given to ways of decreasing the amount
present in the diet.
At this level of intake, a 2,000 calorie diet would provide a daily
intake of 4.4 g of trans fatty acids.
    In 1996, the government of Canada proposed that certain definitions
for nutrient content claims be revised to take into account the trans
fatty acid composition of foods for which claims were made (Ref. 33).
In 1998, Canada presented its proposed revisions to the criteria for
nutrient content claims (Ref. 41).
    Canada proposed to revise the definition of ``saturated fat free''
to less than 0.2 g saturated fatty acids and less than 0.2 g trans
fatty acids per reference amount and per labeled serving and the
definition of ``low saturated fat'' to not more than 2 g saturated and
trans fatty acids combined per reference amount and per labeled serving
and per 50 g if the reference amount is 30 g or 30 milliliters or less,
and not more than 15 percent of energy from saturated and trans fatty
acids combined per reference amount and per labeled serving.
    For the claim ``reduced saturated fat,'' Canada proposed that the
product contain at least 25 percent less saturated fatty acids and,
where present, at least 25 percent less trans fatty acids per reference
amount (unless the trans fatty acid content is less than 0.2 g per
reference amount and per labeled serving) than the reference food and
the reference food must not meet the compositional criteria for ``low
in saturated fatty acids.''
    Canada proposed to define ``trans fatty acids free'' as less than
0.2 g trans fatty acids per reference amount and per labeled serving
and the food must meet the compositional criteria for ``low in
saturates.'' For ``reduced trans fatty acids,'' Canada proposed that
the product contain at least 25 percent and at least 1 g less trans
fatty acids per reference amount than the reference food and the
content of saturated fatty acids must not be increased in comparison to
the reference food.
 
D. Conclusions
 
    Reports from the Federal Government and the NAS in the late 1980's
concluded that trans fatty acids did not appear to have deleterious
health effects. However, the 1995 Dietary Guidelines for Americans
recognized that trans fatty acids may raise blood cholesterol levels
although not as much as saturated fat (Ref. 6). In addition, the NCEP
publication entitled ``Second Report of the Expert Panel on Detection,
Evaluation and Treatment of High Blood Cholestorol in Adults'' stated
that recent research indicates that trans fatty acids raise serum LDL-C
levels (the major dietary risk factor for CHD) nearly as much as
cholesterol-raising saturated fatty acids (Ref. 5).
    Based on an independent evaluation of studies cited in the
petitioner's submission, as well as recent studies in humans identified
by a supplemental literature search, the agency concludes that
controlled intervention studies in different population groups in the
United States and other countries consistently indicate that
consumption of diets containing trans fatty acids, like diets
containing saturated fats, results in increased serum LDL-C compared
with consumption of diets containing cis-
 
[[Page 62754]]
 
monounsaturated or cis-polyunsaturated fat sources. These findings are
consonant with findings from observational studies among free-living
persons in the United States and other countries.
    The magnitude of the effect of trans fatty acids on serum LDL-C
compared to the increase resulting from consumption of diets containing
saturated fat is not known; its estimation is complicated by the
different dietary conditions among studies. Estimates of mean dietary
intake of trans fatty acids by the U.S. population are similar to the
levels of trans fatty acids consumed in four intervention trials in the
United States in which serum LDL-C was adversely affected and in which
trans fatty acid contents of the diets were determined by chemical
analysis (9 and 13 g/day, 9.7 and 12.9 g/day, 12.5 g/day, and as low as
7.6 g/day) (Refs. 12, 13, 34, and 82). Statistically significant
associations between trans fatty acids intakes and increases in serum
LDL-C concentrations among free-living populations were observed with
intakes of 5.7 and 6.7 g/day (Refs. 19 and 21).
    Estimates of dietary intake of trans fatty acids of the U.S.
population by the various approaches described previously and the
estimated levels of trans fatty acids consumed in intervention trials
in which serum LDL-C was adversely affected are similar. Therefore, FDA
concludes that under conditions of use in the United States,
consumption of trans fatty acids contributes to increased serum LDL-C
levels, which increases the risk of CHD. This conclusion is consonant
with recent reports of other government and scientific bodies discussed
previously. Moreover, the similar impact on LDL-C evidenced for trans
fatty acids, as is known for saturated fatty acids, warrants serious
attention from a public health perspective. Thus, the agency finds that
addressing trans fatty acids in nutrition labeling and claims is
important to public health.
 
V. Proposed Regulations
 
A. Nutrition Labeling
 
 1. Inclusion of Trans Fatty Acids in Nutrition Labeling
    FDA received approximately 1,000 letters in response to the
petition. Many of the letters were form letters from consumers in
support of the petition. One comment from the tropical oil industry
supported the disclosure of trans fatty acid content information but
recommended that trans fatty acids be declared as a separate line item
in the nutrition label. FDA also received letters from trade
associations representing the edible fats and oil industries, food
manufacturers, and nutrition and public health associations. These
letters generally disagreed with the petition and opposed modification
of existing food regulations to include consideration of trans fatty
acids. These comments, dating back to 1994, reported that data were
inadequate to assess the overall impact of trans fatty acids on health,
especially at the levels consumed.
    Section 403(q) of the act, which was added by the 1990 amendments,
states that a food shall be deemed to be misbranded if, with certain
exceptions, it fails to bear nutrition labeling. Congress enacted this
statute in recognition of the important role diet plays in the
maintenance of good health. Congress acted shortly after the
publication of two reports (Refs. 2 and 4) that concluded that
scientific evidence substantiated an association between dietary
factors and rates of chronic disease. Without specific nutrition
information on the labels, however, consumers were unable to determine
how individual foods fit into dietary regimens that adhered to the
dietary guidance in the reports. Accordingly, the 1990 amendments
mandated nutrition labeling on most foods to provide consumers with
information about specified nutrients that would help them choose more
healthful diets, as well as to create an incentive to food companies to
improve the nutritional qualities of their products.
    With an appreciation of the evolving nature of nutritional science,
Congress added section 403(q)(2) to the act that provides for nutrients
to be added or deleted from the list of required nutrients in nutrition
labeling if the Secretary (and, by delegation, FDA) finds such action
necessary to assist consumers in maintaining healthy dietary practices.
    When FDA issued the current nutrition labeling regulations on
January 6, 1993, it required saturated fat to be listed. Current
regulations also require monounsaturated fatty acids and
polyunsaturated fatty acids to be listed when claims are made about
fatty acids or cholesterol. Their listing is voluntary at all other
times. For nutrition labeling purposes, monounsaturated and
polyunsaturated fatty acids are defined as the cis isomers, i.e., cis-
monounsaturated and cis, cis- methylene-interrupted polyunsaturated
fatty acids (Sec. 101.9(c)(2)(ii) and (c)(2)(iii)).
    The listing of saturated fat is important information for consumers
who are attempting to make dietary selections because of the positive
relationship between saturated fat intake and increased serum LDL-C
levels. Based on its review of the available scientific literature (see
section IV.B of this document), FDA concludes that the scientific
evidence consistently shows that consumption of trans fatty acids also
contributes to increased serum LDL-C levels. Under current regulations
for the Nutrition Facts panel, trans fatty acids are included in the
declaration of total fat but are not included in the declaration of
types of fatty acids (i.e., saturated, monounsaturated, and
polyunsaturated fatty acids). Therefore, their presence in a food can
only be estimated by subtraction, i.e., by subtracting the sum of
saturated, monounsaturated, and polyunsaturated fatty acids from the
value declared for total fat. This calculation can only be made when
monounsaturated and polyunsaturated fatty acids are listed and is too
cumbersome for most consumers to be expected to accomplish. Therefore,
the food label is not helpful, and may be misleading, to consumers
seeking to purchase and consume foods that do not contain cholesterol-
raising fats because information on trans fatty acids is not readily
available. Accordingly, the agency is persuaded that it would be
beneficial for food labels to include trans fatty acid content in
providing nutrition information so that consumers will not be misled
about the possible impact of a product on the risk of CHD.
Consequently, in accordance with section 403(q)(2)(A) of the act, FDA
is proposing that information on trans fatty acids be added to the
nutrition label to assist consumers in maintaining healthy dietary
practices.
    Four approaches for declaring trans fatty acids are included in the
petition, its amendment, and comments. These are: (1) Include trans
fatty acids with saturated fat and call the total value ``saturated
fat;'' (2) include trans fatty acids with saturated fat, call the total
value ``saturated fat,'' and add an asterisk after the term ``saturated
fat'' when the food contains trans fatty acids that refers to a
footnote stating ``Contains ______ g trans fat;'' (3) include trans
fatty acids with saturated fat and call the total value ``saturated +
trans fat;'' and (4) list trans fatty acids separately under saturated
fat. In addition, the agency considered a fifth approach that combines
two of these four approaches.
    The agency considers the options that would combine saturated fatty
acids and trans fatty acids into one numeric value to be the most
useful way of preventing
 
[[Page 62755]]
 
consumers from being misled about the possible impact of a food
containing trans fatty acids on the risk of CHD. More specifically, the
agency considers the option that would identify the combined amount as
``Saturated fat*'' with the asterisk referring to a footnote indicating
the quantity of trans fat included in that amount to be the most
helpful and least confusing approach for declaring trans fatty acids.
     FDA does not prefer the petitioner's original approach of
including trans fatty acids in the definition of saturated fat in
Sec. 101.9(c)(2)(i). This method would not inform consumers that the
declared value included trans fatty acids or provide them with
information on the trans fatty acid content of the food. In addition,
amending the regulatory definition of saturated fat would be
scientifically inaccurate because trans fatty acids are not saturated,
i.e., they contain double bonds. Current regulations define saturated
fatty acids as ``the sum of all fatty acids containing no double
bonds.'' The proposed approach would maintain this chemical definition.
    Also, one of the principles used by the agency in establishing
nutrient content claims is that the nutrient must be declared in the
nutrition label so that the claim is verifiable by reference to the
nutrition label. Accordingly, establishing a definition for ``trans fat
free'' would be precluded if the trans fatty acid content of the
product were not mentioned in the nutrition label.
    FDA is also not proposing the petitioner's third amended approach
of listing ``saturated + trans fat'' in one line of the nutrition label
because listing ``saturated + trans fat'' with one value representing
their combined weights does not enable consumers to know the content of
either. Furthermore, this approach would increase the economic burden
on industry by requiring label changes for all foods, even those that
do not contain trans fat.
    The agency also considered the approach of listing trans fatty
acids as a separate line item under saturated fat. This approach would
prevent consumers from misclassifying trans fatty acids as saturated
fats, when, in fact, they are chemically mono- and polyunsaturated
fatty acids. However, a great many consumers (almost 90 percent of
consumers in a 1995 survey (Ref. 81)) do not understand that trans
fatty acids raise serum LDL-C levels. Therefore, listing trans fats on
a separate line would not be helpful in assisting them to maintain
healthy dietary practice. Indeed, this approach has the potential of
confusing consumers by undermining the messages in the Dietary
Guidelines for Americans (Ref. 6) and NCEP (Ref. 5) that have focused
on saturated fat. FDA does not want to distract consumers from years of
consumer education messages about saturated fat, especially because the
average intake of saturated fat exceeds the average intake of trans fat
by about fivefold (approximately 25 g versus 5 g/day, respectively)
(Ref. 26). Thus, FDA tentatively concludes that it is preferable for
the two types of cholesterol-raising fats to be labeled in a manner
that emphasizes saturated fats. In this way, consumers will be able to
utilize their knowledge of saturated fat in making food selections.
However, FDA requests comments on this tentative conclusion and whether
it would be preferable to make trans fats a mandatory separate line,
when present, because the magnitude of change in LDL-C may differ
between the two types of fats.
    Finally, the agency considered the two remaining approaches to not
have the weaknesses of the three approaches discussed previously in
this section. One of these approaches combines two options suggested by
the petitioner, i.e., using the name ``Saturated + Trans Fat'' and
using an explanatory footnote stating the individual amounts of
saturated fat and trans fat in the product. The amount of grams
declared and the %DV would continue to be based on the combined value.
This approach would give saturated fat and trans fat equal prominence
and would further ensure that consumers are aware of the inclusion of
trans fats in the amounts declared. It also may not confuse consumers
into believing that trans fats are the same as saturated fats. FDA is
concerned, however, that this approach could confuse consumers who do
not yet know what trans fatty acids are or know about their impact on
health and, therefore, could diminish the usefulness of the nutrition
label and reduce health benefits. In addition, it could lead to
increased costs for firms with products that do not contain trans fatty
acids if such products' labels were required to indicate that they
contained no trans fat. FDA requests comment on this possible approach,
including whether FDA's concerns about potential consumer confusion are
warranted and, if so, whether a consumer education program could
address potential consumer confusion.
    The other of these approaches is the petitioner's amended approach
of declaring the total value of saturated fat and trans fatty acids
following the term ``Saturated fat*'' with an explanatory footnote
stating the amount of trans fatty acids included in the total value.
This approach is beneficial because consumers are unlikely to be
confused about the cholesterol-raising potential of the food, because
the value declared for saturated fats will include trans fatty acids,
and consumers will also have access to information on the actual amount
of trans fatty acids present in a serving of the food. As stated
previously, this approach also builds on the extensive work done by
public health programs, most notably the NCEP. However, this approach
may confuse consumers and lead some to misclassify trans fatty acids as
saturated fats. FDA requests comments on whether this approach provides
consumers with clear information on the presence of and distinction
between trans and saturated fats. In balance, the agency tentatively
concludes that this approach would be the more effective way of
informing consumers of the trans fatty acid content of foods.
    For the reasons discussed above, FDA is proposing to amend
Sec. 101.9(c)(2)(i) to require that the statement of the saturated fat
content of the food declare the number of grams of saturated and trans
fatty acids combined per serving. For ease of administration, the
agency is subdividing current Sec. 101.9(c)(2)(i), with
Sec. 101.9(c)(2)(i)(A) directed at format and rounding requirements and
Sec. 101.9(c)(2)(i)(B) directed at the use of the asterisk and footnote
when trans fatty acids are, or are not, present. In
Sec. 101.9(c)(2)(i)(B), the agency is proposing that the footnote state
``Includes ______ g trans fat'' with the option of using the term
``trans fatty acids'' instead of ``trans fat'' (see sample label in
Fig. 1). The petitioner had suggested the word ``contains'' rather than
``includes;'' however, the agency is concerned that the word
``contains'' may not convey the idea that the amount specified in the
footnote is included in the numerical value declared. The word
``includes'' is more specific, although either word would be acceptable
when the product does not contain trans fats, that is, contains less
than 0.5 g of trans fats per reference amount.
    In recognition of the economic impact of changing food labels to
incorporate trans fatty acid information, however, FDA does not believe
there is a need to change labels of products that do not contain trans
fatty acids and that do not make claims about fatty acids or
cholesterol. Consequently, FDA is proposing in Sec. 101.9(c)(2)(i)(B)
to allow manufacturers to use the footnote ``Includes (or contains) 0 g
trans fat'' or ``Contains no trans fat'' on these labels on a voluntary
basis. This footnote would not be required when there is no
 
[[Page 62756]]
 
trans fat in the food unless fatty acid or cholesterol claims are made.
    To maintain consistency in the nutrition labeling of conventional
foods and of dietary supplements, the agency is also proposing to amend
Sec. 101.36(b)(2)(i) and (b)(2)(iii) (21 CFR 101.36(b)(2)(i) and
(b)(2)(iii)) to specify that, when present, trans fatty acids are to be
incorporated in the nutrition labeling of dietary supplements in the
same manner as for conventional foods.
 
BILLING CODE 4160-01-F
[GRAPHIC] [TIFF OMITTED] TP17NO99.000
 
 
BILLING CODE 4160-01-C
2. Daily Value
    Adding the number of grams of trans fatty acids to the value
declared for saturated fat raises the question of how to calculate the
%DV for saturated fat.
    FDA tentatively concludes that the current regulations that
consider only saturated fat when calculating the %DV do not help
maintain healthy dietary practices, a goal set forth in the 1990
amendments, because trans fatty acids, which FDA has concluded also
increase LDL-C, are not considered. If trans fatty acids are not
considered, consumers who make food choices on the basis of saturated
fat content with the intention of reducing their risk of CHD may be
misled by the declared %DV.
    For the past 20 years, a wide variety of consensus reports have
recommended that Americans consume no more than 30 percent of calories
from fat (Refs. 5, 6, 54, and 55). Many of these reports go on to
recommend that saturated fat account for less than 10 percent of
calories with monounsaturated and polyunsaturated fatty acids
furnishing the remaining calories from fat (Refs. 5 and 56). The Daily
Value for saturated fat was calculated on the basis of these
recommendations (58 FR 2206 at 2219, January 6, 1993).
    Trans fatty acids have not been considered in these dietary
recommendations because their intakes were relatively low at the time
these recommendations were made and their link to increased risk of CHD
has been relatively recent. At this time, the public health and
scientific associations that are the source of these recommendations
have not indicated what impact the recent research on trans fats might
have on the recommendations. However, the agency does not believe that
it should increase the percentage of total calories from fat (i.e.,
from 30 percent or less to some higher value) when adding trans fat to
the Daily Value. Therefore, FDA finds it necessary to consider the
placement of trans fatty acids within the three categories of fatty
acids that are addressed in the recommendations (i.e., saturated fatty
acids, monounsaturated fatty acids, or polyunsaturated fatty acids) to
ensure that consumers are not misled by label statements.
    Dietary recommendations to limit saturated fat to less than 10
percent of calories were an attempt to limit the amount of fats known
to have adverse effects on blood lipids. Evidence has accumulated that
trans fatty acids have physiologic effects similar to saturated fats
and trans fatty acids in foods are used functionally to replace
saturated fat. The agency, therefore, tentatively concludes that it is
reasonable to include trans fatty acids in the %DV for saturated fat.
Doing so, however, would
 
[[Page 62757]]
 
have the effect of lowering the DV for saturated fat on labels of food
products containing both saturated and trans fats since the DV (20g)
would relate to the combined amounts of each. FDA will consider
amending its approach if the public health and scientific organizations
that are the source of current dietary recommendations arrive at
different conclusions. Including trans fats in calculations of the %DV
listed for saturated fat is also the logical outcome of having the
quantitative amounts of these two types of fatty acids declared
together in the nutrition label. Calculating the %DV on the basis of a
quantitative value other than the one declared could be confusing to
consumers. Comments are requested on this approach. In addition,
comments are requested on whether there is a basis for developing a DV
for trans fats if comments were to convince the agency to require a
separate line for trans fat, and how a DV for trans fat should affect
the DV's for total fat and saturated fat. Inasmuch as no authoritative
bodies have recommended values that could be used as a basis for
developing a DV for trans fat, would it be sufficient to list the
quantitative amount of trans fat, with no %DV, as now occurs with
listings of mono- and polyunsaturated fats? It should be noted that,
without a DV for trans fat, consumers would not be able to put the
quantitative amount in the context of a daily diet, and so would not be
able to judge the magnitude of the amount present in relation to usual
or recommended intake levels.
    Based on these tentative conclusions, FDA is proposing to include
trans fats in calculations of the %DV listed for saturated fat.
Accordingly, FDA is proposing to amend Sec. 101.9(d)(7)(ii) by adding
the sentence ``When trans fatty acids are present in a food, the
percent for saturated fat shall be calculated by dividing the amount
declared on the label for saturated fat, which includes trans fatty
acids, by the DRV for saturated fat.''
3. Other Issues
    a. Definition. In revising Sec. 101.9(c)(2)(i) to require the
inclusion of trans fatty acid content in the declared amount of
saturated fat, FDA is proposing to define trans fatty acids as
``unsaturated fatty acids that contain one or more isolated (i.e.,
nonconjugated) double bonds in a trans configuration.'' This proposed
definition is consistent with the way that cis isomers of
polyunsaturated fatty acids are defined in Sec. 101.9(c)(2)(ii) and
(c)(2)(iii).
    b. Methodology. Infrared spectroscopy (IR) and capillary gas
chromatography (GC) are the methods used for the determination of trans
fatty acids. IR is the classical method used for the determination of
total trans fatty acids with isolated trans double bonds, while GC
methods are used for determination of fatty acid composition. The
Official Methods of the Association of Official Analytical Chemists
(AOAC) and Official Methods and Recommended Practices of the American
Oil Chemists Society (AOCS) that are applicable to the determination of
trans fatty acids are described in Appendix B of this document (Refs.
42 through 50). The official method number, title, definition, scope
and applicability of each method, taken directly from the published
method, are included. Specific comments by FDA chemists knowledgeable
in application of these methods are also included.
    Currently, the method of choice for IR determinations is AOCS
Recommended Practice Cd 14d-96 (number 4 in Appendix B) (Ref. 45) and
for GC determinations is AOCS Official Method Ce 1f-96 (number 5 in
Appendix B) (Ref. 46). IR methodology can be used to determine trans
isomers in oils, margarines, shortenings, and other partially
hydrogenated fats and oils with a limit of quantitation of about 1
percent trans as percent of total fat. When trans fat levels are less
than 1 percent of total fat, they can be accurately determined by GC.
GC methods provide more sensitivity but require more time. None of the
IR or GC methods have been collaboratively studied for foods other than
fats and oils. It is likely that the lower limits of quantitation for
these methods will be higher for complex matrices, such as processed
multi-ingredient foods, than for oils and other fats.
    Trans fatty acid values reported in the nutrition label should
utilize compliance procedures in Sec. 101.9(g) that take normal
variability due to production processes into account.
    c. Increments. With respect to how to declare the content of trans
fatty acids in the footnote ``Includes ______ g trans fat,'' FDA
believes that the methodology discussed previously supports declaring
the amount per serving in the same increments specified in
Sec. 101.9(c)(2) for total fat, saturated fat, polyunsaturated fat, and
monounsaturated fat, i.e., to the nearest 0.5 (1/2) g increment below 5
g and to the nearest gram increment above 5 g. If the serving contains
less than 0.5 g, the content shall be expressed as zero g (i.e., ``0''
g) in the footnote, if the footnote is used.
    d. Type size. FDA also is removing the phrase ``in the same type
size'' in Sec. 101.9(c)(2)(i) where it refers to the size of the
statement ``Not a significant source of saturated fat.'' In the
technical amendments of August 18, 1993 (58 FR 44063 at 44066), the
agency did not include footnotes in the types of information that must
use 8 point type under Sec. 101.9(d)(1)(iii). Therefore, under
Sec. 101.9(d)(1)(iii), 6 point type is sufficient for this statement
and the proposed statement ``Includes ______ g trans fat.''
 
B. Nutrient Content Claims
 
    A number of comments agreed with the petitioner's request that the
saturated fat criteria for nutrient content claims should be amended to
refer to the level of saturated and trans fat combined. Other comments
disagreed. One comment suggested that consumer research be initiated to
evaluate consumer understanding about trans fatty acids before such
changes are considered. Another comment stated that the key question of
whether trans fatty acids have an independent cholesterol-raising
effect must be answered before the agency considers changes in food
labeling for trans fatty acids.
    As mentioned, the agency already has recognized that trans fatty
acids should be considered with respect to the claim ``saturated fat
free.'' In the nutrition labeling final rule implementing the 1990
amendments, the agency stated that because:
    [c]onsumers would expect a food bearing a ``saturated fat free
claim'' to be free of saturated fat and other components that
significantly raise serum cholesterol, and [because of] the
potential importance of a saturated fat free claim, the agency
believes that it would be misleading for products that contain
measurable amounts of trans fatty acids to bear a ``saturated fat
free'' claim.
(58 FR 2302 at 2332)
    Consequently, the agency set a separate criterion for trans fat
(i.e., less than 0.5 g) in addition to the criterion for saturated fat
(i.e., less than 0.5 g) for the definition of ``saturated fat free.''
The agency did not set a trans fat criterion for ``low saturated fat''
or for ``reduced saturated fat'' claims in the nutrient content claims
final rule. FDA stated that, because the evidence suggesting that trans
fatty acids raise serum cholesterol was inconclusive, the agency could
not conclude that other nutrient content claims for saturated fat and
cholesterol would be misleading on foods containing trans fatty acids
(58 FR 2302 at 2334 and 2340).
    However, based on its recent review of the available research,
including that
 
[[Page 62758]]
 
published after 1993 and discussed in section IV.B of this document,
FDA now concludes that dietary trans fatty acids have adverse effects
on blood cholesterol measures that are predictive of CHD risk,
specifically LDL-C levels. Consequently, the agency has reconsidered
its 1993 conclusion and has evaluated the potential for saturated fat
and cholesterol claims to be misleading if, as the petitioner suggests,
these foods contain measurable amounts of trans fatty acids. This
reconsideration is done under the authority of section 403(r)(2)(A)(vi)
of the act, which prohibits a claim if the claim is misleading in light
of the level of another nutrient in the food. As noted in section IV.C
of this document, this action is consistent with that taken by other
international government bodies (Refs. 31 through 33).
    Nutrient content claims are voluntary statements that can assist
consumers in selecting foods that may lead to a healthier diet.
Consumers who select foods that have saturated fat or cholesterol
claims should be able to do so with confidence that such products can,
in fact, lead to a healthier diet. Consumer research on dietary fats
and cholesterol suggests that consumers believe that dietary choices,
including the selection of foods low in saturated fat and cholesterol,
will help maintain healthy blood cholesterol levels (Ref. 35). Because
of these expectations and the evidence that trans fatty acids raise
LDL-C, FDA tentatively concludes that it is reasonable to consider the
trans fatty acid content of products that bear these types of nutrient
content claims to prevent such claims from being misleading.
1. Saturated Fat Claims
    a. Saturated fat free claims. With respect to the claim ``saturated
fat free,'' the agency has considered the petitioner's request that the
definition be amended to be less than 0.5 g of saturated fat and trans
fat combined. The agency agrees with the petitioner that products
bearing this claim should be free of components that significantly
raise serum cholesterol. However, the agency does not agree that the
level of 0.5 g should refer to the sum of saturated fat and trans fats
combined because it is not possible to determine, for reasons of
sensitivity, if a sample contains less than 0.5 g of both saturated and
trans fat combined.
    In defining ``free'' levels of nutrients, the approach used by the
agency has been that the level of a nutrient that is defined as
``free'' should be at or near the level of detection for the nutrient
in foods and should be dietetically trivial or physiologically
inconsequential (56 FR 60478 at 60484, November 27, 1991). In the
nutrient content claims final rule, the agency established the ``free''
level of saturated fat at less than 0.5 g per serving because the
majority of the comments that addressed this issue stated that a lower
value cannot be reliably quantified (58 FR 2302 at 2332). With respect
to trans fat, the nutrient content claims final rule stated that 1
percent of total fat was the appropriate criterion for trans fat
because analytical methods for measuring trans fat below that level
were not reliable. As discussed in section I of this document, comments
objected to this criterion and, in response to these comments, the
agency changed the trans fat criterion to less than 0.5 g because this
level can be reliably determined analytically and is consistent with
the definition of ``free'' for fat and saturated fat (58 FR 44020 at
44027, August 18, 1993).
    The petitioner's suggestion that the definition of ``saturated fat
free'' be changed to less than 0.5 g of saturated and trans fat
combined is not analytically feasible because it would require accurate
measurement of both saturated fat and trans fat at levels significantly
below 0.5 g. In the absence of more sensitive methods, which the
petitioner did not provide, it is not appropriate for the agency to set
criteria that cannot be adequately analyzed. Consequently, the agency
is not proposing to change the criteria in Sec. 101.62(c)(1)(i) of less
than 0.5 g of saturated fat and less than 0.5 g of trans fat for the
``saturated fat free'' claim. The agency notes that expressing these
criteria collectively as ``less than 1.0 g of saturated fat and trans
fat combined'' is not preferable because if, for example, one of the
types of fatty acids were present at 0.7 g, it would not be possible to
determine if the combined amount were less than 1.0 g because amounts
of less than 0.3 g cannot be reliably measured. The agency is willing
to reconsider the criteria for this definition in the future if more
sensitive methodologies become practical for routine analyses.
    b. Low saturated fat claims. With respect to ``low saturated fat,''
the petitioner requested that the limit of ``1 g or less of saturated
fatty acids'' in Sec. 101.62(c)(2)(i) be amended to refer to ``1 g or
less total of saturated and trans fat combined.'' FDA agrees that the
level of trans fat should be limited in foods bearing this claim
because consumers may assume that the claim refers to all fats that
adversely affect serum LDL-C levels. However, FDA does not agree that
this claim should be based on the sum of saturated fat and trans fat
combined because, as previously discussed, it is not possible to
reliably measure amounts of either type of fat at values below 0.5 g.
Accordingly, if a food contains 0.8 g of saturated fat, there could be
uncertainty about whether or not it contained 1 g or less of saturated
and trans fat combined if the amount of trans fat were below 0.5 g.
    Consequently, the agency tentatively concludes that separate
criteria need to be established for saturated fat and for trans fat in
the definition of ``low saturated fat.'' However, decreasing the level
of saturated fat to accommodate a trans fat criterion (e.g., 0.5 g or
less of saturated fat) is not feasible because there would be too
little difference between the lowered level and the ``free'' level of
saturated fat (i.e., less than 0.5 g).
    Given this constraint, the agency tentatively concludes that the
saturated fat criterion for ``low saturated fat'' claims should remain
at 1 g or less per reference amount. Therefore, FDA proposes that the
trans fat criterion be less than 0.5 g, the proposed ``free'' level of
trans fat. This proposed action would allow foods that contain
insignificant levels of trans fats to continue to qualify for ``low
saturated fat'' claims.
    The current definition for ``low saturated fat'' includes a second
criterion that the claim not be used on foods that contain more than 15
percent of calories from saturated fat. The petitioner requested that
this criterion be amended to require that the food contain not more
than 15 percent of calories from saturated fat and trans fat combined.
    This second criterion was used to prevent misleading ``low'' claims
on nutrient-dense foods with small serving sizes (58 FR 2302 at 2339).
Since the amendments being proposed in this document would broaden the
term ``saturated fat'' on the label to include both saturated and trans
fatty acids, the agency tentatively concludes that it is reasonable to
amend this criterion to include both types of fatty acids. While it was
not feasible to combine saturated fat and trans fats in the
quantitative requirements discussed previously, it is not a problem in
this instance because the percent of calories can be calculated by
multiplying the declared amount of saturated and trans fats combined
(in grams) by the factor of 9 calories per gram, dividing by the total
caloric content of a serving of the product, and multiplying by 100.
    Accordingly, FDA is proposing to amend the definition of ``low
saturated fat'' in Sec. 101.62(c)(2)(i) to read: ``The food contains 1
g or less of saturated fat and less than 0.5 g of trans fat per
 
[[Page 62759]]
 
reference amount customarily consumed and not more than 15 percent of
calories from saturated fat and trans fat combined.'' Likewise, the
agency is proposing to revise Sec. 101.62(c)(3)(i) for meal products
and main dishes to state that ``low saturated fat claims'' may be made
on meal products and main dishes if the product contains 1 g or less of
saturated fat and less than 0.5 g of trans fat per 100 g, and less than
10 percent calories from saturated fat and trans fat combined. The
agency also proposes to change the term ``saturated fatty acids'' to
the term ``saturated fat'' in these two paragraphs for consistency with
other paragraphs of Sec. 101.62(c).
    It should be noted that the definition for the nutrient content
claim ``healthy'' includes a criterion that the food meet the
definition of ``low saturated fat'' (Sec. 101.65(d)(2)(i) (21 CFR
101.65(d)(2)(i))). It is conceivable that some products may currently
meet the criteria for this claim, yet not meet the proposed criteria
for ``low in saturated fat'' and, therefore, would no longer qualify
for the ``healthy'' claim if the agency takes the action proposed
herein. The same thing is true for health claims that require that a
food bearing the health claim meet the requirements for the claim ``low
in saturated fat'': dietary saturated fat and cholesterol and risk of
coronary heart disease (Sec. 101.75(c)(2)(ii) (21 CFR
101.75(c)(2)(ii))); fruits, vegetables, and grain products that contain
fiber, particularly soluble fiber, and risk of coronary heart disease
(Sec. 101.77(c)(2)(ii)(B) (21 CFR 101.77(c)(2)(ii)(B))); and soluble
fiber from certain foods and risk of coronary heart disease
(Sec. 101.81(c)(2)(iii)(C) ((21 CFR 101.81(c)(2)(iii)(C))).
    c. Reduced saturated fat claims. The agency has defined the term
``reduced saturated fat'' to mean that the saturated fat content of a
food has been reduced by at least 25 percent compared to a reference
food. The petition states that without a limit on the trans fat content
of foods with ``reduced saturated fat'' claims, manufacturers could
replace saturated fat with trans fat.
    The agency has studied the petition's request that the ``reduced
saturated fat'' claim be defined as ``at least 25 percent less of
saturated and trans fatty acids combined per reference amount
customarily consumed than an appropriate reference food.'' Based on its
review of the available scientific literature (see section IV.B of this
document) indicating that dietary trans fat, like saturated fat,
increases serum LDL-C levels, the agency tentatively concludes that
requiring a total reduction of at least 25 percent in saturated fat and
trans fat combined is appropriate and would prevent consumers from
being misled by claims indicating a reduction in saturated fats when
there is not a meaningful reduction in the combined value of saturated
and trans fats. The percent reduction would be calculated by
subtracting the sum of the saturated and trans fats in the labeled food
(either the combined value declared on the nutrition label or the
actual combined values before rounding (58 FR 44020 at 44024)) from the
total of saturated and trans fat in the reference food, dividing by the
total for the reference food, and multiplying by 100.
    However, the agency believes that it is also appropriate to retain
the requirement for at least a 25 percent reduction in saturated fat.
Having only a single criterion that refers to the combined amount of
saturated and trans fat would make it possible for foods with no
reduction in saturated fat, or even an increase, to use the claim
``reduced saturated fat.'' For example, a food containing 4 g of trans
fat and 2 g of saturated fat, could be modified to contain 2 g of trans
fat and 2.5 g of saturated fat. The modified food would contain a total
of 4.5 g of saturated and trans fat combined, which would mean that the
total has been reduced by 25 percent, even though the saturated content
would be increased by 25 percent. The agency tentatively concludes that
it is misleading to allow a food that is reduced in this manner to bear
the claim ``reduced saturated fat.'' Therefore, FDA is proposing that
the definition of ``reduced saturated fat'' in Sec. 101.62(c)(4)(i)
read: ``The food contains at least 25 percent less saturated fat and at
least 25 percent less saturated fat and trans fat combined per
reference amount customarily consumed than an appropriate reference
food as described in Sec. 101.13(j)(1).''
    FDA points out that accompanying information is required with
``reduced claims.'' Section 101.62(c)(4)(ii)(A) requires information on
the identity of the reference food and the percent (or fraction) that
the saturated fat differs between the two foods, e.g., ``Reduced
saturated fat. Contains 50 percent less saturated fat than the national
average for nondairy creamers.'' This information must be declared in
immediate proximity to the most prominent claim. Section
101.62(c)(4)(ii)(B) requires information on the amounts of saturated
fat in the reference food and in the food, e.g., ``Saturated fat
reduced from 3 g to 2 g per serving.'' This information generally must
be declared adjacent to the most prominent claim or to the nutrition
label. The agency is proposing no changes in these provisions.
Accordingly, as proposed, the accompanying information would refer to
the actual amount of saturated fat in the food, not to the amount
declared in the nutrition label, when that value includes trans fats.
For example, if a reference food contained 4 g of saturated fat and
this amount is reduced to 2 g in the product bearing the claim, this
would be stated as a 50 percent reduction in saturated fat from 4 g to
2 g, regardless of the amount of trans fat present. As discussed, if
this rule is finalized as proposed, foods qualifying for this claim
would also have to meet the hidden (i.e., not visible to the consumer)
criterion of at least a 25 percent reduction in saturated fat and trans
fat combined.
2. Trans Fat Claims
    Although the petitioner did not address the use of trans fat
claims, the agency's consideration of the subject petition has prompted
the agency to consider the usefulness of such claims. As discussed
previously, FDA concludes that trans fats contribute to increased serum
LDL-C levels. In light of this conclusion, FDA is considering whether
providing for the use of a ``trans fat free'' claim would assist
consumers in maintaining healthy dietary practices by allowing them to
readily identify foods free of fats known to increase the risk of CHD
or if it would confuse them by detracting from the saturated fat
message of the NCEP and other groups. The agency also is considering
whether the claim is needed to provide an incentive to the food
industry to remove trans fats from foods currently containing them. The
agency requests comments on the usefulness of such a claim in these
contexts. In particular, is allowing manufacturers to use the footnote
``Contains no trans fats'' in the nutrition label when foods are free
of trans fats sufficient to allow these foods to be identified readily
by consumers? In addition, requiring inclusion of trans fat, when
present, in the declaration of saturated fat will increase the amounts
declared. Will avoiding this increased saturated fat declaration
provide sufficient incentive to manufacturers to eliminate trans fats
whenever possible or is the ``trans fat free'' claim also needed?
    FDA is proposing a definition for ``trans fat free'' in this
document to be able to receive comments on the particulars of the
definition and, thus, to be able to proceed to a final rule if the
comments support this action. If comments do not justify the need for
this claim, the agency intends to withdraw the proposed definition.
 
[[Page 62760]]
 
    In arriving at a proposed definition, the agency reviewed its
general approach to defining ``free'' levels of a nutrient when
implementing the 1990 amendments. At that time, FDA stated that the
level of a nutrient that is defined as ``free'' should be at or near
the reliable limit of detection for the nutrient in foods (56 FR 60478
at 60484, November 27, 1991). In technical amendments to the nutrition
labeling final rules, FDA concluded that less than 0.5 g of trans fat
meets this criterion. As a result, the agency required that foods
bearing ``saturated fat free'' claims contain less than 0.5 g of trans
fat per reference amount and per labeled serving (58 FR 44020 at 44027,
August 18, 1993). Because analytical techniques for measuring trans
fats continue to preclude more precise determination, the agency
tentatively concludes that foods bearing the claim ``trans fat free''
should contain less than 0.5 g of trans fat per reference amount
customarily consumed and per labeled serving.
    Section 403(r)(2)(A)(vi) of the act states that a claim may not be
made if the claim is misleading in light of the level of another
nutrient in the food. In the case of a ``trans fat free'' claim, the
agency tentatively concludes that it would be misleading for foods
bearing the claim to contain measurable amounts of saturated fat
because consumers would expect such products to be ``free'' of
components that significantly raise serum LDL-C. Therefore, in addition
to a trans fat criterion of less than 0.5 g, the agency believes that
foods bearing a ``trans fat free'' claim should also meet the criterion
for ``saturated fat free'' of less than 0.5 g of saturated fat per
reference amount and per labeled serving (Sec. 101.62(c)(1)(i)). It
should be noted that the level of ``saturated fat'' specified in
regulations as a criterion for a ``trans fat free'' claim, or for any
other claim, refers to the analytically determined amount of saturated
fat in a food, not to the combined amounts of saturated and trans fat
declared on the label.
    Accordingly, the agency is proposing to add Sec. 101.62(c)(6) to
provide for the use of the claim ``trans fat free'' and its synonyms on
the labels of foods, meal products, and main dishes. Consistent with
other ``free'' claims, the synonyms proposed include ``free of trans
fat,'' ``no trans fat,'' ``zero trans fat,'' ``without trans fat,''
``trivial amount of trans fat,'' ``negligible source of trans fat,'' or
``dietarily insignificant source of trans fat.'' In addition, the
agency is proposing to allow for the synonymous use of the terms
``trans fat'' or ``trans fatty acids.''
    Because the proposed levels for trans fat and saturated fat in
proposed Sec. 101.62(c)(6)(i) would result in ``trans fat free'' and
``saturated fat free'' claims being synonymous, foods that meet the
criteria for the two claims would be able to use either claim or both
claims simultaneously.
    Consistent with parallel provisions for saturated fat in
Sec. 101.62(c)(1)(ii), the agency is proposing to add
Sec. 101.62(c)(6)(ii) that states that a food bearing a ``trans fat
free'' claim shall contain no ingredient that is generally understood
by consumers to contain trans fats unless the listing of the ingredient
in the ingredient statement is followed by an asterisk (or other
symbol) that refers to a statement below the list of ingredients that
states, ``adds a trivial amount of trans fat,'' or other synonymous
phrases. The agency tentatively concludes that this provision is needed
because some consumers may be confused by the listing of ingredients
such as partially hydrogenated oils, for example, on product labels
that bear a ``trans fat free'' claim.
    To ensure that ``trans fat free'' claims are not misleading by
being used on foods that would not typically contain trans fats, and
consistent with parallel provisions in Sec. 101.62(c)(1)(iii) for
saturated fat, the agency also is proposing to add
Sec. 101.62(c)(6)(iii) that states that a food bearing a ``trans fat
free'' claim shall disclose when trans fats are not usually present in
the food (e.g., ``Corn oil, a trans fat free food'').
    The agency notes that it considers statements such as ``no
hydrogenated oils'' or ``hydrogenated fat free'' to be implied claims
that a product is free of trans fatty acids because, as described in
section IV.A of this document, trans fatty acids are primarily the
result of the hydrogenation process. In accordance with
Sec. 101.65(c)(3), such statements would be permissible on a food only
if the food met the criteria for a ``trans fat free'' claim.
    The agency specifically invites comments on the proposed definition
of ``trans fat free'' and on the general usefulness of this claim.
    FDA also considered, but rejected, proposing definitions for ``low
trans fat'' and ``reduced trans fat.'' The agency has consistently
required that definitions for ``low'' claims relate to the total amount
of the nutrient recommended for daily consumption (56 FR 60439 and 58
FR 2302 at 2335). However, because consensus documents do not provide
quantitative recommendations for daily intake of trans fats, FDA
concludes that the claim ``low trans fats'' cannot be defined. In the
case of the claim ``reduced trans fats,'' the agency is concerned that
use of the claim could detract from educational messages that emphasize
saturated fatty acids. However, any person who believes that such a
claim is useful may petition the agency under Sec. 101.69 (21 CFR
101.69).
    The agency notes that proposing a definition for ``trans fat free''
in Sec. 101.62(c)(6) necessitates consideration of the application of
Sec. 101.62(c) ``Fatty acid content claims'' to trans fatty acid
claims. Current Sec. 101.62(c) requires disclosure of total fat and
cholesterol levels in proximity to saturated fat claims. Specifically,
disclosure of total fat is required unless the food contains less than
0.5 g total fat when ``saturated fat free'' claims are made or 3 g or
less total fat when ``low'' or ``reduced'' saturated fat claims are
made. Likewise, disclosure of cholesterol is required unless the food
contains less than 2 milligrams (mg) of cholesterol. These requirements
are in response to sections 201(n), 403(a), and 403(r)(2)(A)(iv) of the
act. Section 403(r)(2)(A)(iv) of the act requires disclosure of the
cholesterol content of the food in immediate proximity to claims about
the level of saturated fat. Similarly, FDA required disclosure of the
amount of total fat adjacent to saturated fat claims because research
suggested that consumers often did not differentiate between total fat
and saturated fat content and, therefore, the level of total fat was a
material fact necessary to prevent consumers from being misled about
the total fat content of the food (56 FR 60478 at 60492 and 58 FR 2302
at 2340).
    The agency believes that consumers are likely to purchase foods
with claims about trans fats for the same purpose as they would
purchase a food with claims about saturated fats, i.e., to help lower
their CHD risk. Also, the agency does not believe that consumers are
any more likely to differentiate between total fat and trans fat than
between total fat and saturated fat. In fact, they may be less likely
to differentiate because there have been no public education programs
aimed at making consumers aware of trans fats, and, consequently, fewer
consumers can be expected to recognize the name ``trans fat.''
Therefore, FDA tentatively concludes that it is reasonable to require
disclosure statements about total fat and cholesterol with both types
of fatty acid claims, and that doing so should prevent consumers from
being misled about the level of total fat and cholesterol in foods
bearing a ``trans fat free'' claim. Accordingly, the agency is
proposing to amend Sec. 101.62(c) to have it apply to trans fat claims
as well as to saturated fat claims.
 
[[Page 62761]]
 
3. Cholesterol Claims
    Under current regulations, cholesterol claims are prohibited when a
food contains more than 2 g of saturated fat per reference amount (or
per labeled serving size for meals and main dishes). The petitioner
requested that this saturated fat threshold be amended to state that
foods bearing cholesterol claims must contain ``2 g or less of
saturated and trans fatty acids combined.''
    The saturated fat threshold was introduced when implementing the
1990 amendments to prevent cholesterol claims from being misleading in
light of the amount of saturated fat present in the food (58 FR 2302 at
2333). This action was issued in accordance with section
403(r)(2)(A)(vi) of the act. As discussed in section IV.B.2 of this
document, FDA has concluded that trans fats have physiologic effects
similar to saturated fats. Because of this effect, FDA tentatively
concludes that it is appropriate for the saturated fat threshold for
cholesterol claims to be the total of saturated and trans fats
combined. At the 2 g level, the agency does not anticipate that
concerns about the sensitivity of analytical methods will preclude
calculation of the combined amount.
    Accordingly, FDA is proposing to revise Sec. 101.62(d)(1)(i)(C) and
(d)(1)(ii)(C) to state that a ``cholesterol free'' claim may be made
when the food contains 2 g or less of saturated fat and trans fat
combined per reference amount customarily consumed or, in the case of a
meal product or main dish product, 2 g or less of saturated fat and
trans fat combined per labeled serving. The proposed change in
Sec. 101.62(d)(1)(ii)(C) also corrects a technical error because this
section currently reads ``less than 2 g of saturated fat'' and it
should read ``2 g or less of saturated fat.'' Similar changes are
proposed for ``low cholesterol claims' for foods and meals and main
dishes in Sec. 101.62(d)(2)(i)(B), (d)(2)(ii)(B), (d)(2)(iii)(B),
(d)(2)(iv)(B), and (d)(3) and for ``reduced cholesterol'' claims for
foods in Sec. 101.62(d)(4)(i)(B) and (d)(4)(ii)(B) and for meals and
main dishes in Sec. 101.62(d)(5)(i)(B) and (d)(5)(ii)(B).
4. Lean and Extra Lean Claims
    As requested by the petitioner and for the reasons noted previously
for cholesterol claims, FDA is proposing to amend the definitions of
``lean'' and ``extra lean'' for foods and meal products to require that
the saturated fat criterion now refer to the level for saturated fat
and trans fat combined.
    Therefore, FDA is proposing to revise Sec. 101.62(e)(1) to state
that seafood and game meat products may use the term ``lean'' if they
contain less than 10 g total fat, 4.5 g or less saturated fat and trans
fat combined, and less than 95 milligrams (mg) cholesterol per
reference amount customarily consumed and per 100 g. Likewise, the
agency is proposing to revise Sec. 101.62(e)(3) to state that the term
``extra lean'' may be used on these foods if they contain less than 5 g
total fat, less than 2 g saturated fat and trans fat combined, and less
than 95 mg cholesterol per reference amount customarily consumed and
per 100 g. Similar revisions are proposed for Sec. 101.62(e)(2) and
(e)(4), which address the use of the terms on labels or in labeling of
meal and main dish products.
    It should be noted that the regulation on the health claim
regarding dietary lipids and cancer includes a criterion in
Sec. 101.73(c)(2)(ii) (21 CFR 101.73(c)(2)(ii)) that the food must meet
the requirements for ``low fat'' in Sec. 101.62, except that fish and
game meats may meet the requirements for ``extra lean'' in Sec. 101.62.
Thus, some fish and game meat products that currently meet the criteria
for this health claim may not be eligible if the proposed definition
for the claim ``extra lean'' is issued.
 
C. Disqualifying and Disclosure Levels
 
    The petitioner requested that FDA amend the disqualifying level for
health claims and the disclosure level for nutrient content claims with
respect to saturated fat. The petitioner also requested that
Sec. 101.14(a)(5) regarding disqualifying nutrient levels for health
claims and the general disclosure requirements for nutrient content
claims in Sec. 101.13(h)(1) be amended by replacing ``4.0 g of
saturated fat'' with ``4.0 g total of saturated and trans fatty acids
combined.'' The petitioner requested similar changes for health claims
for meal and main dish products in Sec. 101.14(a)(5)(i) and (a)(5)(ii)
and for nutrient content claims for these types of products in
Sec. 101.13(h)(2) and (h)(3). The petitioner maintained that health
claims and nutrient content claims are misleading on products
containing high levels of trans fatty acids, and that incorporating
trans fatty acids criteria into these requirements serves to limit the
potential for any such misleading claims.
    The purpose of the disqualifying levels for health claims is to
ensure that health claims cannot be made for products that contain
nutrients in amounts that increase to persons in the general population
the risk of a disease or health-related condition that is diet related
(see section 403(r)(3)(A)(ii) of the act). For example, the
disqualifying level for saturated fat ensures that a sodium and
hypertension claim cannot be made for a product that contains high
levels of saturated fat. Such a claim could lead consumers to believe
that the product is useful in constructing a healthful total daily
diet, when, in fact, it contains a high level of saturated fat, which
increases the risk of heart disease.
    For products bearing nutrient content claims, disclosure levels
direct consumers to information about certain nutrients that are
present in levels high enough to increase the risk of a diet-related
disease or health condition. For example, a product may qualify for a
``good source of vitamin A'' claim yet contain high levels of
cholesterol. The label for such a product must state ``See nutrition
information for cholesterol content'' next to the claim. In this
manner, the label draws attention to the presence of cholesterol, and
the claim is not misleading for failing to reveal a material fact about
the consequences of consuming the food.
    The 1990 amendments directed the agency to take into account the
significance of the food in the total daily diet in determining
disqualifying and disclosure levels. Accordingly, both disqualifying
and disclosure levels were based on 20 percent of the Daily Reference
Values (DRV's) for total fat, saturated fat, cholesterol, and sodium,
taking into account the number of eating occasions and the number of
foods containing these nutrients in the food supply (58 FR 2478 at 2493
and 2494). FDA adopted the 20 percent criterion because it provides a
consistent and appropriate basis for defining the levels at which the
presence of a particular nutrient may be undesirable (58 FR 2478 at
2493 and 2494). Applying the 20 percent criterion to saturated fat,
which has a DRV of 20 g, resulted in a disqualifying and disclosure
level of 4 g for saturated fat.
    FDA is persuaded by the petitioner that the disqualifying and
disclosure level of 4 g of saturated fat should be amended to be ``4 g
total of saturated and trans fatty acids combined.'' As discussed
previously, FDA has concluded that trans fatty acids have been shown to
have physiologic effects on serum LDL-C similar to saturated fatty
acids. Because of this effect, FDA believes that health claims and
nutrient content claims would be misleading on products containing high
levels of trans fatty acids. For this reason, FDA tentatively concludes
that it is
 
[[Page 62762]]
 
appropriate for the level to be the total of saturated and trans fatty
acids combined. Having the saturated fat level be amended to
incorporate trans fat is consistent with tentative conclusions in the
discussion on Daily Value (section V.A.2 of this document) that it is
reasonable to include trans fats in calculations of %DV for saturated
fatty acids. Therefore, FDA is proposing that Sec. 101.14(a)(5)
regarding disqualifying nutrient levels for health claims and the
general disclosure requirements for nutrient content claims in
Sec. 101.13(h)(1) be amended by replacing ``4.0 g of saturated fat''
with ``4.0 g of saturated fat and trans fat combined.'' FDA is
proposing similar changes for health claims for meal and main dish
products in Sec. 101.14(a)(5)(i) and (a)(5)(ii) and for nutrient
content claims for these types of products in Sec. 101.13(h)(2) and
(h)(3). For consistency with others food labeling regulations, FDA also
is proposing in Sec. 101.14(a)(5), (a)(5)(i), and (a)(5)(ii) that the
term ``per label serving size'' be changed to read ``per labeled
serving size.''
    In view of this proposed change, FDA considered whether the
referral statement accompanying nutrient content claims on the labels
of foods that contain more than 4 g of saturated fat and trans fat
should read ``See nutrition information for saturated and trans fat
content.'' FDA tentatively concludes that the statement ``See nutrition
information for saturated fat content'' is sufficient because trans fat
may not be present. Also, if trans fat were present, the amount
declared for saturated fat would include the amount of trans fat in the
food and would have a footnote stating this amount. However, under the
proposed provisions, the agency would not object to the use of a
statement that refers to both saturated fat and trans fat.
 
D. Vegetable Oil Claims
 
    The petitioner requested that FDA require that the fat content in a
product be low in both saturated and trans fatty acids if a vegetable
oil claim is made. The petitioner argued that claims in restaurants
that foods are cooked with ``100% vegetable oil'' are misleading when
the oil contains high levels of total ``heart-unhealthy'' fat. The
petitioner requested that Sec. 101.65(c)(3) be amended to state that
``made with vegetable oil'' is an implied claim that the product is low
in saturated and trans fatty acids combined.
    The agency has stated that there are long established relationships
between ingredients and nutrients that are covered under the definition
of implied nutrient content claims (58 FR 2302 at 2372). FDA has issued
warning letters regarding foods that bear label statements, such as
``100 percent vegetable oil,'' that imply that these ingredients have
low levels of saturated fat when that is not true (58 FR 2302 at 2372).
FDA has said that ingredient claims that make an implied representation
about the level of a nutrient in a food should be considered implied
nutrient content claims (58 FR 2302 at 2372). Section 101.65(c)(3),
which addresses implied nutrient content claims, states, in part, that
a claim ``that a food is made only with vegetable oil is a claim that
the food is low in saturated fat.'' Therefore, because the agency is
proposing to amend the definition of ``low saturated fat'' in
Sec. 101.62(c)(2) to include a trans fatty acid criterion, FDA believes
that the action requested by the petitioner has been addressed and it
is not necessary to propose an additional amendment to
Sec. 101.65(c)(3). Generally, nutrient content claims for restaurant
foods must comply with the same requirements as for retail foods (see
58 FR 2302 at 2386 and 61 FR 40320, August 2, 1996).
 
E. ``Partially Hydrogenated'' in Ingredient Statements
 
    The petitioner stated that the term ``hydrogenated'' is meaningless
to most consumers, but that consumers are familiar with the term
``saturated'' and associate it with fats that can raise blood
cholesterol levels. The petitioner maintained that using the term
``saturated'' instead of the term ``hydrogenated'' would be more
understandable to consumers and would further serve to highlight the
presence of ``heart-unhealthy'' fats. Further, the petitioner argued
that the term ``fully saturated'' or ``partially saturated'' accurately
describes the nature of the hydrogenated fat after the chemical process
of hydrogenation.
    The agency has previously considered this issue. In the Federal
Register of January 6, 1976 (41 FR 1156), the agency established the
term ``partially saturated'' for oils that were partially hydrogenated
for the purpose of ingredient labeling. In November 1976, based on
requests from six trade associations representing the edible oils
industry, FDA reversed itself and proposed to amend its regulations by
substituting ``hydrogenated'' and ``partially hydrogenated'' for
``saturated'' when those modifying terms are required to accompany the
name of a fat or oil ingredient on the labeled foods (41 FR 52481,
November 30, 1976). The trade associations for the edible fats and oils
industry contended that the terms ``saturated'' and ``partially
saturated'' were confusing and misleading to consumers in that they
tended to equate different oils that differ widely in their content of
saturated fats. Data furnished by the trade associations showed that
partially hydrogenated soybean oil has a lower saturated fatty acid
content than unhydrogenated palm kernel oil, hydrogenated palm oil, and
commercially blended shortenings. One association stated that the
partial hydrogenation of an oil that is low in saturated fats (e.g.,
cottonseed oil, soybean oil) results in a product containing less total
saturated fat than a similar product made from a fat or oil that
intrinsically has a much higher degree of saturation, such as animal
fats, palm oil, or coconut oil (41 FR 52481). Based in part on this
information, FDA required use of the term ``partially hydrogenated'' in
its final rule on the label designation of fats and oils (43 FR 12856,
March 28, 1978).
    FDA has re-examined this issue considering the trans fat content as
well as the saturated fat content of fats and oils. A review of the
nutritional content of varied fats and oils shows that many partially
hydrogenated oils contain lower amounts of saturated fatty acids and
trans fatty acids combined than fats that are unhydrogenated (e.g.,
lard) (Ref. 40).
    Therefore, the agency continues to believe that use of the terms
``saturated'' and ``partially saturated'' to describe fats and oils
processed in a certain way may mislead consumers to equate fats and
oils that, in fact, differ substantially in their content of ``heart-
healthy'' fats. This misperception could cause consumers to avoid a
processed oil, which would be required to be identified as ``partially
saturated,'' and instead choose an unprocessed fat or oil, even though
it may contain more saturated fatty acids than the combined amount of
saturated fatty acids and trans fatty acids in another product.
    The agency has stated that the purpose of the regulatory
requirement in Sec. 101.4(b)(14) is to distinguish in the name between
unprocessed and processed fats or oils (43 FR 12856). The term
``hydrogenated'' more accurately makes this distinction because
``saturated'' describes a chemical characteristic of a fatty acid. All
vegetable oils, whether processed or not, are at least partially
saturated, that is, they contain some fatty acids that have only single
bonds. However, a partially saturated oil is not necessarily partially
hydrogenated and a partially saturated oil does not necessarily contain
trans isomers. The terms ``hydrogenated'' and ``partially
hydrogenated'' describe the chemical process of the addition of
 
[[Page 62763]]
 
hydrogen to a natural fat or oil for functional reasons (see section
IV.A of this document).
    The terms ``hydrogenated'' and ``partially hydrogenated'' are not
intended to describe the nutritional properties of fats or oils. The
purpose of the ingredient statement is to identify the ingredients in a
food by listing the common or usual names of each ingredient. The
mechanisms for supplying nutritional information about the finished
food are the nutrition label and nutrient content claims. By
considering both saturated and trans fats in nutrition labeling and
nutrient content claims, this proposed rule, if adopted, will give
consumers additional information to increase their ability to select
foods to help lower their CHD risk. Therefore, FDA is not proposing to
grant the petitioner's request.
 
VI. Preliminary Regulatory Impact Analysis
 
    FDA has examined the impacts of this proposed rule under Executive
Order 12866. Executive Order 12866 directs agencies to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety effects; distributive impacts; and equity). According to
Executive Order 12866, a regulatory action is ``significant'' if it
meets any one of a number of specified conditions, including having an
annual effect on the economy of $100 million or adversely affecting in
a material way a sector of the economy, competition, or jobs or if it
raises novel legal or policy issues. FDA finds that this proposed rule
is economically significant as defined by Executive Order 12866.
    In accordance with the Small Business Regulatory Enforcement and
Fairness Act (Public Law 104-121), the Administrator of the Office of
Information and Regulatory Affairs of the Office of Management and
Budget (the Administrator) has determined that this proposed rule would
be a major rule for the purpose of congressional review. A major rule
for this purpose is defined in 5 U.S.C. 804(2) as one that the
Administrator has determined has resulted or is likely to result in an
annual effect on the economy of $100 million or more; a major increase
in costs or prices for consumers, individual industries, Federal,
State, or local government agencies, or geographic regions; or
significant adverse effects on competition, employment, investment,
productivity, innovation, or on the ability of U.S.-based enterprises
to compete with foreign-based enterprises in domestic or export
markets.
 
A. Need for This Regulation
 
    Current nutrition labeling regulations do not allow manufacturers
to disclose information about the trans fat content in the nutrition
label of their products. The regulations in Sec. 101.9(c) read, in
part, that ``No nutrients or food components other than those listed in
this paragraph as either mandatory or voluntary may be included within
the nutrition label.'' Some of the nutrients listed are total fat,
saturated fat, polyunsaturated fat (voluntary), and monounsaturated fat
(voluntary). Trans fat is not included as either mandatory or voluntary
and, therefore, no information about trans fat may be included in the
Nutrition Facts panel.
    Nutrient content claim regulations in Sec. 101.62(a) read, in part,
that ``A claim about the level of fat, fatty acid, and cholesterol in a
food may only be made on the label or in the labeling of foods if: (1)
The claim uses one of the terms defined in this section in accordance
with the definition of that term.'' No such term is defined for trans
fat.
    This proposed regulation is needed to amend existing regulations to
permit and require manufacturers to provide important health-related
information to consumers regarding the amount of trans fat in food
products. This regulation is also needed to amend existing regulations
of claims that in some manner involve the amount of saturated fat so
that the regulations set limits for trans fat and do not permit
misleading claims.
 
B. Regulatory Alternatives
 
    FDA has considered a number of regulatory alternatives regarding
trans fat. FDA requests comment on the benefits, costs, and any other
aspect of these (and any other) alternatives.
1. Take No New Regulatory Action
    FDA could choose to deny the petition and take no new action in
regard to trans fat. Taking no new regulatory action will be considered
the baseline. Absolute benefits and costs are associated with all
regulatory options, including the baseline. Absolute benefits and costs
can be thought of as the state of the world under various policy
options. A regulatory assessment of an option measures the difference
between the absolute benefits and costs of that option and the absolute
benefits and costs of the baseline. Measured benefits and costs are
therefore zero at the baseline.
    FDA has not selected this option for three reasons. First, it found
that trans fat increases the risk of CHD. Second, consumers would not
be informed as completely as they could be by the nutrition label about
the trans fat content of the food products that they consume. Third,
claims that have limits for saturated fat and not for trans fat may be
misleading.
    Producers have limited incentives to reduce the trans fat content
of food products because current regulations prohibit manufacturers
from using the label to inform consumers about the trans fat content of
their products. This lack of information about trans fat content
results in increased trans fat consumption that is associated with an
increased risk of CHD, as shown in the estimates of benefits when such
information is provided. FDA believes that the proposed option
minimizes any potential for diverting consumers' attention from the
risk of CHD associated with saturated fat, while providing consumers
with information on the trans fat content of food products. The
proposed option also prevents misleading claims and provides producers
with incentives to reduce the trans fat content of food products.
2. Take the Proposed Regulatory Action Described in Section V of this
Document
    The analysis beginning with section VI.C of this document estimates
the benefits and costs of this alternative.
3. Propose to Permit the Voluntary Labeling of Trans Fat and to Permit
Trans Fat Nutrient Content Claims
    FDA could propose voluntary rather than mandatory labeling of trans
fat and propose to allow trans fat claims. This alternative would
directly address the difficulties posed by current regulations in
providing information on trans fat content on the label. However, a
voluntary rule is unlikely to result in information on trans fat
content being provided on the labels of any products with one or more
grams of trans fat. Therefore, consumers would not have important
nutrition information available to them on the labels of many products
where it is most needed. Margarine makers know how to reformulate
margarine to eliminate trans fat. Indeed, many margarine products have
already been reformulated. Voluntary labeling coupled with claims could
therefore possibly provide sufficient incentives to cause the makers of
unreformulated margarine to reformulate their products. Makers of other
food products containing trans fat, however, do not yet know how to
 
[[Page 62764]]
 
reformulate their products. The agency believes that it is unlikely
that voluntary labeling would provide sufficient incentive for
reformulation of many other products. Although (as shown in section
VI.D.6 of this document) reformulating these other food products is
costly, the public health benefits generated by reformulating these
products greatly exceed the costs. Because voluntary labeling leads to
less reformulation and smaller health benefits than mandatory labeling,
the net benefits would be lower for voluntary labeling than for the
proposed rule.
    Voluntary labeling would also require the listing of trans fat on a
separate line in the Nutrition Facts Panel. The problems with a
separate line for trans fat are discussed in the following paragraphs.
4. Alter the Proposed Regulatory Action--Propose Reporting of Trans Fat
on a Separate Line Below Saturated Fat
    FDA is proposing that the line in the Nutrition Facts panel for
saturated fat report the total grams of saturated fat and trans fat
combined, and that the combined amount be used to determine the %DV
labeled for saturated fat. The saturated fat listing will be
accompanied by an asterisk referring to a footnote in the Nutrition
Facts panel indicating the amount of trans fat per serving in grams.
Alternatively, FDA could propose the listing of trans fat on a separate
line under saturated fat. In comparison with the proposed option, this
alternative may make the trans fat content of the product more obvious
to consumers and may provide more incentive to producers to reduce the
amount of trans fat in food. This approach has the potential to confuse
consumers by undermining educational messages that focus on saturated
fat. Also, without a daily value for trans fat, consumers might be
unable to tell if the amount per serving is high or low.
    If the agency were to require listing the amount of trans fat on a
separate line in the Nutrition Facts panel, all labels would have to be
changed--including those for products containing no trans fat. These
additional labeling costs would have no additional benefits associated
with them.
5. Alter the Proposed Regulatory Action--Propose to Report Trans Fat
Differently than in the Proposal
    FDA could propose to include trans fat with saturated fat, call the
total value ``saturated fat,'' and not have the amount of trans fat
declared in a footnote. This alternative would not divert consumers'
attention from the saturated fat content of food products. At the same
time, it would provide consumers with information on combined saturated
and trans fat content and provide producers with incentives to reduce
the level of both saturated and trans fat in their products. However,
it would not provide consumers with information on either the trans fat
content or the actual saturated fat content of food.
    One of the principles used by FDA in establishing nutrient content
claims is that the nutrient must be declared in the Nutrition Facts
panel so that the claim is verifiable by reference to the Nutrition
Facts panel. Accordingly, establishing a definition for ``trans fat
free'' would be precluded if the trans fat content of the product were
not mentioned in the Nutrition Facts panel.
    Alternatively, FDA could propose to include trans fat with
saturated fat and call the total value ``saturated and trans fat''.
This approach would increase the economic burden on industry by
requiring label changes for all foods, even those that do not contain
trans fat. Moreover, consumers would not be able to determine the
content of either saturated or trans fat, and saturated fat and trans
fat content claims would not necessarily be verifiable by reference to
the Nutrition Facts panel.
    As a second alternative, FDA could propose to include trans fat
with saturated fat and call the total value ``saturated and trans
fat,'' with a footnote stating the individual amounts of saturated fat
and trans fat. This approach would lead to higher costs than the
proposed regulatory action if it requires label changes for all foods,
even those that do not contain trans fat.
6. Expand the Proposed Regulatory Action--Propose ``Low Trans Fat'' and
``Reduced Trans Fat'' Claims
    The proposed rule would define a nutrient content claim for ``trans
fat free.'' FDA could propose to define ``low trans fat'' and ``reduced
trans fat'' claims. These claims would provide producers with
additional incentive to reduce the amount of trans fat in food
products. However, FDA has consistently required that definitions for
``low'' claims relate to the total amount of the nutrient recommended
for daily consumption. Because consensus documents do not provide
quantitative recommendations for daily intake of trans fat, FDA
concludes that the claim ``low trans fat'' cannot be defined. In the
case of ``reduced trans fat,'' the agency is concerned that use of the
claim could detract from educational messages that emphasize saturated
fat.
7. Expand the Proposed Regulatory Action--Propose Labeling at Food
Service Establishments
    Partially hydrogenated fats and oils are used extensively in the
food service industry for baking and frying. For example, USDA data
indicate that a single serving of french-fried potatoes from a fast
food restaurant may contain over 3.5 g trans fat per 70 g serving (Ref.
40). If FDA were to require that content information about trans fat be
provided in food service establishments, consumers could more easily
make informed menu choices. However, FDA is not permitted to pursue
this alternative. The 1990 amendments specifically preclude FDA from
requiring nutrition labeling in food service establishments unless the
food bears a nutrition claim or other nutrition information on its menu
or other forms of labeling. If an establishment is making a claim for a
food, the food must meet the criteria for the claim and the amount of
nutrient that is the subject of the claim must be made available.
 
C. Benefits
 
    To estimate the health benefits of the proposed rule, FDA is
following the general approach used to estimate the health benefits for
the implementation of the 1990 amendments (56 FR 60856 at 60869,
November 27, 1991). Accordingly, FDA is estimating: (1) The changes in
trans fat intakes that would result from labeling changes; (2) the
changes in health states that would result from changes in trans fat
intakes; and (3) the value of changes in health states in terms of
life-years gained, number of cases or deaths avoided, and dollar value
of such benefits. FDA considered the adult population of the United
States to be the target population for the estimate of health benefits.
Although changes in dietary intake and biological factors in children
may affect their later risk for CHD as adults, those changes, if
present, have not been quantified and are beyond the scope of the
health benefits assessment for this proposed rule. If reducing the
trans fat intake of children does lead to later reduction in the risk
of CHD, then the analysis of the proposed rule will underestimate the
health benefits of decreasing trans fat intake.
1. Changes in Trans Fat Intakes
    Three aspects of the estimated changes in trans fat intake will be
discussed, as follows:
    a. Baseline trans fat intake,
    b. Quantitative changes in trans fat intake, and
    c. Qualitative changes in the type of macronutrient substituted for
trans fat.
 
[[Page 62765]]
 
    a. Baseline trans fat intake. As reviewed in section IV.B.2.c of
this document, most of the current estimates of trans fat intake have
been based on either food disappearance data or food frequency
questionnaires (Ref. 3 and 70). Because information on trans fat
content of foods is limited, there have been few estimates of trans fat
intake based on dietary surveys using food records or recalls. Allison
et al. (Ref. 26) estimated trans fat intake by linking a special 1995
USDA data base on trans fat content of foods with USDA's CSFII, 1989
through 1991.
    To estimate baseline trans fat intake, FDA first used the special
1995 USDA data base to estimate the trans fat content of food groups
defined by Standard Industrial Classification (SIC) Codes (Ref. 73). As
described in section VI.D.1 of this document, this estimate was limited
to foods with trans fat from partially hydrogenated fats and oils.
Next, FDA linked the trans fat content of SIC Code food groups with
mean intake of food groups in USDA's CSFII 1994 through 1996. For
adults, age 20 and older, mean trans fat intake was estimated at 7.62
g/day for men and 5.54 g/day for women (Ref. 73). The estimated mean
energy intake was 2,455 kcal/day for men and 1,646 kcal/day for women
(Ref. 79). Therefore, trans fats provide approximately 2.79 percent of
energy for men and 3.03 percent of energy for women (using the general
conversion factor in Sec. 101.9(c)(1)(i)(C), 1 g fat = 9 kcal). Because
estimates of baseline trans fat intake as a percent of energy are very
similar for men and women, these data were combined into a single
estimate by a simple average, 2.91 percent of energy.
    FDA's estimate of baseline trans fat intake used in this analysis
is within the range of previous estimates in the literature, summarized
in section IV.B.2.c of this document. The estimates of both FDA and
Allison et al. (Ref. 26) are based on CSFII surveys and the special
USDA trans fat data base. Allison et al. (Ref. 26) reported mean trans
fat intake of 5.3 g/day (2.6 percent of energy). There are several
differences in the method of estimation that would likely account for
the differences in the two estimates. FDA's estimate used CSFII 1994-
1996, was based on mean intake of food groups, and included men and
women age 20 and older. The estimate of Allison et al. used CSFII 1989
through 1991, was based on specific foods eaten by each individual, and
included males and females age three and older.
    As discussed in section VI.D.5 of this document, FDA estimates that
about 30 percent of the margarine products currently on the market have
already been reformulated to remove trans fat. FDA also estimates that,
in the short term, the rest of the margarine on the market would be
reformulated in response to a final rule based on this proposed rule.
Additionally, FDA estimates that some proportion of baked goods
products would eventually be reformulated to remove trans fat. Table 1
of this document shows the average trans fat intake from the food
groups likely to be affected by reformulation. The trans fat intake
from margarine products in Table 1 of this document represents the
intake from the remaining 70 percent of margarine products currently on
the market that is estimated to contain trans fat. As shown in Table 1
of this document, of the 2.91 percent of energy from trans fat intake,
0.39 percent is from the margarine food group, 0.67 percent from breads
and cake products, and 0.98 percent from cookies and crackers.
 
                     Table 1.--Current Average trans Fat Intake by Adults From Food Groups1
----------------------------------------------------------------------------------------------------------------
                                                         Current Average Trans Fat Intake
----------------------------------------------------------------------------------------------------------------
                                              Men\3\                         Women\4\                 Average
   Food Group       SIC Code\2\  -------------------------------------------------------------------------------
                                      gm/day        % of energy       gm/day        % of energy     % of energy
----------------------------------------------------------------------------------------------------------------
Margarine            2079               1.02            0.37%           0.75            0.41%           0.39
Bread/Cake/etc.      2051               1.77            0.65%           1.28            0.70%           0.67
Cookies/Crackers     2052               2.48            0.91%           1.92            1.05%           0.98
All Other                               2.35            0.86%           1.59            0.87%           0.87
Total                                   7.62            2.79%           5.54            3.03%           2.91
----------------------------------------------------------------------------------------------------------------
\1\ Data for adults, age 20 and older (see section VI.C.1 of this document). Conversion factor: 1 gram trans fat
  intake equals 9 kcal.
\2\ SIC, Standard Industrial Classification.
\3\ Mean energy (caloric) intake: 2,455 kcal per day for men.
\4\ Mean energy (caloric) intake: 1,646 kcal per day for women.
 
    b. Quantitative changes in trans fat intake: Four scenarios. FDA
developed several scenarios to demonstrate potential quantitative
changes in trans fat intake based on a range of possible producer and
consumer responses to labeling trans fat content. Although FDA has
characterized these changes as ``producer'' and ``consumer'' responses,
all responses to the proposed rule are based on the interactions in the
food market between changes in producer cost and changes in consumer
demand. In the analysis done for the 21 implementing rules for the 1990
amendments, FDA acknowledged that there would be both costs and
benefits arising from the reformulation of products likely to occur as
a result of the rules. FDA chose not to quantify those costs and
benefits in that analysis (in contrast to the analysis of this proposed
rule) because of the uncertainty associated with estimating producer
reactions to complex label changes.
    For the rule now being proposed, the reactions of producers to the
proposed rule can be estimated quantitatively. Including the reactions
of producers, however, makes it difficult to compare the effects of the
proposed rule with the effects of the 1990 amendments, which may be
considered a standard of comparison for major labeling rules. In
section VI.E of this document, FDA calculates the benefits and costs of
this proposed rule with methods similar to those used for the rules
implementing the 1990 amendments, which allows the effects of the two
rules to be compared. The characteristics of each scenario used to
estimate the effects of the proposed rule are summarized in Table 2 of
this document.
    i. Scenario 1: Maximum response. In Scenario 1, the maximum
response, a combination of reformulation and consumer response
eliminates all trans fat. As shown in Table 2 of this document, in
Scenario 1, 100 percent of trans fat would be removed from the diet,
decreasing the intake of trans fat by 2.91 percent of energy. Because
of the
 
[[Page 62766]]
 
magnitude of producer and consumer response, FDA considers Scenario 1
the least likely of the four scenarios, but has used it to illustrate
the upper bound of possible decreases in trans fat intake.
    ii.  Scenario 2: Some reformulation and some consumers change their
behavior. In Scenario 2, 100 percent of margarine, 3 percent of bread
and cake, and 15 percent of cookies and crackers would be reformulated
to remove trans fat. FDA assumed that the percentage amounts of bread,
cake, cookies, and crackers reformulated would be about double the
percentage number of products reformulated (see Table 17 later in this
document). The percentage change in amounts exceeded the percentage
change in number of products because FDA expected that the products to
be reformulated will all be produced by large firms. Indeed, FDA
expects that all large firms whose products contained claims that would
be lost will reformulate. The agency assumed that these products
account for above-average shares of bread, cake, cookies, and crackers
containing trans fat. FDA requests comments on the assumptions that 3
percent of bread and cake and 15 percent of cookies and crackers will
be reformulated by 7 years after the compliance period (scenario 2).
Given the mean trans fat intake shown in Table 1 of this document,
these reformulations would decrease trans fat intake by 0.56 percent of
energy ((1 x 0.0039) + (0.03 x 0.0067) + (0.15 x 0.0098) = 0.0056).
    Because of the sizable cost of reformulation and the limited
consumer appeal that bread and cake products, cookies, and crackers
with claims have had thus far, FDA assumes that only a small percentage
decrease in trans fat intake from reformulation of the products in
these categories is a likely result of the proposed rule. If producers
believe that consumers will respond more negatively to the information
on trans fat than they have responded thus far to the information on
saturated fat, then the actual number of products reformulated will be
greater. If that happens, the actual benefits of the rule will be
greater than those estimated here; the costs will increase only
proportionally, so the net benefits of the rule would be greater than
estimated in this scenario.
    In this scenario, not all consumers respond to the labeling changes
by eliminating trans fat in the other categories of their diets.
Previous research showed that approximately 45 percent of consumers are
aware of diet-health links, and read and understand nutrition labels
(Refs. 68 and 74). In Scenario 2, therefore, FDA assumed that 45
percent of consumers would eliminate some trans fat from their diets.
    Those consumers who read and understand nutrition labels are
expected, on average, to make choices among existing products that
result in only small changes in trans fat intake. In analyzing the
anticipated health benefits of the regulations implementing the 1990
amendments (56 FR 60856 at 60870), FDA estimated consumer changes in
consumption behavior using the results of previous research, including
a study of grocery store shelf labeling (Refs. 68 and 74). In that
analysis of changes in market share, consumer response to shelf
labeling of 49 product categories resulted in an approximately 1
percent overall decrease in intake of total fat and saturated fat. FDA
therefore used a 1 percent overall decrease in trans fat intake as an
estimate of consumer response to this proposed labeling change. An
overall 1 percent decrease in trans fat intake would be obtained if the
45 percent of consumers who use food labels to make purchase decisions
changed their consumption by 2.2 percent (0.01 <divide> 0.45 = 0.022).
The 55 percent of consumers who do not pay attention to food labels
would decrease trans fat intake by 0.56 percent of energy because of
reformulation only. The remaining 45 percent of consumers would
decrease trans fat intake by 0.61 percent of energy, 0.56 percent due
to reformulation plus 0.05 percent due to elimination of 2.2 percent of
the trans fat from foods not reformulated (0.022 x (0.0291 - 0.0056) =
0.0005). The total change in trans fat intake as a percent of energy
would be 0.58 percent ((0.55 x 0.0056) + (0.45 x 0.0061) = 0.0058).
    The 1-percent decrease in trans fat intake that FDA assumed for
consumers may understate the direct consumer response. The agency took
the 1-percent decrease from studies undertaken in support of the
analysis of the rules implementing the 1990 amendments. The 1990
amendments required labeling changes for all FDA-regulated foods; the
supporting studies estimated the change in fat and saturated fat as
part of the outcome of changes in the overall diet in response to the
new label. Rather than affecting all FDA-regulated foods, however, the
proposed labeling of trans fat will mainly affect foods containing 0.5
g or more of trans fat per serving, which are predominantly products
containing partially hydrogenated fats and oils, as described in
section VI.D.1 of this document (Ref. 73). The narrower scope of the
proposed labeling may, by emphasizing a single substance, generate a
larger direct consumer response.
    In the shelf-labeling study, the reported change in market share
ranged from 1 percent to 40 percent in 18 product categories and no
significant change was reported in the remaining 31 categories (Refs.
72 and 74). The predicted consumer response in the specific product
categories affected by trans fat labeling is, therefore, uncertain. In
previous research, it was noted that different circumstances make it
difficult to generalize consumer response from one food labeling or
health claim situation to another (Ref. 74). In the absence of specific
research on the reaction of consumers to trans fat labeling (Ref. 81),
FDA used the estimate of a 1-percent decrease in intake, as used
previously for the rules implementing the 1990 amendments.
    iii Scenario 3: Less reformulation and some consumers change their
behavior. In Scenario 3, 100 percent of margarine, 1.5 percent of bread
and cake, and 7.5 percent of cookies and crackers would be
reformulated--half the reformulation of baked products of Scenario 2.
Given the mean trans fat intake shown in Table 1 of this document, this
would decrease trans fat intake by 0.48 percent of energy ((1 x 0.0039)
+ (0.015 x 0.0067) + (0.075 x 0.0098) = 0.0048). Scenario 3 assumes the
same direct consumer response as in Scenario 2. Under scenario 3, 55
percent of consumers decrease trans fat intake by 0.48 percent of
energy due to reformulation. The remaining 45 percent of consumers
decrease trans fat intake by 0.53 percent of energy, 0.48 percent due
to reformulation plus 0.05 percent due to elimination of 2.2 percent of
the trans fat from foods not reformulated (0.022 x (0.0291 - 0.0048) =
0.0005). The total change in trans fat intake as a percent of energy
would be 0.50 percent ((0.55 x 0.0048) + (0.45 x 0.0053) = 0.005).
    iv.  Scenario 4: Least reformulation and some consumers change
their behavior. Scenario 4 assumes no reformulation of bread and cake
products, but continues to assume reformulation of margarine. Scenario
4 also assumes the same direct consumer response as in Scenarios 2 and
3. Under this scenario, 55 percent of consumers would decrease trans
fat intake by 0.39 percent of energy due to margarine reformulation
only. The remaining 45 percent of consumers decrease trans fat intake
by 0.45 percent of energy, 0.39 percent due to reformulation plus 0.06
percent due to elimination of 2.2 percent of the trans fat from foods
not reformulated (0.022 x (0.0291 - 0.0039) = 0.0006). The total change
in trans fat
 
[[Page 62767]]
 
intake as a percent of energy would be 0.42 percent ((0.55 x 0.0039) +
(0.45 x 0.0045) = 0.0042).
    As summarized in Table 2 of this document, Scenarios 2 through 4
predict three levels of product reformulation together with an estimate
of consumer behavior. FDA considers Scenarios 2 through 4 to be more
likely than Scenario 1, and has used them as the primary basis for
estimation of health benefits. In addition to representing outcomes
with different likelihoods, the three scenarios represent the effects
of the proposed rule after different periods of time: 3 years after the
effective date for Scenario 4, 8 years after the effective date for
Scenario 3, and 10 years after the effective date for Scenario 2. The
time period for the effects of each of the three scenarios includes the
time for reformulation and the 3 years that pass before changes in diet
affect the risk of CHD.
 
                             Table 2.-- Predicted Changes Due to trans Fat Labeling1
----------------------------------------------------------------------------------------------------------------
  Characteristics of
    Each Scenario            Scenario 1             Scenario 2             Scenario 3            Scenario 4
----------------------------------------------------------------------------------------------------------------
Description            Maximum combined       Some reformulation     Less reformulation     Least reformulation
                        producer and           and a proportion of    and a proportion of    and a proportion of
                        consumer response      consumers have         consumers have         consumers have
                                               partial behavior       partial behavior       partial behavior
                                               change                 change                 change
Margarine Category                            100% Reformulated      100% Reformulated      100% Reformulated
Bread/Rolls Category                          3% Reformulated        1.5% Reformulated      Not Reformulated
Cookies/Pastries                              15% Reformulated       7.5% Reformulated      Not Reformulated
 Category
Foods Not                                     45% of consumers pay   45% of consumers pay   45% of consumers pay
 Reformulated                                  attention to labels    attention to labels    attention to labels
                                               and eliminate 2.2%     and eliminate 2.2%     and eliminate 2.2%
                                               of trans fats          of trans fats          of trans fats
Decrease in Average    2.91                   0.58                   0.50                   0.42
 Trans Fat Intake (%
 of energy)
----------------------------------------------------------------------------------------------------------------
                                      Change in Coronary Heart Disease Risk
----------------------------------------------------------------------------------------------------------------
Method 1, LDL          - 4.28%                - 0.86%                - 0.73%                - 0.61%
Method 2, LDL and HDL  - 8.36%                - 1.67%                - 1.43%                - 1.20%
----------------------------------------------------------------------------------------------------------------
                                  Time Periods for the Effects of Scenarios\2\
----------------------------------------------------------------------------------------------------------------
Time after effective   Scenario 1             Scenario 2             Scenario 3             Scenario 4
 date
----------------------------------------------------------------------------------------------------------------
3 years                Same effects as        Same effects as        Same effects as        Full effect for
                        scenario 4             scenario 4             scenario 4             scenario 4
8 years                Same effects as        Same effects as        Full effect for        Full effect for
                        scenario 3             scenario 3             scenario 3             scenario 4
10 years               Full effect for        Full effect for        Full effect for        Full effect for
                        scenario 2             scenario 2             scenario 3             scenario 4
Hypothetical future    Full effect for        Full effect for        Full effect for        Full effect for
 time (more than 10     scenario 1             scenario 2             scenario 3             scenario 4
 years)
----------------------------------------------------------------------------------------------------------------
\1\ It is assumed in this table that a given percent of energy from trans fats is replaced by the same percent
  of energy from cis-monounsaturated fats, keeping total energy intake constant. The effect of substituting
  other macronutrients for trans fats is shown in Table 3 of this document.
\2\ The calculations used to estimate the changes in risk (listed in the second part of the table) are explained
  below. For the calculations of risk using the LDL model, see section VI.C.2.a of this document. For the
  calculations of risk using the LDL and HDL model, see section VI.C.2.b of this document.
 
    c. Qualitative changes, substituting different macronutrients for
trans fats. Although quantitative decreases in trans fat intake were
estimated for the four scenarios in the preceding section, the actual
substitutions manufacturers and consumers will make as a result of the
labeling change are uncertain. The four scenarios assume that the
margarine food group will be reformulated, and scenarios 1 through 3
assume that a proportion of products in the breads, cookies, and
crackers food groups will be reformulated to eliminate trans fat.
    In choosing among reformulated products, manufacturers and
consumers might use products with saturated fat, cis-monounsaturated
fat, or cis-polyunsaturated fat as substitutes for the trans fat
removed by reformulation. Some industry specialists estimate that
current food technology will require the incorporation of about 0.5 g
saturated fat for every 1 g trans fat removed from a food product by
reformulation (Ref. 73). However, if consumers choose a very low fat
(and low calorie) replacement product, they will obtain almost no fat
in substitution for trans fat. They might then increase their intake of
carbohydrate or other fat to replace the calories from the replacement
product. Similarly, in the four scenarios FDA assumes that at least
some consumers will eliminate at least some trans fat from their diets
because of the labeling change. They will then obtain some combination
of carbohydrate or other fat in the foods they choose in place of trans
fat-containing foods.
    In the scientific literature, cis-monounsaturated fat is often used
as a reference point in describing effects of trans fat intake. Because
there are no available data to predict which macronutrients might, in
fact, replace trans fat, it is important to consider how the
substitution of carbohydrate or of other types of fat would influence
the CHD risk estimates. Therefore, in estimating the potential decrease
in heart disease risk due to trans fat labeling, FDA first estimated
the effect on CHD risk by assuming that the trans fat eliminated from
the diet was replaced with cis-monounsaturated fat while holding energy
(calories) constant. Next, FDA considered the effect on CHD risk of
replacing a given percent of energy from trans fat with the
 
[[Page 62768]]
 
same percent of energy from a combination of 50 percent cis-
monounsaturated fat, plus either 50 percent saturated fat, 50 percent
polyunsaturated fat, or 50 percent carbohydrate. The effects of
different substitutions for trans fats are shown in Table 1 of this
document. In valuing health benefits, FDA assumed likely substitutions
of ingredients for the trans fat now used in different products (see
section VI.C.3 of this document).
2. Changes in Health States Due to Changes in Trans Fat Intake
    FDA used two methods to estimate the potential decrease in CHD
likely to result from decreased intake of trans fat in response to the
labeling change.
    a. Method 1. Decrease in CHD risk due to decreased serum
concentrations of LDL-C.
    b. Method 2. Decrease in CHD risk due to decreased serum
concentrations of LDL-C and increased serum concentrations of HDL-C.
FDA also reviewed the association of CHD risk with trans fat intake
found in large prospective observational cohort studies.
    In the following sections, FDA summarizes the estimated decrease in
CHD using each method.
    a. Method 1: Changes in LDL-C. As noted in section IV.B.2 of this
document, the NCEP Expert Panel (Ref. 5) found increases in serum LDL-C
to be a major risk factor for CHD. In keeping with the recommendations
of the NCEP Expert Panel, FDA used changes in serum LDL-C as the
primary criterion to evaluate the effects of trans fat intake on CHD
risk in Method 1.
    As discussed in section IV.B.2.b of this document, clinical trials
of trans fat feeding have the advantage that they provide evidence for
a cause and effect relationship between a given level of trans fat
intake and the observed changes in physiologic measures such as LDL-C.
However, a single feeding trial usually involves just one or a few test
diets in comparison with a reference diet (called a ``basal'' diet) and
typically provides information on only one (or occasionally two or
more) levels of trans fat intake. When summarizing or comparing the
results of various feeding trials, the different levels of trans fat
intake and different basal diets across studies make the comparisons
necessary for this benefits analysis difficult.
    To overcome these difficulties, FDA used the regression equations
of Katan et al. (Ref. 62) and Zock et al. (Ref. 69) in Method 1 to
estimate the effect of trans fat intake on LDL-C. These authors
considered the results of five feeding trials (and six levels of trans
fat intake), summarizing the CHD risk results as a function of the
level of trans fat intake. Small differences in the basal diets in each
study were accounted for by correction factors based on the regression
equations of Mensink and Katan (Ref. 65). Compared with the results of
a single feeding trial, the coefficients from the regression equations
had three advantages: (1) They were based on data from a larger number
of subjects, (2) they could be generalized over a range of trans fat
intake, and (3) they were adjusted to a common basal diet.
    The regression equation of Katan et al. (Ref. 62) and Zock et al.
(Ref. 69) was based on the following studies that were reviewed in
section IV.B.2 of this document: Judd et al. 1994, Mensink and Katan
1990, Lichtenstein et al. 1993, Nestel et al. 1992, Zock and Katan 1992
(Refs. 7, 8, and 11 through 13). The regression equation showed that
each additional percent of energy from trans fat was predicted to
increase LDL-C by 1.5 mg/deciliter (dL) (0.040 millimol/liter)
(R2 = 0.86, p = 0.0028) when substituted for the same
percent of energy from cis-monounsaturated fat, holding total energy
intake constant.
    Previous research has shown that each 1-percent reduction in total
serum cholesterol is associated with a decrease in CHD risk by a factor
of 2 percent (Ref. 5). To quantify the relationship between changes in
LDL-C and CHD risk, Gordon and coworkers carried out a standardized
reanalysis of CHD incidence in four large prospective studies in the
United States (Refs. 59 through 61). The results of Gordon and
coworkers showed that each increment of 1 mg/dL in LDL-C (0.026
millimol/liter) was predicted to increase CHD risk by a factor of 0.6
percent to 0.8 percent (Refs. 59 through 61). FDA used the midpoint of
this range, a 0.7 percent increase in risk per 1 mg/dL LDL-C increment,
in the present analysis (throughout this analysis, a percent change in
CHD risk means that change as a factor of existing risk). Because
Gordon and coworkers expressed the change in LDL-C in mg/dL rather than
as a percent of mean LDL-C concentration, the information was directly
applicable to the changes in LDL-C in the intervention (feeding)
studies.
    Because an individual's serum lipid concentrations vary over time,
a single measurement of serum lipid levels may underestimate the
magnitude of the association between serum lipids and CHD risk (Refs.
5, 57, and 64). Single measurements include random variation (or error)
that would be removed if repeated measurements of serum lipids were
made and the results for each individual were averaged. The presence of
the additional random variation can statistically mask the actual
relationship between serum lipids and CHD, causing an underestimate of
the magnitude of the association. This apparent weakening of the
observed association relative to the true association is called
regression dilution bias (Refs. 57 and 64). In an analysis of data from
the British United Providence Association, statistical removal of the
regression dilution bias increased the association between serum
cholesterol and CHD by a factor of 1.4 (Ref. 64). In this analysis,
therefore, FDA increased the strength of the relationship between LDL-C
and CHD risk by a factor of 1.4 to correct for regression dilution
bias. Using these relationships, the change in CHD risk due to trans
fat labeling can be predicted under the four consumer response
scenarios.
    Given the mean decrease in trans fat intake of 2.91 percent of
energy in Scenario 1, LDL-C is predicted to decrease by 4.37 mg/dL,
resulting in a decrease in CHD risk of 3.06 percent, or 4.28 percent
(1.4 x 3.06 percent) after adjustment. Because the relationships in
Method 1 are linear, the decreased trans fat intake of the consumers
who do and those who do not use labels to make purchase decisions can
be combined into a single estimate of net decrease in trans fat intake.
For Scenario 2, the net decrease in trans fat intake is 0.58 percent of
energy, predicting a 0.87 mg/dL decrease in LDL-C, a 0.61 percent
decrease in risk of CHD, and a 0.86 percent (1.4 x 0.61 percent)
adjusted decrease in risk of CHD. In Scenario 3, the net decrease in
trans fat intake is 0.50 percent, giving a 0.75 mg/dL decrease in LDL-
C, a 0.52 percent decrease in CHD, and a 0.73 percent (1.4 x 0.52
percent) adjusted decrease in risk of CHD. In Scenario 4, mean trans
fat intake decreases by 0.42 percent of energy, resulting in a 0.63 mg/
dL decrease in LDL-C, a 0.44 percent decrease in CHD risk, and a 0.61
percent (1.4 x 0.44 percent) adjusted decrease in risk of CHD. The
adjusted decreases in risk for the four scenarios are summarized in
Table 2 of this document.
    Because the regression equations of Katan et al. (Ref. 62) and Zock
et al. (Ref. 69) represent the result of a mathematical procedure,
rather than the results of individual experiments, it is important to
consider how the decrease in risk calculated compares with individual
studies or with other summaries of studies. FDA compared these results
with predictions based on the feeding trials of Mensink and Katan
 
[[Page 62769]]
 
(Ref. 7) and Judd et al. (Ref. 12) and on the summary of Kris-Etherton
et al. (Ref. 63). FDA found that the decreased CHD risk predicted in
this analysis was within the range predicted using estimates derived
from individual feeding trials and from other summaries of research.
    In the estimates using Method 1, FDA assumed that energy as trans
fat will be replaced by energy as cis-monounsaturated fat. To account
for the substitution of different macronutrients for trans fat, FDA
compared these estimates with the effect on CHD risk of replacing a
given percent of energy from trans fat with the same percent of energy
from a combination of 50 percent cis-monounsaturated fat plus either 50
percent saturated fat, 50 percent polyunsaturated fat, or 50 percent
carbohydrate. FDA examined this effect by considering the effect of
carbohydrate and other fat on LDL-C. Mensink and Katan (Ref. 65) used
regression equations to summarize the results of 27 clinical feeding
trials on serum lipids. When substituted for 1 percent of energy from
monounsaturated fat, polyunsaturated fat lowered LDL-C slightly (-0.31
mg/dL), carbohydrate raised LDL-C slightly (0.24 mg/dL), and saturated
fat raised LDL-C a similar amount (1.52 mg/dL) to that found for trans
fat (1.50 mg/dL).
    Given these effects of various substitutions on LDL-C, the changes
in CHD risk can be estimated. As examples, the results for Scenarios 2
and 4 are summarized in Table 3 of this document. The replacement of
0.58 percent of energy from trans fat (Scenario 2) with half cis-
monounsaturated fat and half other fat or carbohydrate gives a
decreased adjusted risk of 0.42 percent for saturated fat, 0.95 percent
for polyunsaturated fat, and 0.79 percent for carbohydrate. These risks
compare with 0.86 percent for replacement with only cis-monounsaturated
fat under Scenario 2. Under Scenario 4 (replacement of 0.42 percent of
energy from trans fat), the corresponding decreases in risk are 0.30
percent, 0.68 percent, and 0.56 percent for replacement with half cis-
monounsaturated fat and, respectively, either half saturated fat, half
polyunsaturated fat, or half carbohydrate. These risks compare with
0.61 percent for replacement with only cis-monounsaturated fat. Under
Method 1, then, the decrease in CHD risk is smallest when saturated fat
replaces some of the trans fat that is removed.
    b. Method 2: Changes in HDL-C and LDL-C. As noted in the discussion
on intervention (feeding) studies in section IV.B.2.a of this document
and in Appendix A, Table 1 of this document, trans fat intake appears
to affect not only LDL-C, but also other serum lipids, including HDL-C,
as well. A Consensus Statement on triglyceride, high-density
lipoprotein, and coronary heart disease reported ``considerable support
for a causal relationship'' between HDL-C and CHD (Ref. 71). The NCEP
Expert Panel (Ref. 5) considered LDL-C to be the primary lipid risk
factor for CHD. The Expert Panel also noted, however, the role of HDL-C
as a ``significant'' lipid risk factor for CHD. The Expert Panel
stated, ``Even though there are no data from clinical trials designed
specifically to show that raising HDL-C levels will reduce the risk for
CHD, the strong epidemiological association between low HDL-C and CHD
justifies considering HDL-C in risk assessment.'' The NCEP Expert Panel
(Ref. 5) found that ``the strength and independence of this association
warrants calling low HDL-C * * * a [negative] risk factor for assessing
the risk status of individual patients and for influencing the vigor of
treatment directed at high levels of LDL-C.''
    Although FDA believes that justification for this proposed rule is
primarily through the effect of trans fat intake on LDL-C, trans fat
intake may also be associated with CHD through an effect on HDL-C.
Therefore, with this noted qualification, FDA used changes in both HDL-
C and LDL-C as a second method to quantify the effects of trans fat
intake on CHD risk.
    The effect of trans fat intake on HDL-C was also quantified by
Katan et al. and Zock et al. (Ref. 62 and 69). The regression equation
showed that each additional percent of energy from trans fat was
predicted to decrease HDL-C by 0.4 mg/dL (0.013 millimol/liter)
(R2 = 0.88, p = 0.0019) when substituted for the same
percent of energy from cis-monounsaturated fat, holding total energy
intake constant. According to the analyses of Gordon and coworkers
(Refs. 59 through 61), each 1 mg/dL (0.026 millimol/liter) increment in
HDL-C was predicted to decrease CHD risk by 2 percent to 3 percent. For
the purpose of this analysis, FDA chose the midpoint, a 2.5 percent
decrease in risk per 1 mg/dL HDL-C increment. As described earlier, the
strength of this relationship should be increased by a factor of 1.4 to
account for regression dilution (Ref. 64).
    For Scenario 1, the mean 2.91 percent of energy decrease in trans
fat intake is predicted to increase HDL-C by 1.16 mg/dL, decreasing CHD
risk by 2.91 percent or by 4.08 percent (1.4 x 2.91 percent) adjusted.
The combined effect of the change in CHD risk due to changes in HDL-C
and LDL-C predicts an 8.36 percent decrease in CHD risk in Scenario 1
(4.28 percent decreased risk from lowering LDL-C plus 4.08 percent
decreased risk from raising HDL-C). Applying the same procedures to the
increase in HDL-C in the other scenarios would result in decreasing CHD
risk by 0.82 percent, 0.70 percent, and 0.58 percent (adjusted) for
Scenarios 2 through 4. The combined effect of raising HDL-C and
lowering LDL-C, summarized in Table 2 of this document, would result in
decreasing CHD risk by 1.67 percent, 1.43 percent, and 1.20 percent for
Scenarios 2 through 4. As found for Method 1, the decreased CHD risk
predicted for Method 2 using the regression equations of Katan et al.
and Zock et al. (Refs. 62 and 69) was within the range predicted using
estimates derived from individual feeding trials and from summaries of
research.
    In the estimates using Method 2, which estimated changes in both
HDL-C and LDL-C, FDA assumed that trans fat was replaced by the same
percent of energy as cis-monounsaturated fat. To account for the
substitution of different macronutrients, FDA compared the Method 2
estimates with the effect on CHD risk of replacing a given percent of
energy from trans fat with the same percent of energy from a
combination of half cis-monounsaturated fat and half either saturated
fat, polyunsaturated fat, or carbohydrate. FDA examined these effects
by considering the effects of carbohydrate and other fat on both LDL-C
(summarized previously for Method 1) and HDL-C. The regression
equations of Mensink and Katan (Ref. 65) predicted that when
substituted for one percent of energy from monounsaturated fat,
polyunsaturated fat lowered HDL-C slightly (0.06 mg/dL), saturated fat
raised HDL-C slightly (0.13 mg/dL), and carbohydrate lowered HDL-C by a
similar amount (0.34 mg/dL) to that found for trans fat (0.40 mg/dL).
    Using Method 2, which includes the effects on both HDL-C and LDL-C,
the replacement of 0.58 percent of energy from trans fat (Scenario 2)
with half cis-monounsaturated fat and half other fat or carbohydrate
gives a decreased adjusted risk of 1.37 percent for saturated fat, 1.70
percent for polyunsaturated fat, and 1.26 percent for carbohydrate
(Table 3 of this document). These changes compare with the 1.67 percent
decreased CHD risk calculated for replacement with only cis-
monounsaturated fat under Scenario 2. Using Method 2 and Scenario 4,
the corresponding decreases in risk are 0.98 percent for saturated fat,
1.22 percent for polyunsaturated fat,
 
[[Page 62770]]
 
and 0.90 percent for carbohydrate, compared with 1.20 percent adjusted
decrease in CHD risk for replacement with only cis-monounsaturated fat.
Under Method 2, therefore, the decrease in CHD risk is not as large
when saturated fat or carbohydrate is used to replace some of the trans
fat that is removed.
 
    Table 3.--Predicted Changes in Coronary Heart Disease (CHD) Risk Due to trans Fat Labeling, According to
                                           Substitution for trans Fats
----------------------------------------------------------------------------------------------------------------
                                        Scenario 2                                    Scenario 4
----------------------------------------------------------------------------------------------------------------
     Description          Some reformulation and a proportion of       Least reformulation and a proportion of
----------------------    consumers have partial behavior change        consumers have partial behavior change
 Decrease in average  ------------------------------------------------------------------------------------------
 trans fat intake (%                       0.58                                          0.42
      of energy)      ------------------------------------------------------------------------------------------
----------------------                         Change in CHD Risk:                           Change in CHD Risk:
   Substitution for     Change in CHD Risk:    Method 2, LDL-C and    Change in CHD Risk:    Method 2, LDL-C and
      trans fats          Method 1, LDL-C             HDL-C             Method 1, LDL-C             HDL-C
----------------------------------------------------------------------------------------------------------------
cis-monounsaturated    - 0.86%                - 1.67%                - 0.61%                - 1.20%
 fats
Half saturated and     - 0.42%                - 1.37%                - 0.30%                - 0.98%
 half cis-
 monounsaturated fats
Half cis-              - 0.95%                - 1.70%                - 0.68%                - 1.22%
 polyunsaturated and
 half cis-
 monounsaturated fats
Half carbohydrate and  - 0.79%                -1.26%                 - 0.56%                - 0.90%
 half cis-
 monounsaturated fats
----------------------------------------------------------------------------------------------------------------
 
    In June 1999, Ascherio et al. published an updated regression
equation estimating the effect of trans fat intake on serum lipids
(Ref. 83). The equation of Ascherio et al. incorporated the results of
8 feeding trials at 12 levels of trans fat intake, including 4 levels
of trans fat intake from the newly-published feeding trial of
Lichtenstein et al. (Ref. 82). In Method 1 and Method 2 of this
document, FDA estimated the effect of trans fat intake on serum lipids
using the 1995 regression equations of Katan et al. (Ref. 62) and Zock
et al. (Ref. 69). The 1999 equation of Ascherio et al. (Ref. 83)
estimated the effect of trans fat intake on the ratio of LDL-C to HDL-C
(LDL/HDL ratio), and not on the separate lipid concentrations of LDL-C
and HDL-C. As discussed in greater detail in sections IV.B.2 and VI.C.2
of this document, FDA's primary rationale for this proposed rule is the
effect of trans fat on LDL-C. Therefore, FDA estimated the effects of
trans fat on LDL-C and HDL-C separately, and FDA did not use the 1999
equation of Ascherio et al. However, FDA notes that the effect of trans
fat intake on serum lipid ratios estimated by the 1999 equation of
Ascherio et al. (Ref. 83) is very similar to the effect on serum lipid
ratios estimated by the 1995 equation of Willett and Ascherio (Ref.
84). Moreover, the 1995 equation of Willett and Ascherio incorporated
the results of the same five feeding trials at six levels of trans fat
intake as did the equations of Katan et al. (Ref. 62) and Zock et al.
(Ref 69) that the agency used in Method 1 and Method 2 of this
document. Therefore, FDA concludes that the decreased CHD risk
predicted by Method 1 and Method 2 of this document would not be
appreciably changed even if a regression equation were available to it
that predicted LDL-C and HDL-C separately, and incorporated the most
recently published feeding trials.
    c. Estimates from large prospective studies. As noted in section
IV.B.2.b of this document, FDA reviewed the results from observational
epidemiological studies of trans fat intake and risk of CHD. Because
such studies can provide evidence of an association between a risk
factor and disease, but cannot establish direct cause and effect, FDA
considered the evidence from observational epidemiological studies as
indirect evidence for a relationship.
    Among the observational studies reviewed, FDA is aware of four
large prospective studies reporting association between trans fat
intake and CHD risk (Refs. 19 through 21 and 38). These studies suggest
benefits that are several fold higher than even the high estimate of
benefits presented previously in this analysis (i.e., benefits
estimated for Method 2). FDA is asking for comments on the use of these
studies in estimating benefits.
    In these studies, the dietary intake and the health status of the
prospective cohorts were followed over time. An advantage of
prospective studies is that knowledge of a disease does not influence
the reported dietary intake (from questionnaires) (Ref. 66). However,
in prospective studies (as in other observational epidemiology), there
is error included in individuals' self-reported dietary intake and in
the calculation of trans fat intake from foods reported eaten.
    Additionally, statistical techniques are used to adjust for other
dietary components and other characteristics of the subjects that may
potentially confound the relationship between trans fat intake and CHD.
If a direct cause and effect is present, the size of the effect may be
over- or underestimated if there is bias due to errors in measurement
of the other dietary components or other confounding factors. The
presence of unknown or unmeasured confounding factors is another
potential source of bias. The prospective studies have nevertheless
consistently reported a greater risk of CHD attributable to trans fat
intake than would be accounted for by changes in LDL-C and HDL-C alone.
    Prospective studies typically report the association of a risk
factor with a disease outcome in terms of ``relative risk.'' RR
indicates the degree to which the presence of the risk factor increases
the chance of the health outcome. For example, an RR of 1.5 means that
with the risk factor present there is a 50 percent greater chance of
having the disease than if the risk factor was not present (holding all
other factors constant and assuming a cause and effect relationship for
the risk factor and the disease).
    In the study of Hu et al. (Ref. 38), women completed diet
questionnaires four separate times during a 14-year followup. The RR
for CHD was reported to be 1.93 per 2 percent of energy intake from
trans fat, with a 95 percent confidence interval ranging from 1.43 to
2.61. These numbers indicate that for every 2 percent of energy
(calories) from
 
[[Page 62771]]
 
trans fat, there would be an increased risk of CHD of 93 percent
(compared with the same amount of energy from carbohydrates). When only
the initial diet questionnaire was used in the analysis (instead of all
four questionnaires), greater measurement error was expected, and the
RR for CHD was reduced to 1.62 per 2 percent of energy from trans fat
(95 percent confidence interval from 1.23 to 2.13). This study can be
compared to the study of men by Ascherio et al. (Ref. 19), using a
single diet questionnaire, which reported a RR of 1.36 per 2 percent of
energy from trans fat (95 percent confidence interval from 1.03 to
1.81).
    Three of the prospective studies (Refs. 20, 21, and 38) reported
the CHD risk for the subjects in the top 20 percent of energy intake
from trans fat compared with those in the lowest 20 percent of intake.
Again, the reported RR's were greater than 1.0 with overlapping
confidence intervals. In addition, a report from the Framingham Heart
Study found the RR for CHD in men was 1.12 per teaspoon margarine
intake, with 95 percent confidence interval from 1.05 to 1.20 (Ref.
58). This result corresponds to an RR of 2.05 per 2 percent of energy
from trans fat (95 percent confidence interval from 1.36 to 3.17),
which is very similar to the results of Hu et al. (assuming that a
tablespoon (3 teaspoons) of margarine contains 11 g of fat and that 25
percent of the fat in margarine is trans fat).
    As a further check, the RR reported by Hu et al. (Ref. 38) for
saturated fat may be compared to other prospective studies, such as the
analysis from the Western Electric Study by Shekelle et al. (Ref. 67).
The coefficient reported by Shekelle et al. corresponds to a RR of 1.17
per 5 percent of energy from saturated fat, the same as was reported by
Hu et al. (Ref. 38).
    When used to predict the health benefits of replacing trans fat
with other types of fats or carbohydrates, the Hu et al. (Ref. 38)
paper gives decreases in CHD much larger than those predicted using
only changes in LDL-C and HDL-C. For example, Hu et al. reported that
substitution of monounsaturated fat for trans fat at 2 percent of
energy would decrease CHD risk by 52.4 percent (95 percent confidence
interval of 37 percent to 64 percent).
    Under Scenario 2, FDA calculated the estimated decrease in risk for
CHD when monounsaturated fat is substituted for trans fat. In this
scenario, trans fat intake decreases by 0.61 percent of energy for 45
percent of consumers and by 0.56 percent of energy for 55 percent of
consumers, with a weighted average decrease of 0.58 percent. Using the
relationships of Hu et al. (Ref. 38), the estimated weighted average
decrease in CHD risk is 19.4 percent (95 percent confidence interval of
5.2 percent to 31.6 percent). This decrease is much larger than the
decrease of 1.67 percent estimated for Method 2, which considered
effects for both LDL-C and HDL-C. Even 5.2 percent, the lower limit of
the 95 percent confidence interval, is three times higher than the LDL-
C and HDL-C combined prediction of 1.67 percent.
    Because of the possibilities of errors of measurement (particularly
of dietary intake) or poorly measured or missing confounding variables,
the RR's from these observational studies are imprecise. Although
observational studies have limitations, they also have the advantage
that they can measure directly (within a given study) an association
between dietary intake and disease outcome. This association cannot be
established from the short-term feeding trials. In such trials trans
fat is fed to people for a few weeks, changes in serum lipids are
measured, and it is assumed that the CHD risk associated with trans fat
intake occurs through the mechanism of changes in LDL-C and possibly
HDL-C. In contrast, the observational studies measure actual CHD
occurrence in a large group of people over a period of years, and
describe all CHD risk associated with trans fat intake, regardless of
the mechanism of action by which trans fat intake may be associated
with CHD. The prospective studies therefore raise the possibility that
there may be additional mechanisms by which trans fat contributes to
CHD (such as increases in fasting triglycerides and increases in
lipoprotein (a) (Ref. 62)), and that the actual benefits may be higher
than estimated using Methods 1 and 2.
3. Value of Changes in Health
    In the previous sections, FDA presented potential changes in food
markets because of this proposed rule and described various ways of
calculating the decreases in CHD that would result from those market
changes. Uncertainties in these analyses include:

    
 The size of consumer substitutions among existing
products;
    
 The amount of producer reformulation to avoid losing
market shares;
    
 The types of ingredient substitutions producers will make
to reduce the amount of trans fat in their products; and,
    
 The decrease in CHD that will result from decreased trans
fat in the diet.

    FDA estimated the benefits from the proposed rule for three
scenarios and two methods. The three scenarios estimate plausible
changes over time in the intake of trans fat. The short-term benefits
are associated with the reformulation of margarine and direct consumer
substitutions within the existing product mix (Scenario 4). FDA assumed
that the most likely ingredient substitutions for trans fat in
margarine would be 100 percent cis-monounsaturated fat, or a mixture of
50 percent cis-monounsaturated and 50 percent cis-polyunsaturated fat,
or a mixture of 50 percent cis-monounsaturated and 50 percent saturated
fat (Ref. 73). After 5 years additional benefits are associated with
some reformulation of baked goods (the increase in benefits estimated
for Scenario 3 over Scenario 4). Finally, after 2 more years additional
baked goods reformulation leads to greater benefits (the increase in
benefits estimated for Scenario 2 over Scenario 3). FDA assumed that
the most likely ingredient substitution for trans fat in baked goods
would be a mixture of 50 percent cis-monounsaturated and 50 percent
saturated fat.
    The two methods give low and high estimates of the change in CHD
risk brought about by changing intakes of trans fat. The low method
(Method 1) assumes that the reduction in CHD risk associated with
reduced trans fat intakes comes about through the reduction in LDL-C.
The high method (Method 2) assumes that the reduction in CHD risk comes
about through a combination of reducing LDL-C and increasing HDL-C.
    The reduction in CHD is highly uncertain because the ease of
reformulation, the size of consumer response, and the size of the
effects of trans fat on CHD are uncertain. Also, these changes will
occur over time and can be affected by other, unanticipated events. FDA
dealt with the uncertainty by estimating a range of possible reductions
in CHD associated with the proposed rule. The low and high estimated
benefits can be interpreted as a range of potential effects. As the
previous section showed, however, the actual realized benefits may
exceed the range given by the two methods.
 
[[Page 62772]]
 
 
 
                            Table 4.--Methods and Scenarios Used to Estimate Benefits
----------------------------------------------------------------------------------------------------------------
                                                    Scenarios
-----------------------------------------------------------------------------------------------------------------
             Scenario 4                            Scenario 3                            Scenario 2
----------------------------------------------------------------------------------------------------------------
Margarine reformulation and direct    Margarine reformulation, direct       Margarine reformulation, direct
 consumer response.                    consumer response, and some baked     consumer response, and additional
                                       goods reformulation.                  baked goods reformulation.
All activity begins during the        Margarine reformulation and direct    Margarine reformulation and direct
 compliance period.                    consumer response begins during the   consumer response begins during the
                                       compliance period.                    compliance period.
Health effects occur 3 years after    Some baked goods reformulation is     Some baked goods reformulation is
 effective date.                       completed 5 years after the           completed 5 years after the
                                       effective date.                       effective date.
                                      Health effects from margarine         Additional baked goods reformulation
                                       reformulation, direct consumer        is completed 7 years after the
                                       response occur 3 years after          effective date.
                                       effective date.
                                      Health effects from some baked goods  Health effects from margarine
                                       reformulation occur 8 years after     reformulation, direct consumer
                                       effective date.                       response occur 3 years after
                                                                             effective date.
                                                                            Health effects from some baked goods
                                                                             reformulation occur 8 years after
                                                                             effective date.
                                                                            Health effects from additional baked
                                                                             goods reformulation occur 10 years
                                                                             after effective date.
----------------------------------------------------------------------------------------------------------------
 
 
                                 Methods
------------------------------------------------------------------------
                  Low Estimates of     High Estimates of Change in CHD
     Change in CHD Risk                              Risk
------------------------------------------------------------------------
Assumes that only changes in LDL-C   Assumes that changes in both LDL-C
 affect risk of CHD.                  and HDL-C affect risk of CHD.
------------------------------------------------------------------------
 
    a. CHD morbidity and mortality prevented. FDA calculated the
benefits from the proposed rule as the reduction (from the baseline) in
CHD multiplied by the value of preventing both fatal and nonfatal cases
of CHD. FDA assumed that the cases of CHD prevented by this rule will
have the same proportions of fatal and nonfatal cases as currently
exists in the population. The American Heart Association estimates that
1.1 million heart attack cases of CHD occur annually, with 33 percent
of them fatal. FDA used these estimates as the baseline for the
estimated benefits (Ref. 75). The number of cases varies from year to
year, so FDA treated the annual number of cases as a distribution with
a mean equal to 1.1 million (and a standard deviation of 110,000). FDA
applied the estimated decline in the probability of CHD to the baseline
to get estimates of the number of cases and fatalities prevented by the
proposed rule. FDA estimated the effects using Method 1, which
considers changes only in LDL-C, and using Method 2, which considers
changes in both LDL-C and HDL-C. With Method 1 FDA estimated that, 3
years, 8 years and 10 years after the effective date, the proposed rule
would annually prevent 6,300 cases of CHD and 2,100 deaths, 7,000 cases
and 2,300 deaths, and 7,600 cases and 2,500 deaths. With Method 2 FDA
estimated that, 3 years, 8 years and 10 years after the effective date,
the proposed rule would annually prevent 12,800 cases of CHD and 4,200
deaths, 15,000 cases and 4,900 deaths, and 17,100 cases and 5,600
deaths. Because the association between trans fat consumption and CHD
via changes in LDL-C is more conclusive, the benefits estimated using
Method 1 should be regarded as more certain than the benefits estimated
using Method 2.
    b. Value of CHD morbidity and mortality prevented. The health costs
associated with heart attacks were broken down into the costs of fatal
and nonfatal events. The cost of a fatal event is the discounted years
of life lost multiplied by the dollar value of a quality-adjusted life
year. The average years of life lost from fatal CHD are 13, which is
about 8.4 years when discounted at 7 percent (Ref. 76). FDA used
$100,000 as the value of a life year. That estimate was used by Cutler
and Richardson (Ref. 77) and is close to the estimate used by Zarkin et
al. (Ref. 68) and the estimate used in the economic analysis of the
regulations implementing the 1990 amendments. The average cost per
fatal case is, therefore, approximately $840,000 (8.4 x $100,000).
    For nonfatal cases, FDA estimated the cost to be the sum of the
medical costs, the cost of functional disability, and the cost of pain
and suffering. The functional disability, and pain and suffering
combine to reduce the quality of life for victims. In a recent study,
Cutler and Richardson (Ref. 77) estimated from National Center for
Health Statistics data that the quality adjusted life year for a CHD
survivor was 0.71, which indicates that the annual loss to the victim
is 0.29 quality adjusted years. This loss represents the combined
effects of functional disability and pain and suffering. FDA assumed
that the loss lasts for 13 years, or 8.4 discounted years. FDA did not
estimate the extent to which nonfatal cases reduce life expectancy or
increase other health costs. Because nonfatal cases probably do have
these effects, FDA may have underestimated the health benefits from
preventing nonfatal cases.
    The medical costs for nonfatal CHD are also important. The American
Heart Association estimates that the cost of a new event is about
$22,700 and the total annual costs are $51.1 billion (Ref. 75). If 1.1
million cases lead to $22,700 per case, then all theses cases cost
about $25 billion. The remaining 13.9 million cases average about
$1,900 per year (($51.1 billion - $25 billion) /13.9 million). FDA,
therefore, estimated medical costs per case as $22,700 in the first
year and about $1,900 per year thereafter.
    The total cost per nonfatal case is the sum of lost quality-
adjusted life years multiplied by $100,000 per life year plus the
medical costs of $22,700 plus $1,900 per year times the discounted life
years. FDA estimated the morbidity cost per case to be about $282,000
((0.29 x $100,000 x 8.4) + ($1,900 x 8.4) + $22,700).
    The annual benefits of the proposed rule equal the number of deaths
 
[[Page 62773]]
 
prevented multiplied by the cost per death, plus the number of nonfatal
cases prevented multiplied by the costs per nonfatal case. Because the
number of CHD cases and the number of fatalities vary from year to
year, FDA estimated the benefits with computer simulations that
accounted for the variability. The estimated benefits reported by the
agency are the mean simulated outcomes of Monte Carlo simulations run
with 1,000 iterations.
    The main uncertainty associated with estimating benefits comes from
the lack of knowledge about the correct method linking changes in trans
fat to changes in CHD. FDA represented model uncertainty by presenting
the low results based on the LDL-C alone and the high results based on
the combined effects of trans fat on LDL-C and HDL-C. Representing
uncertainty as a range given by the results for the two methods,
however, understates the true uncertainty because it does not account
for the possibility of other links between trans fat and CHD. If those
other links exist, then the benefits of the proposed rule could be much
higher than estimated by the agency.
    Tables 5 and 6 show the mean of the simulated low and high annual
benefits for Scenarios 2 to 4.
 
[[Page 62774]]
 
 
 
               Table 5.--Low Estimated Benefits of the Proposed Rule for Scenarios 2 to 4 Using Method 1 in Millions of Dollars (benefits discounted at 7 percent in parentheses)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                     Prior to
                                   Three Years                                                                              Seven Years       Eight Years                       Ten Years After
                                      After     Three Years After  Four Years After  Five Years After   Six Years After   After Effective   After Effective  Nine Years After    Effective Date
                                    Effective     Effective Date    Effective Date    Effective Date    Effective Date         Date              Date         Effective Date       and Later
                                       Date
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Scenario 2                                  $0    $2,919 ($2,383)   $2,919 ($2,227)   $2,919 ($2,081)   $2,919 ($1,945)   $2,919 ($1,818)   $3,226 ($1,877)   $3,226 ($1,809)             $3,409
                                                                                                                                                                                     ($1,733\1\)
Scenario 3                                  $0    $2,919 ($2,383)   $2,919 ($2,227)   $2,919 ($2,081)   $2,919 ($1,945)   $2,919 ($1,818)   $3,226 ($1,877)   $3,226 ($1,809)             $3,226
                                                                                                                                                                                     ($1,691\1\)
Scenario 4                                  $0    $2,919 ($2,383)   $2,919 ($2,227)   $2,919 ($2,081)   $2,919 ($1,945)   $2,919 ($1,818)   $2,919 ($1,699)   $2,919 ($1,588)             $2,919
                                                                                                                                                                                    ($1,484\1\)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Discounted values for year ten will continue to decline in later years.
 
 
               Table 6.--High Estimated Benefits of the Proposed Rule for Scenarios 2 to 4 Using Method 2 in Millions of Dollars (benefits discounted at 7 percent in parentheses)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                     Prior to
                                   Three Years                                                                              Seven Years       Eight Years                       Ten Years After
                                      After     Three Years After  Four Years After  Five Years After   Six Years After   After Effective   After Effective  Nine Years After    Effective Date
                                    Effective     Effective Date    Effective Date    Effective Date    Effective Date         Date              Date         Effective Date       and Later
                                       Date
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Scenario 2                                  $0    $5,941 ($4,850)   $5,941 ($4,532)   $5,941 ($4,236)   $5,941 ($3,959)   $5,941 ($3,700)   $6,935 ($4,036)   $6,935 ($3,772)             $7,880
                                                                                                                                                                                     ($4,006\1\)
Scenario 3                                  $0    $5,941 ($4,850)   $5,941 ($4,532)   $5,941 ($4,236)   $5,941 ($3,959)   $5,941 ($3,700)   $6,935 ($4,036)   $6,935 ($3,772)             $6,935
                                                                                                                                                                                     ($3,525\1\)
Scenario 4                                  $0    $5,941 ($4,850)   $5,941 ($4,532)   $5,941 ($4,236)   $5,941 ($3,959)   $5,941 ($3,700)   $5,941 ($3,458)   $5,941 ($3,232)             $5,941
                                                                                                                                                                                     ($3,020\1\)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Discounted values for year ten will continue to decline in later years.
 
 
[[Page 62775]]
 
    Under all scenarios, the benefits are expected to begin 3 years
after the effective date. The 3-year lag occurs because CHD is a
chronic condition, so a dietary change takes several years to begin to
affect the risk of CHD. Under Scenario 3, the benefits increase 8 years
after the effective date. The lag for Scenario 3 is the sum of 3-year
lag for health effects and the 5 years that FDA expects industry to
take to reformulate one-half of the baked goods that can be
successfully reformulated. Under Scenario 2, the benefits increase 10
years after the effective date, with 10 years being the sum of the 3-
year lag for health effects, the 5 years for industry to reformulate
one-half of the baked goods that can be successfully reformulated, and
2 years to reformulate the remaining half of such baked goods. In the
next section, on costs, the agency will explain the assumptions behind
the lag times used to estimate the reformulation of baked goods.
 
D. Costs
 
    FDA has identified several different categories of costs that are
associated with compliance with this proposed rule. Costs of the
regulation include testing costs, decisionmaking costs, relabeling
costs, and reformulation costs (including inventory loss). The basic
formula is described in Figure 2 of this document. Because FDA has
estimated benefits associated with a reduction in trans fat consumption
due to reformulation, the estimated costs associated with reformulation
are included in Figure 2.
 
              Figure 2.--Basic Formula for Cost Estimation
------------------------------------------------------------------------
 
------------------------------------------------------------------------
 
Testing costs per--X--------Number of----------=--------Total testing---
 product                     products tested             costs
                                                        +
Decisionmaking     X        Number of firms    =        Total
 costs per firm              needing to test             decisionmaking
                             their products              costs
                                                        +
Reprinting costs   X        Number of          =        Total
 per information             information                 information
 panel                       panels changed              panel
                                                         reprinting
                                                         costs
                                                        +
Relabeling costs   X        Number of          =        Total relabeling
 per principal               principal                   costs for
 display panel               display panels              principal
                             changed                     display panels
                                                        +
Reformulation      X        Number of          =        Total
 costs (including            products                    reformulation
 inventory loss)             reformulated                costs
 per product                                             (including
                                                         inventory loss)
                                                        = Total costs
------------------------------------------------------------------------
 
    In this analysis, FDA assumed that all product formulations that
include partially hydrogenated oil as an ingredient will be tested to
determine the quantity of trans fat (except for margarine products,
which are all expected to reformulate). The costs are described in
section VI.D.2 of this document.
    The proposed rule states that, for all products containing 0.5 g or
more of trans fat per serving, the amount of trans fat must be added to
the amount of saturated fat in the Nutrition Facts panel and the %DV
for saturated fat must be adjusted accordingly. Also, the adjusted
amount of saturated fat must be marked with an asterisk, and the amount
of trans fat must be stated in a footnote to explain the asterisk. To
avoid listing trans fat in the Nutrition Facts panel, manufacturers may
choose to reformulate their products so that they contain less than 0.5
g trans fat per serving. FDA has estimated the cost of this decision to
relabel or reformulate for each affected firm. These costs are
described in section VI.D.3 of this document.
    If manufacturers choose to relabel only rather than reformulate,
the label for each package size will need to be redesigned and
reprinted. These costs are described in section VI.D.4 of this
document.
    If manufacturers choose to reformulate rather than relabel only,
then the new formulation for each product will need to be developed,
the production process may need to be altered, new ingredients will
need to be purchased, and the new product will need to be consumer
tested. These costs are described in sections VI.D.5 and VI.D.6 of this
document.
    Section VI.C.1.b of this document describes four scenarios for the
effects of the rule. Scenario 1: Maximum Response, estimates the
benefits of totally eliminating trans fats from the diet. The costs
corresponding to this scenario have not been estimated because this
scenario is not expected to occur as a result of this rule. Scenario 2:
Some reformulation and some consumers change their behavior,
corresponds to the full long-term costs estimated in this section.
Scenario 4: Least reformulation and some consumers change their
behavior, corresponds to the near-term costs estimated in this section
for testing, decisionmaking costs, relabeling, and margarine product
reformulation. Scenario 3 is an intermediate scenario between Scenarios
2 and 4. It would correspond to the costs for Scenario 4 plus 50
percent of the costs of the baked product reformulation calculated in
Scenario 2.
1. Products Affected
    The proposed rule covers all food products within the jurisdiction
of the FDA. However, not all FDA-regulated products will be affected by
the proposed rule: Only products that contain 0.5 g or more of trans
fat per serving will be required to label the trans fat content.
Although trans fat does occur naturally in some product groups such as
dairy foods, it is only likely to be present at levels at or above 0.5
g per serving in products containing partially hydrogenated oils.
Therefore, FDA identified the product groups that contain most of the
products that use partially hydrogenated oil as an ingredient.
    These categories do not cover all products that contain partially
hydrogenated oil, but they include the products likely to be affected
most by this rule. Focusing the analysis on these product groups allows
FDA to use data available on product and label content that are
available only by product group. It should be noted, however, that not
all of the products in all of these groups contain partially
hydrogenated oils.
 
[[Page 62776]]
 
    FDA has used data from its Food Label and Package Survey (FLAPS)
data base to estimate the percentage of products in each product group
that contain partially hydrogenated oils. Because FDA did not consider
the FLAPS data to be sufficiently representative of the Cereal and
Refrigerated Spreads product groups for the purpose of this analysis,
FDA has used an informal market survey (Ref. 80) to estimate the
percentage of these products that contain partially hydrogenated oils.
For the Refrigerated Spreads, FDA's informal market survey indicates
that 30 percent of the margarine products have already been
reformulated to reduce trans fat below 0.5 g per serving, some by
removing partially hydrogenated oil from the products. Table 7 of this
document shows the product groups most affected by this proposal and
the percentage and number of products in each group estimated to
contain partially hydrogenated oils. Throughout the cost analysis FDA
has used rounded estimates and has rounded the results of calculations.
The extent of the rounding is reported in the caption for each table.
 
  Table 7.--Product Groups and Number of Products Affected (numbers are rounded to the nearest ten, percentages
                                      are rounded to the nearest 5 percent)
----------------------------------------------------------------------------------------------------------------
                                                                              Percent of
                                                                               Products       Number of Products
                    Product Group                     Number of Products      Containing          Containing
                                                                               Partially           Partially
                                                                           Hydrogenated Oil    Hydrogenated Oil
----------------------------------------------------------------------------------------------------------------
Frozen Breakfast Foods (e.g., waffles, pancakes,            750                 80%                 600
 French toast)
Cereal (e.g., hot, ready-to-eat and granola types)        1,800                 40%                 720
Baking Mixes (e.g., mixes for breads, cakes, and          1,460                 75%               1,100
 cookies)
Breading Products (e.g., breading products and              940                 85%                 800
 croutons)
Frozen Baked Goods (e.g., pies, bagels, breads, and       1,510                 50%                 760
 cookies)
Refrigerated Bread and Pastry Products (e.g., bread       1,770                  5%                  90
 dough and sweet roll dough)
Breads (e.g., bread, cakes, doughnuts and sweet          29,960                 50%              14,980
 rolls)
Crackers                                                  1,910                100%               1,910
Cookies                                                   6,940                 95%               6,590
Baking Needs (e.g., frostings, chocolate chips, and       1,530                 65%               1,000
 pie shells)
Candy and Gum                                            14,910                 40%               5,960
Shortenings and Oils (e.g., lard, cooking oils, and       1,480                 15%                 220
 shortenings)
Refrigerated Spreads (e.g., butter, margarine, and        1,290                 65%                 840
 spreads)
Chip Type Snacks (e.g., popcorn, pretzels, potato        10,220                 70%               7,150
 and corn chips and rice cakes)
Total                                                    76,470                                  42,720
----------------------------------------------------------------------------------------------------------------
 
2. Testing Costs
    For each of the product groups, FDA used the A. C. Nielsen Database
of food products sold in grocery stores with annual sales of $2 million
or more to identify the number of product formulations. For the purpose
of this analysis, FDA assumed that each of these products would be
tested for trans fat content. The Refrigerated Spreads group is not
included because--as will be explained below--FDA expects all margarine
products to be reformulated; there is therefore no reason to test
current margarine products. Research Triangle Institute (RTI) collected
information on trans fat testing costs for FDA. The per product cost of
testing for trans fat is approximately $200 (Ref. 73). Table 8 shows
the number of products in each product group estimated to contain
partially hydrogenated oils and the cost of product testing. Total
testing costs are estimated to be about $8 million.
 
  Table 8.--Number of Products Tested and Cost of Testing by Product Group (numbers are rounded to the nearest
                                                      ten)
----------------------------------------------------------------------------------------------------------------
                                               Number of Products
                                                   Containing        Cost of Testing
                Product Group                       Partially          per Product     Cost of Testing per Group
                                                Hydrogenated Oil
----------------------------------------------------------------------------------------------------------------
Frozen Breakfast Foods                               600                $200                 $120,000
Cereal                                               720                $200                 $144,000
Baking Mixes                                       1,100                $200                 $220,000
Breading Products                                    800                $200                 $160,000
Frozen Baked Goods                                   760                $200                 $152,000
Refrigerated Bread and Pastry Products                90                $200                  $18,000
Breads                                            14,980                $200               $2,996,000
Crackers                                           1,910                $200                 $382,000
Cookies                                            6,590                $200               $1,318,000
Baking Needs                                       1,000                $200                 $200,000
Candy, Gum and Cough Drops                         5,960                $200               $1,192,000
Shortenings and Oils                                 220                $200                  $44,000
Chip Type Snacks                                   7,150                $200               $1,430,000
Total                                             41,880                                   $8,376,000
----------------------------------------------------------------------------------------------------------------
 
    FDA used data from the USDA Food Composition Data to estimate the
number of products that, when tested, are predicted to be found to
contain 0.5 g or more trans fat per serving (Ref. 40). The USDA data
base contains a list of
 
[[Page 62777]]
 
over 200 food products that were analyzed for trans fat content. Where
possible, FDA has grouped the foods in the USDA data base into the
identified product groups and calculated the percentage of the tested
foods in each product group that will be found to contain 0.5 g or more
trans fat per serving. For some product groups, no foods were found in
the USDA data base that contained partially hydrogenated oil. Because
these products are similar to products in the Breads product group, FDA
used the percentage containing 0.5 g or more trans fat from the Breads
product group as a proxy. FDA is aware that some margarine products in
the Refrigerated Spreads product group have recently been reformulated.
Therefore, for this category, FDA used an informal market survey (Ref.
80) to estimate the number of margarine products containing 0.5 g or
more trans fat. Table 9 of this document shows the percentage of foods
in each product group that are estimated to contain 0.5 g or more of
trans fat.
 
 Table 9.--Percentage and Number of Products Containing 0.5 Gram (g) or More trans Fat per Serving (numbers are
                                           rounded to the nearest ten)
----------------------------------------------------------------------------------------------------------------
                                                                             Percentage of
                                                                               Products
                                                                              Containing
                                                      Number of Products       Partially      Number of Products
                    Product Group                         Containing       Hydrogenated Oil    Containing 0.5 g
                                                           Partially        Also Containing    or More Trans Fat
                                                       Hydrogenated Oil      0.5 g or More        per Serving
                                                                             Trans Fat per
                                                                                Serving
----------------------------------------------------------------------------------------------------------------
Frozen Breakfast Foods                                      600              70%\1\                 420
Cereal                                                      720                 40%                 290
Baking Mixes                                              1,100              70%\1\                 770
Breading Products                                           800              70%\1\                 560
Frozen Baked Goods                                          760              70%\1\                 530
Refrigerated Bread and Pastry Products                       90              70%\1\                  60
Breads                                                   14,980                 70%              10,490
Crackers                                                  1,910                100%               1,910
Cookies                                                   6,590                100%               6,590
Baking Needs                                              1,000                100%               1,000
Candy, Gum and Cough Drops                                5,960                 70%               4,170
Shortenings and Oils                                        220                 80%                 180
Refrigerated Spreads                                        840                 80%                 670
Chip Type Snacks                                          7,150                 60%               4,290
Total                                                    42,720                                  31,930
----------------------------------------------------------------------------------------------------------------
\1\ Estimate from the breads product group used as a proxy.
 
3. Decisionmaking Costs
    To comply with this rule, firms will need to gain an understanding
of the policy of the regulation, interpret that policy for their
products, and determine the scope and coverage through analytical
testing. Those firms that determine through testing that they are
making products that contain 0.5 g or more of trans fat per serving
will need to determine the options they have for compliance, gather
information on the implications of each option, and decide whether to
only relabel or to reformulate these products. The costs of all these
decisionmaking activities are the decisionmaking costs of the rule.
    Several factors affect the size of decisionmaking costs, including
the complexity of the regulation, the number of distinct products
affected, the size of the firm, and the length of the compliance
period. This proposal involves analytical testing and product
reformulation, and, therefore, compliance with it demands significant
decisionmaking effort. The more products that a firm makes that are
affected by a regulation, the greater the decisionmaking effort needed
to determine the compliance strategy of the firm. These factors largely
explain why large firms typically have higher decisionmaking costs than
do small firms. An additional factor relating to firm size is that
large firms typically have more complex (and costly) decisionmaking
processes than do small firms. Finally, longer compliance periods (the
length of time between the publication of the final rule and the
effective date of the regulation) reduce decisionmaking costs, because
there is less need for overtime and for the rescheduling of planned
activities. Within the compliance periods considered, a doubling of the
compliance period cuts decisionmaking costs in half. The estimate of
decisionmaking costs presented here is based on a 2-year compliance
period.
    For the purpose of this analysis, FDA assumes that each of the
firms that make products containing 0.5 g or more trans fat per serving
will bear decisionmaking costs for a complex regulation.
    To estimate the number of these firms, FDA estimated the total
number of firms that make foods in each product group. Next, FDA
estimated the percentage of these firms (by group product) that make
foods containing 0.5 g or more trans fat per serving. FDA expects these
firms to bear decisionmaking costs for compliance with this rule.
    Precise data are not available on the number of firms that make
foods for each product group. Instead, FDA has used data from Dun and
Bradstreet Market Identifiers to estimate the number of firms making
food in each Standard Industry Classification (SIC) most closely
related to each product group. Table 10 shows each product group along
with the SIC code that most closely corresponds to each product group.
It also shows the number of small and large firms producing food in
each category. FDA has used the Small Business Administration (SBA)
guidelines to define small businesses in each SIC. Unless otherwise
noted, a small business is defined as one having 500 or fewer
employees.
 
[[Page 62778]]
 
 
 
    Table 10.--Number of Firms Making Products in Each Product Group (numbers are rounded to the nearest ten)
----------------------------------------------------------------------------------------------------------------
                                   Dun & Bradstreet
         Product Group            Market Identifier     Number of Small     Number of Large     Total Number of
                                         SIC                 Firms               Firms               Firms
----------------------------------------------------------------------------------------------------------------
Frozen Breakfast Foods           20389901, 20389904,         10                  10                  20
                                  20389910
Cereal                           2043                     60\1\                  10                  70
Baking Mixes                     204103                      40                  20                  60
Breading Products, Frozen Baked  2051                     3,000               1,340               4,340
 Goods, Refrigerated Bread and
 Pastry Products, Breads
Crackers Cookies                 2052                    660\2\                 280                 940
Baking Needs, Candy, Gum, and    206499                     430                  20                 450
 Cough Drops
Shortenings and Oils,            207901, 207902,          80\2\                  20                 100
 Refrigerated Spreads             207999
Chip Type Snacks                 2096                       320                  90                 410
Total                                                     4,600               1,790               6,390
----------------------------------------------------------------------------------------------------------------
\1\ Small business is defined as 1,000 employees or fewer.
\2\ Small business is defined as 750 employees or fewer.
 
    FDA has information on the percentage of products in each product
group that contain 0.5 g or more of trans fat, but it does not have
information on the percentage of firms in each category that make such
products. To estimate the number of firms affected by the rule, FDA
assumed that when a small percentage of products contain 0.5 g or more
trans fat per serving, then a proportionally smaller percentage of
firms are making such products. Conversely, when a large percentage of
products in a product group contain 0.5 g or more trans fat per
serving, then a proportionally larger percentage of firms are making
such products. In other words, FDA assumed that individual firms are
more likely to make products that are similar in composition to the
preponderance of products on the market and less likely to make
products that are different in composition.
    To translate the estimate of the percentage of products that
contain 0.5 g or more of trans fat into an estimate of the percentage
of firms making such products, FDA has used the cumulative normal
distribution with a mean of 0.5 and a standard deviation of 0.2.
Graphically, this relationship is slightly S-shaped (a standard
deviation larger than 0.2 would yield a more pronounced S-shape). Using
a mean of 0.5 yields the result that when 50 percent of the products
contain 0.5 g or more trans fat per serving, then 50 percent of the
firms are estimated to be making such products.
    Where FDA combined different product groups to fit within a single
SIC, it averaged the percentages of products with 0.5 g or more trans
fat per serving in the product group. Table 11 of this document shows
the percentage and number of firms by size in each SIC estimated to
make products containing 0.5 g or more trans fat per serving. FDA
assumed that small firms are just as likely to make products containing
0.5 g or more trans fat per serving as large firms are.
 
 Table 11.--Percentage and Number of Firms by Size Making Products Containing 0.5 Gram (g) or More trans Fat per
       Serving (numbers are rounded to the nearest ten, percentages are rounded to the nearest 5 percent)
----------------------------------------------------------------------------------------------------------------
                                                         Percentage of      Number of Small     Number of Large
                                     Percentage of       Firms Making        Firms Making        Firms Making
     Dun & Bradstreet Market           Products            Products            Products            Products
         Identifier SIC            Containing 0.5 g    Containing 0.5 g    Containing 0.5 g    Containing 0.5 g
                                   or More trans Fat   or More trans Fat   or More Trans Fat   or More Trans Fat
                                      per Serving         per Serving         per Serving         per Serving
----------------------------------------------------------------------------------------------------------------
20389901,04,10                          55%                 60%                  10                  10
2043                                    15%                  5%                   0                   0
204103                                  55%                 60%                  20                  10
2051                                    30%                 15%                 450                 200
2052                                    95%                100%                 660                 280
206499                                  30%                 15%                  60                   0
207901,02,99                            50%                 50%                  40                  10
2096                                    40%                 30%                 100                  30
Total                                                                         1,340                 540
----------------------------------------------------------------------------------------------------------------
 
    FDA used the Food Labeling Cost Model developed by RTI for the NLEA
rules to estimate the per firm decisionmaking costs borne by firms for
this rule (Ref. 74). FDA did not directly apply the RTI model of costs.
Instead, the agency assumed that the decisionmaking costs per firm for
the proposed rule would be similar in magnitude--although not identical
in detail--to the administrative costs per firm in the RTI model. In
other words, the agency assumed that the level of effort but not the
decisions involved were the same for the firms affected by the proposed
rule and the firms in the RTI model. FDA estimates the decisionmaking
costs to be $3,500 for a small firm and $25,000 for a large firm. Table
12 of this document shows the estimated decisionmaking costs for the
rule.
 
[[Page 62779]]
 
 
 
 Table 12.--Percentage and Number of Firms by Size Making Products Containing 0.5 Gram (g) or More trans Fat per
                                Serving (numbers are rounded to the nearest ten)
----------------------------------------------------------------------------------------------------------------
                      Number of Small     Number of Large
                       Firms Making        Firms Making
 Dun & Bradstreet        Products            Products        Decisionmaking Cost for    Decisionmaking Cost for
 Market Identifier   Containing 0.5 g    Containing 0.5 g      Small Firms per SIC        Large Firms per SIC
        SIC          or More trans Fat   or More trans Fat
                        per Serving         per Serving
----------------------------------------------------------------------------------------------------------------
20389901,04,10             10                  10                  $35,000                   $250,000
2043                        0                   0                       $0                         $0
204103                     20                  10                  $70,000                   $250,000
2051                      450                 200               $1,575,000                 $5,000,000
2052                      660                 280               $2,310,000                 $7,000,000
206499                     60                   0                 $210,000                         $0
207901,02,99               40                  10                 $140,000                   $250,000
2096                      100                  30                 $350,000                   $750,000
Total                   1,340                 540               $4,690,000                $13,500,000
----------------------------------------------------------------------------------------------------------------
 
    Total decisionmaking costs of the rule are estimated to be about
$18 million.
4. Relabeling Costs
    The two areas of a product's label that may be changed are: (1) The
information panel (to alter the saturated fat line and add the footnote
to the nutrition label or to change the list of ingredients), and (2)
the principal display panel (to remove claims). Each firm must choose
whether to change only the labels of existing products to reflect the
proposed changes or to reformulate products to reduce or eliminate
trans fat and relabel the reformulated products appropriately. If a
firm chooses to reformulate a product, it will have to change the
product's ingredient list. Therefore, regardless of how a firm chooses
to comply with this rule, all labels of all products currently
containing 0.5 g or more of trans fat will have to be changed to
reflect changes in either the Nutrition Facts panel or the ingredient
list or both. The cost to change the Nutrition Facts panel is
equivalent to the cost to change the ingredient list.
    a. Changes to the information panel. The number of labels that will
be changed is greater than the number of products that contain 0.5 g or
more trans fat because product formulations come in various-sized
packages. For example, for a cracker product that contains 0.5 g or
more trans fat per serving and that is sold in 3 different-sized
packages, the labels of each of the 3 packages must be changed.
    For each of the product groups, FDA used the A. C. Nielsen Database
of food products sold in grocery stores with annual sales of $2 million
or more to identify the number of food labels. Using this data base for
each product group, FDA has calculated the ratio of the number of
labels stockkeeping units (SKU's) to the number of products. FDA then
multiplied the number of products estimated to contain 0.5 g or more
trans fat per serving with this SKU/product ratio to estimate the
number of labels that will be changed.
    FDA has based its estimate of the cost of changing each information
panel on the expectation of a three-color change and a 2-year
compliance period. The cost of changing labels varies across product
groups because the type of package and label varies. For example, if
the label is attached to the package, the cost of the label change is
less than if the label is an integrated part of the package. With a 2-
year compliance period, there should be no label inventory loss.
    Table 13 of this document shows the estimated number of labels to
be changed in each product group and the cost of the label change.
Total information panel relabeling costs are estimated to be about $30
million.
 
 Table 13.--Number of Information Panels Changed and Cost of Reprinting (numbers are rounded to the nearest ten,
                                   dollars are rounded to the nearest hundred)
----------------------------------------------------------------------------------------------------------------
                                               Number of SKU's\1\
                                                  for Products
                Product Group                    Containing 0.5      Reprinting Cost      Reprinting Cost per
                                               gram or More Trans        per SKU             Product Group
                                                 Fat per Serving
----------------------------------------------------------------------------------------------------------------
Frozen Breakfast Foods                               460              $1,000                 $460,000
Cereal                                               370               $0\2\                       $0
Baking Mixes                                         880                $300                 $264,000
Breading Products                                      0              $1,300                       $0
Frozen Baked Goods                                   620              $1,300                 $806,000
Refrigerated Bread and Pastry Products                70              $1,300                  $91,000
Breads                                            12,800              $1,300              $16,640,000
Crackers                                           2,270                $500               $1,135,000
Cookies                                            8,170                $500               $4,085,000
Baking Needs                                       1,150                $800                 $920,000
Candy, Gum, and Cough Drops                        5,340                $800               $4,272,000
Shortenings and Oils                                 280                $100                  $28,000
Refrigerated Spreads                                 730                $100                  $73,000
Chip Type Snacks                                   5,530                $200               $1,106,000
Total                                             38,670                                  $29,880,000
----------------------------------------------------------------------------------------------------------------
\1\ Stockkeeping units.
\2\ Cereal product labels are changed so frequently that the reprinting cost of changing an information panel
  with a three-color change and a 2-year compliance period amounts to a cost of less than $50 per SKU.
 
 
[[Page 62780]]
 
    b. Changes to principal display panel. In addition to changes that
will be required to change the Nutrition Facts panel or to change the
ingredient statement, there will be label changes required for a
smaller number of products because of the loss of nutrient content
claims about saturated fat or cholesterol. These changes are likely to
involve changes to the principal display panel and other marketing-
related labeling. FDA assumed that claims in the Refrigerated Spread
product group are on margarine products that will be reformulated.
Therefore, claims on these products will not be affected. Costs to make
these changes are related to both costs per SKU (Table 14 of this
document) and costs per firm (Table 15 of this document).
    The types of claims affected by this proposal are low and reduced
saturated fat claims; cholesterol free, low cholesterol, and reduced
cholesterol claims; lean and extra lean claims; healthy claims; and
four health claims with established qualifying levels of saturated fat
as follows: (1) Fat and the risk of cancer (through the saturated fat
criterion for extra lean, Sec. 101.73); (2) dietary saturated fat and
cholesterol and the risk of coronary heart disease (Sec. 101.75); (3)
fruits, vegetables, and grain products that contain fiber and the risk
of coronary heart disease (Sec. 101.77); and (4) soluble fiber from
certain grains and the risk of coronary heart disease (Sec. 101.81).
The cost estimate in this section only refers to the effects of this
proposal on the relevant saturated fat and cholesterol claims. FDA does
not have sufficient information on the number of SKU's with the lean,
extra lean, or healthy claims or the four health claims to include them
in this analysis. FDA believes that not including these costs does not
result in a serious underestimation of the costs of this proposal and
requests comments on this issue.
    To determine the number of SKU's with affected claims, FDA
multiplied the number of products in each product group with such
saturated fat or cholesterol claims by the percentage of products in
the product group estimated to have 0.5 g or more trans fat per
serving. FDA then multiplied the result by the SKU/product ratio for
the product group.
    FDA does not have information to estimate the percentage of
existing saturated fat and cholesterol claims that could not continue
to be made under this proposal. For the purpose of this analysis, FDA
assumed that 50 percent of these claims would be lost. That a
significant portion of claims would be lost is reasonable, because
producers are likely to be making claims on many products that are
nutritionally very near the qualifying limit for the claim. More
stringent qualifying levels for the claims are likely to affect the
presumably large percentage of products that are clustered close to the
existing qualifying levels. FDA's assumptions yield an estimate that
less than eight percent ((2,990 <divide> 38,670) x 100) of the number
of SKU's for products containing 0.5 g or more trans fat per serving
will have changes to the principal display panel.
    Several factors determine the cost of relabeling for claim changes.
There are costs for market testing of a new design for the principal
display panel to replace the design of the panel that had been
previously accepted in the market when the product was able to bear the
claim. There are costs for redesign and reprinting of the principal
display panel. There are also costs for administrative activities
associated with removing the claim from all marketing and labeling.
    FDA has used the RTI Labeling Model to estimate the per SKU
redesign and printing costs associated with the change in the principal
display panel. Table 14 of this document shows the number of SKU's
estimated to need changes in the principal display panel and the
redesign and printing costs of such changes.
 
 Table 14.--Number of Principal Display Panels Changed and Cost of Redesign and Reprinting (numbers are rounded
                                               to the nearest ten)
----------------------------------------------------------------------------------------------------------------
                                               Number of SKU's\1\
                Product Group                  Changed for Claims     Cost per SKU       Cost per Product Group
----------------------------------------------------------------------------------------------------------------
Frozen Breakfast Foods                                40              $1,900                  $76,000
Cereal                                                40                  $0                       $0
Baking Mixes                                          30                $600                  $18,000
Breading Products                                      0              $2,500                       $0
Frozen Baked Goods                                    40              $2,500                 $100,000
Refrigerated Bread and Pastry Products                 0              $2,500                       $0
Breads                                               640              $2,500               $1,600,000
Crackers                                             590                $800                 $472,000
Cookies                                            1,350                $800               $1,080,000
Baking Needs                                          20              $1,500                  $30,000
Candy, Gum, and Cough Drops                            0              $1,500                       $0
Shortenings and Oils                                  20                $100                   $2,000
Chip Type Snacks                                     220                $300                  $66,000
Total                                              2,990                                   $3,444,000
----------------------------------------------------------------------------------------------------------------
\1\ Stockkeeping units.
 
     FDA adapted information from the RTI labeling model to estimate
the additional costs associated with changing principal display panels.
These additional costs consist of market testing costs and marketing
administrative costs. FDA estimates market testing costs--the costs of
employee taste panels, consumer focus groups, and other marketing
tests--to be $2,000 per product for small firms and $23,500 per product
for large firms. Marketing administrative costs include planning the
change to a new label, making decisions about the appearance of the new
principal display panel, and monitoring the marketing tests. The agency
did not have direct estimates of these administrative marketing costs
per product, but industry sources have asserted that these costs are at
least as large as the market testing costs. The agency assumed that
marketing administrative costs per product would be about the same as
the administrative costs per firm associated with a complex labeling
rule in the RTI labeling model because the amounts of effort were
similar. The estimates of marketing administrative costs are $3,500 per
product for small firms and $25,000 per product for large firms. FDA,
therefore estimates the total cost per product of
 
[[Page 62781]]
 
changing a principal display panel to be $5,500 for small firms and
$48,500 for large firms. The estimates for these costs are applied per
product as a weighted average based on the percentage of products made
by small and large firms taken from the Enhanced Establishment Database
of FDA-inspected firms developed by RTI (Ref. 73).
    Table 15 of this document shows the number of products estimated to
need changes in the principal display panel and the cost of market
testing and administrative activity. Total principal display panel
relabeling costs are estimated to be about $43 million ($3 million for
redesign and printing plus $40 million for market testing and
administrative activity). These costs do not include the cost to
producers of the lost value of the firm-specific capital developed by
marketing under existing claims or the cost to consumers of searching
for and switching to new products.
 
     Table 15.--Number of Principal Display Panels Changed and Cost of Marketing Changes and Administrative
     Activities (number of products are rounded to the nearest ten, dollars rounded to the nearest thousand)
----------------------------------------------------------------------------------------------------------------
                                               Number of Products   Average Cost per
                Product Group                  Changed for Claims        Product         Cost per Product Group
----------------------------------------------------------------------------------------------------------------
Frozen Breakfast Foods                                40             $20,000                 $800,000
Cereal                                                30             $19,000                 $570,000
Baking Mixes                                          30             $16,000                 $480,000
Breading Products                                      0             $14,000                       $0
Frozen Baked Goods                                    30             $14,000                 $420,000
Refrigerated Bread and Pastry Products                 0             $14,000                       $0
Breads                                               520             $14,000               $7,280,000
Crackers                                             500             $17,000               $8,500,000
Cookies                                            1,090             $17,000              $18,530,000
Baking Needs                                          20             $14,000                 $280,000
Candy, Gum, and Cough Drops                            0             $14,000                       $0
Shortenings and Oils                                  10             $17,000                 $170,000
Chip Type Snacks                                     170             $15,000               $2,550,000
Total                                              2,440                                  $39,580,000
----------------------------------------------------------------------------------------------------------------
 
5. Margarine Reformulation Costs
    The proposal states that if a product contains 0.5 g or more trans
fat, then its label must meet certain requirements. Manufacturers may
comply with this rule in either of two ways: (1) Relabel the product so
that it complies with the rule, or (2) reformulate the product so that
it contains less than 0.5 g of trans fat and will not be affected by
the rule. When manufacturers are faced with reporting more saturated
fat than previously reported, as well as revealing the presence of
trans fat that consumers had not previously realized was present,
reformulation is a likely response to avoid the reduced demand for
products with labeled trans fat. Therefore, FDA has estimated the costs
of both of these compliance choices.
    FDA assumes that producers will decide whether or not to
reformulate on a product-by-product basis. They will choose to
reformulate when the expected private benefits minus the expected
private costs of reformulating the product exceed the expected private
benefits minus expected private costs of just relabeling the product.
In other words, if a product is expected to lose market share because
of the new disclosure, then manufacturers must compare lost sales to
the cost of reformulation.
    FDA expects that, in the near term, manufacturers will reformulate
all margarine products containing 0.5 g or more of trans fat per
serving in response to this rule. The following five pieces of
information support this expectation. First, in Germany and some other
European countries, the actual, demonstrated market response to
consumer concern about trans fat is that all margarine products have
been reformulated to eliminate trans fat. Second, many people who
currently consume margarine products are likely to do so to consume
less saturated fat than is in butter. Because the rule would raise the
reported amount of saturated fat on any unreformulated margarine
products, these margarine consumers are likely to search for margarine
products with lower levels of reported saturated fat. Third, publicity
of the issue by consumer groups has highlighted margarine as a source
of trans fat and has given prominent attention to reformulated
margarine products. As more margarine products are reformulated, the
emphasis of publicity by consumer groups will probably shift to calling
attention to any remaining margarine products that do not reformulate.
Fourth, information from RTI indicates that producers of margarine know
more about the reformulation of margarine products than producers of
other products know about the reformulation of those products and that,
on the whole, U.S. margarine producers plan to reformulate to eliminate
trans fat (Ref. 73). Fifth, by an informal market survey (Ref. 80), FDA
estimates that 30 percent of margarine products in the United States
have already, before publication of this proposal, been reformulated to
eliminate trans fat.
    For this analysis, FDA estimates that this rule will result in the
reformulation of all 670 remaining margarine products that contain
trans fat to reduce trans fat below 0.5 g per serving within a 2-year
compliance period.
    The reformulation of food products is a very costly process.
Although the process is likely to vary from company to company, the
following provides a description of a typical process. FDA requests
information on processes different from that described here. First,
management, in conjunction with research and development, must
determine which products are the best candidates to be reformulated.
Next, laboratories (either in-house or out-source) are used to develop
a new formula with acceptable characteristics for consumers. Then, an
investigation must be made to determine that the new ingredients are
available in sufficient quantity and at an acceptable price. Also, in
the case of food additives, it may be necessary to determine that the
new ingredients are approved for use in the food being reformulated. It
may also be necessary to find a source for new equipment. If all of
these activities do not rule out a new formulation, then a test kitchen
is used to make the product in small batches. In the test kitchen,
 
[[Page 62782]]
 
some new formulations will be rejected and others will be improved.
    Those new formulations that are found acceptable in the test
kitchen are then tested in a pilot plant. The difference between the
test kitchen and the pilot plant can be dramatic. Formulations that
work well in small batches may be totally unacceptable when produced on
a large scale. If tests at the pilot plant go well, then trials of the
new formulation begin at actual, full-scale processing plants. A
crucial issue for large-scale, commercial production is whether
existing equipment is adaptable to the new product formulation. After
all of these stages, if a new formulation is acceptable for large-
scale, commercial production, then there are costs of label redesign,
marketing, management and employee training, the purchase of new
ingredients, and some inventory loss of either old labels or old
ingredients (because the labels must match the ingredients). This
entire process is time-intensive, taking about 1 year, on average. In
general, large firms will have the capacity to perform all of these
steps in-house, whereas small firms will contract out most of them.
Nevertheless, on a per product basis, the process is the same for large
and small firms.
    FDA has made an estimate of the cost of reformulation based on
information on the cost of reformulating tortilla chips supplied by
industry (Ref. 78). The costs of reformulation are divided into three
categories: (a) Formulation development and testing costs, (b)
inventory loss, and (c) ingredient costs. As described in the following
sections, the total cost of margarine reformulation because of this
rule is estimated to be $302 million.
     a. Formulation development and testing costs. The formulation
development process is estimated to require approximately 5,000 hours
of professional time (product scientists, sensory scientists,
analytical chemists, manufacturing engineers, and quality control
scientists) at $30 per hour per product. This estimate of labor time
may be low. It assumes that the first attempt at reformulation is fully
successful. Additionally, there are operating expenses for the
laboratories, the pilot plants, and the switchover and retooling of
manufacturing plants. Finally, there are costs for market testing to
determine that the new formulation is acceptable to consumers for the
entire shelf life of the product. The shelf-life issue has a
significant impact on the amount of time required to market a new
formulation. For example, if a product has a shelf life of 2 years,
then a new formulation for the product cannot be approved for
production until the new formulation has been shelved for 2 years.
Table 16 of this document shows the estimated per product formulation
development and testing costs. FDA considers these estimates to be
uncertain because of the limited amount of information available at
this time and requests comment on the cost of reformulation on a
product specific basis.
 
    Table 16.--Formulation Development and Testing Costs per Product
------------------------------------------------------------------------
                     Category                               Cost
------------------------------------------------------------------------
Professional Labor (5,000 hours at $30 per hour)       $150,000
Development Facility Operation                         $190,000
Market Testing                                         $100,000
Total                                                  $440,000
------------------------------------------------------------------------
 
    The total cost of formulation development and testing for the 670
margarine products that would be reformulated near-term because of this
rule is $295 million.
     b. Inventory loss. A loss of inventory of either labels for the
old formulation or ingredients that are not included in the new
formulation is expected. The loss of label inventory can be reduced to
zero with a long enough compliance period. However, the reformulation
of a product requires a simultaneous change of ingredients and labels.
Because both ingredients and labels must be ordered months in advance,
it is difficult to order the amount of ingredients and labels such that
both are used up completely in the same package.
    The actual cost of inventory loss depends on how closely producers
are able to coordinate the use of ingredients and labels and on the
cost of disposing of the surplus ingredients or labels. FDA assumed a
fixed amount of $10,000 per SKU for this cost. The total cost of
inventory loss for the 730 margarine SKU's that will be reformulated
because of this rule is $7 million.
     c. Ingredient costs. For margarine reformulation, FDA has
estimated no increase in ingredient costs, because the price of
reformulated margarine products that are already on the market is no
higher than the price of margarine products containing 0.5 g or more
per serving of trans fat. The different ingredients used in the
products appear to have had no impact on the cost of production.
However, as greater numbers of products are reformulated, the increased
demand for the substitute ingredients may increase costs. FDA requests
comments on this aspect of costs.
6. Baked Products Reformulation
    In addition to the near term reformulation of margarine products
expected within the compliance period of the rule, FDA expects that in
the long term some baked products (product groups Breads (including
cakes), Crackers, and Cookies) will be reformulated. On average, these
products contain large amounts of trans fat relative to the amounts of
saturated fat that they contain. FDA's estimate of the amount of
reformulation in these product groups is based on two factors: (1) The
number of claims potentially lost because of the rule, and (2) the size
of the producing firm.
    As described in section VI.D.4.b of this document, only 50 percent
of the SKU's with claims are assumed to lose those claims. Therefore,
only 50 percent of the SKU's with claims are likely to be candidates
for reformulation.
    Because reformulation is so expensive on a per product basis, FDA
assumed that only large firms making these products will reformulate.
Also, in the absence of information, FDA assumed that each large firm
is just as likely as each small firm is to make a product with a claim.
Therefore, the percentage of products losing claims that will be
reformulated is equivalent to the percentage of large firms making
products containing 0.5 g or more trans fat. Table 17 of this document
shows the estimate of the number of products that will be reformulated.
    FDA is assuming that only a very small percentage of the products
in these categories will be reformulated because of the cost of
reformulation and the limited consumer appeal (in terms of market
share) that foods with health claims in these categories have had thus
far. If producers perceive that consumers will respond more negatively
to the information on trans fat than they have responded thus far to
the information on saturated fat, then the actual number of products
reformulated may be greater. If that happens, the actual costs of the
rule will be greater than those estimated here. However, the benefits
will increase to an even greater degree, so that the net benefits of
the rule will be even greater than estimated in this analysis.
 
[[Page 62783]]
 
 
 
 Table 17.--Number of SKU's\1\ and Products Losing Claims Due to Changes in Qualifications for Claims and Number
                of Products Reformulated by Large Firms (numbers are rounded to the nearest ten)
----------------------------------------------------------------------------------------------------------------
                                                                                                   Products
                                                                                               Reformulated as a
                                                                          Number of Products     Percentage of
          Product Group             Number of SKU's   Number of Products   Reformulated Long    Total Products
                                     Losing Claims       Losing Claims       Term (made by      Containing 0.5
                                                                             large firms)     gram or more trans
                                                                                                Fat per Serving
----------------------------------------------------------------------------------------------------------------
Breads                                  640                 530                 160                   1.5%
Crackers                                590                 500                 150                  8%
Cookies                               1,350               1,090                 330                  5%
Total                                                                           640                  3%
----------------------------------------------------------------------------------------------------------------
\1\ Stockkeeping units.
 
    Because FDA has no specific information on the timing of
reformulation, FDA assumed that the reformulation for these baked
products would be divided evenly into two stages. In stage 1, producers
will attempt to reformulate products with the best potential for
reformulation. In stage 2, producers will make use of the products,
knowledge and technologies developed in stage 1 of reformulation to
reformulate a second set of products.
    Stage 1 of products is assumed to take 5 years of ongoing labor
effort in the product development facilities to develop a satisfactory
reformulation for these products. The effort is expected to be fully
successful only in the fifth year. The product development teams
involved in the stage 1 reformulation effort should learn a great deal
about the reformulation of baked products in the process. Therefore,
FDA assumes that reformulation of the stage 2 of products will take 2
years of ongoing labor effort in the product development facilities.
    Tables 18 and 19 of this document show the expected annual cost per
product of the reformulation development process in both stages of
reformulation along with the present value of the costs for each year.
The total discounted present value of the cost of stage 1 reformulation
activity is about $1 million per product and about $400,000 for stage 2
reformulation activity.
    FDA has not attempted to estimate the ongoing increased cost of
substitutes for partially hydrogenated oil. Competition provides
producers with incentives to use the least expensive ingredients that
are acceptable for the quality of product they are making. Therefore,
in general, any change in existing formulations (such as is expected to
occur as a result of this rule) will increase the cost of ingredients.
Even a very small increase in the price of a minor ingredient can
amount to an increase in production costs of millions of dollars when
multiplied by millions of units. However, FDA does not have sufficient
information on the types of substitutes that will be used, on the
volume of substitutes that will be needed, on the future price of the
substitutes at the time that reformulation is completed, or on the
increase in price that could be expected as a result of reformulation
of a sizable part of the food industry. For this reason the estimated
cost of reformulation presented here is likely to be an underestimate
of the true cost. Also, FDA has not included the cost of relabeling the
reformulated baked good products. This cost would be so small in
comparison to the costs of reformulation that it would not change the
discounted estimate at the level of precision used here.
 
Table 18.--Expected Annual and Discounted Cost of Long-Term Reformulation Development Process for a Single Baked
                        Product in Stage 1 (dollars are rounded to the nearest thousand)
----------------------------------------------------------------------------------------------------------------
                                                                                       Present Value (discounted
        Year                        Category                    Annual Expenditure               at 7%)
----------------------------------------------------------------------------------------------------------------
1                     Labor ($150,000) and facilities             $200,000                   $187,000
                       ($50,000)
2                     Labor ($150,000) and facilities             $200,000                   $175,000
                       ($50,000)
3                     Labor ($150,000) and facilities             $200,000                   $163,000
                       ($50,000)
4                     Labor ($150,000) and facilities             $200,000                   $153,000
                       ($50,000)
5                     Fully successful reformulation              $450,000                   $321,000
                       ($450,000)
Total                                                                                        $999,000
----------------------------------------------------------------------------------------------------------------
 
 
Table 19.--Expected Annual and Discounted Cost of Long-Term Reformulation Development Process for a Single Baked
                        Product in Stage 2 (dollars are rounded to the nearest thousand)
----------------------------------------------------------------------------------------------------------------
                                                                                       Present Value (discounted
        Year                        Category                    Annual Expenditure               at 7%)
----------------------------------------------------------------------------------------------------------------
6                     Labor ($150,000) and facilities             $200,000                   $133,000
                       ($50,000)
7                     Fully successful reformulation              $450,000                   $280,000
                       ($450,000)
Total                                                                                        $413,000
----------------------------------------------------------------------------------------------------------------
 
    Table 20 of this document shows the total discounted cost of both
stages of long term reformulation for these baked product categories.
 
[[Page 62784]]
 
 
 
Table 20.--Discounted Cost of Long-Term Baked Good Reformulation (numbers of products are rounded to the nearest
                               five, dollars are rounded to the nearest thousand)
----------------------------------------------------------------------------------------------------------------
                Number of Baked                                   Number of Baked
                   Products                                          Products
   Product      Reformulated in        Discounted Cost of         Reformulated in        Discounted Cost of
    Group      Stage 1 (made by     Reformulation in Stage 1     Stage 2 (made by     Reformulation in Stage 2
                 large firms)                                      large firms)
----------------------------------------------------------------------------------------------------------------
Breads               80                 $80,000,000                    80                 $33,000,000
Crackers             75                 $75,000,000                    75                 $31,000,000
Cookies             165                $165,000,000                   165                 $68,000,000
Total               320                $320,000,000                   320                $132,000,000
----------------------------------------------------------------------------------------------------------------
 
7. Cost Summary
    In summary, Table 21 of this document provides an overview of the
extent of the effect of the rule on products and firms in each product
group significantly affected.
 
                      Table 21.--Summary of Number of Products, Firms, and Labels Affected
----------------------------------------------------------------------------------------------------------------
                                     Number of
                     Number of     Products With     Number of       Number of       Number of       Number of
  Product Group      Products       0.5 gram or     Firms with      Information      Principal       Products
                      Tested      More trans Fat  Decisionmaking  Panels Changed  Display Panels   Reformulated
                                    per Serving        Costs                          Changed
----------------------------------------------------------------------------------------------------------------
Frozen Breakfast      600             420              20             460              40               0
 Foods
Cereal                720             290               0             370              40               0
Baking Mixes        1,100             770              30             880              30               0
Breading              800             560             650               0               0               0
 Products
Frozen Baked          760             530                             620              40               0
 Goods
Refrigerated           90              60                              70               0               0
 Bread and
 Pastry Products
Breads             14,980          10,490                          12,800             640             160
Crackers            1,910           1,910             940           2,270             590             150
Cookies             6,590           6,590                           8,170           1,350             330
Baking Needs        1,000           1,000              60           1,150              20               0
Candy, Gum, and     5,960           4,170                           5,340               0               0
 Cough Drops
Shortenings and       220             180              50             280              20               0
 Oils
Refrigerated            0             670                             730               0             670
 Spreads
Chip Type Snacks    7,150           4,290             130           5,530             220               0
Total              41,880          31,930           1,880          38,670           2,990           1,310
----------------------------------------------------------------------------------------------------------------
 
    To provide cost estimates on the same basis as the benefits
estimates, total costs of the rule are estimated in terms of the three
scenarios that are likely from section VI.C.1.b of this document.
Tables 22, 23, and 24 of this document show the total estimated cost of
the scenarios. FDA has not estimated the distribution of the burden of
costs between producers and consumers. The agency expects that some
fraction of the costs--as measured at the producer's stage--will be
passed on to consumers in the form of increases in the prices of the
foods covered by the proposed rule.
 
                    Table 22.--Costs for Scenario 2: Full Long-Term Yearly Total Costs in Millions (discounted costs in parentheses)1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      One Year      Two Years     Three Years     Four Years     Five Years     Six Years    Seven Years    Eight Years
                       During          After          After          After          After          After          After         After          After
  Cost Category      Compliance      Effective      Effective      Effective      Effective      Effective      Effective     Effective   Effective Date
                       Period           Date           Date           Date           Date           Date          Date          Date         and Later
--------------------------------------------------------------------------------------------------------------------------------------------------------
Testing costs           $8
Decisionmaking         $18
 costs
Relabeling costs       $73
Margarine             $302
 reformulation
 costs
Baked products                     $64 ($60)      $64 ($56)      $64 ($52)      $64 ($49)      $144 ($103)    $64 ($43)     $144 ($90)         $0
 reformulation
 costs
Total costs           $401         $64 ($60)      $64 ($56)      $64 ($52)      $64 ($49)      $144 ($103)    $64 ($43)     $144 ($90)         $0
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Reformulation of all margarine products and some baked products plus some consumer response to the labeling.
 
 
[[Page 62785]]
 
 
                      Table 23.--Costs for Scenario 4: Near-Term Yearly Total Costs in Millions (discounted costs in parentheses)1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                 Eight
                                                           One Year    Two Years     Three    Four Years  Five Years   Six Years     Seven       Years
                                               During        After       After       Years       After       After       After       Years       After
               Cost Category                 Compliance    Effective   Effective     After     Effective   Effective   Effective     After     Effective
                                               Period        Date        Date      Effective     Date        Date        Date      Effective   Date and
                                                                                     Date                                            Date        Later
--------------------------------------------------------------------------------------------------------------------------------------------------------
Testing costs                                    $8
Decisionmaking costs                            $18
Relabeling costs                                $73
Margarine reformulation costs                  $302
Total costs                                    $401          $0          $0          $0          $0          $0          $0          $0         $0
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Reformulation of all margarine products plus some consumer response to the labeling.
 
 
  Table 24.--Costs for Scenario 3: Near-term Costs Plus 50 Percent of Full Long-Term Yearly Total Costs in Millions (discounted costs in parentheses)1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      One Year      Two Years     Three Years     Four Years     Five Years     Six Years    Seven Years    Eight Years
                   During Compli-      After          After          After          After          After          After         After          After
  Cost Category      ance Period     Effective      Effective      Effective      Effective      Effective      Effective     Effective   Effective Date
                                        Date           Date           Date           Date           Date          Date          Date         and Later
--------------------------------------------------------------------------------------------------------------------------------------------------------
Testing costs           $8
Decisionmaking         $18
 costs
Relabeling costs       $73
Margarine             $302
 reformulation
 costs
Baked products                     $32 ($30)      $32 ($28)      $32 ($26)      $32 ($25)      $72 ($52)      $32 ($22)     $72 ($45)          $0
 reformulation
 costs
Total costs           $401         $32 ($30)      $32 ($28)      $32 ($26)      $32 ($25)      $72 ($52)      $32 ($22)     $72 ($45)          $0
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Costs for Scenario 4 plus 50 percent of the costs of the baked product reformulation.
 
    FDA acknowledges that there is a significant amount of uncertainty
in the cost estimates provided here. FDA requests comment on the
following uncertainties. The most significant source of potential
divergence from the reported estimates would be an ongoing increased
cost of substitutes for partially hydrogenated oil for producers of
reformulated products. FDA has not included any costs for this item in
this analysis, so that, if substitute oils do cost more, the costs here
are underestimates.
    Reformulation is a second significant area of uncertainty. The
unknowns include the number of products that will be reformulated, the
cost of reformulation, the number of abandoned attempts at
reformulation, the length of time actually needed to reformulate
products, and the degree to which the reformulation of some products
reduces the cost of reformulating other products. The estimates that
are provided in this analysis might be either over- or underestimates
of the actual costs of reformulation.
    A third major area of uncertainty includes the number of products
containing 0.5 g or more trans fat per serving and the number of
products with affected claims. Actual costs are likely to be higher
than those estimated here because this analysis focused only on product
groups where a substantial portion of the total number of the products
in the group contain partially hydrogenated oil. Among the numerous
categories of foods not included in this analysis, a sizable number of
additional products may be affected by this proposal.
    Finally, restaurants making claims affected by this rule on menus
or in other labeling will need either to update the basis for such
claims or remove them. FDA does not have information to estimate such
costs. However, their existence does suggest that costs reported in
this analysis will be lower than the actual costs.
 
E. Summary of Benefits and Costs
 
    The benefits and costs of the proposed rule occur in different
years. In order to compare costs and the ongoing benefits, the agency
calculated the present value of benefits and costs for Scenarios 2, 3,
and 4 during the compliance period and for 20 years beyond the
compliance period. Each scenario assumes that some consumers reduce
their consumption of trans fat based on labeling changes. Scenario 4
assumes that all margarine products will be reformulated to eliminate
trans fat. Scenarios 3 and 2 assume in addition progressively more
reformulation of baked products as well as assuming that all margarine
products will be reformulated to eliminate trans fat. Table 25 of this
document shows the results.
 
[[Page 62786]]
 
 
 
Table 25.--Present Value of Benefits and Costs of the Proposed Rule in Millions (discounted to compliance period
                             at 7 percent for 20 years after the compliance period)1
----------------------------------------------------------------------------------------------------------------
                                                    Low Estimated        High Estimated
                                                      Benefits              Benefits           Estimated Costs
----------------------------------------------------------------------------------------------------------------
Scenario 4                                          $24,893               $50,664                  $401
Scenario 3                                          $26,516               $55,579                  $628
Scenario 2                                          $27,164               $59,190                  $854
----------------------------------------------------------------------------------------------------------------
\1\ Based on Tables 5, 6, 22, 23, and 24 of this document.
 
F. Comparison With Effects of the Rules Implementing the 1990
Amendments
 
    The procedure used to estimate the benefits and costs of the
proposed labeling rule differs somewhat from the procedure used to
estimate the benefits and costs of the rules implementing the 1990
amendments. The economic analysis of the rules implementing the 1990
amendments did not attempt to estimate the effects of the labeling
rules on product reformulation. For this proposed rule, however, FDA
has sufficient information to estimate the benefits and costs of
product reformulation.
    The results of the current benefit-cost analysis, however, could
cause some confusion in that the inclusion of reformulation benefits
and costs makes the effects of the proposed rule appear large relative
to the effects of the rules implementing the 1990 amendments. Although
those rules affected far more labels and products, FDA did not estimate
the potentially very large effects of reformulation induced by those
rules. To allow comparisons between the effects of this proposed rule
and the effects of the rules implementing the 1990 amendments, FDA has
also estimated only the relabeling effects of this proposed rule. The
relabeling costs of the proposed rule, as shown in Tables 22 to 24
would be approximately $100 million during the compliance period. FDA
calculated this estimate by assuming that margarine products would be
relabeled with their existing formulations rather than being
reformulated. The annual direct benefits, which begin 3 years after the
effective date for the proposed rule, would be approximately 5 percent
of the total after 10 years, or $171 million to $394 million per year.
    The present value of the benefits and costs of the rules
implementing the 1990 amendments were estimated for 20 years at a 5
percent rate of discount. To make the current rule comparable, FDA
estimated the present value of this proposed rule for a 20-year period
at a 5 percent rate of discount. Table 26 of this document shows the
results of the comparison.
 
Table 26.--Comparison of the Benefits and Costs of the Proposed Rule and
  the Benefits and Costs of the Rules Implementing the 1990 Amendments
                 (discounted at 5 percent for 20 years)
------------------------------------------------------------------------
                                 Benefits                  Costs
------------------------------------------------------------------------
Rules implementing the   $4.4 to $26.5 billion    $1.4 to 2.3 billion
 1990 amendments
This proposed rule       $1.7 to $3.8 billion     $100 million
------------------------------------------------------------------------
 
VII. Initial Regulatory Flexibility Analysis
 
A. Introduction
 
    FDA has examined the economic implications of this proposed rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a
rule has a significant economic impact on a substantial number of small
entities, the Regulatory Flexibility Act requires agencies to analyze
regulatory options that would reduce the economic effect of the rule on
small entities.
 
B. Economic Effects on Small Entities
 
1. Number and Type of Small Entities Affected
    The proposed rule will affect food processors in several different
industries. Table 27 of this document shows the number of small
businesses likely to be affected in each SIC. FDA calculated the number
of businesses from a search using Dun & Bradstreet (Ref. 73). The
number of firms listed for each code includes all small firms in the
industry category producing products that contain trans fat. The SBA
size standards apply to the 4-digit SIC codes associated with each
product group.
 
             Table 27.--Number of Small Businesses Affected (numbers are rounded to the nearest ten)
----------------------------------------------------------------------------------------------------------------
                                                                         Small Business
           Description              Standard Industry Classification   Administration Size     Number of Small
                                   and Dun's Market Identifiers Code  Standard (employees)          Firms
----------------------------------------------------------------------------------------------------------------
Frozen Breakfast Foods             20389901, 20389904, 20389910               500                    10
Cereal                             2043                                     1,000                    60
Baking Mixes                       204103                                     500                    40
Breading Products, Frozen Baked    2051                                       500                 3,000
 Goods, Refrigerated Bread and
 Pastry, Breads
Crackers Cookies                   2052                                       750                   660
Baking Needs, Candy, Gum, and      206499                                     500                   430
 Cough Drops
Shortenings and Oils, and          207901, 207902, 207999                     750                    80
 Refrigerated Spreads
Chip Type Snacks                   2096                                       500                   320
 
[[Page 62787]]
 
 
Total small businesses                                                                            4,600
----------------------------------------------------------------------------------------------------------------
 
    Table 27 of this document slightly overstates the number of small
businesses affected by the proposed rule, because it includes some
businesses that would be exempt. The criteria for exemption are: (1)
Annual sales of fewer than 100,000 units; (2) no claims or other
nutrition information on product labels, labeling, or advertising; (3)
fewer than 100 full-time employees; and (4) filing of a notice with the
Office of Food Labeling (Sec. 101.9(j)(18)). FDA has previously
estimated that the exemption for all foods would affect about 1.8
percent of FDA-regulated foods by volume (see 58 FR 2927 at 2928,
January 6, 1993). FDA assumed that the percentage would be the same for
the products affected by this proposed rule. Because FDA did not know
how the exemption would be distributed across product groups, FDA
estimated the effects of exemptions only for the total costs to small
businesses.
2. Costs to Small Entities
    Partially hydrogenated oils account for almost all of the trans fat
in foods covered by the proposed rule; its presence in a product is,
therefore, a proxy for the presence of trans fat. The proposed rule
would cause small businesses whose products contain partially
hydrogenated oil to test for the amount of trans fat per reference
amount. The proposed rule would require a firm to relabel any product
that contains 0.5 g or more of trans fat per serving, unless the firm
chooses to reformulate the product to contain less than 0.5 g of trans
fat per serving.
    FDA calculated the costs to small businesses with the same basic
model that was used in section VI.D of this document to estimate the
total costs. The basic formula is described there in Figure 1. Although
the basic cost formula is the same for large and small firms, the
individual components of costs differ for large and small firms. Small
firms have lower decisionmaking costs, produce fewer products, and
market fewer labels. The reprinting costs per label differ by product
group and according to whether or not the principal display panel has
to be changed. Reformulation is also less likely for small businesses.
FDA assumed that margarine producers would be the only small businesses
that would choose to reformulate within 10 years after the effective
date for the proposed rule. Although FDA made no quantitative estimates
of future reformulation costs for small businesses, it assumed that
after reformulation practices for other product groups become standard
industry knowledge, small businesses would be able to reformulate at
far lower cost than estimated for margarine.
    FDA estimated the total costs of the proposed rule to small
business by estimating the individual categories of costs and summing
them. The first category is testing costs. Small businesses would need
to test their products to determine the amounts of trans fats. FDA did
not have direct estimates of the number of products produced by the
small businesses affected by the proposed rule. FDA estimated the
number of products produced by small businesses by using a sample from
the Enhanced Establishment Database (EED) and assuming that the
proportion of all products produced by small businesses was the same as
the sample proportion (Ref. 73). FDA then multiplied the number of
products in each category by the percent of products in that category
containing partially hydrogenated oil. The result is the estimated
number of products of small businesses that would have to be tested for
trans fat shown in Table 28 of this document.
 
             Table 28.--Number of Products of Small Businesses Containing Partially Hydrogenated Oil
----------------------------------------------------------------------------------------------------------------
                                                                              Percent of
                                                                               Products       Number of Products
                       Product                        Number of Products      Containing          Containing
                                                                               Partially           Partially
                                                                           Hydrogenated Oil    Hydrogenated Oil
----------------------------------------------------------------------------------------------------------------
Frozen Breakfast Foods                                      470                  80                 380
Cereal                                                    1,150                  40                 460
Baking Mixes                                              1,180                  75                 890
Breading Products                                           820                  85                 700
Frozen Baked Goods                                        1,330                  50                 670
Refrigerated Bread and Pastry                             1,560                   5                  80
Breads                                                   26,390                  50              13,200
Crackers                                                  1,480                 100               1,480
Cookies                                                   5,360                  95               5,090
Baking Needs                                              1,380                  65                 900
Candy, Gum, and Cough Drops                              13,390                  40               5,360
Shortenings and Oils                                      1,100                  15                 170
Refrigerated Spreads                                        960                  70                 670
Chip Type Snacks                                          8,890                  70               6,220
Total                                                                                            36,270
----------------------------------------------------------------------------------------------------------------
 
    FDA estimated testing costs to be $200 per product, so the total
cost of testing for small businesses would be approximately $7 million
(36,270 x $200).
    Decisionmaking costs would be borne by those small businesses whose
products contain 0.5 g or more trans fat per reference amount. Table 29
of this document shows the likely number of small businesses with
products containing 0.5 g or more trans fat per reference amount; these
firms would bear decisionmaking costs because of the proposed rule. FDA
estimated the
 
[[Page 62788]]
 
number of small businesses affected by multiplying the number of small
businesses in each category (see Table 10 of this document) by the
percentage of firms in that category making products with 0.5 g or more
trans fat per reference amount.
 
 Table 29.--Number of Small Firms Whose Products Contain 0.5 gram (g) or
                  More trans Fats per Reference Amount
------------------------------------------------------------------------
                                   Percent of Small     Number of Small
                       SIC and       Firms Making        Firms Making
    Description     Dun's Market       Products            Products
                     Identifiers   Containing 0.5 g    Containing 0.5 g
                        Code       or More Trans Fat   or More Trans Fat
------------------------------------------------------------------------
Frozen Breakfast    20389901             60                  10
 Foods               20389904
                     20389910
Cereal              2043                  5                   0
Baking Mixes        204103               60                  20
Breading Products,  2051                 15                 450
 Frozen Baked
 Goods,
 Refrigerated
 Bread and Pastry,
 Breads
Crackers Cookies    2052                100                 660
Baking Needs,       206499               15                  60
 Candy, Gum, and
 Cough Drops
Shortenings and     207901               50                  40
 Oils,               207902
 Refrigerated        207999
 Spreads
Potato Chips and    2096                 30                 100
 Similar Snacks
Total Small                                               1,340
 Businesses
------------------------------------------------------------------------
 
    The decisionmaking costs for small businesses are estimated to be
approximately $3,500 per firm. Total decisionmaking costs would be
approximately $5 million (1,340 x $3,500).
    FDA estimated reprinting costs for information panels on a per
label (SKU) basis. FDA assumed that the proportion of SKU's from small
businesses as a whole equaled the proportion in the EED for each
category of foods.
    Table 30 of this document shows the cost to small businesses of
reprinting information panels.
 
                               Table 30.--Reprinting Costs for Information Panels
----------------------------------------------------------------------------------------------------------------
                                                                                              Cost per Product
                  Description                    Number of SKU's\1\       Cost per SKU              Group
----------------------------------------------------------------------------------------------------------------
Frozen Breakfast Foods                                  230                $1,000              $230,000
Cereal                                                  150                    $0                    $0
Baking Mixes                                            670                  $300              $201,000
Breading Products                                         0                $1,300                    $0
Frozen Baked Goods                                      470                $1,300              $611,000
Refrigerated Bread and Pastry                            50                $1,300               $65,000
Breads                                                9,730                $1,300           $12,649,000
Crackers                                              1,250                  $500              $625,000
Cookies                                               5,330                  $500            $2,665,000
Baking Needs                                            990                  $800              $792,000
Candy, Gum, and Cough Drops                           4,590                  $800            $3,672,000
Shortenings and Oils                                    170                  $100               $17,000
Refrigerated Spreads                                    450                  $100               $45,000
Chips Type Snacks                                     4,150                  $200              $830,000
Total                                                28,230                                 $22,402,000
----------------------------------------------------------------------------------------------------------------
\1\ Stockkeeping units.
 
    In addition to the costs of reprinting information panels, small
businesses making claims may have to change their principal display
panels. The redesign and reprinting cost per SKU change for a small
business is estimated to be $1,200. FDA estimated that small businesses
accounted for about 50 percent of the labels (SKU's) and about 50
percent of the products that would require changes to the principal
display panel. The total number of SKU's estimated in section VI.D.4.a
of this document to require such changes was 2,990; small businesses
therefore accounted for 1,500 products (0.5 x 2,990). The marketing and
administrative costs per product change for a small business is
estimated to be $5,500. The total number of products estimated in
section VI.D.4.b of this document to require changes was 2,440; small
businesses therefore accounted for 1,220 products (0.5 x 2,440). The
total cost to small businesses of changing principal display panels
would be $9 million (($1,200 x 1,500) + ($5,500 x 1,220)).
    FDA assumed that the only small businesses that would reformulate
products to eliminate or reduce trans fat would be margarine producers
responding to market pressures. The reformulation costs for small
businesses producing margarine equals the reformulation costs per
product multiplied by the number of products produced by small firms,
plus the reformulation costs per SKU times the number of SKU's produced
by small firms. FDA assumed that 20 percent of the 670 margarine
products to be reformulated, or 134, are produced by small businesses.
FDA estimated the cost of formulation and testing to be $440,000 per
product. The number of SKU's affected is estimated to be 146 (0.2 x
730). The inventory loss is estimated to be $10,000 per SKU. Table 31
of this document shows the
 
[[Page 62789]]
 
margarine reformulation costs for small businesses.
 
      Table 31.--Margarine Reformulation Costs for Small Businesses
------------------------------------------------------------------------
                                                                 Total
                                                               Costs for
                          Number         Costs per Product or     All
                                              per SKU\1\        Products
                                                                or SKU's
------------------------------------------------------------------------
Products                   134              $440,000           $59
                                                                million
SKU's                      146               $10,000           $2
                                                                million
------------------------------------------------------------------------
\1\ Stockkeeping unit.
 
    Table 32 of this document shows the total costs to small businesses
of the proposed rule. The adjusted total costs of the proposed rule
equal the unadjusted total minus $7 million, 1.8 percent of all
compliance period costs of the proposed rule ($401 million x 0.018)
(see 58 FR 2927 at 2928, January 6, 1993).
 
  Table 32.--Total Costs for Small Businesses (in millions of dollars)
------------------------------------------------------------------------
                   Type of Cost                            Amount
------------------------------------------------------------------------
Testing costs                                                $7
Decisionmaking costs                                         $5
Costs of reprinting information panel                       $22
Costs changing principal display panel                       $9
Formulation and testing costs                               $59
Inventory costs                                              $2
Total                                                      $104
Total adjusted for exemptions                               $97
------------------------------------------------------------------------
 
C. Regulatory Options
 
    The Regulatory Flexibility Act requires that FDA consider options
for regulatory relief for small entities. Some regulatory relief is
already built into the proposed rule. The uniform compliance date
should give small entities sufficient time to avoid many potential
costs of the rule, such as loss of inventory.
1. Exemption for Small Businesses
    The exemption of small businesses from the provisions of the
proposed rule would provide regulatory relief. Table 32 of this
document shows that small businesses are expected to bear total costs
of about $100 million as a result of the proposed rule, an average of
$22,600 per small business. As a first approximation, then, exempting
small businesses would reduce the burden by an average of $22,600 per
small business.
    FDA believes that this option would not be desirable. On the one
hand, because so many of the businesses in the food processing industry
are classified as small by SBA, if small businesses are exempted, much
of the potential benefits from the proposed rule would not be realized.
On the other hand, exempt businesses may be forced by market pressures
to adopt the proposed label in any case. In addition, under section
403(q)(5)(E) of NLEA, very small producers (those with fewer than 100
full-time employees) that: (1) File a notice with the Office of Food
Labeling; (2) make very low volume products (fewer than 100,000 units
annually); and (3) place no claims or other nutrition information on
product labels, labeling, or advertising would already be exempt from
this proposed rule.
2. Longer Compliance Period for Small Businesses
    Longer compliance periods provide regulatory relief for small
businesses. FDA has estimated the costs based on a 2-year compliance
period. The estimated costs will decrease if small businesses are given
more than two years to comply with the proposed rule.
    Labeling costs (decisionmaking, redesign, and printing) fall as the
compliance period rises. With the base period of 2 years, labeling
costs double with each halving of the length of the compliance period
and fall by one-half for each doubling of the compliance period.
Testing and reformulation costs also decline with a lengthening of the
compliance period. Small businesses would have more opportunity to
benefit from technology transfer from large businesses making similar
products.
    Table 33 of this document shows how the burden on small businesses
falls as the compliance period is extended to 18 and 24 months beyond
the effective date. The weights used were the proportion of small
business costs represented by each component.
 
 Table 33.--Effect of Compliance Period on Small Business Costs (adjustment factors relative to effective date)
----------------------------------------------------------------------------------------------------------------
                                                                         18 Months After       24 Months After
                                                     At Proposed       Proposed Effective    Proposed Effective
                                                   Effective Date             Date                  Date
----------------------------------------------------------------------------------------------------------------
Decisionmaking costs                                   100%                   75%                   50%
Testing costs                                          100%                   97%                   93%
Printing costs                                         100%                   75%                   50%
Reformulation costs                                    100%                   97%                   93%
Weighted average costs                                 100%                   89%                   78%
----------------------------------------------------------------------------------------------------------------
 
    In other words, the costs to small businesses would fall by about
11 percent with an 18-month extension beyond a 2-year compliance period
and by about 22 percent with a 24-month extension beyond a 2-year
compliance period. FDA will evaluate the length of the compliance
period if it finalizes this proposal.
3. Exemptions for Particular Products Produced by Small Entities
    In the category of breakfast foods, the average intake of trans fat
for both men and women is less than one-tenth of a gram per day.
Because the entire category contributes so little to the overall
dietary intake of trans fats, exempting small businesses in this
category from the rule would have small effects on health. The
exemption, however, would provide regulatory relief for approximately
70 small
 
[[Page 62790]]
 
businesses (including cereal and frozen breakfast foods). The total
burden on small businesses would fall by less than $500,000 (the sum of
$316,000 relabeling costs and $167,000 testing costs for 835 products).
The relief offered by this option, then, would be small.
    An objection to this option for regulatory relief is that by
exempting an entire class of products, FDA could create incentives for
small firms to create products in that category. These new products
would have no effective limits on trans fat. The exemption would
therefore allow small firms to develop products with high trans fat
content but no indication of that content on the label. The
contribution of breakfast cereals to total dietary intake of trans fats
could increase because of the exemption. The most telling objection to
this option is that exempting some products from the proposed labeling
rule would make the nutrition facts panel inconsistent across product
categories. This inconsistency would be counter to the intent of the
1990 amendments. It would undermine the policy goal of providing
consistent nutrition information to consumers.
 
D. Recordkeeping and Reporting Requirements
 
    The Regulatory Flexibility Act requires FDA to include a
description of the recordkeeping and reporting required for compliance
with this proposed rule. This proposed rule does not require the
preparation of a report or a record.
 
E. The Burden on a Small Business: A Typical Small Business
 
    The average cost per small business would be about $22,600 ($104
million/4,600 firms). In this section FDA will show how a hypothetical
small business could incur this average cost. Although the entity is
hypothetical, the cost estimate is based on costs that a single entity
could in fact bear as a result of the proposed rule. Suppose that a
small business must test and possibly relabel--but does not
reformulate--its products. The firm's three products are in the bread
category and three of its four labels contain claims. The other product
contains less than 0.5 grams of trans fat per serving and, therefore,
its label need not be changed. Table 34 of this document shows the
costs for this hypothetical typical small business. The cost can be
compared to some plausible level of sales revenue to estimate the
potential burden of the rule.
 
           Table 34.--Costs for a Hypothetical Small Business
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Decisionmaking costs      $3,500 per small               $3,500
                           business
Testing costs             $200 per product for 3           $600
                           products
Reprinting information    $1,300 per SKU\1\ for 3        $3,900
 panel costs               SKU's
Changing principal        $1,200 per SKU for 3           $3,600
 display panels            SKU's
Changing principal        $5,500 per product for 2      $11,000
 display panels costs      products
 per product
Total costs                                             $22,600
------------------------------------------------------------------------
\1\ Stockkeeping unit.
 
    The median firm in the food groups covered by the proposed rule has
annual sales of about $500,000. The proposed rule could therefore lead
to a one-time burden of about 5 percent of annual sales ($22,600/
$500,000). If the firm borrowed the funds to pay for the label changes
and other costs at 7 percent for 10 years, the annual payments would be
about $3,200. This estimate may overstate the burden in that the firm
may pass most of the cost on to consumers in the form of higher prices
for its products. Small margarine producers will bear much higher costs
if market pressures force them to reformulate. If the firms are large
enough so that they are not exempted from this rule, they will compare
potential market share losses with the cost of reformulation. FDA
believes that, although the costs of reformulation are large ($450,000
per product), the product volume of even a small plant is large enough
to make reformulation the logical choice.
 
F. Summary
 
    FDA finds that under the Regulatory Flexibility Act (5 U.S.C.
605(b)) this proposed rule will have a significant economic impact on a
substantial number of small entities. Approximately 4,600 small
businesses could be affected by the rule. The total burden on small
entities is estimated to be more than $100 million.
 
VIII. Unfunded Mandates
 
    The Unfunded Mandates Reform Act of 1995 (Public Law 104-4)
requires cost-benefit and other analyses for rules that would cost more
than $100 million in 1 single year. The proposed rule qualifies as
significant rule under the statute. FDA has carried out the cost-
benefit analysis in sections VI.C and VI.D of this document The other
requirements under the Unfunded Mandates Act of 1995 include assessing
the rule's effects on:
    A. Future costs;
    B. Particular regions, communities, or industrial sectors;
    C. National productivity and economic growth;
    D. Full employment and job creation; and,
    E. Exports.
 
A. Future Costs
 
    FDA estimated some of the future costs of the proposed rule in
section VI.D of this document. The reported costs include costs
incurred during the compliance period and up to 7 years after the
effective date. Section VI.D of this document also includes some
qualitative discussion of costs that would occur beyond that time
period. Most of the costs of the rule, however, would occur in the
years immediately after the publication of a final rule. Future costs
beyond that period would likely be small, because the food industry
would have adjusted to the new requirements by that time.
 
B. Particular Regions, Communities, or Industrial Sectors
 
    The proposed rule applies to the food industry and would,
therefore, affect that industry disproportionately. Any long-run
increase in the costs of food production would largely be passed on to
the entire population of consumers.
 
C. National Productivity and Economic Growth
 
    The proposed rule is not expected to substantially affect
productivity or economic growth. It is possible that productivity and
growth in certain sectors of the food industry could be slightly lower
than otherwise because of the need to divert research and development
resources to compliance
 
[[Page 62791]]
 
activities. The diversion of resources to compliance activities would
be temporary. Moreover, FDA anticipates that, because the health
benefits are estimated to be large, both productivity and economic
growth would be higher than in the absence of the rule. In section
VI.C.3 of this document, FDA estimated benefits from the reduction in
functional disability associated with a reduction in nonfatal CHD. A
reduction of functional disability would result in an increase in
productivity. The increased health of the population and the reduction
in direct and indirect health costs could increase both productivity
and economic growth.
 
D. Full Employment and Job Creation
 
    The human resources devoted to producing certain foods would be
redirected by the proposed rule. The proposed rule could lead to some
short-run unemployment as a result of the structural changes within the
food industry, the rise of some product lines and decline of others.
The growth of employment (job creation) could also be temporarily
slower.
 
E. Exports
 
    Because the proposed rule does not mandate any changes in products,
current export products will not be required to change in any way. Food
processors, however, do not necessarily distinguish between production
for export and production for the domestic market. The effect of the
proposed rule on U.S. food exports depends on how foreign consumers
react to information about trans fats and to product formulations that
contain no partially hydrogenated oils. The new label and possible new
formulations could either increase or decrease exports. Germany and
certain other European countries, for example, do not currently use
partially hydrogenated oils, so the proposed rule could make U.S.
exports of margarine and other reformulated products more attractive to
consumers in those countries than they have been. However, it could
also make U.S. exports of unreformulated products that reveal the
presence of trans fat less attractive to consumers in those countries
than they have been.
 
IX. Environmental Impact
 
    The agency has determined under 21 CFR 25.30(k) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
 
X. Paperwork Reduction Act of 1995
 
    This proposed rule contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The title, description, and respondent description of the
information collection provisions are shown in the next paragraphs
below with an estimate of the annual reporting burden. Included in the
estimate is the time for reviewing instructions, searching existing
data sources, gathering and maintaining the data needed, and completing
and reviewing each collection of information.
    FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated information collection techniques or other forms of
information technology.
    Title: Food Labeling; Trans Fatty Acids in Nutrition Labeling and
Nutrient Content Claims.
    Description: Section 403(q)(1)(A) and (q)(1)(B) of the act requires
that the label or labeling of a food bear nutrition information on the
amount of nutrients present in the product. Under these provisions of
the act and section 2(b) of the 1990 amendments, FDA has issued
regulations in Sec. 101.9(c)(2) that require that the nutrition facts
panel disclose information on the amounts of fat and certain fatty
acids in the food product. Similarly, under the provisions of section
403(q)(5)(F) of the act, FDA has issued regulations in Sec. 101.36(b)
that specify the nutrition information that must be on the label or
labeling of dietary supplements.
    The regulations set forth in this proposed rule would require
producers of foods, including dietary supplements, that contain 0.5 g
or more of trans fatty acids per serving to disclose in the nutrition
label the amount of trans fatty acids present in such foods. To do so,
the proposed rule would require that the amount and the %DV for
saturated fatty acids disclosed in the nutrition label of a food
represent the combined amount of saturated and trans fatty acids. In
addition, the amount of trans fatty acids would be disclosed in a
footnote.
    Section 403(r)(2)(B) of the act requires that the labeling of any
food bearing a nutrient content claim that contains a nutrient at a
level that increases to persons in the general population the risk of a
disease or health-related condition that is diet related must contain,
prominently and in immediate proximity to such nutrient content claim,
a disclosure statement specified by the statute. The proposal would
also establish the nutrient content claim ``trans fat free'' as an
authorized nutrient content claim for food, including dietary
supplements. Any food bearing a ``trans fat free'' nutrient content
claim would be required to include a footnote in the nutrition label
disclosing that the product contains 0 g trans fatty acids. In
addition, food products bearing a ``trans fat free'' nutrient content
claim would be required to disclose the level of total fat and
cholesterol, if present at significant levels.
    Description of Respondents: Persons and businesses, including small
businesses.
 
                                     Table 35.--Estimated Reporting Burden1
----------------------------------------------------------------------------------------------------------------
                     Number of     Responses per   Total No. of      Hours per                       Operating
 21 CFR Section     Respondents     Respondents      Responses       Response      Total  hours        costs
----------------------------------------------------------------------------------------------------------------
101.9(c)(2)(i)             1,880                          38,670            2             77,340     $38,256,000
 and
 (d)(7)(ii)\2\
101.36(b)(2)\2\               40                             300            2                600        $210,000
101.62(c)                     25               4             100            0.5               50         $70,000
Totals                     1,945                          39,070                          77,990     $38,536,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital cost or maintenance costs associated with this collection of information.
\2\ The number of responses per respondent under this section varies greatly depending upon the size of the firm
  and the numbers and types of products marketed by the firm.
 
 
[[Page 62792]]
 
    The impact of the proposed requirements concerning trans fatty
acids would be largely a one-time burden created by the need for firms
to revise the labels for those existing products containing trans fatty
acids. FDA estimated the operating costs for food products that might
be affected by this proposed rule by combining the approximate cost of
analysis to determine those products containing more than 0.5 g of
trans fatty acids and the approximate cost of revising the labels for
those products conta ining more than 0.5 g of trans fatty acids. As
noted in section VI of this document in the Preliminary Regulatory
Impact Analysis, FDA estimates that the approximate cost of analysis to
determine the amount of trans fatty acids in affected products to be
approximately $8,376,000 for 41,800 products (see Table 8 of this
document). Also, as noted in section VI of this document, FDA estimates
that there are approximately 1,880 firms producing products that would
be affected by this proposed rule. Further, FDA estimates that there
are approximately 38,670 SKU's for food products, other than dietary
supplements, that would be affected by this proposed rule with the
associated operating costs for revising labels of $29,880,000 (see
Table 13 of this document).
    In the final rule establishing requirements for the nutrition
labeling of dietary supplements, FDA estimated that there were
approximately 850 suppliers of dietary supplements and that they had on
average 40 products each (62 FR 49826 at 49846). Although FDA is
uncertain as to exactly how many dietary supplement suppliers
(certainly, fewer than 40 suppliers) have products that contain trans
fatty acids and welcomes comments on this point, based upon its
experience, it believes that less than 1 percent of the approximate
total of 34,000 dietary supplements, or approximately 300, would
contain trans fatty acids. Based upon its knowledge of food labeling,
FDA estimates that firms would require less than 2 hours per product to
comply with the nutrition labeling requirements in Sec. 101.36(b)(2) of
a final rule based on this proposal.
    FDA also estimates that approximately 25 firms would choose to make
trans fatty acid free claims under proposed Sec. 101.62(c)(6) on
approximately 4 products per firm. Because the regulations supply the
wording that would appear on the label, the making of a ``trans fat
free'' claim and the required disclosure of 0 g trans fatty acids in an
accompanying footnote would impose no burden and would not constitute a
``collection of information'' under the PRA. Rather, the proposed
nutrient content claim ``trans fat free'' and accompanying footnote
would be a ``public disclosure of information originally supplied by
the Federal Government to the recipient for the purpose of disclosure
to the public'' (5 CFR 1320(c)(2)). Because the information on total
fat and cholesterol levels required to be disclosed under
Sec. 101.62(c) would be information that the firms would already have,
FDA estimates that this additional requirement would add less that 0.5
hours burden for each product.
     For the requirements in Secs. 101.36(b)(2) and 101.62(c), FDA has
estimated operating costs by combining the approximate cost of analysis
to determine the level of trans fatty acids in the affected products
requiring disclosure of trans fatty acids ($200 per product) and the
approximate cost of revising labels for those products ($500 per
product). Thus, FDA tentatively finds that the requirements of a final
rule based on this proposal would result in total one-time operating
costs of $38,536,000. FDA expects that, with at least a 1-year
compliance date, firms will coordinate labeling revisions required by
any final rule that may issue based on this proposal with other planned
labeling for its products.
    In compliance with the PRA (44 U.S.C. 3507(d)), the agency has
submitted the information collection provisions of this proposed rule
to OMB for review. Interested persons are requested to send comments
regarding information collection by December 17, 1999, to the Office of
Information and Regulatory Affairs, OMB, New Executive Office Bldg.,
725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Desk Officer
for FDA.
 
XI. Effective Date
 
    The agency proposes that any final rule that may issue based upon
this proposal become effective in accordance with the uniform effective
date for compliance with food labeling requirements that is announced
by notice in the Federal Register and that is not sooner than 1 year
following publication of any final rule based on this proposal.
However, FDA will not object to voluntary compliance immediately upon
publication of the final rule.
 
XII. Comments
 
    Interested persons may, on or before February 15, 2000, submit to
the Dockets Management Branch (address above) written comments
regarding this proposal, except that written comments regarding
collection of information should be submitted to the Office of
Information and Regulatory Affairs, OMB (address above), on or before
December 17, 1999. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
 
XIII. References
 
    The following references have been placed in the Dockets Management
Branch (address above) and may be seen by interested persons between 9
a.m. and 4 p.m., Monday through Friday.
    1. Kris-Etherton, P. M., and R. J. Nicolosi, ``Trans Fatty Acids
and Coronary Heart Disease Risk,'' International Life Sciences
Institute, Washington, DC, 1995.
    2. Department of Health and Human Services (DHHS) ``The Surgeon
General's Report on Nutrition and Health,'' p. 96, Washington, DC,
1988.
    3. Kris-Etherton, P. M., editor, ``Trans Fatty Acids and
Coronary Heart Disease Risk,'' Report of the Expert Panel on Trans
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    8. Zock, P. L., and M. B. Katan, ``Hydrogenation Alternatives:
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of Clinical Nutrition, 65:1419-1426, 1997.
 
[[Page 62793]]
 
    11. Nestel, P. J., M. Noakes, G. B. Belling, R. McArthur, P.
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Pekkanen, M. Pekkarinen, S. Punsar, L. Rasanen, B. Simic, and H.
Toshima, ``Dietary Saturated and trans Fatty Acids and Cholesterol
and 25-Year Mortality from Coronary Heart Disease: The Seven
Countries Study,'' Preventive Medicine, 24:308-315, 1995.
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Acid Intake in Relation to Serum Lipid Concentrations in Adult
Men,'' American Journal of Clinical Nutrition, 56:1019-1024, 1992.
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College of Nutrition, 9:471-486, 1990.
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Fatty Acids Availability in the U.S. Diet,'' American Journal of
Clinical Nutrition, 54:363-369, 1991.
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American Dietetic Association, 99:166-174, 1999.
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Foods,'' pp. 430-439, in Present Knowledge in Nutrition, 6th ed.,
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``Comparison of Capillary Column Gas Chromatographic and AOAC
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in Foods,'' Food Chemistry, 58:149-160, 1997.
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Mossoba, ``Determination of Total trans Fatty Acids in Foods:
Comparison of Capillary-Column Gas Chromatography and Single-Bounce
Horizontal Attenuated Total Reflection Infrared Spectroscopy,''
Journal of the American Oil Chemists Society, 73:1699-1705, 1996.
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Medical Aspects of Food Policy, ``Report on Health and Social
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Department of Health, London, HMSO, p. 10, 1994.
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Content Claims,'' January 19, 1996.
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C. Chen, J. A. Weststrate, G. W. Meijer, J. Wittes, A. H.
Lichtenstein, M. Vilella-Bach, and E. J. Schaefer, ``Effects of
Margarine Compared With Those of Butter on Blood Lipid Profiles
Related to Cardiovascular Disease Risk Factors in Normolipemic
Adults Fed Controlled Diets,'' American Journal of Clinical
Nutrition, 68:768-777, 1998.
    35. Derby, B. M., and S. B. Fein, ``Meeting the NLEA Education
Challenge: A Consumer Research Perspective,'' in Nutrition Labeling
Handbook, R. Shapiro (ed.), Marcel Dekker, Inc., New York, 1995.
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Partially Hydrogenated or Interesterified Fats: Differential Effects
on Plasma Lipids,'' American Journal of Clinical Nutrition, 68:242-
247, 1998.
    37. London, S. J., F. M. Sacks, J. Caesar, M. J. Stamper, D.
Siguel, W. C. Willett, ``Fatty Acid Composition of Subcutaneous
Adipose Tissue and Diet in Post Menopausal U.S. Women,'' American
Journal of Clinical Nutrition, 54:340-345, 1991.
    38. Hu, F. B., M. J. Stampfer, J. E. Manson, E. Rimm, G. A.
Colditz, B. A. Rosner, C. H. Hennekens, and W. C. Willett, ``Dietary
Fat Intake and the Risk of Coronary Heart Disease in Women,'' New
England Journal of Medicine, 337:1491-1499, 1997.
    39. FASEB Expert Panel (Senti, F.R. ed), ``Health Aspects of
Dietary trans Fatty Acids,'' Federation of American Societies for
Experimental Biology and Medicine, Bethesda, MD, 1985.
    40. USDA, Agricultural Research Service, USDA Food Composition
Data, Selected Foods Containing trans Fatty Acids, 1995 (internet
address ``http://www.nal.usda.gov/fnic/foodcomp/Data/index.html'').
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Content Claims,'' Tunney's Pasture, Ottawa, Ontario, March 18, 1998.
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(AOAC), AOAC Official Method 965.34 ``Isolated trans Isomers in
Margarines and Shortenings, Infrared Spectrometric Method,'' AOCS-
AOAC Method, Official Methods of Analysis of AOAC International,
16th ed., 3d revision, 1997, 41.1.36. AOAC International,
Gaithersburg, MD.
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Cd 14-95 (Replaces Cd 14-61, reapproved 1997), ``Isolated trans
Isomers Infrared Spectrometric Method,'' AOAC Official Methods and
Recommended Practices, edited by D. Firestone, Champaign, IL.
    44. AOAC, 1998, AOAC Official Method 994.14, ``Isolated trans
Unsaturated Fatty Acid Content in Partially Hydrogenated Fats,''
Official Methods of Analysis of AOAC International, 16th ed.,
41.1.36A, AOAC International, Gaithersburg, MD. 1998, revision March
1998.
    45. AOCS, AOCS Recommended Practice Cd 14d-96 (Reapproved 1997),
``Isolated trans Geometric Isomers-Single Bounce-Horizontal
Attenuated Total Reflection Infrared Spectroscopic Procedure,'' AOCS
Official Methods and Recommended Practices, edited by D. Firestone,
Champaign, IL.
    46. AOCS, AOCS Official Method Ce 1f-96 (Reapproved 1997)
``Determination of cis- and trans-Fatty Acids in Hydrogentated and
Refined Oils and Fats by Capillary GLC,'' AOCS Official Methods and
Recommended Practices,'' edited by D. Firestone, Champaign, IL.
 
[[Page 62794]]
 
    47. AOCS, AOCS Official Method Ce 1c-89 (Reapproved 1993,
updated 1995), ``Fatty Acid Composition by GLC-cis, cis and trans
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by D. Firestone, Champaign, IL.
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Method,'' (Revised 1995), AOCS Official Methods and Recommended
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    50. AOAC, 1997, AOAC Official Method 994.15, ``Total cis- and
trans Octadecenoic Isomers and General Fatty Acid Composition in
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Vasconcellos, ``Analysis of cis- and trans-Fatty Acid Isomers in
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73:275-282, 1996.
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and M. M. Mossoba, ``Determination of trans Fatty Acids in
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the trans Octadecenoate Content in Favor of the cis Isomers in
Partially Hydrogenated Vegetable Oils,'' Journal of the American Oil
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Association, 264:3044-3046, 1991.
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C. Ellison, and W. P. Castelli, ``Margarine Intake and Subsequent
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Neaton, W. P. Castelli, J. D. Knoke, D. R. Jacobs, S. Bangdiwala,
and H. A. Tyroler, ``High-density Lipoprotein Cholesterol and
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Perspective,'' Journal of Drug Development, 3(Supplement 1):11-17,
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Acids and Their Effects on Lipoproteins in Humans,'' Annual Review
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on Plasman Lipids and Lipoproteins: Human Studies,'' American
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``Systematic Underestimation of Association Between Serum
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of Medicine, 308:363-366, 1994.
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Acids on Serum Lipids and Lipoproteins. A Meta-analysis of 27
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Clinical Nutrition, 55: 45-50, 1992.
 
List of Subjects in 21 CFR Part 101
 
     Food labeling, Nutrition, Reporting and recordkeeping
requirements.
     Therefore, under the Federal Food, Drug, and Cosmetic Act and
under authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 101 be amended as follows:
 
PART 101--FOOD LABELING
 
     1. The authority citation for 21 CFR part 101 continues to read as
follows:
    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371.
     2. Section 101.9 is amended by revising paragraphs (c)(2)(i) and
(d)(7)(ii) to read as follows:
 
 
 Sec. 101.9  Nutrition labeling of food.
 
* * * * *
    (c) * * *
    (2) * * *
    (i) ``Saturated fat,'' or ``Saturated'': A statement of the number
of grams of
 
[[Page 62795]]
 
saturated fat in a serving, defined as the sum of the number of grams
per serving of all fatty acids containing no double bonds (i.e.
``saturated fatty acids'') plus the number of grams per serving of any
unsaturated fatty acids that contain one or more isolated (i.e.,
nonconjugated) double bonds in a trans configuration (i.e., ``trans
fatty acids'' or ``trans fat'').
    (A) The label declaration of saturated fat content information
(i.e., the combined value of saturated fatty acids plus trans fatty
acids) is not required for products that contain less than 0.5 gram of
total fat in a serving if no claims are made about fat, fatty acids, or
cholesterol content, and if ``calories from saturated fat'' is not
declared. Except as provided for in paragraph (f) of this section, if a
statement of the saturated fat content is not required and, as a
result, not declared, the statement ``Not a significant source of
saturated fat'' shall be placed at the bottom of the table of nutrient
values. The term ``Saturated fat'' or ``Saturated'' shall be indented
and the combined value of saturated fatty acids and trans fatty acids
expressed as grams per serving to the nearest 0.5 (1/2)-gram increment
below 5 grams and to the nearest gram increment above 5 grams. If the
serving contains less than 0.5 gram of saturated fatty acids and less
than 0.5 gram of trans fatty acids, the content when declared, shall be
expressed as zero.
    (B) When 0.5 or more grams per serving of trans fatty acids are
present, the heading shall be followed by an asterisk (or other symbol)
(e.g., ``Saturated fat*'') referring to another asterisk (or other
symbol) at the bottom of the nutrition label adjacent to a footnote
stating that the product ``Includes ____g trans fat,'' with the blank
specifying the amount of trans fat present in a serving. Optionally,
when less than 0.5 gram per serving of trans fatty acids are present,
manufacturers may, but need not, use an asterisk (or another symbol)
following ``Saturated fat'' to refer to the footnote ``Includes (or
contains) 0 g trans fat'' or ``Includes (or contains) no trans fat,''
except that the footnote is required when a fatty acid or cholesterol
claim is made. The term ``trans fatty acids'' may be used
interchangeably with ``trans fat.'' Amounts specified within the
footnote shall be expressed as grams per serving to the nearest 0.5 (1/
2)-gram increment below 5 grams and to the nearest gram increment above
5 grams.
* * * * *
    (d) * * *
    (7) * * *
    (ii) A listing of the percent of the DRV as established in
paragraphs (c)(7)(iii) and (c)(9) of this section shall be given in a
column aligned under the heading ``% Daily Value'' established in
paragraph (d)(6) of this section with the percent expressed to the
nearest whole percent for each nutrient declared in the column
described in paragraph (d)(7)(i) of this section for which a DRV has
been established, except that the percent for protein may be omitted as
provided in paragraph (c)(7) of this section. The percent shall be
calculated by dividing either the amount declared on the label for each
nutrient or the actual amount of each nutrient (i.e., before rounding)
by the DRV for the nutrient, except that the percent for protein shall
be calculated as specified in paragraph (c)(7)(ii) of this section.
When trans fatty acids are present in a food, the percent declared for
saturated fat shall be calculated by dividing the amount declared on
the label for saturated fat, which includes trans fatty acids, by the
DRV for saturated fat. The numerical value shall be followed by the
symbol for percent (i.e., %).
* * * * *
    3. Section 101.13 is amended by revising paragraphs (h)(1), (h)(2),
and (h)(3) to read as follows:
 
 
Sec. 101.13   Nutrient content claims--general principles.
 
* * * * *
    (h) * * *
    (1) If a food, except a meal product as defined in Sec. 101.13(l),
a main dish product as defined in Sec. 101.13(m), or food intended
specifically for use by infants and children less than 2 years of age,
contains more than 13.0 g of fat, 4.0 g of saturated fat and trans fat
combined, 60 milligrams (mg) of cholesterol, or 480 mg of sodium per
reference amount customarily consumed, per labeled serving, or, for a
food with a reference amount customarily consumed of 30 g or less or 2
tablespoons or less, per 50 g (for dehydrated foods that must be
reconstituted before typical consumption with water or a diluent
containing an insignificant amount, as defined in Sec. 101.9(f)(1), of
all nutrients per reference amount customarily consumed, the per 50 g
criterion refers to the ``as prepared'' form), then that food must bear
a statement disclosing that the nutrient exceeding the specified level
is present in the food as follows: ``See nutrition information for ----
---- content'' with the blank filled in with the identity of the
nutrient exceeding the specified level, e.g., ``See nutrition
information for fat content.''
    (2) If a food is a meal product as defined in Sec. 101.13(l), and
contains more than 26 g of fat, 8.0 g of saturated fat and trans fat
combined, 120 mg of cholesterol, or 960 mg of sodium per labeled
serving, then that food must disclose, in accordance with the
requirements as provided in paragraph (h)(1) of this section, that the
nutrient exceeding the specified level is present in the food.
    (3) If a food is a main dish product as defined in Sec. 101.13(m),
and contains more than 19.5 g of fat, 6.0 g of saturated fat and trans
fat combined, 90 mg of cholesterol, or 720 mg of sodium per labeled
serving, then that food must disclose, in accordance with the
requirements as provided in paragraph (h)(1) of this section, that the
nutrient exceeding the specified level is present in the food.
* * * * *
    4. Section 101.14 is amended by revising paragraph (a)(5) to read
as follows:
 
 
Sec. 101.14   Health claims: general requirements.
 
    (a) * * *
    (5) Disqualifying nutrient levels means the levels of total fat,
saturated fat and trans fat combined, cholesterol, or sodium in a food
above which the food will be disqualified from making a health claim.
These levels are 13.0 grams (g) of fat, 4.0 g of saturated fat and
trans fat combined, 60 milligrams (mg) of cholesterol, or 480 mg of
sodium, per reference amount customarily consumed, per labeled serving
size, and, only for foods with reference amounts customarily consumed
of 30 g or less or 2 tablespoons or less, per 50 g. For dehydrated
foods that must have water added to them prior to typical consumption,
the per 50 g criterion refers to the as prepared form. Any one of the
levels, on a per reference amount customarily consumed, a per labeled
serving size or, when applicable, a per 50 g basis, will disqualify a
food from making a health claim unless an exception is provided in
subpart E of this part, except that:
    (i) The levels for a meal product as defined in Sec. 101.13(l) are
26.0 g fat, 8.0 g of saturated fat and trans fat combined, 120 mg of
cholesterol, or 960 mg of sodium per labeled serving size, and
    (ii) The levels for a main dish product as defined in
Sec. 101.13(m) are 19.5 g of fat, 6.0 g of saturated fat and trans fat
combined, 90 mg of cholesterol, or 720 mg of sodium per labeled serving
size.
* * * * *
    5. Section 101.36 is amended by adding a sentence after the first
sentence in paragraph (b)(2)(i) and by revising paragraph (b)(2)(iii)
introductory text to read as follows:
 
[[Page 62796]]
 
Sec. 101.36   Nutrition labeling of dietary supplements.
 
* * * * *
    (b) * * *
    (2) * * *
    (i) * * * When trans fatty acids are present, they shall be
declared in accordance with Sec. 101.9(c)(2)(i). * * *
* * * * *
    (iii) The percent of the Daily Value of all dietary ingredients
declared under paragraph (b)(2)(i) of this section shall be listed,
except that the percent for protein may be omitted as provided in
Sec. 101.9(c)(7) and when trans fatty acids are present in a food, the
percent for saturated fat shall be calculated by dividing the amount
declared on the label for saturated fat, which includes trans fatty
acids, by the DRV for saturated fat; no percent shall be given for
subcomponents for which DRV's have not been established (e.g., sugars);
and, for labels of dietary supplements of vitamins and minerals that
are represented or purported to be for use by infants, children less
than 4 years of age, or pregnant or lactating women, no percent shall
be given for total fat, saturated fat, cholesterol, total carbohydrate,
dietary fiber, vitamin K, selenium, manganese, chromium, molybdenum,
chloride, sodium, or potassium.
* * * * *
    6. Section 101.62 is amended by adding paragraph (c)(6), by
revising paragraph (c) introductory text, and paragraphs (c)(2)(i),
(c)(3)(i), (c)(4)(i), (c)(5)(i), (d)(1)(i)(C), (d)(1)(ii)(C),
(d)(2)(i)(B), (d)(2)(ii)(B), (d)(2)(iii)(B), (d)(2)(iv)(B), (d)(3),
(d)(4)(i)(B), (d)(4)(ii)(B), (d)(5)(i)(B), (d)(5)(ii)(B), and (e) to
read as follows:
 
 
Sec. 101.62   Nutrient content claims for fat, fatty acid, and
cholesterol content of foods.
 
* * * * *
    (c) ``Fatty acid content claims.'' The label or labeling of foods
that bear claims with respect to the level of saturated fat or trans
fat shall disclose the level of total fat and cholesterol in the food
in immediate proximity to such claim each time the claim is made and in
type that shall be no less than one-half the size of the type used for
the claim with respect to the level of saturated fat or trans fat.
Declaration of cholesterol content may be omitted when the food
contains less than 2 milligrams (mg) of cholesterol per reference
amount customarily consumed or in the case of a meal or main dish
product less than 2 mg of cholesterol per labeled serving. Declaration
of total fat may be omitted with the terms defined in paragraphs (c)(1)
and (c)(6) of this section when the food contains less than 0.5 g of
total fat per reference amount customarily consumed or, in the case of
a meal product or a main dish product, when the product contains less
than 0.5 g of total fat per labeled serving. The declaration of total
fat may be omitted with the terms defined in paragraphs (c)(2) through
(c)(5) of this section when the food contains 3 g or less of total fat
per reference amount customarily consumed or in the case of a meal
product or a main dish product, when the product contains 3 g or less
of total fat per 100 g and not more than 30 percent calories from fat.
* * * * *
    (2) * * *
    (i) The food contains 1 g or less of saturated fat and less than
0.5 g of trans fat per reference amount customarily consumed and not
more than 15 percent of calories from saturated fat and trans fat
combined; and
* * * * *
    (3) * * *
    (i) The product contains 1 g or less of saturated fat and less than
0.5 g of trans fat per 100 g and less than 10 percent of calories from
saturated fat and trans fat combined; and
* * * * *
    (4) * * *
    (i) The food contains at least 25 percent less saturated fat and at
least 25 percent less saturated fat and trans fat combined per
reference amount customarily consumed than an appropriate reference
food as described in Sec. 101.13(j)(1); and
* * * * *
    (5) * * *
    (i) The food contains at least 25 percent less saturated fat and at
least 25 percent less saturated fat and trans fat combined per 100 g of
food than an appropriate reference food as described in
Sec. 101.13(j)(1); and
* * * * *
    (6) The terms ``trans fat free,'' ``free of trans fat,'' ``no trans
fat,'' ``zero trans fat,'' ``without trans fat,'' ``trivial source of
trans fat,'' ``negligible source of trans fat,'' or ``dietarily
insignificant source of trans fat'' (with ``trans fatty acids''
allowable as a synonym for ``trans fat'') may be used on the label or
in the labeling of foods, provided that:
    (i) The food contains less than 0.5 g of trans fat and less than
0.5 g of saturated fat per reference amount customarily consumed and
per labeled serving or, in the case of a meal product or a main dish
product, less than 0.5 g of trans fat and less than 0.5 g of saturated
fat per labeled serving; and
    (ii) The food contains no ingredient that is generally understood
by consumers to contain trans fat unless the listing of the ingredient
in the ingredient statement is followed by an asterisk (or other
symbol) that refers to the statement below the list of ingredients
which states, ``adds a trivial amount of trans fat,'' ``adds a
negligible amount of trans fat,'' or ``adds a dietarily insignificant
amount of trans fat; and
    (iii) As required in Sec. 101.13(e)(2), if the food meets these
conditions without the benefit of special processing, alteration,
formulation, or reformulation to lower trans fat content, it is labeled
to disclose that trans fat is not usually present in the food (e.g.,
``Corn oil, atrans fat free food'').
    (d) * * *
    (1) * * *
    (i) * * *
    (C) The food contains 2 g or less of saturated fat and trans fat
combined per reference amount customarily consumed or, in the case of a
meal product or main dish product, 2 g or less of saturated fat and
trans fat combined per labeled serving; and
* * * * *
    (ii) * * *
    (C) The food contains 2 g or less of saturated fat and trans fat
combined per reference amount customarily consumed or, in the case of a
meal product or main dish product, 2 g or less of saturated fat and
trans fat combined per labeled serving; and
* * * * *
    (2) * * *
    (i) * * *
    (B) The food contains 2 g or less of saturated fat and trans fat
combined per reference amount customarily consumed; and
* * * * *
    (ii) * * *
    (B) The food contains 2 g or less of saturated fat and trans fat
combined per reference amount customarily consumed; and
* * * * *
    (iii) * * *
    (B) The food contains 2 g or less of saturated fat and trans fat
combined per reference amount customarily consumed;
* * * * *
    (iv) * * *
    (B) The food contains 2 g or less of saturated fat and trans fat
combined per reference amount customarily consumed;
* * * * *
    (3) The terms defined in paragraph (d)(2) of this section may be
used on the label and in labeling of meal products as defined in
Sec. 101.13(l) or a main dish
 
[[Page 62797]]
 
product as defined in Sec. 101.13(m) provided that the product meets
the requirements of paragraph (d)(2) of this section except that the
determination as to whether paragraph (d)(2)(i) or (d)(2)(iii) of this
section applies to the product will be made only on the basis of
whether the meal product contains 26 g or less of total fat per labeled
serving or the main dish product contains 19.5 g or less of total fat
per labeled serving; the requirement in paragraphs (d)(2)(i)(A) and
(d)(2)(iii)(A) of this section shall be limited to 20 mg of cholesterol
per 100 g, and the requirement in paragraphs (d)(2)(i)(B) and
(d)(2)(iii)(B) of this section shall be modified to require that the
food contain 2 g or less of saturated fat and trans fat combined per
100 g rather than per reference amount customarily consumed.
    (4) * * *
    (i) * * *
    (B) The food contains 2 g or less of saturated fat and trans fat
combined per reference amount customarily consumed; and
* * * * *
    (ii) * * *
    (B) The food contains 2 g or less of saturated fat and trans fat
combined per reference amount customarily consumed;
* * * * *
    (5) * * *
    (i) * * *
    (B) The food contains 2 g or less of saturated fat and trans fat
combined per 100 g; and
* * * * *
    (ii) * * *
    (B) The food contains 2 g or less of saturated fat and trans fat
combined per 100 g;
* * * * *
    (e) ``Lean'' and ``extra lean'' claims. (1) The term ``lean'' may
be used on the label or in labeling of foods except meal products as
defined in Sec. 101.13(l) and main dish products as defined in
Sec. 101.13(m) provided that the food is a seafood or game meat product
and as packaged contains less than 10 g of total fat, 4.5 g or less of
saturated fat andtrans fat combined, and less than 95 mg of cholesterol
per reference amount customarily consumed and per 100 g;
    (2) The term defined in paragraph (e)(1) of this section may be
used on the label or in the labeling of meal products as defined in
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m)
provided that the food contains less than 10 g of total fat, 4.5 g or
less of saturated fat and trans fat combined, and less than 95 mg of
cholesterol per 100 g and per labeled serving;
    (3) The term ``extra lean'' may be used on the label or in labeling
of foods except meal products as defined in Sec. 101.13(l) and main
dish products as defined in Sec. 101.13(m) provided that the food is a
discrete seafood or game meat product and as packaged contains less
than 5 g of total fat, less than 2 g of saturated fat and trans fat
combined, and less than 95 mg of cholesterol per reference amount
customarily consumed and per 100 g; and
    (4) The term defined in paragraph (e)(3) of this section may be
used on the label or in the labeling of meal products as defined in
Sec. 101.13(l) and main dish products as defined in Sec. 101.13(m)
provided that the food contains less than 5 g of total fat, less than 2
g of saturated fat and trans fat combined, and less than 95 mg of
cholesterol per 100 g and per labeled serving.
* * * * *
 
    Dated: July 29, 1999.
Jane E. Henney,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
    Note:The following Appendix A and Appendix B will not appear in
the Code of Federal Regulations.
 
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                                                   APPENDIX A
 Table 2.--Observational Studies of Associations of trans Fatty Acids Intakes and Adipose Tissue Concentrations
                               with Risk of Coronary Heart Disease (CHD) in Humans
----------------------------------------------------------------------------------------------------------------
                     Study Design,
                      Main Outcome
    Reference          Measures,           Subjects           Methods            Results            Comments
                     Location, and
                          Date
----------------------------------------------------------------------------------------------------------------
Aro et al., 1995   Case-control.      Men <ls-thn-eq>70  Adipose tissue     Relative risk of   Authors assumed
 (Ref. 16)         Risk of acute       years of age.      samples from the   acute myocardial   that trans fatty
                    myocardial         Cases: 671 men     buttocks were      infarction was     acids intakes
                    infarction.        with first acute   analyzed for       slightly greater   were primarily
                   Finland, Germany,   myocardial         trans fatty        with higher        from
                    Israel,            infarction         acids content.     adipose trans      hydrogenated
                    Netherlands,       consecutively     Calculation of      fatty acids        vegetable oils
                    Norway, Russia,    recruited from     odds ratios        concentrations     but no food
                    United Kingdom,    coronary care      (OR).              when OR's were     intake data were
                    Spain, and         units of                              calculated         collected to
                    Switzerland        participating                         excluding the      verify that this
                    (EURAMIC Study)    hospitals.                            Spanish sites      assumption was
                    1991-1992.         Controls: 717                         but differences    true for all
                                       men without a                         between cases      countries.
                                       history of acute                      and controls
                                       myocardial                            were not
                                       infarction,                           significant.
                                       recruited from                       Although there
                                       the population                        were no overall
                                       in the catchment                      differences in
                                       area and                              mean proportions
                                       frequency-                            of trans fatty
                                       matched for age                       acids in adipose
                                       according to 5-                       tissue samples
                                       year intervals.                       between cases
                                                                             and controls,
                                                                             mean proportion
                                                                             of trans fatty
                                                                             acids in adipose
                                                                             tissue samples
                                                                             differed
                                                                             considerably
                                                                             among centers.
                                                                             Cases in Norway
                                                                             and Finland had
                                                                             significantly
                                                                             higher mean
                                                                             proportions of
                                                                             trans fatty
                                                                             acids than
                                                                             controls.
                                                                             Pattern of
                                                                             adipose tissue
                                                                             fatty acids was
                                                                             different in
                                                                             Spain from other
                                                                             countries in
                                                                             that proportion
                                                                             of trans fatty
                                                                             acids was very
                                                                             low and that of
                                                                             oleic acid was
                                                                             high in Spain.
----------------------------------------------------------------------------------------------------------------
 
[[Page 62813]]
 
 
Ascherio et al.,   Case-control.      239 white males    Patients and       Mean intake of     Patients were not
 1994 (Ref. 18)    Risk of             and females <76    controls were      total trans        asked whether
                    myocardial         years of age       interviewed and    fatty acids was    they had changed
                    infarction .       (mean=57.9         blood samples      4.4 g/day in men   their dietary
                   Boston, MA 1982-    years) diagnosed   taken 8 weeks      (1.5% of energy)   intakes after
                    1983.              with myocardial    after patient's    and 3.6 g/day in   their myocardial
                                       infarction.        myocardial         women (1.7% of     infarction.
                                       Patients had no    infarction.        energy). Median    Serum LDL-C has
                                       previous history   Confirmation of    intakes in the     been shown to
                                       of diabetes,       diagnosis was      lowest and         respond to
                                       high serum         based on           highest            dietary changes
                                       cholesterol,       clinical history   quintiles were     within 3 weeks
                                       myocardial         and creatine       3.1 and 6.7 g/     in clinical
                                       infarction, or     kinase increase.   day for men and    trials and LDL-C
                                       angina.           Trans fatty acids   3.0 and 6.8 g/     in this group
                                      282 control         intake was         day for women.     may reflect
                                       subjects of the    estimated from a  Relative risk       recent dietary
                                       same age           semiquantitative   (RR) of            intakes rather
                                       (mean=57.1         food frequency     myocardial         than diet before
                                       years) and sex     questionnaire      infarction was     myocardial
                                       who had no         and analyzed       2.03 (p=0.0001)    infarction.
                                       history of         values for all     in the highest
                                       diabetes, high     trans isomers of   compared to the
                                       serum              C-18 fatty acids   lowest quintile
                                       cholesterol,       from the           of energy-
                                       myocardial         scientific         adjusted trans
                                       infarction, or     literature.        fatty acids
                                       angina. Control   High density        intake after
                                       subjects were      lipoprotein        adjustment for
                                       selected at        cholesterol (HDL-  cigarette
                                       random from town   C) and low         smoking, history
                                       where patient      density            of hypertension,
                                       resided.           lipoprotein        family history
                                      Sample consisted    cholesterol (LDL-  of CHD, alcohol
                                       of 197 matched     C)                 intake, physical
                                       pairs and an       concentrations     activity, body
                                       additional 42      were measured in   mass index, and
                                       patients and 85    serum.             intakes of
                                       control                               saturated fat,
                                       subjects.                             monounsaturated
                                                                             fat, linoleic
                                                                             acid, and
                                                                             cholesterol.
----------------------------------------------------------------------------------------------------------------
 
[[Page 62814]]
 
 
Ascherio et al.,   Cohort study.      43,757 male        Food frequency     Mean daily intake  Source of food
 1996 (Ref. 19)    Incidence of        health             questionnaire      of trans fatty     composition data
                    fatal coronary     professionals 40-  administered at    acids was 0.8%     not reported.
                    heart disease      75 years of age    beginning of       of energy and     Analyses
                    (CHD) and          free of            study in 1986.     1.6% of energy     conducted with
                    nonfatal           diagnosed         Tracking of fatal   for the lowest     proportion of
                    myocardial         cardiovascular     CHD and nonfatal   and highest        energy
                    infarction.        disease in 1986.   myocardial         quintiles.         contributed by
                   United States                          infarction         Median intakes     different fats
                    1986-1996 for                         occurring          were 1.5 g/day     as continuous
                    these data.                           between return     and 4.3 g/day      variables.
                                                          of the baseline    for the lowest
                                                          questionnaire      and highest
                                                          and January        quintiles.
                                                          1992.             RR of total
                                                         Nonfatal            myocardial
                                                          myocardial         infarction (chi
                                                          infarction         square for
                                                          confirmed by use   trend) was 2.59
                                                          of WHO criteria    (p=0.01) after
                                                          (symptoms plus     adjustment for
                                                          either typical     age, body mass
                                                          ECG changes or     index, smoking,
                                                          increased          alcohol
                                                          activities in      consumption,
                                                          cardiac            physical
                                                          enzymes). Fatal    activity,
                                                          CHD was            history of
                                                          documented by      hypertension or
                                                          death records      high blood
                                                          and medical        cholesterol,
                                                          records or         family history
                                                          necropsy           of myocardial
                                                          reports.           infarction
                                                                             before age 60,
                                                                             and profession.
                                                                             Additional
                                                                             adjustment for
                                                                             dietary fiber
                                                                             intake adjusted
                                                                             for energy
                                                                             reduced chi
                                                                             square value to
                                                                             1.27 (p=0.20).
                                                                            RR of fatal CHD
                                                                             was very similar
                                                                             to that for
                                                                             total myocardial
                                                                             infarction.
----------------------------------------------------------------------------------------------------------------
 
[[Page 62815]]
 
 
Hu et al., 1997    Prospective        80,082 female      Semiquantitative   Median intakes of  Study provides 14
 (Ref. 38)          cohort study       nurses who         food frequency     trans fats were    years of
                    begun in 1976.     completed          questionnaires     1.3, 1.7, 2.0,     followup for
                   Incidence of CHD    dietary            and all trans      2.4, and 2.9% of   this population
                    (nonfatal          questionnaires     isomers of C-18    energy for         group. See
                    myocardial         in 1980. Sample    fatty acids in     quintiles of       Willett et al
                    infarction or      excluded women     foods from 1993    80,082 women.      (1993) for
                    death from CHD)    with previous      Harvard           RR of CHD in        results from 8
                   United States       cancer, angina,    University Food    relation to        years of
                    1980-1994          myocardial         Composition        energy-adjusted    followup.
                                       infarction,        Database.          trans fat intake  Study did not
                                       stroke,           Incidence of CHD    was 1.53           report amounts
                                       diabetes, or       (nonfatal          (p=0.002) for      of trans fatty
                                       high serum total   myocardial         the highest        acids intake.
                                       cholesterol        infarction or      quintile           The median trans
                                       (TC).              death from CHD).   compared to the    fatty acids
                                                          Diagnosis of       lowest after       intakes reported
                                                          myocardial         adjustments for    as % of energy
                                                          infarction was     factors listed     intakes for
                                                          confirmed if WHO   and for intakes    quintiles were
                                                          criteria were      of saturated       calculated to be
                                                          met. Fatal CHD     fatty acids        2.9, 3.8, 4.4,
                                                          was documented     (SFA),             5.3, and 6.4 g/
                                                          by death and       monounsaturated    day in a 2,000
                                                          medical records.   fatty acids        calorie diet.
                                                         Multiple linear     (MUFA), and
                                                          regression         polyunsaturated
                                                          analysis used to   fatty acids
                                                          adjust for age,    (PUFA).
                                                          smoking, body
                                                          mass index,
                                                          hypertension,
                                                          aspirin use,
                                                          vigorous
                                                          exercise,
                                                          alcohol intake,
                                                          menopausal
                                                          status,
                                                          postmenopausal
                                                          hormone
                                                          replacement
                                                          therapy,
                                                          parental history
                                                          of myocardial
                                                          infarction
                                                          before 65 years
                                                          of age, energy
                                                          intake, energy
                                                          from protein,
                                                          use of
                                                          multivitamins,
                                                          and vitamin E
                                                          supplement use.
----------------------------------------------------------------------------------------------------------------
 
[[Page 62816]]
 
 
Kromhout et al.,   Cohort.(25-year    12,763 men 40-59   Dietary            Mean trans fatty   Use of foods
 1995 (Ref. 22)     follow-up of       years of age       information was    acids intakes      available in
                    intercohort CHD    during the years   collected from     calculated from    1987 for dietary
                    mortality).        1958-1964.         small random       the food           composite data
                   CHD mortality and                      samples of 14 of   composites         assumes little
                    serum TC                              the 16 cohorts     analyses ranged    change over the
                    concentrations.                       between 1959 and   between 0.05%      25 years from
                   16 cohorts in                          1964. In 1987,     and 1.84% of       the beginning of
                    Finland, Italy,                       trans fatty        energy among the   the study. Trans
                    Greece, the                           acids (reported    16 cohorts and     fatty acids
                    former                                as elaidic acid)   were associated    could not be
                    Yugoslavia,                           were analyzed in   with SFA intake    measured at the
                    Japan, United                         composites         (r=0.84). Mean     first time
                    States, Italy,                        representing       SFA intake         point.
                    and the                               average food       ranged from 3.8%  Correlations
                    Netherlands                           intakes of each    to 22.7% of        between analyses
                    (Seven Countries                      cohort at          energy. Mean cis   at the two time
                    Study) 1958-1964                      baseline           MUFA intake        points were 0.92
                    to 1987.                              collected from     ranged from 3.8%   (p<0.01) for
                                                          local markets      to 26.9% of        SFA, 0.93
                                                          and prepared       energy. Mean       (p<0.01) for
                                                          according to the   PUFA intake        MUFA, and 0.52
                                                          average            ranged from 3.4%   (p<0.07) for
                                                          consumption        to 8.6% of         PUFA.
                                                          patterns of        energy. Mean      The independent
                                                          cohorts.           dietary            effects of
                                                         International       cholesterol        individual fatty
                                                          Classification     ranged from 141    acids and
                                                          of Diseases        to 612 mg/day.     dietary
                                                          category for      Mean intake of      cholesterol on
                                                          mortality from     trans fatty        serum
                                                          CHD (ICD 410-      acids of cohorts   cholesterol and
                                                          414) was used to   was associated     CHD mortality
                                                          establish cause    with serum TC      could not be
                                                          of death from      (r=0.70, p<0.01)   analyzed in
                                                          CHD.               and 25-year        multivariate
                                                                             mortality rates    models because
                                                                             from CHD           mean intakes of
                                                                             (r=0.78,           individual SFA,
                                                                             p<0.001). Mean     trans fatty
                                                                             intake of all      acids, and
                                                                             SFA was            dietary
                                                                             positively         cholesterol were
                                                                             associated with    highly
                                                                             serum TC           correlated among
                                                                             (r=0.70, p<0.01)   the cohorts.
                                                                             and 25-year CHD
                                                                             mortality rates
                                                                             (r=0.88). Mean
                                                                             cholesterol
                                                                             intake was
                                                                             positively
                                                                             associated with
                                                                             serum TC
                                                                             (r=0.46, NS) and
                                                                             25-year CHD
                                                                             mortality rate
                                                                             (r=0.55,
                                                                             p<0.05).
----------------------------------------------------------------------------------------------------------------
 
[[Page 62817]]
 
 
Pietinen et al.,   Cohort study.      21,930 male        Semi-quantitative  Median intakes of  Major source of
 1997 (Ref. 20)    Observations from   smokers            food frequency     trans fatty        trans fatty
                    a placebo-         excluding prior    questionnaire      acids were 1.3,    acids was
                    controlled         diagnosis of       and analyzed       1.7, 2.0, 2.7,     margarines. Soft
                    primary            myocardial         values of          and 5.6 g/d in     margarines
                    prevention trial   infarction,        Finnish foods      quintiles (2 g/    contained 0% or
                    designed to        angina, stroke,    used to            day = 0.95% of     15-17% of total
                    investigate an     diabetes, or       calculate          energy; % energy   fatty acids as
                    association        exercise-related   intakes of trans   values for         trans fatty
                    between            chest pain.        fatty acids.       medians of other   acids. Hard
                    supplementation                       Analyzed values    quintiles were     margarines
                    with alpha-                           included all       not reported).     contained animal
                    tocopherol, beta-                     trans isomers of  After adjusting     and vegetable
                    carotene, or                          C-16--C-22 fatty   for age and        fats and their
                    both on                               acids.             supplement         trans fatty
                    incidence of                         Occurrence of       group, trans       acids content
                    lung cancer in                        major coronary     fatty acids        ranged from 2.7
                    male smokers.                         events was         intake (as %       to 13% of total
                   Major coronary                         obtained from      energy) was        fatty acids.
                    events and                            the National       related to the    No other category
                    coronary deaths.                      Hospital           risk of major      of fatty acids,
                   Finland 1985-                          Discharge          coronary event.    total fat
                    1993.                                 Register (ICD      RR=1.19 in         (triglycerides),
                                                          410.00 or          highest intake     or cholesterol
                                                          410.99). Deaths    quintile           intakes was
                                                          were identified    compared to        associated with
                                                          through the        lowest ( p for     higher RR of
                                                          Central            trend= 0.06).      major coronary
                                                          Population         After adjustment   event.
                                                          Register and       for
                                                          coronary death     cardiovascular
                                                          was assigned       risk factors,
                                                          when CHD was       RR=1.14 (p for
                                                          described as the   trend=0.16). No
                                                          underlying cause   significant
                                                          of death (ICD      associations
                                                          410-414).          were found
                                                         Data were           between intakes
                                                          adjusted for       of other fatty
                                                          supplementation    acids and the
                                                          group because      risk of CHD
                                                          the main results   death.
                                                          of the trial      With age and
                                                          showed fewer CHD   supplement group
                                                          deaths among       adjustments,
                                                          participants       trans fatty
                                                          given alpha-       acids intake was
                                                          tocopherol than    also associated
                                                          those not given    with risk of CHD
                                                          the vitamin and    death. RR=1.38
                                                          more CHD deaths    in highest
                                                          among those        intake quintile
                                                          given beta-        compared with
                                                          carotene than      lowest (p for
                                                          those not          trend=0.06).
                                                          receiving it.      Significant
                                                                             association
                                                                             remained after
                                                                             adjustment for
                                                                             cardiovascular
                                                                             risk factors. No
                                                                             significant
                                                                             associations
                                                                             were found
                                                                             between intakes
                                                                             of other fatty
                                                                             acids and the
                                                                             risk of CHD
                                                                             death.
                                                                            In the
                                                                             multivariate
                                                                             analyses, there
                                                                             was a
                                                                             significant
                                                                             inverse
                                                                             association
                                                                             between CHD
                                                                             dearth and the
                                                                             intake of SFA
                                                                             and significant
                                                                             direct
                                                                             associations
                                                                             with intake of
                                                                             PUFA and
                                                                             linoleic acid (p
                                                                             trend for both <
                                                                             0.05).
----------------------------------------------------------------------------------------------------------------
 
[[Page 62818]]
 
 
Roberts et al.,    Case-control       Men < 65 years of  Samples of         Mean
 1995 (Ref. 17)     study.             age with no        adipose tissue     concentration of
                   Sudden cardiac      history of CHD     taken from the     trans fatty
                    death due to       Cases: 64 cases    anterior           acids (as a
                    coronary artery    of sudden          abdominal wall     percent of total
                    disease.           cardiac death      were analyzed      fatty acids) was
                   Southampton,        due to coronary    for trans fatty    lower in cases
                    United Kingdom     artery disease.    acids content.     than in controls
                    1990-1991.         Cases were        RR of sudden        (p<0.05).
                                       identified by      cardiac death in  Multivariate OR's
                                       necropsy           cases compared     were not
                                       reports.           with controls      independently
                                       Potential          was calculated     related to the
                                       subjects with a    from the           risk of sudden
                                       diagnosis of CHD   distribution of    cardiac death
                                       before death       trans isomers by   for total trans
                                       were excluded      quintiles in the   fatty acids
                                       from the sample.   control            (C18:1 and
                                      Controls: 286       population.        C18:2) or for
                                       healthy, age-     Independent         trans C18:1
                                       matched men.       contribution of    only.
                                                          trans isomers to
                                                          the risk of
                                                          sudden cardiac
                                                          death assessed
                                                          by multiple
                                                          regression with
                                                          adjustments for
                                                          age, cigarette
                                                          smoking, treated
                                                          hypertension,
                                                          diabetes, and
                                                          oleic and
                                                          linoleic acids
                                                          in adipose
                                                          tissue.
----------------------------------------------------------------------------------------------------------------
Troisi et al.,     Cross-sectional    748 men 43-85      Semiquantitative   Mean trans fatty
 1992 (Ref. 23)     examination of     years of age       food frequency     acids intake was
                    participants in    (mean=62 years)    questionnaire      1.6% of energy
                    the Normative      examined in the    and trans fatty    (3.4 g/day) and
                    Aging Study        Normative Aging    acids (all trans   did not differ
                    begun in 1961.     Study between      isomers of C-18    between groups
                   Serum lipids.       1987 and 1990.     fatty acids)       based on earlier
                   United States       Subjects did not   data from USDA,    serum TC
                    1987-1990.         have               other published    concentration.
                                       hypertension,      sources, and       Correlation
                                       cancer, or         personal           coefficient (r)
                                       diabetes in 1961   communications     for trans fatty
                                       when study         from               acids intake was
                                       began. Exclusion   laboratories and   positively
                                       criteria for the   food               related to serum
                                       present study      manufacturers.     LDL-C (r=0.09,
                                       included taking   Men were divided    p=0.01) and TC
                                       medications that   into two groups    (r=0.07,
                                       could affect       based on whether   p=0.06).
                                       blood lipids.      or not they had   HDL-C was lower
                                                          high serum TC      in men with
                                                          concentrations 3-  higher trans
                                                          5 years earlier.   fatty acids
                                                         Multiple linear     intakes (r=0.08,
                                                          regression         p=0.03).
                                                          analysis used to  Associations
                                                          adjust for age,    between trans
                                                          body mass index,   fatty acids
                                                          waist-to-hip       intake and serum
                                                          ratio, smoking     TC and LDL-C
                                                          status, physical   were stronger in
                                                          activity,          group who had
                                                          alcohol intake,    previously had
                                                          total energy       high serum
                                                          intake, dietary    cholesterol
                                                          cholesterol and    concentrations.
                                                          linoleic acid,
                                                          and previous
                                                          serum
                                                          cholesterol
                                                          concentration.
----------------------------------------------------------------------------------------------------------------
 
[[Page 62819]]
 
 
Willett et al.,    Prospective        85,095 female      Semiquantitative   Median intakes of  Energy-adjusted
 1993 (Ref. 21)     cohort study       nurses who         food frequency     trans fatty        mean intakes of
                    begun in 1976.     completed          questionnaires     acids were 1.3,    trans fatty
                   Incidence of CHD    dietary            and trans fatty    1.8, 2.2, 2.6,     acids were 2.4,
                    (nonfatal          questionnaires     acids              and 3.2% of        3.2, 3.9, 4.5,
                    myocardial         in 1980. Sample    concentrations     energy for         and 5.7 g/day in
                    infarction or      excluded women     (all trans         quintiles of       1980 for the
                    death from CHD).   with previous      isomers of C-18    69,181 women who   quintiles of the
                   United States       angina,            fatty acids) in    reported no        whole cohort.
                    1980-1988.         myocardial         foods from         change in          Intake of trans
                                       infarction,        published          margarine intake   fatty acids was
                                       stroke,            literature.        1970-1980.         strongly
                                       diabetes, or      Incidence of CHD   RR of CHD in        associated with
                                       high serum TC.     (nonfatal          relation to        intake of total
                                                          myocardial         energy-adjusted    MUFA and
                                                          infarction or      trans fatty        linoleic acid.
                                                          death from CHD).   acids intake       RR value
                                                          Diagnosis of       among 69,181       reported in this
                                                          myocardial         women who had      table includes
                                                          infarction         not changed        adjustments for
                                                          confirmed if WHO   margarine          dietary lipid
                                                          criteria were      consumption 1970-  intake
                                                          met. Fatal CHD     1980 was 1.67
                                                          documented by      (p=0.002) for
                                                          death and          the highest
                                                          medical records.   quintile
                                                         Multiple linear     compared to the
                                                          regression         lowest quintile.
                                                          analysis was
                                                          used to adjust
                                                          for age,
                                                          smoking, body
                                                          mass index,
                                                          hypertension,
                                                          alcohol intake,
                                                          menopausal
                                                          status,
                                                          postmenopausal
                                                          estrogen use,
                                                          energy intake,
                                                          dietary lipids,
                                                          family history
                                                          of myocardial
                                                          infarction
                                                          before 60 years
                                                          of age, and
                                                          multivitamin
                                                          use.
----------------------------------------------------------------------------------------------------------------
 
 
                                                   APPENDIX A
       Table 3.--Summary of effects of dietary trans Fatty Acids on Serum LDL-Cholesterol Levels in Humans
----------------------------------------------------------------------------------------------------------------
                        Level and Source of                            Trans Fatty Acids
      Reference         trans Fatty Acids in    Comparison Diet(s)     Intakes (gram (g)/   Change in Serum LDL-
                            Test Diet(s)                                      day)           Cholesterol (LDL-C)
----------------------------------------------------------------------------------------------------------------
Almendingen et al.,    8.5% of energy.        Butter diet. Trans     22.6, 29.3, 33.9, or   <d-arrow>6.0% (0.23
 1995 (Ref. 9)          Partially              isomers provided       38.3 g/day PHSO        millimole per liter
                        hydrogenated soybean   0.9% of energy.        diet.                  (mmol/L), p=0.02)
                        oil margarine                                21.2, 27.6, 31.9, or    after PHSO compared
                        (PHSO).                                       36.1 g/day PHFO        to butter diet.
                       8.0% of energy.                                diet.                 No significant
                        Partially                                    2.4, 3.1, 3.6, or 4.1   difference (NSD)
                        hydrogenated fish                             g/day butter diet.     after PHFO compared
                        oil margarine                                                        to butter.
                        (PHFO).
----------------------------------------------------------------------------------------------------------------
Aro et al., 1997       8.7% of energy. Main   Stearic acid diet      24.9 g/day margarine   <u-arrow>8.3% (0.24
 (Ref. 10)              source was a special   provided 0.5% of       (trans) diet.          mmol/L, p=0.046)
                        margarine.             energy as trans       1.2 g/day stearic       after trans diet
                                               fatty acids and 9.3%   acid diet.             compared to stearic
                                               as stearic acid.      2.3 g/day baseline      acid diet.
                                               Main source was a      diet.                 NSD after trans diet
                                               special margarine.                            compared to
                                              Baseline diet                                  baseline diet.
                                               provided 0.8% of
                                               energy as trans
                                               fatty acids and 3.6%
                                               as stearic acid.
                                               Main fat sources
                                               were dairy with some
                                               meat and coconut
                                               oil.
----------------------------------------------------------------------------------------------------------------
 
[[Page 62820]]
 
 
Judd et al., 1994      3.8% of energy in      Oleic acid diet        7.6 or 11.8 g/day      <u-arrow>6.0% and
 (Ref. 12)              moderate trans diet    provided about 0.7%    moderate trans diet.   7.8% (0.20 and 0.26
                        and 6.6% of energy     of energy as trans    13.2 or 20.5 g/day      mmol/L, p<ls-thn-
                        in high trans diet.    isomers.               high trans diet.       eq>0.05) after
                        Hydrogenated          Saturated fat diet     1.4 or 2.2 g/day        moderate and high
                        vegetable oils.        provided about 0.7%    oleic acid diet and    trans diets
                                               of energy as trans     saturated fat diet.    compared to oleic
                                               isomers.                                      acid diet.
                                                                                            <d-arrow>2.7% (0.10
                                                                                             mmol/L, p<ls-thn-
                                                                                             eq>0.05) after
                                                                                             moderate trans diet
                                                                                             and NSD after high
                                                                                             trans diet compared
                                                                                             to saturated fat
                                                                                             diet.
----------------------------------------------------------------------------------------------------------------
Judd et al., 1998      3.9% of energy from    PUFA margarine diet    Trans margarine diet:  <d-arrow>4.9% (0.17
 (Ref. 34)              trans monoenes.        provided 2.4% of       13 and 9 g/day of      mmol/L, p = 0.005)
                        Partially              energy as trans        trans monoenes for     after consumption
                        hydrogenated tub       monoenes.              males and females.     of trans margarine
                        table spread.         Butter diet provided   PUFA margarine diet:    diet compared to
                                               2.5% of energy as      8 and 6 g/day of       butter diet.
                                               trans monoenes.        trans monoenes for    <u-arrow>0.19% (0.06
                                              Basal diet contained    males and females.     mmol/L, 0 = 0.017)
                                               8.9% trans fatty      Butter diet: 9 and 7    after consumption
                                               acids on a dry         g/day of trans         of trans margarine
                                               weight basis.          monoenes for males     compared to PUFA
                                                                      and females.           margarine diet.
----------------------------------------------------------------------------------------------------------------
Lichtenstein et al.,   0.91% of energy in
 1999 (Ref. 82)         semiliquid margarine
                        diet,
                       3.30% in soft
                        margarine diet,
                       4.15% in shortening
                        diet
                       6.72% in stick
                        margarine diet
                                              Soybean oil diet
                                                                     Soybean oil diet: 1.7
 
 
 
 
                                                                                            <d-arrow>5% to 11%
 
----------------------------------------------------------------------------------------------------------------
Lichtenstein et al.,   4.16% of energy.       Corn oil with trans    12.5 g/day corn oil    <u-arrow>8.4% (0.27
 1993 (Ref. 13)         Commercially           fatty acids            margarine (trans)      mmol/L, p=0.058)
                        available corn oil     providing 0.44% of     diet.                  after trans diet
                        margarine.             energy.               1.2 g/day corn oil      compared to corn
                                              Baseline (usual)        diet.                  oil diet.
                                               diet.                 2.4 g/day baseline     <d-arrow>1.6% (0.46
                                                                      diet.                  mmol/L, p<ls-thn-
                                                                                             eq>0.01) after
                                                                                             trans diet compared
                                                                                             to baseline diet.
----------------------------------------------------------------------------------------------------------------
Mensink and Katan,     10.9% of energy. Main  Oleic acid diet.       33.6 g/day             <u-arrow>13.9% (0.37
 1990 (Ref. 7)          sources were special   containing no trans    hydrogenated           mmol/L, p<0.0001)
                        margarine and          isomers.               margarine (trans)      after trans diet
                        shortening.           Saturated fat diet.     diet.                  compared to oleic
                                               Trans isomers         0 g/day oleic acid      acid diet.
                                               provided 1.8% of       diet.                 <d-arrow>3.2% (0.10
                                               energy.               2.4 g/day saturated     mmol/L, p<0.0001)
                                                                      fat diet.              after trans diet
                                                                                             compared to
                                                                                             saturated fat diet.
----------------------------------------------------------------------------------------------------------------
Nestel et al., 1992     about 7% of energy.   Oleic acid diet.       15.6 g/day margarine   <u-arrow>9.2% (0.36
 (Ref. 11)              Main source of trans   Trans isomers          diet.                  mmol/L, p<0.001)
                        fatty acids was        provided 1.5% of      3.8 g/day oleic acid    after trans diet
                        hydrogenated           energy.                diet.                  compared to oleic
                        vegetable oil         Palmitic acid-         2.7 g/day palmitic      acid diet.
                        margarine.             enriched diet. Trans   acid-enriched diet.   NSD after trans diet
                                               isomers provided <1%                          compared to
                                               of energy.                                    palmitic acid diet.
----------------------------------------------------------------------------------------------------------------
 
[[Page 62821]]
 
 
Noakes and Clifton,    10.4% and 10.3% from   Butter diet. Trans     6.4 g/day for canola-  <d-arrow>(p<0.01)
 1998 (Ref. 36)         2 soft margarines      isomers provided 1.3   trans and 6.8 g/day    after both trans
                        made from partially    and 1.5% of energy     for sunflower-trans.   margarines -12.1%
                        hydrogenated canola    for two dietary       3.5 day and 3.2 g/day   (0.5 mmol/L) after
                        oil and canola oil     groups.                for groups on butter   canola-trans and
                        or sunflower oil.     Trans-free diet.        diet.                  10% (0.47 mmol/L
                                               Intakes of groups     Intakes considered      after sunflower-
                                               fed these margarines   zero for trans-free    trans compared to
                                               were considered to     margarines.            butter.
                                               be zero.                                     NSD after canola-
                                                                                             trans diet compared
                                                                                             to canola-trans-
                                                                                             free diet.
                                                                                            <u-arrow>6.3% (0.25
                                                                                             mmol/L, p<0.01)
                                                                                             after sunflower-
                                                                                             trans diet compared
                                                                                             to sunflower-trans-
                                                                                             free diet.
----------------------------------------------------------------------------------------------------------------
Wood et al., 1993      <nearly-eq>5% of       <nearly-eq>0.75% of    7.9 g/day, minimum,    NSD after trans diet
 (Ref. 15)              energy Commercially    energy provided as     hard margarine diet.   and after butter
                        available corn oil     trans fatty acids in  0.6 g/day, minimum,     diet compared to
                        margarine.             butter diet.           butter diet.           baseline values for
                                              No value reported for                          each test period.
                                               baseline diet.
----------------------------------------------------------------------------------------------------------------
Wood et al., 1993      <nearly-eq>5.5% of     Energy from trans      15.8 g/day, minimum,   <u-arrow>6.1% (0.20
 (Ref. 14)              energy Hard            fatty acids in         hard margarine diet.   mmol/L, p<ls-thn-
                        margarine.             comparison diets was  2.9 g/day, minimum,     eq>0.05) after
                                               0% for soft            butter diet.           trans diet compared
                                               margarine and 1% for  0 g/day, minimum,       to soft margarine
                                               butter.                soft margarine diet.   diet.
                                              Trans fatty acids                             <d-arrow>8.2% (0.31
                                               content was 0% soft                           mmol/L, p<ls-thn-
                                               margarine and 5.3%                            eq>0.05) compared
                                               butter.                                       to butter diet.
----------------------------------------------------------------------------------------------------------------
Zock and Katan, 1992   7.7% of energy Main    Linoleic acid diet     24.5 g/day margarine   <u-arrow>8.5% (0.24
 (Ref. 8)               source of trans        providing 0.1% of      diet.                  mmol/L, p<0.02)
                        fatty acids was        energy as trans and   <0.05 g/day linoleic    after trans diet
                        special margarine      12% as linoleate.      acid diet.             compared to
                        and shortening.       Stearic acid diet      1 g/day stearic acid    linoleic acid diet.
                                               providing 0.3% of      diet.                 NSD compared to
                                               energy as trans and                           stearic acid diet.
                                               8.8%as stearate.
----------------------------------------------------------------------------------------------------------------
 
 
[[Page 62822]]
 
 
                                                   APPENDIX B
  Table 1.--American Oil Chemists Society (AOCS) and Association of Official Analytical Chemists (AOAC) Methods
                                     for Determination of trans Fatty Acids.
----------------------------------------------------------------------------------------------------------------
                                                Definition, Scope, and
                    Method                  Applicability as Stated in the               FDA Comments
                                                   Published Method
----------------------------------------------------------------------------------------------------------------
1    AOAC Official Method 965.34          Infrared spectrometric method.      The method is time-consuming: It
     (Revised 1997; AOCS-AOAC Method)      Method is applicable to             requires derivatization of the
     Isolated Trans Isomers in             determination of isolated trans     fat or oil to fatty acid methyl
      Margarines and Shortenings           bonds in natural or processed       esters (FAME) and weighing and
     (Ref. 42)                             long-chain fatty acids, esters      quantitative dilution of each
                                           and triglycerides with trans        FAME test sample in the volatile
                                           levels <gr-thn-eq>5.0%. For         and toxic solvent carbon
                                           direct analysis of glycerides,      disulfide. The limit of
                                           use procedure described in Method   quantitation of this method of 5%
                                           965.35.                             is too high to allow it to be
                                          For high accuracy, common            generally useful.
                                           interfering absorptions
                                           associated with glycerol backbone
                                           of triglycerides and carboxyl
                                           group of fatty acids must be
                                           eliminated by conversion of these
                                           samples to their methyl esters
                                           prior to analysis.
                                          This method is not applicable, or
                                           is applicable only with specific
                                           precautions, to fats and oils
                                           containing large quantities (over
                                           5%) of conjugated unsaturation;
                                           to materials containing
                                           functional groups which modify
                                           intensity of C-H deformation
                                           around trans bond; to mixed
                                           glycerides with long- and short-
                                           chain moieties; or, in general,
                                           to any material containing
                                           constituents that have functional
                                           groups that give rise to specific
                                           absorption bands at 966 cm-1 or
                                           sufficiently close to interfere
                                           with the 966 cm-1 band of C-H
                                           deformation of isolated trans
                                           double bond.
----------------------------------------------------------------------------------------------------------------
2    AOCS Official Method Cd 14-95        Infrared spectrometric method.      This is the AOCS version of AOAC
     (Reapproved 1997)                     Isolated trans bonds in long-       Method 965.34, with the stated
     Isolated trans Isomers-Infrared       chain fatty acids, esters and       exception that it applies to
      Spectrometric Method                 triglycerides are measured by IR.   trans levels of <gr-thn-eq>0.5%.
     (Ref. 43)                             For high accuracy, common           The data provided with this
                                           interfering absorptions             method do not support the low
                                           associated with the glycerol        limit of quantification of 0.5%.
                                           backbone of triglycerides and the   Use of this method at trans
                                           carboxyl group of fatty acids       levels below 5% is inappropriate.
                                           must be eliminated by conversion    See AOAC Method 965.34.
                                           of these samples to their methyl
                                           esters prior to analysis.
                                          The method is applicable to the
                                           accurate determination of
                                           isolated trans bonds in natural
                                           or processed long-chain acids,
                                           esters and triglyceride with
                                           trans levels <gr-thn-eq>0.5%. The
                                           method is not applicable, or is
                                           applicable only with specific
                                           precautions, to fats and oils
                                           containing functional groups that
                                           modify the intensity of the C-H
                                           deformation around the trans
                                           double bond, to mixed glycerides
                                           having long- and short-chain
                                           moieties, or in general to any
                                           material containing constituents
                                           that have functional groups that
                                           give rise to specific absorption
                                           bands at or sufficiently close to
                                           interfere with the 966 cm-1 (10.3
                                           <greek-m>m) band of the C-H
                                           deformation of the isolated trans
                                           double bond.
                                          The method is not applicable to
                                           samples containing >5% conjugated
                                           unsaturation.
                                          For accurate determinations on
                                           materials with trans levels below
                                           0.5%, AOCS method Ce 1c-89 or Ce
                                           1F-96 is recommended. For the
                                           direct analysis of triglycerides,
                                           AOAC method 965.34 is
                                           recommended.
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[[Page 62823]]
 
 
3    AOAC Official Method 994.14          Infrared spectrophotometric         The experimental procedure is
     Isolated trans Unsaturated Fatty      method. Isolated trans double       similar to that of AOAC Method
      Acid Content in Partially            bonds (the predominant trans        965.34. See comments on AOAC
      Hydrogenated Fats                    configuration in partially          Method 965.34, above.
     (Ref. 44)                             hydrogenated fats) show
                                           absorption at ca 967 cm-1 (10.3
                                           <greek-m>m) deriving from C-H
                                           deformation about the trans bond.
                                           Isolated trans content is
                                           determined by measurement of
                                           intensity of this absorption.
                                           Triglycerides or fatty acids are
                                           converted to methyl esters before
                                           making IR measurements. Total
                                           isolated trans content is
                                           calculated using calibration
                                           curve of absorption versus trans
                                           content of calibration solutions.
                                          The method is applicable to the
                                           determination of total isolated
                                           (i.e., nonconjugated) trans
                                           content in fats and oils
                                           containing >5% trans fatty acids.
                                           The method is not applicable to
                                           samples containing >5% conjugated
                                           unsaturation, materials
                                           containing functional groups
                                           which modify absorption of C-H
                                           deformation around trans bonds,
                                           or any materials in which
                                           specific groups may absorb close
                                           to 967 cm-1.
                                          Results obtained by this method
                                           are comparable to those obtained
                                           by AOAC Method 965.34.
----------------------------------------------------------------------------------------------------------------
4    AOCS Recommended Practice Cd 14d-96  Single Bounce-Horizontal            The method is rapid, requiring 5
      (Reapproved 1997)                    Attenuated Total Reflection (SB-    minutes for experimental work and
     Isolated trans Geometric Isomers      HATR) Infrared Spectroscopic        calculations. It is applicable to
      Single Bounce-Horizontal             procedure. The method is            undiluted (i.e., neat) fats and
      Attenuated Total Reflection          applicable to the accurate          oils, does not require
      Infrared Spectroscopic Procedure     determination of isolated trans     derivatization of fat or oil to
     (Ref. 45)                             double bonds in natural or          fatty acid methyl esters, and
                                           processed oils and fats with        requires neither weighing nor
                                           trans levels equal to or greater    quantitative dilution of fat or
                                           than about 0.8%. This method        oil test samples in carbon
                                           requires no weighing and no         disulfide. The lower limit of
                                           quantitative dilution of TAG or     quantitation is about 1%, which
                                           fatty acid methyl ester test        is sufficiently low to make the
                                           samples in any solvent.             method generally useful for most
                                          Limited data suggest that the        applications. The data provided
                                           lower limit of quantitation may     with this Recommended Practice
                                           be higher for complex systems,      were compared with those obtained
                                           such as biological matrices and     by AOAC Official Methods 965.34
                                           commercial food products. The       and 994.14. Published results
                                           method is not applicable to fats    (Ref. 52) indicated that better
                                           and oils containing large           reproducibility and repeatability
                                           quantities (over about 0.5%) of     were found with Cd 14d-96 than
                                           conjugated unsaturation, to         with the AOAC methods cited. This
                                           materials containing functional     Recommended Practice is expected
                                           groups that modify the intensity    to be voted AOCS Official Method
                                           of the C-H deformation about the    Cd 14d-96 in late 1999.
                                           trans double bond, or in general,
                                           to any materials containing
                                           constituents that have functional
                                           groups that give rise to specific
                                           absorption bands at or
                                           sufficiently close to interfere
                                           with the 966 cm-1 band of the C-H
                                           deformation of the isolated trans
                                           double bond.
                                          For accurate determinations of
                                           materials with trans levels below
                                           about 0.8%, gas chromatography
                                           (e.g., AOCS Method Ce 1f-96 (Ref.
                                           46), JAOCS 73: 275-282, 1996
                                           (Ref. 51)) is recommended.
----------------------------------------------------------------------------------------------------------------
 
[[Page 62824]]
 
 
5    AOCS Official Method Ce 1f-96        Gas-liquid chromatography (GLC)     This method paraphrases one
      (Reapproved 1997)                    method. The method utilizes GLC     submitted by Duchateau (JAOCS
     Determination of cis- and trans       conditions optimized to identify    73:275-282, 1995). The method is
      Fatty Acids in Hydrogenated and      and quantify the trans fatty        the industry standard and
      Refined Oils and Fats by Capillary   acids isomers in vegetable oils     provides the best resolution to
      GLC                                  and fats. The fatty acid methyl     date of cis and trans monoene
     (Ref. 46)                             esters of the sample are            fatty acid methyl esters, and
                                           separated on a capillary gas        hence, leads to better accuracy.
                                           chromatography column having a      The lower limit of quantitation
                                           high polar stationary phase,        was not stated. The method is
                                           according to their chain length,    time-consuming, but it can also
                                           degree of (un)saturation, and       be used to determine fatty acid
                                           geometry and position of the        composition.
                                           double bonds.
                                          The method is specially designed
                                           to evaluate by a single capillary
                                           GLC procedure, the level of trans
                                           isomers as formed during refining
                                           or during hydrogenation of
                                           vegetable oils or fats.
                                          The method may also be used to
                                           report all other fatty acids, for
                                           example, to obtain saturated
                                           fatty acid, monounsaturated fatty
                                           acid, and polyunsaturated fatty
                                           acid levels from the same sample
                                           and same analysis.
----------------------------------------------------------------------------------------------------------------
6    AOCS Official Method Ce 1c-89        Capillary gas-liquid                This method does not provide the
      (Reapproved 1993; Updated 1995)      chromatography (GLC) method. This   best resolution of cis and trans
     Fatty Acid Composition by GLC -       method is for the determination     monounsaturated C18:1 fatty acid
      cis, cis and trans Isomers           of fatty acid composition of        methyl esters. See AOCS Ce 1f-96
     (Ref. 47)                             hydrogenated and unhydrogenated     and related comments.
                                           vegetable fats and oils by
                                           capillary gas-liquid
                                           chromatography (GLC), using an SP
                                           2340 column. The method is
                                           designed to evaluate, by a single
                                           capillary GLC procedure the
                                           following properties of a
                                           vegetable oil: (a) Fatty acid
                                           composition; (b) level of trans
                                           unsaturation; and (c) cis, cis,
                                           methylene-interrupted double
                                           bonds. This procedure reports the
                                           trans content as the area percent
                                           of all components that have one
                                           or more trans double bonds. The
                                           cis, cis value is determined by
                                           summing the results from methyl
                                           linoleate and methyl linolenate.
                                          Trans content as determined by
                                           this procedure may not agree with
                                           trans content as determined by
                                           the infrared spectrophotometric
                                           method (AOCS Official Method Cd
                                           14-61). There is a reported
                                           observation indicating that the
                                           method underestimates the trans-
                                           octadecenoate content in favor of
                                           the cis isomers in partially
                                           hydrogenated vegetable oils (Ref.
                                           53).
----------------------------------------------------------------------------------------------------------------
7    AOAC Official Method 985.21 (Final   Gas chromatographic method. The     The lower limit of quantitation
      Action 1992)                         method is appropriate for           (10%) is too high to make the
     Total trans Fatty Acid Isomers in     determination of total trans        method generally useful. The
      Margarines                           contents of 10-30%. Methyl esters   method does not provide the best
     (Ref. 48)                             of fatty acids from margarines      resolution of cis and trans
                                           are separated and measured by gas   monounsaturated C18:1 fatty acid
                                           chromatography to determine total   methyl esters. See AOCS Official
                                           trans unsaturation content (trans   Method Ce 1f-96.
                                           content of unsaturated 18 C
                                           acids). Results by this method
                                           are comparable to those obtained
                                           by IR method AOAC 965.34.
                                          The method is not applicable to
                                           samples containing hydrogenated
                                           marine oils.
----------------------------------------------------------------------------------------------------------------
 
[[Page 62825]]
 
 
8    AOCS Official Method Cd 14b-93       Combined gas-liquid chromatography- This method was surplussed in 1997
      (Revised 1995; Surplussed, 1997)     infrared spectroscopy (GLC-IR)      and therefore, its use is
     Fatty Acid Composition of Partially   method. This method is for the      discouraged.
      Hydrogenated Oils-A Combined GLC-    determination of fatty acid
      IR Method                            composition of partially
     (Ref. 49)                             hydrogenated vegetable oils and
                                           animal fats containing more than
                                           5% trans fatty acids, by a
                                           combined capillary gas-liquid
                                           chromatography (GLC)-infrared
                                           spectrophotometry (IR) procedure.
                                          This method is a research method
                                           and is not practical for use in
                                           normal operations, especially QA/
                                           QC work. The method will provide
                                           accurate values, but requires
                                           considerable experience in its
                                           applications. This method is
                                           designed to evaluate, by
                                           combining the fatty acid data
                                           determined by capillary GLC with
                                           a very polar flexible fused
                                           silica column, with the total
                                           trans percentages of cis and
                                           trans-octadecenoates, of
                                           partially hydrogenated oils.
                                          The international collaborative
                                           study showed that there was no
                                           advantage in using the combined
                                           GLC-IR method for samples
                                           containing <5% trans fatty acids.
----------------------------------------------------------------------------------------------------------------
9    AOAC Official Method 994.15          Capillary gas chromatographic-      This method is the AOAC version of
     Total cis and trans-Octadecenoic      infrared spectrophotometric         the surplussed method AOCS Cd 14b-
      Isomers and General Fatty Acid       method. Applicable to partially     93 (see above) and, therefore,
      Composition in Hydrogenated          hydrogenated vegetable oils and     its use is discouraged. For
      Vegetable Oils and Animal Fats       terrestrial animal fats             samples containing <5% trans
     (Ref. 50)                             containing >5% trans fatty acids.   content, a direct GLC method
                                          Total trans isomer content           (e.g., AOCS Method Ce 1c-89 or
                                           consists of trans fatty acids       AOCS Method Ce 1f-96) is
                                           that occur in hydrogenated          recommended.
                                           vegetable oils and terrestrial
                                           animal fats. Trans content
                                           consists of trans fatty acids
                                           18:1t; 18:2ct or tc, described as
                                           18:2t; 18:2tt, and 18:3 cct, ctc,
                                           and tcc, described as 18:3t.
                                          Total trans content is determined
                                           by infrared spectrophotometry
                                           (IR) using methyl elaidate as
                                           external standard. Various
                                           isomers of 18:2tt, 18:2t: and
                                           18:3t are resolved; their weight
                                           percentages are determined by gas
                                           chromatography. Based on the IR
                                           determination, the weight
                                           percentage of 18:1t is
                                           calculated.
                                          This method is not applicable to
                                           hydrogenated marine oils and
                                           partially hydrogenated fish oils
                                           that contain high levels of cis
                                           and trans isomers of C<INF>16</INF>, C<INF>18</INF>,
                                           C<INF>20</INF>, and C<INF>22</INF> chain lengths.
----------------------------------------------------------------------------------------------------------------
 
[FR Doc. 99-29537 Filed 11-12-99; 8:45 am]
BILLING CODE 4160-01-F

November 12, 1999 Press Release: FDA Proposes New Rules For Trans Fatty Acids In Nutrition Labeling, Nutrient Content Claims And Health Claims