U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
FDA Prime Connection

Federal Register - Unapproved Substances for Ruminants
 
 
DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
Food and Drug Administration
 
21 CFR Part 589
 
YDocket No. 96N-0135"
 
RIN 0910-AA91
 
Substances Prohibited From Use in Animal Food or Feed; Protein
Derived From Ruminants Prohibited in Ruminant Feed
 
AGENCY: Food and Drug Administration, HHS.
 
ACTION: Advance notice of proposed rulemaking.
 
------------------------------------------------------------
 
SUMMARY: The Food and Drug Administration (FDA) is soliciting
comments on the issue of using protein derived from ruminants (e.g.,
cattle, sheep, goats, mule deer, and elk) in ruminant feed. Animal feed
containing protein derived from ruminants may contain the disease agent
that causes transmissible spongiform encephalopathy (TSE) in animals.
Epidemiological evidence gathered in the United Kingdom (U.K.) suggests
a link between an outbreak of ruminant TSE, specifically bovine
spongiform encephalopathy (BSE) and feeding animals protein derived
from ruminants. In addition information from the U.K. also suggests that
exposure to BSE may explain some of the recent cases of variant
Creutzfeldt-Jakob disease (v-CJD) in the U.K. This action is being taken
to protect the health of animals and to reduce any risk which might be
faced by humans. FDA is requesting scientific and economic information
and other comments relating to the prohibition of ruminant protein in
ruminant feed.
 
DATES: Written comments by June 13, 1996.
 
ADDRESSES: Submit written comments to the Dockets Management
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr.,
rm. 1-23, Rockville, MD 20857.
 
FOR FURTHER INFORMATION CONTACT: George Graber, Center
For Veterinary Medicine (HFV-220), Food and Drug Administration,
7500 Standish Pl., Rockville, MD 20855, 301-594-1724.
 
 
SUPPLEMENTARY INFORMATION:
 
I. Background
 
In the Federal Register of August 29, 1994 (59 FR 44584) FDA issued a
proposed rule declaring that specified offal from adult (more than 12
months of age) sheep and goats is not generally recognized as safe for use
in ruminant feed and is an unapproved food additive when added to
ruminant feed. The proposed rule defined ``specified offal'' as any tissue
from the brain, spinal cord, spleen, thymus, tonsil, lymph nodes, or
intestines of sheep or goats, or any processed product that is reasonably
expected to contain specified offal. Processed products that may contain
specified offal include, but are not limited to, meat meal, meat and bone
meal, animal byproduct meal, meat byproducts, glandular meal, and
cooked bone meal. Accordingly, in the absence of an approved food
additive regulation or investigational exemption, the use in ruminant feed
of ingredients containing specified offal from adult sheep or goats would
cause the feeds to be considered adulterated within the meaning of the
Federal Food, Drug, and Cosmetic Act (the act). FDA proposed the action
because the specified offal may contain the agent that causes scrapie, a
TSE of sheep and goats. Since the proposal was issued, the agency has
been evaluating the comments submitted on the proposal, monitoring the
scientific advances made in understanding the interrelationships among the
animal TSE's, and participating in a number of national and international
task force/symposia to better understand the BSE epidemic. The actions
that would have been prohibited in the proposed rule are considered in this
advance notice of proposed rulemaking. If it is determined that some
action is necessary, the agency believes issuing an advance notice of
proposed rulemaking (ANPRM) will hasten that process.
 
In the U. K., scrapie has been epidemiologically associated with the
occurrence of BSE, another form of TSE. The initial cases of BSE may
have been the result of feeding supplements to cattle that were
contaminated with prions from scrapie-infected sheep offal. Prions are
highly resistant to procedures that modify or destroy nucleic acids. (Refs.
1 and 2). Prions are believed by many scientists to be the agents
responsible for TSE's, and they appear to be modified forms of normal
proteins.
 
BSE has been diagnosed in over 155,600 head of cattle from almost
33,000 herds in the U.K. No cases of BSE have been diagnosed in the
United States. BSE is postulated to have been spread in the U.K. among
cattle by the feeding of processed ruminant protein to cattle. A July 1988
U.K. ban on this feeding practice has resulted in a steady reduction in the
number of cases of BSE detected in cattle, with the new cases occurring
mainly in animals born before the ban was fully implemented.
 
 
Ten cases of CJD have been identified in the U.K. in recent months with
a new neuropathological profile. Other consistent features that are unusual
include the young age of the cases (16 to 39 years old at onset of clinical
signs), clinical findings, and the absence of the electroencephalogram
features typical for CJD. Similar cases have not been identified in other
countries in the European surveillance system. These 10 cases appear to
represent a new variant of CJD (v-CJD), which may be unique to the
U.K. The appearance of these 10 cases of v-CJD raises the possibility that
they are causally linked to BSE. Although this may be the most plausible
explanation for these cases, a link with BSE cannot be confirmed on the
basis of this evidence alone. (Ref. 3). Sporadic occurrences of spongiform
encephalopathy in humans are known to occur at a rate of 1 to 2 per
million population worldwide. A group of international experts convened
in April 1996 by the World Health Organization concluded that there is no
definite link between BSE and v-CJD, but that circumstantial evidence
suggests exposure to BSE may be the most likely explanation. Among
other recommendations, the group recommended that all countries should
ban the use of ruminant tissues in ruminant feed (Ref. 4).
 
II. Issues for Comment
 
No cases of BSE have been diagnosed in the United States. Despite the
fact that there is no problem with BSE in the United States, the agency
believes it would be prudent to solicit information and receive comments
on this issue. Therefore, the agency is assessing whether to provide that
protein derived from ruminants is not generally recognized as safe for use
as a ruminant feed or prior sanctioned for such and is a food additive
subject to section 409 of the act (21 U.S.C. 348). Absent a determination
that it is safe for use as a food additive under section 409 of the act, the
use in ruminant feed of ingredients containing protein derived from
ruminants would cause the feed to be adulterated. Ruminant-derived
protein could be defined as any feed ingredient that is reasonably expected
to contain proteinaceous material that derives from ruminant species.
Processed feed ingredients that may contain ruminant-derived protein
include, but are not limited to, products meeting the following animal feed
definitions: animal byproduct meal, blood meal, cooked bone meal,
glandular meal, meat and bone meal, meat byproducts, and meat meal.
The agency is prepared to consider the exclusion of specific ruminant
products from the prohibition, such as milk products, blood products, fetal
bovine serum, and gelatin based on appropriate and adequate scientific
information which demonstrates no infectivity.
 
In addition, the agency is considering labeling requirements for
ruminant-derived proteins for enforcement purposes.
 
III. Agency Request for Information
 
FDA is soliciting comments on all aspects of this ANPRM, and
specifically requests comments on the following issues:
 
1.   The occurrence in the United States of TSE's in animals.
2.   Scientific information on how TSE's occur and are spread among
animals and among humans and what vectors might be involved.
3.   Scientific information on the ecology of TSE agents, and the
epidemiology, etiology, and pathogenesis of TSE diseases.
4.   Scientific information supporting the exclusion of any
ruminant-derived proteins from the proposed prohibition.
5.   Establishment of Hazard Analysis and Critical Control Points
(HACCP) for the rearing of ruminants, and rendering or other processing
of ruminant derived feed ingredients, that may reduce the need to prohibit
the feeding of ruminant protein to ruminants.
6.   Details of rendering or processing practices that may inactivate the
TSE agents and information and evidence which shows that these practices
are effective.
7.   Data on the amount of material affected by this ruminant protein to
ruminant feed prohibition, specifically: (a) The total volume of the
processed feed ingredients that may contain ruminant-derived protein
which were produced in the United States in recent years, (b) details of
the total volume used for each of these ingredients in the rations of the
various animals in the United States, (c) information on the percentage of
the diet each ingredient typically comprises for each species and what
percentage of the total volume is fed to each species, and (d) other
information.
8.   Economic and environmental adverse consequences or benefits
resulting from a ruminant protein to ruminant feed prohibition on: (a) The
farmer/producer, (b) the slaughter operation, (c) the rendering industry,
(d) the public, (e) the feed manufacturer, (f) other parties that may be
affected.
9.   Potential mitigating factors that would lessen the economic and
environmental impact of the prohibition, specifically: (a) Identification of
nonfeed uses of products containing ruminant-derived protein, (b)
development of rendering or processing processes that would allow the
safe feed use of a portion of the prohibited feed ingredient, (c) alternate
disposal methods, and (d) other mitigating factors.
10.  Descriptive and incremental cost data for incremental tasks
required by the proposed change with respect to person-hours, type of
labor (professional, technical, and clerical), type of equipment to be
purchased, disposal costs, capital expenditures, loss of current markets,
expansion of alternative markets, etc.
11.  Estimates of the average total cost of compliance (including any
expected reporting and recordkeeping costs) for both large and small
businesses in each affected industry segment. Descriptions and numbers of
small businesses affected in each sector.
12.  Information which identifies and explains effective alternative
policy actions which would minimize any negative economic effects on
small businesses and the affected industry as a whole.
13.  Estimates of the level of compliance with the voluntary ban on
feeding ruminant protein to ruminants announced by the livestock industry
on March 29, 1996.
14.  Information on restrictions placed upon beef or sheep imports by
foreign countries that would directly affect U.S. beef or sheep producers.
15.  Identification of potential analytical methods that may be used in
detecting ruminant proteins in feed.
16.  Labeling requirements (i.e., declaring the source of the animal
protein; a prohibition of use statement).
17.  Development of antemortem tests to accurately determine if an
animal has a TSE.
18.  Alternate actions the agency could take to prevent the spread of
TSE's among ruminants.
 
IV. Comments
 
Interested persons may, on or before June 13, 1996, submit to the Dockets
Management Branch (address above), written comments regarding this
ANPRM. 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.
 
This ANPRM is issued under sections 201, 402, 409, and 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 342, 348, and
371) and under the authority of the Commissioner of Food and Drugs.
 
VI. References
 
The following references have been placed on display 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.   Prusiner, S. B. , "Novel Proteinaceous Infectious Particles Cause
Scrapie," Science, 216:136-144, 1982.
2.   Stahl, N. and S. B. Prusiner, "Prions and Prion Proteins," FASEB
Journal, 5:2799-2807, 1991.
3.   Will, R. G. et al., "A New Variant of Creutzfeldt-Jakob Disease in
the UK," Lancet, 347, 921-925, 1996.
4. WHO press release, April 3, 1996, "International Experts Propose
Measures to Limit Spread of BSE and Reduce Possible Human Risk from
Disease."
 
Dated: May 8, 1996.
 
David A. Kessler,
Commissioner of Food and Drugs.
 
Donna E. Shalala,
Secretary of Health and Human Services.
 
YFR Doc. 96-12081 Filed 5-9-96; 2:16 pm"
BILLING CODE 4160-01-F