[Federal Register: January 19, 2001 (Volume 66, Number 13)]
[Rules and Regulations]
[Page 6137-6202]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19ja01-26]
[[Page 6137]]
-----------------------------------------------------------------------
Part V
Department of Health and Human Services
-----------------------------------------------------------------------
Food and Drug Administration
-----------------------------------------------------------------------
21 CFR Part 120
Hazard Analysis and Critical Control Point (HAACP); Procedures for the
Safe and Sanitary Processing and Importing of Juice; Final Rule
[[Page 6138]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 120
[Docket No. 97N-0511]
RIN 0910-AA43
Hazard Analysis and Critical Control Point (HAACP); Procedures
for the Safe and Sanitary Processing and Importing of Juice
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the agency) is
adopting final regulations to ensure the safe and sanitary processing
of fruit and vegetable juices. The regulations mandate the application
of Hazard Analysis and Critical Control Point (HACCP) principles to the
processing of these foods. HACCP is a preventive system of hazard
control. FDA is taking this action because there have been a number of
food hazards associated with juice products and because a system of
preventive control measures is the most effective and efficient way to
ensure that these products are safe.
DATES: Effective Dates: This rule is effective January 22, 2002.
Compliance Date: For small businesses as defined in 21 CFR
120.1(b)(1), the final rule will be binding January 21, 2003. For very
small businesses as defined in 21 CFR 120.1(b)(2), the final rule will
be binding January 20, 2004.
FOR FURTHER INFORMATION CONTACT: Shellee Anderson, Center for Food
Safety and Applied Nutrition (HFS-366), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5023.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. Notice of Intent
B. The Proposal
C. Additional Opportunities for Public Participation
D. NACMCF Public Meeting
II. Response to the Comments
A. Alternatives to HACCP Considered by the Agency
B. Response to the Decision to Propose HACCP
C. Significance of Illness Data
D. Comparison of the Proposal and this Final Regulation
III. The Final Regulation
A. Applicability
B. Definitions
C. Prerequisite Program Standard Operating Procedures
D. Hazard Analysis
E. HACCP Plan
F. Legal Basis
G. Corrective Actions
H. Verification and Validation
I. Records
J. Training
K. Application of Requirements to Imported Products
L. Process Controls
M. HACCP Enforcement Issues
N. Miscellaneous Issues
IV. Effective Date
V. Final Regulatory Impact Analysis
A. Introduction
B. Factors Considered in Developing This Analysis
C. Benefits
D. Costs
E. Summary of Benefits and Costs
VI. Regulatory Flexibility Analysis
A. Objectives
B. Definition of Small Business and Number of Small Businesses
Affected
C. Description of the Impact on Small Entities
D. Minimizing the Burden on Small Entities
E. Summary
VII. Paperwork Reduction Act of 1995
VIII. Environmental Impact
IX. Federalism
X. References
I. Background
A. Notice of Intent
In the Federal Register of August 28, 1997 (62 FR 45593)(Ref. 1),
FDA published a notice of intent (hereinafter referred to as the notice
of intent) that announced a comprehensive program to address the
incidence of foodborne illness related to consumption of fresh juice
and ultimately to address the safety of all juice products. In the
notice of intent, the agency invited comment on the appropriateness of
its strategy to: (1) Initiate rulemaking on a mandatory HACCP program
for some or all juice products; (2) propose that the labels or the
labeling of juice products not specifically processed to prevent,
reduce, or eliminate pathogens bear a warning statement informing
consumers of the risk of illness associated with consumption of the
product; and (3) initiate several educational programs to minimize the
hazards associated with consumption of fresh juices. The agency stated
that it would address comments received within 15 days of publication
of the notice of intent as part of any rule proposed by the agency. FDA
also stated that it would consider all comments to the notice of intent
received after 15 days in any final rulemaking. FDA reviewed all of the
comments received within 15 days of publication and found that they
provided no information that would cause the agency to conclude that
the HACCP proposal was inappropriate. Comments received 15 days after
publication of the notice of intent are discussed in this final rule.
B. The Proposal
In the Federal Register of April 24, 1998 (63 FR 20450) (Ref. 2),
FDA published a proposed rule to establish requirements relating to the
processing of juice and juice products (hereinafter referred to as the
HACCP proposal).\1\ The proposal would have required the application of
HACCP principles by processors and importers to ensure juice safety to
the maximum extent practicable. FDA proposed these regulations because
there had been a number of food hazards, including some directly
affecting children, associated with juice products. The agency
tentatively concluded that the most effective way to ensure the safety
of juice products is to process the products under a system of
preventive control measures based on HACCP principles. Interested
persons were given until July 8, 1998, to comment on the HACCP
proposal. The agency subsequently extended the comment period to August
7, 1998 (63 FR 37057; July 8, 1998) (Ref. 3).
---------------------------------------------------------------------------
\1\ As defined in Sec. 120.1 (21 CFR 120.1) ``juice'' refers
both to beverages that are composed exclusively of an aqueous liquid
or liquids extracted from one or more fruits or vegetables and to
the juice ingredient in those beverages that contain other
ingredients in addition to juice. In this document, the term ``juice
product'' refers both to beverages that contain only juice and to
the juice ingredient of beverages that are composed of juice and
other ingredients.
In the remainder of this document, products not processed to
prevent, reduce, or eliminate hazards will be referred to as
``untreated juice products.'' In addition, processing to ``prevent,
reduce, or eliminate'' hazards will be referred to as processing to
``control'' hazards.
---------------------------------------------------------------------------
In addition to publishing the HACCP proposal, FDA published in the
same issue of the Federal Register (63 FR 20486) (Ref. 4) a proposed
rule (the juice labeling proposal) to require warning labels on juice
that has not been processed to prevent, reduce to acceptable levels, or
eliminate pathogens that may be present. As fully discussed in the
juice labeling proposal, FDA proposed that untreated juice products
bear a warning statement informing at risk consumers of the hazard
posed by untreated juices to allow them to make informed decisions on
whether to purchase and consume such products. The labeling proposal
was finalized on July 8, 1998 (63 FR 37030) (Ref. 5).
FDA issued in the Federal Register of May 1, 1998 (63 FR 24254)
(Ref. 6) a single Preliminary Regulatory Impact Analysis (PRIA) that
addressed both the
[[Page 6139]]
juice labeling proposal and the juice HACCP proposal. Interested
parties were given until May 26, 1998, to comment on aspects of the
PRIA relating to the juice labeling proposal and until July 8, 1998, to
comment on aspects of the PRIA relating to the juice HACCP proposal.
C. Additional Opportunities for Public Participation
Under the juice labeling rule (Sec. 101.17(g) (21 CFR 101.17(g))),
juice and juice products that have not been specifically processed to
attain a 5-log reduction in the pertinent pathogen must bear a warning
label. Similarly, under the juice HACCP proposal (proposed
Sec. 120.24), covered processors must attain a 5-log reduction in the
pertinent pathogen in their HACCP systems. Accordingly, in November
1998, FDA held two technical workshops on how processors could attain a
5-log (i.e., 105) reduction in the pertinent pathogen in
citrus juices (63 FR 57594; October 28, 1998) (Ref. 7). The transcripts
from the two workshops were placed on display in the docket for the
juice HACCP proposal and on the FDA/CFSAN website http://www.fda.gov/).
On December 17, 1998 (63 FR 69579) (Ref. 8), the comment period for the
juice HACCP proposal was reopened until January 19, 1999, to allow
public comment on data and other information that were presented at or
developed as a result of these workshops. In addition, FDA expressly
sought comments on the following four specific topics related to the
application of the 5-log pathogen reduction standard: (1) Appropriate
baselines for the calculation of the 5-log pathogen reduction; (2)
feasible interventions or practices for the cultivation and harvest of
fruits and vegetables, and acquisition of supplies and materials that
may contribute to achieving a 5-log pathogen reduction; (3) feasible
interventions for the production process that may contribute to
achieving a 5-log pathogen reduction; and (4) acceptable methods for
measuring and validating 5-log reductions.
On July 15 and 16, 1999, FDA held a workshop on food safety
controls for the apple cider \2\ industry (64 FR 34125; June 25, 1999)
(Ref. 9). The workshop dealt with issues related to the implementation
of the agency's regulations requiring a warning statement for certain
juice products. Specifically, the workshop addressed pathogen reduction
interventions that may be effective for apple cider production and the
methods used to measure and validate such interventions. Results of
research conducted by Federal, State, private, and academic
institutions were presented.
---------------------------------------------------------------------------
\2\ Although the terms ``apple cider'' and ``apple juice'' may
have different meanings throughout the United States, these terms
are used interchangeably throughout this final rule.
---------------------------------------------------------------------------
In the Federal Register of November 23, 1999 (64 FR 65669) (Ref.
10), FDA announced the availability of new data and information
regarding the safe processing of citrus juice and juice products, and
reopened the comment period for the juice HACCP proposal until January
24, 2000, in order to receive comment on the new data and other
information. In that same notice, in order to develop the most complete
administrative record possible, FDA requested additional data and
information relating to four separate areas: Internalization and
survival of pathogens in produce used to produce juice, especially
citrus fruit; application and measurement of the 5-log reduction
standard; current methods used by juice processors to monitor the
application of heat treatment to juice; and certain economic matters
related to juice regulation. The notice discussed in detail the
particular issues in each of the four areas in which the agency was
seeking comments (64 FR 65669 at 65670 through 65671). Two of these
areas (internalization and survival of pathogens and application and
measurement of the 5-log reduction standard) were also to be the
subject of the December 8 to 9, 1999, public meeting of the National
Advisory Committee on Microbiological Criteria for Foods (NACMCF)
(discussed in more detail below), and the comment period extension was
established so as to permit comments on the identified issues in light
of any information or recommendations coming out of that meeting of the
NACMCF.
D. NACMCF Public Meeting
NACMCF is an advisory committee chartered under the U.S. Department
of Agriculture (USDA) and has members from USDA (Food Safety and
Inspection Service), the Department of Health and Human Services (U.S.
Food and Drug Administration and the Centers for Disease Control and
Prevention (CDC)), the Department of Commerce (National Marine
Fisheries Service), the Department of Defense (Office of the Army
Surgeon General), academia, industry and State agencies. The NACMCF
provides guidance and recommendations to the Secretary of Agriculture
and the Secretary of Health and Human Services regarding the
microbiological safety of foods.
The NACMCF held a public meeting on December 8 to 9, 1999 (64 FR
63281; November 19, 1999) (Refs. 11 and 12) to discuss recent research
and other information related to performance criteria for fresh citrus
juices. FDA sought advice from the NACMCF on two issues. In addition,
the meeting agenda provided an opportunity for public comment.
First, FDA asked the NACMCF about the potential internalization and
survival of pathogens in citrus fruits and citrus juices. The NACMCF
members generally agreed that it is theoretically possible for
microorganisms to enter the interior of apparently sound, intact citrus
fruit under certain conditions (e.g., temperature difference between
fruit and wash water), and that human pathogens appear to be able to
survive, at least under defined laboratory conditions, in the fruit
itself (Ref. 12). However, the NACMCF members concluded, based on the
current information, that the potential for microorganisms to enter and
survive in intact fruit is not likely to result in a significant public
health risk. In particular, the Committee members concluded, based upon
the limited data available, including data presented by the industry,
that although it is theoretically possible, it is unlikely that
pathogens will enter and grow in sound, intact fruit under actual
current industry processing practices.
Second, the agency asked the NACMCF about the application and
measurement of the 5-log pathogen reduction standard to citrus fruit.
In response, the NACMCF outlined the following five basic consensus
decisions related to the application and measurement of the 5-log
reduction standard to citrus juices:
1. The 5-log reduction need not start with the extracted juice but
may begin with the exterior decontamination of citrus fruit. However,
processors should not start a cumulative 5-log reduction until after
the fruit is cleaned (i.e., washed) and culled (i.e., damaged or
dropped fruit is removed so that the remaining fruit is USDA choice
level or higher quality).
2. One possible method to minimize potential microbial infiltration
into the fruit would be by controlling fruit and wash water
temperatures, as well as excluding fruit that is split, punctured, or
otherwise not intact. Laboratory studies indicate that microbial
infiltration of fruit occurred when warm fruit was washed or submerged
into cold water (Refs. 13 and 14).
3. The entire 5-log process must occur under one firm's control and
in one processing facility, i.e., all steps from
[[Page 6140]]
fruit receiving to final juice packaging (and all points included in
the 5-log reduction process) must occur at one facility. If processors
transport fruit or juice to another facility for extraction, blending,
or final packaging, the 5-log reduction must be accomplished in the
second facility.
4. If the expressed juice is aseptically packaged in a single-use
sanitary non-reusable tote (sterile bag in box type package form) and
the bulk packed juice will be repackaged at another facility, a 5-log
reduction process must be performed on that juice prior to final fill
and packaging. If the juice is used directly from the tote (e.g., used
to dispense juice and juice beverages at retail), the 5-log reduction
process need not be repeated. Because juice in tanker trucks is not
juice in a final package form, juice shipped in bulk tankers must
undergo a 5-log reduction process after transport and prior to final
fill and packaging.
5. As part of a HACCP verification program, firms should conduct
microbial testing on the final product if the 5-log reduction process
relies in part on fruit surface treatment. This testing would not be
batch-by-batch testing for lot acceptance prior to shipping, but would
be used to verify the 5-log reduction process. The testing should use
generic E. coli as a means to assess the control of the process and
should be conducted as specified in the HACCP plan, utilizing an
appropriate sampling plan. However, if results indicate (i.e., the
presence of generic E. coli) that the 5-log reduction has not been
achieved, processors should consider testing the juice for specific
pathogens of concern, such as Salmonella or any other microorganisms of
concern, according to an appropriate sampling plan and processors
should take suitable corrective actions. If the 5-log reduction is
applied after the juice is expressed, microbiological testing would not
be required as part of a HACCP verification program.
II. Response to the Comments
FDA received approximately 85 responses, each containing one or
more comments, to the notice of intent. FDA addressed some of these
comments in the juice HACCP proposal. FDA subsequently received
approximately 800 responses, each containing one or more comments, to
the juice HACCP proposal. Comments received in response to the notice
of intent and to the juice HACCP proposal came from industry, trade
organizations, consumers, consumer interest groups, academia, and State
government agencies. Comments concerning labeling issues are discussed
to the extent that they fall within the scope of issues presented by
the juice HACCP proposal. Some of the comments supported the proposal.
Other comments opposed, or suggested modifications of various
provisions of, the proposal. The agency discusses below the significant
comments bearing on the proposed HACCP regulation and, when applicable,
any revisions to the proposed regulation made in response to these
comments. Responses to the notice of intent that bear on the juice
HACCP proposal and that were not addressed in that proposal also are
addressed in this document. For simplicity, the agency's discussion
does not identify comments as to whether they were received in response
to the notice of intent or in response to the juice HACCP proposal.
A. Alternatives to HACCP Considered by the Agency
In developing a strategy to address the hazards associated with
juice, FDA considered the following alternatives to HACCP: (1)
Increased inspections, (2) current good manufacturing practices
(CGMP's), (3) mandatory pasteurization, (4) labeling as a long-term
solution, (5) education, and (6) an approach that would draw a
distinction between untreated apple cider and all other juices. The
agency discussed each alternative in the HACCP proposed rule (63 FR
20450 at 20454) and its reasons for proposing the use of HACCP systems
rather than the alternatives (Ref. 2). FDA received a number of
comments questioning the agency's rejection of certain alternatives.
The agency's responses to those comments are set forth in this section
(section II.A). To provide a meaningful context for the discussion of
the alternatives, FDA is providing the following discussion of HACCP.
HACCP is a focused, efficient, preventive system that minimizes the
chance that foods contaminated with hazardous materials or
microorganisms will be consumed. The strength of HACCP lies in its
ability to enable the processor to identify, systematically and
scientifically, the primary food safety hazards of concern for the
specific products, the specific processes, and the specific
manufacturing facilities in question, and then to implement on a
focused, consistent basis, steps (critical control points (CCP's)) in
food production, processing, or preparation that are critical to
prevent, reduce to acceptable levels, or eliminate hazards from the
particular food being processed. Flexibility in how to address
identified hazards is inherent in HACCP systems. Even when producing
comparable products, no two processors use the same source of incoming
materials or the same processing technique, or manufacture in identical
facilities. Each of these factors (and their many combinations)
presents potential opportunities for contamination of the food. HACCP
focuses the processor on understanding his own process and the hazards
that may be introduced during that process, and identifying specific
controls to prevent, reduce, or eliminate the identified hazards.
The flexibility of the HACCP approach is a critically important
attribute. This flexibility allows manufacturers to adjust CCP's,
adjust techniques used to address CCP's when changes occur in the
system (e.g., use of new ingredients), and readily incorporate new
scientific developments (e.g., use of new control techniques, new
preventive technologies, identification of new hazards). Another
important strength of HACCP is the development of a plan written by the
processor detailing the control measures to be used at CCP's. By
developing a written plan, juice processors gain a working knowledge of
their processing system, its effect on the food, and where in the
system potential contamination may occur. Both the processor and the
agency are able to derive the full benefits of a HACCP system. The
hazard analysis and HACCP plan allow both the processor and the agency
to verify and validate the operation of the system. HACCP's flexibility
also permits processors to select the appropriate control measures in
the context of how the whole system functions, allowing processors to
use the most appropriate and economical methods to control food hazards
that are reasonably likely to occur in their operation. The ability to
choose among various control methods encourages research on and
development of new and innovative technologies to better address
individual situations. Because of its flexibility, HACCP is
particularly advantageous to small businesses and seasonal processors.
HACCP provides the processor with a record of identified food
hazards. It allows quick identification of a breakdown in the
processing system and thus, prevents products with food hazards from
entering the marketplace and causing illness. Moreover, review of
records over a longer period of time (days or weeks) may reveal a trend
toward a breakdown in the system, such as a critical processing
temperature that is slowly drifting down. HACCP records allow
evaluation of whether changes in the processing system require changes
[[Page 6141]]
in CCP's or their critical limits (CL's), thus ensuring that the HACCP
system is up-to-date and adequate to control all food hazards that are
reasonably likely to occur. This recordkeeping also allows regulatory
investigators to readily review the long term performance of a firm's
processing system, rather than relying on a time-limited inspection,
which provides only a snapshot of how well the firm is doing in
producing and distributing safe product on any given day.
HACCP is ideally suited to respond to emerging problems because a
HACCP system is a dynamic system that must be validated periodically to
ensure that all hazards reasonably likely to occur are identified and
controlled via CCP's. Validation of both the hazard analysis and the
HACCP plan entails a thorough review to ensure that all hazards that
are reasonably likely to occur are addressed in the HACCP system.
Because of its preventive yet flexible nature, HACCP is recognized
by food safety professionals as the single most effective means to
assure the safety of foods. It has been endorsed by the National
Academy of Sciences (Ref. 15), the Codex Alimentarius Commission (an
international food standard-setting organization) (Ref. 16), and the
NACMCF (Ref. 17). Increasingly, use of HACCP systems is an indication
to importing countries that food safety systems that provide a
standardized level of public health protection are in place and being
used by producers in exporting countries.
1. Increased Inspection
(Comment 1) Several comments suggested that the increased FDA
inspection approach would be preferable to HACCP.
The agency disagrees. FDA's responsibility is to implement and
enforce the Federal Food, Drug, and Cosmetic Act (the act), i.e., to
oversee the manufacture of safe food. Increased inspection by FDA is a
resource-intensive activity that puts the responsibility and burden for
ensuring food safety on the agency rather than on the juice processors.
Inspections can, of course, provide food processors with valuable
information about improving the safety of their products. However,
safety cannot be effectively inspected into foods. Rather, food
processing systems themselves must be designed and implemented in a
manner that results in the production of safe food. Part 120 (21 CFR
part 120) provides a flexible standard that both the juice industry and
the agency will use to determine the adequacy of a process. HACCP has
been shown to be an approach that effectively ensures the production of
food that is safe and wholesome (Ref. 17). Importantly, the HACCP
approach clearly delineates the processor's responsibility to make safe
products and FDA's responsibility to monitor conformance with the act
through inspections and record review.
(Comment 2) One comment advocated a short-term solution of
increased inspections for adherence to sanitation standard operating
procedures (SSOP's) and CGMP's with zero tolerance for noncompliance.
Another comment stated that the juice industry would welcome increased
inspections as it implements new safety measures.
The agency has been actively monitoring the juice industry,
especially the fresh juice industry, in response to recent outbreaks.
In addition, FDA has conducted inspections to determine compliance with
the label warning statement required by Sec. 101.17(g). The agency will
continue this additional oversight of the juice industry during
implementation of part 120 until it has assurance that the industry is
in compliance.
(Comment 3) One comment suggested that cider operations be
inspected and graded for cleanliness by the States, like restaurants.
The agency disagrees with the comment. Although sanitation (i.e.,
cleanliness) is important in cider and all other food production
operations, it is only a starting point for ensuring that safe food is
produced and distributed to consumers. This limitation exists
regardless of the regulatory agency inspecting for sanitation.
(Comment 4) Several comments suggested that industry-funded
inspections could be used to ensure safe juice.
FDA disagrees with these comments. As discussed above, inspections
are not an adequate substitute for HACCP. Moreover, the agency does not
have the authority to require or accept funds from the industry for
inspections of juice processors.
2. Current Good Manufacturing Practices
(Comment 5) Comments maintained that a survey of several small
citrus producers and juice bars showed that SSOP's and CGMP's are
sufficient to produce safe juice. One comment stated that no additional
regulations are needed for dairies that process juice because dairies
follow sanitation and other procedures outlined by the National
Conference on Interstate Milk Shipments (NCIMS) and the application of
these principles affects other products made in these facilities.
The agency disagrees that CGMP's and SSOP's alone are adequate to
control microbial hazards in juice although it does believe that CGMP's
play an important role in juice safety. The survey referenced by the
comment, was conducted by the Florida Department of Agriculture &
Consumer Services and found that 17 out of 383 samples analyzed (4.4
percent) were positive for generic E. coli and did not indicate what,
if any, other microorganisms were present. While generic E. coli are
not pathogens, their presence is indicative of fecal contamination and
may be indicative of the presence of pathogens such as E. coli O157:H7.
(The significance of fecal contamination is discussed in more detail in
the response to comment 143.) Therefore, it is unclear how the comments
concluded that CGMP's and SSOP's provide adequate control of potential
food hazards to assure the safety of the food by relying on the survey
data.
The NCIMS procedures (i.e., the Pasteurized Milk Ordinance (PMO)
(Ref.18)) were developed to assure the safety of milk. While there may
be some fundamental principles, such as basic sanitation procedures,
that apply to both the production of milk and juice, the products are
vulnerable to different hazards. Moreover, States administer the PMO,
and the agency has no information indicating consistency in the
application of the PMO to juice inspections in dairies. Thus,
investigators in some States may use the PMO as a guide in conducting
dairy juice operations and others may not. Therefore, the agency does
not believe that application of NCIMS procedures in some dairies that
process juice negates the need for juice-specific HACCP regulations.
(Comment 6) Several comments argued that the examples of
nonmicrobial hazards (e.g., tin, lead, nitrates, patulin, glass, or
plastic) cited in the juice HACCP proposal are CGMP violations and
would not be included in a processor's HACCP plan.
The agency does not agree with the comments. Whether or not a
nonmicrobial food hazard jeopardizes the safety of a juice product is
determined by the processor during the hazard analysis of his process.
If potential nonmicrobial food hazards are not reasonably likely to
occur, then the HACCP plan does not need to address these hazards with
CCP's. Thus, FDA does not believe that it is reasonable to make a
global statement that CGMP's in part 110 (21 CFR part 110) are adequate
[[Page 6142]]
to control nonmicrobial hazards in all systems, because that
determination must be made by each individual processor through a
hazard analysis of the individual system.
(Comment 7) Several comments noted that the risks posed by the
nonmicrobial hazards identified by FDA cannot be quantified for
economic purposes, that microbial hazards alone are not an adequate
basis on which to mandate HACCP, and that CGMP's are adequate.
FDA disagrees with these comments. There are nonmicrobial food
hazards that may be reasonably likely to occur in juice. Some non-
microbial hazards, such as glass, tin, and copper, present acute risks
(Ref. 6), and result in acute illnesses or injuries that generate
medical and hospital costs, as well as lost productivity costs.
The adverse health effects of other nonmicrobial hazards are
chronic (long-term) in nature. For example, long-term exposure to the
mycotoxin, patulin, has been shown to be toxic in safety assessments
conducted in the United States (Refs. 19 and 20) and by international
organizations (Refs. 21 and 22). Patulin is produced by several species
of mold that can grow on apples, particularly if bruised or otherwise
damaged, and has been found to occur at high levels in some apple juice
products. The long-term toxic effects in young children are of
particular concern because children consume larger quantities of apple
juice relative to body weight than other age groups. A compilation of
data from three surveys showed that nearly one-fifth of the samples of
apple juice contained levels of patulin in excess of 50 microgram/liter
(g/L) (Ref. 23), the level recently established by FDA in
draft guidance as the maximum level that should be present in foods
(Ref. 24).
The agency recognizes that quantifying the economic effects of
chronic non-microbial hazards is difficult. Given the difficulties in
quantification, FDA chose to not include nonmicrobial hazards with
chronic health risks in the PRIA, thereby underestimating the benefits
of the proposal. Nevertheless, hazards with chronic health risks exist
and the potential effects on health are real. Thus, hazards with
chronic health risks must be considered, along with nonmicrobial
hazards with acute health consequences and microbial hazards, during
the hazard analysis and a determination made as to whether the
potential hazard is reasonably likely to occur (comment 63 discusses
how a hazard analysis must be conducted) and thus, must be included in
the HACCP plan.
(Comment 8) Several comments maintained that the enforcement of
CGMP's or sanitation standards would ensure the safety of all juices.
The agency disagrees with the comments. Outbreaks of foodborne
disease have been associated with juice despite the fact that the
processors appear to have been actively implementing CGMP's. Increased
compliance with the CGMP regulations in part 110, including all
sanitation provisions, is certainly desirable. However, CGMP's are
general in nature and apply to all types of facilities that process all
types of food products from highly processed foods to raw foods that
are merely packaged and labeled. CGMP's were not designed specifically
to address individual production facilities (for juice or any other
commodity) or the unique attributes associated with specific foodborne
hazards. HACCP systems, as discussed in section II.A of this document,
provide focused, product- and process-specific prevention and control
of potential hazards. HACCP augments the controls established through
CGMP's by: (1) Determining the food hazards that are reasonably likely
to occur in a specific facility and process and thus, warrant extra
consideration beyond application of routine food safety measures, (2)
identifying a specific CGMP or additional control measure that must be
undertaken to prevent this food hazard that is reasonably likely to
occur from reaching the consumer, and (3) developing a verifiable
procedure for assuring that each control measure was applied and was
effective. This focused consideration of hazards and their prevention
provides a higher degree of safety assurance than application of
CGMP's.
3. Mandatory Pasteurization
(Comment 9) Several comments requested that the agency mandate
pasteurization or use of a universal thermal process (thermal kill) to
ensure juice safety. The comments maintained that mandatory
pasteurization is a reasonable, science-based solution that would
ensure safe juice, is consistent with FDA's mission to protect the
public health, and would assure consumers and regulators that the
microbial hazards associated with juice are being prevented in the most
effective manner. Conversely, a number of comments opposed mandatory
pasteurization. They argued that nutritional value is lost from heat
treatment; some consumers prefer unpasteurized juice; pasteurized juice
may become contaminated after treatment and still put consumers at
risk; and the apple cider and fresh juice industry would be destroyed.
Based upon the available information, FDA does not believe that it
is necessary or appropriate to mandate pasteurization or other thermal
treatment of juice. The agency is aware of the reasons why processors
pasteurize or elect not to pasteurize their juice products.
Pasteurization, a heat treatment sufficient to destroy pathogens, is an
effective and proven technology that will attain the 5-log reduction in
pathogens and, thus ensure microbiologically safe juice. Pasteurization
also results in a longer shelf-life of refrigerated juices. With proper
post-processing handling, pasteurization assures consumers and
regulators that the potential microbial hazards associated with juice
are prevented. However, pasteurization is not the only method for
addressing potential microbial contamination. This was discussed
extensively in the juice HACCP proposal (63 FR 20450 at 20454) (Ref. 2)
and again in the juice labeling final rule (63 FR 37030 at 37041) (Ref.
5). This approach is supported by the NACMCF recommendation that FDA
establish safety performance criteria for appropriate target organisms
rather than mandating a specific intervention technology (Ref. 25).
Mandating a specific intervention technology such as pasteurization
would limit the development of new, potentially less costly
technologies that may be as effective as pasteurization. New nonthermal
technologies (e.g., UV irradiation and pulsed light, as approved by
FDA; high pressure) may be able to achieve the required pathogen
reduction. The use of non-thermal technologies will provide consumers
with a greater selection of safe products to purchase. Furthermore,
mandatory pasteurization would not control non-microbial hazards in
juice. Therefore, FDA is declining to mandate pasteurization for juice.
(Comment 10) One comment stated that pasteurization should be
mandatory for apple cider to eliminate a major source of health risks.
FDA disagrees with the comment. Under Sec. 120.24, apple cider
processors must treat their juice to achieve a 5-log reduction in the
pertinent pathogen. At the present time, the agency is not aware of any
technology that can accomplish the 5-log reduction in apple juice
products except by treating the extracted juice with a ``kill step.''
However the ``kill step'' does not necessarily have to be
pasteurization. This approach allows for innovation in
[[Page 6143]]
the development of new processes to achieve the 5-log pathogen
reduction.
4. Labeling
(Comment 11) Two comments suggested that FDA require either
pasteurization or a permanent warning label statement for producers who
do not pasteurize. One comment stated that FDA should require HACCP
with a CCP of either a 5-log performance standard for pathogen
reduction or a warning label.
FDA disagrees with the comments. Under Sec. 120.24, juice
processors must achieve the 5-log reduction in their juice. As
discussed in both the HACCP proposal and in this final rule, it is
possible for firms to manufacture juice to achieve this reduction by
means other than pasteurization. The alternative presented in the
comments, labeling, has some limitations as a public health measure.
The effectiveness of labeling untreated juice to alert consumers to
possible harmful effects from its consumption relies on consumers'
reading, comprehending, and acting on the information in the labeling.
Although labeling can provide consumers with the information to make
food safety related choices, education is an important factor in a
consumer's choice. Therefore, there are limitations to the
effectiveness of labeling.
The agency mandated the use of warning label statements on juice
largely as an interim step to establishing the HACCP regulation. For
most juice products, the warning label is a short term solution. While
FDA is reluctant to rely on labeling as the sole safety measure, the
agency recognizes that in certain circumstances, labeling may, on
balance, provide the most reasonable approach to protect the public
health. FDA believes that HAACP, as required in this final rule, is a
reasonable approach because, in contrast to some other food safety
problems, the facts show that, for juice, processor control of
pathogens is reasonably achievable. Moreover, a warning label does not
substitute for adequate processing of juice, is not an appropriate
substitute for the 5-log performance standard, and would not be
considered a CCP for juice under part 120.
For juice produced by retailers (as defined in the rule), however,
the warning statement is a long term solution. The agency discussed its
reasons for exempting retail establishments from part 120 in the juice
HACCP proposal (63 FR 20450 at 20464) (Ref. 2), and these reasons are
further discussed in section III.B.2.b of this document. The agency
intends to work closely with the States to provide recommendations for
implementing measures that will assure safe juice at retail. Therefore,
the agency concludes that its current regulations and programs are
balanced and appropriate for juice and juice products.
(Comment 12) Several comments asked that FDA make the warning
label statement a permanent option because, if it is adequate to ensure
consumer safety with products exempt from HACCP, it should be adequate
for all juice products.
FDA disagrees with the comments. As noted in the previous response,
while the warning label statement may be effective, particularly with
consumers aware of juice safety problems, it has limitations as a
public health measure. The warning label statement simply informs
consumers that the juice bearing the statement has not been treated to
control pathogens and that the consumption of untreated juice may pose
a risk of illness. As noted, the effectiveness of any warning label
relies on consumer education and action. FDA is not changing the
warning label statement requirements in this rulemaking.
5. Education
(Comment 13) Several comments maintained that increasing industry
education is all that is needed to ensure the safety of all juices.
The agency disagrees. While FDA supports and encourages processor
education as a way to improve the safety of the food supply, such
measures alone, without being teamed with implementation of an
effective food safety control program, such as HACCP, and government
oversight, will not ensure consumer protection from hazards that may be
present in juice. Training and education is only one step in the
effective implementation of any food safety system, including HACCP.
Effectively, this final rule requires the industry to improve their
education in food safety in order to implement effective HACCP systems.
Implementation of an effective HACCP system demonstrates a processor's
understanding of HACCP principles and the ability to translate theory
into production of safer food. Therefore, the agency concludes that
increased industry education alone would not be sufficient to ensure
the safety of all juices.
6. Alternative Approach
(Comment 14) Many comments supported the alternative approach
outlined in the proposed rule (63 FR 20450 at 20456) (Ref. 2) that
would: (1) Require producers of apple cider to choose between HACCP
with a performance standard and labeling and (2) require processors of
all other juices to choose between HACCP, a performance standard, and
labeling.
The agency has evaluated the alternative approaches and concludes
that HACCP with a performance standard is the most effective and
efficient approach to ensure safe juice. FDA notes that no data or
other information were submitted to persuade the agency that the
alternative approach described in the proposal would provide adequate
public health assurance as would be provided by the HACCP regulation
set forth below. Although more outbreaks have been traced to the
consumption of apple juice than other juices, a fact reflected in the
proposed alternative approach, the agency concludes that, because
microbial, chemical, and physical hazards may occur in all juices, and
outbreaks have been associated with a variety of juices, there is a
need to regulate all juices in the same general manner. Furthermore,
the performance standard and the label warning statement only address
microbial hazards. In contrast, HACCP systems address physical and
chemical, as well as microbiological, hazards, thus providing greater
assurance that juice is safe. Therefore, the agency is requiring that
all juice processors with the exception of those specifically exempted
by Sec. 120.3(j)(2) use HACCP systems as set forth in part 120.
B. Response to the Decision to Propose HACCP
FDA proposed to require HACCP for juice products because it had
tentatively concluded that HACCP was an appropriate system of
preventive controls necessary to produce safe juice products. The
evidence presented in the proposal demonstrated that juice has been a
vehicle for pathogens that have caused a number of foodborne illness
outbreaks. While pathogens can be controlled through heat treatment,
the data (Ref. 2) clearly demonstrate that there are potential
nonmicrobiological hazards associated with juice that cannot be
controlled through heat treatment. For these reasons, FDA tentatively
concluded that a HACCP program that addresses all potential hazards
(i.e., microbiological, chemical, and physical), allows each juice
manufacturer to evaluate its own process, and to institute appropriate
controls for all hazards identified as reasonably likely to occur in
that manufacturer's process should be established.
[[Page 6144]]
(Comment 15) Several comments advocated HACCP limited to pathogen
control.
The agency disagrees with the comments. While pathogen control is a
significant part of any HACCP system for juice, there are potential
chemical and physical hazards that can occur in juice, with significant
public health implications, and these hazards may be most effectively
controlled through application of HACCP (Ref. 2). HACCP provides a way
to focus on specific CCP's addressing specific hazards, both microbial
and non-microbial (e.g., tin, lead, nitrates, patulin, glass, or
plastic) that are relevant to juice processing operations and products.
These hazards may be appropriately identified in the hazard analysis as
hazards that are reasonably likely to occur and controlled through a
HACCP plan.
There are a number of potential hazards for juice that are
nonmicrobial in nature. For example, juice products have become
contaminated with cleaning solution. If this contamination is a hazard
that is reasonably likely to occur in a particular process (e.g., there
is a repeated history of its occurrence), the processor must establish
controls in its HACCP plan to prevent the contamination rather than
address the contamination in their SSOP's.
Similarly, some juice products have been recalled due to the
presence of glass. Glass shards in juice represent a severe and acute
public health threat. Processors who package in glass must consider
whether glass in their final product is reasonably likely to occur in
the absence of control. If so, processors must establish controls for
glass in their HACCP plans.
Excess detinning represents another potential nonmicrobial hazard
for juice. Certain juices are purposely packaged to allow some
detinning of the can in order to protect the color quality of the
product. However, detinning can be accelerated by unusually high
nitrate content in the product or by elevated temperatures during
storage or shipping (Refs. 26). Excessive detinning has resulted in
consumer illness (Refs. 26 and 27). Thus, processors of juice products
that employ detinning as a means of color protection must determine
whether it is necessary to establish specific control measures, i.e., a
CCP, because excessive detinning is reasonably likely to occur.
Potential hazards may also be caused by the nature of incoming
materials. Patulin in apple juice products is one such example. Patulin
is a mycotoxin produced by several species of mold that can grow on
apples, particularly if bruised or otherwise damaged. A compilation of
data from three surveys showed that 19 percent of samples of apple
juice contained levels of patulin in excess of 50 g/L (Ref.
23). FDA has recently issued guidance describing 50 parts per billion
(ppb) as a recommended level for patulin (Refs. 19 and 24). For apple
juice processors, patulin may represent a hazard that is reasonably
likely to occur when juice is made from bruised or damaged fruit, as
even moderate bruising can result in mold growth on apples. Moreover,
patulin may be a chronic potential hazard and therefore particular
attention must be given to the frequency of occurrence. Therefore, a
prudent processor must determine whether the frequency of occurrence of
this potential hazard in juice is unacceptable without controls. If
patulin is reasonably likely to occur at unacceptably high levels,
processors must include it as a hazard in their HACCP plans. Patulin is
not the sole mycotoxin that may be a hazard in juice. There is evidence
that other mycotoxins, such as ochratoxin in grapes and Alternaria
toxins in fruit and vegetable products (Ref. 28), may be emerging
public health problems in juices and at least warrant monitoring of
future developments.
Lead contamination has also been associated with juices. In 1996,
infant apple prune and prune juices were recalled for unacceptable
levels of lead (Refs. 29 and 30). More recently, unacceptable levels of
lead have been found in babyfood containing carrots and in carrots in
frozen mixed vegetables as a result of lead contamination in the soil
(Refs. 31 and 32). Juice made from produce with high lead levels will
also be high in lead. A German survey of lead in foods found that 12
percent of fruit juices contained elevated levels of lead and over 5
percent of fruits had elevated levels of lead (Ref. 33). It is well
recognized that lead has no known ``no-effect level'' and consumption
of lead-contaminated food is a recognized health problem, particularly
for children in their developmental stages. Responsible processors
should exercise control to ensure that their juice products do not
contain lead at harmful levels. Again, HACCP provides both the
necessary control and flexibility to address the problem of lead
contamination. If a processor is importing juice from a geographic
region known to have a problem with lead contamination in foods, that
processor should identify lead as a hazard in their HACCP plan.
However, if a juice processor determines through its hazard analysis
that, given their source, incoming materials are not reasonably likely
to be contaminated with lead, that processor would not need to identify
lead as a hazard in its HACCP plan. Importantly, processors who are
currently implementing HACCP to address microbial hazards only already
have the infrastructure in place to analyze their processing system and
can then determine if there are chemical or physical hazards that are
reasonably likely to occur. Therefore, with minimal effort, these
processors can readily expand the scope of their HACCP system to
include consideration of all potential hazards.
Based upon the foregoing, the agency concludes that chemical and
physical hazards, as well as pathogens, may pose public health risks in
juice products. These hazards, when they are reasonably likely to
occur, require specific preventive controls. HACCP is the most
appropriate system to control both microbial and nonmicrobial hazards
that are reasonably likely to occur in juice products.
(Comment 16) Several comments suggested that quality assurance
systems devised specifically for juices would be appropriate
alternatives to mandatory HACCP with a performance standard. The
comments contended that the quality assurance systems developed by and
for the citrus industry in conjunction with the University of Florida
(Ref. 34) are adequate to ensure the safety of citrus juices and that
the Apple Hill Quality Assurance Program (Ref. 35) is adequate to
ensure the safety of apple juice. Some comments asserted that these
programs are just as effective as HACCP, while being less expensive to
implement.
FDA encourages the efforts by industry, universities, State and
local government agencies, and others to develop programs to ensure the
safety and quality of the food supply and is aware of several such
programs. The agency has reviewed the quality assurance programs
mentioned by the comments and finds that the HACCP system in part 120
provides a greater level of public health assurance. If a processor can
implement a quality assurance program that also meets the requirements
of part 120, then FDA does not object to the processor using that
program for its HACCP system. However, quality and safety are not
necessarily synonymous. Quality programs focus on the combination of
attributes or characteristics of a product that have significance in
determining the degree of acceptability of that product by consumers.
Safety programs focus on hazards and public health assurance. Quality
assurance systems may not address all public health
[[Page 6145]]
hazards just as safety programs may not address all quality issues.
(Comment 17) Several comments requested that FDA exempt from the
HACCP regulation processors who pasteurize their product, make shelf-
stable product, or meet the 5-log performance standard because the aim
of the rule should be pathogen control. The comments said that HACCP is
regulatory overkill and it is unfair to impose HACCP on the 98 percent
who pasteurize in order to control the real risk from the 2 percent who
do not. The comments noted that illness outbreak evidence only supports
the need for interventions to control pathogens in unpasteurized juice
because there have been no reported outbreaks of illness from
consumption of pasteurized juice.
The agency agrees that, when used with appropriate times and
temperatures, thermal pasteurization \3\ is a proven and effective
method for controlling pathogens. However, the effectiveness of
pasteurization is dependent on implementation of an integrated system
that validates and verifies the efficacy of the pasteurization process.
It is likely that processors who make concentrated, shelf-stable, or
pasteurized juices have already incorporated HACCP principles, aimed at
control of pathogens, into their processing operations (Ref. 36).
Processors already attaining the 5-log reduction performance standard
are likely to have established process parameters (i.e., critical
limits), are monitoring the process, and are keeping records of their
monitoring. Therefore, it should require minimal effort for processors
that make concentrated, shelf-stable, or pasteurized juices to satisfy
the requirements of part 120 relating to pathogen control. Moreover, as
discussed in section L of this document ``Process Controls,'' in
recognition of the effectiveness of thermal treatments for pathogen
control, FDA is providing in part 120 an alternative method for
processors making shelf-stable juices or certain juice concentrates to
comply with the 5-log reduction in the pertinent pathogen. The agency
believes that the alternative method is reasonable because the
processes for shelf-stable juices and concentrates are so rigorous that
they exceed the minimum requirements for control of microbiological
hazards. A copy of the thermal process in a processor's hazard analysis
will provide evidence that the process is adequate.
---------------------------------------------------------------------------
\3\ FDA has not defined what pasteurization means in terms of
juice and juice products because of the unique characteristics of
the many various types of juice and juice products. The scientific
literature provides data on adequate pasteurization times and
temperatures. Prudent processors using pasteurization rely on this
research data for their particular types of juices.
---------------------------------------------------------------------------
Importantly, pathogen control is not the only problem with juice
safety. As discussed in the juice HACCP proposal (63 FR 20450 at 20451)
(Ref. 2) and in the response to comment 15, there are also established
chemical and physical risks with juice. A juice product can only be
considered safe if all hazards (i.e., microbial, chemical, and
physical) are considered and, if these hazards are reasonably likely to
occur, are controlled. Therefore, FDA concludes that processors of
thermally processed juice must comply completely with this HACCP
regulation, but can do so with minimal added effort.
(Comment 18) Some comments contended that the HACCP proposal goes
way beyond establishing necessary measures to ensure juice safety and
is neither reasonable nor economically feasible for an industry
characterized by small producers, family businesses, seasonal
production, and very little prior experience in food safety management.
Comments also noted that there is a low level of compliance with
seafood HACCP among small producers and the success of juice HACCP will
depend upon small processors complying with costly regulations.
Conversely, several comments argued that HACCP is the appropriate food
safety system for small producers because it can be implemented without
being overly burdensome and forcing them out of business.
The flexibility of HACCP allows the processor to control hazards
identified in the hazard analysis in a manner that best fits an
individual operation, large or small. In addition, if small producers
actually have very little prior experience or knowledge in food safety
management, as some comments asserted, then HACCP training and
consultation are very much needed by this group and will provide
specific food safety goals customized to their individual operations.
Thus, features of the agency's regulatory strategy will accommodate
small processors. First, FDA intends to provide a juice HACCP hazards
and controls guidance that will assist processors. Second, this final
rule has a staggered compliance schedule (Sec. 120.1(b)(1) and (b)(2)),
which provides small and very small juice processors additional time to
implement fully the final rule.
The agency's HACCP strategy for the seafood industry, which is
dominated by small processors, has been to acknowledge that the
implementation of HACCP can be an educational process, especially with
regard to science-based analysis, and thus to allow for the progression
in mastering the HACCP system that accompanies that process. The
progress in implementing HACCP systems that the seafood industry is
making suggests that other segments of the food industry, including
those populated by small businesses, can also benefit from a HACCP
program, even if complete understanding of what constitutes full
implementation of a HACCP system is not immediate.
(Comment 19) Several comments stated that HACCP presents an undue
burden to the pasteurized juice industry with no consumer benefits. The
comments stated that the chemical hazards cited by FDA are not
reasonably likely to occur and that there has never been a foodborne
illness outbreak associated with pasteurized juice.
The agency does not agree. The preamble to the proposed rule
described incidents of illness associated with chemical contaminants in
juice (63 FR 20450 at 20451) (Ref. 2). Chemical hazards can occur in
juice regardless of pasteurization. Moreover, for some juices, the risk
of chemical contamination can be high, depending on the quality of the
incoming produce and the chosen processing steps. In fact, in two
recent incidents, juice was recalled by the processor in one case due
to the presence of dairy and egg allergens (Refs. 37 and 38), and in
the other, due to the presence of cleaning solution (Refs. 39, 40, and
41). As discussed earlier in comment 15, the risk of patulin
contamination in apple juice is high if the processor uses bruised
apples.
The agency does not agree that HACCP for the pasteurized juice
industry does not convey benefits to consumers. While the classic
definition of pasteurization is a heat-treatment to destroy pathogens,
the agency has no assurance that all juice processors who believe they
are pasteurizing their products actually have all the controls in place
to assure that every particle of the juice is receiving sufficient heat
to destroy pathogens. Moreover, pasteurization alone does not assure
the safety of juice products. Proper handling of the product after
pasteurization is required to prevent post-process contamination. A
HACCP system based on CGMP's provides assurance to the processor, as
well as to the agency and the consumer, that pasteurized products are
safe.
The agency is required, by Executive Order and law, to consider
both the costs and benefits to consumers and industry. This analysis
can be found in the PRIA, and the Regulatory Flexibility
[[Page 6146]]
Analysis in sections V and VI of this final rule. Based on FDA's
analysis, the benefits (i.e., prevention of illness) of this final rule
outweigh the costs to industry.
A few comments expressed concern that HACCP regulations may be
enforced at the expense of CGMP's.
The agency does not agree with the comments. In fact, FDA expects
that the opposite will be true. A HACCP system cannot be operating
properly if a processor is not following CGMP's because CGMP's provide
the foundation for an adequate and appropriate HACCP system. Therefore,
to evaluate the effectiveness of a HACCP system, processors and agency
inspectors must also evaluate processors' adherence to CGMP's.
(Comment 20) One comment stated that HACCP as set forth in the
proposal places the responsibility for product safety on the government
rather than the processor.
FDA does not agree with this comment. Each juice processor is
responsible for developing a system of preventive controls by adapting
the HACCP principles in new part 120 to its specific operation and
needs. Under HACCP, the manufacturer is responsible for knowing and
understanding its manufacturing process, identifying points where
contamination can occur, and implementing control measures in order to
produce safe food. To accomplish this, the processor must: (1) Have an
individual who is trained in HACCP conduct a hazard analysis, determine
where controls are needed, and validate the adequacy of any HACCP plan
that is developed; (2) put those controls in place and verify that they
are working through monitoring and recordkeeping; and (3) revalidate
the HACCP plan at least annually or any time there is a significant
change in the process or whenever scientific information demonstrates a
new risk that processors have not previously considered in their hazard
analysis. FDA's responsibility is to conduct oversight to ensure that
HACCP is properly implemented and is effective.
(Comment 21) Several comments stated that HACCP's cost is not
justified because most foodborne illness occurs as a result of problems
that originate after juice leaves the processor and HACCP will not
remedy these problems. One comment cited a source that estimated that
food manufacturers are involved in less than 10 percent of foodborne
disease outbreaks of known origin (Ref. 42).
FDA maintains that all steps in juice production and handling are
potential points of contamination in the absence of adequate controls,
not just post-process handling. Processors must consider prevention of
post-process contamination to the extent feasible. For example, post-
process piping must prevent contamination from occurring prior to
packaging. HACCP systems are implemented to assure the safety of food
when it leaves the processor's control and under normal handling
conditions after that. The agency points out that the CAST report cited
by the comment includes all foods (not just juice) and all food sources
(processors, food service, institutions) and is limited to microbial
contamination of foods. The majority of juice outbreaks have not been
caused by post-process contamination but rather by contaminated
incoming product or contamination during processing (Ref. 43). Thus,
the performance standard (5-log reduction in pathogen level)
established by this rulemaking is set to ensure that the final product
is not contaminated with illness-causing bacteria that may have been
present on incoming fruit. In addition, processors must use CGMP's,
SSOP's, and HACCP to ensure that product is not contaminated with
pathogens while in the processing facility.
(Comment 22) Several comments stated that hazards in juice are
adequately dealt with under State laws (i.e., Connecticut, Florida,
Illinois, Maryland, Massachusetts, Michigan, New Jersey, New Hampshire,
Wisconsin).
The agency applauds State efforts to ensure the safety of juice
produced and sold in their States. However, while there may be some
State laws that govern the manufacture of juices, these laws are
generally not as comprehensive as this HACCP rule. In addition, not all
juice producing States have applicable State laws. This HACCP final
rule provides a uniform minimum level of public health protection
across the country for juices. FDA believes that this final rule will
enhance State efforts and help extend the food safety efforts of some
States to all States.
C. Significance of Illness Data
The preamble to the proposed regulation described occurrences of
juice-related foodborne illness in the United States. It is well
recognized that foodborne illnesses are significantly underreported to
public health authorities (Ref. 44). Consequently, precise data on the
numbers and causes of foodborne illness do not exist. The primary
purpose of these regulations is to ensure that juice is safe through
the use of preventive controls that are systematically and routinely
applied in juice processing, and applied in a way that can be verified
as effective by company management as well as regulatory authorities.
(Comment 23) Many comments questioned the validity of FDA's risk
assessment on juice. They stated that it was not scientific and sound,
not probabilistic, didn't include pasteurized juice, and contains
inaccuracies. However, comments did not specifically identify the
inaccuracies.
FDA maintains that its ``Preliminary Investigation into the
Morbidity and Mortality Associated with the Consumption of Fruit and
Vegetable Juices'' is sound. As outlined in the juice labeling final
rule (63 FR 37030 at 37031) (Ref. 5), the agency performed a detailed
evaluation of the potential hazards posed by untreated juices. This
evaluation is part of the record of the HACCP proposal and was included
as an appendix to the PRIA (63 FR 24292; May 1, 1998) (Ref. 6). The
evaluation was based on available scientific information, included
pasteurized juice, and examined both heat-treatable microbial hazards
and non-heat-treatable hazards. Non-heat-treatable hazards are
discussed in section VII and the evidence is summarized in table 7 of
FDA's Investigation. The conclusion that the most significant juice-
borne hazards are associated with non-heat-treated juice was based on
this investigation.
(Comment 24) One comment stated that all outbreaks in cider have
been traced to using dropped apples or unsanitary processing conditions
and that eliminating these circumstances will stop outbreaks in cider.
FDA disagrees with the comment because the causes of cider-related
outbreaks are not limited to using drops or processing in an insanitary
facility. In fact, from a structural standpoint, apples are susceptible
to contamination because they have an open blossom end, and thus, the
interior of the fruit can be contaminated while the exterior appears
clean and blemish free (Ref. 45). This potential for contamination is
confirmed by data that show that cider, even when it is made from tree-
picked fruit and processed under CGMP's, can contain pathogens and
provide an environment conducive to the survival of pathogens of public
health significance (Ref. 13).
(Comment 25) Several comments maintained that the risk from juice
is low and does not warrant a HACCP regulation.
The agency does not agree with the comments. There are documented
cases of lifethreatening foodborne illness associated with the
consumption of various juice products contaminated with pathogens such
as E. coli O157:H7,
[[Page 6147]]
Salmonella species, Cryptosporidium, and Vibrio cholerae. Some of the
illnesses associated with juices have been very severe (e.g., cases of
long-term reactive arthritis and severe chronic illness) (Ref. 2). In
one case, consumption of contaminated juice resulted in the death of a
child and in another case, consumption of contaminated juice
contributed to the death of an elderly man. These reported outbreaks
likely represent only a fraction of the outbreaks and sporadic cases
that actually occur (Ref. 44).
Chemical and physical hazards have also been associated with
juices. Examples of these hazards were included in the proposal (63 FR
20450 at 20451) (Ref. 2) and are discussed in detail in the response to
comment 15.
The evidence demonstrates that hazards can be present in juice. The
comments did not provide the agency with additional data that either
contradict FDA's hazard evaluation (Ref. 6) or that can be used to
reevaluate the health risks associated with consumption of juice
products. Therefore, FDA believes that the public health risk
associated with consumption of juices is sufficiently high to justify
mandating use of HACCP systems.
(Comment 26) Many comments argued that HACCP is no longer
necessary for juice because of the safety improvements made by the
juice industry since the 1996 outbreak of E. coli O157:H7 in apple
juice. They stated that these improvements are evidenced by the fact
that there has not been an outbreak associated with juice since 1997.
FDA disagrees with the comments. There have been documented
outbreaks of juice-associated foodborne illness since 1997. The agency
acknowledges the recent steps taken by the industry to address
microbial contamination of juice. Nevertheless, while there were no
reported outbreaks attributed to juice in the United States in 1997 and
1998, there were several outbreaks in 1999 and 2000. These outbreaks
are discussed below.
In early 1999 in south Florida, there were 16 reported cases from
Salmonella typhi linked to the consumption of frozen mamey, a product
often used to make juice beverages (Ref. 46).
During June 1999, there was an outbreak of Salmonella serotype
Muenchen infection associated with consumption of unpasteurized orange
juice (Ref. 47). As of April 2000, a total of 423 cases, including one
that contributed to a death, from S. Muenchen infection had been
reported. Nine additional Salmonella serotypes were identified from
orange juice collected from the implicated firm.
In October 1999, there was an outbreak of E. coli O157:H7 in
commercially-processed unpasteurized apple cider in Oklahoma with 9
illnesses (7 children) and 6 hospitalizations (4 cases of hemolytic
uremic syndrome (HUS)) (Ref. 48).
While no illnesses were reported in October 1998, the State of
Florida found Salmonella Manhattan in an unpasteurized juice blend
containing strawberry, apple, and papaya juice (Ref. 49).
In November 1999, the same firm involved in the June 1999 outbreak
initiated and subsequently expanded a recall because their routine
testing found Salmonella in samples of unpasteurized orange juice (Ref.
50). The product had been distributed to restaurants and other food
service establishments in eight U.S. States and one Canadian Province
and to one retail store in Oregon. No known illnesses were associated
with this incident.
In April 2000, there was an outbreak of Salmonella Enteritidis
associated with unpasteurized orange juice (Ref. 51). As of May 2000,
143 cases traced to this orange juice had been identified in Arizona,
California, Colorado, Minnesota, Nevada, Washington, and Wyoming.
Also in April 2000, 24 people who attended a conference in Atlanta,
Georgia, were reported ill with viral gastroenteritis (Ref. 52). Fresh-
squeezed unpasteurized fruit smoothies were implicated in this
outbreak. CDC detected Norwalk-like virus in three patient stools.
Thus, the potential for juice-related illness still exists,
although the number of illness outbreaks linked to juice may vary from
year to year. In addition, the agency has no information indicating
that all members of the juice industry have implemented adequate safety
improvements to address the potential for microbial contamination and
other potential hazards in their products. The fact that outbreaks
continue to occur is evidence to the contrary.
(Comment 27) One comment asserted that most problems associated
with citrus juices were a result of insanitary processing conditions at
small or very small businesses or contamination by asymptomatic food
handlers, and HACCP would not prevent problems in either situation.
The agency disagrees with this comment. FDA often finds in their
investigations into outbreaks that the exact cause of the outbreak is
unknown. The agency may find various possible causes that include those
mentioned by the comment. However, as discussed throughout this
preamble, insanitary conditions and workers' health are not the only
source of food hazards in juice. For example, if juice is made from
contaminated fruit and the 5-log reduction is not accomplished, an
outbreak could occur. HACCP systems do provide greater assurance than
CGMP's and SSOP's alone that juice is safe. HACCP recordkeeping
provisions allow processors and regulators to detect process deviations
and stop distribution of or recall product before it results in an
outbreak.
(Comment 28) Several comments stated that the rules should cover
apple products only, asserting this is where problems have occurred.
The agency disagrees that only apple juice should be covered by
part 120, and all other juices should be exempt. There have been
illness outbreaks from other types of juice, e.g., orange juice. Some
of these were cited in the proposal (63 FR 20450) (Ref. 2). As
discussed in comment 27, additional outbreaks since publication of the
proposal have occurred. Therefore, FDA concludes that because there are
documented foodborne illness risks associated with juices other than
apple juice, all types of juice must be covered under part 120.
(Comment 29) Many comments argued that juice regulations should
not be more stringent than regulations for other foods that are more
hazardous, such as seafood or meat and poultry. Many comments noted
that seafood HACCP has no performance standard but is a much higher
risk food than juice.
The agency disagrees that juice is being regulated more stringently
than warranted. HACCP for juice mirrors FDA's HACCP regulations for
seafood and USDA's regulations for meat and poultry. In contrast to
most seafood and meat and poultry, juice is generally consumed as sold.
The record of this proceeding demonstrates that microbial contamination
of juice is a substantial public health risk and that a performance
standard is achievable as a practical matter. Thus, to ensure the
safety of juice products, FDA is establishing a mandatory HACCP program
that includes a performance standard to prevent, reduce, or eliminate
levels of pathogens known to cause foodborne illness. The performance
standard ensures that controls within the HACCP system are working
effectively to reduce the risk of illness and that the final product is
safe.
(Comment 30) One comment maintained that the physical hazards
related to juice are a result of metal cans
[[Page 6148]]
and glass, both of which are not used by the fresh juice industry.
FDA recognizes that juices that are minimally processed usually are
packaged in plastic to provide for expansion of the product. Whether or
not packaging materials are included in a processor's HACCP plan will
be determined in the processor's hazard analysis. If the hazard
analysis shows that a particular operation has no physical hazards,
such as metal or glass, that are reasonably likely to occur, no control
measures are required for such hazards. Even if there are no physical
hazards in fresh juice that require controls, the risk of microbial
contamination of fresh juice is well-documented and a HACCP approach is
needed to address these risks.
(Comment 31) One comment stated that the Bacillus cereus incident
cited by FDA is not significant and any final rule should clearly state
that sporeformers are not a problem that needs to be considered in a
treatment system for juice.
The agency has considered the issues surrounding hazards from spore
forming bacteria. Regulations in parts 113 and 114 (21 CFR parts 113
and 114) already address the hazard from Clostridium botulinum in low
acid canned foods and acidified foods. Spore forming bacteria have not
been associated with public health problems in juice that has been
properly handled (e.g., refrigerated) after leaving the processing
plant. Therefore, FDA does not anticipate that processors' hazard
analyses will establish that spore forming bacteria are a hazard that
is reasonably likely to occur.
D. Comparison of the Proposal and This Final Regulation
The comments received generated some clarifications of and changes
in provisions of the proposed regulation. These are discussed in detail
in the comments noted after each item. Among the most significant
clarifications and changes are the following:
Clarification that the regulation covers intrastate, as
well as interstate juice (discussed in comments 33 and 74)
Adoption of the most recent NACMCF definition of ``food
hazard'' (comment 39)
Elimination of the proposed exemption from the regulation
for retail establishments that produce juice on their premises and sell
40,000 or less gallons of juice per year (comment 47)
Addition of a definition of ``retail establishment''
(comment 48)
Clarification of how a hazard analysis is conducted
(comments 63 to 70)
Clarification of application of the 5-log pathogen
reduction performance standard (comments 115 and 131 to 139)
Creation of an exemption for shelf-stable juice processors
and concentrated juice processors from the requirement for a pathogen
reduction critical control point, under specific conditions (comment
140)
Establishment of a process verification sampling and
testing procedure for citrus juices that use surface treatment as part
of the 5-log pathogen reduction process (comment 142 to 143)
III. The Final Regulation
A. Applicability
The agency proposed in Sec. 120.1(a) that any juice sold as such or
used as an ingredient in beverages be processed in accordance with the
requirements of part 120 (63 FR 20450 at 20462) (Ref. 2). As proposed,
juice is the aqueous liquid expressed or extracted from one or more
fruits or vegetables, purees of the edible portions of one or more
fruits or vegetables, or any concentrates of such liquid or puree.
(Comment 32) One comment requested that FDA define juice as the
aqueous liquid expressed or otherwise extracted from food and that this
definition should be synonymous with juice definitions in other
regulations, i.e., food standards. One comment noted that food products
(e.g., fruit cocktail) other than beverages contain fruit juice.
FDA advises that the purpose of Sec. 120.1(a) is to define the
scope of what is covered under part 120 rather than to provide a
general definition for the term ``juice.'' Part 120 only covers
products sold as juice or used as an ingredient in beverages. The
agency recognizes that products other than beverages, e.g., canned
fruit cocktail, may contain fruit or vegetable juice. However, the
foodborne illness outbreaks prompting the juice HACCP proposal were
associated with juices and juice products that were beverages rather
than juice ingredients contained in non-beverage products. Therefore,
FDA is not defining ``juice'' in the general sense requested by the
comment.
(Comment 33) Several comments requested that FDA clarify whether
the juice HACCP regulation covers only interstate commerce.
FDA intends that this final rule cover both ``interstate juice''
(i.e., juice that is shipped in interstate commerce or that is made
using one or more components that were shipped in interstate commerce)
and ``intrastate juice'' (i.e., juice that is made entirely from
components grown within a single State and then sold to the ultimate
consumer within the same State).
As noted in the proposal, FDA is relying upon both its authority
under the act, 21 U.S.C. 321 et seq., and the Public Health Service
Act, 42 U.S.C. 241, 242l, 264. FDA's authority to regulate ``interstate
juice'' is discussed in detail below in comment 74. Under section 361
of the Public Health Service Act (42 U.S.C. 264), the Surgeon General
is authorized to issue and enforce regulations to prevent the
introduction, transmission, or spread of communicable diseases from one
State to another State. (This authority has been delegated to the
Commissioner of Food and Drugs, 5 CFR 5.10(a)(4).) Activities that are
wholly intrastate in character, such as the production and final sale
to consumers of a regulated article within one State, are subject to
regulation under section 361 of the PHS Act State of Louisiana v.
Mathews, 427 F. Supp. 174, 176 (E.D. La. 1977). The record in this
rulemaking amply demonstrates that juice can function as a vehicle for
transmitting foodborne illness caused by pathogens such as Salmonella
and E. coli O157:H7. Similarly, the record (Ref. 53) demonstrates that
consumers (particularly out-of-State tourists and other travelers) are
likely to purchase and/or consume ``intrastate'' juice. These consumers
subsequently take the juice back to their home State where the juice is
consumed or carry a communicable disease back to their home State,
thereby creating the risk that foodborne illness may occur in the home
State as a result of such consumption.
The agency believes that its intent to regulate both ``interstate''
and ``intrastate'' juice was evident from Sec. 120.1(a) of the
proposal, which stated that the requirements of part 120 would apply to
``any juice'' without qualification as to its ``interstate'' or
``intrastate'' character. However, to clarify further the products to
which this final rule applies, FDA is adding a sentence to
Sec. 120.1(a) as follows: ``The requirements of this part shall apply
to any juice regardless of whether the juice, or any of its
ingredients, is or has been shipped in interstate commerce (as defined
in section 201(b) of the Federal Food, Drug, and Cosmetic Act, 21
U.S.C. 321(b)).''
(Comment 34) Some comments requested that FDA exempt citrus juices
from the HACCP regulation because these juices contain organic acids
that stop microbial growth, the pH of citrus juices is too low for
pathogen growth, and peel oil contains an antimicrobial agent. One
comment included data
[[Page 6149]]
indicating that Listeria and E. coli O157:H7 cannot survive in lemon
and lime juices under normal storage conditions and requested that
these two juices be exempted from the HACCP rule.
The agency disagrees that citrus juices should be exempt from the
requirements of part 120. Although the organic acids, pH, and peel oil
in citrus juice may inhibit (i.e., prevent or slow down) the growth of
pathogens, such organisms can still be present in citrus juice and may
cause illness if consumed. Fruits and vegetables differ in their
inherent chemical composition; even within varieties of particular
fruits or vegetables, there can be some variation in composition
depending on growing conditions. However, the comments provided no data
to show how the chemical composition of a citrus juice (pH or
antimicrobial compounds in peel oil) will ensure the safety of fresh
citrus juice. In fact, because the amount of peel oil in juice will
vary from process to process, the agency disagrees that the
antimicrobial effects of citrus peel oil can adequately control
pathogens in juice. Similarly, the organic acid in citrus juice (i.e.,
citric acid) has not been shown to provide any additional protection
against pathogen contamination and survival compared to the acid found
in apple juice (Refs. 54, 55, and 56).
A 1997 study of E. coli O157:H7 behavior in apple juice and orange
juice, particularly under refrigerated conditions, demonstrated that
even in the relatively acidic environment of these juices, this
organism can survive (Ref. 57). In the study, juice was inoculated with
E. coli O157:H7. After a 24-day period at refrigeration temperatures,
there was only a small decline in numbers of E. coli O157:H7. The fact
that E. coli O157:H7 can survive in orange juice and that human
illnesses from other pathogens, such as S. Muenchen and other
Salmonella species, have been traced to orange juice demonstrates that,
if contaminated, orange juice has the potential to cause human illness.
Lemon and lime juices are more acidic than other types of citrus
juice. The strong acidity of these juices does have an antimicrobial
effect as the comment's data demonstrated. However, the resistance of
oocysts to the strong acidity of these juices is not known. In
addition, there can be differences in acidity between varieties of
lemons and limes, and thus, differences in their inherent antimicrobial
effects. These juices may be diluted and sweetened to make them
palatable as beverages, thus changing antimicrobial parameters. In
addition, there may be chemical and physical hazards that are
reasonably likely to occur in these types of juices that pH and acids
cannot control. Therefore, FDA concludes that the chemical composition
of lemon and lime juices does not justify exempting these juices from
this rule. If processors can demonstrate that the inherent
antimicrobial qualities of a juice are adequate to accomplish the 5-log
reduction in the pertinent pathogen under refrigerated conditions (or
freezing conditions, if the product is frozen) prior to the product
leaving the processing facility, then the antimicrobial parameters,
along with the necessary time to accomplish the 5-log reduction, could
constitute CCP's. FDA notes, however, that under the final rule,
processors must establish critical limits and monitor each of the CCP's
as part of their HACCP systems.
(Comment 35) Some comments maintained that there is less inherent
risk from citrus juices because citrus processing limits contact time
of peel and juice. The comments included data from citrus processors
that separate the peel from the juice with only a small fraction of
peel contacting the juice.
The agency disagrees that there is less risk from citrus juices
such that these juices should not be subject to part 120. The
significance of peel/juice contact as a source of pathogens in the
juice depends on several factors, including the microbial load on the
peel and the amount of contact of the peel with the juice. If the small
fraction of peel, as described by the comments, is contaminated and
comes into contact with the juice, that contact is significant. As
discussed in the proposed rule (63 FR 20450) (Ref. 2) and also in the
response to comment 26, there have been outbreaks of food borne illness
associated with orange juice.
(Comment 36) A few comments requested that FDA exempt apple cider
from the HACCP regulation because the agency found no pathogen
contamination in the 1997 cider survey, which, according to the
comment, indicates that there is no real risk from pathogens in cider.
FDA's 1997 survey involved inspection of fresh unpasteurized apple
cider operations at 237 processors in 32 States (Ref. 45) during which
the agency collected samples at various processing steps. These samples
were analyzed for E. coli O157:H7, Salmonella, Staphylococcus aureus,
fecal coliforms, and generic E. coli. Although the survey did not
detect any pathogens in finished juice products, one firm's apples
tested positive for Salmonella, demonstrating that pathogens can occur
on incoming apples. (The analytical method used for Salmonella has
since been improved to better detect low levels of this pathogen in
acidic foods, such as apple juice.) Results also showed that samples of
wash water from several firms tested positive for generic E. coli and
fecal coliforms; overall, generic E. coli was found in 15 percent of
the finished product samples. The presence of fecal coliforms and
generic E. coli are widely recognized as indicators of fecal
contamination (Ref. 58). Further, the survey concluded that it is
likely that any microbial hazards that are introduced at the beginning
of processing will be carried through to the finished product; no
microbial reduction will occur during the process (Ref. 45).
The agency disagrees that these results indicate there is no real
risk from pathogens in cider. Contrary to the comments' contention, the
cider survey results affirm that risk factors such as fecal coliforms,
an indicator of the possible presence of pathogens, as well as
pathogenic bacteria, such as Salmonella, are present in cider
processing operations and could give rise to microbiological safety
hazards in finished cider products.
Finally, illness outbreaks associated with apple cider continue to
occur. In particular, in October 1999 in Oklahoma, there was an
outbreak related to E. coli O157:H7 in a commercially produced,
unpasteurized apple cider, that resulted in nine reported illnesses.
The agency, therefore, is not granting the requested exemption.
(Comment 37) Several comments requested that FDA clarify whether
concentrates are covered under the rule.
The agency advises that under the final rule, a juice concentrate
satisfies the definition of ``juice'' in Sec. 120.1, and thus,
producers of concentrates are required to comply with part 120.
(Comment 38) One comment requested that FDA clarify whether
processors of beverages that include juice as an ingredient but do not
produce the juice itself are covered under the juice HACCP regulation.
One comment stated that dairies using concentrates that are processed
to meet the 5-log requirement or untreated juices that are further
pasteurized should not be subject to the HACCP regulation.
The agency advises that any juice processing activity, including
juice ingredient processing, must comply with the provisions of part
120. Dairies making juice, regardless of whether they use concentrates,
must comply with part
[[Page 6150]]
120. However, dairies producing a non-juice beverage that contains a
juice ingredient (e.g., a dairy-based beverage containing orange juice)
are not required to comply with part 120 in terms of the process for
producing that non-juice beverage. Processors of juice used as a
beverage ingredient must comply with the provisions of part 120.
B. Definitions
1. Food Hazard
FDA proposed in Sec. 120.3(e) (finalized as Sec. 120.3(g)) that
``food hazard'' means any biological, chemical, or physical property
that may cause a food to be unsafe for human consumption.
(Comment 39) One comment requested that FDA adopt the most recent
NACMCF definition of a food hazard to clarify the mechanism by which a
hazard analysis is conducted.
The agency agrees with this comment. The NACMCF currently defines
``hazard'' as a ``biological, chemical, or physical agent that is
reasonably likely to cause illness or injury in the absence of its
control'' (Ref. 17). The definition differs from, but is not
inconsistent with, the definitions for food hazards used in the seafood
HACCP and meat and poultry HACCP regulations. Adopting the most recent
NACMCF recommendations to the extent feasible will allow the HACCP
regulation to remain current with the science of HACCP.
In the first step of a hazard analysis, processors must identify
all the hazards that could potentially occur in the juice. Potential
hazards are those microbial, chemical, and physical agents that are
reasonably likely to cause illness or injury regardless of the
likelihood of their occurrence. FDA intends to publish a juice HACCP
hazards and controls guidance to assist processors in this step of the
hazard analysis.
Second, processors must determine whether the potential hazards
identified are ``reasonably likely to occur'' in their particular
process. Under Sec. 120.7(b), a hazard is ``reasonably likely to
occur'' if a prudent processor would establish controls because
experience, illness data, scientific reports, or other information
provide a basis to conclude that there is a reasonable possibility
that, in the absence of those controls, the food hazard will occur in
the particular type of product being processed.
In the NACMCF's view, if a hazard has a severe, acute public health
impact (e.g., illness caused by a pathogen, injury caused by ingestion
of glass), that hazard presents a significant risk even at an extremely
low frequency of occurrence and must be appropriately identified as a
hazard that is ``reasonably likely to occur'' (Ref. 17). FDA concurs in
this view. On the other hand, chronic hazards would need to occur at a
higher frequency to be identified as a hazard that is ``reasonably
likely to occur.'' In the case of chronic hazards, it must be
understood that the illness or injury need not be caused by any
specific occurrence of the hazard but may occur with exposure to the
hazard over time. Each hazard identified in the hazard analysis as
``reasonably likely to occur'' requires the identification of at least
one CCP, the critical step or steps in the process that must be
controlled to prevent, reduce to acceptable levels, or eliminate the
hazard.
Because hazards can be either acute or chronic (i.e., having short-
term or long-term effects, respectively) and the purpose of HACCP is to
focus on public health hazards that are ``reasonably likely to occur,''
FDA finds that the NACMCF definition better describes what must be
considered in a hazard analysis. Therefore, the agency is modifying
Sec. 120.3(g) to state that a ``food hazard'' means any biological,
chemical, or physical agent that is reasonably likely to cause illness
or injury in the absence of its control.
2. Processing
The agency proposed in Sec. 120.3(h)(1) (finalized as
Sec. 120.3(j)(1)) to define ``processing'' as activities that are
directly related to the production of juice products. However, for
purposes of proposed part 120, certain activities were proposed to be
exempted by Sec. 120.3(h)(2) (finalized as Sec. 120.3(j)(2)). These
are: (1) Harvesting, picking, or transporting raw agricultural
ingredients of juice products, without otherwise engaging in
processing; (2) the operation of a retail establishment; and (3) the
operation of a retail establishment that is a very small business and
that makes juice on its premises, provided that the establishment's
total sales of juice and juice products do not exceed 40,000 gallons
per year, and that sells the juice (a) directly to consumers or (b)
directly to consumers and other retail establishments.
a. Harvesting, Picking, and Transporting Raw Agricultural Products.
(Comment 40) Several comments objected to the definition of
processing in proposed Sec. 120.3(h)(2)(i) (finalized as
120.3(j)(2)(i)) excluding harvesting, picking, and transporting raw
agricultural ingredients of juice products because this will leave a
big gap in the farm to table system and contamination is very likely to
occur in this gap. One comment advocated mandatory HACCP that either
begins at the farm including harvesting, picking, and transport or
includes a ``kill step.''
The agency has concluded that it would be unduly burdensome to
require that harvesting, picking, and transportation be included as
part of a processor's HACCP system or to require a kill step. Under
HACCP, processors are responsible for evaluating their production
system for hazards and establishing CCP's. This includes the quality of
incoming raw materials. FDA encourages farmers and processors to
evaluate and modify their agricultural practices in accordance with
FDA's ``Guide to Minimize Microbial Food Safety Hazards for Fresh
Fruits and Vegetables'' (Ref. 59). This guidance document is based upon
certain basic principles and practices associated with minimizing
microbial food safety hazards from the field through distribution of
fresh fruits and vegetables. Farmers should take all steps to ensure
their products are safe for the intended food use, but safe juice can
be produced without these activities at the farm level coming under the
processor's HACCP system. Processors can control hazards that may be
present on incoming produce by: (1) Rejecting produce at receipt that
does not meet processor specifications; (2) removing contaminated
produce during initial processing; (3) cleaning and sanitizing produce;
(4) using, as a minimum standard, the 5-log reduction in the pertinent
pathogen as set forth in Sec. 120.24; and (5) using any other effective
method.
The agency does not believe it is appropriate to mandate a ``kill
step'' in the absence of HACCP at the farm. It is the processor's
decision, based on its hazard analysis whether or not the first CCP in
its HACCP system is at the point of receipt of raw materials, to
control hazards that may have occurred earlier. The hazard analysis
must be based on experience, illness data, scientific reports, or other
information that provide a basis to conclude that there is a reasonable
possibility that, in the absence of HACCP controls, the food hazard
will occur in the particular type of product being processed. The
performance standard establishes the minimum level of microbial
pathogen reduction the process must be able to provide to produce safe
juice and this may be met by a ``kill step'' or any other appropriate
method. The 5-log reduction in the pertinent pathogen is adequate to
ensure that the juice is safe when done under a HACCP system with a
foundation of CGMP's and SSOP's.
[[Page 6151]]
(Comment 41) One comment suggested that the definition of
processing should at least mention FDA's ``Guide to Minimize Microbial
Food Safety Hazards for Fresh Fruits and Vegetables'' (GAP's).
FDA has considered the comment's suggestion and believes that
reference to the GAP's in part 120 would be useful. However, the agency
finds that it is more appropriate to discuss the GAP's in terms of the
application of part 120. Therefore, FDA is modifying Sec. 120.1(a) to
state that raw agricultural ingredients are not subject to the
requirements of this part and that processors should apply existing
agency guidance to minimize microbial food safety hazards for fresh
fruits and vegetables in handling raw agricultural products.
b. Retail.
(Comment 42) Several comments were opposed to excluding retail
establishments from the definition of processing in proposed
Sec. 120.3(h)(2)(ii) (finalized as Sec. 120.3(j)(2)(ii)). The comments
expressed concern because outbreaks associated with products processed
in retail establishments will be equally devastating to the industry as
a whole. One comment stated that relying on the Food Code and State
regulators is inadequate because: (1) The adoption of Food Code
provisions is voluntary and varies widely on a State-by-State basis and
(2) State regulators do not have the resources to inspect retail
establishments on a regular basis.
The agency recognizes that retail is an important segment of the
juice industry and that retailers may also mishandle products. FDA is
concerned that juice sold at retail be safe. However, retail
establishments pose a unique situation for the implementation of HACCP.
Retail establishments, in general, deal with a greater variety of
products and processes at relatively lower volumes than non-retail
producers. For example, cider retailers at farmers' markets will
generally sell other products, including fresh produce, as well as
apple cider. Therefore, because retail establishments handle lower
volumes of a variety of products, HACCP systems at retail are
significantly different from HACCP systems in processing plants.
Because of the wide variety of products and processes used by retail
establishments, the relatively low volumes of juices produced, the
normally small area of product distribution, and the large number of
retail establishments, FDA has chosen to focus its regulatory resources
on manufacturers that produce larger quantities of widely distributed
products.
Even though retail establishments are not included in this
rulemaking, prudent retailers should take steps to ensure the safety of
their products. FDA traditionally provides guidance to the retail
industry through the Food Code and works with the States to implement
Food Code provisions. The States should be aware that the Food Code is
responsive to many of the concerns raised in the comment. FDA
encourages juice retailers to implement Food Code provisions. Also, FDA
provides training and other forms of technical assistance to States and
local Governments who inspect retail food establishments through the
agency's retail Federal/State cooperative program. The agency will
continue to provide this support through the Federal/State cooperative
mechanism. FDA recognizes that not all States have adopted the Food
Code.
Finally, more than 25 States have adopted the Food Code as law with
most other States in the process of adopting the Code. However, retail
establishments pose an inspection burden well beyond the capacity of
FDA. There are not sufficient resources to adequately inspect the many
retail establishments in the United States.
Although retail establishments are not covered in this final rule,
they are subject to Sec. 101.17(g), which requires that packaged
untreated juice products carry a statement informing consumers that the
product has not been pasteurized and, therefore, may contain harmful
bacteria that can cause serious illness in children, the elderly, and
persons with weakened immune systems.
(Comment 43) One comment suggested that, rather than exempting all
retail establishments from the definition for processors, only
retailers who produce in batches of less than 32 ounces at a time or
who sell product in glass containers that can be washed and reused
might be exempted because the less fruit and vegetables that go into a
batch, the lower the risk.
The agency agrees with the concept that the smaller the batch, the
lower the microbial risk. Larger establishments produce larger
quantities of juice that are often widely distributed. Retail
establishments produce much smaller quantities of juice that are more
likely (but not always) consumed locally. Thus, the public health
impact of a foodborne illness outbreak associated with larger firms is
likely to be greater. However, the special considerations discussed in
the response to the previous comment still exist for retail firms,
regardless of batch size. Therefore, FDA concludes that it is
appropriate that part 120 excludes operators of retail establishments
from the definition of processor.
(Comment 44) One comment requested that FDA establish national
standards for juice processors in the Food Code if the agency excludes
retail establishments from the definition for processing. Conversely,
several comments stated that the provisions of the Food Code adequately
ensure juice safety at retail. A few comments stated that the
guidelines developed by the Fresh Citrus Juice Task Force in
combination with Food Code provisions are adequate to ensure the safety
of citrus juice without mandatory HACCP for retailers.
FDA agrees with the comments that maintain that the Food Code
describes appropriate controls that can be applied to reduce juice
hazards at retail. The agency has traditionally relied on the Food Code
to provide guidance to retail establishments. As noted in the response
to comment 42, FDA will work with the States through its Federal/State
mechanism. The agency urges retailers to implement State and industry
guidance in their establishments to ensure the safety of juice.
(Comment 45) One comment suggested that all juice, like milk,
should be pastuerized and FDA should not permit the sale of untreated
juice since raw milk sales are not allowed.
The agency agrees. Under Sec. 120.24(a), processors must include in
their HACCP plans control measures that will produce, at a minimum, a
5-log reduction in the pertinent pathogen. Thus, all juice subject to
part 120 will be treated to control microorganisms.
(Comment 46) One comment requested information on which processors
will not be covered under either the juice labeling rule or the juice
HACCP rule and which processors, if any, have a permanent labeling
option.
The agency advises that Sec. 101.17(g) requires that any packaged
juice in interstate commerce that has not been specifically processed
to prevent, reduce, or eliminate the presence of pathogens must bear
the warning statement. Under this final rule, a juice retailer as
defined in Sec. 120.3(l) is not required to establish a HACCP system;
however, any juice produced by that retailer that includes an
interstate ingredient or is shipped in interstate commerce must bear
the warning label statement. Such a retailer may avoid the labeling
requirements by treating its product to achieve a 5-log reduction in
the pertinent microorganism.
c. 40,000 gallon exemption.
(Comment 47) Most of the comments on the 40,000 gallon exemption
from both large and small processors requested that FDA withdraw the
exemption in proposed Sec. 120.3(h)(2)(iii)
[[Page 6152]]
(the definition of ``processing''). The comments stated that small
processors are just as likely to produce contaminated juice as larger
processors and that company size should not dictate compliance with
regulations when public safety is at stake. The comments also noted
that this exemption does not maximize public health protection.
The comments have persuaded the agency to exclude from this final
rule the exemption proposed for very small retail businesses who sell
less than 40,000 gallons of juice annually either to consumers directly
or to other retailers. FDA agrees that company size should not dictate
compliance with food safety rules. The agency also agrees with comments
that stated that this exemption does not protect the public health.
Although large processing firms can be responsible for more widespread
outbreaks than the firms in the proposed exemption because of their
broader product distribution, those smaller businesses can make juice
that may cause an outbreak. Further, other regulations addressing
public health concerns (e.g., seafood HACCP in part 123 (21 CFR part
123) mandatory pasteurization of milk and milk products in 21 CFR
1240.61) do not contain such exemptions. Therefore, the agency is
removing the exemption from this final rule. FDA notes that those
producers who would have been covered by the 40,000 gallon exemption
and who are strictly engaged in retail sales would not be required to
comply with this final rule consistent with Sec. 120.3(j)(2)(ii). Juice
produced by these retailers would be required to bear the label warning
statement as described in the response to comment 46.
3. Retail Establishment
(Comment 48) Several comments requested that FDA define ``retail
establishment'' for clarity. One comment requested that FDA revise
proposed Sec. 120.3(h) so that retailers who sell to other retailers
are covered by the definition for processors.
FDA agrees with the comment that recommended establishing a
definition of ``retail establishment.'' The FDA Food Code has a
definition of `` food establishment'', which, given the purpose and
scope of the Food Code, is essentially a definition of a retail
establishment. In establishing a definition for ``retail
establishment'' in this final rule, FDA is relying on this Food Code
definition. The Food Code definition of `` food establishment'' has
been in existence for many years, and is recognized by the States. The
Food Code definition includes establishments in which juice is produced
and sold directly to consumers in stores, from roadside stands, at
farmers' markets, and in food service operations (such as juice bars
and restaurants).
FDA also agrees with the comment that requested that juice
retailers who sell to other retailers be subject to the HACCP
regulation. FDA believes that this approach will contribute to public
health protection. Accordingly, under this final rule, only a retail
establishment that limits its juice business to direct consumer sales
would qualify for exemption from the requirements of this HACCP
regulation, and would be subject to regulation by the State in which it
operates. Thus, the ``retail establishment'' definition in this
regulation is consistent with the Food Code, and also describes
establishments that are included and excluded specifically for the
purpose of this regulation. For example, a retail establishment,
central kitchen, or processing facility that provides juice to more
than one retail operation (e.g., juice production operation that
provides juice to outlets of a chain supermarket) would not be
considered a retail establishment that is exempt from this regulation.
However, a retail establishment that produces juice for sale directly
to consumers at that location and at other locations under the same
ownership would be considered a retail establishment exempt from this
regulation. Therefore, the agency is adding a Sec. 120.3(l) to define a
``retail establishment'' as an operation that provides juice directly
to consumers, and does not include an establishment that sells or
distributes juice to other business entities as well as directly to
consumers. ``Provides'' includes storing, preparing, packaging,
serving, and vending. (Because the agency is establishing an additional
definition in Sec. 120.3, it is recodifying the other terms in
Sec. 120.3 so that they continue to appear in alphabetical order.)
4. Verification and Validation
(Comment 49) Several comments requested that the terms
``validation'' and ``verification'' be defined and be used consistent
with NACMCF principles.
FDA agrees with the comments. The agency intends that the terms
``validation'' and ``verification'' be used consistent with NACMCF
principles throughout this final rule. The NACMCF has established
definitions for these terms that the agency finds useful (Ref. 17).
According to the NACMCF definition, validation is a subset of
verification (Ref. 17). Therefore, in this final rule the agency is
amending Sec. 120.3(p) and (q) to include the NACMCF definitions of
both validation and verification as follows:
Validation means that element of verification focused on collecting
and evaluating scientific and technical information to determine
whether the HACCP plan, when properly implemented, will effectively
control the identified hazards;
Verification means those activities, other than monitoring, that
establish the validity of the HACCP plan and that the system is
operating according to the plan.
C. Prerequisite Program Standard Operating Procedures
The HACCP proposal discussed two types of prerequisite program
standard operating procedures (SOP's). FDA proposed to require the
first type, SSOP's, in Sec. 120.6. SSOP's cover sanitary conditions and
practices before, during, and after processing. The agency requested
comment (63 FR 20450 at 20466) (Ref. 2) on a second prerequisite
program to provide control over materials as they enter the plant.
However, the agency did not propose to require incoming material SOP's
in part 120.
(Comment 50) One comment asked that if FDA requires prerequisite
program SOP's, the agency should be more specific about what is to be
included in the prerequisite program SOP's. It stated that some SOP's
ensure wholesomeness and quality and should not be a part of HACCP.
The agency advises that it is requiring that processors implement
SSOP's in part 120 at this time and not any other type of SOP. The
SSOP's in Sec. 120.6 do include specific standards that must be
maintained. The SSOP's as described in Sec. 120.6(a) address insanitary
conditions and are not directed to ensure wholesomeness and quality
although they may have a beneficial effect on these attributes.
1. SSOP's
(Comment 51) Several comments stated that SSOP's are covered under
CGMP's and should not also be covered in HACCP and neither SSOP's nor
CGMP's should be a written requirement for HACCP. One comment stated
that SSOP's should not be written for the same reasons that SSOP's are
not written for seafood HACCP. One comment stated that prerequisite
program SSOP's should not be mandated and that CGMP's provide an
adequate basis for HACCP. However, other comments maintained that
SSOP's and CGMP's should be a part of written HACCP programs.
[[Page 6153]]
It is important to understand the difference between CGMP's,
SSOP's, and HACCP. The agency has established CGMP's in part 110. These
regulations provide general guidance on such matters as facility
design, materials, personnel practices, and cleaning and sanitation
procedures. In Sec. 120.5, FDA requires that part 110 apply in
determining whether the facilities, methods, practices, and controls
used to process food are safe, and whether the food has been processed
under sanitary conditions. Processors do not need to make a record of
these activities for FDA review. However, the agency will continue to
include in its inspections determinations of processor compliance with
CGMP's. All appropriate CGMP's must be implemented, whether they are
incorporated into a processor's HACCP system or not, because they
reflect norms of good processing.
SSOP's are specific sanitation CGMP's that FDA has found are key to
the successful implementation of a HACCP system. Not all CGMP's deal
with sanitation issues (e.g., contamination with aflatoxin or other
natural toxins in Sec. 110.80(a)(3)). As required by Sec. 120.6(a),
SSOP's emphasize sanitation conditions and practices before, during,
and after processing. Because of the importance of sanitation to a
facility, processors must monitor SSOP conditions and practices during
processing to at least ensure compliance with part 110. If sanitation
conditions and practices are not met, processors must take corrective
actions (Sec. 120.6((b)). Insanitary conditions can directly result in
food hazards, especially microbiological hazards. Inadequate sanitation
has a direct effect on whether the HACCP plan can adequately control
food hazards. For example, insanitary conditions can cause post process
contamination.
Both CGMP's and SSOP's have a broad scope. As noted in section
II.A, HACCP is a system to identify specific points in a particular
manufacturers process where risks exist and critical controls are
needed to control the identified risks. CGMP's and SSOP's both play an
important role in HACCP in that they form the foundation upon which the
HACCP system is built.
FDA stated in the proposal (63 FR 20450 at 20467) (Ref. 2) that the
records bearing on the monitoring of relevant sanitation conditions and
practices and the agency's access to such records are essential if
SSOP's are to be part of an effective regulatory strategy. Although the
agency elected not to require written SSOP's under the seafood HACCP
regulation, it required that seafood processors establish SSOP's and
maintain records monitoring and documenting corrective actions. Juice
is significantly different than seafood in that juice is generally
consumed as sold whereas seafood is generally cooked, thus sanitation
takes on increased importance. Because of the significance of sanitary
conditions, the agency concludes that juice processors must maintain
SSOP records in the same manner as that required for other HACCP
records.
(Comment 52) One comment requested that FDA require that the
quality and safety of water used in juice processing plants be
verified.
The agency agrees that water used in juice processing plants must
be safe and of an adequate sanitary quality for its intended use. This
is consistent with the CGMP requirements in Sec. 110.37(a). Section
120.6(a)(1) of this final rule requires that juice processors have
SSOP's that address the safety of the water that comes into contact
with food or food contact surfaces or that is used in the manufacture
of ice. Processors must examine the source of the water used in their
facilities and determine the necessary provisions to ensure the water's
safety. The processor's particular obligations may vary, depending on
the source of the water. Water from community water supplies is tested
for many substances and the processor can obtain the results of that
testing from the local water authority. In the case of well water,
processors must know that the water they use is safe because such water
could present potential hazards. Thus, processors using well water need
to test the water. Moreover, if substances in the water are hazards
that are reasonably likely to occur, one or more CCP's must be
established and included in the HACCP plan.
(Comment 53) One comment requested that FDA require processors to
monitor for water and cleaning solution contamination.
FDA believes that, given the regulation as proposed, the requested
revision is unnecessary. Section 120.6(a)(1) already requires
processors to have and implement SSOP's relating to water quality and
Sec. 120.6(a)(5) requires processors to have and implement SSOP's
relating to the protection of food from cleaning compounds. Processors
must monitor their SSOP's and take corrective actions for sanitation
conditions and practices where the specified conditions are not met
(Sec. 120.6(b)). In addition, processors must maintain records that
document monitoring and any corrective actions taken (Sec. 120.6(c)).
If either water or cleaning solution contamination is a hazard that is
reasonably likely to occur, one or more control measures must be
included in the HACCP plan for each hazard identified.
(Comment 54) One comment requested that FDA clarify whether
Sec. 120.6(a)(5) permits certain amounts of ``no rinse'' sanitizers to
come into contact with product.
The agency advises that ``no rinse'' sanitizers used according to
product directions do not present a contamination problem and, with
appropriate use, their presence would not be considered a violation of
Sec. 120.6(a)(5).
(Comment 55) One comment requested that FDA set an ``acceptable
level of infestation'' for insect control and require that processors
use insect light traps as monitoring devices. Another comment requested
that FDA revise Sec. 120.6(a)(8) to read as follows: ``Exclusion of
pests from the food plant and prevention of contamination from pests
within the plant, as well as in packaging and raw materials delivered
to the plant.''
FDA disagrees that it should establish an ``acceptable level of
infestation'' for insects or that it should revise Sec. 120.6(a)(8) as
the comment requested. Exclusion of pests from the food plant is
included as a necessary part of SSOP's in Sec. 120.6(a)(8). The
comment's requested modification is already implied in
Sec. 120.6(a)(8). Pests are recognized sources of microbial
contamination, as well as filth, in foods. The agency believes that
generally no unusual pest control requirements are necessary for juice
processing operations beyond the general requirements for pest control
in all food processing facilities, as laid out in part 110. However,
if, during its hazard analysis, a processor identifies pests or
contamination from pests as a food hazard that is reasonably likely to
occur in its particular system, the processor will need to establish a
control measure, critical limits, and a means of monitoring.
(Comment 56) One comment requested that FDA add the following to
Sec. 120.6(b): ``The requirements under this section shall apply both
to the processor's own premises and the premises of any supplier of raw
materials and packaging, as far as this is relevant.'' The comment
concluded that this is necessary because packaging and raw materials
are particular sources of contamination in most food processing plants.
FDA agrees that incoming materials can be a possible source of
contamination in juice processing plants but points out that the focus
of this
[[Page 6154]]
regulation is the production of safe juice by juice processors.
Nevertheless, processors are urged to take steps to control hazards
before the hazards enter the processing facility. Under part 120,
processors must control food hazards in the juice products they make.
If a processor's hazard analysis indicates that a hazard is reasonably
likely to occur in incoming materials, then an appropriate control
(such as a supplier agreement concerning that hazard) must be a part of
the processor's HACCP plan, and the processor must monitor the CCP and
verify supplier performance. Thus, FDA concludes that raw materials and
packaging are already covered adequately and is not modifying
Sec. 120.6(b) as the comment requested.
(Comment 57) One comment stated that corrective actions should not
be required for CGMP's and SSOP's.
FDA advises that there are no corrective actions specifically
required for CGMP's in these HACCP regulations. However, part 120 sets
forth monitoring and corrective action requirements for SSOP's.
Insanitary conditions create an environment in which products may
become contaminated with pathogens or other substances. If a product
becomes contaminated because of insanitary conditions, it is important
that corrections be made as quickly as possible so as not to subject
subsequently processed product to conditions that could introduce food
hazards. Therefore, processors need to monitor the performance of
SSOP's to ensure that the SSOP's are functioning as designed, and that
any problems that arise are corrected. The comment did not provide data
to persuade the agency to conclude otherwise.
(Comment 58) One comment suggested that FDA only require SSOP's in
a HACCP plan if their control is essential to eliminate or control a
public health risk, as determined in the hazard analysis. The comment
contended that a distinction must be made between failure to meet
sanitation requirements and failure to meet a food safety/HACCP
requirement. The comment further stated that singling out items to be
included in SSOP's implies that the other sanitation requirements in
part 110 are not that important, and this is not the case. It stated
that if FDA establishes SSOP's that, at the very least, no
recordkeeping requirements should be associated with SSOP's.
FDA advises that processors are not required to include sanitation
controls in their HACCP plans. Section 120.6(d) allows processors the
option of including sanitation controls in the HACCP plan, but they are
under no obligation to do so as long as the sanitation controls are
being implemented through the SSOP. Insanitary facilities or equipment,
poor food handling, improper personal hygiene, and similar insanitary
conditions create an environment in which products may become
contaminated with pathogens and other substances. A processor may
determine that a task normally covered by SSOP's may be of such
importance that it must be included in the HACCP plan because it
controls a hazard that is reasonably likely to occur. Similarly, an
SSOP task may simply be more efficiently or effectively performed under
the HACCP plan rather than SSOP controls, and thus, a processor may
choose to incorporate the SSOP task into the HACCP system. However,
HACCP controls generally focus on discrete steps or ``points'' in a
processing system, while sanitation and sanitation controls generally
have broader, plantwide applicability. Thus, sanitation does not always
lend itself well to HACCP controls. Therefore, the agency is not
modifying Sec. 120.6(d) as requested.
FDA disagrees that singling out items to be included in SSOP's
implies that the other provisions of part 110 are not important.
Rather, the items listed in Sec. 120.6(a) are to assist processors in
identifying and implementing key sanitation activities. Sanitation
controls, such as controls preventing use of contaminated water in
juice making, have a direct impact on the presence or absence of
pathogens during processing, which in turn, directly affects the
effectiveness of the HACCP plan. No matter how reliable the process is,
insanitary conditions can cause the product to become contaminated with
pathogens. It is because of the critical role that sanitation plays in
the production of safe juice that FDA is requiring SSOP's, identifying
specific items to be included, and requiring recordkeeping. However,
processors must comply with all provisions of part 110 in addition to
having SSOP's as required under Sec. 120.5.
2. Other SOP's
(Comment 59) Several comments requested that FDA require written,
monitored, and verified SOP's for incoming materials. One comment
contended that reasonable procedures for these SOP's should include no
use of dropped apples, no contact with water that could contain
pathogens, no manure as fertilizer, steam cleaning of crates in contact
with fruit between lots, and regular inspections of source farms and
orchards. Another comment suggested that incoming material SOP's be
required only for producers that do not pasteurize their product.
The agency is not convinced of the need for mandatory incoming
material SOP's because these activities may be adequately controlled
under the CGMP's in part 110. However, FDA does recognize the value of
incoming material SOP's, and it encourages processors to establish and
monitor incoming material conditions and practices and to take
corrective actions when needed. Processors must evaluate the need for
controls at all points in their process, including incoming materials.
If incoming materials are reasonably likely to present a hazard, then
the hazard must be controlled by one or more CCP's in the HACCP plan,
even if a processor has an incoming material SOP.
Many of the controls mentioned in the comments are addressed in
FDA's ``Guide to Minimize Microbial Food Safety Hazards for Fresh
Fruits and Vegetables.'' As noted earlier, FDA encourages farmers and
processors to evaluate and modify their agricultural practices in
accordance with GAP guidance. Processors may include GAP's in any SOP's
for incoming materials that they may establish.
Finally, because all processors, regardless of whether or not they
pasteurize, must meet the performance standard required under
Sec. 120.24, as well as the other requirements of part 120, there is no
need to differentiate between processors for the purposes of requiring
incoming material SOP's, and thus, to require more SSOP's from a
processor that does not pasteurize.
(Comment 60) One comment requested that FDA hold a public meeting
for input on incoming material SOP's.
The agency does not believe that such a public meeting is
necessary. There have been many opportunities for interested parties to
comment on all issues related to HACCP, including incoming material
SOP's (see section I.B of this final rule). FDA requested public input
in the HACCP proposed rule (63 FR 20450 at 20466) (Ref. 2) and in this
final rule has considered all significant comments received. In
addition, some issues surrounding incoming materials for citrus juices
were discussed at the public NACMCF meeting in December, 1999 (Ref.
12). Finally, FDA intends to issue a juice HACCP hazards and controls
guidance, which will provide another opportunity for public input on
the incoming materials issue.
(Comment 61) One comment suggested that the GAP's for fresh
produce can be used in conjunction
[[Page 6155]]
with SOP's to ensure the safety of incoming material.
FDA agrees that the use of GAP's in combination with SOP's may
enhance the safety of incoming materials. FDA's GAP's for fresh produce
provide valuable guidance for use in the production and post harvest
handling of raw agricultural commodi