[Federal Register Volume 66, Number 13 (Friday, January 19, 2001)]
[Rules and Regulations]
[Pages 6138-6202]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1291]
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Part V
Department of Health and Human Services
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Food and Drug Administration
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21 CFR Part 120
Hazard Analysis and Critical Control Point (HAACP); Procedures for the
Safe and Sanitary Processing and Importing of Juice; Final Rule
Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules
and Regulations
[[Page 6138]]
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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.
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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).
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\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.
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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.
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\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.
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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
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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
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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
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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)
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(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.
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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 commodities. As noted, the agency also
intends to publish a juice HACCP hazards and controls guidance that
will provide additional guidance on ensuring the safety of incoming
materials.
(Comment 62) One comment stated that HACCP should include a
requirement for incoming materials testing to prevent another outbreak
like the one in 1996.
The agency disagrees that it should require incoming materials
testing in part 120, although it encourages processors to test incoming
materials as appropriate. Testing may be used as a control measure for
a hazard that is reasonably likely to occur and it may also be used to
gather information on a product or supplier for use in the hazard
analysis. However, testing may not be useful in all cases. Microbial
contamination of fresh produce is usually at low levels and is not
uniformly distributed throughout a lot. Thus, while detecting a
pathogen, such as E. coli O157:H7, would allow a processor to avoid
using contaminated produce, failure to detect pathogens by testing does
not provide assurance that the hazard is not present in incoming
materials. The 5-log reduction in the pertinent pathogen as implemented
in a HACCP system provides the assurance that microbial hazards are
under control throughout the process. Therefore, the agency is not
requiring the testing of incoming materials.
D. Hazard Analysis
The agency proposed in Sec. 120.7 that processors develop a written
hazard analysis to determine whether there are hazards that are
reasonably likely to occur for each type of juice produced by a
processor and to identify the control measures that the processor can
apply to control those hazards.
(Comment 63) One comment requested that FDA clarify how a hazard
analysis is conducted. The comment suggested that FDA emphasize the
NACMCF recommendations, including consideration of both likelihood of
occurrence and severity of hazards. The comment expressed concern that
without considering both the likelihood of occurrence and severity of
hazards, HACCP plans would not be consistent with international
practice and World Trade Organization (WTO) obligations, which state
that scientific determinations of risk are needed to form a sound basis
for food safety standards.
The agency agrees that the approach outlined by the NACMCF will
best assist processors in conducting a hazard analysis. First,
processors will benefit from using the five preliminary steps set forth
by the NACMCF, which are to assemble a HACCP team, describe the food
and its distribution, identify the intended use and consumers of the
food, develop a flow diagram that describes the process, and verify the
flow diagram (Ref. 17). Although the agency is not specifically
requiring that processors use these preliminary steps, these steps will
aid processors in focusing on their specific product and process.
According to the NACMCF, processors must accomplish three
objectives in the hazard analysis: (1) Identify hazards that are
reasonably likely to occur and their associated control measures; (2)
identify needed modifications to a process or product so that product
safety is further assured or improved; and (3) provide a basis for
determining CCP's in the HACCP plan (Ref. 17). FDA agrees with these
objectives.
The first NACMCF objective is accomplished in three steps. First,
processors must list all the potential hazards that could be present in
the juice. During this step, the processor's HACCP expert or team
reviews the ingredients used in the product, the activities conducted
at each step in the process and the equipment used, the final product
and its method of storage and distribution, and the intended use and
consumers of the product. A list of categories of potential food
hazards is found in Sec. 120.7(c). Based on this review, the
processor's HACCP team develops a list of potential biological,
chemical, or physical food hazards that may be introduced, increased,
or controlled at each step in the production process. A hazard analysis
must be conducted for each type of juice product manufactured by the
processor because different hazards may be associated with different
juice products. (For example, patulin need only be considered in apple
juice products.)
The processor must then identify those food hazards that are
reasonably likely to occur. According to NACMCF, this step takes into
account both the consequences of exposure (i.e., severity) and the
probability of occurrence (i.e., frequency) of the health impact of the
potential hazards in question (Ref. 17). FDA agrees with the NACMCF
approach. Accordingly, when applying the phrase ``reasonably likely to
occur,'' a processor must consider both severity and frequency of
potential hazards. The NACMCF stated that consideration of the
likelihood of the hazard's occurrence is usually based upon a
combination of experience, epidemiological data, and information in the
technical literature (Ref. 17). The NACMCF also stated that
consideration should be given to the effects of short term, as well as
long-term, exposure to the potential hazards. Because this process
takes into consideration both frequency and severity, a potential
hazard may be identified as reasonably likely to occur even though it
occurs infrequently because the public health consequences when it does
occur are so severe, e.g., HUS in small children from E. coli O157:H7
in juice. This approach also provides greater harmony for international
trade because it is the same approach recommended by the Codex
Alimentarius Commission, which is a recognized standard setting body by
the WTO. Hazards that are not reasonably likely to occur do not require
further consideration within a HACCP plan but are controlled under
CGMP's.
Identification of control measures is a third step in the first
NACMCF objective in developing a hazard analysis. For example, juice
processors must identify the process they will use to achieve the 5-log
reduction in the pertinent pathogen. This may be pasteurization,
surface treatments for citrus, or other effective methods. Therefore,
Sec. 120.7 requires that processors identify the measures that they
will apply to control the hazards that have been identified as
reasonably likely to occur. These control measures must be included in
the HACCP plan as well as the hazard analysis.
Under the second NACMCF objective, processors must review their
current process to determine deficiencies in controlling food hazards
and then identify the changes that must be made to ensure that food
hazards are controlled. For example, some juice beverages may be
thinner or thicker than others, a characteristic that may affect how
fast the product flows through the pasteurizer; in this stage of the
hazard analysis, the processor must review its process to determine
whether the product is flowing through the pasteurizer at a rate
sufficient to ensure that all particles of the juice receive the
appropriate treatment in terms of both time and temperature to achieve,
at a minimum, the 5-log reduction in the pertinent pathogen.
The third NACMCF objective requires that processors use the hazard
analysis to provide a basis for determining CCP's in the HACCP plan.
For example, some
[[Page 6156]]
processors may run different juice beverages on the same line during
the same day with only a water flush between products. If one juice
product contains a potential allergen, such as a soy ingredient, then a
possible control measure is that this product be run last in the day
with a thorough cleaning of the system before the next day's startup.
To clarify the necessary steps in developing a hazard analysis, as
the comment requested, the agency is codifying them in Sec. 120.7(a).
(Because the agency is adding these steps to Sec. 120.7, it is
recodifying the other paragraphs in Sec. 120.7 for clarity.)
(Comment 64) A few comments objected to the requirement of a
written hazard analysis because the seafood HACCP regulation does not
require a written hazard analysis. However, some comments supported
such a requirement.
FDA acknowledges that a written hazard analysis is not required by
the seafood HACCP regulation and believes that, at the time that the
regulation was established, this was appropriate. Although the seafood
HACCP regulation does not require a written hazard analysis for agency
record review, seafood processors are strongly urged to have a written
hazard analysis to resolve differences between the processor and the
agency about whether a HACCP plan is needed and about the selection of
hazards, CCP's, and CL's.
Since the issuance of the seafood HACCP regulation, the HACCP
concept and how best to implement HACCP has evolved in step with
industry's increasing experience with HACCP; part of that evolution is
the idea that the hazard analysis should be written. Processors will
have a better HACCP system if they document the hazard analysis
process. A thorough hazard analysis is the key to preparing an
effective HACCP plan. According to the NACMCF, if the hazard analysis
is not done correctly and the hazards warranting control are not
properly identified, the plan will not be effective regardless of how
well it is followed (Ref. 17).
Another aspect of HACCP implementation that affects the need for a
written hazard analysis is the availability of specially trained
investigators. At the time the seafood HACCP program was established,
FDA had sufficient resources to hire and specifically train
investigators in seafood HACCP, as well as to provide assistance to the
industry in implementing HACCP. With expansion of HACCP into other
commodity areas, the agency does not have the resources to develop
cadres of investigators with expertise in a single commodity, such as
juice. With a written hazard analysis, investigators can more easily
determine whether processors have adequately considered all juice
hazards and have adequately identified those hazards that are
reasonably likely to occur.
Even though a written hazard analysis is not required by the
seafood HACCP regulation, that regulation, as well as USDA's meat and
poultry HACCP regulations, require a systematic and comprehensive
hazard analysis. In addition, USDA's meat and poultry HACCP regulations
require a written hazard analysis. Thus, the only difference in the
juice final rule and the seafood HACCP regulation is that the analysis
is written, not that it is or is not required. FDA believes that the
additional step of recording the hazard analysis poses no significant
burden, economic or otherwise, to juice processors and, on the
contrary, has advantages for the processor. A written hazard analysis
provides processors with a ready record of the decisions made in
conducting a safety analysis of their process, which they may use in
evaluating potential changes to the system and for discussions with
regulatory officials. Further, written hazard analyses are useful to
processors in that they help provide the rationale for the
establishment of critical limits and other plan components. Having the
basis for these decisions available will be helpful when processors
experience changes in personnel, especially those associated with the
HACCP process, and in responding to unanticipated CL deviations.
A written hazard analysis need not be a highly detailed document,
but it must reflect consideration of all the potential hazards that
could occur in a processor's system for a product and the processor's
decisions about whether these hazards are reasonably likely to occur.
The hazard analysis may be as simple as a checklist of potential
hazards and the reason why certain decisions were made. A written
hazard analysis clearly and rationally demonstrates that processors
have considered all potential hazards, identified those hazards that
are reasonably likely to occur and are associated with their product
and process, and identified CCP's and CL's in their HACCP plan.
(Comment 65) Several comments stated that HACCP should only cover
hazards that are reasonably likely to occur and that have been
documented.
FDA agrees that processors need only control in their HACCP plan
those hazards that are reasonably likely to occur and that have been
documented. The hazard analysis is where processors differentiate
between unlikely hazards and hazards that are reasonably likely to
occur in the absence of controls. This determination is made for each
type of juice processed in a particular facility. Data such as
experience, illness data, scientific reports, or other information may
be used as documentation as to whether the hazard is reasonably likely
to occur in juice and, if so, how the hazard is best controlled.
(Comment 66) One comment requested that the agency revise proposed
Sec. 120.7(a) to state generally that all physical, chemical, and
microbiological hazards be considered, instead of providing a numbered
list of potential hazards to be considered in the hazard analysis.
FDA disagrees that all physical, chemical, and microbiological
hazards must be considered, but only those that can be introduced both
within and outside the particular processing environment, including
hazards that can occur before, during, and after harvest. The agency
points out that the provision now codified as Sec. 120.7(c), simply
provides guidance in the form of a minimum list of potential physical,
chemical, and microbiological hazards that processors should consider.
The list is not intended to be all-encompassing, and is not so
constructed. FDA believes that this guidance is useful because it
provides detail about the types of potential hazards that fall into the
more general categories of physical, chemical, and microbiological
hazards. For these reasons, FDA declines to revise Sec. 120.7(c) as
requested.
(Comment 67) Several comments argued that unapproved pesticide
residues, unapproved food and color additives, and food allergens are
not appropriate for inclusion in HACCP because, categorically, they are
not a significant threat to public health and are already covered by
other regulations. One of the comments supported its claim of
inappropriateness by pointing out that FDA failed to give any examples
of problems caused by unlawful pesticide residues or unapproved food
and color additives. Therefore, it stated, these are not problems that
should be covered by HACCP, but addressed under CGMP's.
FDA disagrees that certain types of potential hazards, such as
those mentioned in Sec. 120.7(c), need not be considered in a hazard
analysis. For example, pesticide residues above tolerance may be
potential hazards. However, it is unlikely that pesticide residues
above tolerance will need to be identified during a hazard analysis as
hazards that must be included in the
[[Page 6157]]
HACCP plan because they occur infrequently and the public health impact
of infrequent exposure is not severe.
The agency recognizes that there are effective governmental control
programs in place in the United States to assure generally that
unlawful pesticide residues are unlikely to occur. For pesticides,
these controls include pesticide registration, applicator licensure,
and government sampling and enforcement programs. Likewise, unapproved
food and color additives are generally unlikely to occur in juice
products because prudent processors would not intentionally add them to
their products. Thus, for crops grown in the United States, a processor
may ordinarily conclude that the controls for pesticide use are such
that it is not reasonably likely that unlawful pesticide residues will
be present in crops (including residues at levels above tolerance). A
processor is responsible for assessing the adequacy of control for
pesticide use for crops grown outside the United States and determining
whether such controls are sufficient to make it unlikely that unlawful
pesticide residues will be present. If foreign governmental controls
are sufficient, HACCP controls would not likely be necessary in the
processor's HACCP plan. If foreign governmental controls are not
sufficient, the processor may need to include appropriate controls in
its HACCP plan.
Similarly, unapproved food and color additives would be reasonably
likely to occur only if, because of their presence in the production
plant and the potential for formulation errors, there was a real
likelihood that they may be inadvertently added to the product or added
at higher than the allowable rate. A food or color additive may also be
used on the product by a processor's supplier. This may pose a hazard
where the food or color additive is a potential allergen or causes
sensitivity reactions in susceptible individuals. For example, a
processor may make several types of juice drinks, some containing FD&C
Yellow No. 5. The likelihood and severity of a reaction to Yellow No. 5
is a factor that must be considered in determining whether the
unintended presence, whether by misformulation or cross contamination,
of the ingredient or additive in a food is reasonably likely to occur
and, therefore, constitutes a potential hazard.
Therefore, the agency concludes that if unlawful pesticide residues
and unapproved food and color additives are hazards that are reasonably
likely to occur, it is appropriate that a processor identify them in
its hazard analysis and include them in its HACCP plan.
(Comment 68) Several comments suggested that pesticide control
should be handled as an agreement between processor and grower, not as
a CCP.
The agency advises that if an agreement between a processor and a
grower adequately assures that unlawful pesticide residues will not be
a hazard that is reasonably likely to occur, then controls for that
particular hazard need not be included in the HACCP plan. Agreements
between processors and growers on pesticide issues may be particularly
useful for produce grown in areas where government controls may not be
sufficient to ensure that unlawful pesticide residues are not a hazard
that is reasonably likely to occur.
(Comment 69) One comment noted that unapproved food and color
additives are not an issue for orange juice because it has a standard
of identity.
The existence of a standard of identity, such as for orange juice
or tomato juice, is no guarantee that an unapproved food or color
additive has not been intentionally or inadvertently added to the juice
product. However, as noted previously, if a processor's hazard analysis
establishes that unapproved food and color additives are not a hazard
that is reasonably likely to occur, such additives do not need to be
controlled as part of a HACCP plan.
(Comment 70) One comment requested that proposed Sec. 120.7(b) be
withdrawn as the list of what a processor should evaluate because it is
already covered under part 110 and can be addressed by prerequisite
programs.
The agency stated in the proposal that it was including in proposed
Sec. 120.7(b) (now codified as Sec. 120.7(d)) some elements that would
be useful for juice processors to consider in a hazard analysis (63 FR
20450 at 20468) (Ref. 2). Although CGMP's and SSOP's address a wide
variety of situations and hazards, a particular food hazard may be
reasonably likely to occur in the absence of its control and,
therefore, necessitate HACCP controls. To assist processors in
identifying all hazards that are reasonably likely to occur in their
products, and their public health impact, FDA is, therefore, retaining
the list in Sec. 120.7(d) to guide processors in their hazard analyses.
(Comment 71) One comment requested that FDA revise the list of
what processors should consider in evaluating the safety of their
products to include cooling, ice, and water quality specifically.
The list in Sec. 120.7(c) simply provides examples to guide
processors and is not intended to be all inclusive. Ice and water
quality are issues that generally will be addressed in the SSOP
requirement in Sec. 120.6(a)(1). Therefore, the agency is not modifying
Sec. 120.7(c) as requested. However, because the list in Sec. 120.7(c)
is guidance for processors, it does not preclude a processor from
considering ice and water quality in its hazard analysis. If ice or
water quality poses a hazard that is reasonably likely to occur, then
the hazard must be addressed in the HACCP plan.
E. HACCP Plan
The agency proposed that processors have and implement a written
HACCP plan for a given process whenever a hazard analysis of that
process establishes that there are one or more food hazards that are
reasonably likely to occur during such processing. The written HACCP
plan is to include the following seven principles: (1) Conduct a hazard
analysis, (2) determine the critical control points, (3) establish
critical limits, (4) establish monitoring procedures, (5) establish
corrective actions, (6) establish verification procedures, and (7)
establish recordkeeping and documentation procedures. These seven
elements are derived from the NACMCF principles of HACCP.
(Comment 72) One comment requested that FDA delete the term
``during processing'' in Sec. 120.8(a) because some of the problems in
the past have come from fruit contaminated on receipt and the term
could be read to mean that only hazards that could occur during
processing should be considered in the hazard analysis.
The agency does not agree with the comment. Section 120.7 requires
that processors conduct a hazard analysis to determine the hazards that
are reasonably likely to occur in their juice. If a hazard is
reasonably likely to occur in the juice, the source of the hazard is
immaterial. Therefore, FDA is not revising Sec. 120.8(a) to delete the
term ``during processing.''
(Comment 73) One comment requested that FDA delete proposed
Sec. 120.8(b)(2)(ii) because it appears to contradict the definition
for processing in proposed Sec. 120.3(h)(1) (finalized as
Sec. 120.3(j)(1)). The comment asserted that Sec. 120.8(b)(2)(ii)
states that CCP's should include food hazards that occur before,
during, and after harvesting, yet processing is defined as excluding
harvesting, picking, or transporting raw materials, which places it
beyond the control of a processor.
The agency is not making the requested change because the language
in question, along with the definition of
[[Page 6158]]
processor in Sec. 120.3(k), serves to identify those who are required
to comply with part 120 and is not a basis for excluding potential food
hazards from consideration. Specifically, the definition of processing
in Sec. 120.3(j)(1) excludes the activities of harvesting, picking, or
transporting raw materials even if these materials may be intended for
use in juice processing under Sec. 120.3(k). Only those engaged in
``processing'' juice are ``processors'' and are subject to the
requirements in part 120. However, juice processors are responsible for
addressing the hazards that may be present in/on the foods produced
during their process, including hazards that result from
characteristics of the incoming produce. One way to address potential
hazards presented by incoming materials is by examining those materials
when received and rejecting those that may contain hazards. Another way
is to process juice in a manner to control pathogens or other hazards
that may have been present on incoming materials. Therefore, FDA
believes that the definition of ``processing'' does not conflict with
Sec. 120.8(b)(2)(ii) and is not making the requested change.
F. Legal Basis
The agency proposed in Sec. 120.9 that failure of a processor to
have and to implement a HACCP system that complies with Secs. 120.6,
120.7, and 120.8, or otherwise to operate in accordance with the
requirements of this part, renders the juice products of that processor
adulterated under section 402(a)(4) of the act (21 U.S.C. 342(a)(4)).
(Comment 74) A number of comments asserted that FDA lacks the
statutory authority to require juice processors to establish HACCP
programs. Several comments claimed that section 402(a)(4) of the act
cannot be read to authorize a broad range of HACCP controls and to
provide that the failure to observe any of those controls would render
food prepared under such conditions adulterated within the meaning of
section 402(a)(4) of the act.
FDA disagrees with these comments. As shown below, the agency has
ample authority to require juice processors to establish HACCP
systems.\4\
---------------------------------------------------------------------------
\4\ Comments on the seafood HACCP final rule raised similar
questions as to FDA's authority to require seafood processors to
establish HACCP systems and to require recordkeeping and record
access. In response to the proposed juice HACCP rule, one trade
associations filed a copy of its comments on the seafood HACCP
proposal. The agency's detailed response to the comments on the
seafood proposal, set out at 60 FR 65098-65012, is incorporated by
reference into the preamble of this final rule.
---------------------------------------------------------------------------
FDA is issuing these regulations under the authority of the act and
the Public Health Service Act (PHS Act). Specifically, FDA is relying
on sections 402(a)(4) of the act and 701(a) of the act (21 U.S.C.
371(a)) and section 361 of the PHS Act (42 U.S.C. 264).
Under section 402(a)(4) of the act, a food is adulterated if it has
been prepared, packed, or held under insanitary conditions whereby it
may have been contaminated with filth, or whereby it may have been
rendered injurious to health. It is important to recognize that section
402(a)(4) of the act addresses conditions that may render a food
injurious to health, rather than conditions that have actually caused
the food to be injurious. See United States v. 1,200 Cans, Pasteurized
Whole Eggs, Etc., 339 F. Supp. 131, 141 (N.D. Ga. 1972). See also
United States v. H.B. Gregory, Co., 502 F.2d 700, 705 (7th Cir. 1974),
cert. den. 422 U.S. 1007 (1975). As noted in the notice of proposed
rulemaking, 63 FR 20450 and 20457 (Ref. 2), the question is whether the
conditions of a juice processing operation are such that it is
reasonably possible that the juice produced by that operation may be
rendered injurious to health. Based upon the information available to
the agency and filed in the record of this proceeding, FDA has
concluded that, if a juice processor does not incorporate certain basic
controls into its procedures for preparing, packing, and holding juice,
it is reasonably possible that the juice may be rendered injurious to
health and, therefore, adulterated under the act. FDA is authorized by
21 U.S.C. 371 to adopt regulations for the efficient enforcement of the
act.
FDA believes that the comments disputing the agency's authority to
issue these regulations advocate an unduly narrow interpretation of the
act generally and of section 342(a)(4) specifically. It is well-settled
that the act is to be interpreted broadly so as to achieve its goal of
public health protection. United States v. Bacto-Unidisk, 393 U.S. 784,
798 (1969). Section 402(a)(4) of the act deems adulterated food that is
prepared, packed, or held under ``insanitary'' conditions. The term
``insanitary'' is not defined in the act. ``Sanitary'' describes that
which ``pertains to health, with especial [sic] reference to
cleanliness and freedom from infective and deleterious influences,''
Black's Law Dictionary, 6th Ed.(1990); use of the prefix ``in'' denotes
the absence or opposite of sanitary. Thus, ``unsanitary conditions''
are those that contribute to unhealthiness generally, including unclean
conditions or those that promote infection or disease.
The case law interpreting section 402(a)(4) of the act is
consistent with this broad reading of ``insanitary conditions.'' In
particular, in United States v. Nova Scotia Food Products Corp., 568
F.2d 240 (2d Cir. 1977), the Second Circuit rejected a restrictive
reading of 402(a)(4) of the act, concluding that this section provided
the FDA with authority to establish by regulation processing parameters
to control or eliminate harmful substances present in food intended for
further processing. See United States v. Nova Scotia Foods, 417 F.S.
1364, 1368-1369 (E.D.N.Y. 1976), aff'd supra, 568 F.2d 240. At issue in
Nova Scotia were FDA's regulations governing the time, temperature, and
salinity for processing smoked fish, 568 F.2d at 243, 247 to 248, and
provisions designed to minimize the outgrowth and toxin formation of
Clostridium botulinum Type E, 568 F.2d at 243. The regulations in
question defined sanitary conditions for processing such fish; fish
processed under conditions not complying with the regulation were
deemed adulterated within the meaning of section 402(a)(4) of the act,
21 CFR 128a.2 (1971); 35 FR 17401 (November 13, 1970) (Ref. 60).
Although the Court posited that ``insanitary conditions'' could be
narrowly interpreted to refer to insanitary conditions in the plant,
such as the presence of insects and rodents, the Court rejected this
narrow interpretation, 568 F.2d at 245 to 246, and held that under
section 402(a)(4) of the act, ``insanitary conditions'' may include
``inadequate sanitary conditions of prevention'' (568 F.2d at 247). In
rejecting the narrower reading of 402(a)(4) of the act, the Court
recognized a ``larger general purpose on the part of Congress in
protecting the public health'' (568 F.2d at 248).
This final rule requires that juice processors implement and
maintain HACCP systems. As discussed in detail above, HACCP systems are
designed to prevent, control, or eliminate hazards that are reasonably
likely to occur during food production, including hazards that are
present in in-coming materials, such as pathogens and other
contaminants. Under the final rule, Sec. 120.9, the failure of a juice
processor to establish and maintain an adequate HACCP system renders
juice produced under that system adulterated within the meaning of
section 402(a)(4) of the act. Thus, the provisions of this final rule
are essentially comparable to those addressed in Nova Scotia.
In addition, FDA relies on its authority under the Public Health
[[Page 6159]]
Service Act in issuing this regulation to the extent that the
regulation seeks to control illnesses caused by pathogenic
microorganisms. Under section 361 of the PHS 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). See
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 food-borne illness caused by
pathogens such as Salmonella and E. coli O157:H7. Juice produced in one
State and shipped and sold in another State may be contaminated with
pathogens and thus may result in the transmission of food-borne illness
from State to State. The record similarly establishes that juice may be
produced and sold to a visiting consumer in one State, with the
consumer subsequently taking the juice to a second State. Given that
juice can function as a vehicle for transmitting human pathogens, this
situation creates the possibility that food-borne illness will be
transmitted from one State to another. In light of the record of this
proceeding, FDA has concluded that a system of HACCP controls is
necessary to prevent the spread of communicable disease via consumption
of contaminated juice, and that the PHS Act provides the agency with
the authority to establish such HACCP requirements for juice.
(Comment 75) Several comments challenged the agency's authority to
require that certain records be maintained and that FDA be granted
access to those records. The thrust of these comments is that the act
does not explicitly authorize the agency to require food processors to
maintain records or to require access to records maintained by food
processors. The comments observed that section 704 of the act (21
U.S.C. 374), the act's general records access provision, contains
specific authorization for agency access to records relating to drugs
and restricted medical devices but that, by its terms, the authority of
section 704 does not extend to records relating to foods. Thus, the
comments conclude that the records access provisions of the juice HACCP
proposal are unlawful.
FDA disagrees with this comment because the agency has adequate
authority under the act and the PHS Act both to require the maintenance
of records and to compel official access to such records for the
efficient enforcement of the act. Importantly, FDA is not relying on
its authority in section 704 of the act to require the keeping of HACCP
records and to require official access to such records. As discussed in
the response to the previous comment, in terms of the act, this final
rule implements section 402(a)(4) and utilizes FDA's authority in
section 701(a) of the act to issue regulations for the efficient
enforcement of the act. FDA is similarly relying on sections 402(a)(4)
and 701 to establish the recordkeeping and access to records
requirements of this rule. That this is sufficient authority is
established in the caselaw.
In particular, in National Confectioners Assoc. v. Califano, 569
F.2d 690 (D.C. Cir. 1978), the D.C. Circuit held that FDA had authority
to establish recordkeeping requirements for food processors. In
Confectioners, the recordkeeping provisions of the regulations were
challenged on the grounds that they would permit prosecution where
processing conditions were completely sanitary, but required records
were deficient. Such an outcome, it was argued, would be beyond the
scope of section 402(a)(4) of the act, one of the particular sections
relied upon as authority for the regulation as a whole. The court
rejected this argument, holding that the principal consideration was
whether the statutory scheme as a whole justified the regulations.
Although the records in question in Confectioners were coding and
distribution records that FDA desired in order to facilitate recalls,
the court's ruling as to the validity of the regulations was not
limited to recalls or shipping records. Indeed, Confectioners is
appropriately read to authorize FDA to establish regulations that have
a limited scope, are not unreasonably onerous, and clearly assist in
the efficient enforcement of the act (569 F.2d 693 n. 9). In addition,
the Confectioners court recognized that FDA has a role both in
preventing and in remedying commerce in adulterated foods, and that the
act imposes on the FDA an equal duty to perform each role (569 F.2d at
694).
It is widely accepted that recordkeeping and inspectional access to
records are essential components of a HACCP-type system. Through
records maintenance and review, a processor can, over time, develop a
comprehensive picture of its process and identify shortcomings or
potential shortcomings. Similarly, records maintenance and access
provide the appropriate regulatory authorities with the opportunity to
oversee, in a comprehensive way, the operation of the processor's HACCP
plan, thereby ensuring that contaminated juice products will not enter
the marketplace.
Like the records at issue in Confectioners, the records at issue
with respect to this final rule are designed to prevent the
introduction into commerce of adulterated foods (569 F.2d at 694). In
this case, the recordkeeping and access required under this final rule
meet the Confectioners test. First, the requirements are limited. The
HACCP recordkeeping and record access requirements in the final rule
are tied specifically to the CCP's, i.e., those points in the process
at which control is essential if there is to be assurance that the
resultant product will not be injurious to health is to be achieved.
Second, this limited amount of recordkeeping assists FDA in the
efficient enforcement of the act. By focusing on the CCP's, the
requirements ensure that the processor and the agency focus on those
aspects of processing that present the greatest threat to food safety;
by documenting whether the HACCP plan and its preventive controls are
being followed, these records enable regulators to verify proper
operation of the HACCP system or identify malfunctioning of the system,
again ensuring that adulterated foods are not produced and distributed
to consumers. As such, the record-keeping requirements assist in the
effective and efficient enforcement of the act. Finally, the HACCP
recordkeeping burden is not unduly onerous because the required records
are limited to the development of appropriate controls and documenting
those aspects of processing that are critical to food safety. The
documentation required in the final rule is narrowly tailored to ensure
that only essential information needs to be recorded and maintained.
Because the preventive controls required by HACCP are essential to the
production of safe food as a matter of design, the statutory scheme is
benefited by agency access to records that demonstrate that these
controls are being systematically applied.
Similarly, FDA's authority under the PHS Act (42 U.S.C. 264),
provides a separate and sufficient basis for the recordkeeping and
records access provisions of this rule, at least to the extent that
these requirements relate to the transmission of communicable disease.
The record of this proceeding clearly shows that juice can function as
a transmitter of human disease caused by foodborne pathogens, such as
Salmonella and E. coli O157:H7. Likewise, the record demonstrates that
a system of preventative controls, such as those based upon HACCP, will
control or eliminate this risk from juice
[[Page 6160]]
consumption. As discussed in more detail below, records for the HACCP
operation, and official access to these records, are central to the
effectiveness of HACCP. Thus, the PHS Act clearly authorizes the
records maintenance and access requirements of this final rule.
(Comment 76) A few comments stated that the factual and legal
justifications for mandatory HACCP relate to the presence of pathogens
in the final product, which is not true of the pasteurized juice
industry. Comments maintained that section 402(a)(4) of the act does
not authorize a broad range of controls and that seafood HACCP was
predicated on the conclusion that there were sufficient hazards in all
fishery products. One comment stated that the factual predicate relied
upon in the seafood rule does not exist for juice. The comment
maintained that a review of the data in the proposed rule indicates
that microbiological hazards gave rise to the entire HACCP proceeding
and these hazards do not exist in pasteurized and shelf stable juices.
The agency addressed the legal authority for this rule in the
response to comment 74. FDA disagrees that the factual predicate for
juice HACCP is not adequate. The record demonstrates that there are
significant potential hazards in the production of juice, including
pasteurized and shelf stable juices. These potential hazards in juice
can be divided along the lines of the NACMCF food hazard definition:
Microbiological, chemical, and physical. Microbiological hazards can be
controlled with some type of heat treatment or other process that
prevents, reduces, or eliminates the pathogens. Chemical hazards are
not normally affected by heat and other treatments that are used to
reduce the microbial contamination of foods and thus, must be
controlled by other means (e.g., rejection of incoming materials with
high lead levels). Likewise, physical hazards must be controlled in
some manner other than by thermal or equivalent treatments. All three
types of hazards require that the specific hazard be identified (e.g.,
bacterial species; mycotoxin identity; foreign matter present, such as
glass), a means for preventing or controlling the hazard identified,
and the means of control consistently and effectively used. The public
health effects of microbial hazards are most often acute, although
long-term, chronic effects have been identified (e.g., arthritis).
Chemical hazards are most often associated with chronic adverse health
affects, although they may also have immediate, acute affects (e.g.,
excess tin leaching from container lining can cause vomiting). Physical
hazards cause acute health affects, such as cuts in the mouth from
glass or metal fragments in the food. These hazards are discussed in
more detail below.
Microbial hazards--There is a long history of foodborne illness
outbreaks associated with microbial contamination of a variety of
juices. The public health consequences may be minimal (some
gastrointestinal distress), severe (hospitalization, HUS), or fatal.
Among the pathogens that have been associated with juices are E. coli
O157:H7, Salmonella, Cryptosporidium, and certain viruses. Identified
sources of pathogens include water, fruit, processing under insanitary
conditions, and infected workers and food handlers.
Juices, particularly fruit juices, have traditionally not been
considered vehicles for human pathogens. Fruit juices, in particular,
are acidic, and such acidity generally would inhibit the growth of most
pathogens. Over the past few decades, however, it has become well
documented that some pathogens have adapted to this acidic environment,
making juices susceptible to microbial contamination and subsequent
survival of the pathogens in the juice products.
Regarding the comment that pasteurized juices should not be subject
to HACCP, is without foundation because ``pasteurized'' products may
potentially contain chemical or physical hazards. HACCP systems control
all types of food hazards, not just the microbial hazards that adequate
heat treatments will control. In recognition of the lethality of the
heat treatment that shelf stable and concentrated juice products
receive, FDA has modified the pathogen control requirements in
Sec. 120.24 for these product groups. This modification to the proposed
rule is discussed in detail in the response to comment 140.
Chemical hazards--There is also a history of foodborne illness
outbreaks caused by a variety of chemical hazards in foods. These
hazards include the presence of tin, lead, and poisonous plant
materials. FDA recall data show that additional types of chemical
substances with the potential to cause illness or injury have triggered
recalls of products from the market (e.g., food ingredients that cause
allergic-type reactions such as FD&C Yellow No. 5), cleaning solutions,
copper from copper pipe fittings on processing equipment. Symptoms of
reported juice outbreaks usually are limited to acute gastrointestinal
effects. Chronic effects of chemical contaminants are difficult to
assess because long-term monitoring of the health of individuals that
experience illness or injury caused by chemical hazards is required and
there are no data indicating that this type of monitoring occurs. Some
chemical hazards, such as patulin, have known chronic effects of
sufficient public health concern that FDA is in the process of issuing
guidance documents concerning maximum levels that should be present in
foods (Refs. 19 and 24).
Sources of chemical contaminants in juices include packaging
materials, plant (botanical) material, processing and cleaning
equipment, formulation errors, contaminated ingredients, and
contaminated fruit (e.g., patulin in apples). Unlike microbial
contaminants, chemical contaminants cannot be destroyed or easily
removed from contaminated foods, and thus, appropriate controls must be
established to prevent the contamination in the first instance.
Physical hazards--FDA recall data indicate that glass and fragments
of other packaging materials frequently cause companies to recall juice
products. However, the agency has no data on illnesses or injuries
caused by those packaging materials.
(Comment 77) One comment stated that United States vs. Nova Scotia
Foods Products Corporation cannot be read to authorize HACCP controls.
The comment maintained that this case cannot be said to support FDA's
proposal to impose a complex and detailed regulatory scheme on
pasteurized products. Additionally, the comment stated that since FDA
cannot demonstrate a need or legal justification for HACCP for
pasteurized products, its authority to require recordkeeping and record
inspection under such a HACCP program has no statutory basis.
In the response to comment 74, the agency has explained at some
length the basis for its reliance on United States v. Nova Scotia
Foods, 417 F.S. 1364, 1368-69 (E.D.N.Y. 1976), aff'd supra, 568 F.2d
240. Similarly, in the response to comment 75, FDA has explained at
length the legal basis for the recordkeeping and records access
provisions of this final rule. In sum, both the rule itself and the
recordkeeping provisions are clearly authorized by the act and the PHS
Act.
G. Corrective Actions
FDA proposed to require in Sec. 120.10 that processors take
appropriate corrective actions whenever a deviation from a critical
limit occurs. All corrective actions must be fully documented in
records and are subject to verification under Sec. 120.11(a)(iv)(B).
(Comment 78) One comment requested that FDA revise
Sec. 120.10(a)(1)
[[Page 6161]]
and (b)(3) to remove the wording ``otherwise adulterated'' because it
broadens the scope of the rule beyond food safety and the focus of
HACCP should be on food safety. The comment further stated that
adulteration is covered in part 110 and should not also be covered in
part 120.
The agency disagrees that the requested revisions are necessary.
HACCP plans only address food hazards that are reasonably likely to
occur. Under Sec. 120.3(g) a ``food hazard'' is defined as ``any
biological, chemical, or physical agent that is reasonably likely to
cause illness or injury in the absence of its control.'' Thus, a HACCP
plan is already focused on food safety. FDA also disagrees that
adulteration is addressed exclusively by part 110. In fact, the legal
basis for this final rule is, in part an adulteration provision,
402(a)(4) of the act and juice not processed under conditions not
complying with this final rule is adulterated (see Sec. 120.9).
(Comment 79) A few comments suggested that in Sec. 120.10(b)(5)
the words ``timely validation'' probably should be ``timely
verification'' or ``timely review'' and that in Sec. 120.13(a)(3) the
term ``verifying'' should be used in place of ``validating'' to be
consistent with NACMCF's HACCP guidelines.
The agency agrees with the comments. When there is a process
deviation, processors must undertake a review to see if there have been
sufficient changes such that a revalidation of the HACCP plan is
warranted. The fact that processors have discovered a deviation
indicates that the HACCP plan is working. Therefore, FDA is modifying
Sec. 120.10(b)(5) to use the term ``timely verification'' and
Sec. 120.13(a)(3) to use the term ``verifying.'' As noted previously,
the agency is defining the terms ``validation'' and ``verification,''
in Sec. 120.3(p) and (q), respectively.
H. Verification and Validation
(Comment 80) One comment requested that FDA not require a review
of consumer complaints in the HACCP program. The comment maintained
that review of consumer complaints is untimely because the product has
already been processed and reached the consumer. Additionally, the
comment stated that consumer complaints, or lack thereof, cannot attest
to the effectiveness of a process. Another comment suggested that it
should be up to the management to determine which consumer complaints
need followup in relation to HACCP compliance. One comment stated that
only consumer complaints that indicate a deviation should be held for
HACCP review.
The agency disagrees that processors should not review consumer
complaints as part of their HACCP programs. The agency recognizes that
review of consumer complaints is of limited use as a preventive tool
because the consumer making the complaint already has the product.
However, such review may alert the processor to a problem that, if
resolved, would prevent recurrence of the problem with other consumers.
The agency also recognizes that the receipt or absence of complaints
does not alone attest to the adequacy of a HACCP system. However, it is
FDA's experience that consumer injury or illness complaints can
identify problems traceable to inadequate controls at the food
processing facility (Ref. 61). Where information that has potential
relevance to food safety is available to a processor as a result of its
own consumer complaint system, it is entirely appropriate for the
processor to consider that information in assessing the adequacy of its
HACCP program. FDA concludes, therefore, that processors should
evaluate, as part of their HACCP verification procedures, the consumer
complaints that they receive to determine whether the complaints relate
to the adequate performance of control measures or reveal unidentified
hazards.
FDA agrees that it is up to management to determine which consumer
complaints need followup in relation to HACCP compliance as part of its
verification procedures. This final rule does not require that
processors hold consumer complaints for HACCP record review, except as
the processor deems necessary as documentation of verification
procedures.
(Comment 81) One comment requested that FDA revise
Sec. 120.11(a)(1)(iii) by adding at the end of the sentence ``where
these are other than standard operating procedures or CCP's'' to
clarify that testing required under standard operating procedures or
CCP's is not optional.
The agency disagrees that the requested revision of
Sec. 120.11(a)(1)(iii) is appropriate. The requested revision would
make the testing mandatory as part of verification activities for SOP's
and CCP's. This was not the intent of the provision. In the preamble to
the proposal, the agency acknowledged the shortcomings of end-product
testing as a process control, especially microbiological testing, but
encouraged inclusion of testing in HACCP systems where it is
appropriate. SOP's and CCP monitoring requirements do not necessarily
need to be end-product or in-process tested, except where FDA is
requiring end-product testing. Monitoring could consist of ensuring
that the product was processed within time/temperature parameters or
time/sanitizer concentration parameters. Therefore, FDA is not making
the requested modification.
(Comment 82) One comment suggested that verification should
include actual times and temperatures taken and recorded and that there
should be penalties for noncompliance.
The agency agrees with the comment. Verification activities include
timely review of monitoring records in accordance with
Sec. 120.11(a)(1)(iv). Monitoring records must include actual
measurements (e.g., times and temperatures) in accordance with
Sec. 120.8(b)(7), except as exempted by Sec. 120.24. Consequently,
verification must include checking the actual measurements that are
recorded in the monitoring records. As proposed, the rule has an
enforcement mechanism. Specifically, under Sec. 120.9, failure of a
juice processor to have and to implement a HACCP system in accordance
with part 120 will render the juice products of that processor
adulterated under section 402(a)(4) of the act. Penalties for
noncompliance are FDA refusing entry to imported products and
instituting legal actions such as seizure, multiple seizures, or
injunction, against unlawful products or their producers.
(Comment 83) One comment maintained that weekly review of
production records is inadequate and suggested that records be reviewed
before each batch of product leaves the plant.
FDA disagrees with the comment. The agency stated in the proposed
rule that weekly review of HACCP monitoring and corrective action
records would provide the industry with the necessary flexibility to
move a highly perishable commodity like fresh juice through processing
and distribution without interruption, while still facilitating timely
feedback of information. FDA notes that the comment provided no
information to demonstrate that weekly review of records is inadequate.
In fact, weekly record review will quickly indicate whether the HACCP
system is out of control on a regular basis, which is a sign that the
system is not adequate to assure safety and that revalidation of the
system is required. Thus, the agency concludes that weekly review of
monitoring and corrective action records is adequate for verification
purposes. FDA notes that the requirement for weekly review does not
preclude a processor from reviewing
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production records on a more frequent basis if the processor wishes to
do so.
(Comment 84) One comment suggested that FDA revise
Sec. 120.11(a)(1)(iv)(A) to provide for values that are outside
critical limits and for which corrective actions are taken (covered in
Sec. 120.11(a)(1)(iv)(B)).
The agency disagrees that the requested revision of
Sec. 120.11(a)(1)(iv)(A) is necessary because under
Sec. 120.11(a)(1)(iv)(B) processors must review records to ensure that
the records are complete and to verify that appropriate corrective
actions were taken. Therefore, FDA is not making the requested
modification.
(Comment 85) Several comments pointed out that the proposed annual
validation requirement in Sec. 120.11(b) is not consistent with NACMCF
HACCP guidelines. The comments requested that, instead, FDA require
validation whenever there are significant process changes or equipment/
system failures.
The agency is not persuaded that it should modify the requirement
for annual validation. Section 120.11(b) is consistent with the NACMCF
HACCP guidelines in that processors must validate their process as
needed (Ref. 17). The NACMCF provided as examples whenever there is an
unexplained system failure; a significant product, process or packaging
change occurs; or new hazards are recognized. FDA has simply defined
``as needed'' as at least annually or whenever any changes in the
process occur that could affect the hazard analysis or alter the HACCP
plan in any way. Therefore, FDA is not modifying Sec. 120.11(b) as the
comments requested.
(Comment 86) One comment requested that FDA not require a
processor to validate the HACCP plan any time changes occur in the
prerequisite programs. The comment requested that FDA revise
Sec. 120.11(b) to delete this requirement.
The agency agrees with the comment. It is rare that a change in
SSOP's will make the HACCP plan ineffective. Validation is not a paper
exercise and may be time consuming and expensive. Therefore, FDA is
modifying Sec. 120.11(b) to delete the proposed requirement. FDA notes
that the final rule requires revalidation when there is any change in
the process, including a change in the SSOP's, that decreases the
effectiveness of the HACCP plan.
(Comment 87) One comment expressed concern that the proposed
validation requirements would have the effect of locking producers into
one supplier and that this would stop product development and
innovation.
The agency does not agree with the comment. All food processors
must take safety considerations into account when contemplating changes
in their processes, regardless of whether they are operating under a
HACCP system. The agency recognizes that validation could be costly if
frequent changes are made in the process that could affect the hazard
analysis or alter the HACCP plan and, thus, processors may be reluctant
to make changes, even if the changes have the potential to improve the
process or the safety of the final product. A change in the supplier of
raw ingredients may be a change requiring revalidation. However, a
prudent processor will check new suppliers before making any changes to
determine that the supplier will not be a source of any safety
concerns. Because HACCP systems need to be revalidated only when
changes in the process occur that could affect the hazard analysis or
alter the HACCP plan in any way, not every change will require
revalidation. Similarly, because a hazard analysis needs to be
revalidated only when there are process changes that could reasonably
be expected to affect whether a food hazard exists, not every process
change will require revalidation of the hazard analysis. Therefore, FDA
concludes that the requirements of Sec. 120.11(b) and (c) are important
for the public safety and will have minimum impact on conscientious
processors.
I. Records
The agency proposed that processors maintain records documenting
their HACCP system. FDA also proposed general record requirements, and
other provisions or requirements dealing with documentation, record
retention, official review, public disclosure, and records maintained
on computers.
(Comment 88) One comment was concerned that the agency was trying
to get access to processors' CGMP records under Sec. 120.12(a)(1) and
that this could be a disincentive for companies to keep thorough
records.
The agency disagrees with the comment. Section 120.12(a)(1)
requires that processors maintain records documenting the
implementation of the SSOP's in Sec. 120.6. SSOP'S are select CGMP
sanitation requirements that the agency believes are so important to
the effective implementation of HACCP that they require separate,
specific provisions. The agency believes that the sanitation controls
in Sec. 120.6 are of significant importance to the proper
implementation of HACCP because sanitation controls, such as controls
preventing contamination from pests, have a direct impact on the
presence or absence of pathogens during processing, which in turn,
directly affects the effectiveness of the HACCP plan. Access to
specific SSOP records is important to investigators making reasonable
judgements about whether the HACCP plan is working properly.
Accordingly, the final rule requires that SSOP records must be
maintained and made available during inspections. However, the agency
has no intention of requiring, and processors need not make available
to FDA, any other CGMP-related records.
(Comment 89) One comment recommended that the agency delete from
the regulation any reference to records for end-product or in-process
testing. The comment stated that individual processors would keep
testing records for FDA review only if it is part of the verification
of their HACCP plan.
The agency disagrees that any modification of the regulation is
necessary and is not making the requested change. The regulation only
requires that end-product or in-process testing records associated with
verification of the HACCP plan be available for FDA review and thus, is
consistent with the comment. As discussed in section III.L.6, the
agency is establishing periodic end-product testing requirements for
purposes of process verification of citrus juices that use fruit
surface treatment to achieve the 5-log reduction in the pertinent
pathogen; processors are required to provide FDA with access to these
records.
(Comment 90) One comment stated that a processor with only one
location should not have to provide its location on all records, as
required in Sec. 120.12(b)(1).
The agency agrees with the comment and is modifying
Sec. 120.12(b)(1) to read as follows: ``The name of the processor or
importer and the location of the processor or importer, if the
processor or importer has more than one location.''
(Comment 91) Two comments stated that date and time may not be
necessary on all records. One comment contended that the date and time
are only important on monitoring and corrective action records and,
therefore, should only be required on these records.
The agency believes that the date of the activity is important on
all HACCP records. The date allows the processor and the FDA
investigator to assess whether the record is current, to identify when
any deviation occurred, and to track corrective actions. However, the
time of an activity is not necessary on records other than
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monitoring and corrective action records (i.e., it is not necessary on
the hazard analysis or HACCP plan). Therefore, the agency is modifying
Sec. 120.12(b)(2) to state that the time of the activity need not be
included on records required under Sec. 120.12(a)(2), (a)(3), and
(a)(5).
(Comment 92) One comment suggested that there is no need for the
hazard analysis to be signed unless there is no HACCP plan because the
hazard analysis did not indicate the need for a HACCP plan.
FDA disagrees with the comment. The signature of the most
responsible individual onsite at the processing facility or by a higher
level official of the company is important for both the hazard analysis
and the HACCP plan. The signature reflects the fact that management has
reviewed, accepted, and is responsible for the content of the hazard
analysis and any resulting plan. Therefore, the agency concludes that
both the hazard analysis and any resulting HACCP plan must be signed.
(Comment 93) One comment suggested that the final rule should
allow initialing of records instead of a signature, as is done with low
acid canned foods.
The agency disagrees with the comment. The food canning
establishment registration and the food process filing form for low
acid canned foods both require the signature of an authorized
individual. Other low acid canned food records must be signed or
initialed (Sec. 113.100). Part 120 has similar requirements for juice
product records. Section 120.12(b)(3) states that all records shall
include the signature or initials of the person performing the
operation or creating the record. However, given their centrality in a
HACCP program, it is important that the hazard analysis and the HACCP
plan be reviewed and authorized by the most responsible individual
onsite at the processing facility or by a higher level official of the
processor so as to signify that management of the firm is aware of and
has accepted these records (Sec. 120.12(c)). Therefore, the agency is
not modifying part 120 to permit the initialing of the hazard analysis
and the HACCP plan.
(Comment 94) One comment argued that consumer complaints often
involve quality issues and are primarily handled at headquarters
facilities, not processing plants. Therefore, the comment stated that
consumer complaint records should not be part of HACCP recordkeeping
requirements.
The agency points out that consumer complaint records are not
required to be maintained or access given to them under part 120.
Processors are required to review consumer complaints as a part of
their verification procedures (Sec. 120.11(a)(1)(i)) to determine
whether complaints relate to the performance of the HACCP plan or to
reveal previously unidentified hazards. Processors may choose to
include consumer complaints in their HACCP records to document
verification of the HACCP system, but it is not required.
(Comment 95) One comment stated that the period that records must
be held is out of line with product shelf life because fresh juice only
lasts 14 days. The comment suggested that records could be kept for 3
months rather than 1 to 2 years.
FDA disagrees with the comment. Some problems, such as trends in
the frequency of process deviations, may not be easily recognized in a
``snapshot'' record review. By reviewing records covering a longer
period of time, a processor may be able to identify certain process
deviations. Moreover, while it may be true that most fresh products
will be unusable within 3 months, some products are processed for
longer shelf-life (such as flash pasteurized, refrigerated juices), and
retention times of less than 1 year do not provide for sufficient
information for the processor's or FDA's verification activities. (See
Sec. 120.11(b).) Therefore, FDA has made no changes to
Sec. 120.12(d)(1).
(Comment 96) One comment requested that FDA revise
Sec. 120.12(d)(1) to read ``Subject to part Sec. 120.14, all records
required by this part * * *,'' because there are other importer
requirements for recordkeeping outlined in Sec. 120.14.
The agency disagrees with the comment. Section 120.12(d)(1)
requires both processors and importers to retain all records required
by part 120. Under Sec. 120.12(d)(1), importers must retain the records
required under Sec. 120.14 at the importer's place of business in the
United States. Therefore, the agency concludes that the modification is
not necessary.
(Comment 97) One comment noted that proposed Sec. 120.12(d)(2)
requires processors to maintain records related to the adequacy of
equipment or processes. The comment stated that if equipment is old or
modifications have been made to it, firms may have trouble getting a
letter to that effect from the manufacturer. Therefore, the comment
stated, scientific studies will have to be performed to determine
adequacy, which will be costly, especially for small processors. The
comment stated that the requirement is not consistent with parts 113
and 114. It stated that a written communication summarizing
requirements to achieve an adequate process would be adequate.
FDA has reevaluated the provision in Sec. 120.12(d)(2) and
concludes that it does not afford any additional significant protection
to consumers and may add unnecessary burdens for processors. Therefore,
the agency is deleting Sec. 120.12(d)(2) and recodifying paragraphs
Sec. 120.12(d)(3) and (d)(4) as Sec. 120.12(d)(2) and (d)(3),
respectively.
(Comment 98) One comment suggested that FDA restrict recordkeeping
requirements to records produced at the manufacturing facility. The
comment stated that data used to establish processes should be
maintained by the individual or organization that developed the record,
not by the processing plant.
FDA disagrees with the comment. It is vital that each processing
plant maintain or have access to all records required under part 120,
that pertain to products produced by that plant for purposes of both
processor review and FDA inspections. The agency has made provision for
offsite storage of records, to the extent feasible, to reduce plant
storage burden. Specifically, under Sec. 120.12(d)(2), electronic
records are considered to be onsite if they are accessible from an
onsite location and comply with Sec. 120.12(g). In addition, under
Sec. 120.12(d)(2), offsite storage is allowed for certain monitoring
records after 6 months following the date that the monitoring occurred
as long as the records can be retrieved and provided onsite within 24
hours. Finally, under Sec. 120.12(d)(3), seasonal processors may store
records at a reasonably accessible location at the end of the seasonal
pack.
Records (such as the hazard analysis, HACCP plans, and
verification, including validation, records for products processed in
the plant) are needed by both the processor and FDA to determine
whether the HACCP system or systems are properly implemented and
effective. HACCP systems and associated records may be tailored to each
specific processing facility and for different products processed in
the facility. Therefore, the agency concludes that all records required
by part 120 must be retained at the processing facility to which they
relate (or reasonably accessible when offsite storage is permitted) or
at the importer's place of business in the United States. As discussed
in previous comments, FDA recognizes that processors may review
information (e.g., consumer complaints) to develop/evaluate their
systems that is not required to be maintained and to which processors
are not required to grant FDA
[[Page 6164]]
access. Processors may maintain this information at any location that
is convenient for the processor.
(Comment 99) One comment pointed out an inconsistency between the
preamble to the proposed rule that stated that after 6 months the SSOP
and HACCP monitoring and corrective action records could be stored
offsite, and the codified language in proposed Sec. 120.12(d)(3) that
refers to the storage of SSOP records and the HACCP plan offsite.
FDA agrees that the proposal's preamble and codified were
inconsistent. The agency realizes that some juice processors may be
required to store records that could require a great deal of space
(e.g., the SSOP and HACCP monitoring and corrective action records) and
that there may not be adequate storage space in the processing facility
for all of these records. However, because of their direct relevance to
ensuring safe processing operations at a facility, FDA has concluded
that records dealing with the HACCP plan must remain on site for at
least 6 months. After that period, such records may be stored off-site
if they can be retrieved and returned on-site to the plant within 24
hours so that plant managers and FDA investigators have ready access to
the records for use in evaluating the effectiveness of the HACCP plan.
Therefore, FDA is modifying Sec. 120.12(d)(2) to refer to paragraphs
(a)(1) and (a)(4) instead of (a)(1) and (a)(3).
(Comment 100) One comment requested that FDA delete Sec. 120.12(e)
because the agency does not have the statutory authority to see
consumer complaints.
The agency advises that consumer complaints are not required
records under Sec. 120.12(a) and the rule does not seek to require that
FDA be given access to such records. Thus, the agency concludes that no
action is necessary in response to this comment.
(Comment 101) Several comments expressed concern about the
confidentiality of records associated with an abandoned process. They
stated that a manufacturer's processing methods are often considered
trade secret even for products that have been abandoned. The comments
suggested that the agency make provisions for this in the final rule
and handle abandoned product records in the same manner as existing
product information. One comment added that current process lines may
use technology similar to that used for an abandoned product and that
abandoned products may be brought back into production.
The agency advises that the agency intended that proposed
Sec. 120.12(f) not permit public disclosure of processing records
except where they have been previously disclosed to the public or where
they relate to an abandoned product or ingredient and are no longer
trade secret or confidential commercial or financial information. FDA
acknowledges that the proposal was less than clear as to the status of
an abandoned product process. To clarify the final rule, FDA is
striking the work ``thus'' from Sec. 120.12(f) so that the trade secret
status of a product process may be maintained by the processor and the
information not necessarily subject to public disclosure even though
the particular product has been abandoned. The public availability of
such information will be evaluated by FDA on a case-by-case basis.
(Comment 102) Several comments requested that HACCP documents in
FDA's possession not be made available under the Freedom of Information
Act (FOIA).
FOIA provides consumers and others with the opportunity to obtain
records in the possession of Federal agencies, including FDA, upon
request. There are, however, some restrictions on the types of records
available under FOIA. For example, confidential commercial information
and trade secrets are exempt from disclosure 5 U.S.C. 552(b)(4). The
agency concluded in the seafood HACCP final rule (60 FR 65096 at 65138)
(Ref. 62), that HACCP plans, as a general rule, meet the definition of
trade secret information, and thus, even if these plans are in agency
files, they likely would not be available under FOIA. However, because
FDA is bound by FOIA and the agency's implementing regulation in 21 CFR
part 20, the agency is unable to exclude categorically all HACCP
records in agency files from public disclosure.
J. Training
The agency proposed that only individuals trained in HACCP be
responsible for certain key functions in a HACCP system. The agency is
correcting an error in Sec. 120.13(a)(3), as proposed, so that the
section references Sec. 120.10(b)(5) instead of Sec. 120.10(c)(5)
because there is no paragraph (c)(5).
(Comment 103) Several comments requested that FDA provide training
for the juice industry.
FDA has limited resources to use for training. Therefore, the
agency has no plans at present to provide specific HACCP training for
the juice industry. However, the agency is interested in cooperating
with States and the industry in the development of training programs.
FDA worked with the Seafood Alliance to develop a seafood HACCP
curriculum and training courses. A similar cooperative effort would be
very beneficial in juice processing. Also, the agency is in the process
of developing a juice HACCP hazards and controls guide, which will
assist juice processors in the development of their HACCP systems.
(Comment 104) One comment questioned whether the agency will
acknowledge the equivalency of juice HACCP training, as mentioned in
Sec. 120.13(b), offered by other parties (such as a trade association
or academic institution) as it did for seafood HACCP. The comment asked
how and who would determine training adequacy. Another comment
suggested that equivalency of training programs would be better dealt
with by establishing training objectives, such as the system used in
meat and poultry HACCP, rather than specific materials and curricula.
FDA believes that the development of seafood HACCP training,
through the Seafood Alliance, was beneficial for all parties. A basic
curriculum was developed, which the agency reviewed, that was available
for the industry's use. The agency has encouraged trainers to evaluate
their courses against the materials developed by the Alliance and to
make modifications necessary to ensure that programs were consistent
with and provided at least an equivalent level of instruction to the
Alliance course. FDA is very interested in cooperating with all
interested parties, including academia, consumer groups, and the juice
industry, to develop training programs that incorporate the most
appropriate objectives and materials. FDA will acknowledge the
equivalency of training in the same manner as is done for seafood
HACCP.
(Comment 105) One comment argued that criteria for adequate HACCP
training should be left up to the States to determine, but did not
provide any support for this opinion. The comment also asked that FDA
provide States with guidance and funding to carry out HACCP training
for existing State personnel and to certify HACCP specialists.
The agency currently intends to provide training to States, through
contracts and State partnerships. The agency recognizes that the
effectiveness of juice HACCP hinges on consistent implementation and
regulation throughout the United States and training, particularly for
investigators, plays an important role in such consistency. As noted
above, FDA is interested in cooperative work with
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States, academia, and industry to develop training programs.
(Comment 106) One comment stated that individual companies should
be permitted to determine when experience can substitute for HACCP
training. Another comment argued that experience can never substitute
for training, although the comment contained no data or other
information to support the claim.
FDA believes that in certain circumstances, appropriate job
experience can be an adequate substitute for formal HACCP training. FDA
is aware that some juice processors have had successful HACCP programs
in place for a long period of time and, as a result, employees working
with those systems have gained a working knowledge about HACCP that is
more than adequate to meet the training requirement. Moreover, FDA's
experience is that other segments of the food industry have HACCP
programs in place and employee experience gained working with those
systems may be transferred successfully to juice processing. It is the
responsibility of processors to determine that their HACCP system is
functioning appropriately and is in compliance with part 120, a
responsibility that includes ensuring that those individuals involved
in designing and implementing the HACCP system are qualified.
(Comment 107) One comment suggested that FDA develop a test to
determine whether particular job experience can substitute for HACCP
training. The comment asked if FDA is developing such a test.
FDA has no plans to develop a test to determine whether job
experience can substitute for HACCP training. Job experience that is
equivalent to training gained under an adequate standardized HACCP
curriculum is certainly one way that individuals may gain the training
required in Sec. 120.13(a). However, as noted, it is the responsibility
of individual companies to ensure that qualified individuals conduct
the hazard analysis and develop the HACCP plan, whether such individual
is qualified through training or job experience.
K. Application of Requirements to Imported Products
The agency proposed in Sec. 120.14 specific requirements for
importers of juice products because FDA typically does not inspect
foreign food establishments. Under Sec. 120.14 of the proposed rule,
importers of juice either must ensure that all juice offered for entry
into the United States has been processed in compliance with part 120
or import such juice from a country that has an appropriate memorandum
of understanding (MOU) with the United States. In addition, importers
must maintain records that document the performance and results of the
affirmative steps taken to demonstrate compliance with Sec. 120.14.
(Comment 108) Several comments contended that the juice HACCP
regulation should not apply to imports. However, other comments
disagreed. A few comments suggested that only imported fresh juice be
covered, not juices that have been documented to have been thermally
processed to meet the 5-log performance standard.
The agency advises that this final rule will cover all imported and
domestic fresh or processed juices. First, under the act, all products
in interstate commerce, whether imported or domestic, must adhere to
the same standards. Moreover, imported juices may have many of the same
potential food hazards as domestic products. FDA discussed outbreaks
associated with imported juices in the proposed rule (63 FR 20450 at
20450) (Ref. 2), and some of the recent outbreaks discussed in response
to comment 26 were associated with imported juice (Refs. 46 and 47). In
addition, imported juices may contain food hazards not normally
associated with domestic products. The differences in the types of food
hazards may be the function of a number of factors, including
differences in processing systems and sources of raw ingredients. The
fact that HACCP is based on prevention of specific hazards makes it
applicable, in general, to food processing wherever the processing
occurs. Therefore, the agency agrees with those comments that stated
that the rule must apply equally to imported and domestic juice
products, because the potential risks are the comparable. The safety of
juice must be ensured regardless of where it is produced.
(Comment 109) One comment suggested that FDA clarify the reference
to ``imported food'' in the introductory sentence of Sec. 120.14 to
identify that juice is the specifically covered product.
The agency agrees with this suggestion and has revised the
introductory sentence of Sec. 120.14 by replacing the word ``food''
with the word ``juice.''
L. Process Controls
1. Performance Standard
The agency proposed to require that juice processors, except those
that are subject to part 113 or part 114, include in their HACCP plans
control measures that will produce at least a 5-log (10\5\) reduction
in the pertinent microorganism. As proposed, the pertinent
microorganism means the pathogen that is likely to occur in juice and
that is most resistant to the pathogen reduction technology used and,
if it occurs, is likely to be of public health significance. The
proposed reduction must be for a period at least as long as the shelf
life of the product when stored under normal and moderate abuse
conditions.
(Comment 110) Several comments advocated a regulatory scheme of
HACCP without the performance standard proposed by FDA. The comments
argued that a performance standard is not necessary to ensure the
safety of all products (e.g., citrus). Comments stated that requiring a
performance standard negates the strength and function of HACCP and
indicates that FDA does not trust HACCP alone. The comments asserted
that FDA should require either the performance standard or HACCP, but
not both.
The agency disagrees that having the performance standard as an
integral part of HACCP weakens the HACCP system. As NACMCF has pointed
out, the performance standard enhances HACCP by establishing the
appropriate level of health protection that must be achieved (Ref. 25).
The 5-log reduction performance standard assures public health
protection for consumers and assists processors by establishing a
minimum microbial standard for safe juice. Particularly for non-heat
treated juice, the 5-log reduction requirement provides a standard
against which processors can measure the effectiveness of combinations
of HACCP controls. Including a performance standard as part of HACCP
sets a goal for processors without mandating the means by which they
must achieve that goal and also provides a means of determining the
equivalence of alternative strategies for controlling pathogens.
Finally, FDA disagrees with the suggestion that a performance standard
alone will ensure safe juice. As noted previously, there are hazards in
addition to microbial contamination, and a performance standard alone
does not address the chemical and physical hazards that may be present
in juice.
(Comment 111) Many comments stated that the final rule should
identify a safety goal instead of a performance standard and let
industry decide how to meet it.
FDA points out that the performance standard in Sec. 120.24 is a
microbial safety goal and that the final rule allows the industry to
decide how to achieve the safety goal. Elsewhere in this
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preamble, FDA has included guidance on the application of the 5-log
standard, and FDA also intends to issue a juice HACCP hazards and
controls guidance. Both of these forms of guidance are available to the
juice industry to help in deciding how to achieve the safety goal.
Therefore, the agency concludes that no modification is necessary in
response to this comment.
(Comment 112) A few comments suggested that producers who do not
use dropped fruit should be able to use HACCP without a performance
standard. One comment contended that a 5-log reduction is not necessary
when the source of the fruit is known and processors follow CGMP's.
This comment did not provide evidence to persuade FDA that using
tree-picked fruit, along with HACCP, would make the 5-log performance
standard unnecessary. In fact, produce, in general, including tree
picked fruit, may not be pathogen free. Agricultural water, birds,
insects, and harvesters are vectors that can potentially contaminate
produce even though the produce has not come into contact with the
ground. Even if pathogens are present on or in the produce used to make
juice, processors can make safe juice by attaining the 5-log reduction
performance standard.
(Comment 113) Many comments stated that the 5-log performance
standard was not appropriate because processors would have to
pasteurize their juice to meet the standard. A few comments stated that
the 5-log performance standard is unreasonable, counterproductive, and
precludes consideration of harvesting and farming practices that help
ensure safety.
The agency disagrees with the comments. The performance standard in
Sec. 120.24 allows for the use of alternative technologies. The basis
for 5-log is discussed in response to comment 124. As noted in section
III.L.4, application of 5-log must occur where the treatment has direct
contact with any and all pathogens that may be present. For most
juices, this will entail direct treatment of the juice after
extraction. For citrus juice only, the available data and information
show that surface treatments can be used to meet all or part of the
performance standard. In either case, treatments should be applied at a
single location under the processor's control and immediately before
packaging, in order to prevent post-process contamination of the juice.
Although fruit producers and juice manufacturers are encouraged to
follow GAP's, GAP's such as water and manure management are generally
aimed at minimizing the potential for contamination rather than
eliminating pathogens that may be present. Thus, use of GAP's would not
be a substitute for the 5-log reduction treatment.
(Comment 114) A few comments suggested that, in addition to the 5-
log reduction performance standard, producers should be given the
option that Food Safety and Inspection Service (FSIS) gives for
fermented sausage, which is batch testing to determine that the product
contains less than a certain level of pertinent pathogens and then use
a 2-log reduction on the batch tested.
FDA disagrees with the comments' suggestion. Juice is significantly
different from a fermented meat product in that a fermented meat
product is typically inoculated with bacterial cultures as part of the
production process. The growth of the added microorganisms modifies the
food environment so that pathogenic bacteria are inhibited or
inactivated; there is no comparable inoculation and inhibition activity
with juice. Moreover, this process occurs over an extended period of
time (3 to 6 weeks is common), which allows time for test results to be
completed. Juice, especially juice that is minimally processed, must be
processed and consumed within a significantly shorter period than
fermented products and, thus, extensive microbial testing of finished,
processed products is not practical. Therefore, because there is no
counterpart in juice processing to the inhibition or inactivation of
pathogens by an added bacterial culture, the agency concludes that
batch testing to establish that juice contains a minimum level of
pertinent pathogens followed by a 2-log reduction in the pertinent
pathogen is not an appropriate substitute for the 5-log reduction
performance standard.
(Comment 115) Several comments maintained that there are no data
to show that certain combinations of preventive steps are not adequate
to ensure juice safety. One comment argued that a combination of
grading, washing, sanitation, and current extraction techniques are
sufficient to meet the 5-log reduction.
FDA is not prohibiting the use of appropriate cumulative controls
to attain the 5-log reduction for citrus products. However, as
discussed in section III.L.4, FDA has determined that the 5-log
reduction must occur where the treatment has direct contact with all
pathogens, if they are present. Further, cumulative controls must be
completed in a single production facility under the control of the
processor, be effective against the pertinent pathogen, be validated,
and be vigorously implemented to ensure that the full 5-log reduction
is consistently achieved under commercial processing conditions. GAP's
and CGMP's that do not meet these criteria would be in addition to, but
not count as part of, the 5-log reduction. The agency notes that it is
the responsibility of the processor to demonstrate that combinations of
preventive steps are adequate to achieve the 5-log pathogen reduction
standard.
(Comment 116) A few comments expressed concern that no attention
was being given to preventing the presence of pathogens in juice.
Prevention of pathogens in juice is the reason HACCP was proposed
and is being finalized. The agency has always taken the position that
food safety is enhanced by the use of the highest quality incoming
materials. The agency strongly encourages growers to implement
preventive controls and has issued GAP guidance to assist growers in
the production of safe produce that is not contaminated. FDA is issuing
part 120 to assist processors in establishing preventive controls.
Specifically, Sec. 120.7(b) provides that the hazard analysis shall
include hazards that can be introduced both within and outside the
processing plant environment, including hazards that can occur before,
during, and after harvest. In addition, Sec. 120.7(d) requires that
processors evaluate product ingredients to determine their potential
effect on the safety of the finished food.
(Comment 117) One comment requested that FDA explain how the
performance standard applies to each different juice (apple, citrus,
vegetable, and blends).
FDA advises that the performance standard in Sec. 120.24 applies to
all juice, including blends of more than one type of juice. Processes
for attaining a 5-log reduction will vary significantly depending on
the target pathogen and the type of juice produced. Therefore, it is up
to each processor to determine how best to apply the performance
standard to its process. FDA intends to develop a juice HACCP hazards
and controls guidance for juice that will provide processors
information on the application of the performance standard in addition
to that provided in this final rule. The scientific literature is
another source of information for processors on recent developments to
attain the 5-log reduction for various types of fruits and vegetable
juices. Guidance documents from State agencies may also provide
information.
(Comment 118) One comment suggested that all processors should be
required to meet the chosen performance standard the same way.
[[Page 6167]]
The agency disagrees with the comment. FDA specifically chose not
to mandate that processors use a particular method to meet the
performance standard in order to provide flexibility and to encourage
innovation. Different methods that have been validated to meet the 5-
log reduction standard can be effective in controlling pathogens to the
appropriate level, which is the goal of the performance standard.
Mandating a specific technology for processors to use would eliminate
the incentive for processors to develop new and possibly improved
alternative methods. FDA does not want to limit innovative approaches
to achieving food safety or the flexibility for processors to choose
the most appropriate method for a particular operation.
(Comment 119) Some comments requested a zero tolerance for E. coli
O157:H7 in juice. One comment was concerned that the NACMCF may have
recommended a higher threshold of risk than consumers would consider
acceptable. It stated that there is no acceptable level of risk with
regards to E. coli O157:H7 because it is so virulent that a single
organism could be deadly. The comment sought scientific evidence that
the 5-log performance standard will truly kill these organisms, as
opposed to represent a reasonable number of organisms killed.
The agency disagrees with the comments. FDA notes that no food
processing method can be shown scientifically to achieve a ``zero''
level for a pathogen or any other contaminant potentially present in
the processed food due to the detection limits of the relevant
analytical methods. For example, the methods used to detect E. coli in
juice in several State surveys had a detection limit of 1 cell per
3.33 milliliter (mL) juice. Thus, a negative result does not
necessarily mean that the microorganism is not present, just that it is
not present at detectable levels. Furthermore, if pathogens are not
distributed homogeneously throughout a product, they may be present in
the product but not in the sample tested. Conversely, food processing
methods can be shown scientifically to reduce, by mathematical
increments (i.e., by ``logs''), the level of pathogens that may be
present in juice and, as a result, to reduce the risk of illness from
juice. FDA has received no comments to undermine the assumption based
on the NACMCF recommendation that the 5-log performance standard will
adequately protect consumers from E. coli O157:H7 and other pathogens.
(Comment 120) One comment contended that a 5-log performance
standard is unenforceable and that FDA should set pathogen reduction
goals similar to those established for meat and poultry.
FDA disagrees that the 5-log performance standard is unenforceable.
The reasons FDA did not set a zero tolerance for pathogens, as was done
for certain pathogens in meat and poultry, already have been discussed
in the response to comment 114. By virtue of the requirements of part
120, FDA believes that the performance standard is enforceable. That
is, as part of their HACCP plan, processors must have a validated
procedure for achieving a 5-log reduction in the pertinent pathogen for
their process and also must have documentation to demonstrate to FDA
that the standard is being achieved. Processors who cannot meet these
requirements will not be in compliance with part 120 and thus, will be
subject to regulatory action.
(Comment 121) A few comments suggested that FDA use ``safe
harbor'' guidelines rather than require the 5-log reduction to ensure
juice safety.
The comment did not define the term ``safe harbor.'' FDA assumes,
however, that by ``safe harbor'', the comment means that FDA would
provide guidance, such as times and temperatures for thermal
treatments, that, if complied with, would be deemed to achieve the 5-
log reduction, thus providing a basis to conclude that the processor is
in compliance with Sec. 120.24. FDA is currently working with industry
to develop guidance on how to achieve the 5-log reduction, and has
already met with the apple industry and citrus juice industry to
discuss technological options for achieving the performance standard.
Although the agency is developing guidance to assist processors in
achieving the 5-log reduction, FDA does not intend such guidance to
provide a ``safe harbor''. Thus, juice processors will not be absolved
from adopting HACCP and demonstrating through validation and
verification that they have met the performance standard.
(Comment 122) One comment noted the statement in the agency's PRIA
statement (63 FR 24254 at 24264) (Ref. 6) that other methods of meeting
the performance standard may not be as effective as pasteurization or
prevent as much illness seems to indicate an agency lack of confidence
in methods other than pasteurization.
FDA disagrees with the interpretation of the PRIA statement. The
statement referenced from the PRIA reads ``To the extent that
processors adopt controls for these hazards other than flash
pasteurization which are less effective, the percentage of cases
prevented may be smaller than those estimated here.'' The benefits of
the rule with regard to illness prevention were developed based on the
amount of illness that would be prevented if all juices were
pasteurized because, at the time the proposal was published,
pasteurization was the primary effective, commercially implemented
method for controlling pathogens in juice that had been validated to
meet the performance standard. Since the publication of the proposal,
it has become evident that there may be methods other than
pasteurization, some of which may require FDA approval for their use,
that could be used to treat juice (e.g., use of UV irradiation, high
pressure). While it is true that pasteurization treatments
significantly exceed the 5-log pathogen reduction performance standard,
the statement in the PRIA was not intended to imply that methods other
than pasteurization are not effective at preventing illness or that
these other methods cannot meet the 5-log reduction performance
standard.
(Comment 123) One comment noted that pasteurization would add a
complicated and unnecessary step to cider production that will take
time and require documentation.
FDA is not requiring in this rulemaking that juice be pasteurized.
This rulemaking requires that juice be processed under a HACCP system
that contains a control or controls that have been validated to achieve
a 5-log reduction in the target pathogen. A juice processor may choose
to meet the 5-log reduction requirement by pasteurizing product or by
any other validated means. Although pasteurization is the primary
option available for cider at this time, this final rule does not
preclude the development or use of alternative technologies to achieve
a 5-log reduction. For example, FDA recently amended the food additive
regulations to provide for the safe use of ultraviolet (UV) irradiation
to reduce human pathogens and other microorganisms in juice products
(65 FR 71056, November 29, 2000) (Ref. 75). Importantly, however, the
processor chooses to meet the 5-log reduction requirement, the process
utilized by the processor must be validated and verified as achieving a
5-log reduction in the pertinent microorganism. The risks associated
with consumption of cider and other juices are well established (see 63
FR 20450 (Ref. 2) and section II.C of this final rule) and justify
regulatory requirements that processors establish controls for
pathogens and the other hazards associated with juice.
[[Page 6168]]
2. Magnitude of Reduction
(Comment 124) Many comments questioned the scientific basis for
the
5-log reduction performance standard. A few comments contended that it
was too stringent based on actual numbers of ubiquitous coliform
bacteria found in cider in State surveys. In support, a survey
submitted as part of a comment questioning the basis of a 5-log
reduction standard showed that samples of apples in cider mills in
Maryland contained an average of only 3-logs of ubiquitous coliform
bacteria and no generic E. coli or E. coli O157:H7. Some comments
asserted that a 5-log performance standard is premature considering
that the source of E. coli O157:H7 contamination in apple juice is not
known and suggested that FDA adopt a 3-log performance standard until
scientific data are developed to support the need for a 5-log standard.
The comments stated that without data to provide baseline numbers for
contamination of juice, any performance standard selected might be
inappropriately stringent or lax. The comments maintained that the 5-
log standard is particularly excessive if a processor is using CGMP's
and only uses prime fruit.
Conversely, one comment suggested that the 7-log performance
standard used by other high risk food processors would afford more
consumer protection. It suggested that the agency compare the
protection offered by 5, 6, and 7 log performance standards because E.
coli keeps proving to be more resistant to controls than previously
thought and because a 5-log reduction may not be adequate for all
strains of E. coli.
FDA discussed the cider survey results in the response to comment
36. In that discussion, the agency noted the limitations of the
analytical methods and advised that the survey results did in fact
affirm that risk factors such as fecal coliforms, an indicator of the
possible presence of pathogens, are present in cider operations and
could give rise to microbial food safety hazards in the finished juice.
In establishing the 5-log standard, FDA is relying on the advice of
a panel of recognized food safety experts, the NACMCF. In making this
recommendation, the Fresh Produce Working Group of the NACMCF
considered various situations that could occur with juice (Ref. 63).
First, they considered what levels of E. coli might typically occur in
juice and added a standard 100-fold safety margin. The Working Group
then considered a worst case scenario where produce could be
contaminated with bovine feces, a source of E. coli O157:H7. They
determined that a 5-log reduction would both eliminate the E. coli
O157:H7 contamination and provide a safety margin. In addition to the
information factored into determination of the 5-log reduction
performance standard, regulatory precedents were considered. The 5-log
pathogen reduction performance standard is used by FDA for Salmonella
inactivation for in-shell egg pasteurization and by FSIS for
inactivation of E. coli O157:H7 in fermented sausage. The agency has
evaluated the NACMCF advice and concluded that the 5-log performance
standard recommended by the NACMCF is the most appropriate standard to
ensure that juice is safe.
This pathogen reduction performance standard, in combination with
the requirement that measurement of the
5-log reduction begins after cleaning and culling of citrus fruits and,
for all other juices, when the treatment has direct contact with any
pathogens in the juice (discussed in the response to comment 131),
provides adequate public health assurance while minimizing the impact
of treatments on the sensory attributes of the juices (Ref. 64). While
a 3-log reduction could be adequate under certain circumstances, it
does not ensure that juice is safe under all circumstances that may
occur. In contrast, the 5-log reduction performance standard has a
built-in safety factor that provides additional consumer protection.
In light of the comments, FDA has considered a 6- or 7-log
reduction standard and concluded this additional level of reduction is
not necessary to compensate for possible future microbial resistance.
The 5-log reduction refers to numbers of microorganisms, not resistance
of microorganisms. Strains of microorganisms may become more resistant
to heat, acid, sanitizers or other controls over time. Because
microorganisms are capable of developing resistance, it is critical
that juice processors periodically verify and validate their process to
determine the continued effectiveness of the process. If resistance
occurs, processors may need to make appropriate changes in their
process so that their process continues to attain a 5-log reduction in
pathogens. Therefore, the agency concludes that increasing the
performance standard to attain a greater log reduction is not necessary
to compensate for possible future increased resistance of pathogens.
(Comment 125) One comment asserted that a 1000-fold safety factor
is not consistent with other performance standards set by FDA, although
the comment did not reference any specific performance standards. The
comment maintained that a performance standard should be based on
actual levels of pathogens found in or on fruit plus a 1-or 2-log
safety factor.
FDA has concluded that the 5-log performance standard recommended
by the NACMCF is the most appropriate standard to assure that juice is
safe. In the response to comment 124, FDA discussed how the Fresh
Produce Working Group of the NACMCF arrived at the 5-log pathogen
reduction performance standard. This performance standard includes the
customary 100-fold safety factor, not a 1,000-fold safety factor as
asserted by the comment. Therefore, the agency concludes that the 5-log
value is consistent with other performance standards set by FDA and, in
fact, was arrived at using the 100-fold (2 log) safety factor the
comment suggested.
(Comment 126) Several comments stated that 5-log is not an
appropriate performance standard for citrus juice because, in trial
studies, researchers have not been able to inoculate fruit with
sufficient numbers of microorganisms to measure a 5-log reduction. One
comment stated that minimum safety performance criteria should be
established for citrus because the likelihood of contamination in
citrus juices is not high. However, another comment suggested that a 5-
log performance standard would be appropriate for orange juice because
it can be attained without heat and a 3-log performance standard would
be appropriate for apple juice because this may be the maximum
attainable without heat treatment.
FDA proposed the 5-log performance standard based on safety
considerations and on the recommendation of the NACMCF (Ref. 63). As
mentioned in the response to comment 124, while a 3-log reduction could
be adequate under certain circumstances to ensure that juice is safe,
the 5-log performance standard has a 2-log safety factor that offers
additional consumer protection. In addition, the agency found in its
review of performance criteria for other foods, that a 5-log reduction
in pathogens is the standard for product safety in several cases (Ref.
63). Although the target pathogen may differ among juice types and,
thus, change the specific processing parameters (e.g., temperature,
processing time) for attaining a 5-log reduction, FDA maintains that
the 5-log performance standard is appropriate for all juices. The one
area where FDA has data to suggest differences between citrus juice and
other juices is with respect to the
[[Page 6169]]
potential for pathogen infiltration. Specifically, the available data
show that the potential internalization of pathogens in sound, intact
citrus fruit is not likely to present a significant public health risk
(see the response to 132). Thus, for citrus juice only, the agency has
determined that surface treatments may be used to achieve the 5-log
reduction standard. Accordingly, citrus juice processors have an
additional option in how to achieve the performance standard (i.e., 5-
log reduction), but the standard is the same.
FDA also rejects the comment's implicit suggestion that the
performance standard should be based on what is technically feasible.
In order to assure safe food, a performance standard must be based on
safety, not on whether it is attainable using only certain
technologies, such as heat treatment. Presenters at the Florida and
California FDA workshops on the 5-log pathogen reduction (November 12,
1998 and November 19, 1998) and FDA research presented at the December
8 to 10, 1999, NACMCF meeting demonstrated that researchers could and
had inoculated fruit with pathogens to a level that permits measurement
of a 5-log reduction. Therefore, FDA is not persuaded that the
performance standard should be different for different produce used to
make juice.
(Comment 127) Several comments noted that the 5-log performance
standard was chosen by NACMCF and that there was no representative of
the fresh juice industry on the Committee. The comments maintained that
NACMCF may not have considered written comments that were submitted
after the public meeting when making its recommendation.
The NACMCF based its recommendation for a 5-log performance
standard for juice on safety considerations, which included a
scientific evaluation and rationale for a 5-log reduction standard. FDA
reviewed the advice from NACMCF and chose to propose the same standard
for HACCP systems for juice because the agency determined that the 5-
log standard is supported scientifically. The structure of the NACMCF
and the way it functions allow for public comment during the meeting,
which comments the Committee considers in developing its
recommendations. The fresh juice industry presented their views to the
NACMCF during the meeting in question. FDA, on the other hand,
typically announces a period of time during which comments related to
the public NACMCF meeting may be submitted. In reaching its conclusion
to propose a 5-log reduction standard, the agency considered written
comments, including comments submitted after the meeting, on the
appropriateness of the 5-log reduction standard, along with comments
presented at the NACMCF meetings and the NACMCF recommendations.
(Comment 128) A few comments requested that FDA not require small
producers to meet the 5-log performance standard until alternatives to
pasteurization are validated. The comments argued that pasteurization
is too costly for small producers.
The agency understands the small processors' concerns. However, the
5-log reduction is based on safety, and therefore, processors must meet
the standard in Sec. 120.24, in their HACCP systems in order for public
health to be protected. FDA has documented outbreaks that have been
attributed to small processors (Ref. 65). In recognition of the
circumstances of small processors, however, the agency is establishing
staggered compliance dates such that there is an additional 1 year for
small processors and an additional 2 years for very small processors to
comply with the HACCP final rule. Importantly, such processors must use
the label warning statement if they are not processing their product to
achieve the 5-log reduction. FDA believes that this approach does not
substantially compromise safety and at the same time provides
accommodation to small and very small processors. Therefore, the agency
declines to modify the regulation to exempt small producers from the
5-log performance standard.
3. Pertinent Pathogens
(Comment 129) Some comments provided views on the types of
microorganisms that should be considered the pertinent microorganism
for measuring the 5-log reduction. One comment contended that the
chosen target organism must make scientific sense based on their
extremes of pathogenic viability across multiple reduction steps. A few
comments stated that Listeria monocytogenes should not be a target
pathogen for the performance standard because there is no history of
problems with Listeria in juice. However, other comments stated that E.
coli O157:H7 and L. monocytogenes are both appropriate target
pathogens, especially because Listeria contamination is a risk to
pregnant women. One comment also stated that Salmonella is not an
appropriate target microorganism because it is not as acid-resistant as
E. coli O157:H7.
FDA has concluded that target pathogens must be chosen on the basis
of historical association with a product and the way in which the
product is processed. For example, there have been apple juice
outbreaks associated with E. coli O157:H7, Salmonella spp., and
Cryptosporidium parvum. Salmonella species have been associated with
outbreaks from orange juice. The NACMCF recommended the use of E. coli
O157:H7 or Listeria monocytogenes as the target organism, as
appropriate. This recommendation is based on the number of known
outbreaks of E. coli O157:H7 in juice and the ubiquitous nature of L.
monocytogenes. FDA advises that if L. monocytogenes becomes a source of
outbreaks in the future, especially affecting pregnant women, then
processors must consider whether L. monocytogenes should serve as the
pertinent microorganism for their product.
Processors must also consider the manner in which they are
achieving the 5-log reduction and the microbial resistance to the
process. For example, a new technology may be effective in attaining a
5-log reduction of E. coli O157:H7 in apple juice, but may allow the
survival of Cryptosporidium. E. coli O157:H7 is known to be unusually
acid-resistant and L. monocytogenes is relatively heat-resistant. The
5-log pathogen reduction standard applies to the most resistant
microorganism of concern under the processing conditions used. If the
microorganism is resistant to a particular treatment and the treatment
does not therefore deliver a 5-log reduction in the microorganism,
then, obviously, the 5-log reduction standard has not been met. FDA
plans to provide additional information in its Juice HACCP hazards and
controls guidance to assist producers in identifying the pertinent
microorganism for measuring the 5-log standard.
(Comment 130) Several comments requested that FDA clarify how
surrogate microorganisms should be chosen to validate cumulative steps
used to achieve a 5-log reduction (e.g., use of sanitizers). One
comment requested that FDA require industry to use an agreed upon
``cocktail'' of surrogates to validate processes.
FDA advises that surrogates should be equally or more resistant to
the processing conditions than is the target pathogen to assure that
the process also destroys the pathogen. As noted in the response to
comment 129, one treatment may be effective in reducing one type of
pathogen but have less or no effect on another. FDA will be providing
additional guidance on the selection and effective use of surrogate
microorganisms for process validation in its juice HACCP hazards and
controls guidance. FDA believes that it is the
[[Page 6170]]
responsibility of the producer to validate the processes it chooses to
use in manufacturing juice products, including determining appropriate
surrogate microorganisms. Therefore, FDA is not requiring use of a
``cocktail'' of surrogates to validate processes.
In choosing and using surrogates, it is important to remember that
a cumulative 5-log reduction must be achieved. Therefore, a processor
must have evidence that there is a total reduction of 5 logs in the
surrogate population and that the same 1- or 2-log reduction is not
being counted repeatedly. In other words, if one step reduces the
surrogate by 2 logs, the next step must reduce the surrogate by an
additional number of microorganisms. In addition, care must be taken
that there is no growth of microorganisms between steps.
4. Application of the Performance Standard
(Comment 131) Several comments maintained that, because of the
possibility that pathogens may become internalized into fruit (or
vegetables), the treatment(s) will need to be applied after the juice
has been extracted so that the treatment has intimate (i.e., direct)
contact with pathogens. One comment suggested that FDA require at least
part of the treatment be applied directly to the juice. Conversely,
another comment maintained that, except for warm apples in cold water,
the potential for pathogen infiltration is hypothetical. Even then,
according to the comment, use of potable water and hygienically
maintained tanks could control pathogen internalization despite a
temperature differential that could cause water to be pulled into the
fruit.
As stated previously, FDA believes that, for all fruits and
vegetables, the pathogen reduction control process must begin at the
point where the pathogen reduction treatment directly contacts the
pathogens. Inherent in the NACMCF recommendation of the
5-log pathogen reduction standard was the assumption that the
treatment(s) would be applied in a way that would effectively reduce
the entire population of the microorganism of concern by 5-log. In
making this recommendation, NACMCF did not contemplate treatments that
may eliminate some pathogens while not reaching others, as would be the
case for surface treatment of produce susceptible to pathogen
internalization. In fact, the NACMCF specifically advised that surface
treatments would have little effect on pathogens if they are
internalized.
Contrary to the comment, the potential for infiltration is not
hypothetical because information and data from the scientific
literature demonstrate that, under certain conditions, microorganisms
can become internalized. (Refs. 13 and 14) Such internalization may
occur through natural plant structures or through decayed or damaged
sites on the fruit or vegetable. Water, insects, and birds, all of
which may carry human pathogens, can serve as pathogen vectors,
resulting in contamination of fruits and vegetables. Internalization
may occur before or after harvest although submerging warm harvested
fruit in cold water (such as dump tanks and flumes) increases the
potential for infiltration into susceptible produce. Similarly,
exposing vulnerable external points of fruit or vegetables may also
cause water to be taken-up along with pathogens if they are present.
Accordingly, for most fruits and vegetables, this means that the
pathogen reduction treatment must be applied to the juice after
extraction. Moreover, processors should include in their HACCP plans,
where appropriate, precautions to avoid or minimize the potential for
infiltration (such as by avoiding submerging warm fruit in colder
water). In addition, while CGMP's and SSOP's, such as using potable
water and sanitary operating conditions during washing, are a base for
HACCP, they will not necessarily prevent or correct pathogen
infiltration into fruits and vegetables. If pathogens have become
internalized in fruit or vegetables, wash treatments, even if conducted
consistent with CGMP's, will not eliminate them.
In the case of citrus fruits, FDA considered in the preamble to the
proposed rule that the structure of citrus fruits prevented
internalization of microorganisms, and thus, for citrus fruits,
pathogenic microorganisms are likely to be restricted to the surface of
the fruit. As such, FDA tentatively concluded that surface treatments
of citrus fruit would satisfy the criterion for direct contact with all
pathogens and could, therefore, be counted towards the 5-log reduction
standard (see also the response to comment 132).
In response to comments challenging this agency conclusion and in
the absence of scientific studies directly on this topic, FDA conducted
two studies to determine the validity of its assumption, and made the
results available for public comment. The results of one study provided
evidence that internalization, survival, and growth of human bacterial
pathogens may occur inside oranges. The results of the second study
demonstrated that there is uptake of water by oranges and grapefruit
when there is a transitory pressure differential between the interior
and exterior of the fruit. At the December 1999 NACMCF meeting, FDA
asked the NACMCF to consider the potential for internalization of
microorganisms by citrus fruits. The NACMCF concluded that it is
theoretically possible for microorganisms to internalize in sound,
intact citrus fruit under conditions where a temperature differential
between fruit and wash water may cause water to be drawn into the
fruit. The Committee stated that while this was demonstrated in
laboratory conditions, the probability of its actual occurrence under
current industry practices was not demonstrated. Accordingly, the
NACMCF concluded, based on the available evidence, that the potential
internalization and survival of pathogens in sound, intact citrus fruit
is not likely to present a significant public health risk.
FDA agrees with the NACMCF conclusion. Importantly, the comments
did not provide any data for FDA to conclude otherwise. Thus, the
agency is requiring in Sec. 120.24 that the 5-log standard be met by
treatments applied directly to the juice, except that citrus juice
processors may use treatments to fruit surfaces, provided the 5-log
reduction process for citrus begins after cleaning and culling and is
accomplished in a single production facility under the control of the
processor. (The terms ``cleaning'' and ``culling'' are discussed below
in the response to comment 132.)
At the present time, FDA believes that only citrus fruits have been
demonstrated to be adequately impervious to internal contamination such
that it is reasonable to rely on surface treatments of these fruits,
and therefore, use of surface treatments to achieve all or part of the
required 5-log pathogen reduction is restricted to citrus fruit.
Whenever sufficient scientific data are provided to the agency to
establish that, for other fruits and vegetables, it is appropriate to
begin the 5-log reduction process at other points than the extracted
juice or that establish that surface treatment is no longer an
acceptable method to contribute to the 5-log reduction for citrus
fruit, FDA will review this conclusion.
(Comment 132) A number of comments contained suggestions or asked
for clarification about where to start treatment for purposes of
calculating the 5-log pathogen reduction. A few comments maintained
that processors grading fruit to reduce potential contamination, and
processors using other best management practices,
[[Page 6171]]
should be able to count these practices towards the 5-log reduction
standard. One comment claimed that FDA should allow the measuring of
pathogen reduction to begin prior to processing to achieve and count
reductions in pathogens from proven sources, such as by cleaning and
culling dirty or damaged fruit. Another comment maintained that a 2-log
reduction is possible from using tree picked apples instead of drops
and that this practice (i.e., excluding drops) should be counted
towards achieving the 5-log reduction.
In contrast, several comments stated that the earliest possible
point to start counting the 5-log reduction is with clean, sound fruit.
One comment maintained that, while overtly damaged fruit carry a
greater risk of contamination, apparently sound fruit may also be
contaminated and that, therefore, culling is not a screen for microbial
contamination.
FDA agrees that food safety is enhanced by the highest quality
incoming materials. However, as noted in response to comment 112, FDA
does not believe that GAP's (such as using tree picked fruit) or CGMP's
(such as washing and culling fruit) are a replacement for the 5-log
reduction. Nor can these practices substitute for a portion of the 5-
log treatment. Establishment of the 5-log pathogen reduction standard
as adequate public health protection was based upon certain starting
conditions, including cleaning and culling the produce, and the
principal that the pathogen reduction treatment must directly contact
the microbiological hazard. As noted, for juice made from fruits and
vegetables in which there is a potential for pathogen infiltration,
such contact is likely to occur only after the juice has been
extracted; for citrus, where pathogen internalization is unlikely under
current industry conditions, the 5-log reduction process does not need
to start with the extracted juice but may begin with exterior
decontamination of fruit after cleaning and culling.
FDA is defining in Sec. 123.3(a) and (f) the terms ``cleaned'' and
``culled'' as described by NACMCF to establish the starting point for
surface treatments for citrus. Cleaned means washed with water of
adequate sanitary quality. Culled means separation of damaged fruit
from undamaged. For processors of citrus juices using treatments to
fruit surfaces to comply with Sec. 120.24, culled means undamaged,
tree-picked fruit (i.e., USDA choice or higher quality). For all
juices, cleaning and culling operations would be part of CGMP's, and
fruit being tree-picked is not applicable to the 5-log reduction. This
is consistent with the NACMCF recommendation that cleaning and culling
of citrus fruits not be considered part of the 5-log reduction of
pathogens. The agency notes that all produce used for making juice must
be cleaned and culled prior to the start of the 5-log reduction
according to CGMP's. However, FDA is defining these terms to clearly
set forth the basic starting conditions for the 5-log reduction,
especially in regard to surface treated citrus.
(Comment 133) One comment suggested developing a standard for
fruit for juicing that includes no dropped fruit, no blemishes or
dimples, and rinsing with pathogen-free water. The comment suggested
that beginning with fruit of a standardized quality would not count
toward the 5-log reduction, but would ensure that all processors start
with fruit of the same high quality. One comment argued that treatments
that can achieve a 5-log reduction in pathogens when applied to sound,
clean fruit may be adequate for producing safe product but questioned
whether a greater reduction might be necessary if starting with fruit
that was dirty or damaged.
FDA is not setting a standard for fruit quality or expressly
prohibiting the use of drops in most juices. As with any food, FDA
encourages the highest possible quality incoming materials in the
production of juice. The Produce Working Group of the NACMCF arrived at
the 5-log reduction recommendation by considering a ``worse case''
scenario where fruit was heavily contaminated with feces, as might
occur with the use of drops. The Committee concluded that a 5-log
reduction treatment would eliminate pathogens and provide a 100-fold
safety margin. Thus, FDA concludes that the 5-log reduction applied
directly to the juice will eliminate pathogens that may otherwise be
introduced by the use of drops. FDA cautions, however, that juice
producers that are exempt from or that have not yet adopted HACCP,
including the 5-log reduction standard, can reduce their risk of
producing contaminated product by avoiding drops and by culling tree
picked fruit before extraction.
The agency is establishing a standard for citrus fruit that is
treated only with surface treatment. For these juices, drops may not be
used. The NACMCF suggested, and FDA agrees, that for citrus juices,
only tree-picked fruit should be used, and fruit should be cleaned and
culled to be USDA choice or higher quality. Although pathogen
infiltration is unlikely in sound, intact citrus fruit, drops and
damaged fruit are likely to be more susceptible to pathogen
infiltration and, therefore, should not be used for juice that relies
on surface treatment.
Furthermore, in some cases, damage incurred when fruit drops to the
ground may foster nonmicrobial contamination such as the mycotoxin
patulin, which may occur in damaged apples. Patulin, if present in the
apples, will not be decreased by the 5-log performance standard. In
these cases, the processor must have controls in place to ensure that
the final juice does not contain unsafe levels of the mycotoxin.
(Comment 134) Several comments urged FDA to define sound fruit. A
few comments noted that culling is a subjective process and therefore
may not be consistently applied. One comment suggested that the agency
establish mandatory common minimum standards and technologies (e.g.,
black lighting) to ensure consistency in culling operations. Another
comment suggested that FDA specify that fruit be culled of unsound
fruit before dirty fruit is placed into a flume where it might
contaminate sound fruit.
In the case of citrus juice where a surface treatment is used to
achieve, at least in part, the 5-log reduction, the agency has
specified that the fruit shall be ``culled'' and ``cleaned.'' As noted,
these terms are defined in Sec. 120.3. Fruit and vegetable grading
criteria (e.g., for USDA choice level or higher, as will be required
for surface treated citrus fruit) have been established by USDA.
Although there may be some degree of subjectivity in culling citrus
fruit, visibly damaged fruit is apparent and is unlikely to meet the
requirements for USDA choice level or higher. Application of CGMP's,
along with the 5-log performance standard beginning at a point after
cleaning and culling of citrus fruit, should overcome any potential
risks that may result from subjective processes such as culling.
As stated in response to comment 132, FDA is not setting a standard
for fruit where the juice is treated after extraction to achieve a 5-
log reduction, although processors may consider including standards for
incoming fruit as appropriate to their operations in establishing a
HACCP plan. Additional guidance will be provided in the agency's juice
HACCP hazards and controls guidance.
(Comment 135) Several comments requested that FDA develop a guide
for industry that states the log reduction achieved for each potential
processing step. A few comments requested that pasteurization
guidelines for juice be published in a guide, and one comment asked
whether or not heat treatment at
[[Page 6172]]
161 deg.F for 15 seconds results in the appropriate 5-log reduction in
juice. Another comment questioned how to calculate a 5-log reduction
for banana juice.
FDA plans to publish a juice HACCP hazards and controls guidance to
assist the juice industry in implementing these regulations. FDA
intends that the guidance will contain pasteurization guidelines and
information about achieving the performance standard in other ways. The
agency is unable to comment on whether a heat treatment of 161 deg.F
for 15 seconds results in a 5-log pathogen reduction without
information about the characteristics of the juice as well as the
thermal resistance characteristics of the pathogen of concern.
Appropriate 5-log pathogen reduction treatments for specific juices
(such as banana juice) will vary, depending on the characteristics of
the juice (e.g., acidity, viscosity, percentage of pulp) and processing
conditions. Processors may find it necessary to consult additional
resources to determine and implement the most appropriate process to
achieve the 5-log pathogen reduction, such as information from State
public health or agriculture agencies, universities, extension
services, and private consultants. The agency emphasizes that it is the
processor's responsibility to validate the chosen pathogen reduction
process to assure its effectiveness in consistently achieving a 5-log
or greater reduction.
(Comment 136) Many comments expressed confusion about the use of
cumulative steps to reach the 5-log pathogen reduction requirement. A
few comments also requested that FDA clarify exactly what would be
required if two different processors perform steps that in the final
product add up to a
5-log reduction. A number of comments stated that separating cumulative
pathogen reduction steps by time and or by location is not acceptable.
These comments argued that such separation provided opportunities for
recontamination of product and regrowth of any existing pathogens that
had not yet been eliminated in the product, that any multiple step
intervention should take place in a single location, and urged FDA to
ensure time between treatments is kept to a minimum once an
intervention sequence is begun. Several comments on transporting juice
between facilities suggested that FDA require that bulk transport juice
(e.g., juice shipped in tanker trucks) be pasteurized upon arrival at
the final facility because of the potential for contamination during
transport.
FDA agrees with the comments expressing concern about the potential
for recontamination or regrowth of surviving pathogens if individual
treatments designed to achieve a 5-log reduction are separated by time
or space. At the December 8 to 9, 1999, meeting of the NACMCF, FDA
asked the Committee to consider certain questions about the application
of the 5-log reduction standard, focusing on citrus juices. Questions
included the impact of separation in time and space between cumulative
steps in the 5-log reduction process. The Committee members agreed that
separating steps in the 5-log reduction by time, and especially by
location, is likely to increase the risk of failure of the pathogen
reduction process (Ref. 12). Thus, the NACMCF recommended that all the
steps needed to achieve the required 5-log reduction should occur under
one firm's control and within a single production facility. These
restrictions are designed to reduce the risk of recontamination of
juice already processed to achieve all or part of the 5-log reduction.
Both time and the act of transportation, between processors, present an
opportunity for recontamination. Even if a processor moves product from
one building to another within the same facility, this movement must be
accomplished under CGMP's and the processor must insure that
recontamination does not occur. As noted, there have been several
recent outbreaks of microbially contaminated fresh juice; investigation
of these outbreaks establish that the concern about recontamination is
not just theoretical because the evidence suggests that transportation
may have played a role in these outbreaks. In April 2000, FDA was
notified by CDC of a foodborne disease outbreak involving over 140
reported cases from 10 States. CDC determined that the illness was
caused by Salmonella Enteritidis in unpasteruized orange juice, a
component of which had been imported in bulk. Previously, in July 1999,
an outbreak of Salmonella Serotype Muenchen occurred in 15 States and 2
Canadian provinces with over 300 cases reported. Again, the product was
fresh orange juice, a portion of which was imported. In this second
outbreak, several serotypes of Salmonella were isolated from tanker
truckloads of juice tested at the United States/Mexican border (Ref.
67).
FDA agrees with the NACMCF recommendations that all the steps
needed to achieve the required 5-log reduction should occur under one
firm's control and within a single production facility. Although the
NACMCF recommendation focused on citrus juice, based on the comments,
FDA believes that this recommendation should be extended to all juices.
Because of the potential for contamination at a facility over which the
final processor/packager has little or no control and because of the
potential for contamination during bulk transport, FDA has concluded
that there should not be any carryover from one facility to another of
any portion of pathogen reduction that contributes to a total 5-log
pathogen reduction. If a treated juice is transported to another
facility for final packaging or blending and packaging operations, the
entire 5-log reduction must be repeated. To clarify this point, the
agency is adding paragraph (c) to Sec. 120.24 to state that processors
must complete the 5-log performance standard and final product
packaging within a single processing facility under CGMP's.
FDA also notes that, for citrus juice producers relying on surface
treatments for the 5-log reduction, the single facility criterion also
applies to the requirement that processors start with clean, choice or
higher grade fruit. Although some juice processors may receive fruit
that has been cleaned and graded at another facility, fruit may require
additional cleaning and culling to remove any fruit damaged in storage
or transit. It is the responsibility of the final juice processor
(i.e., the processor at the location where the 5-log treatment will be
applied) to ensure that fruit is clean and of appropriate grade before
beginning the 5-log reduction.
Even within a single production facility, time between cumulative
steps may provide an opportunity for growth or recontamination.
Therefore, processors should include in their HACCP plans controls to
protect against regrowth of pathogens between steps (e.g., limiting
hold time and/or temperature) and to prevent recontamination of the
juice during or after processing (e.g., aseptic handling between steps
or between treatment and packaging).
FDA also agrees with the concern expressed by comments on the
potential for juice to be contaminated during bulk transport. This is
an area of particular concern to the agency because, as mentioned
above, bulk transport appears to be a common factor in several recent
outbreaks. However, the agency has no information nor was any
information submitted by comments that the 5-log reduction standard
applied to juice in general would not be sufficient to ensure the
safety of juice that is shipped in bulk, provided that the transported
juice receive the entire
[[Page 6173]]
5-log reduction at the facility where it will be packaged. Therefore,
FDA is not requiring at this time that juice shipped in bulk between
facilities be subject to additional treatment.
(Comment 137) One comment expressed concern that a cumulative
process will be more easily overwhelmed by especially dirty fruit than
would a single kill-step process. The comment contended that the risk
of contamination in a multi-step process is increased over the risk in
a single kill-step process because of the potential that contamination
can be introduced between steps. One comment expressed concern that
validation studies on a cumulative 5-log reduction cannot account for
all variables and, thus, meeting the performance standard cannot be
guaranteed.
HACCP principles and this final rule require that a processor
validate the HACCP plan for its particular process under commercial
operating conditions. This validation requirement exists for plans
utilizing both single-step and cumulative pathogen reduction controls.
FDA recognizes that within a processing system time delays may occur
between stages of the treatment; the processor must take any delays
into consideration, establish appropriate controls, and validate the
HACCP plan for that system. The 5-log reduction performance standard
was established to ensure the safety of juice regardless of the
pathogen reduction system chosen or the microbial load of the incoming
fruit. Furthermore, as discussed in response to comment 132, citrus
juice processors using surface disinfection to achieve all or part of
the 5-log reduction must start with cleaned and culled fruit as defined
in Sec. 120.3 (a) and (f).
(Comment 138) Several comments maintained that juice should be
packaged immediately before or after the intervention treatment. One
comment stated that a processor could hold and cool a heat treated
product before packaging if sufficient controls were in place to
preclude recontamination of the product.
As noted earlier, time between cumulative steps and between
application of the 5-log reduction and packaging increases the risk of
failure (see response to comment 136). Therefore, to reduce the risk of
recontamination, juice should be packaged immediately before or after
application of the 5-log pathogen reduction treatment. The potential
for recontamination between application of the 5-log reduction
treatment and packaging (such as might occur when product is held and
cooled) should be considered in the development of the HACCP plan and
appropriate controls established that are designed to prevent
recontamination. Processors not packaging juice immediately after
treatment should have sufficient controls in place (e.g., aseptic
equipment) to ensure the safety achieved by the 5-log reduction can be
consistently maintained.
(Comment 139) One comment asked if the regulation allowed for the
application of 5-log reduction to a juice ingredient at any time (e.g.,
before or after blending). The comment argued that the juice ingredient
used to manufacture dairy beverages usually receives a 5-log treatment
by the supplier and that the finished beverage is often pasteurized at
the dairy.
Juice that is intended for use in further manufacturing is
generally shipped in bulk. As discussed in the response to comment 136,
the NACMCF recommended and FDA agrees that if bulk transport juice will
be repackaged at another facility, the 5-log reduction process must be
performed on the juice at the facility where it is packed into final
packages. If treated juice is packaged into a bulk-type sterile
package, such as a single use sanitary tote, then reprocessing is not
necessary unless it is repackaged. If juice shipped in sterile totes is
to be repackaged at a different facility, the juice product sold to
consumers must be retreated to attain the 5-log reduction at the
facility where final packaging is performed. As discussed earlier,
separation in time and location increases the risk of failure of the
HACCP system, including the 5-log reduction. Therefore, FDA is not
providing for carryover of any part of the 5-log reduction when juice,
not in its final packaged form, is transported between two facilities.
Juice destined for use as an ingredient in another juice beverage
must also undergo a 5-log reduction process. The processor may choose
either to treat the juice ingredients before blending or to treat the
final product, so long as the entire 5-log reduction is completed in a
single production facility under the control of the processor and the
processor minimizes time between treatment and packaging.
(Comment 140) Several comments noted that shelf-stable juices are
processed well in excess of the 5-log reduction necessary for pathogen
control. The comments requested that FDA exempt shelf-stable juice
producers from a CCP for pathogen reduction because the shelf-stability
of the product is proof that their process greatly exceeds safety
performance criteria. Comments also requested that the same
consideration be given to concentrated juices.
The agency agrees with the comments and is providing an exemption
from the requirements of Sec. 120.24 for shelf-stable and concentrated
juices, under specific conditions. Shelf-stable juice products are
generally processed at high temperatures in a single step to destroy
spoilage microorganisms and enzymes (Ref. 68). These temperatures far
exceed what is needed to attain the 5-log reduction in the pertinent
pathogen. Therefore, FDA concludes that it is reasonable to exempt a
processor of shelf-stable juices from the requirements of Sec. 120.24,
if the firm uses a single thermal processing step to attain shelf-
stability.
FDA also recognizes that the production of thermally concentrated
juice utilizes thermal treatments similar to those used for the
production of shelf-stable juices (Ref. 68). A thermal concentration
process generally consists of an initial thermal treatment, similar to
that used for shelf-stable juices, followed by several thermal
evaporation steps. For this reason, the agency has concluded that when
a thermal processing step is used before a thermal evaporation process,
the processor should be exempt from the 5-log reduction requirement.
Accordingly, FDA is adding Sec. 120.24(a)(2) exempting juice
processors using a single thermal processing step sufficient to achieve
shelf-stability of the juice or a thermal concentration process that
includes thermal treatment of all ingredients from the requirements of
Sec. 120.24 (the
5-log reduction requirement). When completing the written hazard
analysis as required by Sec. 120.7, processors of shelf-stable and
concentrated products using a thermal treatment need not identify
pathogens as a hazard that is reasonably likely to occur. To
demonstrate that its process is sufficient for the exemption, a
processor must include a copy of the thermal process used to achieve
shelf-stability or concentration in its written hazard analysis as
required by Sec. 120.7.
Shelf-stable or concentrated juice processors are not exempt from
the requirement to conduct a written hazard analysis because of the
possibility that chemical or physical hazards may be reasonably likely
to occur. However, if, based on its hazard analysis a processor exempt
from Sec. 120.24 determines that there are no chemical or physical
hazards that are reasonably likely to occur in its juice product, then
that processor is not required to have a HACCP plan. Juice processors
that do not have a HACCP plan need not
[[Page 6174]]
comply with the following provisions of part 120:
Sec. 120.8, HACCP plan
Sec. 120.10, Corrective actions
Sec. 120.11(a) (except paragraph (a)(1)(i)), Verification
Sec. 120.11(b), Validation of the HACCP plan
Sec. 120.12(a)(3) and (a)(4), Required records
Sec. 120.24(a) (except paragraph (a)(2)), Process controls
Sec. 120.25, Process verification for certain processors
FDA anticipates that, in the future, processors making shelf-stable
or concentrated juice may use alternative nonthermal processing
technologies. While the control mechanism of these nonthermal
technologies may eliminate spoilage microorganisms, the effect on
pathogens is uncertain. Therefore, the exemption under
Sec. 120.24(a)(2) does not extend to nonthermal processes.
5. Validation of the Performance Standard
(Comment 141) One comment stated that the cost of validating a 5-
log reduction procedure would be prohibitive to small producers because
the validation studies would have to take place in a pilot plant.
Another comment stated that processors should be able to validate
procedures and critical control limits based on literature reviews, in-
plant experience, recommendations from consultants, and routine
testing.
The agency disagrees with the comment that argued that validation
would be too expensive for small processors because it would have to
take place in a pilot plant. FDA notes that validation studies need not
occur in a pilot plant. There are several options available to a
processor in validating its 5-log reduction procedure and in
establishing critical limits. Although it is preferable to establish
limits for CCP's and validate individual processes in a pilot plant or
in the processing facility where they will be carried out, FDA
recognizes that this may not be feasible for small processors. As
suggested by the second comment, many alternatives are available. For
example, small processors that use identical procedures for producing
juice could validate these processes cooperatively. It is also
acceptable to use referenced procedures for achieving a particular log
reduction provided a processor can demonstrate that the referenced
procedure is being followed exactly (or more stringently), as outlined
in the literature, and is effective in the processor's operation. Small
producers may also elect to use proven technologies (e.g., thermal
treatments) that have been extensively validated, and as such can be
readily adopted with minimal need to conduct in depth microbiological
validation testing.
FDA was unsure what the second comment meant when referring to
``routine testing'' as a way to validate HACCP. It may be that the
comment was referring to ``verification'' (e.g., routine testing and
monitoring) to ensure that the HACCP plan is functioning correctly,
rather than ``validation''. Verification and validation are further
discussed in the following section.
6. Process Verification
(Comment 142) Several comments expressed concern about the
effectiveness of cumulative steps in meeting the 5-log reduction. One
comment pointed out that the efficacy of a cumulative step process for
citrus assumes perfect grading and that the interior of citrus is
sterile. The comment stated that perfect grading is not possible
because pathogens that may have entered the fruit through a
microperforation may not be detected and the fruit could have a
contaminated interior. The comment also maintained that no steps in the
cumulative process described in the proposed rule were designed to
prevent reproduction of pathogens in the juice during storage. A few
comments concerned about the effectiveness of cumulative treatments
argued that FDA should require end-product testing to verify HACCP for
all non-pasteurized juice. One comment advocated continuous testing for
unpasteurized juice and periodic testing for pasteurized juice.
Conversely, one comment maintained that, in most cases, microbial
testing is not necessary nor is it the best method for verifying HACCP.
However, this comment suggested that microbial testing be required for
citrus juice using surface treatments to achieve 5-log since, according
to the comment, there are few other steps that can be used to verify
cumulative processes that include surface treatment.
FDA's response to these comments requires an understanding of the
differences between two HACCP concepts: validation and verification.
Verification includes all activities, except monitoring, that establish
the soundness of the HACCP plan and that the system is operating
according to the plan. Many verification activities, such as process
verification, are an on-going (e.g., daily or weekly) part of operating
under a HACCP plan. Validation is a subset of verification activities
that occurs when a HACCP plan is first set up and whenever significant
changes are made that may have an impact on the effectiveness of the
system. Validation focuses on collecting and evaluating scientific and
technical information to determine whether the HACCP plan, when
properly implemented, will effectively control all hazards that are
reasonably likely to occur. In contrast, verification assesses whether
the HACCP plan, once established, is working properly.
FDA disagrees that microbiological testing of the final juice
should be required of all juice manufacturers. If juice is treated to
achieve a 5-log reduction in a target pathogen after the juice is
expressed, the extent of the reduction (>100,000-fold) in combination
with the low levels of pathogens that have been detected in untreated
juice would likely result in a post-treatment level of microorganisms
that is too low to be detected using reasonable sampling and analytical
methods. Moreover, microorganisms are not likely to be uniformly
distributed throughout the juice and, accordingly, may not be present
in the sample tested even though they are in the juice. This can result
in false negative test results. Determination that the product has been
adequately treated is more effectively verified by review of the
monitoring records for the appropriate CCP. Thus, as a general rule,
FDA is not requiring end product testing as part of verification for
processes where the juice itself has been directly treated. The
exception to this general rule is that processors of citrus juice that
use surface treatments to achieve the 5-log reduction performance
standard will be required to conduct end product testing to verify that
their HACCP system, including the cumulative step 5-log reduction, is
operating as it is designed to operate. This verification testing is
discussed in more detail below. Of course, even where not required,
processors may elect to use end product testing as part of the
verification of the HACCP plan.
Conversely, except for techniques like pasteurization, where
industry has a long history and experience of using time-temperature
parameters as an indicator of microbial destruction, a processor will
likely need to conduct studies using samples inoculated with pathogens
(or surrogates) to confirm that their HACCP process does result in a
5-log reduction in the pertinent pathogen.
In light of comments expressing concern about the efficacy of
cumulative steps, including surface treatment of cleaned and culled
citrus fruit, FDA has evaluated the need for additional forms of
process verification for some
[[Page 6175]]
products. As noted, verification is designed to demonstrate that the
HACCP plan is achieving the level of process control intended and thus
producing safe food on a continuing basis. Verification is broader than
ongoing process monitoring alone. The purpose of monitoring is to
measure and document that those identified steps that must operate
within specified limits on a continuing basis in order to control a
foodborne hazard (i.e., CCP's) are in fact operating within
specifications. Ideally, monitoring involves continuous, ``real-time''
measurements so that process deviations can be detected and corrected
immediately.
Conversely, verification entails both the periodic review of
monitoring data and the acquisition of additional data to assess
whether the HACCP plan is functioning as intended. The additional data
are not necessarily data relating to a CCP, but could be data relating
to another step in a process that reflects the effectiveness of a prior
CCP(s) (e.g., sampling of citrus fruit surfaces for levels of acid
resistant mesophilic aerobic microorganisms after treatment of the
fruit with an acidic antimicrobial wash). Furthermore, since
verification data are only acquired on a periodic basis, types of
analyses that require too much time to be effective means for
monitoring CCP's can nevertheless be highly effective tools for
verifying a HACCP plan. Verification activities may include review of
CCP-monitoring records; collection of either in-line or finished
product samples for microbiological, chemical, or physical analysis;
and direct observations of monitoring activities and corrective
actions. The frequency of verification activities will vary depending
on factors such as the type of process, volume of product, the results
of prior monitoring and verification activities, and past frequency of
process deviations.
As discussed in detail previously, at its December 1999 meeting,
the NACMCF considered at length the effectiveness of surface treatment
to eliminate microbiological concerns related to citrus fruits. There
has been a continuing question of whether the integrity of the outer
surface of citrus fruit is sufficiently impervious such that pathogenic
microorganisms cannot enter the fruit. If the surface were sufficiently
impervious, surface treatments might effectively reduce the risk from
microbiological hazards. The NACMCF (1999) concluded that the potential
for the uptake and growth of bacterial pathogens such as Salmonella
Hartford and E. coli O157:H7 by intact citrus fruit is unlikely, given
current industry practices, and that surface treatment of intact,
healthy citrus fruit should adequately reduce microbiological risks.
However, the NACMCF also concluded that under certain limited
conditions, internalization of pathogenic bacteria is possible.
Further, the NACMCF noted that surface treatments of fruits would have
little effect on internalized pathogenic microorganisms (Ref. 12). In
addition, although the NACMCF concluded internalization of pathogens in
sound citrus is unlikely under current industry practices, FDA research
confirmed that if a temperature differential exists between the fruit
and wash water, washing may cause internalization of pathogens in
citrus and other produce through indiscernible punctures of the skin.
The NACMCF observed that while microbiological testing is seldom
effective as a means of monitoring a CCP, such testing can play a role
in verifying HACCP programs (Ref. 17). Similarly, the International
Commission on Microbiological Specifications for Foods (Ref. 69) has
recognized microbiological testing of product as one type of HACCP
verification.
In relation to HACCP and citrus juice manufacture, the NACMCF (Ref.
12) recommended that periodic microbiological testing of juice be a
component of the HACCP verification activities undertaken by those
citrus juice manufacturers who rely on surface treatment of fruit to
achieve all or part of the microbiological performance standard (5-log
reduction).
Because of continuing questions about the possibility of pathogen
internalization and because of the lack of alternative verification
steps available for processors using cumulative steps, including
surface treatments, to achieve the 5-log reduction, FDA concludes that,
for citrus juices that rely solely or in part on surface treatments,
periodic microbial testing to verify the effectiveness of cumulative
processes is integral to the process control verification. Therefore,
in Sec. 120.25, FDA is requiring microbial testing for such juice
products. This testing is in addition to verification and validation
requirements set forth in Sec. 120.11.
(Comment 143) As noted above, several comments argued that FDA
should require microbial testing for some or all juices. Some comments
favored microbial testing of finished product but did not specify
sampling plans or methods. A few comments suggested that FDA could
permit companies to test for indicator organisms because E. coli
O157:H7 is hard to detect. One comment argued that such a requirement
would eliminate the need for a HACCP system.
FDA disagrees with the comment that maintained that end product
testing would eliminate the need for HACCP for juice. As discussed in
response to comment 142, microbial testing is limited in its ability to
detect process deviations in a timely manner, especially for products
with a short shelf-life, such as fresh juice.
FDA agrees with the comment that suggested that indicator organisms
could be used for process verification. While microbiological testing
for specific pathogens might be a direct means of verifying that a
surface treatment is effective and that pathogens have not been
internalized in the fruit, analyses for individual pathogens can be
highly complex. Testing for pathogens also has limitations, including
the potential for pathogens to be present at low levels compared to
other microorganisms and the detection limit of the test. There is also
the question of which pathogens that may be present on the surface of
the fruit should be the focus of any testing. For example, testing for
Salmonella, E. coli O157:H7, and Cryptosporidium parvum might be
appropriate since all three have been implicated in disease outbreaks
related to juices. Another limitation of testing for pathogens is that
testing for one pathogen (e.g. Salmonella) will not detect another
(e.g., E. coli O157:H7), even if the second pathogen is present. An
alternative would be to select a microorganism whose presence is
indicative of a loss of process control. Since all three of the
pathogens above are fecal in origin, the ideal indicator microorganism
would be one that is indicative of fecal contamination.
FDA has considered several different possible indicator
microorganisms and has concluded that biotype I Escherichia coli (i.e.,
generic E. coli) is the most suitable indicator microorganism for
verifying the effectiveness of surface treatments in attaining the 5-
log reduction standard. This microorganism is generally regarded by the
scientific community as the best indicator microorganism for processes
intended to control fecal contamination (Refs. 15 and 70). When
present, generic E. coli generally occurs at levels several magnitudes
greater than the levels of enteric pathogens that are associated with
fecal contamination. Consequently, testing for generic E. coli is more
likely to detect product where the 5-log reduction standard has not
been achieved. Thus, FDA concludes that any citrus juice manufacturer
that relies solely or in part on surface treatment of
[[Page 6176]]
the fruit to achieve the 5-log reduction performance standard shall,
for each different type of juice product produced, conduct analyses of
the final product for biotype I Escherichia coli.
The next issue is how the analysis should be performed.
Historically, the juice industry has used the standard
3-tube MPN (most probable number) method in FDA's Bacteriological
Analytical Manual (BAM) for analysis of coliform and E. coli in juices.
However, this method has several limitations. First, as noted in a
paper entitled ``Derivation of Sampling Plan to Meet the Testing
Requirement in the Juice HACCP Final Rule for Citrus Juices That Rely
Solely Or in Part on Surface Treatments to Achieve the 5-Log Reduction
Standard'' (``Surface Treatment Sampling Plan'') (Ref. 71), the BAM
method can only analyze a small sample size of 3.33 mL with a detection
limit of 0.3 E. coli/mL. In addition, the high acidity of some juices,
including most citrus juices, can interfere with the detection
efficiency of the test. Using an analytical method that can test a
larger sample size (i.e., 20 mL) and by including an enrichment step to
reduce interference by acidity should improve an analysis for generic
E. coli and thus assist a citrus juice processor using surface
treatments to verify whether the process is achieving the 5-log
reduction. Consequently, FDA has developed the method, ``Analysis for
Escherichia coli in Juices--Modification of AOAC Official Method
992.30,'' to detect the presence or absence of E. coli in a 20 mL
sample of juice (consisting of two 10 mL subsamples) (Ref. 72). In the
future, FDA intends to place this method in the BAM. After publication
of this final rule, the method will be available on FDA's Internet site
at www.cfsan.fda.gov.
In order to facilitate uniform and effective application of this
requirement, FDA has added to Sec. 120.25, specific requirements for
sample collection and testing. Under this provision, one 20 mL sample,
consisting of two 10 mL subsamples, of finished juice shall be analyzed
for the presence of generic E. coli from each 1,000 gallons of juice
produced per day. If less than 1,000 gallons of juice are produced per
day, samples must be taken for each 1,000 gallons produced, or once
every 5 working days that the facility is producing that juice,
whichever comes first. If either 10 mL subsample is positive for E.
coli, then the 20 mL sample is recorded as being positive for generic
E. coli.
In addition to the general corrective action requirements in
Sec. 120.10, FDA is also adding requirements in Sec. 120.25 to spell
out the specific steps that should be taken if a processor subject to
the requirements of Sec. 120.25 finds one or more juice samples
positive for E. coli. Generic E. coli is relatively ubiquitous. Thus,
the occasional sample that is positive for E. coli does not necessarily
indicate that microorganisms of fecal origin are not restricted to the
surface of the fruit or that surface treatments are insufficient to
assure product safety. Nevertheless, an occasional positive sample
should prompt a review of the monitoring records relating to the 5-log
reduction standard to determine whether pathogen reduction treatments
and post process controls designed to prevent re-contamination are
being properly delivered. Because generic E. coli is an indicator of
fecal contamination, processors finding generic E. coli in a single
sample may consider testing another sample of the same juice for
specific pathogens of concern, such as Salmonella and E. coli O157:H7,
to determine whether, in fact, pathogens are present in the juice. FDA
is not requiring pathogen testing for the occasional, single positive
for E. coli. However, if the review of monitoring records or the
additional testing shows that the 5-log reduction has not been
achieved, such as a sample is found to be positive for the presence of
a pathogen or a deviation in the process or its delivery is found, the
processor shall take corrective action as set forth in Sec. 120.10 of
this final rule. Corrective action requirements for a single positive
generic E. coli are set forth in 120.25(d).
More than an occasional 20 mL sample positive for generic E. coli
is an indication that the HACCP process is not sufficient to assure
product safety. Under Sec. 120.25, processors relying in whole or in
part on surface treatments of the fruit shall have in place a sampling
and testing plan sufficient to distinguish between the occasional
positive sample and more frequent positives that are indicative of a
failure to deliver the 5-log reduction. One way to distinguish between
a chance event and an event that results from other factors (such as a
failure to deliver the 5-log reduction) is to examine a defined series
of tests and assess whether the unusual happens too frequently to be
due to chance alone. FDA has evaluated the available data and
information, and based on that analysis, has determined that two
positives in any series of seven contiguous tests is an appropriate
criterion in a sampling plan designed to signal a citrus juice
processor relying on surface treatments that its 5-log reduction
standard has not been achieved. This standard would alert processors
relatively quickly that their system is not delivering the 5-log
reduction and, at the same time, would have a relatively small
incidence of ``false alarms'' for processors who are achieving a 5-log
reduction. The statistical basis for this criterion is described in the
paper entitled ``Derivation of Sampling Plan to Meet the Testing
Requirement in the Juice HACCP Final Rule for Citrus Juices That Rely
Solely Or in Part on Surface Treatments to Achieve the 5-Log Reduction
Standard'' (Surface Treatment Sampling Plan) (Ref. 71).
FDA acknowledges that there were certain limitations in the data it
had available to estimate E. coli levels that would be expected in
juice not treated to reduce pathogenic microorganisms. For example,
available data on E. coli levels in citrus juice were limited to orange
juice. However, FDA believes that the sampling plan set out in the
Surface Treatment Sampling Plan (Ref. 71) can appropriately be applied
to all types of citrus juice. Orange juice represents a significant
portion of the citrus juice market. For those citrus juices that have a
lower occurrence of E. coli compared to orange juice, using the same
sampling plan will provide an equivalent or greater level of food
safety assurance for consumers without increasing any burden, such as
the risk of false alarms, for processors. Moreover, a single standard
sampling plan will simplify implementation and evaluation of HACCP for
citrus juice processors using surface treatments. Other aspects of the
data, including its limitations, are discussed in the Surface Treatment
Sampling Plan (Ref. 71). FDA believes that the assumptions made, based
on its review of available data, were sufficiently sound and reasonable
to support this sampling plan. Therefore, FDA is specifying in
Sec. 120.25(e) that finding two samples positive for E. coli out of a
series of seven sequential tests indicates that the 5-log reduction was
not achieved. As additional data become available, the agency will
consider those data and make adjustments in the HACCP regulation or in
the Juice HACCP hazards and controls guide as appropriate.
Under Sec. 120.25(e), if a processor finds two positives out of
seven tests, the control measures to achieve the 5-log reduction would
no longer be considered adequate. This would require immediate action
to ensure that no product enters commerce that was produced where the
5-log reduction was not achieved, because inadequately processed juice
creates the potential for the transmission of foodbourne
[[Page 6177]]
illnesses. In addition, the processors would need to determine the
source of the failure and to take steps to correct the failure.
Corrective actions must include a review of the monitoring records for
control measures to attain the 5-log reduction standard, and the
processor must correct those conditions and practices that are not met.
If the review of monitoring records or the additional testing shows
that the 5-log reduction has not been achieved, such as a deviation in
the process or its delivery, the processor shall take corrective action
as set forth in Sec. 120.10 of this final rule. The processor should
also review the aspects of the HACCP plan relating to the 5-log
reduction standard to determine whether the conditions and practices
specified in the plan relating to the 5-log reduction standard are
being met. If those conditions and practices are being met, and no
other source of the problem can be found (e.g., post process
contamination), the processor should conclude that the treatment,
although delivered as intended, was not able to achieve the intended 5-
log pathogen reduction. In such case, the processor shall revalidate
its HACCP plan in relation to the 5-log reduction standard.
While the control measures relating to the 5-log reduction standard
are being evaluated, and until all corrective actions have been
completed, including, if necessary, revalidation of those aspects of
the HACCP plan relating to the 5-log reduction standard, the processor
must use an alternative process or processes to achieve the 5-log
reduction after the juice has been expressed. Processors should
consider why the monitoring and verification results are not in accord,
such as through an inadequate process or a failure in process delivery,
and whether an alternate approach to achieving the 5-log reduction is
needed. Once these steps have been taken, processors may again use the
validated approach that relies solely or in part on surface treatments
rather than the alternative process.
FDA has concluded that two positive E. coli samples in a series of
seven tests indicate that the control measures to attain the 5-log
reduction standard are inadequate and immediate corrective actions are
necessary. Two positives in a window larger than seven tests may be due
to chance rather than a failure to deliver the 5-log reduction.
However, processors may wish to review test results over a larger
window as a possible early warning that the process may be approaching
failure. FDA intends to provide additional information in its Juice
HACCP hazards and controls guide to assist processors in ensuring their
review is sufficiently extensive to determine that no trends towards
loss of control are occurring.
The agency concludes that new Sec. 120.25 is a highly effective
tool for verifying the 5-log reduction standard for processors using
surface treatments. In addition, FDA is modifying Sec. 120.11(a)(1) to
include new paragraph (vi) to clarify that the activities in
Sec. 120.25 are part of the processor's verification activities.
7. Other Issues
(Comment 144) One comment requested that FDA clarify what is meant
by moderate abuse conditions. The comment stated that E. coli may be
less tolerant under these conditions, so moderate abuse could be a kill
step for E. coli.
FDA discussed what it considered to be moderate abuse in the
proposal (63 FR 20450 at 20478) (Ref. 2). FDA acknowledges that in some
circumstances moderate abuse such as slightly elevated temperature in
an acidic juice may actually decrease the numbers of certain
microorganisms. If a processor intends to use a specific period of
elevated holding temperature as a treatment, then the processor must
validate the treatment as required for any CCP.
(Comment 145) A few comments asked that FDA eliminate the
requirement that the 5-log reduction be maintained throughout shelf-
life of the product. The comments maintained that there is no risk of
recontamination once the juice is bottled.
FDA agrees that there is little risk of recontamination after a
juice is bottled if the container is not damaged and the juice is
handled under CGMP's. However, because of the importance of attaining
the 5-log reduction for juice to be safe, it is reasonable that juice
retain this characteristic throughout the period that it is available
for consumption by consumers. Therefore, FDA is not amending
Sec. 120.24.
(Comment 146) One comment suggested that the performance standard
should be phased in as data on meeting the performance standard becomes
available. Another comment suggested that initially, a 3-log reduction
could be required, then the following year a 4-log reduction would be
required and finally a 5-log reduction.
The agency does not agree. FDA is providing ample opportunity to
accommodate processors that may have difficulty implementing the 5-log
reduction performance standard. First, the agency has required, since
the effective date of the juice labeling final rule, that juice be
treated to control pathogens (i.e., meet a 5-log reduction performance
standard) or bear a warning label statement. Since that same time, FDA
also has been working with the juice industry, through workshops and
programs, on the development of techniques that meet the performance
standard. Finally, depending on their size, processors will have 1 to 3
years to implement this rule because the agency is providing additional
time for small and very small businesses to implement their HACCP
systems. Therefore, FDA concludes that it has already provided the
means and reasonable time for processors to identify and implement
available means to meet the 5-log reduction performance standard.
M. HACCP Enforcement Issues
(Comment 147) One comment requested that FDA establish a
preapproval system for HACCP including plant registration, filing of
HACCP plans, regular inspections, validation and verification of HACCP
plans with microbial testing and tracebacks.
FDA believes that a preapproval system for HACCP plans would unduly
burden the agency's resources without substantially increasing public
health benefits. The effectiveness of a HACCP plan, including
monitoring, recordkeeping, and verification, can best be evaluated
under actual operating conditions. Therefore, as part of its
enforcement plan for juice HACCP, FDA plans to do inspections of juice
processing facilities to ensure compliance with the HACCP regulations
after they become effective. These inspections will include collection
and analysis of product samples for pathogens and other contaminants.
The agency is putting juice processors on notice that FDA is
committed to inspecting all high risk firms annually, even before the
effective date of this final rule, and intends to include sample
collection and analysis as an integral part of that process. In the
agency's view, processors of untreated juices, including firms
producing citrus juices using surface treatments, fall into the
category of high risk firms.
(Comment 148) One comment stated that tracebacks are very
important and the need for information relating to origin of the
product was not covered in the proposed rule.
FDA agrees that tracebacks are important and believes that the
ability to traceback from a foodborne illness outbreak to the source is
critical to controlling the size and duration of the outbreak. The
source of an outbreak may
[[Page 6178]]
be contaminated raw produce or contamination of product during
production and distribution. Processors must implement CGMP's to
address raw produce suitability for processing and, if there are
hazards that are reasonably likely to occur in raw produce, implement
HACCP controls for such hazards. The recordkeeping requirements of this
rule mandate that all records include the identity of the product and
the production code where appropriate. The purpose of these
requirements is to ensure that records maintained under part 120 can be
readily linked to a product and to the timeframe in which the product
was manufactured. Linking a record to a specific product will be
especially important when a product must be isolated or recalled. The
information required in Sec. 120.12 will help ensure that, when
tracebacks are necessary, they can be carried out efficiently.
(Comment 149) One comment suggested that third party inspections
should be done to validate HACCP and the results should be publicized.
FDA encourages such self-regulated programs within industry as
third party inspections. Validation of the HACCP plan may be done by
any individual, including a third party, that has been trained in
accordance with Sec. 120.13. The validity of the HACCP plan will
ultimately affect the overall compliance status of firms, as determined
through the inspection process. This status is public information.
(Comment 150) One comment suggested that FDA should model its
HACCP regulation after that of FSIS with more frequent and less lenient
inspections and validation testing.
Differences in the way FDA and FSIS implement their HACCP programs
are due to differences in the products being regulated. Also, FSIS's
authority and funding provides for the presence of inspectors in meat
and poultry plants on a daily basis, whereas FDA's authority and
resources do not require or allow for such frequent inspections. FDA,
to the extent it is able, will work with juice processors during
inspections to properly implement part 120.
(Comment 151) A few comments questioned whether FDA was planning
to ask states to enforce the HACCP regulations in light of the agency's
limited resources. Another comment stated that the States should verify
compliance with any applicable safety regulations.
FDA cannot mandate that a State ensure that a firm is complying
with FDA regulations. However, FDA has a long history of working
cooperatively with the States to enforce food safety regulations, and
the agency hopes to continue these cooperative relationships with
States in the context of juice HACCP. FDA notes that some States adopt
FDA requirements as their own laws and regulations; with those States,
the final rule will effectively be enforced by the States.
(Comment 152) One comment requested that first inspections of
HACCP systems be nonregulatory.
The agency recognizes the benefits of a nonregulatory (i.e.,
educational) first inspection of implementation of a new HACCP system.
For the seafood HACCP program, FDA elected to make the first inspection
educational, rather than regulatory, as long as there were no urgent
public health problems. FDA chose that approach because, for most
processors, the first inspection provided the first direct feedback
from the agency on the status of the firm's HACCP system. FDA will
consider whether the same approach is warranted for some or all juice
processors.
(Comment 153) One comment questioned the type of training that FDA
would be providing its investigators to ensure that they understand the
relevance of microbial data and that they will not go on ``witch
hunts'' to find something wrong with the facility.
FDA's food processor investigators have considerable experience
with HACCP in that most are currently conducting seafood HACCP
inspections. Investigators are trained to look for violations of FDA
regulations and to employ discretion and good judgment (e.g., consider
the significance of the violation) in determining how inspectional
findings are handled. Further, an investigator's significant
inspectional findings are reviewed by multiple higher level FDA
employees to confirm the violation prior to the initiation of any
regulatory action by the agency.
N. Miscellaneous Issues
(Comment 154) One comment suggested that FDA develop a juice HACCP
pilot program.
FDA currently has a HACCP pilot program that includes juice
processors. To date, two pasteurized juice processors and one fresh
juice processor have completed the HACCP pilot program. FDA has used
experience gained from the participation of these juice processors in
the HACCP pilot program in proposing and finalizing this rule (Ref.
73).
(Comment 155) Several comments stated that FDA should not impose
regulations on industry that will scare consumers into buying only
certain foods (i.e., pasteurized juices).
It is not the aim of this rulemaking to scare consumers into buying
only certain foods, such as pasteurized juices. However, juices have
been the source of a number of outbreaks of illness and the death of
one child, as well as have contributed to the death of an elderly man.
Juices have also been the source of chemical and physical contaminants
that have adverse public health effects, such as high lead levels, the
presence of patulin, and the presence of glass pieces. For these
reasons, the agency has determined that measures are necessary to
ensure that juice is safe and to prevent additional illnesses and
deaths, particularly among at risk groups. The primary purpose of this
rulemaking is to protect the public, not scare them. FDA believes that
these measures will promote public confidence in the safety of juice
products.
IV. Effective Date
FDA proposed that any final rule based on the proposal become
effective 1 year after its date of publication in the Federal Register.
Further, FDA proposed that any final rule based on the proposal would
not be binding on small businesses as defined in Sec. 120.1(b)(1) until
2 years after publication in the Federal Register; and for very small
businesses as defined in Sec. 120.1(b)(2), the final rule would not be
binding until 3 years after publication in the Federal Register.
(Comment 156) Many comments expressed concern that small
businesses have the longest time to comply with the rules, even though
outbreak data indicate that these producers are most likely responsible
for producing contaminated juice.
The agency considered, in the HACCP proposal, the various issues
surrounding the need for processors to immediately implement HACCP
programs and the need to consider options to minimize the burden of the
cost of implementation to small businesses (63 FR 20450 at 20463) (Ref.
2). To address the most immediate concerns (i.e., pathogens) with
juice, FDA has since finalized the warning label statement regulation
in Sec. 101.17(g) and has engaged in extensive education to alert
consumers to the problems of consuming untreated juice. All juice
shipped in interstate commerce or made from ingredients shipped in
interstate commerce, including that produced by small businesses, that
has not been processed to achieve a 5-log reduction in pathogens must
be labeled with a warning for consumers (Sec. 101.17(g)). Thus, even if
not produced under a HACCP system, the products of these
[[Page 6179]]
small businesses will have some safeguards to protect public health. In
addition to the label warning requirement, FDA encourages processors to
implement a HACCP system as soon as possible to reduce hazards in juice
rather than use the warning label statement. Consequently, the agency
has decided to focus initial implementation of HACCP on processors that
produce the largest quantity of juice and thus have the potential of
affecting the largest number of consumers should contaminated product
reach the marketplace.
(Comment 157) Several comments requested that the regulations
become effective for all processors 1 year after the rule is finalized
and several comments requested that the regulations become effective
for all processors 2 years after the rule is finalized.
The agency disagrees with the comments. As noted, FDA considered
various options for the implementation of the effective date in the
proposed rule. The final rule requires that the bulk of juice produced
in the United States will be processed under a HACCP system within 1
year. The agency realizes that it may take longer for small and very
small businesses to fully implement HACCP systems and has extended the
effective date for one or 2 years, respectively, to give them adequate
time to comply.
V. Final Regulatory Impact Analysis
A. Introduction
FDA has examined the impact of this final rule under Executive
Order 12866. Executive Order 12866 directs Federal agencies to assess
the benefits and costs of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects; distributive impacts; and equity). Under the
Executive Order, a regulatory action is ``significant'' if it meets any
one of a number of specified conditions, including having an annual
effect on the economy of $100 million; adversely affecting some sector
of the economy in a material way; or adversely affecting competition or
jobs. A regulation is also considered a significant regulatory action
if it raises novel legal or policy issues. FDA finds that this final
rule is a significant regulatory action as defined by Executive Order
12866.
The Small Business Regulatory Enforcement Fairness Act of 1996
(Public Law 104-121) defines a major rule for the purpose of
congressional review as having caused or being likely to cause one or
more of the following: an annual effect on the economy of $100 million;
a major increase in costs or prices; significant effects on
competition, employment, productivity, or innovation; or significant
effects on the ability of United States-based enterprises to compete
with foreign-based enterprises in domestic or export markets. In
accordance with the Small Business Regulatory Enforcement Fairness Act,
OMB has determined that this final rule is a major rule for the purpose
of congressional review.
In addition, FDA has determined that this rule is not a significant
rule under the Unfunded Mandates Reform Act of 1995 (UMRA) requiring
benefit-cost and other analyses. Under UMRA a significant rule is
defined as ``a Federal mandate that may result in the expenditure by
State, local and tribal governments in the aggregate, or by the private
sector, of $100,000,000 (adjusted annually for inflation) in any 1
year''.
This Final Regulatory Impact Analysis reflects changes made in the
regulation from the proposed rule to the final rule and changes in
estimates as a response to comments. It also includes responses to
comments on the PRIA. Where there were no changes in the estimates
provided in the PRIA, the estimates are summarized here. Interested
persons are directed to the text of the PRIA (Ref. 6) for a fuller
explanation of the estimates over which there was no controversy or
changes. The PRIA discussed a number of regulatory alternatives. FDA
received some comments on these alternatives, however, none were
specifically economic in nature. Thus, FDA's responses to comments on
these alternatives are given in section III.1. There were no specific
economic comments on the regulatory alternatives outlined in the PRIA.
B. Factors Considered in Developing This Analysis
This final rule requires all juice processors (as defined in the
rule), regardless of size, to implement a HACCP program with a 5-log
reduction (that is, a 100,000-fold reduction in pathogens) performance
criterion. In the proposed rule, FDA tentatively exempted retailers. In
addition, FDA tentatively decided to exempt as retailers very small
businesses that make juice on their premises and whose total sales of
juice and juice products do not exceed 40,000 gallons per year and who
sell directly to consumers and other retailers. Based on the comments
and other information, FDA has determined that it is necessary to cover
such very small businesses. The estimated benefits and costs for this
final rule reflect this change in the coverage of the rule.
Table 1 gives the time to the effective dates by size of firm in
terms of time from the date of publication of this final rule.
Table 1.--Time to Effective Date by Size of Firm
------------------------------------------------------------------------
Firm size Time to effective date
------------------------------------------------------------------------
Large firms............................... 12 months.
Small firms............................... 24 months.
Very small firms.......................... 36 months.
------------------------------------------------------------------------
For purposes of this rule, the agency is defining large processors
as those who have more than 500 employees, small processors as those
who have less than 500 employees and very small processors as those who
have: (1) Total annual sales of less than $500,000, or (2) that have
total annual sales of greater than $500,000 but total annual food sales
of less than $50,000, or (3) that employ fewer than 100 full-time
equivalent employees and annually sell less than 100,000 units of the
juice in the United States.
This rule follows the implementation of the juice labeling rule,
which covers juice that is packaged and has not been subjected to a 5-
log reduction treatment. Because the coverage of the juice labeling
rule and this juice HACCP rule overlap, and because to some extent both
rules address microbial hazards associated with juice, it is necessary
to take into account the benefits and costs estimated for juice
labeling to avoid double-counting benefits and costs for juice HACCP.
C. Benefits
This analysis provides estimated benefits due to reduced adverse
health effects. Presented here is a summary of the analysis provided
for the proposed rule. Comments are addressed, and any changes from the
analysis for the proposed rule are detailed in each section as
appropriate.
FDA uses the following steps to estimate health benefits:
1. The most significant hazards in juice are described in terms of
severity and duration;
2. The hazards are described in terms of resulting health effects
and symptoms when they cause illness;
3. The health effects and symptoms are translated into consumer
utility losses;
4. The utility losses are translated into values in terms of lost
dollars (this gives the cost per case for every combination
[[Page 6180]]
of level of severity and for the specified duration for each hazard);
5. The average annual number of reported cases associated with
juice covered by this final rule are listed;
6. The factors used to account for under reporting of foodborne
illness are explained;
7. The estimates of the average annual number of cases are given;
8. The estimated number of cases is divided according to level of
severity;
9. The percentages of each type of hazard expected to be prevented
by the proposal are listed; and
10. The total health benefits of the proposal are derived by
multiplying steps 4, 7, and 8.
That is, TB = RC x CF x CR x V, where
TB = total health benefits in dollars,
RC = number of reported cases,
CF = under reporting correction factor,
CR = percent of cases reduced,
V = dollar value per case averted (medical costs + value of pain and
lost function).
One comment stated that FDA had underestimated the amount of
untreated juice consumed and, therefore, had underestimated the number
of cases of illness associated with juice. FDA disagrees that the cases
of illness addressed by the rule have been underestimated due to
incorrect consumption estimates. FDA did not estimate the number of
illnesses based on consumption. Instead, the agency estimated the
number of illnesses by multiplying confirmed illnesses associated with
juice by factors accounting for under-reporting of foodborne illness.
Thus, FDA does not agree with this comment.
One comment questioned the model used to calculate benefits and
asked if it has been ``calibrated.'' The comment did not explain how
the word calibrated is used in this case. FDA assumed that it meant to
compare the estimates obtained using this model with the actual number
of illnesses related to juice. FDA has used this model to calculate
benefits for rules involving microbial hazards since 1994. The model is
an adaptation of peer-reviewed research on estimating the costs of
illness and injury (Ref. 74). The model is the best method known to FDA
for estimating the benefits of rules involving microbial hazards, and
is similar to that used by FSIS for similar rules. Because the actual
number of cases of illness is not observable, it is not possible to
compare the model's estimates to the actual number of illnesses.
1. Description of Microbial Hazards in Juice
The most significant health risks associated with juice products
are those that result from microbial contamination. There are other
non-microbial potential hazards related to juice that this rule is
designed to control. FDA does not have enough data to quantify benefits
for these non-microbial hazards. From 1992 to 1998 the hazards
associated with commercially processed, packaged juice produced by
nonretail establishments included Bacillus cereus, Cryptosporidium
parvum, E. coli O157:H7, and Salmonella non typhi. Most of the
information in section C of this document (Benefits) is taken from
``Appendix: Preliminary Investigation into the Morbidity and Mortality
Associated with the Consumption of Fruit and Vegetable Juices'' (Ref.
6, the Appendix). The Appendix includes hazards other than those for
which benefits have been estimated in this analysis. The hazards
considered in section C of this document are those for which the risk
is highest, meaning that they are the most significant in terms of
probability of occurrence and/or severity of outcome.
Some comments stated that C. parvum should have been included in
the estimate of benefits for the HACCP proposal. The comments cite
FDA's inclusion of C. parvum in the list of hazards in the Appendix.
FDA included C. parvum as a hazard addressed by the labeling rule but
not as a hazard addressed by the proposed HACCP rule. The only
documented cases of juice-related C. parvum illnesses from commercially
produced products from 1992 to 1996 were from juice produced by
processors making less than 40,000 gallons per year. Because these
processors were included under the retail exemption from the proposed
HACCP rule, the proposed HACCP rule would not have addressed the C.
parvum hazard. Because this final HACCP rule covers all processors
regardless of the volume of juice they produce, C. parvum is a hazard
addressed by this final rule.
2. Description of Health Effects and Symptoms of Microbial Hazards in
Juice
In order to quantify the loss (disutility) that individuals
experience from becoming ill, the pain, suffering, and mobility loss
must be scaled. Individuals who become ill suffer losses of functional
status in terms of mobility, ability to do other physical activity, and
ability to engage in social activities. Individuals who become ill also
experience additional losses from the symptoms of the illness.
One comment stated that symptoms and functional effects associated
with some cases are more severe than those described by FDA. FDA agrees
with this comment. However, it is equally true that symptoms and
functional effects associated with some cases are less severe than
those described by FDA. The symptoms and functional effects described
by FDA were developed with the assistance of medical doctors at FDA and
are those of a typical case for each level of severity for each hazard.
Effects vary to a considerable degree across cases of any illness or
disease. Such variance is not captured by this analysis. However, FDA
believes that the use of typical cases is appropriate for this
analysis.
3. Utility Losses From Microbial Hazards in Juice
Decreases in functional status and symptoms and problems associated
with illness translate into values of disutility. Utility losses for
survivors are derived by multiplying the total disutility per day by
the number of days that symptoms of the illness persists. This gives
the utility loss for survivors in terms of the number of quality
adjusted life days (QALD's) for each case of the categories of severity
for each hazard. A QALD is a day of perfect health.
4. Value of Losses From Microbial Hazards in Juice
FDA values a QALD at $630. The value of utility losses for
survivors comes from multiplying the number of QALD's lost due to the
illness by the value of a QALD. This represents the value of pain and
function losses that individuals experience. Additionally, there are
the societal costs of medical treatment. These costs are shared
generally between insurance companies and individuals. They include all
aspects of medical expenses (e.g., physician visits, laboratory tests,
prescriptions and therapies, hospital stays). The value of losses per
case is the sum of the value of utility losses for survivors and the
medical costs for the categories of severity for each hazard.
5. Distribution of the Reported Cases per Year for Microbial Hazards in
Juice
The analysis for the proposed rule used the average number of
reported cases from 1992 through 1996 for each hazard for the types of
products covered by the rule.
Some comments claimed that FDA had miscalculated the benefits of
the HACCP proposal by including outbreaks associated with non-
commercially
[[Page 6181]]
produced juice. Although other parts of the proposed rule and the
Appendix refer to outbreaks associated with non-commercially produced
juice, the estimate of the benefits of the HACCP rule was based only on
outbreaks associated with commercially produced juice.
Some comments stated that FDA had miscalculated the average number
of cases per year. These comments used data presented in the Appendix
to recalculate the average number of cases per year. The comments were
confused because the Appendix lists several outbreaks that were
associated with non-commercially produced juice. Because this
regulation covers only commercially produced juice, outbreaks
associated with non-commercially produced juice were not included in
the calculation of the average annual number of cases. Thus, the
average annual number of cases was properly calculated.
Tables 2 and 3 should clarify which outbreaks FDA has used in this
analysis, and why some outbreaks were not used.
Table 2.--Juice Outbreaks (1992 to 2000) Used To Calculate Benefits
----------------------------------------------------------------------------------------------------------------
Number of
Product and year of event Hazard cases Source of data on event
----------------------------------------------------------------------------------------------------------------
Orange juice, 1994....................... B. cereus................... 85 FDA recall data.
Orange juice, 1995....................... Salmonella spp.............. 62 Outbreak data.
Apple juice, 1996........................ E. coli O157:H7............. 70 Outbreak data.
Apple juice, 1996........................ E. coli O157:H7............. 14 Outbreak data.
Apple juice, 1996........................ C. parvum................... 31 Outbreak data.
Apple juice, 1996........................ E. coli O157:H7............. 1 Pennsylvania State Health
Dept.
Orange juice, 1999....................... Salmonella muenchen......... 423 Outbreak data.
Apple juice, 1999........................ E. coli O157:H7............. 9 Oklahoma State Health Dept.
Orange juice, 2000....................... Salmonella enteritidis...... 88 Outbreak data.
----------------------------------------------------------------------------------------------------------------
Table 3.--Juice Outbreaks (1992 to 2000) Not Used to Calculate Benefits
----------------------------------------------------------------------------------------------------------------
Source of data on
Product and year of event Hazard Number of cases event Reason not included
----------------------------------------------------------------------------------------------------------------
Orange juice Mixing Compound, Salmonella agona. 25............... FDA recall Data.. Orange Julius compound
1992. is mixed with juice
at the retail
location but does not
contain juice.
Apple juice, 1993.............. C. parvum........ 160.............. Outbreak Data.... Juice not made by
commercial
establishment.
Juice flavored Drinks, 1993.... C. parvum........ Unknown.......... FDA recall Data.. Approved municipal
water supply was
contaminated, rule
not expected to
prevent such
occurrences.
Carrot juice, 1993............. Clostridium 1................ Washington State Home-made product.
botulinum. Health Dept.
Orange juice, 1993............. Unknown.......... 23............... Ohio State Health Contamination likely
Dept. caused by consumer.
Watermelon Juice, 1993......... S. spp........... 18............... Florida State Home-made product.
Health Dept.
Apple juice, 1996.............. E. coli 157:H7... 6................ Outbreak data.... Juice not made by
Commercial
establishment.
----------------------------------------------------------------------------------------------------------------
Some comments claimed that FDA's analysis had not taken into
account the efforts to control hazards made by the industry after the
October 1996 outbreak. To estimate the number of illnesses that the
proposed rule would prevent, FDA used the most recent 5-year period for
which final CDC numbers were available. In the analysis of the proposed
rule, FDA did not include 1997 in the estimate of illnesses that the
rule would prevent because there was too great of a possibility that
illnesses that had actually occurred had not yet been reported. FDA can
now add the 1997 to 2000 experience to the 1992 to 1996 experience. By
doing so FDA addresses this comments concern. The average number of
cases reported per year for each hazard is described in table 4.
Table 4.--Average Reported Cases Per Year for Microbial Hazards in Juice
(1992 to 2000)
------------------------------------------------------------------------
Average No. of
Hazard cases reported
per year
------------------------------------------------------------------------
B. cereus............................................ 2
C. parvum............................................ 3
E. coli O157:H7...................................... 10
Salmonella (non-typhi)............................... 64
------------------------------------------------------------------------
6. Estimates of Factors Needed To Offset Underreporting of Foodborne
Illness
It is widely recognized that the total number of foodborne
illnesses is much greater than those numbers reported to the CDC. In
order to compensate for the rate of underreporting, the number of known
cases associated with a hazard (i.e., reported to CDC) is multiplied by
factors that are estimated to account for underreporting.
One comment took issue with the underreporting correction factors
used by FDA. The comment stated that no underreporting correction
factor should ever exceed 100. In the analysis accompanying the
proposed rule, FDA used two estimates of underreporting correction
factors that have been widely cited on this issue. FDA does not agree
that underreporting correction factors should never exceed 100. The
appropriate correction factors are those based on the best information
available, without any limit created by a predetermined number.
Since the PRIA, CDC has published estimates of foodborne illness;
in this final estimate of costs and benefits, FDA
[[Page 6182]]
is relying on these recent CDC estimates. The estimates of
underreporting correction factors used in the PRIA relied heavily on
research that was over 20 years old. In some cases, the research
preceded the recognition that E. coli O157:H7 was a pathogen. The
correction factors based on this research required a significant amount
of adaptation, extrapolation and interpolation by FDA. By relying on
the recent CDC estimates of foodborne illness to determine correction
factors, FDA is reducing its reliance on dated research and its own
extrapolations. FDA believes that the estimates of benefits based on
CDC estimates of foodborne illness should be more objective.
The underreporting correctiion factors calculated from the CDC
reported by Mead et al, show the relationship between estimated total
cases and culture-confirmed total cases. The factors are based on
surveys estimating the probability that: (1) A person who becomes ill
seeks medical care, and (2) the probability that the physician will
obtain a stool culture from the person, and (3) the probability that
the laboratory will test for the pathogen. The factor for a particular
pathogen is the inverse of the multiplicative product of those three
probabilities. FDA is relying on the CDC point estimates of the average
number of cases per year and the CDC underreporting factor. Because CDC
did not provide ranges for these estimates, FDA has insufficient
information to probide a range of estimates for the benefits of this
rule. FDA's use of a point estimate for the number of illnesses should
not, however, be interpreted as implying the absence of uncertainty
about these estimates.
For two of the hazards in this analysis, E. coli O157:H7 and
Salmonella, FDA has used correction factors based on the ratio of total
estimated cases to active surveillance cases estimated. FDA has used
these factors for these hazards because the juice outbreaks for these
hazards associated with this rule were discovered through the active
surveillance of the FoodNet system. The FoodNet system is designed to
identify interstate outbreaks and to more thoroughly discover cases
associated with an outbreak.
For B. cereus FDA has used a correction factor based on the ratio
of total estimated cases to reported outbreak cases. FDA has used this
factor for this hazard because the juice outbreaks for this hazard
associated with this rule were discovered through the standard outbreak
reporting process. B. cereus is not a hazard tested for in the FoodNet
system, and because of its mild symptoms is very likely to be
underreported.
For C. parvum FDA has used a correction factor based on the ratio
of total estimated cases to 10 percent of the estimated passive
surveillance cases. According to CDC, reported outbreak cases account
for only 10 percent of the cases accounted for through passive
surveillance. FDA has used this factor for C. parvum because the juice
outbreaks for this hazard associated with this rule were discovered
through the standard passive surveillance process. C. parvum is not a
hazard tested for in the FoodNet system, nor is it on the list of
hazards reportable to CDC. Because of its mild symptoms it is very
likely to be underreported.
The correction factors used in this analysis are given in table 5.
Table 5.--Estimates of Factors Needed To Offset Underreporting of
Foodborne Illness
------------------------------------------------------------------------
Hazard Correction factor
------------------------------------------------------------------------
B. cereus............................................ 380
C. parvum............................................ 1,071
E. coli O157:H7...................................... 20
Salmonella (non-typhi)............................... 38
------------------------------------------------------------------------
7. Estimates of Juice-Associated Cases Per Year
In table 6, FDA has estimated ranges of the likely annual number of
cases that occur for each of the four pathogens studied.
Table 6.--Estimate of Juice-Associated Cases Covered per Year
------------------------------------------------------------------------
Hazard Case
------------------------------------------------------------------------
B. cereus............................................ 3,420
C. parvum............................................ 3,210
E. coli O157:H7...................................... 200
Salmonella (non-typhi)............................... 2,430
------------------------------------------------------------------------
8. Estimate of Juice-Associated Cases per Year Not Prevented by
Labeling Rule
FDA estimated that the juice labeling rule would prevent up to 140
juice-associated illnesses (10 C. parvum, 40 E. coli, 90 Salmonella) as
consumers avoid consumption of untreated juice. This HACCP rule will
effectively supersede the labeling rule for all those processing
establishments covered by the labeling rule. Therefore, once it goes
into effect, the HACCP rule will be responsible for prevented juice-
related illnesses and not the labeling rule. However, this analysis
should attribute to the juice HACCP rule prevention of only those
illnesses that would not have been prevented by the juice labeling rule
had this rule not superseded it. To estimate the potential benefits of
this HACCP final rule, FDA subtracted 140 cases that were estimated to
be prevented by the labeling rule (assuming that 16 percent of
consumers read the label and do not consume untreated juice) from the
estimates provided in table 6. The 16 percent consumer response
estimates are the largest estimates of consumer response that FDA has
made for the juice labeling rule. Therefore, subtracting the 16 percent
consumer response estimates from the estimates of the total number of
juice-related illnesses yields the lowest number of illnesses that may
be prevented by this juice HACCP final rule. Table 7 gives estimates of
the number of juice-related illnesses per year not prevented by the
juice labeling rule. The estimates in table 7 come from subtracting the
estimated 140 cases prevented by the labeling rule from the estimated
cases in table 6.
Table 7.--The Estimated Number of Juice-Associated Cases Not Prevented by the Labeling Rule Divided According to
Level of Severity
----------------------------------------------------------------------------------------------------------------
Hazard Severity Percent Cases
----------------------------------------------------------------------------------------------------------------
Mild................................. 99 3,390
Moderate............................. 1 30
Severe............................... .03 1
B. cereus..................................... Total cases.......................... 100 3,421
Mild................................. 90 2,890
Moderate............................. 9 290
Severe............................... .7 20
Death................................ .02 1
C. parvum..................................... Total cases.......................... 100 3,200
[[Page 6183]]
Mild................................. 59 95
Moderate............................. 38 60
Severe-acute......................... 3 5
Severe-chronic....................... 4 10
Death................................ .0 0
E. coli O157:H7............................... Total cases.......................... 100 160
Mild................................. 68 1,590
Moderate............................. 31 730
Severe............................... 1 20
ReA-short term....................... 2 50
ReA-long term........................ 5 120
Death................................ 5 120
Salmonella (non typhi)........................ Total cases.......................... 100 2,340
----------------------------------------------------------------------------------------------------------------
9. Percent of Cases Preventable by HACCP Proposal
Table 8 indicates the percent of cases for each hazard expected to
be prevented by the rule. In general, most pathogens will be eliminated
when a 5-log treatment is applied. For example, E. coli O157:H7, C.
parvum and Salmonella should all be completely eliminated from juice by
standard methods of flash pasteurization (in the absence of
extraordinarily high counts, detrimental human intervention, or
equipment failure). However, hazards associated with B. cereus will not
necessarily be eliminated by heat treatment. This bacterium forms
spores that are more difficult to kill by the usual heat process
applied to juice.
In the proposed rule, FDA tentatively exempted certain small retail
processors. FDA estimated that the exemption for small retail
processors would affect 14 percent of the volume of unpasteurized
juice. Therefore, the agency estimated that though pathogen controls
may be 100 percent effective in controlling some hazards, such controls
would only prevent 86 percent of the cases of illness from these
hazards, because of the 14 percent of juice not covered. The final rule
covers all processors of juice as defined in the final rule; therefore,
controls will affect the full volume of juice made by processors.
(Retailers are not covered by this rule. Retailers are those businesses
that sell only direct to consumers and include grocery stores,
supermarkets, farms, roadside stands, restaurants, and eating places.)
Table 8.--Percent of Cases Preventable by HACCP Proposal
------------------------------------------------------------------------
Percent of cases
Hazard preventable by
HAACP proposal
------------------------------------------------------------------------
B. cereus............................................ 10
C. parvum............................................ 100
E. coli O157:H7...................................... 100
Salmonella (non typhi)............................... 100
------------------------------------------------------------------------
Table 9 indicates the number of cases for each hazard expected to
be prevented by the rule.
Table 9.--Estimates of Juice-Associated Cases per Year Prevented by HACCP Rule
----------------------------------------------------------------------------------------------------------------
Percent of
Hazard Severity cases Cases
----------------------------------------------------------------------------------------------------------------
Mild................................. 99 340
Moderate............................. 1 0
Severe............................... .3 0
B. cereus..................................... Total case........................... 100 340
Mild................................. 90 2,890
Moderate............................. 9 290
Severe............................... 7 20
Death................................ .02 1
C. parvum..................................... Total cases.......................... 100 3,200
Mild................................. 59 95
Moderate............................. 38 60
Severe-acute......................... 3 5
Severe-chronic....................... 4 10
Death................................ .08 0
E. coli O157:H7............................... Total cases.......................... 100 160
Mild................................. 68 1,590
Moderate............................. 31 730
Severe............................... 1 20
ReA-short term....................... 2 50
ReA-long term........................ 5 120
Death................................ .04 1
Salmonella (non typhi)........................ Total cases.......................... 100 2,340
----------------------------------------------------------------------------------------------------------------
[[Page 6184]]
10. Estimates of Annual Benefits for HACCP Proposal
The total benefits for the categories of severity for each hazard
are derived by multiplying the number of cases prevented by this rule
by the estimates of the value of utility losses and medical costs per
case. The sum of those benefits for each hazard is the total benefits
of this rule for pathogen control. Table 10 gives the estimate of
benefits for each hazard.
Table 10.--Estimates of Juice-Associated Cases per Year Preventable by
HACCP Rule
------------------------------------------------------------------------
Hazard Severity Dollars
------------------------------------------------------------------------
Mild.............. $102,000
B. cereus....................... Total............. 102,000
Mild.............. 5,780,000
Moderate.......... 1,450,000
Severe............ 360,000
Death............. 5,000,000
C. parvum....................... Total............. 12,590,000
Mild.............. 190,000
Moderate.......... 240,000
Severe-acute...... 165,000
Severe-chronic.... 12,210,000
E. coli O157:H7................. Total............. 12,805,000
Mild.............. 1,590,000
Moderate.......... 1,460,000
Severe............ 320,000
ReA-short term.... 350,000
ReA-long term..... 117,120,000
Death............. 5,000,000
Salmonella (non typhi).......... Total............. $125,840,000
------------------------------------------------------------------------
Table 11 presents the estimate of annual benefits based on table
10.
Table 11.--Estimates of Annual Microbially Related Benefits for HACCP
Proposal
------------------------------------------------------------------------
Hazard Dollars
------------------------------------------------------------------------
B. cereus............................................ $102,000
C. parvum............................................ 12,590,000
E. coli O157:H7...................................... 12,805,000
Salmonella (non typhi)............................... $125,840,000
------------------
Total.............................................. 151,000,000
------------------------------------------------------------------------
11. Pesticide Residues
There are two potential benefits associated with the regulation of
pesticides: (1) Decreases in cancer and other illness caused by chronic
consumption of pesticide residues and, (2) social benefits associated
with reductions in the costs of recapturing firm goodwill. FDA cannot
quantify the cost savings that will occur because of more vigilant
monitoring of pesticide residues by firms under a HACCP rule.
12. Summary of Benefits
Table 12 summarizes the benefits of this rule.
Table 12.--Benefits of Juice HACCP Rule
------------------------------------------------------------------------
Type of benefit Annual value
------------------------------------------------------------------------
Reduced illness and death from Controlling $151 million.
pathogens.
Reduced harm from physical and chemical Not quantified, effects
hazards. often long-term and
probably small.
Total Quantified Benefits................. $151 million
------------------------------------------------------------------------
D. Costs
The costs of these rules have been estimated by multiplying the
costs for each proposed requirement on a per-plant basis by the number
of plants affected by each requirement. Cost per plant will vary by
current practice, product, and size.
1. Coverage
In the proposal, FDA tentatively decided that retailers would
include processors that are very small businesses, that make juice on
their premises, and that directly sell juice or juice products to
consumers and other retailers--provided that retail sales of juice and
juice products do not exceed 40,000 gallons per year. As noted, FDA has
decided in the final rule not to exclude such processors from the
rule's requirements. The final rule covers all processors of juice
except those who are retailers. Retailers are those businesses that
sell only direct to consumers and include grocery stores, supermarkets,
farms, roadside stands, restaurants, and other eating places.
Since FDA published the proposed rule, it collected data showing
that 24 percent of very small apple juice processors only sell juice
direct to consumers. FDA assumes that the same percentage of very small
orange juice processors only sell juice direct to consumers. Therefore,
about 380 very small apple and 70 very small orange juice processors
are exempted from the rule as retailers.
FDA estimated that 5 percent (about 50 plants) of the 900 plants in
the FDA Official Establishment Inventory (OEI) would have implemented
HACCP as required by this rule by the effective date of the rule even
if FDA had not done this rulemaking. No HACCP costs are attributable to
this rule for these plants.
Table 13 shows the estimated number of establishments affected by
the rule. These numbers exclude the retailers and the 5 percent of
plants already doing HACCP.
Table 13.--Number of Plants Affected by the Rule
------------------------------------------------------------------------
Number of
Plant type establishments
affected
------------------------------------------------------------------------
Juice manufacturers in the OEI....................... 850
Very small apple juice makers........................ 1,220
Very small orange juice makers....................... 230
Total.............................................. 2,300
------------------------------------------------------------------------
2. Length of Production Period
The agency has assumed that 50 percent of the 850 plants in the OEI
plus all of the 1,450 very small juice makers affected by the HACCP
rule produce seasonally. Table 14 shows the length of the production
period for plants producing seasonally and year round.
Table 14.--Plants' Production Period
------------------------------------------------------------------------
Weeks of Hours of
operation operation Number of
per year per day plants
------------------------------------------------------------------------
Seasonal......................... 16 12 1,875
Year Round....................... 52 24 425
Total.......................... 2,300
------------------------------------------------------------------------
[[Page 6185]]
3. Cost Estimates by Requirement
a. HACCP costs.
i. CGMP's (Sec. 120.5)
ii. Prerequisite Program SOP's (Sec. 120.6)
iii. Hazard Analysis (Sec. 120.7)
iv. HACCP Plan (Sec. 120.8)
v. Corrective Actions (Sec. 120.10)
vi. Verification and Validation (Sec. 120.11)
vii. Process Verification for Certain Citrus Processors(Sec. 120.25)
viii. HACCP Records (Sec. 120.12)
ix. Training (Sec. 120.13)
x. Imports and Foreign Processors (Sec. 120.14)
b. Summary of Costs.
c. Take First Year and Recurring Cost Per Activity.
a. HACCP costs.--i. CGMP's (Sec. 120.5). No costs are attributed to
this section for this rulemaking. In 1996, only 6 percent of the plants
inspected were cited for official action. Thus, an overwhelming
majority of firms are complying with part 110. Therefore, there is no
additional cost of complying with this provision because plants are
already complying with part 110. Therefore, FDA assumed that this rule
will have no effect on the enforcement of the CGMP's for juice
products.
ii. Prerequisite program SOP's (Sec. 120.6).--Developing SOP's. The
cost per plant of developing SOP's is approximately $260. If one half
of the 850 domestic plants in the OEI and all of the 1,450 very small
juice processors do not currently have SOP's, then they will have to
develop them to comply with this regulation. Under these assumptions,
the total cost for the industry to develop SOP's is approximately
$488,000 ($260 x 1,875 plants).
Implementing sanitation controls with corrections of deviations
from SOP's. Based on information from inspection reports, FDA assumes
that about 30 percent of all 2,300 covered juice plants (about 690
plants) are likely to have sanitation controls that are insufficiently
implemented, but which do not warrant administrative or regulatory
action. If it costs each of these 690 plants $500 to implement
sanitation controls and to correct deviations from SOP's earlier than
they would do otherwise, then the total cost for this requirement is
$345,000. Because this cost is discounted, it is added as a one-time
expenditure in the total costs.
Monitoring and documenting of SOP's. Table 15 shows the
distribution of per plant and total industry costs based on the
estimate in table 25 for SOP monitoring and documenting needed to
comply with this rule.
Table 15.--Total Annual Cost of SOP Monitoring and Documenting
----------------------------------------------------------------------------------------------------------------
Annual per
plant SOP Annual SOP
monitoring and Number of monitoring and
documenting plants documenting
cost cost
----------------------------------------------------------------------------------------------------------------
Seasonal........................................................ $100 1,662 $166,000
Year round...................................................... 340 213 72,000
-----------------------------------------------
Totals...................................................... 1,875 238,000
----------------------------------------------------------------------------------------------------------------
iii. Hazard analysis (Sec. 120.7). FDA estimates that performing a
hazard analysis takes 20 labor hours. At $13 per labor hour the cost of
performing a hazard analysis is about $250 per plant. Approximately
2,300 plants will need to perform a hazard analysis to comply with this
rule. Therefore, the total cost to perform a hazard analysis is
approximately $575,000.
iv. HACCP plan (Sec. 120.8)--HACCP plan development. FDA estimates
that developing a HACCP plan takes 60 labor hours. At $13 per labor
hour the cost of developing a HACCP plan is about $750 per plant. Only
those plants that determine from their hazard analysis that they have
hazards that are reasonably likely to occur will have to develop a
HACCP plan.
Processors that produce shelf-stable or juice concentrate may
conclude after their hazard analysis that they need not include
pathogen control in any HACCP plan as required by Sec. 120.24(a), if
they include a copy of the thermal process in their written hazard
analysis. These processors only need a HACCP plan if they have other
hazards that are reasonably likely to occur.
Table 16 shows those processors expected to develop HACCP plans.
Adding the categories of processors that develop HACCP plans yields
a total of about 1,560 out of the original 2,300 processors that
perform a hazard analysis. This may be a small overestimate because
some of the citrus processors that now do not make self-stable products
may begin to do so because of this rule. It also may be a small
overestimate because of the small potential for overlap among the
categories.
Table 16.--Number of Plants with HACCP Plans
------------------------------------------------------------------------
------------------------------------------------------------------------
Processors with pathogen Hazards............................... 1,460
Processors with natural toxin Hazards.......................... 20
Processors with pesticide Hazards.............................. 80
--------
Total processors with HACCP Plans.......................... 1,560
------------------------------------------------------------------------
Approximately 1,560 plants will need to develop a HACCP plan at a
cost of $750 each to comply with this rule. Therefore, the total cost
to develop HACCP plans is approximately $1,170,000.
Pathogen controls. In response to this rule, many processors that
are not now heat-treating their products are likely to begin doing so.
Processors may choose any lawful means to achieve the required 5-log
reduction. However, costs here are estimated for pasteurization as the
lowest-cost technology now available.
In the PRIA FDA estimated that costs for initiating pasteurization
range from $18,000 for a very small seasonal operation to $35,000 for a
larger year round operation. FDA received many comments claiming that
the initial cost for initiating pasteurization was $30,000 even for a
small operation. Because of the number of comments claiming that the
initiation of pasteurization would cost $30,000 for a small operation,
FDA has used a range for its estimate of the cost of initiating
pasteurization for very small processors.
Of the 2,300 processors covered by the HACCP rule only a portion of
these will need to initiate pasteurization. In this final rule,
processors of shelf-stable juice and juice concentrate will not need to
incur additional costs for the control of pathogens. FDA estimates that
this new provision in the final rule applies to about 600 processors
(70 percent of the processors listed in the OEI) affected by this rule.
[[Page 6186]]
FDA estimates that all but 20 of the rest of the affected
processors listed in the OEI (230 plants) and 30 percent of the 1,220
very small apple juice processors (370 plants) are already operating
pasteurization equipment. Therefore, 600 plants do not need to
implement additional pathogen controls.
For the purpose of this analysis, FDA has concluded that it is
unlikely that fresh orange juice processors will have to pasteurize
their products to achieve a 5-log reduction when a HACCP program is
adopted because of the nature of the fruits, the availability of
effective surface treatments and the methods of juice extraction
commonly used by industry. However, given the information gained from
the December 1999 NACMCF meeting on citrus juice and the several recent
outbreaks associated with fresh citrus juice, it is clear that most
fresh orange processors will need to incur additional costs to
implement effective 5-log pathogen reduction controls. In the PRIA, FDA
estimated that costs for these processors were limited to the costs of
creating and operating a HACCP system with appropriate monitoring and
recordkeeping of the necessary CCP's, not to purchasing pasteurizing
equipment. In this final analysis, FDA is estimating costs for fresh
orange juice processors to improve pathogen controls. Although the
measures to improve such controls will not necessarily be
pasteurization, FDA is estimating these costs to be equivalent to the
costs for initiating pasteurization. FDA only has cost data for
pasteurization which is also the only widely-adopted commerical
technology for controlling pathogens in juice. Citrus processors may
choose to adopt a technology more expensive that the $18,000 to $30,000
estimated here for the implementation of pasteurization. However, the
more expensive technologies would likely be adopted for reasons other
than compliance with this rule.
Therefore, 20 affected processors listed in the OEI, 300 very small
citrus processors and 850 very small apple juice processors (a total of
1,170 plants) will incur costs to implement additional pathogen
controls. Table 17 shows the first year total cost of pathogen control
attributable to the HACCP rule.
Table 17.--First Year Cost of Pathogen Control Attributable to HACCP Proposal
----------------------------------------------------------------------------------------------------------------
Number of
Processor type Cost per plant plants Total
----------------------------------------------------------------------------------------------------------------
Very small apple juice processors............................ $18,000-$30,000 850 $15,300,000-25,50
0,000
Very small orange juice processors........................... 18,000-30,000 300 5,400,000-9,000,0
00
Juice processors in the OEI.................................. 35,000-58,000 20 700,000-1,160,000
--------------------------------------------------
Total.................................................... ................. 1,170 21,400,000-35,660
,000
----------------------------------------------------------------------------------------------------------------
Pasteurization will require ongoing costs for operation and
maintenance. FDA estimates these annual costs for labor, utilities, and
materials subsequent to the first year to be $7,000 per year for very
small processors and $8,000 per year for processors in the OEI. The
total cost of pathogen control in subsequent years is given in table
18.
Table 18.--Subsequent Year Cost of Pathogen Control Attributable to HACCP Rule
----------------------------------------------------------------------------------------------------------------
Number of
Processor type Cost per plant plants Total
----------------------------------------------------------------------------------------------------------------
Very small apple juice processors............................... $7,000 850 $5,950,000
Very small orange juice Processors.............................. 7,000 300 2,100,000
Juice processors in the OEI..................................... 8,000 20 160,000
-----------------------------------------------
Total....................................................... .............. 1,170 8,210,000
----------------------------------------------------------------------------------------------------------------
Other costs are related to processing for pathogen control. The
pasteurization of juice causes changes in the characteristics of the
products, primarily in terms of texture and taste. Some current
consumers of nonheat-treated juice will bear the costs of losing a
particular product as well as costs of searching for products with the
characteristics that they prefer. Thus, one cost of these regulations
is the limited loss of ``fresh'' juice: that is, juice that is not heat
(or otherwise) processed.
Some consumer comments indicated a strong preference for fresh
juice; however, although FDA expressly asked for comments on this issue
in its November 1999 notice, no comments suggested any means of
estimating this cost. FDA has no information on how readily consumers
will accept pasteurized juice in the place of fresh juice nor does FDA
have any other information that could be used to estimate that cost.
Glass and direct food additive HACCP controls. FDA has not
attributed any costs for control of glass or unapproved direct food
additives although these potential hazards are among those that are
likely to be relevant for juice. The agency believes that even if
broken glass is determined to be a hazard to processors packing juice
in glass, these processors are already currently implementing every
feasible control for this potential hazard in order to limit their
liability and to provide consumer protection. Additionally, although
approximately 25 percent of the processing plants pack juice in glass
containers, this number is diminishing rapidly for economic and safety
reasons.
Regarding food additives, many juice products contain food or color
additives for the purpose of coloring or extending product shelf life.
However the agency
[[Page 6187]]
believes that even if unapproved food additives are determined to be a
hazard, these processors using direct food additives in juice are
already currently implementing sufficient controls for these potential
hazards as FDA strictly regulates them.
Natural toxin controls. FDA believes that in most every case
processors of domestic apples should be able to control natural toxin
hazards such as patulin, by processing controls such as washing and
culling. This can be accomplished at no additional cost.
Processors using imported juice concentrate are likely to need to
initiate a sampling regime for natural toxins. FDA assumes that the 23
large plants will randomly sample 30 shipments per year at a cost of
$150 per sample. The total marginal cost of patulin testing is
approximately $104,000 (30 tests x $150/test x 23 firms). Costs per
plant are $4,500. If any lots are found positive, costs will be
incurred for taking corrective action.
Pesticide controls. FDA believes that all 175 affected plants
operated by large firms are currently doing a sufficient amount of
sampling and monitoring (or receiving supplier certificates) for
pesticides residues. Therefore, FDA assumed that there are no
additional costs for large firms to control this potential hazard. This
does not mean that FDA believes that no large firms will identify
pesticides as a hazard that needs to be controlled under HACCP. Large
and small firms are more likely than very small firms to use imported
produce, which may not be subjected to as strict controls as U.S.
produce in all cases. FDA believes that 10 percent of all large and
small firms (80 plants total) will determine that pesticide hazards are
reasonably likely to occur. However, FDA believes that all large firms
are already sufficiently addressing this issue with present
expenditures. FDA made this estimate based on its knowledge of the
magnitude of the pesticide problem in juice.
If processors determine that pesticide residues are hazards for
their product, then they must run pesticide residue tests to ensure
that there are no pesticides either over tolerance or used on products
for which there is no tolerance. FDA believes that 10 percent of the
shipments received by small processors must be covered by a sampling
plan. Sixty-five small plants are believed to cover their shipments
with a pesticide-sampling plan. Average cost per plant is estimated to
be $1,500. The total annual marginal cost of pesticide testing is
approximately $98,000 (10 tests x $150/test x 65 firms).
v. Corrective actions (Sec. 120.10).--Corrective action plan. The
development of a corrective action plan for juice products is less
expensive than revalidation after each deviation from a CL. FDA
estimates that a corrective action plan for juice products can be
developed in 4 hours with a cost per plant of approximately $50 (about
4 hours of management time).
All of the plants that develop HACCP plans as a result of this rule
will develop corrective action plans to comply with this rule. The
total cost for 1,560 plants at $50 each to develop corrective action
plans is approximately $78,000.
Corrective actions. Plants operating under HACCP plans will take
corrective actions when CL's are exceeded for hazards such as pesticide
residues, unacceptable fruit for pathogen controls, and presence of
natural toxins. Costs of corrective actions are expected to decline as
processors gain more experience under a HACCP system and as the number
of corrective actions decreases. Tables 19 and 20 show the estimated
first year and subsequent year costs of corrective actions per plant.
Table 19.--Cost of First Year Corrective Actions
----------------------------------------------------------------------------------------------------------------
Number of
Plant type Cost per plant plants Total cost
----------------------------------------------------------------------------------------------------------------
Seasonal........................................................ $450 1,490 $671,000
Year round...................................................... 1,460 70 102,000
-----------------------------------------------
Totals...................................................... 1,560 773,000
----------------------------------------------------------------------------------------------------------------
Table 20.--Cost of Subsequent Year Corrective Actions
----------------------------------------------------------------------------------------------------------------
Number of
Plant type Cost per plant plants Total cost
----------------------------------------------------------------------------------------------------------------
Seasonal........................................................ $110 1,490 $164,000
Year round...................................................... 340 70 24,000
-----------------------------------------------
Totals...................................................... 1,560 188,000
----------------------------------------------------------------------------------------------------------------
Verification and validation (Sec. 120.11).--Verification. The
record verification cost per plant per production cycle is given in
table 21.
Table 21.--Cost of Record Verification
----------------------------------------------------------------------------------------------------------------
Number of
Plant type Cost per plant plants Total cost
----------------------------------------------------------------------------------------------------------------
Seasonal........................................................ $420 1,490 $626,000
Year Round...................................................... 1,350 70 95,000
-----------------------------------------------
Totals...................................................... .............. 1,560 721,000
----------------------------------------------------------------------------------------------------------------
Validation. Processors with HACCP plans must validate their HACCP
plans during the first year after implementation and at least annually,
or whenever any changes occur that could affect or alter the hazard
analysis, or
[[Page 6188]]
HACCP plan. Further, processors who have no HACCP plans because there
are no hazards that are reasonably likely to occur in that process (as
may be the case with processors of shelf-stable or concentrated juice),
the processor must reassess their hazard analysis when any significant
change occurs. Examples of things that may change include: (1) Raw
material specifications or sources of raw materials, (2) product
formulation, (3) processing methods or systems, (4) packaging, (5)
finished product distribution systems, or (6) intended consumers or use
by consumers.
Tables 22 and 23 give the estimated cost for validation in the
first and subsequent years.
Table 22.--Cost of First Year Validation
----------------------------------------------------------------------------------------------------------------
Number of Cost per Number of
Plant type validations validation plants Total cost
----------------------------------------------------------------------------------------------------------------
Seasonal Small Business..................................... 1 $1,000 1,640 $1,640,000
Year Round Business......................................... 2 1,000 120 240,000
Year Round Small Shelf-Stable or Concentrate Business....... 1 1,000 130 130,000
Year Round Large Business................................... 2 600 80 96,000
Year Round Large Shelf-Stable or Concentrate Business....... 1 600 95 57,000
---------------------------------------------------
Totals.................................................. 2,265 ........... 2,065 $2,163,000
----------------------------------------------------------------------------------------------------------------
Table 23.--Cost of Subsequent Year Validation
----------------------------------------------------------------------------------------------------------------
Number of Cost per Number of
Plant type validations validation plants Total cost
----------------------------------------------------------------------------------------------------------------
Seasonal Small Business..................................... 1 $1,000 1,490 $1,490,000
Year Round Small Business................................... 2 1,000 35 70,000
Year Round Large Business................................... 2 600 35 42,000
---------------------------------------------------
Totals.................................................. 1,630 ........... 1,560 1,602,000
----------------------------------------------------------------------------------------------------------------
vii. Process verification for certain citrus processors
(Sec. 120.25). Citrus processors that decide to rely on surface
treatments of the fruit to achieve the requisite 5-log reduction
(rather than treating the juice directly) are required to sample their
final product to verify the effectiveness of the HACCP plan. These
processors are required to test two 10 mL subsamples for generic E.
coli every 1,000 gallons or every 5 days whichever is more frequent.
FDA assumes that the cost of testing two 10 mL subsamples for generic
E. coli is $50. FDA estimates that there are 240 citrus processors that
will be affected by this section. To estimate the number of samples,
FDA began with the estimated annual U.S. untreated orange juice
consumption estimate of 11,700,000 gallons. FDA then assumed that 10
million gallons were packaged for resale and therefore covered by this
rule. FDA then assumed that the 180 processors that would sample at a
frequency of once every 5 days on average process 750 gallons during
that time. These processors are assumed to be seasonal processors
operating for only 16 weeks a year. FDA made these assumptions based on
its knowledge of microbial testing and beliefs about the volume of
untreated packaged juice sold by small processors. That set of
processors accounts for 2,160,000 gallons annually. The remaining 60
processors share production of the remaining 7,840,000 gallons
resulting in about 130 samples per year per processor.
Table 24 shows the estimated cost for process verification sampling
for these citrus processors.
Table 24.--Estimated Cost for Verification Sampling
----------------------------------------------------------------------------------------------------------------
Number of Number of Cost per
Sample frequency samples processors sample cost Total
----------------------------------------------------------------------------------------------------------------
Every 5 days................................................ 16 180 $50 $144,000
Every 1,000 Gallons......................................... 130 60 50 390,000
---------------------------------------------------
Total................................................... 10,720 240 ........... $534,000
----------------------------------------------------------------------------------------------------------------
Also, any time that 2 process-verification samples test positive
for generic E. coli in a series of 7 samples there is a process
verification failure. The processor must not sell the product without
further processing and must review its monitoring records, reevaluate
its HACCP plan, and if no obvious deficiencies in the HACCP plan are
discovered, must revalidate its HACCP plan. FDA estimates that even if
all citrus processors that rely on surface treatments to achieve a 5-
log reduction are fully successful in achieving the 5-log reduction, 2
samples in a series of 7 will test positive for generic E. coli once in
every 1,000 samples. Based on an estimate of 10,720 samples taken per
year, this will occur about 11 times per year. FDA assumes that the
cost of further processing of the product will be more expensive than
withdrawing and destroying the product, which should not exceed 1,000
gallons. FDA assumes that the cost of withdrawing and destroying the
product plus the cost of reviewing monitoring records, reevaluating and
revalidating HACCP plan is $20,000. FDA made this assumption based on
its experience with such small lot market withdrawls. Therefore, the
additional cost of a process verification failure is $220,000 per year.
The annualized cost of a process verification failure is $320 for a
seasonal processor sampling every 5
[[Page 6189]]
days ((16/1,000) x $20,000 = $320) and $2,600 for a year round
processor sampling every 1,000 gallons ((130/1,000) x $20,000 =
$2,600).
The total cost of process verification testing for untreated citrus
juice is $764,000 per year ($534,000 + $220,000 = $764,000).
viii. HACCP records (Sec. 120.12).--Monitoring and recordkeeping.
The additional monitoring and recordkeeping that needs to be done
throughout the entire plant is estimated to be equivalent to 5 percent
of one worker's time (3 minutes per hour of operation per plant). Table
25 shows the annual cost of additional monitoring and recordkeeping per
plant. It also shows the distribution of per plant costs and total
industry costs for the additional monitoring and recordkeeping needed
to comply with this final rule.
Table 25.--Cost of Monitoring and Recordkeeping
----------------------------------------------------------------------------------------------------------------
Plant type Cost per plant Number of plants Total cost
----------------------------------------------------------------------------------------------------------------
Seasonal............................................... $900 1,490 $1,341,000
Year Round............................................. 5,600 70 392,000
--------------------------------------------------------
Totals............................................. ................. 1,560 $1,733,000
----------------------------------------------------------------------------------------------------------------
Record maintenance and storage. The annual cost of record
maintenance and storage per plant is described in table 26.
Table 26.--Cost of Record Maintenance
----------------------------------------------------------------------------------------------------------------
Plant type Cost per plant Number of plants Total cost
----------------------------------------------------------------------------------------------------------------
Seasonal............................................... $360 1,490 $536,000
Year Round............................................. 830 70 58,000
--------------------------------------------------------
Totals............................................. ................. 1,560 $694,000
----------------------------------------------------------------------------------------------------------------
ix. Training (Sec. 120.13).--HACCP coordinator training. Processors
may need to employ a HACCP coordinator to carry out the duties
specified for such a person. FDA estimates that the cost of HACCP
coordinator training is $1,300 for each of the 2,300 processing plants,
or a total industry cost of $2,990,000.
Employee training in HACCP. Each processor with a HACCP plan will
need to train employees in their HACCP-related activities. This
analysis assumes that each plant must train 5 employees or 10 percent
of their employees in HACCP-related responsibilities, whichever is
greater. Table 27 describes the cost of training each employee for 8
hours annually (the equivalent of 40 minutes per month for 10 percent
of the employees) and the total cost of this level of training.
Table 27.--Cost of Employee Training
----------------------------------------------------------------------------------------------------------------
Number of
Average plant employment employees Cost per Number of Total cost
trained employee plants
----------------------------------------------------------------------------------------------------------------
3........................................................... 3 $100 1,459 $437,700
7........................................................... 5 100 10 5,000
15.......................................................... 5 100 19 9,500
35.......................................................... 5 100 28 14,000
75.......................................................... 8 100 29 23,200
175......................................................... 16 100 15 27,000
---------------------------------------------------
Totals.................................................. 5,160 ........... 1,560 $516,000
----------------------------------------------------------------------------------------------------------------
x. Imports and foreign processors (Sec. 120.14).--Importers. The
agency estimates that the cost of these activities will be $10,000 for
each of the 120 importers in the first year, decreasing to $5,000 in
subsequent years. Total costs for importers is $1,200,000 in the first
year and $600,000 in subsequent years.
Foreign juice processors. The estimated first year cost per foreign
juice exporter is approximately $26,000, and the cost in subsequent
years is $22,000. Therefore the total cost in the first year for 300
foreign processors is approximately $8 million and approximately $7
million in subsequent years. Tables 33 and 34 in the Regulatory
Flexibility Analysis, which follows, shows typical costs for large
plants that have not already implemented HACCP. The agency assumes that
these costs are representative of foreign plants exporting to the
United States.
b. Summary of Costs--The total quantified costs are approximately
$44 to $58 million in the first year and $23 million in all subsequent
years. Table 28 summarizes costs of the rule by provision.
[[Page 6190]]
c. Table 28.--Total First Year and Recurring Cost per Activity
------------------------------------------------------------------------
Activity First year costs Recurring costs
------------------------------------------------------------------------
Develop SOP's..................... $488,000 .................
Prerequisite Program SOP's........ 345,000 .................
Monitoring and Documenting for SOP 238,000 238,000
Hazard analysis................... 575,000 .................
HACCP plan........................ 1,170,000 .................
Pathogen controls................. 21,400,000-35,660 8,210,000
,000
Natural toxin controls............ 104,000 104,000
Pesticide controls................ 98,000 98,000
Corrective action plan............ 78,000 .................
Corrective actions................ 773,000 188,000
Verification...................... 721,000 721,000
Validation........................ 2,163,000 1,602,000
Process verification.............. 764,000 764,000
HACCP monitoring and recordkeeping 1,733,000 1,733,000
Record maintenance and storage.... 694,000 694,000
HACCP coordinator training........ 2,990,000 .................
Employee training................. 516,000 516,000
Importers......................... 1,200,000 600,000
Foreign processors................ 8,000,000 7,000,000
------------------------------------------------------------------------
Totals........................ 44,000,000-58,000 23,000,000
,000
------------------------------------------------------------------------
E. Summary of Benefits and Costs
FDA has examined the benefits and costs of this rule as required
under Executive Order 12866. Over time, the relationship between
benefits and costs changes, so that, to compare them properly, benefits
and costs must be discounted to the present year (the time at which the
decisions are being made). The quantified benefits (discounted annually
over an infinite time horizon at 7 percent) are expected to be about $2
billion ($151 million/7 percent) and the quantified costs (discounted
annually over an infinite time horizon at 7 percent) are expected to be
about $400 million.
VI. Regulatory Flexibility Analysis
FDA has examined the impact of this rule as required by the
Regulatory Flexibility Act (5 U.S.C. 601-612). If a rule has a
significant impact on a substantial number of small entities, the RFA
requires agencies to analyze options that would minimize the economic
impact of that rule on small entities. The agency acknowledges that
this rule is likely to have a significant impact on a substantial
number of small entities.
A. Objectives
The RFA requires a succinct statement of the purpose and objectives
of any rule that will have a significant impact on a substantial number
of small entities. The HACCP rule is being issued to ensure that juice
processors control all physical, chemical, and microbial hazards in
their products.
B. Definition of Small Business and Number of Small Businesses Affected
The RFA requires a statement of the definition of small business
used in the analysis and a description of the number of small entities
affected.
Table 29 shows the definition of small business for each type of
establishment affected and a description of the number of small
entities affected by the rule. The agency has accepted the Small
Business Administration (SBA) definitions of small business for this
analysis.
Table 29.--Approximate Number of Small Plants Covered by These Rules
----------------------------------------------------------------------------------------------------------------
North American
industry SBA definition of Category defined Percent of No. of
Type of establishment classification small by category as small by SBA small businesses
system codes covered
----------------------------------------------------------------------------------------------------------------
Juice manufacturers in the OEI... 311421, 311411 Less than 500 75% 675
employees.
Roadside-type apple juice Makers. 311421, 311411 Less than 500 100% 1,220
employees.
Roadside orange juice Makers..... 311421, 311411 Less than 500 100% 230
employees.
------------------------------------------------------------------------------
Totals........................... ................. .................... ................. 2,125
----------------------------------------------------------------------------------------------------------------
C. Description of the Impact on Small Entities
1. Costs to Small Entities
Because there is a broad distribution of products covered, firm
types, current processing practices and sizes, it would be misleading
to report average per firm costs. However, some idea of the costs can
be gained from the following examples. The impacts that the costs will
have on a firm will vary depending on the total revenue derived from
juice by a firm and the profit (return on sales) associated with juice
production. Data on food manufacturing firms indicates that 75 percent
of firms have return on sales of less than 5 percent.
The first example (table 30) is of a small seasonal apple cider
plant that is now producing nonheat-treated juice, with fruit from a
known source, and that has not developed or implemented sanitation
SOP's. This plant will need to buy a pasteurizer (or find and validate
a different process that achieves a 5-log reduction). The next example
(table 31)
[[Page 6191]]
is a small plant that is producing orange juice concentrate year round
with fruit from a known source, and that has already developed and
implemented sanitation SOP's (except that records have not been kept on
SOP's). The third example (table 32) is a small plant operating year
round producing unpasteurized orange juice, using commingled fruit, and
that has not developed or implemented sanitation SOP's.
These three illustrative small plants can be compared to two
illustrative large plants. The first large plant (table 33) is a large
shelf-stable apple juice plant with many employees that operates year
round and that imports some apples and therefore must test for patulin,
and has not developed or implemented sanitation SOP's. The second large
plant (table 34) is a large shelf-stable tomato juice processor using
fruit from a known source and with sanitation SOP's fully implemented.
Table 30.--Costs for Illustrative Small Seasonal Apple Cider Processor
------------------------------------------------------------------------
Cost in first Cost in
Type of cost year subsequent years
------------------------------------------------------------------------
Develop SOP's..................... $260
Sanitation SOP's.................. 500
Monitoring and Documenting of 100 $100
SOP's............................
Hazard analysis................... 250
HACCP plan........................ 750
Pathogen controls................. 18,000-30,000 7,900
Corrective action plan............ 50
Corrective actions................ 450 110
Verification...................... 420 420
Validation........................ 1,000 500
HACCP monitoring and recordkeeping 900 900
Record maintenance & storage...... 360 360
Training of coordinator........... 1,300
Employee training................. 300 300
-------------------------------------
Totals........................ 24,700-36,700 10,600
------------------------------------------------------------------------
Table 31.--Cost for Illustrative Small Year Round Concentrated Orange
Juice Processor
------------------------------------------------------------------------
Cost in first Cost in
Type of cost year subsequent years
------------------------------------------------------------------------
Monitoring and documenting of $340 $340
SOP's............................
Hazard analysis................... 250
Validation........................ 1,000
Training of coordinator........... 1,300
-------------------------------------
Totals........................ 2,900 300
------------------------------------------------------------------------
Table 32.--Cost for Illustrative Small Year Round Unpasteurized Orange
Juice Processor
------------------------------------------------------------------------
Cost in first Cost in
Type of cost year subsequent years
------------------------------------------------------------------------
Develop SOP's..................... $260
Monitoring and documenting of 340 $340
SOP's............................
Hazard analysis................... 250
HACCP plan........................ 750
Pathogen controls................. 18,000-30,000 7,900
Corrective action Plan............ 50
Corrective actions................ 1,460 340
Verification...................... 1,350 1,350
Validation........................ 2,000 1,000
Process verification testing...... 7,800 7,800
Annualized cost of Process 2,600 2,600
Verification Failure.............
HACCP monitoring and Recordkeeping 5,600 5,600
Record maintenance & storage...... 830 830
Training of coordinator........... 1,300
Employee training................. 500 500
-------------------------------------
Totals........................ 43,100-55,100 28,300
------------------------------------------------------------------------
Table 33.--Costs for Illustrative Large Year Round Apple Juice Processor
------------------------------------------------------------------------
Cost in first Cost in
Type of cost year subsequent years
------------------------------------------------------------------------
Develop SOP's..................... $260
[[Page 6192]]
Sanitation SOP's.................. 500
Monitoring and documenting of 340 $340
SOP's............................
Hazard analysis................... 250
HACCP plan........................ 750
Natural toxin control............. 4,500 4,500
Corrective action plan............ 50
Corrective actions................ 1,460 340
Verification...................... 1,350 1,350
Validation........................ 1,200 1,200
HACCP monitoring and recordkeeping 5,600 5,600
Record maintenance................ 680 680
Record storage.................... 150
Training of coordinator........... 1,300
Employee training................. 8,300 8,300
-------------------------------------
Totals........................ 24,000 20,000
------------------------------------------------------------------------
Table 34.--Costs for Illustrative Large Year Round Shelf-Stable Tomato
Juice Processor
------------------------------------------------------------------------
Cost in first Cost in
Type of cost year subsequent years
------------------------------------------------------------------------
Hazard analysis................... $250
Validation........................ 600
Training of coordinator........... 1,300
-------------------------------------
Totals........................ 2,000 $0
------------------------------------------------------------------------
Some comments stated that the rule would be burdensome on small
juice processors and that some processors would have to cease producing
juice. FDA is issuing a tiered, extended compliance period giving the
smallest firms the most time to comply with the rule. Extending the
compliance period by 1 year for small firms could save each one $500 to
$31,600 (using a 7 percent discount rate). Extending the compliance
period by 2 years for very small firms could save each one $900 to
$61,000 (using a 7 percent discount rate). These savings accrue just
from delaying the time at which the expenditures for compliance must
take place. The amount of savings increases as the cost of compliance
increases. One effect of the cost savings will be to reduce small firm
failure. FDA believes that this extended compliance period will provide
small firms with significant relief in the cost of preparing for HACCP
and making necessary changes to comply with this rule.
2. Professional Skills Required for Compliance
The RFA requires a description of the professional skills required
for compliance with this rule. Table 35 describes the professional
skills required for compliance with the various activities required by
this rule.
Table 35.--Professional Skills Required for Compliance
------------------------------------------------------------------------
Section Professional skills
Required activity of rule required for compliance
------------------------------------------------------------------------
Developing prerequisite program Sec. 120 Managers familiar with
SOP's. .6 incoming materials and
plant sanitation.
Implementing sanitation controls Sec. 120 Production workers who
with corrections of deviations .6 are able to maintain the
from prerequisite program SOP's. sanitation controls as
described in the
sanitation SOP's and
supervisors or managers
who can determine what
corrective actions are
necessary for deviations
from SOP's.
Monitoring and documenting of Sec. 120 Production workers who
prerequisite Program SOP's. .6 are appropriately
trained to monitor and
keep records on
observations and
measurements for
prerequisite program
SOP's.
Developing hazard analysis and Secs. 12 Supervisors or managers
HACCP plan.. 0.7 and who fulfill the role of
120.8 HACCP coordinator as
well as microbiologists,
chemists, and attorneys.
Implementing pathogen controls.... Sec. 120 Production workers who
.8 are appropriately
trained to monitor and
keep records on
observations and
measurements at CCP's.
Implementing pesticide controls... Sec. 120 Production workers who
.8 are appropriately
trained to carry out
tests, to monitor, and
to keep records on
observations and
measurements at CCP's.
Tracking corrective actions....... Sec. 120 Production workers who
.10 are trained to take
corrective action
described in corrective
action plans and
supervisors or managers
who can determine what
corrective actions are
necessary for deviations
from CL's.
Verification...................... Sec. 120 Supervisors or managers
.11 who fulfill the role of
HACCP coordinator.
Validation........................ Sec. 120 Food scientists or food
.11 technologists who can
perform a scientific
review of the process.
Process verification.............. Sec. 120 Microbiologists and
.25 production workers who
are trained to take
process verification
samples and food
scientists or food
technologists who can
perform a scientific
review of the process in
the event of a process
verification failure.
[[Page 6193]]
Monitoring and recordkeeping...... Sec. 120 Production workers who
.12 are appropriately
trained to monitor and
keep records on
observations and
measurements at CCP's.
Record maintenance................ Sec. 120 Clerical or production
.12 workers.
HACCP coordinator training Sec. 120 Supervisors or managers
coordinator. .13 who fulfill the role of
HACCP.
HACCP employee training........... Sec. 120 Clerical and production
.13 workers.
Imports........................... Sec. 120 Clerical workers as well
.14 as supervisors or
managers who fulfill the
role of HACCP
coordinator.
------------------------------------------------------------------------
3. Recordkeeping requirements
The RFA requires a description of the recordkeeping requirements of
the proposed rule. Table 36 shows the provisions for which records need
to be made and kept by small businesses, the number of small businesses
affected, the annual frequency that the records need to be made, the
amount of time needed for making each record, and the total number of
hours for each provision in the first year and then in subsequent
years.
Table 36.--Small Business Recordkeeping Requirements
----------------------------------------------------------------------------------------------------------------
Number of
small Hours per Total
21 CFR provisions entities Annual record per Total hours subsequent
keeping frequency small first year years
records entity
----------------------------------------------------------------------------------------------------------------
120.6 Monitoring and Recordkeeping of SOP's... 1,660 16 0.5 13,300 13,300
210 52 ........... 5,500 5,500
120.7 Hazard analysis......................... 2,125 1 20 42,500 0
120.8 HACCP plan.............................. 1,930 1 60 115,800 0
120.8 Pesticide Controls by Supplier 1,700 160 .02 5,400 5,400
Certificate...................................
120.11 Verification........................... 1,450 16 2 46,400 46,400
380 52 \1\ 8 39,500 39,500
120.11 Validation............................. 1,450 1 \2\ 4 11,600 5,800
380 2 ........... 6,100 3,000
120.12 HACCP records.......................... 1,450 1,440 .05 104,400 104,400
380 8,640 ........... 164,200 164,200
120.12 Record maintenance..................... 1,450 16 1 23,200 23,200
----------------------------------------------------------------
Totals..................................... ........... ........... ........... 598,000 431,000
----------------------------------------------------------------------------------------------------------------
\1\First year. \2\ Subsequent year.
D. Minimizing the Burden on Small Entities
The RFA requires an evaluation of any regulatory overlaps and
regulatory alternatives that would minimize the costs to small
entities.
There are two alternatives that the agency has considered to
provide regulatory relief for small entities. First, FDA considered and
is proposing the option of exempting some small entities from the
requirements of these rules. Second, FDA considered and is proposing
the option of lengthening the compliance period for small entities.
1. Exempt Small Entities
One alternative for alleviating the burden for small entities would
be to exempt them from the provisions of this rule. FDA proposed to
exempt retailers who, for the purposes of this rule, the agency
tentatively decided would include very small businesses that make juice
on their premises and whose total sales of juice and juice products do
not exceed 40,000 gallons per year and who sell directly to consumers
or directly to consumers and other retailers.
Revenue from sales of 40,000 gallons of nonheat treated juice may
be approximately $160,000 with annual profits ranging from $1,600 to
$16,000 per year (1 percent to 10 percent). This exemption covered most
of the very small businesses, although less than 15 percent of the
volume of unpasteurized juice. However, packaged products sold by these
types of processors are covered under the labeling rule.
As detailed in response to comment 47, the comments that FDA
received on this exemption were almost entirely critical of the
exemption. Based upon the comments and other information available to
the agency, FDA has decided not to finalize this proposed exemption.
2. Extend Compliance Period
FDA is issuing a tiered, extended compliance period giving the
smallest firms the most time to comply with the rule. Extending the
compliance period by 1 year for small firms could save each one $500 to
$31,600 (using a 7 percent discount rate). Extending the compliance
period by 2 years for very small firms could save each one $900 to
$61,000 (using a 7 percent discount rate). These savings accrue just
from delaying the time at which the expenditures for compliance must
take place. The amount of savings increases as the cost of compliance
increases.
Additional savings may come as smaller firms learn more efficient
compliance strategies from larger firms that must comply earlier and as
new, less costly technologies that may be employed by small firms are
developed during the extended compliance period. FDA is unable to
quantify these additional savings of the extended compliance period
although one effect of the cost savings will be to reduce small firm
failure.
FDA believes that this extended compliance period will provide
small firms with significant relief in the cost of preparing for HACCP
and making
[[Page 6194]]
necessary changes to comply with this rule.
E. Summary
FDA has examined the impact of this rule on small businesses in
accordance with the RFA. This analysis, together with the rest of the
preamble constitutes the final RFA. FDA has determined that this rule
is likely to have a significant impact on a substantial number of small
entities.
VII. Paperwork Reduction Act of 1995
This final rule contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). A
description of these information provisions is given below with an
estimate of the annual recordkeeping burden. Included in the estimate
is the time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and
reviewing each collection of information.
Title: Hazard Analysis and Critical Control Point (HACCP)
Procedures for the Safe and Sanitary Processing of Juice--Recordkeeping
requirements for processors of fruit and vegetable juices
Description: This final rule mandates the application of HACCP
procedures to fruit and vegetable juice processing. HACCP is a
preventative system of hazard control that can be used by all food
processors to ensure the safety of their products to consumers. FDA is
finalizing these regulations because a system of preventative control
is the most effective and efficient way to ensure that these food
products are safe. FDA's mandate to ensure the safety of the nation's
food supply is derived principally from the act (21 U.S.C. 321 et
seq.). Under the act, FDA has authority to ensure that all foods in
interstate commerce, or that have been shipped in interstate commerce,
are not contaminated or otherwise adulterated, are produced and held
under sanitary conditions, and are not misbranded or deceptively
packaged; under 21 U.S.C. 371, the act authorizes the agency to issue
regulations for its efficient enforcement. The agency also has
authority under the Public Health Service Act (42 U.S.C. 264) to issue
and enforce regulations to prevent the introduction, transmission, or
spread of communicable diseases from one State to another other State.
Information development and recordkeeping are essential parts of any
HACCP system. The information collection requirements of this rule are
narrowly tailored to focus on the development of appropriate controls
and documenting those aspects of processing that are critical to food
safety. Through this final rule, FDA is implementing its authority
under section 402(a)(4) of the act. The information development and
recordkeeping requirements of this final rule are likewise an
implementation of section 402(a)(4) of the act.
Description of Respondents: Businesses and other for-profit
institutions.
In the Federal Register of April 24, 1998, the agency requested
comments on the proposed collection of information provisions contained
in the HACCP proposal. One comment was received. This comment asserted
that the change in sequence in the proposed rule for the last two steps
of the seven principles of HACCP is a change that will result in many
paperwork changes. The seven principles of HACCP have been articulated
by the NACMCF.
The agency does not agree with this comment. Prior to 1997, the
NACMCF listed establishing recordkeeping and documentation procedures
and establishing verification procedures as the sixth and seventh
principles of HACCP; this is the order in which the principles are
reflected in FDA's seafood HACCP regulation, part 123. When the NACMCF
revised its HACCP principles and application guidelines in 1997, it
reversed the order of the last two steps. Thus, the sequence in part
120 for the seven principles of HACCP is identical to the sequence most
recently outlined by NACMCF. The 1997 change does not require a change
in the analytical approach or in the information to be assembled by
juice processors as they apply the HACCP principles to their process.
The agency does not anticipate that there will be a need for processors
to complete additional paperwork simply because there has been a change
in the order of the seven principles of HACCP or because there will be
a slight difference in the juice HACCP regulation and the seafood HACCP
regulation. It is FDA's position that as long as all the essential
elements are present in the written HACCP plan, the plan will be
complete.
FDA estimates the burden of this collection of information as
follows:
Table 37.--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR sections Number of frequency of Total annual Hours per Total hours
recordkeepers records records record
----------------------------------------------------------------------------------------------------------------
120.6(a) & 120.12(a)(1) & (b)... 1,875 1 1,875 4 \2\ 7,500
120.6(c) & 120.12(a)(1) & (b)... 1,875 365 684,375 0.1 68,437.5
120.7; 120.10 (a); & 2,300 1.1 2,530 20 50,600
120.12(a)(2), (b) & (c)........
120.8 (except monitoring records 1,840 1 1,840 60 \2\ 110,400
required under 120.8(b)(7)); &
120.12(a)(3),(b)& (c)..........
120.8(b)(7) & 120.12(a)(4)(i), & 1,450 14,600 21,170,000 0.01 211,700
(b)............................
120.10(c) & 120.12(a)(4)(ii), & 1,840 12 22,080 0.1 2,208
(b)............................
120.11(a)(1)(iv); 120.11(a)(2); 1,840 52 95,680 0.1 9,568
120.12(a)(5)...................
120.11(b) & 120.12(a)(5), & (b). 1,840 1 1,840 4 7,360
120.11 (c) & 120.12(a)(5) & (b). 1,840 1 1,840 4 7,360
120.14(a)(2); & 120.14 (c) & (d) 308 1 308 4 1,232
----------------------------------------------------------------------------------------------------------------
Totals First year--476,365.5 Subsequent years--358,465.5
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ First year only.
The burden estimates in table 37 above are based on an estimate of
the total number of juice manufacturing plants (i.e., 2,300) affected
by this final rule. Included in this total are 850 plants currently
identified in FDA's OEI plus 1,220 very small apple juice manufacturers
and 230 very small orange juice manufacturers (see table 13
[[Page 6195]]
in section V). The figures in table 36 are derived by estimating the
number of plants affected by each portion of this final rule and
multiplying the corresponding number by the number of records required
annually and the hours needed to complete the record. These numbers
were obtained from the agency's final RIA prepared for this final rule.
Moreover, these estimates assume that every processor will prepare
SSOP's and a HACCP plan and maintain the associated monitoring records
and that every importer will require product safety specifications. In
fact, there are likely to be some small number of juice processors
that, based upon their hazard analysis, determine that they are not
required to have a HACCP plan under this final rule.
Table 37 provides a breakdown of the total estimated recordkeeping
burden for the first year and subsequent years. The estimates in this
table have been reviewed by the agency's HACCP experts, who have
practical experience in observing various processing operations and
related recordkeeping activities.
The information collection provisions of this final rule have been
submitted to OMB for review.
Prior to the effective date of this final rule, FDA will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or disapprove the information collection provisions in this
final rule. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.
VIII. Environmental Impact
The agency has previously considered the environmental effects of
the action being taken in this final rule. As announced in the proposed
rule published in the Federal Register of April 24, 1998 (63 FR 20450)
(Ref. 2), the agency determined that under 21 CFR 25.30(j) this action
is of a type that does not individually or cumulatively have a
significant impact on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement was
required.
(Comment 158) Two comments were received in response to the
potential environmental impact of this rule. One comment stated that
``* * * the extensive recordkeeping requirements under the juice
proposal will increase paper consumption significantly, which will not
be considered `environmentally friendly.' '' This comment did not
provide evidence to support this assertion.
FDA agrees that the recordkeeping requirement in the HACCP final
rule may increase paper consumption. However, the agency disagrees that
this increase will be significant. The agency believes that the paper
used for the required recordkeeping will be a very small fraction of
the overall amount of paper used in the United States. Therefore, this
use will not significantly increase the production, use and disposal of
paper and, thus, will not result in significant adverse impacts on the
environment. Additionally, FDA notes that Sec. 120.12(g) of the final
rule permits records to be maintained electronically. When the
regulated entities maintain records electronically, the need for paper
is reduced.
(Comment 159) One comment on the proposed rule stated that efforts
to achieve 5-log reduction will lead to possible excessive pollution of
the environment from disposal of unessential sanitizers. This comment
did not provide evidence to support this assertion.
The agency has concluded that even if some increase in the use of
sanitizing products should result, the products used would be either
registered with the U.S. EPA or regulated by FDA for use on food
contact articles under Sec. 178.1010 (21 CFR 178.1010) or both.
Environmental review is part of EPA's pesticide registration process
and is part of FDA's process for listing sanitizing solutions under
Sec. 178.1010. FDA expects processors to use all sanitizing products
according to directions on product labels and under the supervision of
experienced persons. Use of the sanitizing products in this manner
should ensure that any increased use will not result in adverse effects
on the environment.
The agency has concluded that these comments on the potential for
adverse environmental effects will not affect its previous
determination that this action will not have a significant impact on
the human environment and that an environmental impact statement is not
required.
IX. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government (Ref. 75). Accordingly, the agency has
concluded that the rule does not contain policies that have federalism
implications as defined in the order and, consequently, a federalism
summary impact statement is not required.
X. References
The following information has been placed on display in the Dockets
Management Branch (address above), and may be seen by interested
persons between 9 a.m. and 4 p.m. Monday through Friday.
1. FDA, Department of Health and Human Services (DHHS), ``Fruit And
Vegetable Juice Beverages: Notice of Intent to Develop a HACCP
Program, Interim Warning Statement, and Educational Program,'' 21
CFR part 120, 62 FR 45593-45596, August 28, 1997.
2. FDA, DHHS, ``Hazard Analysis and Critical Control Point (HACCP);
Procedures for the Safe and Sanitary Processing and Importing of
Juice,'' proposed rule, 21 CFR part 120, 63 FR 20450-20486, April
24, 1998.
3. FDA, DHHS, ``Hazard Analysis and Critical Control Point (HACCP);
Procedures for the Safe and Sanitary Processing and Importing of
Juice;'' extension of comment period, 21 CFR part 120, 63 FR 37057,
July 8, 1998.
4. FDA, DHHS, ``Food Labeling: Warning and Notice Statements;
Labeling of Juice Products,'' proposed rule, 21 CFR part 101, 63 FR
20486-20493, April 24, 1998.
5. FDA, DHHS,``Food Labeling: Warning and Notice Statements;
Labeling of Juice Products,'' 21 CFR part 101, 63 FR 37030-37056,
July 8, 1998.
6. FDA, DHHS, ``Preliminary Regulatory Impact Analysis and Initial
Regulatory Flexibility Analysis of the Proposed Rules to Ensure the
Safety of Juice and Juice Products,'' preliminary regulatory impact
anaysis, 21 CFR parts 101 and 120, 63 FR 24254-24378, May 1, 1998.
7. FDA, DHHS, ``Food Labeling: Warning and Notice Statements;
Labeling of Juice Products; Technical Scientific Workshops; Requests
for Additional Time to Achieve the Pathogen Reduction Standard,'' 21
CFR part 101, 63 FR 57594-57596, October 28,1998.
8. FDA, DHHS, ``Hazard Analysis and Critical Control Point (HACCP);
Procedures for the Safe and Sanitary Processing and Importing of
Juice: Reopening of Comment Period,'' 21 CFR part 120, 63 FR 69579-
69580, December 17, 1998.
9. FDA, DHHS, ``Apple Cider Food Safety Control: Workshop,'' 21 CFR
part 101, 64 FR 34125-34126, June 25, 1999.
10. FDA, DHHS, ``Hazard Analysis and Critical Control Point (HACCP);
Procedures for Safe and Sanitary Processing and Importing of Juice;
Availability of New Data and Information and Reopening of Comment
Period,'' 21 CFR part 120, 64 FR 65669-65671, November 23, 1999.
11. FSIS, USDA, ``National Advisory Committee on Microbiological
Criteria
[[Page 6196]]
for Foods,'' 64 FR 63281-63282, November 19, 1999.
12. NACMCF, ``National Advisory Committee on Microbiological
Criteria for Foods, Meeting on Fresh Citrus Juice; Transcript of
Proceedings,'' December 8 to 10, 1999, public meeting.
13. Buchanan, R. L., S. G. Edelson, R. L. Miller, and G. M. Sapers,
``Contamination of intact apples after immersion in an aqueous
environment containing Escherichia coli O157:H7,''Journal of Food
Protection, 62(5):444-450, 1999.
14. Walderhaug, M. O., S. G. Edelson-Mammel, A. J. DeJesus, B. S.
Eblen, A. J. Miller, and R. L. Buchanan, ``Routes of infiltration,
survival, and growth of Salmonella enterica serovar hartford and
Escherichia coli O157:H7 in oranges,'' Abstract, Presented at
International Association for Food Protection meeting, August 6 to
9, 2000.
15. National Academy of Sciences (NAS), National Research Council
(NCR), An Evaluation of the Role of Microbiological Criteria for
Foods and Food Ingredients, pp. 41-54, 308-335, National Academy
Press, Washington, DC, 1985.
16. Codex Alimentarius Commission, Recommended International Code of
Practice: General Requirements (Food Hygiene) [CAC/RCP 1-1969, Rev.
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of the United Nations, World Health Organization, Rome.
17. NACMCF, 1998, Hazard Analysis and Critical Control Point
Principles and Application Guidelines, Adopted August 14, 1997.
Journal of Food Protection, 61(6):762-775.
18. FDA, PHS, DHHS, Grade ``A'' Pasteurized Milk Ordinance, 1999
Revision, Public Health Service/Food and Drug Administration
Publication No. 229.
19. FDA, 2000, Patulin in Apple Juice, Apple Juice Concentrates and
Apple Juice Products; (Draft) Guidance for FDA Components and
Industry: Apple Juice, Apple Juice Concentrates, and Apple Juice
Products--Adulteration with Patulin. Web address: http://
vm.cfsan.fda.gov/~dms/patubckg.html.
20. FDA Memorandum to Terry Troxell From D. Jesse Wagstaff, May 5,
1994, concerning Hazards of Patulin in Apple Juice.
21. IARC, Patulin, International Agency for Research on Cancer
(IARC), Monographs on the Evaluation of the Carcinogenic Risk of
Chemicals to Humans, 40:83-98, 1986.
22. WHO, Patulin, World Health Organization (WHO) Food Additives
Series 26:143-165, 1990.
23. Dinovi, M., and S. Carberry, FDA Memorandum to P. M. Bolger,
Patulin in Apple Juice, Estimate of Exposure, CSMP Request of 6-16-
93, September 3, 1993.
24. FDA, 2000, ``Guidance for FDA Components and Industry; Apple
Juice, Apple Juice Concentrates and Apple Juice Products--
Adulteration with Patulin; Draft Compliance Policy Guide,'' (also 65
FR 37791-37792, June 16, 2000) Web Address: http://vm.cfsan.fda.gov/
~dms/patuguid.html
25. NACMCF, National Advisory Committee on Microbiological Criteria
for Foods (NACMCF) Recommendations on Fresh Juice, April 9, 1997.
26. Barker, W. H., and V. Runte, ``Tomato juice-associated
gastroenteritis, Washington and Oregon, 1969,'' American Journal of
Epidemiology, 96(2): 219-226, 1972.
27. FDA Memorandum to Samuel I. Shibko from Ivan Boyer, December 14,
1987, concerning the Review of the Acute Toxicity of Tin in Humans
for the Joint FAO/WHO Committee on Food Additives.
28. FDA Memorandum to the File from Mary Trucksess, September 26,
2000, Mycotoxins other than Patulin in Juices.
29. FDA health hazard evaluation, classification, and FDA
Enforcement Report for recall #F-072-7, November 14 and 20, 1996.
30. FDA health hazard evaluation, classification, and FDA
Enforcement Report for recall #F-073-7, November 14 and 20, 1996.
31. FDA Enforcement Report and USDA and Heinz news releases for
recall #F-095-9 of Strained Beginner carrots, and vegetable chicken
dinner baby food, December 23, 1998, and October 9, 1998.
32. FDA Enforcement Report for recall of frozen carrots and mixed
frozen vegetables, April 14, 1999.
33. Government of the Federal Republic of Germany, 1999, Comment
concerning the Codex Committee on Food Additives and Contaminants,
with reference to Codex Document CX/FAC 99/19, December 1998 Draft
Maximum Levels for Lead.
34. Schmidt, R. H., C. A. Sims, M. E. Parish, S. Pao, and M. A.
Ismail, A Model HACCP Plan for Small-Scale, Fresh-Squeezed (Not
Pasteurized) Citrus Juice Operations. Publication CIR 1179, Food
Science and Nutrition Department, Florida Cooperative Extension
Service, Institute of Food and Agricultural Sciences, University of
Florida, 1997.
35. Bolster, D., Apple Hill Quality Assurance Program and
Guidelines, Presentation during FDA's Apple Cider Food Safety
Control Workshop, July 15 to 16, 1999.
36. CFSAN, FDA, Hazard Analysis and Critical Control Point (HACCP)
Pilot Program for Selected Food Manufacturers; Interim Report of
Observations and Comments, June 19, 1996.
36a. Katz, F., and J. Giese, ``Science gives specialty juice a big
slice of the market,'' Journal Food Technology, 52(11):44-48, 1998.
36b. Cady, J. R., Letter from the National Food Processors
Association. May 31, 1994.
37. FDA Enforcement Report for recall #F-645/657-0 for undeclared
egg and milk protein, August 2, 2000.
38. FDA health hazard evaluation, classification, and FDA
Enforcement Report for recall #F-250-4, January 27, 1994, and
February 9, 1994.
39. FDA health hazard evaluation, classification, and FDA
Enforcement Report for recall #F-529-1, September 4, and 17, 1991.
40. FDA health hazard evaluation, classification, and FDA
Enforcement Report for firm-initiated recall #F-492-7, July 2 and
16, 1997.
41. FDA health hazard evaluation, classification, and FDA
Enforcement Report for recall #F-364-2, June 23 and July 2, 1992.
42. CAST. 1994, Prevention of Foodborne Illness, chapter 7, pp. 61-
72, In Foodborne Pathogens: Risks and Consequences, Task Force
Report No. 122, Council for Agricultural Science and Technology,
Ames, Iowa.
43. Luedtke, A., and D. Powell, 2000, Fact Sheet: A Timeline of
Fresh Juice Outbreaks, Web Address: http://www.plant.uoguelph.ca/safefood/micro-haz/juice-outbreaks.htm>
44. Mead, P. S., L. Slutsker, V. Dietz, L. F. McCaig, J. S. Bresee,
C. Shapiro, P. M. Griffin, and R.V. Tauxe, ``Food-related illness
and death in the United States,'' Emerging Infectious Diseases,
5(5):607-625, 1999.
45. CFSAN, FDA Report of 1997 Inspections of Fresh, Unpasteurized
Apple Cider Manufacturers--Summary of Results--January 1999.
46. FDA, HHS, FDA Announces Voluntary Nationwide Recall of Certain
Frozen Mamey Brands, HHS News, March 8, 1999, Web address: http://www.fda.gov/bbs/topics/NEWS/NEW00676.html>
47. Anonymous, Outbreak of Salmonella serotype muenchen infections
associated with unpasteurized orange juice--United States and
Canada, June 1999. Morbidity and Mortality Weekly Report (MMWR),
48(27):581-585, July 16, 1999.
48. OSDH. E. coli Health Warning Issued in Northeastern Oklahoma.
Oklahoma State Department of Health News Release, October 13, 1999.
49. State of Florida, Food Analysis Report for Laboratory No. 98/FO-
07398, October 27, 1998; Associated Press. State issues warning
about tainted juice, 1998; Garcia, L. M. 1998. Traces of bacteria
found in juice from local farm, October 25, 1998, The Herald
(Miami).
50. FDA Enforcement Reports and HHS press release for recall #F-660/
661-9, #F-662-9, #F-089-0. September 1 and 15, 1999, November 16 and
19, 1999, and February 2, 2000.
51. FDA Memorandum from Robert L. Racer, April 21, 2000, concerning
April 20 Recall of All Fresh, Un-Pasteurized Citrus Juice Products
because of Possible Health Risks.
52. CDC, An Outbreak of Norwalk-like Virus Associated with a Juice
Processor in Georgia: Possible Environmental Health Antecedents. The
Environmental Health Services Branch, National Center for
Environmental Health, Centers for Disease Control and Prevention,
July 5, 2000.
53. Podoski, B.W., FDA Memorandum to the File. Regulation of
Intrastate Fresh Juice, 2000.
[[Page 6197]]
54. Buchanan, R.L., and M.H. Golden, ``Interactions between pH and
malic acid concentration on the inactivation of Listeria
monocytogenes,'' Journal of Food Safety, 18:37-48, 1998.
55. Buchanan, R.L., and S.G. Edelson, ``pH-Dependent Stationary-
Phase Acid Resistance Response of Enterohemorrhagic Escherichia coli
in the Presence of Various Acidulants,'' Journal of Food Protection
62(3):211-218, 1999.
56. Dock, L.L., J.D. Floros, and R. H. Linton, ``Heat inactivation
of Escherichia coli O157:H7 in apple cider containing malic acid,
sodium benzoate, and potassium sorbate,'' Journal of Food
Protection, 63(8):1026-1031, 2000.
57. Parish, M.E., J.A. Narciso, and L. M. Friedrich, ``Survival of
Salmonellae in orange juice,'' Journal of Food Safety, 17:273-281,
1997.
58. Jay, J.M. 1996, ``Indicators of Food Microbial Quality and
Safety,'' chapter 18, pp. 387-395, In Modern Food Microbiology, 5th
ed., Chapman & Hall, N.Y.
59. FDA, DHHS, ``Guidance for Industry; Guide to Minimize Microbial
Food Safety Hazards for Fresh Fruits and Vegetables,'' 1998.
60. FDA, DHEW, Fish and Seafood Products, Subpart A--Smoked and
Smoke-Flavored Fish, final rule, 21 CFR part 128a, 35 FR 17401-
17402, November 13, 1970.
61. FDA Memorandum to Patricia Spitzig from Oliver D. Cook, July 11,
1995, concerning relationships between consumer complaints and
process controls.
62. FDA, DHHS, ``Procedures for the Safe and Sanitary Processing and
Importing of Fish and Fishery Products,'' final rule, 21 CFR parts
123 and 1240, 60 FR 65096-65202, at 65138, December 18, 1995.
63. Buchanan, R.L., FDA Memorandum to the Record, National Advisory
Committee Recommendations on Microbiological Criteria for Foods,
June 15, 1998.
64. FDA, FDA Technical Scientific Workshop on How Citrus Juice Firms
Can Achieve 5-log Pathogen Reduction. Transcript of Public Meeting,
November 12, and November 19, 1998.
65. FDA, 2000, ``Compilation of Juice/Cider Outbreaks Associated
with Microbial Hazards'' (1974-2000), July 21, 2000.
66. Kautter, D.A., FDA Memorandum to K. Carson, Revised Synopsis of
NACMCF Discussions, March 20, 2000 and October 24, 2000.
67. FDA memorandum to Robert Buchanan from Sherri McGarry and John
Sanders, February 23, 2000, concerning Salmonella outbreak
associated with orange juice. FDA memorandum from Maxine Heinitz,
August 19, 1999, concerning update to Salmonella database.
68. Larkin, J.W., FDA Memorandum to OPDFB, Microbiological Critical
Control Point for Certain Shelf-stable and Concentrated Juice
Products, September 29, 2000.
69. ICMSF, 1988, Microorganisms in Foods 4: Application of the
Hazard Analysis Critical Control Point (HACCP) System to Ensure
Microbiological Safety and Quality, Blackwell Scientific
Publications, Boston, p. 26.
70. FSIS, USDA, ``Pathogen Reduction; Hazard Analysis and Critical
Control Point (HACCP) Systems,'' final rule with request for
comments, 9 CFR parts 304, 308, 310, 320, 327, 381, 416, and 417, 61
FR 38806-38855, July 25, 1996.
71. Garthright, W. E., S. Chirtel, and Q. Graves, Derivation of
Sampling Plan to Meet the Testing Requirement in the Juice HACCP
Final Rule for Citrus Juices that Rely Solely or in Part on Surface
Treatments to Achieve the 5-Log Reduction Standard, 2000.
72. CFSAN, FDA, Hazard Analysis and Critical Control Point (HACCP)
Pilot Program for Selected Food Manufacturers; Second Interim Report
of Observations and Comments, October 31, 1997.
73. Kaplan, R. M., J. P. Anderson, and T. G. Ganiats, ``The Quality
of Well-being Scale: Rationale for a Single Quality of Life Index,''
In Quality of Life Assessment: Key Issues in the 1990s, edited by
Stuart R. Walker and Rachel M. Rosser, pp. 65-94 and 442-444, The
Netherlands: Kluwar Academic Publishers, 1993.
74. FDA, DHHS, ``Irradiation in the Production, Processing, and
Handling of Food,'' final rule, 21 CFR part 179, 65 FR 71056-71058,
November 29, 2000.
75. Bluhm, L. and B. Podoski, FDA Memorandum to the File,
``Federalism Implications''--Fresh and Processed Juices/State
Regulations and Practices, May 17, 2000.
76. Anderson, S., FDA Memorandum to the File, ``Federalism
Implications''--Rule 20-49 of the Florida Department of Citrus,
January 10, 2001.
List of Subjects in 21 CFR Part 120
Foods, Fruit juices, Imports, Reporting and recordkeeping
requirements, Vegetable juices.
Therefore, under the Federal Food, Drug, and Cosmetic Act, under
the Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, 21 CFR chapter I is amended as follows:
1. Part 120 is added to read as follows:
PART 120--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP)
SYSTEMS
Subpart A--General Provisions
Sec.
120.1 Applicability.
120.3 Definitions.
120.5 Current good manufacturing practice.
120.6 Sanitation standard operating procedures.
120.7 Hazard analysis.
120.8 Hazard Analysis and Critical Control Point (HACCP) plan.
120.9 Legal basis.
120.10 Corrective actions.
120.11 Verification and validation.
120.12 Records.
120.13 Training.
120.14 Application of requirements to imported products.
Subpart B--Pathogen Reduction
120.20 General.
120.24 Process controls.
120.25 Process verification for certain processors.
Authority: 21 U.S.C. 321, 342, 343, 346, 348, 371, 374, 379e,
381, 393; 42 U.S.C. 241, 242l, 264.
Subpart A--General Provisions
Sec. 120.1 Applicability.
(a) Any juice sold as such or used as an ingredient in beverages
shall be processed in accordance with the requirements of this part.
Juice means 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. 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)). Raw agricultural ingredients
of juice are not subject to the requirements of this part. Processors
should apply existing agency guidance to minimize microbial food safety
hazards for fresh fruits and vegetables in handling raw agricultural
products.
(b) The regulations in this part shall be effective January 22,
2002. However, by its terms, this part is not binding on small and very
small businesses until the dates listed in paragraphs (b)(1) and (b)(2)
of this section.
(1) For small businesses employing fewer than 500 persons the
regulations in this part are binding on January 21, 2003.
(2) For very small businesses that have either total annual sales
of less than $500,000, or if their total annual sales are greater than
$500,000 but their total food sales are less than $50,000; or the
person claiming this exemption employed fewer than an average of 100
full-time equivalent employees and fewer than 100,000 units of juice
were sold in the United States, the regulations are binding on January
20, 2004.
Sec. 120.3 Definitions.
The definitions of terms in section 201 of the Federal Food, Drug,
and Cosmetic Act, Sec. 101.9(j)(18)(vi), and part 110 of this chapter
are applicable to
[[Page 6198]]
such terms when used in this part, except where redefined in this part.
The following definitions shall also apply:
(a) Cleaned means washed with water of adequate sanitary quality.
(b) Control means to prevent, eliminate, or reduce.
(c) Control measure means any action or activity to prevent, reduce
to acceptable levels, or eliminate a hazard.
(d) Critical control point means a point, step, or procedure in a
food process at which a control measure can be applied and at which
control is essential to reduce an identified food hazard to an
acceptable level.
(e) Critical limit means the maximum or minimum value to which a
physical, biological, or chemical parameter must be controlled at a
critical control point to prevent, eliminate, or reduce to an
acceptable level the occurrence of the identified food hazard.
(f) Culled means separation of damaged fruit from undamaged fruit.
For processors of citrus juices using treatments to fruit surfaces to
comply with Sec. 120.24, culled means undamaged, tree-picked fruit that
is U.S. Department of Agriculture choice or higher quality.
(g) Food hazard means any biological, chemical, or physical agent
that is reasonably likely to cause illness or injury in the absence of
its control.
(h) Importer means either the U.S. owner or consignee at the time
of entry of a food product into the United States, or the U.S. agent or
representative of the foreign owner or consignee at the time of entry
into the United States. The importer is responsible for ensuring that
goods being offered for entry into the United States are in compliance
with all applicable laws. For the purposes of this definition, the
importer is ordinarily not the custom house broker, the freight
forwarder, the carrier, or the steamship representative.
(i) Monitor means to conduct a planned sequence of observations or
measurements to assess whether a process, point, or procedure is under
control and to produce an accurate record for use in verification.
(j)(1) Processing means activities that are directly related to the
production of juice products.
(2) For purposes of this part, processing does not include:
(i) Harvesting, picking, or transporting raw agricultural
ingredients of juice products, without otherwise engaging in
processing; and
(ii) The operation of a retail establishment.
(k) Processor means any person engaged in commercial, custom, or
institutional processing of juice products, either in the United States
or in a foreign country, including any person engaged in the processing
of juice products that are intended for use in market or consumer
tests.
(l) Retail establishment is an operation that provides juice
directly to the 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.
(m) Shall is used to state mandatory requirements.
(n) Shelf-stable product means a product that is hermetically
sealed and, when stored at room temperature, should not demonstrate any
microbial growth.
(o) Should is used to state recommended or advisory procedures or
to identify recommended equipment.
(p) 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 food hazards.
(q) 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.
Sec. 120.5 Current good manufacturing practice.
Part 110 of this chapter applies in determining whether the
facilities, methods, practices, and controls used to process juice are
safe, and whether the food has been processed under sanitary
conditions.
Sec. 120.6 Sanitation standard operating procedures.
(a) Sanitation controls. Each processor shall have and implement a
sanitation standard operating procedure (SSOP) that addresses
sanitation conditions and practices before, during, and after
processing. The SSOP shall address:
(1) Safety of the water that comes into contact with food or food
contact surfaces or that is used in the manufacture of ice;
(2) Condition and cleanliness of food contact surfaces, including
utensils, gloves, and outer garments;
(3) Prevention of cross contamination from insanitary objects to
food, food packaging material, and other food contact surfaces,
including utensils, gloves, and outer garments, and from raw product to
processed product;
(4) Maintenance of hand washing, hand sanitizing, and toilet
facilities;
(5) Protection of food, food packaging material, and food contact
surfaces from adulteration with lubricants, fuel, pesticides, cleaning
compounds, sanitizing agents, condensate, and other chemical, physical,
and biological contaminants;
(6) Proper labeling, storage, and use of toxic compounds;
(7) Control of employee health conditions that could result in the
microbiological contamination of food, food packaging materials, and
food contact surfaces; and
(8) Exclusion of pests from the food plant.
(b) Monitoring. The processor shall monitor the conditions and
practices during processing with sufficient frequency to ensure, at a
minimum, conformance with those conditions and practices specified in
part 110 of this chapter that are appropriate both to the plant and to
the food being processed. Each processor shall correct, in a timely
manner, those conditions and practices that are not met.
(c) Records. Each processor shall maintain SSOP records that, at a
minimum, document the monitoring and corrections prescribed by
paragraph (b) of this section. These records are subject to the
recordkeeping requirements of Sec. 120.12.
(d) Relationship to Hazard Analysis and Critical Control Point
(HACCP) plan. Sanitation standard operating procedure controls may be
included in the HACCP plan required under Sec. 120.8(b). However, to
the extent that they are implemented in accordance with this section,
they need not be included in the HACCP plan.
Sec. 120.7 Hazard analysis.
(a) Each processor shall develop, or have developed for it, a
written hazard analysis to determine whether there are food hazards
that are reasonably likely to occur for each type of juice processed by
that processor and to identify control measures that the processor can
apply to control those hazards. The written hazard analysis shall
consist of at least the following:
(1) Identification of food hazards;
(2) An evaluation of each food hazard identified to determine if
the hazard is reasonably likely to occur and thus, constitutes a food
hazard that must be addressed in the HACCP plan. A food hazard that is
reasonably likely to occur is one for which 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. This
[[Page 6199]]
evaluation shall include an assessment of the severity of the illness
or injury if the food hazard occurs;
(3) Identification of the control measures that the processor can
apply to control the food hazards identified as reasonably likely to
occur in paragraph (a)(2) of this section;
(4) Review of the current process to determine whether
modifications are necessary; and
(5) Identification of critical control points.
(b) The hazard analysis shall include food hazards that can be
introduced both within and outside the processing plant environment,
including food hazards that can occur before, during, and after
harvest. The hazard analysis shall be developed by an individual or
individuals who have been trained in accordance with Sec. 120.13 and
shall be subject to the recordkeeping requirements of Sec. 120.12.
(c) In evaluating what food hazards are reasonably likely to occur,
consideration should be given, at a minimum, to the following:
(1) Microbiological contamination;
(2) Parasites;
(3) Chemical contamination;
(4) Unlawful pesticides residues;
(5) Decomposition in food where a food hazard has been associated
with decomposition;
(6) Natural toxins;
(7) Unapproved use of food or color additives;
(8) Presence of undeclared ingredients that may be allergens; and
(9) Physical hazards.
(d) Processors should evaluate product ingredients, processing
procedures, packaging, storage, and intended use; facility and
equipment function and design; and plant sanitation, including employee
hygiene, to determine the potential effect of each on the safety of the
finished food for the intended consumer.
(e) HACCP plans for juice need not address the food hazards
associated with microorganisms and microbial toxins that are controlled
by the requirements of part 113 or part 114 of this chapter. A HACCP
plan for such juice shall address any other food hazards that are
reasonably likely to occur.
Sec. 120.8 Hazard Analysis and Critical Control Point (HACCP) plan.
(a) HACCP plan. Each processor shall have and implement a written
HACCP plan whenever a hazard analysis reveals one or more food hazards
that are reasonably likely to occur during processing, as described in
Sec. 120.7. The HACCP plan shall be developed by an individual or
individuals who have been trained in accordance with Sec. 120.13 and
shall be subject to the recordkeeping requirements of Sec. 120.12. A
HACCP plan shall be specific to:
(1) Each location where juice is processed by that processor; and
(2) Each type of juice processed by the processor. The plan may
group types of juice products together, or group types of production
methods together, if the food hazards, critical control points,
critical limits, and procedures required to be identified and performed
by paragraph (b) of this section are essentially identical, provided
that any required features of the plan that are unique to a specific
product or method are clearly delineated in the plan and are observed
in practice.
(b) The contents of the HACCP plan. The HACCP plan shall, at a
minimum:
(1) List all food hazards that are reasonably likely to occur as
identified in accordance with Sec. 120.7, and that thus must be
controlled for each type of product;
(2) List the critical control points for each of the identified
food hazards that is reasonably likely to occur, including as
appropriate:
(i) Critical control points designed to control food hazards that
are reasonably likely to occur and could be introduced inside the
processing plant environment; and
(ii) Critical control points designed to control food hazards
introduced outside the processing plant environment, including food
hazards that occur before, during, and after harvest;
(3) List the critical limits that shall be met at each of the
critical control points;
(4) List the procedures, and the frequency with which they are to
be performed, that will be used to monitor each of the critical control
points to ensure compliance with the critical limits;
(5) Include any corrective action plans that have been developed in
accordance with Sec. 120.10(a), and that are to be followed in response
to deviations from critical limits at critical control points;
(6) List the validation and verification procedures, and the
frequency with which they are to be performed, that the processor will
use in accordance with Sec. 120.11; and
(7) Provide for a recordkeeping system that documents the
monitoring of the critical control points in accordance with
Sec. 120.12. The records shall contain the actual values and
observations obtained during monitoring.
(c) Sanitation. Sanitation controls may be included in the HACCP
plan. However, to the extent that they are monitored in accordance with
Sec. 120.6, they are not required to be included in the HACCP plan.
Sec. 120.9 Legal basis.
Failure of a processor to have and to implement a Hazard Analysis
and Critical Control Point (HACCP) system that complies with
Secs. 120.6, 120.7, and 120.8, or otherwise to operate in accordance
with the requirements of this part, shall render the juice products of
that processor adulterated under section 402(a)(4) of the Federal Food,
Drug, and Cosmetic Act. Whether a processor's actions are consistent
with ensuring the safety of juice will be determined through an
evaluation of the processor's overall implementation of its HACCP
system.
Sec. 120.10 Corrective actions.
Whenever a deviation from a critical limit occurs, a processor
shall take corrective action by following the procedures set forth in
paragraph (a) or paragraph (b) of this section.
(a) Processors may develop written corrective action plans, which
become part of their HACCP plans in accordance with Sec. 120.8(b)(5),
by which processors predetermine the corrective actions that they will
take whenever there is a deviation from a critical limit. A corrective
action plan that is appropriate for a particular deviation is one that
describes the steps to be taken and assigns responsibility for taking
those steps, to ensure that:
(1) No product enters commerce that is either injurious to health
or is otherwise adulterated as a result of the deviation; and
(2) The cause of the deviation is corrected.
(b) When a deviation from a critical limit occurs, and the
processor does not have a corrective action plan that is appropriate
for that deviation, the processor shall:
(1) Segregate and hold the affected product, at least until the
requirements of paragraphs (b)(2) and (b)(3) of this section are met;
(2) Perform or obtain a review to determine the acceptability of
the affected product for distribution. The review shall be performed by
an individual or individuals who have adequate training or experience
to perform such review;
(3) Take corrective action, when necessary, with respect to the
affected product to ensure that no product enters commerce that is
either injurious to health or is otherwise adulterated as a result of
the deviation;
(4) Take corrective action, when necessary, to correct the cause of
the deviation; and
[[Page 6200]]
(5) Perform or obtain timely verification in accordance with
Sec. 120.11, by an individual or individuals who have been trained in
accordance with Sec. 120.13, to determine whether modification of the
HACCP plan is required to reduce the risk of recurrence of the
deviation, and to modify the HACCP plan as necessary.
(c) All corrective actions taken in accordance with this section
shall be fully documented in records that are subject to verification
in accordance with Sec. 120.11(a)(1)(iv)(B) and the recordkeeping
requirements of Sec. 120.12.
Sec. 120.11 Verification and validation.
(a) Verification. Each processor shall verify that the Hazard
Analysis and Critical Control Point (HACCP) system is being implemented
according to design.
(1) Verification activities shall include:
(i) A review of any consumer complaints that have been received by
the processor to determine whether such complaints relate to the
performance of the HACCP plan or reveal previously unidentified
critical control points;
(ii) The calibration of process monitoring instruments;
(iii) At the option of the processor, the performance of periodic
end-product or in-process testing; except that processors of citrus
juice that rely in whole or in part on surface treatment of fruit shall
perform end-product testing in accordance with Sec. 120.25.
(iv) A review, including signing and dating, by an individual who
has been trained in accordance with Sec. 120.13, of the records that
document:
(A) The monitoring of critical control points. The purpose of this
review shall be, at a minimum, to ensure that the records are complete
and to verify that the records document values that are within the
critical limits. This review shall occur within 1 week (7 days) of the
day that the records are made;
(B) The taking of corrective actions. The purpose of this review
shall be, at a minimum, to ensure that the records are complete and to
verify that appropriate corrective actions were taken in accordance
with Sec. 120.10. This review shall occur within 1 week (7 days) of the
day that the records are made; and
(C) The calibrating of any process monitoring instruments used at
critical control points and the performance of any periodic end-product
or in-process testing that is part of the processor's verification
activities. The purpose of these reviews shall be, at a minimum, to
ensure that the records are complete and that these activities occurred
in accordance with the processor's written procedures. These reviews
shall occur within a reasonable time after the records are made; and
(v) The following of procedures in Sec. 120.10 whenever any
verification procedure, including the review of consumer complaints,
establishes the need to take a corrective action; and
(vi) Additional process verification if required by Sec. 120.25.
(2) Records that document the calibration of process monitoring
instruments, in accordance with paragraph (a)(1)(iv)(B) of this
section, and the performance of any periodic end-product and in-process
testing, in accordance with paragraph (a)(1)(iv)(C) of this section,
are subject to the recordkeeping requirements of Sec. 120.12.
(b) Validation of the HACCP plan. Each processor shall validate
that the HACCP plan is adequate to control food hazards that are
reasonably likely to occur; this validation shall occur at least once
within 12 months after implementation and at least annually thereafter
or whenever any changes in the process occur that could affect the
hazard analysis or alter the HACCP plan in any way. Such changes may
include changes in the following: Raw materials or source of raw
materials; product formulation; processing methods or systems,
including computers and their software; packaging; finished product
distribution systems; or the intended use or consumers of the finished
product. The validation shall be performed by an individual or
individuals who have been trained in accordance with Sec. 120.13 and
shall be subject to the recordkeeping requirements of Sec. 120.12. The
HACCP plan shall be modified immediately whenever a validation reveals
that the plan is no longer adequate to fully meet the requirements of
this part.
(c) Validation of the hazard analysis. Whenever a juice processor
has no HACCP plan because a hazard analysis has revealed no food
hazards that are reasonably likely to occur, the processor shall
reassess the adequacy of that hazard analysis whenever there are any
changes in the process that could reasonably affect whether a food
hazard exists. Such changes may include changes in the following: Raw
materials or source of raw materials; product formulation; processing
methods or systems, including computers and their software; packaging;
finished product distribution systems; or the intended use or intended
consumers of the finished product. The validation of the hazard
analysis shall be performed by an individual or individuals who have
been trained in accordance with Sec. 120.13, and, records documenting
the validation shall be subject to the recordkeeping requirements of
Sec. 120.12.
Sec. 120.12 Records.
(a) Required records. Each processor shall maintain the following
records documenting the processor's Hazard Analysis and Critical
Control Point (HACCP) system:
(1) Records documenting the implementation of the sanitation
standard operating procedures (SSOP's) (see Sec. 120.6);
(2) The written hazard analysis required by Sec. 120.7;
(3) The written HACCP plan required by Sec. 120.8;
(4) Records documenting the ongoing application of the HACCP plan
that include:
(i) Monitoring of critical control points and their critical
limits, including the recording of actual times, temperatures, or other
measurements, as prescribed in the HACCP plan; and
(ii) Corrective actions, including all actions taken in response to
a deviation; and
(5) Records documenting verification of the HACCP system and
validation of the HACCP plan or hazard analysis, as appropriate.
(b) General requirements. All records required by this part shall
include:
(1) The name of the processor or importer and the location of the
processor or importer, if the processor or importer has more than one
location;
(2) The date and time of the activity that the record reflects,
except that records required by paragraphs (a)(2), (a)(3), and (a)(5)
of this section need not include the time;
(3) The signature or initials of the person performing the
operation or creating the record; and
(4) Where appropriate, the identity of the product and the
production code, if any. Processing and other information shall be
entered on records at the time that it is observed. The records shall
contain the actual values and observations obtained during monitoring.
(c) Documentation. (1) The records in paragraphs (a)(2) and (a)(3)
of this section shall be signed and dated by the most responsible
individual onsite at the processing facility or by a higher level
official of the processor. These signatures shall signify that these
records have been accepted by the firm.
(2) The records in paragraphs (a)(2) and (a)(3) of this section
shall be signed and dated:
(i) Upon initial acceptance;
(ii) Upon any modification; and
[[Page 6201]]
(iii) Upon verification and validation in accordance with
Sec. 120.11.
(d) Record retention. (1) All records required by this part shall
be retained at the processing facility or at the importer's place of
business in the United States for, in the case of perishable or
refrigerated juices, at least 1 year after the date that such products
were prepared, and for, in the case of frozen, preserved, or shelf
stable products, 2 years or the shelf life of the product, whichever is
greater, after the date that the products were prepared.
(2) Offsite storage of processing records required by paragraphs
(a)(1) and (a)(4) of this section is permitted after 6 months following
the date that the monitoring occurred, if such records can be retrieved
and provided onsite within 24 hours of request for official review.
Electronic records are considered to be onsite if they are accessible
from an onsite location and comply with paragraph (g) of this section.
(3) If the processing facility is closed for a prolonged period
between seasonal packs, the records may be transferred to some other
reasonably accessible location at the end of the seasonal pack but
shall be immediately returned to the processing facility for official
review upon request.
(e) Official review. All records required by this part shall be
available for review and copying at reasonable times.
(f) Public disclosure. (1) All records required by this part are
not available for public disclosure unless they have been previously
disclosed to the public, as defined in Sec. 20.81 of this chapter, or
unless they relate to a product or ingredient that has been abandoned
and no longer represent a trade secret or confidential commercial or
financial information as defined in Sec. 20.61 of this chapter.
(2) Records required to be maintained by this part are subject to
disclosure to the extent that they are otherwise publicly available, or
that disclosure could not reasonably be expected to cause a competitive
hardship, such as generic type HACCP plans that reflect standard
industry practices.
(g) Records maintained on computers. The maintenance of
computerized records, in accordance with part 11 of this chapter, is
acceptable. Sec. 120.13 Training.
(a) Only an individual who has met the requirements of paragraph
(b) of this section shall be responsible for the following functions:
(1) Developing the hazard analysis, including delineating control
measures, as required by Sec. 120.7.
(2) Developing a Hazard Analysis and Critical Control Point (HACCP)
plan that is appropriate for a specific processor, in order to meet the
requirements of Sec. 120.8;
(3) Verifying and modifying the HACCP plan in accordance with the
corrective action procedures specified in Sec. 120.10(b)(5) and the
validation activities specified in Sec. 120.11(b) and (c); and
Sec. 120.7;
(4) Performing the record review required by Sec. 120.11(a)(1)(iv).
(b) The individual performing the functions listed in paragraph (a)
of this section shall have successfully completed training in the
application of HACCP principles to juice processing at least equivalent
to that received under standardized curriculum recognized as adequate
by the Food and Drug Administration, or shall be otherwise qualified
through job experience to perform these functions. Job experience may
qualify an individual to perform these functions if such experience has
provided knowledge at least equivalent to that provided through the
standardized curriculum. The trained individual need not be an employee
of the processor.
Sec. 120.14 Application of requirements to imported products.
This section sets forth specific requirements for imported juice.
(a) Importer requirements. Every importer of juice shall either:
(1) Obtain the juice from a country that has an active memorandum
of understanding (MOU) or similar agreement with the Food and Drug
Administration, that covers the food and documents the equivalency or
compliance of the inspection system of the foreign country with the
U.S. system, accurately reflects the relationship between the signing
parties, and is functioning and enforceable in its entirety; or
(2) Have and implement written procedures for ensuring that the
juice that such importer receives for import into the United States was
processed in accordance with the requirements of this part. The
procedures shall provide, at a minimum:
(i) Product specifications that are designed to ensure that the
juice is not adulterated under section 402 of the Federal Food, Drug,
and Cosmetic Act because it may be injurious to health or because it
may have been processed under insanitary conditions; and
(ii) Affirmative steps to ensure that the products being offered
for entry were processed under controls that meet the requirements of
this part. These steps may include any of the following:
(A) Obtaining from the foreign processor the Hazard Analysis and
Critical Control Point (HACCP) plan and prerequisite program of the
standard operating procedure records required by this part that relate
to the specific lot of food being offered for import;
(B) Obtaining either a continuing or lot specific certificate from
an appropriate foreign government inspection authority or competent
third party certifying that the imported food has been processed in
accordance with the requirements of this part;
(C) Regularly inspecting the foreign processor's facilities to
ensure that the imported food is being processed in accordance with the
requirements of this part;
(D) Maintaining on file a copy, in English, of the foreign
processor's hazard analysis and HACCP plan, and a written guarantee
from the foreign processor that the imported food is processed in
accordance with the requirements of this part;
(E) Periodically testing the imported food, and maintaining on file
a copy, in English, of a written guarantee from the foreign processor
that the imported food is processed in accordance with the requirements
of this part; or
(F) Other such verification measures as appropriate that provide an
equivalent level of assurance of compliance with the requirements of
this part.
(b) Competent third party. An importer may hire a competent third
party to assist with or perform any or all of the verification
activities specified in paragraph (a)(2) of this section, including
writing the importer's verification procedures on the importer's
behalf.
(c) Records. The importer shall maintain records, in English, that
document the performance and results of the affirmative steps specified
in paragraph (a)(2)(ii) of this section. These records shall be subject
to the applicable provisions of Sec. 120.12.
(d) Determination of compliance. The importer shall provide
evidence that all juice offered for entry into the United States has
been processed under conditions that comply with this part. If
assurances do not exist that an imported juice has been processed under
conditions that are equivalent to those required of domestic processors
under this part, the product will appear to be adulterated and will be
denied entry.
[[Page 6202]]
Subpart B--Pathogen Reduction
Sec. 120.20 General.
This subpart augments subpart A of this part by setting forth
specific requirements for process controls.
Sec. 120.24 Process controls.
(a) In order to meet the requirements of subpart A of this part,
processors of juice products shall include in their Hazard Analysis and
Critical Control Point (HACCP) plans control measures that will
consistently produce, at a minimum, a 5 log (i.e., 10\5\) reduction,
for a period at least as long as the shelf life of the product when
stored under normal and moderate abuse conditions, in the pertinent
microorganism. For the purposes of this regulation, the ``pertinent
microorganism'' is the most resistant microorganism of public health
significance that is likely to occur in the juice. The following juice
processors are exempt from this paragraph:
(1) A juice processor that is subject to the requirements of part
113 or part 114 of this chapter; and
(2) A juice processor using a single thermal processing step
sufficient to achieve shelf-stability of the juice or a thermal
concentration process that includes thermal treatment of all
ingredients, provided that the processor includes a copy of the thermal
process used to achieve shelf-stability or concentration in its written
hazard analysis required by Sec. 120.7.
(b) All juice processors shall meet the requirements of paragraph
(a) of this section through treatments that are applied directly to the
juice, except that citrus juice processors may use treatments to fruit
surfaces, provided that the 5-log reduction process begins after
culling and cleaning as defined in Sec. 120.3(a) and (f) and the
reduction is accomplished within a single production facility.
(c) All juice processors shall meet the requirements of paragraphs
(a) and (b) of this section and perform final product packaging within
a single production facility operating under current good manufacturing
practices. Processors claiming an exemption under paragraph (a)(1) or
(a)(2) of this section shall also process and perform final product
packaging of all juice subject to the claimed exemption within a single
production facility operating under current good manufacturing
practices.
Sec. 120.25 Process verification for certain processors.
Each juice processor that relies on treatments that do not come
into direct contact with all parts of the juice to achieve the
requirements of Sec. 120.24 shall analyze the finished product for
biotype I Escherichia coli as follows:
(a) One 20 milliliter (mL) sample (consisting of two 10 mL
subsamples) for each 1,000 gallons of juice produced shall be sampled
each production day. If less than 1,000 gallons of juice is produced
per day, the sample must be taken for each 1,000 gallons produced but
not less than once every 5 working days that the facility is producing
that juice. Each subsample shall be taken by randomly selecting a
package of juice ready for distribution to consumers.
(b) If the facility is producing more than one type of juice
covered by this section, processors shall take subsamples according to
paragraph (a) of this section for each of the covered juice products
produced.
(c) Processors shall analyze each subsample for the presence of E.
coli by the method entitled ``Analysis for Escherichia coli in Citrus
Juices--Modification of AOAC Official Method 992.30'' or another method
that is at least equivalent to this method in terms of accuracy,
precision, and sensitivity in detecting E. coli. This method is
designed to detect the presence or absence of E. coli in a 20 mL sample
of juice (consisting of two 10 mL subsamples). The method is as
follows:
(1) Sample size. Total-20 mL of juice; perform analysis using two
10 mL aliquots.
(2) Media. Universal Preenrichment Broth (Difco, Detroit, MI), EC
Broth (various manufacturers).
(3) Method. ColiComplete (AOAC Official Method 992.30--modified).
(4) Procedure. Perform the following procedure two times:
(i) Aseptically inoculate 10 mL of juice into 90 mL of Universal
Preenrichment Broth (Difco) and incubate at 35 deg.C for 18 to 24
hours.
(ii) Next day, transfer 1 mL of preenriched sample into 10 mL of EC
Broth, without durham gas vials. After inoculation, aseptically add a
ColiComplete SSD disc into each tube.
(iii) Incubate at 44.5 deg.C for 18 to 24 hours.
(iv) Examine the tubes under longwave ultra violet light (366 nm).
Fluorescent tubes indicate presence of E. coli.
(v) MUG positive and negative controls should be used as reference
in interpreting fluorescence reactions. Use an E. coli for positive
control and 2 negative controls--a MUG negative strain and an
uninoculated tube media.
(d) If either 10 mL subsample is positive for E. coli, the 20 mL
sample is recorded as positive and the processor shall:
(1) Review monitoring records for the control measures to attain
the 5-log reduction standard and correct those conditions and practices
that are not met. In addition, the processor may choose to test the
sample for the presence of pathogens of concern.
(2) If the review of monitoring records or the additional testing
indicates that the 5-log reduction standard was not achieved (e.g., a
sample is found to be positive for the presence of a pathogen or a
deviation in the process or its delivery is identified), the processor
shall take corrective action as set forth in Sec. 120.10.
(e) If two samples in a series of seven tests are positive for E.
coli, the control measures to attain the 5-log reduction standard shall
be deemed to be inadequate and the processor shall immediately:
(1) Until corrective actions are completed, use an alternative
process or processes that achieve the 5-log reduction after the juice
has been expressed;
(2) Perform a review of the monitoring records for control measures
to attain the 5-log reduction standard. The review shall be
sufficiently extensive to determine that there are no trends towards
loss of control;
(i) If the conditions and practices are not being met, correct
those that do not conform to the HACCP plan; or
(ii) If the conditions and practices are being met, the processor
shall validate the HACCP plan in relation to the 5-log reduction
standard; and
(3) Take corrective action as set forth in Sec. 120.10. Corrective
actions shall include ensuring no product enters commerce that is
injurious to health as set forth in Sec. 120.10(a)(1).
Dated: December 20, 2000.
Jane E. Henny,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 01-1291 Filed 1-18-01; 8:45 am]
BILLING CODE 4160-01-P