[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  

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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

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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

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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

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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

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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

[[Page 6165]]

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

[[Page 6166]]

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.

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    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. 
3 (1997), 2nd ed.], HACCP Annex. Food and Agriculture Organization 
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