# Hazard Analysis and Critical Control Point (HAACP); Procedures for the Safe and Sanitary Processing and Importing of Juice

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URL: https://www.frixlaw.com/law-library/documents/fr%3A01-1291

## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** January 19, 2001
- **Citation:** 66 FR 6138

## Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 120
[Docket No. 97N-0511]
RIN 0910-AA43
Hazard Analysis and Critical Control Point (HAACP); Procedures for the Safe and Sanitary Processing and Importing of Juice

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA or the agency) is adopting final regulations to ensure the safe and sanitary processing of fruit and vegetable juices. The regulations mandate the application of Hazard Analysis and Critical Control Point (HACCP) principles to the processing of these foods. HACCP is a preventive system of hazard control. FDA is taking this action because there have been a number of food hazards associated with juice products and because a system of preventive control measures is the most effective and efficient way to ensure that these products are safe.

DATES:

Effective Dates: This rule is effective January 22, 2002.

Compliance Date:
For small businesses as defined in 21 CFR 120.1(b)(1), the final rule will be binding January 21, 2003. For very small businesses as defined in 21 CFR 120.1(b)(2), the final rule will be binding January 20, 2004.

FOR FURTHER INFORMATION CONTACT:

Shellee Anderson, Center for Food Safety and Applied Nutrition (HFS-366), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-5023.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background

A. Notice of Intent

B. The Proposal

C. Additional Opportunities for Public Participation

D. NACMCF Public Meeting

II. Response to the Comments

A. Alternatives to HACCP Considered by the Agency

B. Response to the Decision to Propose HACCP

C. Significance of Illness Data

D. Comparison of the Proposal and this Final Regulation

III. The Final Regulation

A. Applicability

B. Definitions

C. Prerequisite Program Standard Operating Procedures

D. Hazard Analysis

E. HACCP Plan

F. Legal Basis

G. Corrective Actions

H. Verification and Validation

I. Records

J. Training

K. Application of Requirements to Imported Products

L. Process Controls

M. HACCP Enforcement Issues

N. Miscellaneous Issues

IV. Effective Date

V. Final Regulatory Impact Analysis

A. Introduction

B. Factors Considered in Developing This Analysis

C. Benefits

D. Costs

E. Summary of Benefits and Costs

VI. Regulatory Flexibility Analysis

A. Objectives

B. Definition of Small Business and Number of Small Businesses Affected

C. Description of the Impact on Small Entities

D. Minimizing the Burden on Small Entities

E. Summary

VII. Paperwork Reduction Act of 1995

VIII. Environmental Impact

IX. Federalism

X. References

I. Background

A. Notice of Intent

In the
Federal Register
of August 28, 1997 (62 FR 45593)(Ref. 1), FDA published a notice of intent (hereinafter referred to as the notice of intent) that announced a comprehensive program to address the incidence of foodborne illness related to consumption of fresh juice and ultimately to address the safety of all juice products. In the notice of intent, the agency invited comment on the appropriateness of its strategy to: (1) Initiate rulemaking on a mandatory HACCP program for some or all juice products; (2) propose that the labels or the labeling of juice products not specifically processed to prevent, reduce, or eliminate pathogens bear a warning statement informing consumers of the risk of illness associated with consumption of the product; and (3) initiate several educational programs to minimize the hazards associated with consumption of fresh juices. The agency stated that it would address comments received within 15 days of publication of the notice of intent as part of any rule proposed by the agency. FDA also stated that it would consider all comments to the notice of intent received after 15 days in any final rulemaking. FDA reviewed all of the comments received within 15 days of publication and found that they provided no information that would cause the agency to conclude that the HACCP proposal was inappropriate. Comments received 15 days after publication of the notice of intent are discussed in this final rule.

B. The Proposal

In the
Federal Register
of April 24, 1998 (63 FR 20450) (Ref. 2), FDA published a proposed rule to establish requirements relating to the processing of juice and juice products (hereinafter referred to as the HACCP proposal).
1

The proposal would have required the application of HACCP principles by processors and importers to ensure juice safety to the maximum extent practicable. FDA proposed these regulations because there had been a number of food hazards, including some directly affecting children, associated with juice products. The agency tentatively concluded that the most effective way to ensure the safety of juice products is to process the products under a system of preventive control measures based on HACCP principles. Interested persons were given until July 8, 1998, to comment on the HACCP proposal. The agency subsequently extended the comment period to August 7, 1998 (63 FR 37057; July 8, 1998) (Ref. 3).

1
As defined in § 120.1 (21 CFR 120.1) “juice” refers both to beverages that are composed exclusively of an aqueous liquid or liquids extracted from one or more fruits or vegetables and to the juice ingredient in those beverages that contain other ingredients in addition to juice. In this document, the term “juice product” refers both to beverages that contain only juice and to the juice ingredient of beverages that are composed of juice and other ingredients.

In the remainder of this document, products not processed to prevent, reduce, or eliminate hazards will be referred to as “untreated juice products.” In addition, processing to “prevent, reduce, or eliminate” hazards will be referred to as processing to “control” hazards.

In addition to publishing the HACCP proposal, FDA published in the same issue of the
Federal Register
(63 FR 20486) (Ref. 4) a proposed rule (the juice labeling proposal) to require warning labels on juice that has not been processed to prevent, reduce to acceptable levels, or eliminate pathogens that may be present. As fully discussed in the juice labeling proposal, FDA proposed that untreated juice products bear a warning statement informing at risk consumers of the hazard posed by untreated juices to allow them to make informed decisions on whether to purchase and consume such products. The labeling proposal was finalized on July 8, 1998 (63 FR 37030) (Ref. 5).

FDA issued in the
Federal Register
of May 1, 1998 (63 FR 24254) (Ref. 6) a single Preliminary Regulatory Impact Analysis (PRIA) that addressed both the

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 (§ 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 § 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.
, 10
5
) reduction in the pertinent pathogen in citrus juices (63 FR 57594; October 28, 1998) (Ref. 7). The transcripts from the two workshops were placed on display in the docket for the juice HACCP proposal and on the FDA/CFSAN website http://www.fda.gov/). On December 17, 1998 (63 FR 69579) (Ref. 8), the comment period for the juice HACCP proposal was reopened until January 19, 1999, to allow public comment on data and other information that were presented at or developed as a result of these workshops. In addition, FDA expressly sought comments on the following four specific topics related to the application of the 5-log pathogen reduction standard: (1) Appropriate baselines for the calculation of the 5-log pathogen reduction; (2) feasible interventions or practices for the cultivation and harvest of fruits and vegetables, and acquisition of supplies and materials that may contribute to achieving a 5-log pathogen reduction; (3) feasible interventions for the production process that may contribute to achieving a 5-log pathogen reduction; and (4) acceptable methods for measuring and validating 5-log reductions.

On July 15 and 16, 1999, FDA held a workshop on food safety controls for the apple cider
2

industry (64 FR 34125; June 25, 1999) (Ref. 9). The workshop dealt with issues related to the implementation of the agency's regulations requiring a warning statement for certain juice products. Specifically, the workshop addressed pathogen reduction interventions that may be effective for apple cider production and the methods used to measure and validate such interventions. Results of research conducted by Federal, State, private, and academic institutions were presented.

2
Although the terms “apple cider” and “apple juice” may have different meanings throughout the United States, these terms are used interchangeably throughout this final rule.

In the
Federal Register
of November 23, 1999 (64 FR 65669) (Ref. 10), FDA announced the availability of new data and information regarding the safe processing of citrus juice and juice products, and reopened the comment period for the juice HACCP proposal until January 24, 2000, in order to receive comment on the new data and other information. In that same notice, in order to develop the most complete administrative record possible, FDA requested additional data and information relating to four separate areas: Internalization and survival of pathogens in produce used to produce juice, especially citrus fruit; application and measurement of the 5-log reduction standard; current methods used by juice processors to monitor the application of heat treatment to juice; and certain economic matters related to juice regulation. The notice discussed in detail the particular issues in each of the four areas in which the agency was seeking comments (64 FR 65669 at 65670 through 65671). Two of these areas (internalization and survival of pathogens and application and measurement of the 5-log reduction standard) were also to be the subject of the December 8 to 9, 1999, public meeting of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) (discussed in more detail below), and the comment period extension was established so as to permit comments on the identified issues in light of any information or recommendations coming out of that meeting of the NACMCF.

D. NACMCF Public Meeting

NACMCF is an advisory committee chartered under the U.S. Department of Agriculture (USDA) and has members from USDA (Food Safety and Inspection Service), the Department of Health and Human Services (U.S. Food and Drug Administration and the Centers for Disease Control and Prevention (CDC)), the Department of Commerce (National Marine Fisheries Service), the Department of Defense (Office of the Army Surgeon General), academia, industry and State agencies. The NACMCF provides guidance and recommendations to the Secretary of Agriculture and the Secretary of Health and Human Services regarding the microbiological safety of foods.

The NACMCF held a public meeting on December 8 to 9, 1999 (64 FR 63281; November 19, 1999) (Refs. 11 and 12) to discuss recent research and other information related to performance criteria for fresh citrus juices. FDA sought advice from the NACMCF on two issues. In addition, the meeting agenda provided an opportunity for public comment.

First, FDA asked the NACMCF about the potential internalization and survival of pathogens in citrus fruits and citrus juices. The NACMCF members generally agreed that it is theoretically possible for microorganisms to enter the interior of apparently sound, intact citrus fruit under certain conditions (
e.g.
, temperature difference between fruit and wash water), and that human pathogens appear to be able to survive, at least under defined laboratory conditions, in the fruit itself (Ref. 12). However, the NACMCF members concluded, based on the current information, that the potential for microorganisms to enter and survive in intact fruit is not likely to result in a significant public health risk. In particular, the Committee members concluded, based upon the limited data available, including data presented by the industry, that although it is theoretically possible, it is unlikely that pathogens will enter and grow in sound, intact fruit under actual current industry processing practices.

Second, the agency asked the NACMCF about the application and measurement of the 5-log pathogen reduction standard to citrus fruit. In response, the NACMCF outlined the following five basic consensus decisions related to the application and measurement of the 5-log reduction standard to citrus juices:

1. The 5-log reduction need not start with the extracted juice but may begin with the exterior decontamination of citrus fruit. However, processors should not start a cumulative 5-log reduction until after the fruit is cleaned (
i.e.,
washed) and culled (
i.e.
, damaged or dropped fruit is removed so that the remaining fruit is USDA choice level or higher quality).

2. One possible method to minimize potential microbial infiltration into the fruit would be by controlling fruit and wash water temperatures, as well as excluding fruit that is split, punctured, or otherwise not intact. Laboratory studies indicate that microbial infiltration of fruit occurred when warm fruit was washed or submerged into cold water (Refs. 13 and 14).

3. The entire 5-log process must occur under one firm's control and in one processing facility,
i.e.
, all steps from

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

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 § 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

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 (μg/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 § 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

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 § 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 § 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.

(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 μg/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

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 (§ 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

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,

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

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 § 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 § 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 § 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 § 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

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 § 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

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 § 120.3(e) (finalized as § 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 § 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 § 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 § 120.3(h)(1) (finalized as § 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 § 120.3(h)(2) (finalized as § 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 § 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 § 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.

(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 § 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 § 120.3(h)(2)(ii) (finalized as § 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 § 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 § 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 § 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 § 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 § 120.3(h)(2)(iii)

(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 § 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 § 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 § 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 § 120.3, it is recodifying the other terms in § 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 § 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 § 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 § 120.6 do include specific standards that must be maintained. The SSOP's as described in § 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.

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 § 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 § 110.80(a)(3)). As required by § 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 (§ 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 § 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 § 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 (§ 120.6(b)). In addition, processors must maintain records that document monitoring and any corrective actions taken (§ 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 § 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 § 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 § 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 § 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 § 120.6(a)(8). The comment's requested modification is already implied in § 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 § 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

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 § 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 pro

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A01-1291. Public record. Not legal advice.