6138 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

1As 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.

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).

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

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6139

2Although the terms ‘‘apple cider’’ and ‘‘apple

juice’’ may have different meanings throughout the

United States, these terms are used interchangeably

throughout this final rule.

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., 105) reduction in the

pertinent pathogen in citrus juices (63

FR 57594; October 28, 1998) (Ref. 7).

The transcripts from the two workshops

were placed on display in the docket for

the juice HACCP proposal and on the

FDA/CFSAN website http://

www.fda.gov/). On December 17, 1998

(63 FR 69579) (Ref. 8), the comment

period for the juice HACCP proposal

was reopened until January 19, 1999, to

allow public comment on data and other

information that were presented at or

developed as a result of these

workshops. In addition, FDA expressly

sought comments on the following four

specific topics related to the application

of the 5-log pathogen reduction

standard: (1) Appropriate baselines for

the calculation of the 5-log pathogen

reduction; (2) feasible interventions or

practices for the cultivation and harvest

of fruits and vegetables, and acquisition

of supplies and materials that may

contribute to achieving a 5-log pathogen

reduction; (3) feasible interventions for

the production process that may

contribute to achieving a 5-log pathogen

reduction; and (4) acceptable methods

for measuring and validating 5-log

reductions.

On July 15 and 16, 1999, FDA held a

workshop on food safety controls for the

apple cider 2 industry (64 FR 34125;

June 25, 1999) (Ref. 9). The workshop

dealt with issues related to the

implementation of the agency’s

regulations requiring a warning

statement for certain juice products.

Specifically, the workshop addressed

pathogen reduction interventions that

may be effective for apple cider

production and the methods used to

measure and validate such

interventions. Results of research

conducted by Federal, State, private,

and academic institutions were

presented.

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

6140 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

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 nonreusable 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

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6141

in CCP’s or their critical limits (CL’s),

thus ensuring that the HACCP system is

up-to-date and adequate to control all

food hazards that are reasonably likely

to occur. This recordkeeping also allows

regulatory investigators to readily

review the long term performance of a

firm’s processing system, rather than

relying on a time-limited inspection,

which provides only a snapshot of how

well the firm is doing in producing and

distributing safe product on any given

day.

HACCP is ideally suited to respond to

emerging problems because a HACCP

system is a dynamic system that must be

validated periodically to ensure that all

hazards reasonably likely to occur are

identified and controlled via CCP’s.

Validation of both the hazard analysis

and the HACCP plan entails a thorough

review to ensure that all hazards that are

reasonably likely to occur are addressed

in the HACCP system.

Because of its preventive yet flexible

nature, HACCP is recognized by food

safety professionals as the single most

effective means to assure the safety of

foods. It has been endorsed by the

National Academy of Sciences (Ref. 15),

the Codex Alimentarius Commission (an

international food standard-setting

organization) (Ref. 16), and the

NACMCF (Ref. 17). Increasingly, use of

HACCP systems is an indication to

importing countries that food safety

systems that provide a standardized

level of public health protection are in

place and being used by producers in

exporting countries.

1. Increased Inspection

(Comment 1) Several comments

suggested that the increased FDA

inspection approach would be

preferable to HACCP.

The agency disagrees. FDA’s

responsibility is to implement and

enforce the Federal Food, Drug, and

Cosmetic Act (the act), i.e., to oversee

the manufacture of safe food. Increased

inspection by FDA is a resourceintensive 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

6142 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

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 (longterm) 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 nonmicrobial 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

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6143

the development of new processes to

achieve the 5-log pathogen reduction.

4. Labeling

(Comment 11) Two comments

suggested that FDA require either

pasteurization or a permanent warning

label statement for producers who do

not pasteurize. One comment stated that

FDA should require HACCP with a CCP

of either a 5-log performance standard

for pathogen reduction or a warning

label.

FDA disagrees with the comments.

Under § 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.

6144 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

(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

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6145

3FDA 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.

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 shelfstable 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.

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

6146 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

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 postprocess 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-heattreatable 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-heattreated 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,

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6147

Salmonella species, Cryptosporidium,

and Vibrio cholerae. Some of the

illnesses associated with juices have

been very severe (e.g., cases of long-term

reactive arthritis and severe chronic

illness) (Ref. 2). In one case,

consumption of contaminated juice

resulted in the death of a child and in

another case, consumption of

contaminated juice contributed to the

death of an elderly man. These reported

outbreaks likely represent only a

fraction of the outbreaks and sporadic

cases that actually occur (Ref. 44).

Chemical and physical hazards have

also been associated with juices.

Examples of these hazards were

included in the proposal (63 FR 20450

at 20451) (Ref. 2) and are discussed in

detail in the response to comment 15.

The evidence demonstrates that

hazards can be present in juice. The

comments did not provide the agency

with additional data that either

contradict FDA’s hazard evaluation (Ref.

6) or that can be used to reevaluate the

health risks associated with

consumption of juice products.

Therefore, FDA believes that the public

health risk associated with consumption

of juices is sufficiently high to justify

mandating use of HACCP systems.

(Comment 26) Many comments

argued that HACCP is no longer

necessary for juice because of the safety

improvements made by the juice

industry since the 1996 outbreak of E.

coli O157:H7 in apple juice. They stated

that these improvements are evidenced

by the fact that there has not been an

outbreak associated with juice since

1997.

FDA disagrees with the comments.

There have been documented outbreaks

of juice-associated foodborne illness

since 1997. The agency acknowledges

the recent steps taken by the industry to

address microbial contamination of

juice. Nevertheless, while there were no

reported outbreaks attributed to juice in

the United States in 1997 and 1998,

there were several outbreaks in 1999

and 2000. These outbreaks are discussed

below.

In early 1999 in south Florida, there

were 16 reported cases from Salmonella

typhi linked to the consumption of

frozen mamey, a product often used to

make juice beverages (Ref. 46).

During June 1999, there was an

outbreak of Salmonella serotype

Muenchen infection associated with

consumption of unpasteurized orange

juice (Ref. 47). As of April 2000, a total

of 423 cases, including one that

contributed to a death, from S.

Muenchen infection had been reported.

Nine additional Salmonella serotypes

were identified from orange juice

collected from the implicated firm.

In October 1999, there was an

outbreak of E. coli O157:H7 in

commercially-processed unpasteurized

apple cider in Oklahoma with 9

illnesses (7 children) and 6

hospitalizations (4 cases of hemolytic

uremic syndrome (HUS)) (Ref. 48).

While no illnesses were reported in

October 1998, the State of Florida found

Salmonella Manhattan in an

unpasteurized juice blend containing

strawberry, apple, and papaya juice

(Ref. 49).

In November 1999, the same firm

involved in the June 1999 outbreak

initiated and subsequently expanded a

recall because their routine testing

found Salmonella in samples of

unpasteurized orange juice (Ref. 50).

The product had been distributed to

restaurants and other food service

establishments in eight U.S. States and

one Canadian Province and to one retail

store in Oregon. No known illnesses

were associated with this incident.

In April 2000, there was an outbreak

of Salmonella Enteritidis associated

with unpasteurized orange juice (Ref.

51). As of May 2000, 143 cases traced

to this orange juice had been identified

in Arizona, California, Colorado,

Minnesota, Nevada, Washington, and

Wyoming.

Also in April 2000, 24 people who

attended a conference in Atlanta,

Georgia, were reported ill with viral

gastroenteritis (Ref. 52). Fresh-squeezed

unpasteurized fruit smoothies were

implicated in this outbreak. CDC

detected Norwalk-like virus in three

patient stools.

Thus, the potential for juice-related

illness still exists, although the number

of illness outbreaks linked to juice may

vary from year to year. In addition, the

agency has no information indicating

that all members of the juice industry

have implemented adequate safety

improvements to address the potential

for microbial contamination and other

potential hazards in their products. The

fact that outbreaks continue to occur is

evidence to the contrary.

(Comment 27) One comment

asserted that most problems associated

with citrus juices were a result of

insanitary processing conditions at

small or very small businesses or

contamination by asymptomatic food

handlers, and HACCP would not

prevent problems in either situation.

The agency disagrees with this

comment. FDA often finds in their

investigations into outbreaks that the

exact cause of the outbreak is unknown.

The agency may find various possible

causes that include those mentioned by

the comment. However, as discussed

throughout this preamble, insanitary

conditions and workers’ health are not

the only source of food hazards in juice.

For example, if juice is made from

contaminated fruit and the 5-log

reduction is not accomplished, an

outbreak could occur. HACCP systems

do provide greater assurance than

CGMP’s and SSOP’s alone that juice is

safe. HACCP recordkeeping provisions

allow processors and regulators to

detect process deviations and stop

distribution of or recall product before

it results in an outbreak.

(Comment 28) Several comments

stated that the rules should cover apple

products only, asserting this is where

problems have occurred.

The agency disagrees that only apple

juice should be covered by part 120, and

all other juices should be exempt. There

have been illness outbreaks from other

types of juice, e.g., orange juice. Some

of these were cited in the proposal (63

FR 20450) (Ref. 2). As discussed in

comment 27, additional outbreaks since

publication of the proposal have

occurred. Therefore, FDA concludes

that because there are documented

foodborne illness risks associated with

juices other than apple juice, all types

of juice must be covered under part 120.

(Comment 29) Many comments

argued that juice regulations should not

be more stringent than regulations for

other foods that are more hazardous,

such as seafood or meat and poultry.

Many comments noted that seafood

HACCP has no performance standard

but is a much higher risk food than

juice.

The agency disagrees that juice is

being regulated more stringently than

warranted. HACCP for juice mirrors

FDA’s HACCP regulations for seafood

and USDA’s regulations for meat and

poultry. In contrast to most seafood and

meat and poultry, juice is generally

consumed as sold. The record of this

proceeding demonstrates that microbial

contamination of juice is a substantial

public health risk and that a

performance standard is achievable as a

practical matter. Thus, to ensure the

safety of juice products, FDA is

establishing a mandatory HACCP

program that includes a performance

standard to prevent, reduce, or

eliminate levels of pathogens known to

cause foodborne illness. The

performance standard ensures that

controls within the HACCP system are

working effectively to reduce the risk of

illness and that the final product is safe.

(Comment 30) One comment

maintained that the physical hazards

related to juice are a result of metal cans

6148 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

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 welldocumented 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 shelfstable 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 nonbeverage 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

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6149

indicating that Listeria and E. coli

O157:H7 cannot survive in lemon and

lime juices under normal storage

conditions and requested that these two

juices be exempted from the HACCP

rule.

The agency disagrees that citrus juices

should be exempt from the requirements

of part 120. Although the organic acids,

pH, and peel oil in citrus juice may

inhibit (i.e., prevent or slow down) the

growth of pathogens, such organisms

can still be present in citrus juice and

may cause illness if consumed. Fruits

and vegetables differ in their inherent

chemical composition; even within

varieties of particular fruits or

vegetables, there can be some variation

in composition depending on growing

conditions. However, the comments

provided no data to show how the

chemical composition of a citrus juice

(pH or antimicrobial compounds in peel

oil) will ensure the safety of fresh citrus

juice. In fact, because the amount of

peel oil in juice will vary from process

to process, the agency disagrees that the

antimicrobial effects of citrus peel oil

can adequately control pathogens in

juice. Similarly, the organic acid in

citrus juice (i.e., citric acid) has not been

shown to provide any additional

protection against pathogen

contamination and survival compared to

the acid found in apple juice (Refs. 54,

55, and 56).

A 1997 study of E. coli O157:H7

behavior in apple juice and orange juice,

particularly under refrigerated

conditions, demonstrated that even in

the relatively acidic environment of

these juices, this organism can survive

(Ref. 57). In the study, juice was

inoculated with E. coli O157:H7. After

a 24-day period at refrigeration

temperatures, there was only a small

decline in numbers of E. coli O157:H7.

The fact that E. coli O157:H7 can

survive in orange juice and that human

illnesses from other pathogens, such as

S. Muenchen and other Salmonella

species, have been traced to orange juice

demonstrates that, if contaminated,

orange juice has the potential to cause

human illness.

Lemon and lime juices are more

acidic than other types of citrus juice.

The strong acidity of these juices does

have an antimicrobial effect as the

comment’s data demonstrated.

However, the resistance of oocysts to the

strong acidity of these juices is not

known. In addition, there can be

differences in acidity between varieties

of lemons and limes, and thus,

differences in their inherent

antimicrobial effects. These juices may

be diluted and sweetened to make them

palatable as beverages, thus changing

antimicrobial parameters. In addition,

there may be chemical and physical

hazards that are reasonably likely to

occur in these types of juices that pH

and acids cannot control. Therefore,

FDA concludes that the chemical

composition of lemon and lime juices

does not justify exempting these juices

from this rule. If processors can

demonstrate that the inherent

antimicrobial qualities of a juice are

adequate to accomplish the 5-log

reduction in the pertinent pathogen

under refrigerated conditions (or

freezing conditions, if the product is

frozen) prior to the product leaving the

processing facility, then the

antimicrobial parameters, along with the

necessary time to accomplish the 5-log

reduction, could constitute CCP’s. FDA

notes, however, that under the final

rule, processors must establish critical

limits and monitor each of the CCP’s as

part of their HACCP systems.

(Comment 35) Some comments

maintained that there is less inherent

risk from citrus juices because citrus

processing limits contact time of peel

and juice. The comments included data

from citrus processors that separate the

peel from the juice with only a small

fraction of peel contacting the juice.

The agency disagrees that there is less

risk from citrus juices such that these

juices should not be subject to part 120.

The significance of peel/juice contact as

a source of pathogens in the juice

depends on several factors, including

the microbial load on the peel and the

amount of contact of the peel with the

juice. If the small fraction of peel, as

described by the comments, is

contaminated and comes into contact

with the juice, that contact is

significant. As discussed in the

proposed rule (63 FR 20450) (Ref. 2) and

also in the response to comment 26,

there have been outbreaks of food borne

illness associated with orange juice.

(Comment 36) A few comments

requested that FDA exempt apple cider

from the HACCP regulation because the

agency found no pathogen

contamination in the 1997 cider survey,

which, according to the comment,

indicates that there is no real risk from

pathogens in cider.

FDA’s 1997 survey involved

inspection of fresh unpasteurized apple

cider operations at 237 processors in 32

States (Ref. 45) during which the agency

collected samples at various processing

steps. These samples were analyzed for

E. coli O157:H7, Salmonella,

Staphylococcus aureus, fecal coliforms,

and generic E. coli. Although the survey

did not detect any pathogens in finished

juice products, one firm’s apples tested

positive for Salmonella, demonstrating

that pathogens can occur on incoming

apples. (The analytical method used for

Salmonella has since been improved to

better detect low levels of this pathogen

in acidic foods, such as apple juice.)

Results also showed that samples of

wash water from several firms tested

positive for generic E. coli and fecal

coliforms; overall, generic E. coli was

found in 15 percent of the finished

product samples. The presence of fecal

coliforms and generic E. coli are widely

recognized as indicators of fecal

contamination (Ref. 58). Further, the

survey concluded that it is likely that

any microbial hazards that are

introduced at the beginning of

processing will be carried through to the

finished product; no microbial

reduction will occur during the process

(Ref. 45).

The agency disagrees that these

results indicate there is no real risk from

pathogens in cider. Contrary to the

comments’ contention, the cider survey

results affirm that risk factors such as

fecal coliforms, an indicator of the

possible presence of pathogens, as well

as pathogenic bacteria, such as

Salmonella, are present in cider

processing operations and could give

rise to microbiological safety hazards in

finished cider products.

Finally, illness outbreaks associated

with apple cider continue to occur. In

particular, in October 1999 in

Oklahoma, there was an outbreak

related to E. coli O157:H7 in a

commercially produced, unpasteurized

apple cider, that resulted in nine

reported illnesses. The agency,

therefore, is not granting the requested

exemption.

(Comment 37) Several comments

requested that FDA clarify whether

concentrates are covered under the rule.

The agency advises that under the

final rule, a juice concentrate satisfies

the definition of ‘‘juice’’ in § 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

6150 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

120. However, dairies producing a nonjuice 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 longterm 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.

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6151

(Comment 41) One comment

suggested that the definition of

processing should at least mention

FDA’s ‘‘Guide to Minimize Microbial

Food Safety Hazards for Fresh Fruits

and Vegetables’’ (GAP’s).

FDA has considered the comment’s

suggestion and believes that reference to

the GAP’s in part 120 would be useful.

However, the agency finds that it is

more appropriate to discuss the GAP’s

in terms of the application of part 120.

Therefore, FDA is modifying § 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 Stateby-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)

6152 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

(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.

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6153

It is important to understand the

difference between CGMP’s, SSOP’s,

and HACCP. The agency has established

CGMP’s in part 110. These regulations

provide general guidance on such

matters as facility design, materials,

personnel practices, and cleaning and

sanitation procedures. In § 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

6154 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

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 processors the option of

including sanitation controls in the

HACCP plan, but they are under no

obligation to do so as long as the

sanitation controls are being

implemented through the SSOP.

Insanitary facilities or equipment, poor

food handling, improper personal

hygiene, and similar insanitary

conditions create an environment in

which products may become

contaminated with pathogens and other

substances. A processor may determine

that a task normally covered by SSOP’s

may be of such importance that it must

be included in the HACCP plan because

it controls a hazard that is reasonably

likely to occur. Similarly, an SSOP task

may simply be more efficiently or

effectively performed under the HACCP

plan rather than SSOP controls, and

thus, a processor may choose to

incorporate the SSOP task into the

HACCP system. However, HACCP

controls generally focus on discrete

steps or ‘‘points’’ in a processing

system, while sanitation and sanitation

controls generally have broader,

plantwide applicability. Thus,

sanitation does not always lend itself

well to HACCP controls. Therefore, the

agency is not modifying § 120.6(d) as

requested.

FDA disagrees that singling out items

to be included in SSOP’s implies that

the other provisions of part 110 are not

important. Rather, the items listed in

§ 120.6(a) are to assist processors in

identifying and implementing key

sanitation activities. Sanitation controls,

such as controls preventing use of

contaminated water in juice making,

have a direct impact on the presence or

absence of pathogens during processing,

which in turn, directly affects the

effectiveness of the HACCP plan. No

matter how reliable the process is,

insanitary conditions can cause the

product to become contaminated with

pathogens. It is because of the critical

role that sanitation plays in the

production of safe juice that FDA is

requiring SSOP’s, identifying specific

items to be included, and requiring

recordkeeping. However, processors

must comply with all provisions of part

110 in addition to having SSOP’s as

required under § 120.5.

2. Other SOP’s

(Comment 59) Several comments

requested that FDA require written,

monitored, and verified SOP’s for

incoming materials. One comment

contended that reasonable procedures

for these SOP’s should include no use

of dropped apples, no contact with

water that could contain pathogens, no

manure as fertilizer, steam cleaning of

crates in contact with fruit between lots,

and regular inspections of source farms

and orchards. Another comment

suggested that incoming material SOP’s

be required only for producers that do

not pasteurize their product.

The agency is not convinced of the

need for mandatory incoming material

SOP’s because these activities may be

adequately controlled under the CGMP’s

in part 110. However, FDA does

recognize the value of incoming

material SOP’s, and it encourages

processors to establish and monitor

incoming material conditions and

practices and to take corrective actions

when needed. Processors must evaluate

the need for controls at all points in

their process, including incoming

materials. If incoming materials are

reasonably likely to present a hazard,

then the hazard must be controlled by

one or more CCP’s in the HACCP plan,

even if a processor has an incoming

material SOP.

Many of the controls mentioned in the

comments are addressed in FDA’s

‘‘Guide to Minimize Microbial Food

Safety Hazards for Fresh Fruits and

Vegetables.’’ As noted earlier, FDA

encourages farmers and processors to

evaluate and modify their agricultural

practices in accordance with GAP

guidance. Processors may include GAP’s

in any SOP’s for incoming materials that

they may establish.

Finally, because all processors,

regardless of whether or not they

pasteurize, must meet the performance

standard required under § 120.24, as

well as the other requirements of part

120, there is no need to differentiate

between processors for the purposes of

requiring incoming material SOP’s, and

thus, to require more SSOP’s from a

processor that does not pasteurize.

(Comment 60) One comment

requested that FDA hold a public

meeting for input on incoming material

SOP’s.

The agency does not believe that such

a public meeting is necessary. There

have been many opportunities for

interested parties to comment on all

issues related to HACCP, including

incoming material SOP’s (see section I.B

of this final rule). FDA requested public

input in the HACCP proposed rule (63

FR 20450 at 20466) (Ref. 2) and in this

final rule has considered all significant

comments received. In addition, some

issues surrounding incoming materials

for citrus juices were discussed at the

public NACMCF meeting in December,

1999 (Ref. 12). Finally, FDA intends to

issue a juice HACCP hazards and

controls guidance, which will provide

another opportunity for public input on

the incoming materials issue.

(Comment 61) One comment

suggested that the GAP’s for fresh

produce can be used in conjunction

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6155

with SOP’s to ensure the safety of

incoming material.

FDA agrees that the use of GAP’s in

combination with SOP’s may enhance

the safety of incoming materials. FDA’s

GAP’s for fresh produce provide

valuable guidance for use in the

production and post harvest handling of

raw agricultural commodities. As noted,

the agency also intends to publish a

juice HACCP hazards and controls

guidance that will provide additional

guidance on ensuring the safety of

incoming materials.

(Comment 62) One comment stated

that HACCP should include a

requirement for incoming materials

testing to prevent another outbreak like

the one in 1996.

The agency disagrees that it should

require incoming materials testing in

part 120, although it encourages

processors to test incoming materials as

appropriate. Testing may be used as a

control measure for a hazard that is

reasonably likely to occur and it may

also be used to gather information on a

product or supplier for use in the hazard

analysis. However, testing may not be

useful in all cases. Microbial

contamination of fresh produce is

usually at low levels and is not

uniformly distributed throughout a lot.

Thus, while detecting a pathogen, such

as E. coli O157:H7, would allow a

processor to avoid using contaminated

produce, failure to detect pathogens by

testing does not provide assurance that

the hazard is not present in incoming

materials. The 5-log reduction in the

pertinent pathogen as implemented in a

HACCP system provides the assurance

that microbial hazards are under control

throughout the process. Therefore, the

agency is not requiring the testing of

incoming materials.

D. Hazard Analysis

The agency proposed in § 120.7 that

processors develop a written hazard

analysis to determine whether there are

hazards that are reasonably likely to

occur for each type of juice produced by

a processor and to identify the control

measures that the processor can apply to

control those hazards.

(Comment 63) One comment

requested that FDA clarify how a hazard

analysis is conducted. The comment

suggested that FDA emphasize the

NACMCF recommendations, including

consideration of both likelihood of

occurrence and severity of hazards. The

comment expressed concern that

without considering both the likelihood

of occurrence and severity of hazards,

HACCP plans would not be consistent

with international practice and World

Trade Organization (WTO) obligations,

which state that scientific

determinations of risk are needed to

form a sound basis for food safety

standards.

The agency agrees that the approach

outlined by the NACMCF will best

assist processors in conducting a hazard

analysis. First, processors will benefit

from using the five preliminary steps set

forth by the NACMCF, which are to

assemble a HACCP team, describe the

food and its distribution, identify the

intended use and consumers of the food,

develop a flow diagram that describes

the process, and verify the flow diagram

(Ref. 17). Although the agency is not

specifically requiring that processors

use these preliminary steps, these steps

will aid processors in focusing on their

specific product and process.

According to the NACMCF,

processors must accomplish three

objectives in the hazard analysis: (1)

Identify hazards that are reasonably

likely to occur and their associated

control measures; (2) identify needed

modifications to a process or product so

that product safety is further assured or

improved; and (3) provide a basis for

determining CCP’s in the HACCP plan

(Ref. 17). FDA agrees with these

objectives.

The first NACMCF objective is

accomplished in three steps. First,

processors must list all the potential

hazards that could be present in the

juice. During this step, the processor’s

HACCP expert or team reviews the

ingredients used in the product, the

activities conducted at each step in the

process and the equipment used, the

final product and its method of storage

and distribution, and the intended use

and consumers of the product. A list of

categories of potential food hazards is

found in § 120.7(c). Based on this

review, the processor’s HACCP team

develops a list of potential biological,

chemical, or physical food hazards that

may be introduced, increased, or

controlled at each step in the

production process. A hazard analysis

must be conducted for each type of juice

product manufactured by the processor

because different hazards may be

associated with different juice products.

(For example, patulin need only be

considered in apple juice products.)

The processor must then identify

those food hazards that are reasonably

likely to occur. According to NACMCF,

this step takes into account both the

consequences of exposure (i.e., severity)

and the probability of occurrence (i.e.,

frequency) of the health impact of the

potential hazards in question (Ref. 17).

FDA agrees with the NACMCF

approach. Accordingly, when applying

the phrase ‘‘reasonably likely to occur,’’

a processor must consider both severity

and frequency of potential hazards. The

NACMCF stated that consideration of

the likelihood of the hazard’s

occurrence is usually based upon a

combination of experience,

epidemiological data, and information

in the technical literature (Ref. 17). The

NACMCF also stated that consideration

should be given to the effects of short

term, as well as long-term, exposure to

the potential hazards. Because this

process takes into consideration both

frequency and severity, a potential

hazard may be identified as reasonably

likely to occur even though it occurs

infrequently because the public health

consequences when it does occur are so

severe, e.g., HUS in small children from

E. coli O157:H7 in juice. This approach

also provides greater harmony for

international trade because it is the

same approach recommended by the

Codex Alimentarius Commission, which

is a recognized standard setting body by

the WTO. Hazards that are not

reasonably likely to occur do not require

further consideration within a HACCP

plan but are controlled under CGMP’s.

Identification of control measures is a

third step in the first NACMCF objective

in developing a hazard analysis. For

example, juice processors must identify

the process they will use to achieve the

5-log reduction in the pertinent

pathogen. This may be pasteurization,

surface treatments for citrus, or other

effective methods. Therefore, § 120.7

requires that processors identify the

measures that they will apply to control

the hazards that have been identified as

reasonably likely to occur. These control

measures must be included in the

HACCP plan as well as the hazard

analysis.

Under the second NACMCF objective,

processors must review their current

process to determine deficiencies in

controlling food hazards and then

identify the changes that must be made

to ensure that food hazards are

controlled. For example, some juice

beverages may be thinner or thicker

than others, a characteristic that may

affect how fast the product flows

through the pasteurizer; in this stage of

the hazard analysis, the processor must

review its process to determine whether

the product is flowing through the

pasteurizer at a rate sufficient to ensure

that all particles of the juice receive the

appropriate treatment in terms of both

time and temperature to achieve, at a

minimum, the 5-log reduction in the

pertinent pathogen.

The third NACMCF objective requires

that processors use the hazard analysis

to provide a basis for determining CCP’s

in the HACCP plan. For example, some

6156 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

processors may run different juice

beverages on the same line during the

same day with only a water flush

between products. If one juice product

contains a potential allergen, such as a

soy ingredient, then a possible control

measure is that this product be run last

in the day with a thorough cleaning of

the system before the next day’s startup.

To clarify the necessary steps in

developing a hazard analysis, as the

comment requested, the agency is

codifying them in § 120.7(a). (Because

the agency is adding these steps to

§ 120.7, it is recodifying the other

paragraphs in § 120.7 for clarity.)

(Comment 64) A few comments

objected to the requirement of a written

hazard analysis because the seafood

HACCP regulation does not require a

written hazard analysis. However, some

comments supported such a

requirement.

FDA acknowledges that a written

hazard analysis is not required by the

seafood HACCP regulation and believes

that, at the time that the regulation was

established, this was appropriate.

Although the seafood HACCP regulation

does not require a written hazard

analysis for agency record review,

seafood processors are strongly urged to

have a written hazard analysis to resolve

differences between the processor and

the agency about whether a HACCP plan

is needed and about the selection of

hazards, CCP’s, and CL’s.

Since the issuance of the seafood

HACCP regulation, the HACCP concept

and how best to implement HACCP has

evolved in step with industry’s

increasing experience with HACCP; part

of that evolution is the idea that the

hazard analysis should be written.

Processors will have a better HACCP

system if they document the hazard

analysis process. A thorough hazard

analysis is the key to preparing an

effective HACCP plan. According to the

NACMCF, if the hazard analysis is not

done correctly and the hazards

warranting control are not properly

identified, the plan will not be effective

regardless of how well it is followed

(Ref. 17).

Another aspect of HACCP

implementation that affects the need for

a written hazard analysis is the

availability of specially trained

investigators. At the time the seafood

HACCP program was established, FDA

had sufficient resources to hire and

specifically train investigators in

seafood HACCP, as well as to provide

assistance to the industry in

implementing HACCP. With expansion

of HACCP into other commodity areas,

the agency does not have the resources

to develop cadres of investigators with

expertise in a single commodity, such as

juice. With a written hazard analysis,

investigators can more easily determine

whether processors have adequately

considered all juice hazards and have

adequately identified those hazards that

are reasonably likely to occur.

Even though a written hazard analysis

is not required by the seafood HACCP

regulation, that regulation, as well as

USDA’s meat and poultry HACCP

regulations, require a systematic and

comprehensive hazard analysis. In

addition, USDA’s meat and poultry

HACCP regulations require a written

hazard analysis. Thus, the only

difference in the juice final rule and the

seafood HACCP regulation is that the

analysis is written, not that it is or is not

required. FDA believes that the

additional step of recording the hazard

analysis poses no significant burden,

economic or otherwise, to juice

processors and, on the contrary, has

advantages for the processor. A written

hazard analysis provides processors

with a ready record of the decisions

made in conducting a safety analysis of

their process, which they may use in

evaluating potential changes to the

system and for discussions with

regulatory officials. Further, written

hazard analyses are useful to processors

in that they help provide the rationale

for the establishment of critical limits

and other plan components. Having the

basis for these decisions available will

be helpful when processors experience

changes in personnel, especially those

associated with the HACCP process, and

in responding to unanticipated CL

deviations.

A written hazard analysis need not be

a highly detailed document, but it must

reflect consideration of all the potential

hazards that could occur in a

processor’s system for a product and the

processor’s decisions about whether

these hazards are reasonably likely to

occur. The hazard analysis may be as

simple as a checklist of potential

hazards and the reason why certain

decisions were made. A written hazard

analysis clearly and rationally

demonstrates that processors have

considered all potential hazards,

identified those hazards that are

reasonably likely to occur and are

associated with their product and

process, and identified CCP’s and CL’s

in their HACCP plan.

(Comment 65) Several comments

stated that HACCP should only cover

hazards that are reasonably likely to

occur and that have been documented.

FDA agrees that processors need only

control in their HACCP plan those

hazards that are reasonably likely to

occur and that have been documented.

The hazard analysis is where processors

differentiate between unlikely hazards

and hazards that are reasonably likely to

occur in the absence of controls. This

determination is made for each type of

juice processed in a particular facility.

Data such as experience, illness data,

scientific reports, or other information

may be used as documentation as to

whether the hazard is reasonably likely

to occur in juice and, if so, how the

hazard is best controlled.

(Comment 66) One comment

requested that the agency revise

proposed § 120.7(a) to state generally

that all physical, chemical, and

microbiological hazards be considered,

instead of providing a numbered list of

potential hazards to be considered in

the hazard analysis.

FDA disagrees that all physical,

chemical, and microbiological hazards

must be considered, but only those that

can be introduced both within and

outside the particular processing

environment, including hazards that can

occur before, during, and after harvest.

The agency points out that the provision

now codified as § 120.7(c), simply

provides guidance in the form of a

minimum list of potential physical,

chemical, and microbiological hazards

that processors should consider. The list

is not intended to be all-encompassing,

and is not so constructed. FDA believes

that this guidance is useful because it

provides detail about the types of

potential hazards that fall into the more

general categories of physical, chemical,

and microbiological hazards. For these

reasons, FDA declines to revise

§ 120.7(c) as requested.

(Comment 67) Several comments

argued that unapproved pesticide

residues, unapproved food and color

additives, and food allergens are not

appropriate for inclusion in HACCP

because, categorically, they are not a

significant threat to public health and

are already covered by other regulations.

One of the comments supported its

claim of inappropriateness by pointing

out that FDA failed to give any

examples of problems caused by

unlawful pesticide residues or

unapproved food and color additives.

Therefore, it stated, these are not

problems that should be covered by

HACCP, but addressed under CGMP’s.

FDA disagrees that certain types of

potential hazards, such as those

mentioned in § 120.7(c), need not be

considered in a hazard analysis. For

example, pesticide residues above

tolerance may be potential hazards.

However, it is unlikely that pesticide

residues above tolerance will need to be

identified during a hazard analysis as

hazards that must be included in the

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6157

HACCP plan because they occur

infrequently and the public health

impact of infrequent exposure is not

severe.

The agency recognizes that there are

effective governmental control programs

in place in the United States to assure

generally that unlawful pesticide

residues are unlikely to occur. For

pesticides, these controls include

pesticide registration, applicator

licensure, and government sampling

and enforcement programs. Likewise,

unapproved food and color additives are

generally unlikely to occur in juice

products because prudent processors

would not intentionally add them to

their products. Thus, for crops grown in

the United States, a processor may

ordinarily conclude that the controls for

pesticide use are such that it is not

reasonably likely that unlawful

pesticide residues will be present in

crops (including residues at levels above

tolerance). A processor is responsible

for assessing the adequacy of control for

pesticide use for crops grown outside

the United States and determining

whether such controls are sufficient to

make it unlikely that unlawful pesticide

residues will be present. If foreign

governmental controls are sufficient,

HACCP controls would not likely be

necessary in the processor’s HACCP

plan. If foreign governmental controls

are not sufficient, the processor may

need to include appropriate controls in

its HACCP plan.

Similarly, unapproved food and color

additives would be reasonably likely to

occur only if, because of their presence

in the production plant and the

potential for formulation errors, there

was a real likelihood that they may be

inadvertently added to the product or

added at higher than the allowable rate.

A food or color additive may also be

used on the product by a processor’s

supplier. This may pose a hazard where

the food or color additive is a potential

allergen or causes sensitivity reactions

in susceptible individuals. For example,

a processor may make several types of

juice drinks, some containing FD&C

Yellow No. 5. The likelihood and

severity of a reaction to Yellow No. 5 is

a factor that must be considered in

determining whether the unintended

presence, whether by misformulation or

cross contamination, of the ingredient or

additive in a food is reasonably likely to

occur and, therefore, constitutes a

potential hazard.

Therefore, the agency concludes that

if unlawful pesticide residues and

unapproved food and color additives are

hazards that are reasonably likely to

occur, it is appropriate that a processor

identify them in its hazard analysis and

include them in its HACCP plan.

(Comment 68) Several comments

suggested that pesticide control should

be handled as an agreement between

processor and grower, not as a CCP.

The agency advises that if an

agreement between a processor and a

grower adequately assures that unlawful

pesticide residues will not be a hazard

that is reasonably likely to occur, then

controls for that particular hazard need

not be included in the HACCP plan.

Agreements between processors and

growers on pesticide issues may be

particularly useful for produce grown in

areas where government controls may

not be sufficient to ensure that unlawful

pesticide residues are not a hazard that

is reasonably likely to occur.

(Comment 69) One comment noted

that unapproved food and color

additives are not an issue for orange

juice because it has a standard of

identity.

The existence of a standard of

identity, such as for orange juice or

tomato juice, is no guarantee that an

unapproved food or color additive has

not been intentionally or inadvertently

added to the juice product. However, as

noted previously, if a processor’s hazard

analysis establishes that unapproved

food and color additives are not a

hazard that is reasonably likely to occur,

such additives do not need to be

controlled as part of a HACCP plan.

(Comment 70) One comment

requested that proposed § 120.7(b) be

withdrawn as the list of what a

processor should evaluate because it is

already covered under part 110 and can

be addressed by prerequisite programs.

The agency stated in the proposal that

it was including in proposed § 120.7(b)

(now codified as § 120.7(d)) some

elements that would be useful for juice

processors to consider in a hazard

analysis (63 FR 20450 at 20468) (Ref. 2).

Although CGMP’s and SSOP’s address a

wide variety of situations and hazards,

a particular food hazard may be

reasonably likely to occur in the absence

of its control and, therefore, necessitate

HACCP controls. To assist processors in

identifying all hazards that are

reasonably likely to occur in their

products, and their public health

impact, FDA is, therefore, retaining the

list in § 120.7(d) to guide processors in

their hazard analyses.

(Comment 71) One comment

requested that FDA revise the list of

what processors should consider in

evaluating the safety of their products to

include cooling, ice, and water quality

specifically.

The list in § 120.7(c) simply provides

examples to guide processors and is not

intended to be all inclusive. Ice and

water quality are issues that generally

will be addressed in the SSOP

requirement in § 120.6(a)(1). Therefore,

the agency is not modifying § 120.7(c) as

requested. However, because the list in

§ 120.7(c) is guidance for processors, it

does not preclude a processor from

considering ice and water quality in its

hazard analysis. If ice or water quality

poses a hazard that is reasonably likely

to occur, then the hazard must be

addressed in the HACCP plan.

E. HACCP Plan

The agency proposed that processors

have and implement a written HACCP

plan for a given process whenever a

hazard analysis of that process

establishes that there are one or more

food hazards that are reasonably likely

to occur during such processing. The

written HACCP plan is to include the

following seven principles: (1) Conduct

a hazard analysis, (2) determine the

critical control points, (3) establish

critical limits, (4) establish monitoring

procedures, (5) establish corrective

actions, (6) establish verification

procedures, and (7) establish

recordkeeping and documentation

procedures. These seven elements are

derived from the NACMCF principles of

HACCP.

(Comment 72) One comment

requested that FDA delete the term

‘‘during processing’’ in § 120.8(a)

because some of the problems in the

past have come from fruit contaminated

on receipt and the term could be read

to mean that only hazards that could

occur during processing should be

considered in the hazard analysis.

The agency does not agree with the

comment. Section 120.7 requires that

processors conduct a hazard analysis to

determine the hazards that are

reasonably likely to occur in their juice.

If a hazard is reasonably likely to occur

in the juice, the source of the hazard is

immaterial. Therefore, FDA is not

revising § 120.8(a) to delete the term

‘‘during processing.’’

(Comment 73) One comment

requested that FDA delete proposed

§ 120.8(b)(2)(ii) because it appears to

contradict the definition for processing

in proposed § 120.3(h)(1) (finalized as

§ 120.3(j)(1)). The comment asserted that

§ 120.8(b)(2)(ii) states that CCP’s should

include food hazards that occur before,

during, and after harvesting, yet

processing is defined as excluding

harvesting, picking, or transporting raw

materials, which places it beyond the

control of a processor.

The agency is not making the

requested change because the language

in question, along with the definition of

6158 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

4Comments on the seafood HACCP final rule

raised similar questions as to FDA’s authority to

require seafood processors to establish HACCP

systems and to require recordkeeping and record

access. In response to the proposed juice HACCP

rule, one trade associations filed a copy of its

comments on the seafood HACCP proposal. The

agency’s detailed response to the comments on the

seafood proposal, set out at 60 FR 65098–65012, is

incorporated by reference into the preamble of this

final rule.

processor in § 120.3(k), serves to

identify those who are required to

comply with part 120 and is not a basis

for excluding potential food hazards

from consideration. Specifically, the

definition of processing in § 120.3(j)(1)

excludes the activities of harvesting,

picking, or transporting raw materials

even if these materials may be intended

for use in juice processing under

§ 120.3(k). Only those engaged in

‘‘processing’’ juice are ‘‘processors’’ and

are subject to the requirements in part

120. However, juice processors are

responsible for addressing the hazards

that may be present in/on the foods

produced during their process,

including hazards that result from

characteristics of the incoming produce.

One way to address potential hazards

presented by incoming materials is by

examining those materials when

received and rejecting those that may

contain hazards. Another way is to

process juice in a manner to control

pathogens or other hazards that may

have been present on incoming

materials. Therefore, FDA believes that

the definition of ‘‘processing’’ does not

conflict with § 120.8(b)(2)(ii) and is not

making the requested change.

F. Legal Basis

The agency proposed in § 120.9 that

failure of a processor to have and to

implement a HACCP system that

complies with §§ 120.6, 120.7, and

120.8, or otherwise to operate in

accordance with the requirements of

this part, renders the juice products of

that processor adulterated under section

402(a)(4) of the act (21 U.S.C. 342(a)(4)).

(Comment 74) A number of

comments asserted that FDA lacks the

statutory authority to require juice

processors to establish HACCP

programs. Several comments claimed

that section 402(a)(4) of the act cannot

be read to authorize a broad range of

HACCP controls and to provide that the

failure to observe any of those controls

would render food prepared under such

conditions adulterated within the

meaning of section 402(a)(4) of the act.

FDA disagrees with these comments.

As shown below, the agency has ample

authority to require juice processors to

establish HACCP systems.4

FDA is issuing these regulations

under the authority of the act and the

Public Health Service Act (PHS Act).

Specifically, FDA is relying on sections

402(a)(4) of the act and 701(a) of the act

(21 U.S.C. 371(a)) and section 361 of the

PHS Act (42 U.S.C. 264).

Under section 402(a)(4) of the act, a

food is adulterated if it has been

prepared, packed, or held under

insanitary conditions whereby it may

have been contaminated with filth, or

whereby it may have been rendered

injurious to health. It is important to

recognize that section 402(a)(4) of the

act addresses conditions that may

render a food injurious to health, rather

than conditions that have actually

caused the food to be injurious. See

United States v. 1,200 Cans, Pasteurized

Whole Eggs, Etc., 339 F. Supp. 131, 141

(N.D. Ga. 1972). See also United States

v. H.B. Gregory, Co., 502 F.2d 700, 705

(7th Cir. 1974), cert. den. 422 U.S. 1007

(1975). As noted in the notice of

proposed rulemaking, 63 FR 20450 and

20457 (Ref. 2), the question is whether

the conditions of a juice processing

operation are such that it is reasonably

possible that the juice produced by that

operation may be rendered injurious to

health. Based upon the information

available to the agency and filed in the

record of this proceeding, FDA has

concluded that, if a juice processor does

not incorporate certain basic controls

into its procedures for preparing,

packing, and holding juice, it is

reasonably possible that the juice may

be rendered injurious to health and,

therefore, adulterated under the act.

FDA is authorized by 21 U.S.C. 371 to

adopt regulations for the efficient

enforcement of the act.

FDA believes that the comments

disputing the agency’s authority to issue

these regulations advocate an unduly

narrow interpretation of the act

generally and of section 342(a)(4)

specifically. It is well-settled that the act

is to be interpreted broadly so as to

achieve its goal of public health

protection. United States v. BactoUnidisk, 393 U.S. 784, 798 (1969).

Section 402(a)(4) of the act deems

adulterated food that is prepared,

packed, or held under ‘‘insanitary’’

conditions. The term ‘‘insanitary’’ is not

defined in the act. ‘‘Sanitary’’ describes

that which ‘‘pertains to health, with

especial [sic] reference to cleanliness

and freedom from infective and

deleterious influences,’’ Black’s Law

Dictionary, 6th Ed.(1990); use of the

prefix ‘‘in’’ denotes the absence or

opposite of sanitary. Thus, ‘‘unsanitary

conditions’’ are those that contribute to

unhealthiness generally, including

unclean conditions or those that

promote infection or disease.

The case law interpreting section

402(a)(4) of the act is consistent with

this broad reading of ‘‘insanitary

conditions.’’ In particular, in United

States v. Nova Scotia Food Products

Corp., 568 F.2d 240 (2d Cir. 1977), the

Second Circuit rejected a restrictive

reading of 402(a)(4) of the act,

concluding that this section provided

the FDA with authority to establish by

regulation processing parameters to

control or eliminate harmful substances

present in food intended for further

processing. See United States v. Nova

Scotia Foods, 417 F.S. 1364, 1368–1369

(E.D.N.Y. 1976), aff’d supra, 568 F.2d

240. At issue in Nova Scotia were FDA’s

regulations governing the time,

temperature, and salinity for processing

smoked fish, 568 F.2d at 243, 247 to

248, and provisions designed to

minimize the outgrowth and toxin

formation of Clostridium botulinum

Type E, 568 F.2d at 243. The regulations

in question defined sanitary conditions

for processing such fish; fish processed

under conditions not complying with

the regulation were deemed adulterated

within the meaning of section 402(a)(4)

of the act, 21 CFR 128a.2 (1971); 35 FR

17401 (November 13, 1970) (Ref. 60).

Although the Court posited that

‘‘insanitary conditions’’ could be

narrowly interpreted to refer to

insanitary conditions in the plant, such

as the presence of insects and rodents,

the Court rejected this narrow

interpretation, 568 F.2d at 245 to 246,

and held that under section 402(a)(4) of

the act, ‘‘insanitary conditions’’ may

include ‘‘inadequate sanitary conditions

of prevention’’ (568 F.2d at 247). In

rejecting the narrower reading of

402(a)(4) of the act, the Court recognized

a ‘‘larger general purpose on the part of

Congress in protecting the public

health’’ (568 F.2d at 248).

This final rule requires that juice

processors implement and maintain

HACCP systems. As discussed in detail

above, HACCP systems are designed to

prevent, control, or eliminate hazards

that are reasonably likely to occur

during food production, including

hazards that are present in in-coming

materials, such as pathogens and other

contaminants. Under the final rule,

§ 120.9, the failure of a juice processor

to establish and maintain an adequate

HACCP system renders juice produced

under that system adulterated within

the meaning of section 402(a)(4) of the

act. Thus, the provisions of this final

rule are essentially comparable to those

addressed in Nova Scotia.

In addition, FDA relies on its

authority under the Public Health

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6159

Service Act in issuing this regulation to

the extent that the regulation seeks to

control illnesses caused by pathogenic

microorganisms. Under section 361 of

the PHS Act (42 U.S.C. 264), the

Surgeon General is authorized to issue

and enforce regulations to prevent the

introduction, transmission, or spread of

communicable diseases from one State

to another State; this authority has been

delegated to the Commissioner of Food

and Drugs, 5 CFR 5.10(a)(4). See State

of Louisiana v. Mathews, 427 F. Supp.

174, 176 (E.D. La. 1977). The record in

this rulemaking amply demonstrates

that juice can function as a vehicle for

transmitting food-borne illness caused

by pathogens such as Salmonella and E.

coli O157:H7. Juice produced in one

State and shipped and sold in another

State may be contaminated with

pathogens and thus may result in the

transmission of food-borne illness from

State to State. The record similarly

establishes that juice may be produced

and sold to a visiting consumer in one

State, with the consumer subsequently

taking the juice to a second State. Given

that juice can function as a vehicle for

transmitting human pathogens, this

situation creates the possibility that

food-borne illness will be transmitted

from one State to another. In light of the

record of this proceeding, FDA has

concluded that a system of HACCP

controls is necessary to prevent the

spread of communicable disease via

consumption of contaminated juice, and

that the PHS Act provides the agency

with the authority to establish such

HACCP requirements for juice.

(Comment 75) Several comments

challenged the agency’s authority to

require that certain records be

maintained and that FDA be granted

access to those records. The thrust of

these comments is that the act does not

explicitly authorize the agency to

require food processors to maintain

records or to require access to records

maintained by food processors. The

comments observed that section 704 of

the act (21 U.S.C. 374), the act’s general

records access provision, contains

specific authorization for agency access

to records relating to drugs and

restricted medical devices but that, by

its terms, the authority of section 704

does not extend to records relating to

foods. Thus, the comments conclude

that the records access provisions of the

juice HACCP proposal are unlawful.

FDA disagrees with this comment

because the agency has adequate

authority under the act and the PHS Act

both to require the maintenance of

records and to compel official access to

such records for the efficient

enforcement of the act. Importantly,

FDA is not relying on its authority in

section 704 of the act to require the

keeping of HACCP records and to

require official access to such records.

As discussed in the response to the

previous comment, in terms of the act,

this final rule implements section

402(a)(4) and utilizes FDA’s authority in

section 701(a) of the act to issue

regulations for the efficient enforcement

of the act. FDA is similarly relying on

sections 402(a)(4) and 701 to establish

the recordkeeping and access to records

requirements of this rule. That this is

sufficient authority is established in the

caselaw.

In particular, in National

Confectioners Assoc. v. Califano, 569

F.2d 690 (D.C. Cir. 1978), the D.C.

Circuit held that FDA had authority to

establish recordkeeping requirements

for food processors. In Confectioners,

the recordkeeping provisions of the

regulations were challenged on the

grounds that they would permit

prosecution where processing

conditions were completely sanitary,

but required records were deficient.

Such an outcome, it was argued, would

be beyond the scope of section 402(a)(4)

of the act, one of the particular sections

relied upon as authority for the

regulation as a whole. The court rejected

this argument, holding that the

principal consideration was whether the

statutory scheme as a whole justified the

regulations. Although the records in

question in Confectioners were coding

and distribution records that FDA

desired in order to facilitate recalls, the

court’s ruling as to the validity of the

regulations was not limited to recalls or

shipping records. Indeed, Confectioners

is appropriately read to authorize FDA

to establish regulations that have a

limited scope, are not unreasonably

onerous, and clearly assist in the

efficient enforcement of the act (569

F.2d 693 n. 9). In addition, the

Confectioners court recognized that

FDA has a role both in preventing and

in remedying commerce in adulterated

foods, and that the act imposes on the

FDA an equal duty to perform each role

(569 F.2d at 694).

It is widely accepted that

recordkeeping and inspectional access

to records are essential components of a

HACCP-type system. Through records

maintenance and review, a processor

can, over time, develop a

comprehensive picture of its process

and identify shortcomings or potential

shortcomings. Similarly, records

maintenance and access provide the

appropriate regulatory authorities with

the opportunity to oversee, in a

comprehensive way, the operation of

the processor’s HACCP plan, thereby

ensuring that contaminated juice

products will not enter the marketplace.

Like the records at issue in

Confectioners, the records at issue with

respect to this final rule are designed to

prevent the introduction into commerce

of adulterated foods (569 F.2d at 694).

In this case, the recordkeeping and

access required under this final rule

meet the Confectioners test. First, the

requirements are limited. The HACCP

recordkeeping and record access

requirements in the final rule are tied

specifically to the CCP’s, i.e., those

points in the process at which control

is essential if there is to be assurance

that the resultant product will not be

injurious to health is to be achieved.

Second, this limited amount of

recordkeeping assists FDA in the

efficient enforcement of the act. By

focusing on the CCP’s, the requirements

ensure that the processor and the agency

focus on those aspects of processing that

present the greatest threat to food safety;

by documenting whether the HACCP

plan and its preventive controls are

being followed, these records enable

regulators to verify proper operation of

the HACCP system or identify

malfunctioning of the system, again

ensuring that adulterated foods are not

produced and distributed to consumers.

As such, the record-keeping

requirements assist in the effective and

efficient enforcement of the act. Finally,

the HACCP recordkeeping burden is not

unduly onerous because the required

records are limited to the development

of appropriate controls and

documenting those aspects of

processing that are critical to food

safety. The documentation required in

the final rule is narrowly tailored to

ensure that only essential information

needs to be recorded and maintained.

Because the preventive controls

required by HACCP are essential to the

production of safe food as a matter of

design, the statutory scheme is benefited

by agency access to records that

demonstrate that these controls are

being systematically applied.

Similarly, FDA’s authority under the

PHS Act (42 U.S.C. 264), provides a

separate and sufficient basis for the

recordkeeping and records access

provisions of this rule, at least to the

extent that these requirements relate to

the transmission of communicable

disease. The record of this proceeding

clearly shows that juice can function as

a transmitter of human disease caused

by foodborne pathogens, such as

Salmonella and E. coli O157:H7.

Likewise, the record demonstrates that a

system of preventative controls, such as

those based upon HACCP, will control

or eliminate this risk from juice

6160 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

consumption. As discussed in more

detail below, records for the HACCP

operation, and official access to these

records, are central to the effectiveness

of HACCP. Thus, the PHS Act clearly

authorizes the records maintenance and

access requirements of this final rule.

(Comment 76) A few comments

stated that the factual and legal

justifications for mandatory HACCP

relate to the presence of pathogens in

the final product, which is not true of

the pasteurized juice industry.

Comments maintained that section

402(a)(4) of the act does not authorize a

broad range of controls and that seafood

HACCP was predicated on the

conclusion that there were sufficient

hazards in all fishery products. One

comment stated that the factual

predicate relied upon in the seafood

rule does not exist for juice. The

comment maintained that a review of

the data in the proposed rule indicates

that microbiological hazards gave rise to

the entire HACCP proceeding and these

hazards do not exist in pasteurized and

shelf stable juices.

The agency addressed the legal

authority for this rule in the response to

comment 74. FDA disagrees that the

factual predicate for juice HACCP is not

adequate. The record demonstrates that

there are significant potential hazards in

the production of juice, including

pasteurized and shelf stable juices.

These potential hazards in juice can be

divided along the lines of the NACMCF

food hazard definition: Microbiological,

chemical, and physical. Microbiological

hazards can be controlled with some

type of heat treatment or other process

that prevents, reduces, or eliminates the

pathogens. Chemical hazards are not

normally affected by heat and other

treatments that are used to reduce the

microbial contamination of foods and

thus, must be controlled by other means

(e.g., rejection of incoming materials

with high lead levels). Likewise,

physical hazards must be controlled in

some manner other than by thermal or

equivalent treatments. All three types of

hazards require that the specific hazard

be identified (e.g., bacterial species;

mycotoxin identity; foreign matter

present, such as glass), a means for

preventing or controlling the hazard

identified, and the means of control

consistently and effectively used. The

public health effects of microbial

hazards are most often acute, although

long-term, chronic effects have been

identified (e.g., arthritis). Chemical

hazards are most often associated with

chronic adverse health affects, although

they may also have immediate, acute

affects (e.g., excess tin leaching from

container lining can cause vomiting).

Physical hazards cause acute health

affects, such as cuts in the mouth from

glass or metal fragments in the food.

These hazards are discussed in more

detail below.

Microbial hazards—There is a long

history of foodborne illness outbreaks

associated with microbial

contamination of a variety of juices. The

public health consequences may be

minimal (some gastrointestinal distress),

severe (hospitalization, HUS), or fatal.

Among the pathogens that have been

associated with juices are E. coli

O157:H7, Salmonella, Cryptosporidium,

and certain viruses. Identified sources of

pathogens include water, fruit,

processing under insanitary conditions,

and infected workers and food handlers.

Juices, particularly fruit juices, have

traditionally not been considered

vehicles for human pathogens. Fruit

juices, in particular, are acidic, and such

acidity generally would inhibit the

growth of most pathogens. Over the past

few decades, however, it has become

well documented that some pathogens

have adapted to this acidic

environment, making juices susceptible

to microbial contamination and

subsequent survival of the pathogens in

the juice products.

Regarding the comment that

pasteurized juices should not be subject

to HACCP, is without foundation

because ‘‘pasteurized’’ products may

potentially contain chemical or physical

hazards. HACCP systems control all

types of food hazards, not just the

microbial hazards that adequate heat

treatments will control. In recognition of

the lethality of the heat treatment that

shelf stable and concentrated juice

products receive, FDA has modified the

pathogen control requirements in

§ 120.24 for these product groups. This

modification to the proposed rule is

discussed in detail in the response to

comment 140.

Chemical hazards—There is also a

history of foodborne illness outbreaks

caused by a variety of chemical hazards

in foods. These hazards include the

presence of tin, lead, and poisonous

plant materials. FDA recall data show

that additional types of chemical

substances with the potential to cause

illness or injury have triggered recalls of

products from the market (e.g., food

ingredients that cause allergic-type

reactions such as FD&C Yellow No. 5),

cleaning solutions, copper from copper

pipe fittings on processing equipment.

Symptoms of reported juice outbreaks

usually are limited to acute

gastrointestinal effects. Chronic effects

of chemical contaminants are difficult to

assess because long-term monitoring of

the health of individuals that experience

illness or injury caused by chemical

hazards is required and there are no

data indicating that this type of

monitoring occurs. Some chemical

hazards, such as patulin, have known

chronic effects of sufficient public

health concern that FDA is in the

process of issuing guidance documents

concerning maximum levels that should

be present in foods (Refs. 19 and 24).

Sources of chemical contaminants in

juices include packaging materials,

plant (botanical) material, processing

and cleaning equipment, formulation

errors, contaminated ingredients, and

contaminated fruit (e.g., patulin in

apples). Unlike microbial contaminants,

chemical contaminants cannot be

destroyed or easily removed from

contaminated foods, and thus,

appropriate controls must be established

to prevent the contamination in the first

instance.

Physical hazards—FDA recall data

indicate that glass and fragments of

other packaging materials frequently

cause companies to recall juice

products. However, the agency has no

data on illnesses or injuries caused by

those packaging materials.

(Comment 77) One comment stated

that United States vs. Nova Scotia Foods

Products Corporation cannot be read to

authorize HACCP controls. The

comment maintained that this case

cannot be said to support FDA’s

proposal to impose a complex and

detailed regulatory scheme on

pasteurized products. Additionally, the

comment stated that since FDA cannot

demonstrate a need or legal justification

for HACCP for pasteurized products, its

authority to require recordkeeping and

record inspection under such a HACCP

program has no statutory basis.

In the response to comment 74, the

agency has explained at some length the

basis for its reliance on United States v.

Nova Scotia Foods, 417 F.S. 1364,

1368–69 (E.D.N.Y. 1976), aff’d supra,

568 F.2d 240. Similarly, in the response

to comment 75, FDA has explained at

length the legal basis for the

recordkeeping and records access

provisions of this final rule. In sum,

both the rule itself and the

recordkeeping provisions are clearly

authorized by the act and the PHS Act.

G. Corrective Actions

FDA proposed to require in § 120.10

that processors take appropriate

corrective actions whenever a deviation

from a critical limit occurs. All

corrective actions must be fully

documented in records and are subject

to verification under § 120.11(a)(iv)(B).

(Comment 78) One comment

requested that FDA revise § 120.10(a)(1)

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6161

and (b)(3) to remove the wording

‘‘otherwise adulterated’’ because it

broadens the scope of the rule beyond

food safety and the focus of HACCP

should be on food safety. The comment

further stated that adulteration is

covered in part 110 and should not also

be covered in part 120.

The agency disagrees that the

requested revisions are necessary.

HACCP plans only address food hazards

that are reasonably likely to occur.

Under § 120.3(g) a ‘‘food hazard’’ is

defined as ‘‘any biological, chemical, or

physical agent that is reasonably likely

to cause illness or injury in the absence

of its control.’’ Thus, a HACCP plan is

already focused on food safety. FDA

also disagrees that adulteration is

addressed exclusively by part 110. In

fact, the legal basis for this final rule is,

in part an adulteration provision,

402(a)(4) of the act and juice not

processed under conditions not

complying with this final rule is

adulterated (see § 120.9).

(Comment 79) A few comments

suggested that in § 120.10(b)(5) the

words ‘‘timely validation’’ probably

should be ‘‘timely verification’’ or

‘‘timely review’’ and that in

§ 120.13(a)(3) the term ‘‘verifying’’

should be used in place of ‘‘validating’’

to be consistent with NACMCF’s

HACCP guidelines.

The agency agrees with the

comments. When there is a process

deviation, processors must undertake a

review to see if there have been

sufficient changes such that a

revalidation of the HACCP plan is

warranted. The fact that processors have

discovered a deviation indicates that the

HACCP plan is working. Therefore, FDA

is modifying § 120.10(b)(5) to use the

term ‘‘timely verification’’ and

§ 120.13(a)(3) to use the term

‘‘verifying.’’ As noted previously, the

agency is defining the terms

‘‘validation’’ and ‘‘verification,’’ in

§ 120.3(p) and (q), respectively.

H. Verification and Validation

(Comment 80) One comment

requested that FDA not require a review

of consumer complaints in the HACCP

program. The comment maintained that

review of consumer complaints is

untimely because the product has

already been processed and reached the

consumer. Additionally, the comment

stated that consumer complaints, or lack

thereof, cannot attest to the effectiveness

of a process. Another comment

suggested that it should be up to the

management to determine which

consumer complaints need followup in

relation to HACCP compliance. One

comment stated that only consumer

complaints that indicate a deviation

should be held for HACCP review.

The agency disagrees that processors

should not review consumer complaints

as part of their HACCP programs. The

agency recognizes that review of

consumer complaints is of limited use

as a preventive tool because the

consumer making the complaint already

has the product. However, such review

may alert the processor to a problem

that, if resolved, would prevent

recurrence of the problem with other

consumers. The agency also recognizes

that the receipt or absence of complaints

does not alone attest to the adequacy of

a HACCP system. However, it is FDA’s

experience that consumer injury or

illness complaints can identify

problems traceable to inadequate

controls at the food processing facility

(Ref. 61). Where information that has

potential relevance to food safety is

available to a processor as a result of its

own consumer complaint system, it is

entirely appropriate for the processor to

consider that information in assessing

the adequacy of its HACCP program.

FDA concludes, therefore, that

processors should evaluate, as part of

their HACCP verification procedures,

the consumer complaints that they

receive to determine whether the

complaints relate to the adequate

performance of control measures or

reveal unidentified hazards.

FDA agrees that it is up to

management to determine which

consumer complaints need followup in

relation to HACCP compliance as part of

its verification procedures. This final

rule does not require that processors

hold consumer complaints for HACCP

record review, except as the processor

deems necessary as documentation of

verification procedures.

(Comment 81) One comment

requested that FDA revise

§ 120.11(a)(1)(iii) by adding at the end of

the sentence ‘‘where these are other

than standard operating procedures or

CCP’s’’ to clarify that testing required

under standard operating procedures or

CCP’s is not optional.

The agency disagrees that the

requested revision of § 120.11(a)(1)(iii)

is appropriate. The requested revision

would make the testing mandatory as

part of verification activities for SOP’s

and CCP’s. This was not the intent of

the provision. In the preamble to the

proposal, the agency acknowledged the

shortcomings of end-product testing as

a process control, especially

microbiological testing, but encouraged

inclusion of testing in HACCP systems

where it is appropriate. SOP’s and CCP

monitoring requirements do not

necessarily need to be end-product or

in-process tested, except where FDA is

requiring end-product testing.

Monitoring could consist of ensuring

that the product was processed within

time/temperature parameters or time/

sanitizer concentration parameters.

Therefore, FDA is not making the

requested modification.

(Comment 82) One comment

suggested that verification should

include actual times and temperatures

taken and recorded and that there

should be penalties for noncompliance.

The agency agrees with the comment.

Verification activities include timely

review of monitoring records in

accordance with § 120.11(a)(1)(iv).

Monitoring records must include actual

measurements (e.g., times and

temperatures) in accordance with

§ 120.8(b)(7), except as exempted by

§ 120.24. Consequently, verification

must include checking the actual

measurements that are recorded in the

monitoring records. As proposed, the

rule has an enforcement mechanism.

Specifically, under § 120.9, failure of a

juice processor to have and to

implement a HACCP system in

accordance with part 120 will render

the juice products of that processor

adulterated under section 402(a)(4) of

the act. Penalties for noncompliance are

FDA refusing entry to imported

products and instituting legal actions

such as seizure, multiple seizures, or

injunction, against unlawful products or

their producers.

(Comment 83) One comment

maintained that weekly review of

production records is inadequate and

suggested that records be reviewed

before each batch of product leaves the

plant.

FDA disagrees with the comment. The

agency stated in the proposed rule that

weekly review of HACCP monitoring

and corrective action records would

provide the industry with the necessary

flexibility to move a highly perishable

commodity like fresh juice through

processing and distribution without

interruption, while still facilitating

timely feedback of information. FDA

notes that the comment provided no

information to demonstrate that weekly

review of records is inadequate. In fact,

weekly record review will quickly

indicate whether the HACCP system is

out of control on a regular basis, which

is a sign that the system is not adequate

to assure safety and that revalidation of

the system is required. Thus, the agency

concludes that weekly review of

monitoring and corrective action

records is adequate for verification

purposes. FDA notes that the

requirement for weekly review does not

preclude a processor from reviewing

6162 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

production records on a more frequent

basis if the processor wishes to do so.

(Comment 84) One comment

suggested that FDA revise

§ 120.11(a)(1)(iv)(A) to provide for

values that are outside critical limits

and for which corrective actions are

taken (covered in § 120.11(a)(1)(iv)(B)).

The agency disagrees that the

requested revision of

§ 120.11(a)(1)(iv)(A) is necessary

because under § 120.11(a)(1)(iv)(B)

processors must review records to

ensure that the records are complete and

to verify that appropriate corrective

actions were taken. Therefore, FDA is

not making the requested modification.

(Comment 85) Several comments

pointed out that the proposed annual

validation requirement in § 120.11(b) is

not consistent with NACMCF HACCP

guidelines. The comments requested

that, instead, FDA require validation

whenever there are significant process

changes or equipment/system failures.

The agency is not persuaded that it

should modify the requirement for

annual validation. Section 120.11(b) is

consistent with the NACMCF HACCP

guidelines in that processors must

validate their process as needed (Ref.

17). The NACMCF provided as

examples whenever there is an

unexplained system failure; a significant

product, process or packaging change

occurs; or new hazards are recognized.

FDA has simply defined ‘‘as needed’’ as

at least annually or whenever any

changes in the process occur that could

affect the hazard analysis or alter the

HACCP plan in any way. Therefore,

FDA is not modifying § 120.11(b) as the

comments requested.

(Comment 86) One comment

requested that FDA not require a

processor to validate the HACCP plan

any time changes occur in the

prerequisite programs. The comment

requested that FDA revise § 120.11(b) to

delete this requirement.

The agency agrees with the comment.

It is rare that a change in SSOP’s will

make the HACCP plan ineffective.

Validation is not a paper exercise and

may be time consuming and expensive.

Therefore, FDA is modifying § 120.11(b)

to delete the proposed requirement.

FDA notes that the final rule requires

revalidation when there is any change

in the process, including a change in the

SSOP’s, that decreases the effectiveness

of the HACCP plan.

(Comment 87) One comment

expressed concern that the proposed

validation requirements would have the

effect of locking producers into one

supplier and that this would stop

product development and innovation.

The agency does not agree with the

comment. All food processors must take

safety considerations into account when

contemplating changes in their

processes, regardless of whether they

are operating under a HACCP system.

The agency recognizes that validation

could be costly if frequent changes are

made in the process that could affect the

hazard analysis or alter the HACCP plan

and, thus, processors may be reluctant

to make changes, even if the changes

have the potential to improve the

process or the safety of the final

product. A change in the supplier of raw

ingredients may be a change requiring

revalidation. However, a prudent

processor will check new suppliers

before making any changes to determine

that the supplier will not be a source of

any safety concerns. Because HACCP

systems need to be revalidated only

when changes in the process occur that

could affect the hazard analysis or alter

the HACCP plan in any way, not every

change will require revalidation.

Similarly, because a hazard analysis

needs to be revalidated only when there

are process changes that could

reasonably be expected to affect whether

a food hazard exists, not every process

change will require revalidation of the

hazard analysis. Therefore, FDA

concludes that the requirements of

§ 120.11(b) and (c) are important for the

public safety and will have minimum

impact on conscientious processors.

I. Records

The agency proposed that processors

maintain records documenting their

HACCP system. FDA also proposed

general record requirements, and other

provisions or requirements dealing with

documentation, record retention, official

review, public disclosure, and records

maintained on computers.

(Comment 88) One comment was

concerned that the agency was trying to

get access to processors’ CGMP records

under § 120.12(a)(1) and that this could

be a disincentive for companies to keep

thorough records.

The agency disagrees with the

comment. Section 120.12(a)(1) requires

that processors maintain records

documenting the implementation of the

SSOP’s in § 120.6. SSOP’S are select

CGMP sanitation requirements that the

agency believes are so important to the

effective implementation of HACCP that

they require separate, specific

provisions. The agency believes that the

sanitation controls in § 120.6 are of

significant importance to the proper

implementation of HACCP because

sanitation controls, such as controls

preventing contamination from pests,

have a direct impact on the presence or

absence of pathogens during processing,

which in turn, directly affects the

effectiveness of the HACCP plan. Access

to specific SSOP records is important to

investigators making reasonable

judgements about whether the HACCP

plan is working properly. Accordingly,

the final rule requires that SSOP records

must be maintained and made available

during inspections. However, the

agency has no intention of requiring,

and processors need not make available

to FDA, any other CGMP-related

records.

(Comment 89) One comment

recommended that the agency delete

from the regulation any reference to

records for end-product or in-process

testing. The comment stated that

individual processors would keep

testing records for FDA review only if it

is part of the verification of their

HACCP plan.

The agency disagrees that any

modification of the regulation is

necessary and is not making the

requested change. The regulation only

requires that end-product or in-process

testing records associated with

verification of the HACCP plan be

available for FDA review and thus, is

consistent with the comment. As

discussed in section III.L.6, the agency

is establishing periodic end-product

testing requirements for purposes of

process verification of citrus juices that

use fruit surface treatment to achieve

the 5-log reduction in the pertinent

pathogen; processors are required to

provide FDA with access to these

records.

(Comment 90) One comment stated

that a processor with only one location

should not have to provide its location

on all records, as required in

§ 120.12(b)(1).

The agency agrees with the comment

and is modifying § 120.12(b)(1) to read

as follows: ‘‘The name of the processor

or importer and the location of the

processor or importer, if the processor

or importer has more than one

location.’’

(Comment 91) Two comments stated

that date and time may not be necessary

on all records. One comment contended

that the date and time are only

important on monitoring and corrective

action records and, therefore, should

only be required on these records.

The agency believes that the date of

the activity is important on all HACCP

records. The date allows the processor

and the FDA investigator to assess

whether the record is current, to

identify when any deviation occurred,

and to track corrective actions.

However, the time of an activity is not

necessary on records other than

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6163

monitoring and corrective action

records (i.e., it is not necessary on the

hazard analysis or HACCP plan).

Therefore, the agency is modifying

§ 120.12(b)(2) to state that the time of

the activity need not be included on

records required under § 120.12(a)(2),

(a)(3), and (a)(5).

(Comment 92) One comment

suggested that there is no need for the

hazard analysis to be signed unless

there is no HACCP plan because the

hazard analysis did not indicate the

need for a HACCP plan.

FDA disagrees with the comment. The

signature of the most responsible

individual onsite at the processing

facility or by a higher level official of

the company is important for both the

hazard analysis and the HACCP plan.

The signature reflects the fact that

management has reviewed, accepted,

and is responsible for the content of the

hazard analysis and any resulting plan.

Therefore, the agency concludes that

both the hazard analysis and any

resulting HACCP plan must be signed.

(Comment 93) One comment

suggested that the final rule should

allow initialing of records instead of a

signature, as is done with low acid

canned foods.

The agency disagrees with the

comment. The food canning

establishment registration and the food

process filing form for low acid canned

foods both require the signature of an

authorized individual. Other low acid

canned food records must be signed or

initialed (§ 113.100). Part 120 has

similar requirements for juice product

records. Section 120.12(b)(3) states that

all records shall include the signature or

initials of the person performing the

operation or creating the record.

However, given their centrality in a

HACCP program, it is important that the

hazard analysis and the HACCP plan be

reviewed and authorized by the most

responsible individual onsite at the

processing facility or by a higher level

official of the processor so as to signify

that management of the firm is aware of

and has accepted these records

(§ 120.12(c)). Therefore, the agency is

not modifying part 120 to permit the

initialing of the hazard analysis and the

HACCP plan.

(Comment 94) One comment argued

that consumer complaints often involve

quality issues and are primarily handled

at headquarters facilities, not processing

plants. Therefore, the comment stated

that consumer complaint records should

not be part of HACCP recordkeeping

requirements.

The agency points out that consumer

complaint records are not required to be

maintained or access given to them

under part 120. Processors are required

to review consumer complaints as a part

of their verification procedures

(§ 120.11(a)(1)(i)) to determine whether

complaints relate to the performance of

the HACCP plan or to reveal previously

unidentified hazards. Processors may

choose to include consumer complaints

in their HACCP records to document

verification of the HACCP system, but it

is not required.

(Comment 95) One comment stated

that the period that records must be

held is out of line with product shelf life

because fresh juice only lasts 14 days.

The comment suggested that records

could be kept for 3 months rather than

1 to 2 years.

FDA disagrees with the comment.

Some problems, such as trends in the

frequency of process deviations, may

not be easily recognized in a ‘‘snapshot’’

record review. By reviewing records

covering a longer period of time, a

processor may be able to identify certain

process deviations. Moreover, while it

may be true that most fresh products

will be unusable within 3 months, some

products are processed for longer shelflife (such as flash pasteurized,

refrigerated juices), and retention times

of less than 1 year do not provide for

sufficient information for the

processor’s or FDA’s verification

activities. (See § 120.11(b).) Therefore,

FDA has made no changes to

§ 120.12(d)(1).

(Comment 96) One comment

requested that FDA revise § 120.12(d)(1)

to read ‘‘Subject to part § 120.14, all

records required by this part * * *,’’

because there are other importer

requirements for recordkeeping outlined

in § 120.14.

The agency disagrees with the

comment. Section 120.12(d)(1) requires

both processors and importers to retain

all records required by part 120. Under

§ 120.12(d)(1), importers must retain the

records required under § 120.14 at the

importer’s place of business in the

United States. Therefore, the agency

concludes that the modification is not

necessary.

(Comment 97) One comment noted

that proposed § 120.12(d)(2) requires

processors to maintain records related to

the adequacy of equipment or processes.

The comment stated that if equipment is

old or modifications have been made to

it, firms may have trouble getting a letter

to that effect from the manufacturer.

Therefore, the comment stated,

scientific studies will have to be

performed to determine adequacy,

which will be costly, especially for

small processors. The comment stated

that the requirement is not consistent

with parts 113 and 114. It stated that a

written communication summarizing

requirements to achieve an adequate

process would be adequate.

FDA has reevaluated the provision in

§ 120.12(d)(2) and concludes that it does

not afford any additional significant

protection to consumers and may add

unnecessary burdens for processors.

Therefore, the agency is deleting

§ 120.12(d)(2) and recodifying

paragraphs § 120.12(d)(3) and (d)(4) as

§ 120.12(d)(2) and (d)(3), respectively.

(Comment 98) One comment

suggested that FDA restrict

recordkeeping requirements to records

produced at the manufacturing facility.

The comment stated that data used to

establish processes should be

maintained by the individual or

organization that developed the record,

not by the processing plant.

FDA disagrees with the comment. It is

vital that each processing plant

maintain or have access to all records

required under part 120, that pertain to

products produced by that plant for

purposes of both processor review and

FDA inspections. The agency has made

provision for offsite storage of records,

to the extent feasible, to reduce plant

storage burden. Specifically, under

§ 120.12(d)(2), electronic records are

considered to be onsite if they are

accessible from an onsite location and

comply with § 120.12(g). In addition,

under § 120.12(d)(2), offsite storage is

allowed for certain monitoring records

after 6 months following the date that

the monitoring occurred as long as the

records can be retrieved and provided

onsite within 24 hours. Finally, under

§ 120.12(d)(3), seasonal processors may

store records at a reasonably accessible

location at the end of the seasonal pack.

Records (such as the hazard analysis,

HACCP plans, and verification,

including validation, records for

products processed in the plant) are

needed by both the processor and FDA

to determine whether the HACCP

system or systems are properly

implemented and effective. HACCP

systems and associated records may be

tailored to each specific processing

facility and for different products

processed in the facility. Therefore, the

agency concludes that all records

required by part 120 must be retained at

the processing facility to which they

relate (or reasonably accessible when

offsite storage is permitted) or at the

importer’s place of business in the

United States. As discussed in previous

comments, FDA recognizes that

processors may review information (e.g.,

consumer complaints) to develop/

evaluate their systems that is not

required to be maintained and to which

processors are not required to grant FDA

6164 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

access. Processors may maintain this

information at any location that is

convenient for the processor.

(Comment 99) One comment

pointed out an inconsistency between

the preamble to the proposed rule that

stated that after 6 months the SSOP and

HACCP monitoring and corrective

action records could be stored offsite,

and the codified language in proposed

§ 120.12(d)(3) that refers to the storage

of SSOP records and the HACCP plan

offsite.

FDA agrees that the proposal’s

preamble and codified were

inconsistent. The agency realizes that

some juice processors may be required

to store records that could require a

great deal of space (e.g., the SSOP and

HACCP monitoring and corrective

action records) and that there may not

be adequate storage space in the

processing facility for all of these

records. However, because of their

direct relevance to ensuring safe

processing operations at a facility, FDA

has concluded that records dealing with

the HACCP plan must remain on site for

at least 6 months. After that period,

such records may be stored off-site if

they can be retrieved and returned onsite to the plant within 24 hours so that

plant managers and FDA investigators

have ready access to the records for use

in evaluating the effectiveness of the

HACCP plan. Therefore, FDA is

modifying § 120.12(d)(2) to refer to

paragraphs (a)(1) and (a)(4) instead of

(a)(1) and (a)(3).

(Comment 100) One comment

requested that FDA delete § 120.12(e)

because the agency does not have the

statutory authority to see consumer

complaints.

The agency advises that consumer

complaints are not required records

under § 120.12(a) and the rule does not

seek to require that FDA be given access

to such records. Thus, the agency

concludes that no action is necessary in

response to this comment.

(Comment 101) Several comments

expressed concern about the

confidentiality of records associated

with an abandoned process. They stated

that a manufacturer’s processing

methods are often considered trade

secret even for products that have been

abandoned. The comments suggested

that the agency make provisions for this

in the final rule and handle abandoned

product records in the same manner as

existing product information. One

comment added that current process

lines may use technology similar to that

used for an abandoned product and that

abandoned products may be brought

back into production.

The agency advises that the agency

intended that proposed § 120.12(f) not

permit public disclosure of processing

records except where they have been

previously disclosed to the public or

where they relate to an abandoned

product or ingredient and are no longer

trade secret or confidential commercial

or financial information. FDA

acknowledges that the proposal was less

than clear as to the status of an

abandoned product process. To clarify

the final rule, FDA is striking the work

‘‘thus’’ from § 120.12(f) so that the trade

secret status of a product process may

be maintained by the processor and the

information not necessarily subject to

public disclosure even though the

particular product has been abandoned.

The public availability of such

information will be evaluated by FDA

on a case-by-case basis.

(Comment 102) Several comments

requested that HACCP documents in

FDA’s possession not be made available

under the Freedom of Information Act

(FOIA).

FOIA provides consumers and others

with the opportunity to obtain records

in the possession of Federal agencies,

including FDA, upon request. There are,

however, some restrictions on the types

of records available under FOIA. For

example, confidential commercial

information and trade secrets are

exempt from disclosure 5 U.S.C.

552(b)(4). The agency concluded in the

seafood HACCP final rule (60 FR 65096

at 65138) (Ref. 62), that HACCP plans,

as a general rule, meet the definition of

trade secret information, and thus, even

if these plans are in agency files, they

likely would not be available under

FOIA. However, because FDA is bound

by FOIA and the agency’s implementing

regulation in 21 CFR part 20, the agency

is unable to exclude categorically all

HACCP records in agency files from

public disclosure.

J. Training

The agency proposed that only

individuals trained in HACCP be

responsible for certain key functions in

a HACCP system. The agency is

correcting an error in § 120.13(a)(3), as

proposed, so that the section references

§ 120.10(b)(5) instead of § 120.10(c)(5)

because there is no paragraph (c)(5).

(Comment 103) Several comments

requested that FDA provide training for

the juice industry.

FDA has limited resources to use for

training. Therefore, the agency has no

plans at present to provide specific

HACCP training for the juice industry.

However, the agency is interested in

cooperating with States and the industry

in the development of training

programs. FDA worked with the

Seafood Alliance to develop a seafood

HACCP curriculum and training

courses. A similar cooperative effort

would be very beneficial in juice

processing. Also, the agency is in the

process of developing a juice HACCP

hazards and controls guide, which will

assist juice processors in the

development of their HACCP systems.

(Comment 104) One comment

questioned whether the agency will

acknowledge the equivalency of juice

HACCP training, as mentioned in

§ 120.13(b), offered by other parties

(such as a trade association or academic

institution) as it did for seafood HACCP.

The comment asked how and who

would determine training adequacy.

Another comment suggested that

equivalency of training programs would

be better dealt with by establishing

training objectives, such as the system

used in meat and poultry HACCP, rather

than specific materials and curricula.

FDA believes that the development of

seafood HACCP training, through the

Seafood Alliance, was beneficial for all

parties. A basic curriculum was

developed, which the agency reviewed,

that was available for the industry’s use.

The agency has encouraged trainers to

evaluate their courses against the

materials developed by the Alliance and

to make modifications necessary to

ensure that programs were consistent

with and provided at least an equivalent

level of instruction to the Alliance

course. FDA is very interested in

cooperating with all interested parties,

including academia, consumer groups,

and the juice industry, to develop

training programs that incorporate the

most appropriate objectives and

materials. FDA will acknowledge the

equivalency of training in the same

manner as is done for seafood HACCP.

(Comment 105) One comment

argued that criteria for adequate HACCP

training should be left up to the States

to determine, but did not provide any

support for this opinion. The comment

also asked that FDA provide States with

guidance and funding to carry out

HACCP training for existing State

personnel and to certify HACCP

specialists.

The agency currently intends to

provide training to States, through

contracts and State partnerships. The

agency recognizes that the effectiveness

of juice HACCP hinges on consistent

implementation and regulation

throughout the United States and

training, particularly for investigators,

plays an important role in such

consistency. As noted above, FDA is

interested in cooperative work with

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6165

States, academia, and industry to

develop training programs.

(Comment 106) One comment stated

that individual companies should be

permitted to determine when

experience can substitute for HACCP

training. Another comment argued that

experience can never substitute for

training, although the comment

contained no data or other information

to support the claim.

FDA believes that in certain

circumstances, appropriate job

experience can be an adequate

substitute for formal HACCP training.

FDA is aware that some juice processors

have had successful HACCP programs

in place for a long period of time and,

as a result, employees working with

those systems have gained a working

knowledge about HACCP that is more

than adequate to meet the training

requirement. Moreover, FDA’s

experience is that other segments of the

food industry have HACCP programs in

place and employee experience gained

working with those systems may be

transferred successfully to juice

processing. It is the responsibility of

processors to determine that their

HACCP system is functioning

appropriately and is in compliance with

part 120, a responsibility that includes

ensuring that those individuals involved

in designing and implementing the

HACCP system are qualified.

(Comment 107) One comment

suggested that FDA develop a test to

determine whether particular job

experience can substitute for HACCP

training. The comment asked if FDA is

developing such a test.

FDA has no plans to develop a test to

determine whether job experience can

substitute for HACCP training. Job

experience that is equivalent to training

gained under an adequate standardized

HACCP curriculum is certainly one way

that individuals may gain the training

required in § 120.13(a). However, as

noted, it is the responsibility of

individual companies to ensure that

qualified individuals conduct the

hazard analysis and develop the HACCP

plan, whether such individual is

qualified through training or job

experience.

K. Application of Requirements to

Imported Products

The agency proposed in § 120.14

specific requirements for importers of

juice products because FDA typically

does not inspect foreign food

establishments. Under § 120.14 of the

proposed rule, importers of juice either

must ensure that all juice offered for

entry into the United States has been

processed in compliance with part 120

or import such juice from a country that

has an appropriate memorandum of

understanding (MOU) with the United

States. In addition, importers must

maintain records that document the

performance and results of the

affirmative steps taken to demonstrate

compliance with § 120.14.

(Comment 108) Several comments

contended that the juice HACCP

regulation should not apply to imports.

However, other comments disagreed. A

few comments suggested that only

imported fresh juice be covered, not

juices that have been documented to

have been thermally processed to meet

the 5-log performance standard.

The agency advises that this final rule

will cover all imported and domestic

fresh or processed juices. First, under

the act, all products in interstate

commerce, whether imported or

domestic, must adhere to the same

standards. Moreover, imported juices

may have many of the same potential

food hazards as domestic products. FDA

discussed outbreaks associated with

imported juices in the proposed rule (63

FR 20450 at 20450) (Ref. 2), and some

of the recent outbreaks discussed in

response to comment 26 were associated

with imported juice (Refs. 46 and 47). In

addition, imported juices may contain

food hazards not normally associated

with domestic products. The differences

in the types of food hazards may be the

function of a number of factors,

including differences in processing

systems and sources of raw ingredients.

The fact that HACCP is based on

prevention of specific hazards makes it

applicable, in general, to food

processing wherever the processing

occurs. Therefore, the agency agrees

with those comments that stated that the

rule must apply equally to imported and

domestic juice products, because the

potential risks are the comparable. The

safety of juice must be ensured

regardless of where it is produced.

(Comment 109) One comment

suggested that FDA clarify the reference

to ‘‘imported food’’ in the introductory

sentence of § 120.14 to identify that

juice is the specifically covered product.

The agency agrees with this

suggestion and has revised the

introductory sentence of § 120.14 by

replacing the word ‘‘food’’ with the

word ‘‘juice.’’

L. Process Controls

1. Performance Standard

The agency proposed to require that

juice processors, except those that are

subject to part 113 or part 114, include

in their HACCP plans control measures

that will produce at least a 5-log (105)

reduction in the pertinent

microorganism. As proposed, the

pertinent microorganism means the

pathogen that is likely to occur in juice

and that is most resistant to the

pathogen reduction technology used

and, if it occurs, is likely to be of public

health significance. The proposed

reduction must be for a period at least

as long as the shelf life of the product

when stored under normal and

moderate abuse conditions.

(Comment 110) Several comments

advocated a regulatory scheme of

HACCP without the performance

standard proposed by FDA. The

comments argued that a performance

standard is not necessary to ensure the

safety of all products (e.g., citrus).

Comments stated that requiring a

performance standard negates the

strength and function of HACCP and

indicates that FDA does not trust

HACCP alone. The comments asserted

that FDA should require either the

performance standard or HACCP, but

not both.

The agency disagrees that having the

performance standard as an integral part

of HACCP weakens the HACCP system.

As NACMCF has pointed out, the

performance standard enhances HACCP

by establishing the appropriate level of

health protection that must be achieved

(Ref. 25). The 5-log reduction

performance standard assures public

health protection for consumers and

assists processors by establishing a

minimum microbial standard for safe

juice. Particularly for non-heat treated

juice, the 5-log reduction requirement

provides a standard against which

processors can measure the

effectiveness of combinations of HACCP

controls. Including a performance

standard as part of HACCP sets a goal

for processors without mandating the

means by which they must achieve that

goal and also provides a means of

determining the equivalence of

alternative strategies for controlling

pathogens. Finally, FDA disagrees with

the suggestion that a performance

standard alone will ensure safe juice. As

noted previously, there are hazards in

addition to microbial contamination,

and a performance standard alone does

not address the chemical and physical

hazards that may be present in juice.

(Comment 111) Many comments

stated that the final rule should identify

a safety goal instead of a performance

standard and let industry decide how to

meet it.

FDA points out that the performance

standard in § 120.24 is a microbial

safety goal and that the final rule allows

the industry to decide how to achieve

the safety goal. Elsewhere in this

6166 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

preamble, FDA has included guidance

on the application of the 5-log standard,

and FDA also intends to issue a juice

HACCP hazards and controls guidance.

Both of these forms of guidance are

available to the juice industry to help in

deciding how to achieve the safety goal.

Therefore, the agency concludes that no

modification is necessary in response to

this comment.

(Comment 112) A few comments

suggested that producers who do not

use dropped fruit should be able to use

HACCP without a performance

standard. One comment contended that

a 5-log reduction is not necessary when

the source of the fruit is known and

processors follow CGMP’s.

This comment did not provide

evidence to persuade FDA that using

tree-picked fruit, along with HACCP,

would make the 5-log performance

standard unnecessary. In fact, produce,

in general, including tree picked fruit,

may not be pathogen free. Agricultural

water, birds, insects, and harvesters are

vectors that can potentially contaminate

produce even though the produce has

not come into contact with the ground.

Even if pathogens are present on or in

the produce used to make juice,

processors can make safe juice by

attaining the 5-log reduction

performance standard.

(Comment 113) Many comments

stated that the 5-log performance

standard was not appropriate because

processors would have to pasteurize

their juice to meet the standard. A few

comments stated that the 5-log

performance standard is unreasonable,

counterproductive, and precludes

consideration of harvesting and farming

practices that help ensure safety.

The agency disagrees with the

comments. The performance standard in

§ 120.24 allows for the use of alternative

technologies. The basis for 5-log is

discussed in response to comment 124.

As noted in section III.L.4, application

of 5-log must occur where the treatment

has direct contact with any and all

pathogens that may be present. For most

juices, this will entail direct treatment

of the juice after extraction. For citrus

juice only, the available data and

information show that surface

treatments can be used to meet all or

part of the performance standard. In

either case, treatments should be

applied at a single location under the

processor’s control and immediately

before packaging, in order to prevent

post-process contamination of the juice.

Although fruit producers and juice

manufacturers are encouraged to follow

GAP’s, GAP’s such as water and manure

management are generally aimed at

minimizing the potential for

contamination rather than eliminating

pathogens that may be present. Thus,

use of GAP’s would not be a substitute

for the 5-log reduction treatment.

(Comment 114) A few comments

suggested that, in addition to the 5-log

reduction performance standard,

producers should be given the option

that Food Safety and Inspection Service

(FSIS) gives for fermented sausage,

which is batch testing to determine that

the product contains less than a certain

level of pertinent pathogens and then

use a 2-log reduction on the batch

tested.

FDA disagrees with the comments’

suggestion. Juice is significantly

different from a fermented meat product

in that a fermented meat product is

typically inoculated with bacterial

cultures as part of the production

process. The growth of the added

microorganisms modifies the food

environment so that pathogenic bacteria

are inhibited or inactivated; there is no

comparable inoculation and inhibition

activity with juice. Moreover, this

process occurs over an extended period

of time (3 to 6 weeks is common), which

allows time for test results to be

completed. Juice, especially juice that is

minimally processed, must be processed

and consumed within a significantly

shorter period than fermented products

and, thus, extensive microbial testing of

finished, processed products is not

practical. Therefore, because there is no

counterpart in juice processing to the

inhibition or inactivation of pathogens

by an added bacterial culture, the

agency concludes that batch testing to

establish that juice contains a minimum

level of pertinent pathogens followed by

a 2-log reduction in the pertinent

pathogen is not an appropriate

substitute for the 5-log reduction

performance standard.

(Comment 115) Several comments

maintained that there are no data to

show that certain combinations of

preventive steps are not adequate to

ensure juice safety. One comment

argued that a combination of grading,

washing, sanitation, and current

extraction techniques are sufficient to

meet the 5-log reduction.

FDA is not prohibiting the use of

appropriate cumulative controls to

attain the 5-log reduction for citrus

products. However, as discussed in

section III.L.4, FDA has determined that

the 5-log reduction must occur where

the treatment has direct contact with all

pathogens, if they are present. Further,

cumulative controls must be completed

in a single production facility under the

control of the processor, be effective

against the pertinent pathogen, be

validated, and be vigorously

implemented to ensure that the full 5-

log reduction is consistently achieved

under commercial processing

conditions. GAP’s and CGMP’s that do

not meet these criteria would be in

addition to, but not count as part of, the

5-log reduction. The agency notes that it

is the responsibility of the processor to

demonstrate that combinations of

preventive steps are adequate to achieve

the 5-log pathogen reduction standard.

(Comment 116) A few comments

expressed concern that no attention was

being given to preventing the presence

of pathogens in juice.

Prevention of pathogens in juice is the

reason HACCP was proposed and is

being finalized. The agency has always

taken the position that food safety is

enhanced by the use of the highest

quality incoming materials. The agency

strongly encourages growers to

implement preventive controls and has

issued GAP guidance to assist growers

in the production of safe produce that

is not contaminated. FDA is issuing part

120 to assist processors in establishing

preventive controls. Specifically,

§ 120.7(b) provides that the hazard

analysis shall include hazards that can

be introduced both within and outside

the processing plant environment,

including hazards that can occur before,

during, and after harvest. In addition,

§ 120.7(d) requires that processors

evaluate product ingredients to

determine their potential effect on the

safety of the finished food.

(Comment 117) One comment

requested that FDA explain how the

performance standard applies to each

different juice (apple, citrus, vegetable,

and blends).

FDA advises that the performance

standard in § 120.24 applies to all juice,

including blends of more than one type

of juice. Processes for attaining a 5-log

reduction will vary significantly

depending on the target pathogen and

the type of juice produced. Therefore, it

is up to each processor to determine

how best to apply the performance

standard to its process. FDA intends to

develop a juice HACCP hazards and

controls guidance for juice that will

provide processors information on the

application of the performance standard

in addition to that provided in this final

rule. The scientific literature is another

source of information for processors on

recent developments to attain the 5-log

reduction for various types of fruits and

vegetable juices. Guidance documents

from State agencies may also provide

information.

(Comment 118) One comment

suggested that all processors should be

required to meet the chosen

performance standard the same way.

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6167

The agency disagrees with the

comment. FDA specifically chose not to

mandate that processors use a particular

method to meet the performance

standard in order to provide flexibility

and to encourage innovation. Different

methods that have been validated to

meet the 5-log reduction standard can

be effective in controlling pathogens to

the appropriate level, which is the goal

of the performance standard. Mandating

a specific technology for processors to

use would eliminate the incentive for

processors to develop new and possibly

improved alternative methods. FDA

does not want to limit innovative

approaches to achieving food safety or

the flexibility for processors to choose

the most appropriate method for a

particular operation.

(Comment 119) Some comments

requested a zero tolerance for E. coli

O157:H7 in juice. One comment was

concerned that the NACMCF may have

recommended a higher threshold of risk

than consumers would consider

acceptable. It stated that there is no

acceptable level of risk with regards to

E. coli O157:H7 because it is so virulent

that a single organism could be deadly.

The comment sought scientific evidence

that the 5-log performance standard will

truly kill these organisms, as opposed to

represent a reasonable number of

organisms killed.

The agency disagrees with the

comments. FDA notes that no food

processing method can be shown

scientifically to achieve a ‘‘zero’’ level

for a pathogen or any other contaminant

potentially present in the processed

food due to the detection limits of the

relevant analytical methods. For

example, the methods used to detect E.

coli in juice in several State surveys had

a detection limit of < 1 cell per 3.33

milliliter (mL) juice. Thus, a negative

result does not necessarily mean that

the microorganism is not present, just

that it is not present at detectable levels.

Furthermore, if pathogens are not

distributed homogeneously throughout

a product, they may be present in the

product but not in the sample tested.

Conversely, food processing methods

can be shown scientifically to reduce,

by mathematical increments (i.e., by

‘‘logs’’), the level of pathogens that may

be present in juice and, as a result, to

reduce the risk of illness from juice.

FDA has received no comments to

undermine the assumption based on the

NACMCF recommendation that the 5-

log performance standard will

adequately protect consumers from E.

coli O157:H7 and other pathogens.

(Comment 120) One comment

contended that a 5-log performance

standard is unenforceable and that FDA

should set pathogen reduction goals

similar to those established for meat and

poultry.

FDA disagrees that the 5-log

performance standard is unenforceable.

The reasons FDA did not set a zero

tolerance for pathogens, as was done for

certain pathogens in meat and poultry,

already have been discussed in the

response to comment 114. By virtue of

the requirements of part 120, FDA

believes that the performance standard

is enforceable. That is, as part of their

HACCP plan, processors must have a

validated procedure for achieving a 5-

log reduction in the pertinent pathogen

for their process and also must have

documentation to demonstrate to FDA

that the standard is being achieved.

Processors who cannot meet these

requirements will not be in compliance

with part 120 and thus, will be subject

to regulatory action.

(Comment 121) A few comments

suggested that FDA use ‘‘safe harbor’’

guidelines rather than require the 5-log

reduction to ensure juice safety.

The comment did not define the term

‘‘safe harbor.’’ FDA assumes, however,

that by ‘‘safe harbor’’, the comment

means that FDA would provide

guidance, such as times and

temperatures for thermal treatments,

that, if complied with, would be

deemed to achieve the 5-log reduction,

thus providing a basis to conclude that

the processor is in compliance with

§ 120.24. FDA is currently working with

industry to develop guidance on how to

achieve the 5-log reduction, and has

already met with the apple industry and

citrus juice industry to discuss

technological options for achieving the

performance standard. Although the

agency is developing guidance to assist

processors in achieving the 5-log

reduction, FDA does not intend such

guidance to provide a ‘‘safe harbor’’.

Thus, juice processors will not be

absolved from adopting HACCP and

demonstrating through validation and

verification that they have met the

performance standard.

(Comment 122) One comment noted

the statement in the agency’s PRIA

statement (63 FR 24254 at 24264) (Ref.

6) that other methods of meeting the

performance standard may not be as

effective as pasteurization or prevent as

much illness seems to indicate an

agency lack of confidence in methods

other than pasteurization.

FDA disagrees with the interpretation

of the PRIA statement. The statement

referenced from the PRIA reads ‘‘To the

extent that processors adopt controls for

these hazards other than flash

pasteurization which are less effective,

the percentage of cases prevented may

be smaller than those estimated here.’’

The benefits of the rule with regard to

illness prevention were developed

based on the amount of illness that

would be prevented if all juices were

pasteurized because, at the time the

proposal was published, pasteurization

was the primary effective, commercially

implemented method for controlling

pathogens in juice that had been

validated to meet the performance

standard. Since the publication of the

proposal, it has become evident that

there may be methods other than

pasteurization, some of which may

require FDA approval for their use, that

could be used to treat juice (e.g., use of

UV irradiation, high pressure). While it

is true that pasteurization treatments

significantly exceed the 5-log pathogen

reduction performance standard, the

statement in the PRIA was not intended

to imply that methods other than

pasteurization are not effective at

preventing illness or that these other

methods cannot meet the 5-log

reduction performance standard.

(Comment 123) One comment noted

that pasteurization would add a

complicated and unnecessary step to

cider production that will take time and

require documentation.

FDA is not requiring in this

rulemaking that juice be pasteurized.

This rulemaking requires that juice be

processed under a HACCP system that

contains a control or controls that have

been validated to achieve a 5-log

reduction in the target pathogen. A juice

processor may choose to meet the 5-log

reduction requirement by pasteurizing

product or by any other validated

means. Although pasteurization is the

primary option available for cider at this

time, this final rule does not preclude

the development or use of alternative

technologies to achieve a 5-log

reduction. For example, FDA recently

amended the food additive regulations

to provide for the safe use of ultraviolet

(UV) irradiation to reduce human

pathogens and other microorganisms in

juice products (65 FR 71056, November

29, 2000) (Ref. 75). Importantly,

however, the processor chooses to meet

the 5-log reduction requirement, the

process utilized by the processor must

be validated and verified as achieving a

5-log reduction in the pertinent

microorganism. The risks associated

with consumption of cider and other

juices are well established (see 63 FR

20450 (Ref. 2) and section II.C of this

final rule) and justify regulatory

requirements that processors establish

controls for pathogens and the other

hazards associated with juice.

6168 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

2. Magnitude of Reduction

(Comment 124) Many comments

questioned the scientific basis for the

5-log reduction performance standard. A

few comments contended that it was too

stringent based on actual numbers of

ubiquitous coliform bacteria found in

cider in State surveys. In support, a

survey submitted as part of a comment

questioning the basis of a 5-log

reduction standard showed that samples

of apples in cider mills in Maryland

contained an average of only 3-logs of

ubiquitous coliform bacteria and no

generic E. coli or E. coli O157:H7. Some

comments asserted that a 5-log

performance standard is premature

considering that the source of E. coli

O157:H7 contamination in apple juice is

not known and suggested that FDA

adopt a 3-log performance standard

until scientific data are developed to

support the need for a 5-log standard.

The comments stated that without data

to provide baseline numbers for

contamination of juice, any performance

standard selected might be

inappropriately stringent or lax. The

comments maintained that the 5-log

standard is particularly excessive if a

processor is using CGMP’s and only

uses prime fruit.

Conversely, one comment suggested

that the 7-log performance standard

used by other high risk food processors

would afford more consumer protection.

It suggested that the agency compare the

protection offered by 5, 6, and 7 log

performance standards because E. coli

keeps proving to be more resistant to

controls than previously thought and

because a 5-log reduction may not be

adequate for all strains of E. coli.

FDA discussed the cider survey

results in the response to comment 36.

In that discussion, the agency noted the

limitations of the analytical methods

and advised that the survey results did

in fact affirm that risk factors such as

fecal coliforms, an indicator of the

possible presence of pathogens, are

present in cider operations and could

give rise to microbial food safety

hazards in the finished juice.

In establishing the 5-log standard,

FDA is relying on the advice of a panel

of recognized food safety experts, the

NACMCF. In making this

recommendation, the Fresh Produce

Working Group of the NACMCF

considered various situations that could

occur with juice (Ref. 63). First, they

considered what levels of E. coli might

typically occur in juice and added a

standard 100-fold safety margin. The

Working Group then considered a worst

case scenario where produce could be

contaminated with bovine feces, a

source of E. coli O157:H7. They

determined that a 5-log reduction would

both eliminate the E. coli O157:H7

contamination and provide a safety

margin. In addition to the information

factored into determination of the 5-log

reduction performance standard,

regulatory precedents were considered.

The 5-log pathogen reduction

performance standard is used by FDA

for Salmonella inactivation for in-shell

egg pasteurization and by FSIS for

inactivation of E. coli O157:H7 in

fermented sausage. The agency has

evaluated the NACMCF advice and

concluded that the 5-log performance

standard recommended by the NACMCF

is the most appropriate standard to

ensure that juice is safe.

This pathogen reduction performance

standard, in combination with the

requirement that measurement of the

5-log reduction begins after cleaning

and culling of citrus fruits and, for all

other juices, when the treatment has

direct contact with any pathogens in the

juice (discussed in the response to

comment 131), provides adequate

public health assurance while

minimizing the impact of treatments on

the sensory attributes of the juices (Ref.

64). While a 3-log reduction could be

adequate under certain circumstances, it

does not ensure that juice is safe under

all circumstances that may occur. In

contrast, the 5-log reduction

performance standard has a built-in

safety factor that provides additional

consumer protection.

In light of the comments, FDA has

considered a 6- or 7-log reduction

standard and concluded this additional

level of reduction is not necessary to

compensate for possible future

microbial resistance. The 5-log

reduction refers to numbers of

microorganisms, not resistance of

microorganisms. Strains of

microorganisms may become more

resistant to heat, acid, sanitizers or other

controls over time. Because

microorganisms are capable of

developing resistance, it is critical that

juice processors periodically verify and

validate their process to determine the

continued effectiveness of the process. If

resistance occurs, processors may need

to make appropriate changes in their

process so that their process continues

to attain a 5-log reduction in pathogens.

Therefore, the agency concludes that

increasing the performance standard to

attain a greater log reduction is not

necessary to compensate for possible

future increased resistance of pathogens.

(Comment 125) One comment

asserted that a 1000-fold safety factor is

not consistent with other performance

standards set by FDA, although the

comment did not reference any specific

performance standards. The comment

maintained that a performance standard

should be based on actual levels of

pathogens found in or on fruit plus a 1-

or 2-log safety factor.

FDA has concluded that the 5-log

performance standard recommended by

the NACMCF is the most appropriate

standard to assure that juice is safe. In

the response to comment 124, FDA

discussed how the Fresh Produce

Working Group of the NACMCF arrived

at the 5-log pathogen reduction

performance standard. This

performance standard includes the

customary 100-fold safety factor, not a

1,000-fold safety factor as asserted by

the comment. Therefore, the agency

concludes that the 5-log value is

consistent with other performance

standards set by FDA and, in fact, was

arrived at using the 100-fold (2 log)

safety factor the comment suggested.

(Comment 126) Several comments

stated that 5-log is not an appropriate

performance standard for citrus juice

because, in trial studies, researchers

have not been able to inoculate fruit

with sufficient numbers of

microorganisms to measure a 5-log

reduction. One comment stated that

minimum safety performance criteria

should be established for citrus because

the likelihood of contamination in citrus

juices is not high. However, another

comment suggested that a 5-log

performance standard would be

appropriate for orange juice because it

can be attained without heat and a 3-log

performance standard would be

appropriate for apple juice because this

may be the maximum attainable without

heat treatment.

FDA proposed the 5-log performance

standard based on safety considerations

and on the recommendation of the

NACMCF (Ref. 63). As mentioned in the

response to comment 124, while a 3-log

reduction could be adequate under

certain circumstances to ensure that

juice is safe, the 5-log performance

standard has a 2-log safety factor that

offers additional consumer protection.

In addition, the agency found in its

review of performance criteria for other

foods, that a 5-log reduction in

pathogens is the standard for product

safety in several cases (Ref. 63).

Although the target pathogen may differ

among juice types and, thus, change the

specific processing parameters (e.g.,

temperature, processing time) for

attaining a 5-log reduction, FDA

maintains that the 5-log performance

standard is appropriate for all juices.

The one area where FDA has data to

suggest differences between citrus juice

and other juices is with respect to the

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6169

potential for pathogen infiltration.

Specifically, the available data show

that the potential internalization of

pathogens in sound, intact citrus fruit is

not likely to present a significant public

health risk (see the response to 132).

Thus, for citrus juice only, the agency

has determined that surface treatments

may be used to achieve the 5-log

reduction standard. Accordingly, citrus

juice processors have an additional

option in how to achieve the

performance standard (i.e., 5-log

reduction), but the standard is the same.

FDA also rejects the comment’s

implicit suggestion that the performance

standard should be based on what is

technically feasible. In order to assure

safe food, a performance standard must

be based on safety, not on whether it is

attainable using only certain

technologies, such as heat treatment.

Presenters at the Florida and California

FDA workshops on the 5-log pathogen

reduction (November 12, 1998 and

November 19, 1998) and FDA research

presented at the December 8 to 10, 1999,

NACMCF meeting demonstrated that

researchers could and had inoculated

fruit with pathogens to a level that

permits measurement of a 5-log

reduction. Therefore, FDA is not

persuaded that the performance

standard should be different for

different produce used to make juice.

(Comment 127) Several comments

noted that the 5-log performance

standard was chosen by NACMCF and

that there was no representative of the

fresh juice industry on the Committee.

The comments maintained that

NACMCF may not have considered

written comments that were submitted

after the public meeting when making

its recommendation.

The NACMCF based its

recommendation for a 5-log

performance standard for juice on safety

considerations, which included a

scientific evaluation and rationale for a

5-log reduction standard. FDA reviewed

the advice from NACMCF and chose to

propose the same standard for HACCP

systems for juice because the agency

determined that the 5-log standard is

supported scientifically. The structure

of the NACMCF and the way it

functions allow for public comment

during the meeting, which comments

the Committee considers in developing

its recommendations. The fresh juice

industry presented their views to the

NACMCF during the meeting in

question. FDA, on the other hand,

typically announces a period of time

during which comments related to the

public NACMCF meeting may be

submitted. In reaching its conclusion to

propose a 5-log reduction standard, the

agency considered written comments,

including comments submitted after the

meeting, on the appropriateness of the

5-log reduction standard, along with

comments presented at the NACMCF

meetings and the NACMCF

recommendations.

(Comment 128) A few comments

requested that FDA not require small

producers to meet the 5-log performance

standard until alternatives to

pasteurization are validated. The

comments argued that pasteurization is

too costly for small producers.

The agency understands the small

processors’ concerns. However, the

5-log reduction is based on safety, and

therefore, processors must meet the

standard in § 120.24, in their HACCP

systems in order for public health to be

protected. FDA has documented

outbreaks that have been attributed to

small processors (Ref. 65). In

recognition of the circumstances of

small processors, however, the agency is

establishing staggered compliance dates

such that there is an additional 1 year

for small processors and an additional 2

years for very small processors to

comply with the HACCP final rule.

Importantly, such processors must use

the label warning statement if they are

not processing their product to achieve

the 5-log reduction. FDA believes that

this approach does not substantially

compromise safety and at the same time

provides accommodation to small and

very small processors. Therefore, the

agency declines to modify the regulation

to exempt small producers from the

5-log performance standard.

3. Pertinent Pathogens

(Comment 129) Some comments

provided views on the types of

microorganisms that should be

considered the pertinent microorganism

for measuring the 5-log reduction. One

comment contended that the chosen

target organism must make scientific

sense based on their extremes of

pathogenic viability across multiple

reduction steps. A few comments stated

that Listeria monocytogenes should not

be a target pathogen for the performance

standard because there is no history of

problems with Listeria in juice.

However, other comments stated that E.

coli O157:H7 and L. monocytogenes are

both appropriate target pathogens,

especially because Listeria

contamination is a risk to pregnant

women. One comment also stated that

Salmonella is not an appropriate target

microorganism because it is not as acidresistant as E. coli O157:H7.

FDA has concluded that target

pathogens must be chosen on the basis

of historical association with a product

and the way in which the product is

processed. For example, there have been

apple juice outbreaks associated with E.

coli O157:H7, Salmonella spp., and

Cryptosporidium parvum. Salmonella

species have been associated with

outbreaks from orange juice. The

NACMCF recommended the use of E.

coli O157:H7 or Listeria monocytogenes

as the target organism, as appropriate.

This recommendation is based on the

number of known outbreaks of E. coli

O157:H7 in juice and the ubiquitous

nature of L. monocytogenes. FDA

advises that if L. monocytogenes

becomes a source of outbreaks in the

future, especially affecting pregnant

women, then processors must consider

whether L. monocytogenes should serve

as the pertinent microorganism for their

product.

Processors must also consider the

manner in which they are achieving the

5-log reduction and the microbial

resistance to the process. For example,

a new technology may be effective in

attaining a 5-log reduction of E. coli

O157:H7 in apple juice, but may allow

the survival of Cryptosporidium. E. coli

O157:H7 is known to be unusually acidresistant and L. monocytogenes is

relatively heat-resistant. The 5-log

pathogen reduction standard applies to

the most resistant microorganism of

concern under the processing

conditions used. If the microorganism is

resistant to a particular treatment and

the treatment does not therefore deliver

a 5-log reduction in the microorganism,

then, obviously, the 5-log reduction

standard has not been met. FDA plans

to provide additional information in its

Juice HACCP hazards and controls

guidance to assist producers in

identifying the pertinent microorganism

for measuring the 5-log standard.

(Comment 130) Several comments

requested that FDA clarify how

surrogate microorganisms should be

chosen to validate cumulative steps

used to achieve a 5-log reduction (e.g.,

use of sanitizers). One comment

requested that FDA require industry to

use an agreed upon ‘‘cocktail’’ of

surrogates to validate processes.

FDA advises that surrogates should be

equally or more resistant to the

processing conditions than is the target

pathogen to assure that the process also

destroys the pathogen. As noted in the

response to comment 129, one treatment

may be effective in reducing one type of

pathogen but have less or no effect on

another. FDA will be providing

additional guidance on the selection

and effective use of surrogate

microorganisms for process validation

in its juice HACCP hazards and controls

guidance. FDA believes that it is the

6170 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

responsibility of the producer to

validate the processes it chooses to use

in manufacturing juice products,

including determining appropriate

surrogate microorganisms. Therefore,

FDA is not requiring use of a ‘‘cocktail’’

of surrogates to validate processes.

In choosing and using surrogates, it is

important to remember that a

cumulative 5-log reduction must be

achieved. Therefore, a processor must

have evidence that there is a total

reduction of 5 logs in the surrogate

population and that the same 1- or 2-log

reduction is not being counted

repeatedly. In other words, if one step

reduces the surrogate by 2 logs, the next

step must reduce the surrogate by an

additional number of microorganisms.

In addition, care must be taken that

there is no growth of microorganisms

between steps.

4. Application of the Performance

Standard

(Comment 131) Several comments

maintained that, because of the

possibility that pathogens may become

internalized into fruit (or vegetables),

the treatment(s) will need to be applied

after the juice has been extracted so that

the treatment has intimate (i.e., direct)

contact with pathogens. One comment

suggested that FDA require at least part

of the treatment be applied directly to

the juice. Conversely, another comment

maintained that, except for warm apples

in cold water, the potential for pathogen

infiltration is hypothetical. Even then,

according to the comment, use of

potable water and hygienically

maintained tanks could control

pathogen internalization despite a

temperature differential that could

cause water to be pulled into the fruit.

As stated previously, FDA believes

that, for all fruits and vegetables, the

pathogen reduction control process

must begin at the point where the

pathogen reduction treatment directly

contacts the pathogens. Inherent in the

NACMCF recommendation of the

5-log pathogen reduction standard was

the assumption that the treatment(s)

would be applied in a way that would

effectively reduce the entire population

of the microorganism of concern by 5-

log. In making this recommendation,

NACMCF did not contemplate

treatments that may eliminate some

pathogens while not reaching others, as

would be the case for surface treatment

of produce susceptible to pathogen

internalization. In fact, the NACMCF

specifically advised that surface

treatments would have little effect on

pathogens if they are internalized.

Contrary to the comment, the

potential for infiltration is not

hypothetical because information and

data from the scientific literature

demonstrate that, under certain

conditions, microorganisms can become

internalized. (Refs. 13 and 14) Such

internalization may occur through

natural plant structures or through

decayed or damaged sites on the fruit or

vegetable. Water, insects, and birds, all

of which may carry human pathogens,

can serve as pathogen vectors, resulting

in contamination of fruits and

vegetables. Internalization may occur

before or after harvest although

submerging warm harvested fruit in

cold water (such as dump tanks and

flumes) increases the potential for

infiltration into susceptible produce.

Similarly, exposing vulnerable external

points of fruit or vegetables may also

cause water to be taken-up along with

pathogens if they are present.

Accordingly, for most fruits and

vegetables, this means that the pathogen

reduction treatment must be applied to

the juice after extraction. Moreover,

processors should include in their

HACCP plans, where appropriate,

precautions to avoid or minimize the

potential for infiltration (such as by

avoiding submerging warm fruit in

colder water). In addition, while

CGMP’s and SSOP’s, such as using

potable water and sanitary operating

conditions during washing, are a base

for HACCP, they will not necessarily

prevent or correct pathogen infiltration

into fruits and vegetables. If pathogens

have become internalized in fruit or

vegetables, wash treatments, even if

conducted consistent with CGMP’s, will

not eliminate them.

In the case of citrus fruits, FDA

considered in the preamble to the

proposed rule that the structure of citrus

fruits prevented internalization of

microorganisms, and thus, for citrus

fruits, pathogenic microorganisms are

likely to be restricted to the surface of

the fruit. As such, FDA tentatively

concluded that surface treatments of

citrus fruit would satisfy the criterion

for direct contact with all pathogens and

could, therefore, be counted towards the

5-log reduction standard (see also the

response to comment 132).

In response to comments challenging

this agency conclusion and in the

absence of scientific studies directly on

this topic, FDA conducted two studies

to determine the validity of its

assumption, and made the results

available for public comment. The

results of one study provided evidence

that internalization, survival, and

growth of human bacterial pathogens

may occur inside oranges. The results of

the second study demonstrated that

there is uptake of water by oranges and

grapefruit when there is a transitory

pressure differential between the

interior and exterior of the fruit. At the

December 1999 NACMCF meeting, FDA

asked the NACMCF to consider the

potential for internalization of

microorganisms by citrus fruits. The

NACMCF concluded that it is

theoretically possible for

microorganisms to internalize in sound,

intact citrus fruit under conditions

where a temperature differential

between fruit and wash water may cause

water to be drawn into the fruit. The

Committee stated that while this was

demonstrated in laboratory conditions,

the probability of its actual occurrence

under current industry practices was

not demonstrated. Accordingly, the

NACMCF concluded, based on the

available evidence, that the potential

internalization and survival of

pathogens in sound, intact citrus fruit is

not likely to present a significant public

health risk.

FDA agrees with the NACMCF

conclusion. Importantly, the comments

did not provide any data for FDA to

conclude otherwise. Thus, the agency is

requiring in § 120.24 that the 5-log

standard be met by treatments applied

directly to the juice, except that citrus

juice processors may use treatments to

fruit surfaces, provided the 5-log

reduction process for citrus begins after

cleaning and culling and is

accomplished in a single production

facility under the control of the

processor. (The terms ‘‘cleaning’’ and

‘‘culling’’ are discussed below in the

response to comment 132.)

At the present time, FDA believes that

only citrus fruits have been

demonstrated to be adequately

impervious to internal contamination

such that it is reasonable to rely on

surface treatments of these fruits, and

therefore, use of surface treatments to

achieve all or part of the required 5-log

pathogen reduction is restricted to citrus

fruit. Whenever sufficient scientific data

are provided to the agency to establish

that, for other fruits and vegetables, it is

appropriate to begin the 5-log reduction

process at other points than the

extracted juice or that establish that

surface treatment is no longer an

acceptable method to contribute to the

5-log reduction for citrus fruit, FDA will

review this conclusion.

(Comment 132) A number of

comments contained suggestions or

asked for clarification about where to

start treatment for purposes of

calculating the 5-log pathogen

reduction. A few comments maintained

that processors grading fruit to reduce

potential contamination, and processors

using other best management practices,

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6171

should be able to count these practices

towards the 5-log reduction standard.

One comment claimed that FDA should

allow the measuring of pathogen

reduction to begin prior to processing to

achieve and count reductions in

pathogens from proven sources, such as

by cleaning and culling dirty or

damaged fruit. Another comment

maintained that a 2-log reduction is

possible from using tree picked apples

instead of drops and that this practice

(i.e., excluding drops) should be

counted towards achieving the 5-log

reduction.

In contrast, several comments stated

that the earliest possible point to start

counting the 5-log reduction is with

clean, sound fruit. One comment

maintained that, while overtly damaged

fruit carry a greater risk of

contamination, apparently sound fruit

may also be contaminated and that,

therefore, culling is not a screen for

microbial contamination.

FDA agrees that food safety is

enhanced by the highest quality

incoming materials. However, as noted

in response to comment 112, FDA does

not believe that GAP’s (such as using

tree picked fruit) or CGMP’s (such as

washing and culling fruit) are a

replacement for the 5-log reduction. Nor

can these practices substitute for a

portion of the 5-log treatment.

Establishment of the 5-log pathogen

reduction standard as adequate public

health protection was based upon

certain starting conditions, including

cleaning and culling the produce, and

the principal that the pathogen

reduction treatment must directly

contact the microbiological hazard. As

noted, for juice made from fruits and

vegetables in which there is a potential

for pathogen infiltration, such contact is

likely to occur only after the juice has

been extracted; for citrus, where

pathogen internalization is unlikely

under current industry conditions, the

5-log reduction process does not need to

start with the extracted juice but may

begin with exterior decontamination of

fruit after cleaning and culling.

FDA is defining in § 123.3(a) and (f)

the terms ‘‘cleaned’’ and ‘‘culled’’ as

described by NACMCF to establish the

starting point for surface treatments for

citrus. Cleaned means washed with

water of adequate sanitary quality.

Culled means separation of damaged

fruit from undamaged. For processors of

citrus juices using treatments to fruit

surfaces to comply with § 120.24, culled

means undamaged, tree-picked fruit

(i.e., USDA choice or higher quality).

For all juices, cleaning and culling

operations would be part of CGMP’s,

and fruit being tree-picked is not

applicable to the 5-log reduction. This is

consistent with the NACMCF

recommendation that cleaning and

culling of citrus fruits not be considered

part of the 5-log reduction of pathogens.

The agency notes that all produce used

for making juice must be cleaned and

culled prior to the start of the 5-log

reduction according to CGMP’s.

However, FDA is defining these terms to

clearly set forth the basic starting

conditions for the 5-log reduction,

especially in regard to surface treated

citrus.

(Comment 133) One comment

suggested developing a standard for

fruit for juicing that includes no

dropped fruit, no blemishes or dimples,

and rinsing with pathogen-free water.

The comment suggested that beginning

with fruit of a standardized quality

would not count toward the 5-log

reduction, but would ensure that all

processors start with fruit of the same

high quality. One comment argued that

treatments that can achieve a 5-log

reduction in pathogens when applied to

sound, clean fruit may be adequate for

producing safe product but questioned

whether a greater reduction might be

necessary if starting with fruit that was

dirty or damaged.

FDA is not setting a standard for fruit

quality or expressly prohibiting the use

of drops in most juices. As with any

food, FDA encourages the highest

possible quality incoming materials in

the production of juice. The Produce

Working Group of the NACMCF arrived

at the 5-log reduction recommendation

by considering a ‘‘worse case’’ scenario

where fruit was heavily contaminated

with feces, as might occur with the use

of drops. The Committee concluded that

a 5-log reduction treatment would

eliminate pathogens and provide a 100-

fold safety margin. Thus, FDA

concludes that the 5-log reduction

applied directly to the juice will

eliminate pathogens that may otherwise

be introduced by the use of drops. FDA

cautions, however, that juice producers

that are exempt from or that have not

yet adopted HACCP, including the 5-log

reduction standard, can reduce their

risk of producing contaminated product

by avoiding drops and by culling tree

picked fruit before extraction.

The agency is establishing a standard

for citrus fruit that is treated only with

surface treatment. For these juices,

drops may not be used. The NACMCF

suggested, and FDA agrees, that for

citrus juices, only tree-picked fruit

should be used, and fruit should be

cleaned and culled to be USDA choice

or higher quality. Although pathogen

infiltration is unlikely in sound, intact

citrus fruit, drops and damaged fruit are

likely to be more susceptible to

pathogen infiltration and, therefore,

should not be used for juice that relies

on surface treatment.

Furthermore, in some cases, damage

incurred when fruit drops to the ground

may foster nonmicrobial contamination

such as the mycotoxin patulin, which

may occur in damaged apples. Patulin,

if present in the apples, will not be

decreased by the 5-log performance

standard. In these cases, the processor

must have controls in place to ensure

that the final juice does not contain

unsafe levels of the mycotoxin.

(Comment 134) Several comments

urged FDA to define sound fruit. A few

comments noted that culling is a

subjective process and therefore may

not be consistently applied. One

comment suggested that the agency

establish mandatory common minimum

standards and technologies (e.g., black

lighting) to ensure consistency in

culling operations. Another comment

suggested that FDA specify that fruit be

culled of unsound fruit before dirty fruit

is placed into a flume where it might

contaminate sound fruit.

In the case of citrus juice where a

surface treatment is used to achieve, at

least in part, the 5-log reduction, the

agency has specified that the fruit shall

be ‘‘culled’’ and ‘‘cleaned.’’ As noted,

these terms are defined in § 120.3. Fruit

and vegetable grading criteria (e.g., for

USDA choice level or higher, as will be

required for surface treated citrus fruit)

have been established by USDA.

Although there may be some degree of

subjectivity in culling citrus fruit,

visibly damaged fruit is apparent and is

unlikely to meet the requirements for

USDA choice level or higher.

Application of CGMP’s, along with the

5-log performance standard beginning at

a point after cleaning and culling of

citrus fruit, should overcome any

potential risks that may result from

subjective processes such as culling.

As stated in response to comment

132, FDA is not setting a standard for

fruit where the juice is treated after

extraction to achieve a 5-log reduction,

although processors may consider

including standards for incoming fruit

as appropriate to their operations in

establishing a HACCP plan. Additional

guidance will be provided in the

agency’s juice HACCP hazards and

controls guidance.

(Comment 135) Several comments

requested that FDA develop a guide for

industry that states the log reduction

achieved for each potential processing

step. A few comments requested that

pasteurization guidelines for juice be

published in a guide, and one comment

asked whether or not heat treatment at

6172 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

161 °F for 15 seconds results in the

appropriate 5-log reduction in juice.

Another comment questioned how to

calculate a 5-log reduction for banana

juice.

FDA plans to publish a juice HACCP

hazards and controls guidance to assist

the juice industry in implementing

these regulations. FDA intends that the

guidance will contain pasteurization

guidelines and information about

achieving the performance standard in

other ways. The agency is unable to

comment on whether a heat treatment of

161 °F for 15 seconds results in a 5-log

pathogen reduction without information

about the characteristics of the juice as

well as the thermal resistance

characteristics of the pathogen of

concern. Appropriate 5-log pathogen

reduction treatments for specific juices

(such as banana juice) will vary,

depending on the characteristics of the

juice (e.g., acidity, viscosity, percentage

of pulp) and processing conditions.

Processors may find it necessary to

consult additional resources to

determine and implement the most

appropriate process to achieve the 5-log

pathogen reduction, such as information

from State public health or agriculture

agencies, universities, extension

services, and private consultants. The

agency emphasizes that it is the

processor’s responsibility to validate the

chosen pathogen reduction process to

assure its effectiveness in consistently

achieving a 5-log or greater reduction.

(Comment 136) Many comments

expressed confusion about the use of

cumulative steps to reach the 5-log

pathogen reduction requirement. A few

comments also requested that FDA

clarify exactly what would be required

if two different processors perform steps

that in the final product add up to a

5-log reduction. A number of comments

stated that separating cumulative

pathogen reduction steps by time and or

by location is not acceptable. These

comments argued that such separation

provided opportunities for

recontamination of product and

regrowth of any existing pathogens that

had not yet been eliminated in the

product, that any multiple step

intervention should take place in a

single location, and urged FDA to

ensure time between treatments is kept

to a minimum once an intervention

sequence is begun. Several comments

on transporting juice between facilities

suggested that FDA require that bulk

transport juice (e.g., juice shipped in

tanker trucks) be pasteurized upon

arrival at the final facility because of the

potential for contamination during

transport.

FDA agrees with the comments

expressing concern about the potential

for recontamination or regrowth of

surviving pathogens if individual

treatments designed to achieve a 5-log

reduction are separated by time or

space. At the December 8 to 9, 1999,

meeting of the NACMCF, FDA asked the

Committee to consider certain questions

about the application of the 5-log

reduction standard, focusing on citrus

juices. Questions included the impact of

separation in time and space between

cumulative steps in the 5-log reduction

process. The Committee members

agreed that separating steps in the 5-log

reduction by time, and especially by

location, is likely to increase the risk of

failure of the pathogen reduction

process (Ref. 12). Thus, the NACMCF

recommended that all the steps needed

to achieve the required 5-log reduction

should occur under one firm’s control

and within a single production facility.

These restrictions are designed to

reduce the risk of recontamination of

juice already processed to achieve all or

part of the 5-log reduction. Both time

and the act of transportation, between

processors, present an opportunity for

recontamination. Even if a processor

moves product from one building to

another within the same facility, this

movement must be accomplished under

CGMP’s and the processor must insure

that recontamination does not occur. As

noted, there have been several recent

outbreaks of microbially contaminated

fresh juice; investigation of these

outbreaks establish that the concern

about recontamination is not just

theoretical because the evidence

suggests that transportation may have

played a role in these outbreaks. In

April 2000, FDA was notified by CDC of

a foodborne disease outbreak involving

over 140 reported cases from 10 States.

CDC determined that the illness was

caused by Salmonella Enteritidis in

unpasteruized orange juice, a

component of which had been imported

in bulk. Previously, in July 1999, an

outbreak of Salmonella Serotype

Muenchen occurred in 15 States and 2

Canadian provinces with over 300 cases

reported. Again, the product was fresh

orange juice, a portion of which was

imported. In this second outbreak,

several serotypes of Salmonella were

isolated from tanker truckloads of juice

tested at the United States/Mexican

border (Ref. 67).

FDA agrees with the NACMCF

recommendations that all the steps

needed to achieve the required 5-log

reduction should occur under one firm’s

control and within a single production

facility. Although the NACMCF

recommendation focused on citrus

juice, based on the comments, FDA

believes that this recommendation

should be extended to all juices.

Because of the potential for

contamination at a facility over which

the final processor/packager has little or

no control and because of the potential

for contamination during bulk transport,

FDA has concluded that there should

not be any carryover from one facility to

another of any portion of pathogen

reduction that contributes to a total 5-

log pathogen reduction. If a treated juice

is transported to another facility for

final packaging or blending and

packaging operations, the entire 5-log

reduction must be repeated. To clarify

this point, the agency is adding

paragraph (c) to § 120.24 to state that

processors must complete the 5-log

performance standard and final product

packaging within a single processing

facility under CGMP’s.

FDA also notes that, for citrus juice

producers relying on surface treatments

for the 5-log reduction, the single

facility criterion also applies to the

requirement that processors start with

clean, choice or higher grade fruit.

Although some juice processors may

receive fruit that has been cleaned and

graded at another facility, fruit may

require additional cleaning and culling

to remove any fruit damaged in storage

or transit. It is the responsibility of the

final juice processor (i.e., the processor

at the location where the 5-log treatment

will be applied) to ensure that fruit is

clean and of appropriate grade before

beginning the 5-log reduction.

Even within a single production

facility, time between cumulative steps

may provide an opportunity for growth

or recontamination. Therefore,

processors should include in their

HACCP plans controls to protect against

regrowth of pathogens between steps

(e.g., limiting hold time and/or

temperature) and to prevent

recontamination of the juice during or

after processing (e.g., aseptic handling

between steps or between treatment and

packaging).

FDA also agrees with the concern

expressed by comments on the potential

for juice to be contaminated during bulk

transport. This is an area of particular

concern to the agency because, as

mentioned above, bulk transport

appears to be a common factor in

several recent outbreaks. However, the

agency has no information nor was any

information submitted by comments

that the 5-log reduction standard

applied to juice in general would not be

sufficient to ensure the safety of juice

that is shipped in bulk, provided that

the transported juice receive the entire

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6173

5-log reduction at the facility where it

will be packaged. Therefore, FDA is not

requiring at this time that juice shipped

in bulk between facilities be subject to

additional treatment.

(Comment 137) One comment

expressed concern that a cumulative

process will be more easily

overwhelmed by especially dirty fruit

than would a single kill-step process.

The comment contended that the risk of

contamination in a multi-step process is

increased over the risk in a single killstep process because of the potential

that contamination can be introduced

between steps. One comment expressed

concern that validation studies on a

cumulative 5-log reduction cannot

account for all variables and, thus,

meeting the performance standard

cannot be guaranteed.

HACCP principles and this final rule

require that a processor validate the

HACCP plan for its particular process

under commercial operating conditions.

This validation requirement exists for

plans utilizing both single-step and

cumulative pathogen reduction controls.

FDA recognizes that within a processing

system time delays may occur between

stages of the treatment; the processor

must take any delays into consideration,

establish appropriate controls, and

validate the HACCP plan for that

system. The 5-log reduction

performance standard was established

to ensure the safety of juice regardless

of the pathogen reduction system

chosen or the microbial load of the

incoming fruit. Furthermore, as

discussed in response to comment 132,

citrus juice processors using surface

disinfection to achieve all or part of the

5-log reduction must start with cleaned

and culled fruit as defined in § 120.3 (a)

and (f).

(Comment 138) Several comments

maintained that juice should be

packaged immediately before or after

the intervention treatment. One

comment stated that a processor could

hold and cool a heat treated product

before packaging if sufficient controls

were in place to preclude

recontamination of the product.

As noted earlier, time between

cumulative steps and between

application of the 5-log reduction and

packaging increases the risk of failure

(see response to comment 136).

Therefore, to reduce the risk of

recontamination, juice should be

packaged immediately before or after

application of the 5-log pathogen

reduction treatment. The potential for

recontamination between application of

the 5-log reduction treatment and

packaging (such as might occur when

product is held and cooled) should be

considered in the development of the

HACCP plan and appropriate controls

established that are designed to prevent

recontamination. Processors not

packaging juice immediately after

treatment should have sufficient

controls in place (e.g., aseptic

equipment) to ensure the safety

achieved by the 5-log reduction can be

consistently maintained.

(Comment 139) One comment asked

if the regulation allowed for the

application of 5-log reduction to a juice

ingredient at any time (e.g., before or

after blending). The comment argued

that the juice ingredient used to

manufacture dairy beverages usually

receives a 5-log treatment by the

supplier and that the finished beverage

is often pasteurized at the dairy.

Juice that is intended for use in

further manufacturing is generally

shipped in bulk. As discussed in the

response to comment 136, the NACMCF

recommended and FDA agrees that if

bulk transport juice will be repackaged

at another facility, the 5-log reduction

process must be performed on the juice

at the facility where it is packed into

final packages. If treated juice is

packaged into a bulk-type sterile

package, such as a single use sanitary

tote, then reprocessing is not necessary

unless it is repackaged. If juice shipped

in sterile totes is to be repackaged at a

different facility, the juice product sold

to consumers must be retreated to attain

the 5-log reduction at the facility where

final packaging is performed. As

discussed earlier, separation in time and

location increases the risk of failure of

the HACCP system, including the 5-log

reduction. Therefore, FDA is not

providing for carryover of any part of

the 5-log reduction when juice, not in

its final packaged form, is transported

between two facilities.

Juice destined for use as an ingredient

in another juice beverage must also

undergo a 5-log reduction process. The

processor may choose either to treat the

juice ingredients before blending or to

treat the final product, so long as the

entire 5-log reduction is completed in a

single production facility under the

control of the processor and the

processor minimizes time between

treatment and packaging.

(Comment 140) Several comments

noted that shelf-stable juices are

processed well in excess of the 5-log

reduction necessary for pathogen

control. The comments requested that

FDA exempt shelf-stable juice producers

from a CCP for pathogen reduction

because the shelf-stability of the product

is proof that their process greatly

exceeds safety performance criteria.

Comments also requested that the same

consideration be given to concentrated

juices.

The agency agrees with the comments

and is providing an exemption from the

requirements of § 120.24 for shelf-stable

and concentrated juices, under specific

conditions. Shelf-stable juice products

are generally processed at high

temperatures in a single step to destroy

spoilage microorganisms and enzymes

(Ref. 68). These temperatures far exceed

what is needed to attain the 5-log

reduction in the pertinent pathogen.

Therefore, FDA concludes that it is

reasonable to exempt a processor of

shelf-stable juices from the requirements

of § 120.24, if the firm uses a single

thermal processing step to attain shelfstability.

FDA also recognizes that the

production of thermally concentrated

juice utilizes thermal treatments similar

to those used for the production of

shelf-stable juices (Ref. 68). A thermal

concentration process generally consists

of an initial thermal treatment, similar

to that used for shelf-stable juices,

followed by several thermal evaporation

steps. For this reason, the agency has

concluded that when a thermal

processing step is used before a thermal

evaporation process, the processor

should be exempt from the 5-log

reduction requirement.

Accordingly, FDA is adding

§ 120.24(a)(2) exempting juice

processors using a single thermal

processing step sufficient to achieve

shelf-stability of the juice or a thermal

concentration process that includes

thermal treatment of all ingredients

from the requirements of § 120.24 (the

5-log reduction requirement). When

completing the written hazard analysis

as required by § 120.7, processors of

shelf-stable and concentrated products

using a thermal treatment need not

identify pathogens as a hazard that is

reasonably likely to occur. To

demonstrate that its process is sufficient

for the exemption, a processor must

include a copy of the thermal process

used to achieve shelf-stability or

concentration in its written hazard

analysis as required by § 120.7.

Shelf-stable or concentrated juice

processors are not exempt from the

requirement to conduct a written hazard

analysis because of the possibility that

chemical or physical hazards may be

reasonably likely to occur. However, if,

based on its hazard analysis a processor

exempt from § 120.24 determines that

there are no chemical or physical

hazards that are reasonably likely to

occur in its juice product, then that

processor is not required to have a

HACCP plan. Juice processors that do

not have a HACCP plan need not

6174 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

comply with the following provisions of

part 120:

• § 120.8, HACCP plan

• § 120.10, Corrective actions

• § 120.11(a) (except paragraph

(a)(1)(i)), Verification

• § 120.11(b), Validation of the HACCP

plan

• § 120.12(a)(3) and (a)(4), Required

records

• § 120.24(a) (except paragraph (a)(2)),

Process controls

• § 120.25, Process verification for

certain processors

FDA anticipates that, in the future,

processors making shelf-stable or

concentrated juice may use alternative

nonthermal processing technologies.

While the control mechanism of these

nonthermal technologies may eliminate

spoilage microorganisms, the effect on

pathogens is uncertain. Therefore, the

exemption under § 120.24(a)(2) does not

extend to nonthermal processes.

5. Validation of the Performance

Standard

(Comment 141) One comment stated

that the cost of validating a 5-log

reduction procedure would be

prohibitive to small producers because

the validation studies would have to

take place in a pilot plant. Another

comment stated that processors should

be able to validate procedures and

critical control limits based on literature

reviews, in-plant experience,

recommendations from consultants, and

routine testing.

The agency disagrees with the

comment that argued that validation

would be too expensive for small

processors because it would have to take

place in a pilot plant. FDA notes that

validation studies need not occur in a

pilot plant. There are several options

available to a processor in validating its

5-log reduction procedure and in

establishing critical limits. Although it

is preferable to establish limits for CCP’s

and validate individual processes in a

pilot plant or in the processing facility

where they will be carried out, FDA

recognizes that this may not be feasible

for small processors. As suggested by

the second comment, many alternatives

are available. For example, small

processors that use identical procedures

for producing juice could validate these

processes cooperatively. It is also

acceptable to use referenced procedures

for achieving a particular log reduction

provided a processor can demonstrate

that the referenced procedure is being

followed exactly (or more stringently),

as outlined in the literature, and is

effective in the processor’s operation.

Small producers may also elect to use

proven technologies (e.g., thermal

treatments) that have been extensively

validated, and as such can be readily

adopted with minimal need to conduct

in depth microbiological validation

testing.

FDA was unsure what the second

comment meant when referring to

‘‘routine testing’’ as a way to validate

HACCP. It may be that the comment was

referring to ‘‘verification’’ (e.g., routine

testing and monitoring) to ensure that

the HACCP plan is functioning

correctly, rather than ‘‘validation’’.

Verification and validation are further

discussed in the following section.

6. Process Verification

(Comment 142) Several comments

expressed concern about the

effectiveness of cumulative steps in

meeting the 5-log reduction. One

comment pointed out that the efficacy of

a cumulative step process for citrus

assumes perfect grading and that the

interior of citrus is sterile. The comment

stated that perfect grading is not

possible because pathogens that may

have entered the fruit through a

microperforation may not be detected

and the fruit could have a contaminated

interior. The comment also maintained

that no steps in the cumulative process

described in the proposed rule were

designed to prevent reproduction of

pathogens in the juice during storage. A

few comments concerned about the

effectiveness of cumulative treatments

argued that FDA should require endproduct testing to verify HACCP for all

non-pasteurized juice. One comment

advocated continuous testing for

unpasteurized juice and periodic testing

for pasteurized juice. Conversely, one

comment maintained that, in most

cases, microbial testing is not necessary

nor is it the best method for verifying

HACCP. However, this comment

suggested that microbial testing be

required for citrus juice using surface

treatments to achieve 5-log since,

according to the comment, there are few

other steps that can be used to verify

cumulative processes that include

surface treatment.

FDA’s response to these comments

requires an understanding of the

differences between two HACCP

concepts: validation and verification.

Verification includes all activities,

except monitoring, that establish the

soundness of the HACCP plan and that

the system is operating according to the

plan. Many verification activities, such

as process verification, are an on-going

(e.g., daily or weekly) part of operating

under a HACCP plan. Validation is a

subset of verification activities that

occurs when a HACCP plan is first set

up and whenever significant changes

are made that may have an impact on

the effectiveness of the system.

Validation focuses on collecting and

evaluating scientific and technical

information to determine whether the

HACCP plan, when properly

implemented, will effectively control all

hazards that are reasonably likely to

occur. In contrast, verification assesses

whether the HACCP plan, once

established, is working properly.

FDA disagrees that microbiological

testing of the final juice should be

required of all juice manufacturers. If

juice is treated to achieve a 5-log

reduction in a target pathogen after the

juice is expressed, the extent of the

reduction (>100,000-fold) in

combination with the low levels of

pathogens that have been detected in

untreated juice would likely result in a

post-treatment level of microorganisms

that is too low to be detected using

reasonable sampling and analytical

methods. Moreover, microorganisms are

not likely to be uniformly distributed

throughout the juice and, accordingly,

may not be present in the sample tested

even though they are in the juice. This

can result in false negative test results.

Determination that the product has been

adequately treated is more effectively

verified by review of the monitoring

records for the appropriate CCP. Thus,

as a general rule, FDA is not requiring

end product testing as part of

verification for processes where the

juice itself has been directly treated. The

exception to this general rule is that

processors of citrus juice that use

surface treatments to achieve the 5-log

reduction performance standard will be

required to conduct end product testing

to verify that their HACCP system,

including the cumulative step 5-log

reduction, is operating as it is designed

to operate. This verification testing is

discussed in more detail below. Of

course, even where not required,

processors may elect to use end product

testing as part of the verification of the

HACCP plan.

Conversely, except for techniques like

pasteurization, where industry has a

long history and experience of using

time-temperature parameters as an

indicator of microbial destruction, a

processor will likely need to conduct

studies using samples inoculated with

pathogens (or surrogates) to confirm that

their HACCP process does result in a

5-log reduction in the pertinent

pathogen.

In light of comments expressing

concern about the efficacy of cumulative

steps, including surface treatment of

cleaned and culled citrus fruit, FDA has

evaluated the need for additional forms

of process verification for some

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6175

products. As noted, verification is

designed to demonstrate that the

HACCP plan is achieving the level of

process control intended and thus

producing safe food on a continuing

basis. Verification is broader than

ongoing process monitoring alone. The

purpose of monitoring is to measure and

document that those identified steps

that must operate within specified

limits on a continuing basis in order to

control a foodborne hazard (i.e., CCP’s)

are in fact operating within

specifications. Ideally, monitoring

involves continuous, ‘‘real-time’’

measurements so that process

deviations can be detected and

corrected immediately.

Conversely, verification entails both

the periodic review of monitoring data

and the acquisition of additional data to

assess whether the HACCP plan is

functioning as intended. The additional

data are not necessarily data relating to

a CCP, but could be data relating to

another step in a process that reflects

the effectiveness of a prior CCP(s) (e.g.,

sampling of citrus fruit surfaces for

levels of acid resistant mesophilic

aerobic microorganisms after treatment

of the fruit with an acidic antimicrobial

wash). Furthermore, since verification

data are only acquired on a periodic

basis, types of analyses that require too

much time to be effective means for

monitoring CCP’s can nevertheless be

highly effective tools for verifying a

HACCP plan. Verification activities may

include review of CCP-monitoring

records; collection of either in-line or

finished product samples for

microbiological, chemical, or physical

analysis; and direct observations of

monitoring activities and corrective

actions. The frequency of verification

activities will vary depending on factors

such as the type of process, volume of

product, the results of prior monitoring

and verification activities, and past

frequency of process deviations.

As discussed in detail previously, at

its December 1999 meeting, the

NACMCF considered at length the

effectiveness of surface treatment to

eliminate microbiological concerns

related to citrus fruits. There has been

a continuing question of whether the

integrity of the outer surface of citrus

fruit is sufficiently impervious such that

pathogenic microorganisms cannot enter

the fruit. If the surface were sufficiently

impervious, surface treatments might

effectively reduce the risk from

microbiological hazards. The NACMCF

(1999) concluded that the potential for

the uptake and growth of bacterial

pathogens such as Salmonella Hartford

and E. coli O157:H7 by intact citrus fruit

is unlikely, given current industry

practices, and that surface treatment of

intact, healthy citrus fruit should

adequately reduce microbiological risks.

However, the NACMCF also concluded

that under certain limited conditions,

internalization of pathogenic bacteria is

possible. Further, the NACMCF noted

that surface treatments of fruits would

have little effect on internalized

pathogenic microorganisms (Ref. 12). In

addition, although the NACMCF

concluded internalization of pathogens

in sound citrus is unlikely under

current industry practices, FDA research

confirmed that if a temperature

differential exists between the fruit and

wash water, washing may cause

internalization of pathogens in citrus

and other produce through indiscernible

punctures of the skin.

The NACMCF observed that while

microbiological testing is seldom

effective as a means of monitoring a

CCP, such testing can play a role in

verifying HACCP programs (Ref. 17).

Similarly, the International Commission

on Microbiological Specifications for

Foods (Ref. 69) has recognized

microbiological testing of product as

one type of HACCP verification.

In relation to HACCP and citrus juice

manufacture, the NACMCF (Ref. 12)

recommended that periodic

microbiological testing of juice be a

component of the HACCP verification

activities undertaken by those citrus

juice manufacturers who rely on surface

treatment of fruit to achieve all or part

of the microbiological performance

standard (5-log reduction).

Because of continuing questions about

the possibility of pathogen

internalization and because of the lack

of alternative verification steps available

for processors using cumulative steps,

including surface treatments, to achieve

the 5-log reduction, FDA concludes that,

for citrus juices that rely solely or in

part on surface treatments, periodic

microbial testing to verify the

effectiveness of cumulative processes is

integral to the process control

verification. Therefore, in § 120.25, FDA

is requiring microbial testing for such

juice products. This testing is in

addition to verification and validation

requirements set forth in § 120.11.

(Comment 143) As noted above,

several comments argued that FDA

should require microbial testing for

some or all juices. Some comments

favored microbial testing of finished

product but did not specify sampling

plans or methods. A few comments

suggested that FDA could permit

companies to test for indicator

organisms because E. coli O157:H7 is

hard to detect. One comment argued

that such a requirement would

eliminate the need for a HACCP system.

FDA disagrees with the comment that

maintained that end product testing

would eliminate the need for HACCP for

juice. As discussed in response to

comment 142, microbial testing is

limited in its ability to detect process

deviations in a timely manner,

especially for products with a short

shelf-life, such as fresh juice.

FDA agrees with the comment that

suggested that indicator organisms

could be used for process verification.

While microbiological testing for

specific pathogens might be a direct

means of verifying that a surface

treatment is effective and that pathogens

have not been internalized in the fruit,

analyses for individual pathogens can

be highly complex. Testing for

pathogens also has limitations,

including the potential for pathogens to

be present at low levels compared to

other microorganisms and the detection

limit of the test. There is also the

question of which pathogens that may

be present on the surface of the fruit

should be the focus of any testing. For

example, testing for Salmonella, E. coli

O157:H7, and Cryptosporidium parvum

might be appropriate since all three

have been implicated in disease

outbreaks related to juices. Another

limitation of testing for pathogens is that

testing for one pathogen (e.g.

Salmonella) will not detect another

(e.g., E. coli O157:H7), even if the

second pathogen is present. An

alternative would be to select a

microorganism whose presence is

indicative of a loss of process control.

Since all three of the pathogens above

are fecal in origin, the ideal indicator

microorganism would be one that is

indicative of fecal contamination.

FDA has considered several different

possible indicator microorganisms and

has concluded that biotype I Escherichia

coli (i.e., generic E. coli) is the most

suitable indicator microorganism for

verifying the effectiveness of surface

treatments in attaining the 5-log

reduction standard. This microorganism

is generally regarded by the scientific

community as the best indicator

microorganism for processes intended to

control fecal contamination (Refs. 15

and 70). When present, generic E. coli

generally occurs at levels several

magnitudes greater than the levels of

enteric pathogens that are associated

with fecal contamination. Consequently,

testing for generic E. coli is more likely

to detect product where the 5-log

reduction standard has not been

achieved. Thus, FDA concludes that any

citrus juice manufacturer that relies

solely or in part on surface treatment of

6176 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

the fruit to achieve the 5-log reduction

performance standard shall, for each

different type of juice product

produced, conduct analyses of the final

product for biotype I Escherichia coli.

The next issue is how the analysis

should be performed. Historically, the

juice industry has used the standard

3-tube MPN (most probable number)

method in FDA’s Bacteriological

Analytical Manual (BAM) for analysis of

coliform and E. coli in juices. However,

this method has several limitations.

First, as noted in a paper entitled

‘‘Derivation of Sampling Plan to Meet

the Testing Requirement in the Juice

HACCP Final Rule for Citrus Juices That

Rely Solely Or in Part on Surface

Treatments to Achieve the 5-Log

Reduction Standard’’ (‘‘Surface

Treatment Sampling Plan’’) (Ref. 71),

the BAM method can only analyze a

small sample size of 3.33 mL with a

detection limit of 0.3 E. coli/mL. In

addition, the high acidity of some

juices, including most citrus juices, can

interfere with the detection efficiency of

the test. Using an analytical method that

can test a larger sample size (i.e., 20 mL)

and by including an enrichment step to

reduce interference by acidity should

improve an analysis for generic E. coli

and thus assist a citrus juice processor

using surface treatments to verify

whether the process is achieving the 5-

log reduction. Consequently, FDA has

developed the method, ‘‘Analysis for

Escherichia coli in Juices—Modification

of AOAC Official Method 992.30,’’ to

detect the presence or absence of E. coli

in a 20 mL sample of juice (consisting

of two 10 mL subsamples) (Ref. 72). In

the future, FDA intends to place this

method in the BAM. After publication

of this final rule, the method will be

available on FDA’s Internet site at

www.cfsan.fda.gov.

In order to facilitate uniform and

effective application of this

requirement, FDA has added to

§ 120.25, specific requirements for

sample collection and testing. Under

this provision, one 20 mL sample,

consisting of two 10 mL subsamples, of

finished juice shall be analyzed for the

presence of generic E. coli from each

1,000 gallons of juice produced per day.

If less than 1,000 gallons of juice are

produced per day, samples must be

taken for each 1,000 gallons produced,

or once every 5 working days that the

facility is producing that juice,

whichever comes first. If either 10 mL

subsample is positive for E. coli, then

the 20 mL sample is recorded as being

positive for generic E. coli.

In addition to the general corrective

action requirements in § 120.10, FDA is

also adding requirements in § 120.25 to

spell out the specific steps that should

be taken if a processor subject to the

requirements of § 120.25 finds one or

more juice samples positive for E. coli.

Generic E. coli is relatively ubiquitous.

Thus, the occasional sample that is

positive for E. coli does not necessarily

indicate that microorganisms of fecal

origin are not restricted to the surface of

the fruit or that surface treatments are

insufficient to assure product safety.

Nevertheless, an occasional positive

sample should prompt a review of the

monitoring records relating to the 5-log

reduction standard to determine

whether pathogen reduction treatments

and post process controls designed to

prevent re-contamination are being

properly delivered. Because generic E.

coli is an indicator of fecal

contamination, processors finding

generic E. coli in a single sample may

consider testing another sample of the

same juice for specific pathogens of

concern, such as Salmonella and E. coli

O157:H7, to determine whether, in fact,

pathogens are present in the juice. FDA

is not requiring pathogen testing for the

occasional, single positive for E. coli.

However, if the review of monitoring

records or the additional testing shows

that the 5-log reduction has not been

achieved, such as a sample is found to

be positive for the presence of a

pathogen or a deviation in the process

or its delivery is found, the processor

shall take corrective action as set forth

in § 120.10 of this final rule. Corrective

action requirements for a single positive

generic E. coli are set forth in 120.25(d).

More than an occasional 20 mL

sample positive for generic E. coli is an

indication that the HACCP process is

not sufficient to assure product safety.

Under § 120.25, processors relying in

whole or in part on surface treatments

of the fruit shall have in place a

sampling and testing plan sufficient to

distinguish between the occasional

positive sample and more frequent

positives that are indicative of a failure

to deliver the 5-log reduction. One way

to distinguish between a chance event

and an event that results from other

factors (such as a failure to deliver the

5-log reduction) is to examine a defined

series of tests and assess whether the

unusual happens too frequently to be

due to chance alone. FDA has evaluated

the available data and information, and

based on that analysis, has determined

that two positives in any series of seven

contiguous tests is an appropriate

criterion in a sampling plan designed to

signal a citrus juice processor relying on

surface treatments that its 5-log

reduction standard has not been

achieved. This standard would alert

processors relatively quickly that their

system is not delivering the 5-log

reduction and, at the same time, would

have a relatively small incidence of

‘‘false alarms’’ for processors who are

achieving a 5-log reduction. The

statistical basis for this criterion is

described in the paper entitled

‘‘Derivation of Sampling Plan to Meet

the Testing Requirement in the Juice

HACCP Final Rule for Citrus Juices That

Rely Solely Or in Part on Surface

Treatments to Achieve the 5-Log

Reduction Standard’’ (Surface

Treatment Sampling Plan) (Ref. 71).

FDA acknowledges that there were

certain limitations in the data it had

available to estimate E. coli levels that

would be expected in juice not treated

to reduce pathogenic microorganisms.

For example, available data on E. coli

levels in citrus juice were limited to

orange juice. However, FDA believes

that the sampling plan set out in the

Surface Treatment Sampling Plan (Ref.

71) can appropriately be applied to all

types of citrus juice. Orange juice

represents a significant portion of the

citrus juice market. For those citrus

juices that have a lower occurrence of E.

coli compared to orange juice, using the

same sampling plan will provide an

equivalent or greater level of food safety

assurance for consumers without

increasing any burden, such as the risk

of false alarms, for processors.

Moreover, a single standard sampling

plan will simplify implementation and

evaluation of HACCP for citrus juice

processors using surface treatments.

Other aspects of the data, including its

limitations, are discussed in the Surface

Treatment Sampling Plan (Ref. 71). FDA

believes that the assumptions made,

based on its review of available data,

were sufficiently sound and reasonable

to support this sampling plan.

Therefore, FDA is specifying in

§ 120.25(e) that finding two samples

positive for E. coli out of a series of

seven sequential tests indicates that the

5-log reduction was not achieved. As

additional data become available, the

agency will consider those data and

make adjustments in the HACCP

regulation or in the Juice HACCP

hazards and controls guide as

appropriate.

Under § 120.25(e), if a processor finds

two positives out of seven tests, the

control measures to achieve the 5-log

reduction would no longer be

considered adequate. This would

require immediate action to ensure that

no product enters commerce that was

produced where the 5-log reduction was

not achieved, because inadequately

processed juice creates the potential for

the transmission of foodbourne

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6177

illnesses. In addition, the processors

would need to determine the source of

the failure and to take steps to correct

the failure. Corrective actions must

include a review of the monitoring

records for control measures to attain

the 5-log reduction standard, and the

processor must correct those conditions

and practices that are not met. If the

review of monitoring records or the

additional testing shows that the 5-log

reduction has not been achieved, such

as a deviation in the process or its

delivery, the processor shall take

corrective action as set forth in § 120.10

of this final rule. The processor should

also review the aspects of the HACCP

plan relating to the 5-log reduction

standard to determine whether the

conditions and practices specified in the

plan relating to the 5-log reduction

standard are being met. If those

conditions and practices are being met,

and no other source of the problem can

be found (e.g., post process

contamination), the processor should

conclude that the treatment, although

delivered as intended, was not able to

achieve the intended 5-log pathogen

reduction. In such case, the processor

shall revalidate its HACCP plan in

relation to the 5-log reduction standard.

While the control measures relating to

the 5-log reduction standard are being

evaluated, and until all corrective

actions have been completed, including,

if necessary, revalidation of those

aspects of the HACCP plan relating to

the 5-log reduction standard, the

processor must use an alternative

process or processes to achieve the 5-log

reduction after the juice has been

expressed. Processors should consider

why the monitoring and verification

results are not in accord, such as

through an inadequate process or a

failure in process delivery, and whether

an alternate approach to achieving the

5-log reduction is needed. Once these

steps have been taken, processors may

again use the validated approach that

relies solely or in part on surface

treatments rather than the alternative

process.

FDA has concluded that two positive

E. coli samples in a series of seven tests

indicate that the control measures to

attain the 5-log reduction standard are

inadequate and immediate corrective

actions are necessary. Two positives in

a window larger than seven tests may be

due to chance rather than a failure to

deliver the 5-log reduction. However,

processors may wish to review test

results over a larger window as a

possible early warning that the process

may be approaching failure. FDA

intends to provide additional

information in its Juice HACCP hazards

and controls guide to assist processors

in ensuring their review is sufficiently

extensive to determine that no trends

towards loss of control are occurring.

The agency concludes that new

§ 120.25 is a highly effective tool for

verifying the 5-log reduction standard

for processors using surface treatments.

In addition, FDA is modifying

§ 120.11(a)(1) to include new paragraph

(vi) to clarify that the activities in

§ 120.25 are part of the processor’s

verification activities.

7. Other Issues

(Comment 144) One comment

requested that FDA clarify what is

meant by moderate abuse conditions.

The comment stated that E. coli may be

less tolerant under these conditions, so

moderate abuse could be a kill step for

E. coli.

FDA discussed what it considered to

be moderate abuse in the proposal (63

FR 20450 at 20478) (Ref. 2). FDA

acknowledges that in some

circumstances moderate abuse such as

slightly elevated temperature in an

acidic juice may actually decrease the

numbers of certain microorganisms. If a

processor intends to use a specific

period of elevated holding temperature

as a treatment, then the processor must

validate the treatment as required for

any CCP.

(Comment 145) A few comments

asked that FDA eliminate the

requirement that the 5-log reduction be

maintained throughout shelf-life of the

product. The comments maintained that

there is no risk of recontamination once

the juice is bottled.

FDA agrees that there is little risk of

recontamination after a juice is bottled

if the container is not damaged and the

juice is handled under CGMP’s.

However, because of the importance of

attaining the 5-log reduction for juice to

be safe, it is reasonable that juice retain

this characteristic throughout the period

that it is available for consumption by

consumers. Therefore, FDA is not

amending § 120.24.

(Comment 146) One comment

suggested that the performance standard

should be phased in as data on meeting

the performance standard becomes

available. Another comment suggested

that initially, a 3-log reduction could be

required, then the following year a 4-log

reduction would be required and finally

a 5-log reduction.

The agency does not agree. FDA is

providing ample opportunity to

accommodate processors that may have

difficulty implementing the 5-log

reduction performance standard. First,

the agency has required, since the

effective date of the juice labeling final

rule, that juice be treated to control

pathogens (i.e., meet a 5-log reduction

performance standard) or bear a warning

label statement. Since that same time,

FDA also has been working with the

juice industry, through workshops and

programs, on the development of

techniques that meet the performance

standard. Finally, depending on their

size, processors will have 1 to 3 years

to implement this rule because the

agency is providing additional time for

small and very small businesses to

implement their HACCP systems.

Therefore, FDA concludes that it has

already provided the means and

reasonable time for processors to

identify and implement available means

to meet the 5-log reduction performance

standard.

M. HACCP Enforcement Issues

(Comment 147) One comment

requested that FDA establish a

preapproval system for HACCP

including plant registration, filing of

HACCP plans, regular inspections,

validation and verification of HACCP

plans with microbial testing and

tracebacks.

FDA believes that a preapproval

system for HACCP plans would unduly

burden the agency’s resources without

substantially increasing public health

benefits. The effectiveness of a HACCP

plan, including monitoring,

recordkeeping, and verification, can best

be evaluated under actual operating

conditions. Therefore, as part of its

enforcement plan for juice HACCP, FDA

plans to do inspections of juice

processing facilities to ensure

compliance with the HACCP regulations

after they become effective. These

inspections will include collection and

analysis of product samples for

pathogens and other contaminants.

The agency is putting juice processors

on notice that FDA is committed to

inspecting all high risk firms annually,

even before the effective date of this

final rule, and intends to include

sample collection and analysis as an

integral part of that process. In the

agency’s view, processors of untreated

juices, including firms producing citrus

juices using surface treatments, fall into

the category of high risk firms.

(Comment 148) One comment stated

that tracebacks are very important and

the need for information relating to

origin of the product was not covered in

the proposed rule.

FDA agrees that tracebacks are

important and believes that the ability

to traceback from a foodborne illness

outbreak to the source is critical to

controlling the size and duration of the

outbreak. The source of an outbreak may

6178 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

be contaminated raw produce or

contamination of product during

production and distribution. Processors

must implement CGMP’s to address raw

produce suitability for processing and, if

there are hazards that are reasonably

likely to occur in raw produce,

implement HACCP controls for such

hazards. The recordkeeping

requirements of this rule mandate that

all records include the identity of the

product and the production code where

appropriate. The purpose of these

requirements is to ensure that records

maintained under part 120 can be

readily linked to a product and to the

timeframe in which the product was

manufactured. Linking a record to a

specific product will be especially

important when a product must be

isolated or recalled. The information

required in § 120.12 will help ensure

that, when tracebacks are necessary,

they can be carried out efficiently.

(Comment 149) One comment

suggested that third party inspections

should be done to validate HACCP and

the results should be publicized.

FDA encourages such self-regulated

programs within industry as third party

inspections. Validation of the HACCP

plan may be done by any individual,

including a third party, that has been

trained in accordance with § 120.13.

The validity of the HACCP plan will

ultimately affect the overall compliance

status of firms, as determined through

the inspection process. This status is

public information.

(Comment 150) One comment

suggested that FDA should model its

HACCP regulation after that of FSIS

with more frequent and less lenient

inspections and validation testing.

Differences in the way FDA and FSIS

implement their HACCP programs are

due to differences in the products being

regulated. Also, FSIS’s authority and

funding provides for the presence of

inspectors in meat and poultry plants on

a daily basis, whereas FDA’s authority

and resources do not require or allow

for such frequent inspections. FDA, to

the extent it is able, will work with juice

processors during inspections to

properly implement part 120.

(Comment 151) A few comments

questioned whether FDA was planning

to ask states to enforce the HACCP

regulations in light of the agency’s

limited resources. Another comment

stated that the States should verify

compliance with any applicable safety

regulations.

FDA cannot mandate that a State

ensure that a firm is complying with

FDA regulations. However, FDA has a

long history of working cooperatively

with the States to enforce food safety

regulations, and the agency hopes to

continue these cooperative relationships

with States in the context of juice

HACCP. FDA notes that some States

adopt FDA requirements as their own

laws and regulations; with those States,

the final rule will effectively be

enforced by the States.

(Comment 152) One comment

requested that first inspections of

HACCP systems be nonregulatory.

The agency recognizes the benefits of

a nonregulatory (i.e., educational) first

inspection of implementation of a new

HACCP system. For the seafood HACCP

program, FDA elected to make the first

inspection educational, rather than

regulatory, as long as there were no

urgent public health problems. FDA

chose that approach because, for most

processors, the first inspection provided

the first direct feedback from the agency

on the status of the firm’s HACCP

system. FDA will consider whether the

same approach is warranted for some or

all juice processors.

(Comment 153) One comment

questioned the type of training that FDA

would be providing its investigators to

ensure that they understand the

relevance of microbial data and that

they will not go on ‘‘witch hunts’’ to

find something wrong with the facility.

FDA’s food processor investigators

have considerable experience with

HACCP in that most are currently

conducting seafood HACCP inspections.

Investigators are trained to look for

violations of FDA regulations and to

employ discretion and good judgment

(e.g., consider the significance of the

violation) in determining how

inspectional findings are handled.

Further, an investigator’s significant

inspectional findings are reviewed by

multiple higher level FDA employees to

confirm the violation prior to the

initiation of any regulatory action by the

agency.

N. Miscellaneous Issues

(Comment 154) One comment

suggested that FDA develop a juice

HACCP pilot program.

FDA currently has a HACCP pilot

program that includes juice processors.

To date, two pasteurized juice

processors and one fresh juice processor

have completed the HACCP pilot

program. FDA has used experience

gained from the participation of these

juice processors in the HACCP pilot

program in proposing and finalizing this

rule (Ref. 73).

(Comment 155) Several comments

stated that FDA should not impose

regulations on industry that will scare

consumers into buying only certain

foods (i.e., pasteurized juices).

It is not the aim of this rulemaking to

scare consumers into buying only

certain foods, such as pasteurized

juices. However, juices have been the

source of a number of outbreaks of

illness and the death of one child, as

well as have contributed to the death of

an elderly man. Juices have also been

the source of chemical and physical

contaminants that have adverse public

health effects, such as high lead levels,

the presence of patulin, and the

presence of glass pieces. For these

reasons, the agency has determined that

measures are necessary to ensure that

juice is safe and to prevent additional

illnesses and deaths, particularly among

at risk groups. The primary purpose of

this rulemaking is to protect the public,

not scare them. FDA believes that these

measures will promote public

confidence in the safety of juice

products.

IV. Effective Date

FDA proposed that any final rule

based on the proposal become effective

1 year after its date of publication in the

Federal Register. Further, FDA

proposed that any final rule based on

the proposal would not be binding on

small businesses as defined in

§ 120.1(b)(1) until 2 years after

publication in the Federal Register; and

for very small businesses as defined in

§ 120.1(b)(2), the final rule would not be

binding until 3 years after publication in

the Federal Register.

(Comment 156) Many comments

expressed concern that small businesses

have the longest time to comply with

the rules, even though outbreak data

indicate that these producers are most

likely responsible for producing

contaminated juice.

The agency considered, in the HACCP

proposal, the various issues surrounding

the need for processors to immediately

implement HACCP programs and the

need to consider options to minimize

the burden of the cost of

implementation to small businesses (63

FR 20450 at 20463) (Ref. 2). To address

the most immediate concerns (i.e.,

pathogens) with juice, FDA has since

finalized the warning label statement

regulation in § 101.17(g) and has

engaged in extensive education to alert

consumers to the problems of

consuming untreated juice. All juice

shipped in interstate commerce or made

from ingredients shipped in interstate

commerce, including that produced by

small businesses, that has not been

processed to achieve a 5-log reduction

in pathogens must be labeled with a

warning for consumers (§ 101.17(g)).

Thus, even if not produced under a

HACCP system, the products of these

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6179

small businesses will have some

safeguards to protect public health. In

addition to the label warning

requirement, FDA encourages

processors to implement a HACCP

system as soon as possible to reduce

hazards in juice rather than use the

warning label statement. Consequently,

the agency has decided to focus initial

implementation of HACCP on

processors that produce the largest

quantity of juice and thus have the

potential of affecting the largest number

of consumers should contaminated

product reach the marketplace.

(Comment 157) Several comments

requested that the regulations become

effective for all processors 1 year after

the rule is finalized and several

comments requested that the regulations

become effective for all processors 2

years after the rule is finalized.

The agency disagrees with the

comments. As noted, FDA considered

various options for the implementation

of the effective date in the proposed

rule. The final rule requires that the

bulk of juice produced in the United

States will be processed under a HACCP

system within 1 year. The agency

realizes that it may take longer for small

and very small businesses to fully

implement HACCP systems and has

extended the effective date for one or 2

years, respectively, to give them

adequate time to comply.

V. Final Regulatory Impact Analysis

A. Introduction

FDA has examined the impact of this

final rule under Executive Order 12866.

Executive Order 12866 directs Federal

agencies to assess the benefits and costs

of available regulatory alternatives and,

when regulation is necessary, to select

regulatory approaches that maximize

net benefits (including potential

economic, environmental, public health

and safety effects; distributive impacts;

and equity). Under the Executive Order,

a regulatory action is ‘‘significant’’ if it

meets any one of a number of specified

conditions, including having an annual

effect on the economy of $100 million;

adversely affecting some sector of the

economy in a material way; or adversely

affecting competition or jobs. A

regulation is also considered a

significant regulatory action if it raises

novel legal or policy issues. FDA finds

that this final rule is a significant

regulatory action as defined by

Executive Order 12866.

The Small Business Regulatory

Enforcement Fairness Act of 1996

(Public Law 104–121) defines a major

rule for the purpose of congressional

review as having caused or being likely

to cause one or more of the following:

an annual effect on the economy of $100

million; a major increase in costs or

prices; significant effects on

competition, employment, productivity,

or innovation; or significant effects on

the ability of United States-based

enterprises to compete with foreignbased enterprises in domestic or export

markets. In accordance with the Small

Business Regulatory Enforcement

Fairness Act, OMB has determined that

this final rule is a major rule for the

purpose of congressional review.

In addition, FDA has determined that

this rule is not a significant rule under

the Unfunded Mandates Reform Act of

1995 (UMRA) requiring benefit-cost and

other analyses. Under UMRA a

significant rule is defined as ‘‘a Federal

mandate that may result in the

expenditure by State, local and tribal

governments in the aggregate, or by the

private sector, of $100,000,000 (adjusted

annually for inflation) in any 1 year’’.

This Final Regulatory Impact Analysis

reflects changes made in the regulation

from the proposed rule to the final rule

and changes in estimates as a response

to comments. It also includes responses

to comments on the PRIA. Where there

were no changes in the estimates

provided in the PRIA, the estimates are

summarized here. Interested persons are

directed to the text of the PRIA (Ref. 6)

for a fuller explanation of the estimates

over which there was no controversy or

changes. The PRIA discussed a number

of regulatory alternatives. FDA received

some comments on these alternatives,

however, none were specifically

economic in nature. Thus, FDA’s

responses to comments on these

alternatives are given in section III.1.

There were no specific economic

comments on the regulatory alternatives

outlined in the PRIA.

B. Factors Considered in Developing

This Analysis

This final rule requires all juice

processors (as defined in the rule),

regardless of size, to implement a

HACCP program with a 5-log reduction

(that is, a 100,000-fold reduction in

pathogens) performance criterion. In the

proposed rule, FDA tentatively

exempted retailers. In addition, FDA

tentatively decided to exempt as

retailers very small businesses that

make juice on their premises and whose

total sales of juice and juice products do

not exceed 40,000 gallons per year and

who sell directly to consumers and

other retailers. Based on the comments

and other information, FDA has

determined that it is necessary to cover

such very small businesses. The

estimated benefits and costs for this

final rule reflect this change in the

coverage of the rule.

Table 1 gives the time to the effective

dates by size of firm in terms of time

from the date of publication of this final

rule.

TABLE 1.—TIME TO EFFECTIVE DATE

BY SIZE OF FIRM

Firm size

Time to

effective

date

Large firms ............................ 12 months.

Small firms ............................ 24 months.

Very small firms .................... 36 months.

For purposes of this rule, the agency

is defining large processors as those

who have more than 500 employees,

small processors as those who have less

than 500 employees and very small

processors as those who have: (1) Total

annual sales of less than $500,000, or (2)

that have total annual sales of greater

than $500,000 but total annual food

sales of less than $50,000, or (3) that

employ fewer than 100 full-time

equivalent employees and annually sell

less than 100,000 units of the juice in

the United States.

This rule follows the implementation

of the juice labeling rule, which covers

juice that is packaged and has not been

subjected to a 5-log reduction treatment.

Because the coverage of the juice

labeling rule and this juice HACCP rule

overlap, and because to some extent

both rules address microbial hazards

associated with juice, it is necessary to

take into account the benefits and costs

estimated for juice labeling to avoid

double-counting benefits and costs for

juice HACCP.

C. Benefits

This analysis provides estimated

benefits due to reduced adverse health

effects. Presented here is a summary of

the analysis provided for the proposed

rule. Comments are addressed, and any

changes from the analysis for the

proposed rule are detailed in each

section as appropriate.

FDA uses the following steps to

estimate health benefits:

1. The most significant hazards in

juice are described in terms of severity

and duration;

2. The hazards are described in terms

of resulting health effects and symptoms

when they cause illness;

3. The health effects and symptoms

are translated into consumer utility

losses;

4. The utility losses are translated into

values in terms of lost dollars (this gives

the cost per case for every combination

6180 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

of level of severity and for the specified

duration for each hazard);

5. The average annual number of

reported cases associated with juice

covered by this final rule are listed;

6. The factors used to account for

under reporting of foodborne illness are

explained;

7. The estimates of the average annual

number of cases are given;

8. The estimated number of cases is

divided according to level of severity;

9. The percentages of each type of

hazard expected to be prevented by the

proposal are listed; and

10. The total health benefits of the

proposal are derived by multiplying

steps 4, 7, and 8.

That is, TB = RC x CF x CR x V, where

TB = total health benefits in dollars,

RC = number of reported cases,

CF = under reporting correction factor,

CR = percent of cases reduced,

V = dollar value per case averted

(medical costs + value of pain and

lost function).

One comment stated that FDA had

underestimated the amount of untreated

juice consumed and, therefore, had

underestimated the number of cases of

illness associated with juice. FDA

disagrees that the cases of illness

addressed by the rule have been

underestimated due to incorrect

consumption estimates. FDA did not

estimate the number of illnesses based

on consumption. Instead, the agency

estimated the number of illnesses by

multiplying confirmed illnesses

associated with juice by factors

accounting for under-reporting of

foodborne illness. Thus, FDA does not

agree with this comment.

One comment questioned the model

used to calculate benefits and asked if

it has been ‘‘calibrated.’’ The comment

did not explain how the word calibrated

is used in this case. FDA assumed that

it meant to compare the estimates

obtained using this model with the

actual number of illnesses related to

juice. FDA has used this model to

calculate benefits for rules involving

microbial hazards since 1994. The

model is an adaptation of peer-reviewed

research on estimating the costs of

illness and injury (Ref. 74). The model

is the best method known to FDA for

estimating the benefits of rules

involving microbial hazards, and is

similar to that used by FSIS for similar

rules. Because the actual number of

cases of illness is not observable, it is

not possible to compare the model’s

estimates to the actual number of

illnesses.

1. Description of Microbial Hazards in

Juice

The most significant health risks

associated with juice products are those

that result from microbial

contamination. There are other nonmicrobial potential hazards related to

juice that this rule is designed to

control. FDA does not have enough data

to quantify benefits for these nonmicrobial hazards. From 1992 to 1998

the hazards associated with

commercially processed, packaged juice

produced by nonretail establishments

included Bacillus cereus,

Cryptosporidium parvum, E. coli

O157:H7, and Salmonella non typhi.

Most of the information in section C of

this document (Benefits) is taken from

‘‘Appendix: Preliminary Investigation

into the Morbidity and Mortality

Associated with the Consumption of

Fruit and Vegetable Juices’’ (Ref. 6, the

Appendix). The Appendix includes

hazards other than those for which

benefits have been estimated in this

analysis. The hazards considered in

section C of this document are those for

which the risk is highest, meaning that

they are the most significant in terms of

probability of occurrence and/or

severity of outcome.

Some comments stated that C. parvum

should have been included in the

estimate of benefits for the HACCP

proposal. The comments cite FDA’s

inclusion of C. parvum in the list of

hazards in the Appendix. FDA included

C. parvum as a hazard addressed by the

labeling rule but not as a hazard

addressed by the proposed HACCP rule.

The only documented cases of juicerelated C. parvum illnesses from

commercially produced products from

1992 to 1996 were from juice produced

by processors making less than 40,000

gallons per year. Because these

processors were included under the

retail exemption from the proposed

HACCP rule, the proposed HACCP rule

would not have addressed the C.

parvum hazard. Because this final

HACCP rule covers all processors

regardless of the volume of juice they

produce, C. parvum is a hazard

addressed by this final rule.

2. Description of Health Effects and

Symptoms of Microbial Hazards in Juice

In order to quantify the loss

(disutility) that individuals experience

from becoming ill, the pain, suffering,

and mobility loss must be scaled.

Individuals who become ill suffer losses

of functional status in terms of mobility,

ability to do other physical activity, and

ability to engage in social activities.

Individuals who become ill also

experience additional losses from the

symptoms of the illness.

One comment stated that symptoms

and functional effects associated with

some cases are more severe than those

described by FDA. FDA agrees with this

comment. However, it is equally true

that symptoms and functional effects

associated with some cases are less

severe than those described by FDA.

The symptoms and functional effects

described by FDA were developed with

the assistance of medical doctors at FDA

and are those of a typical case for each

level of severity for each hazard. Effects

vary to a considerable degree across

cases of any illness or disease. Such

variance is not captured by this

analysis. However, FDA believes that

the use of typical cases is appropriate

for this analysis.

3. Utility Losses From Microbial

Hazards in Juice

Decreases in functional status and

symptoms and problems associated with

illness translate into values of disutility.

Utility losses for survivors are derived

by multiplying the total disutility per

day by the number of days that

symptoms of the illness persists. This

gives the utility loss for survivors in

terms of the number of quality adjusted

life days (QALD’s) for each case of the

categories of severity for each hazard. A

QALD is a day of perfect health.

4. Value of Losses From Microbial

Hazards in Juice

FDA values a QALD at $630. The

value of utility losses for survivors

comes from multiplying the number of

QALD’s lost due to the illness by the

value of a QALD. This represents the

value of pain and function losses that

individuals experience. Additionally,

there are the societal costs of medical

treatment. These costs are shared

generally between insurance companies

and individuals. They include all

aspects of medical expenses (e.g.,

physician visits, laboratory tests,

prescriptions and therapies, hospital

stays). The value of losses per case is the

sum of the value of utility losses for

survivors and the medical costs for the

categories of severity for each hazard.

5. Distribution of the Reported Cases per

Year for Microbial Hazards in Juice

The analysis for the proposed rule

used the average number of reported

cases from 1992 through 1996 for each

hazard for the types of products covered

by the rule.

Some comments claimed that FDA

had miscalculated the benefits of the

HACCP proposal by including outbreaks

associated with non-commercially

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6181

produced juice. Although other parts of

the proposed rule and the Appendix

refer to outbreaks associated with noncommercially produced juice, the

estimate of the benefits of the HACCP

rule was based only on outbreaks

associated with commercially produced

juice.

Some comments stated that FDA had

miscalculated the average number of

cases per year. These comments used

data presented in the Appendix to

recalculate the average number of cases

per year. The comments were confused

because the Appendix lists several

outbreaks that were associated with

non-commercially produced juice.

Because this regulation covers only

commercially produced juice, outbreaks

associated with non-commercially

produced juice were not included in the

calculation of the average annual

number of cases. Thus, the average

annual number of cases was properly

calculated.

Tables 2 and 3 should clarify which

outbreaks FDA has used in this analysis,

and why some outbreaks were not used.

TABLE 2.—JUICE OUTBREAKS (1992 TO 2000) USED TO CALCULATE BENEFITS

Product and year of event Hazard Number

of cases Source of data on event

Orange juice, 1994 ........................................................................ B. cereus .................................. 85 FDA recall data.

Orange juice, 1995 ........................................................................ Salmonella spp. ........................ 62 Outbreak data.

Apple juice, 1996 .......................................................................... E. coli O157:H7 ........................ 70 Outbreak data.

Apple juice, 1996 .......................................................................... E. coli O157:H7 ........................ 14 Outbreak data.

Apple juice, 1996 .......................................................................... C. parvum ................................. 31 Outbreak data.

Apple juice, 1996 .......................................................................... E. coli O157:H7 ........................ 1 Pennsylvania State Health

Dept.

Orange juice, 1999 ........................................................................ Salmonella muenchen .............. 423 Outbreak data.

Apple juice, 1999 .......................................................................... E. coli O157:H7 ........................ 9 Oklahoma State Health Dept.

Orange juice, 2000 ........................................................................ Salmonella enteritidis ............... 88 Outbreak data.

TABLE 3.—JUICE OUTBREAKS (1992 TO 2000) NOT USED TO CALCULATE BENEFITS

Product and year of

event Hazard Number of cases Source of data onevent Reason not included

Orange juice Mixing

Compound, 1992.

Salmonella agona ...... 25 ............................... FDA recall Data ......... Orange Julius compound is mixed with juice

at the retail location but does not contain

juice.

Apple juice, 1993 ....... C. parvum .................. 160 ............................. Outbreak Data ........... Juice not made by commercial establishment.

Juice flavored Drinks,

1993.

C. parvum .................. Unknown .................... FDA recall Data ......... Approved municipal water supply was contaminated, rule not expected to prevent

such occurrences.

Carrot juice, 1993 ...... Clostridium botulinum 1 ................................. Washington State

Health Dept.

Home-made product.

Orange juice, 1993 .... Unknown .................... 23 ............................... Ohio State Health

Dept.

Contamination likely caused by consumer.

Watermelon Juice,

1993.

S. spp. ........................ 18 ............................... Florida State Health

Dept.

Home-made product.

Apple juice, 1996 ....... E. coli 157:H7 ............ 6 ................................. Outbreak data ............ Juice not made by Commercial establishment.

Some comments claimed that FDA’s

analysis had not taken into account the

efforts to control hazards made by the

industry after the October 1996

outbreak. To estimate the number of

illnesses that the proposed rule would

prevent, FDA used the most recent 5-

year period for which final CDC

numbers were available. In the analysis

of the proposed rule, FDA did not

include 1997 in the estimate of illnesses

that the rule would prevent because

there was too great of a possibility that

illnesses that had actually occurred had

not yet been reported. FDA can now add

the 1997 to 2000 experience to the 1992

to 1996 experience. By doing so FDA

addresses this comments concern. The

average number of cases reported per

year for each hazard is described in

table 4.

TABLE 4.—AVERAGE REPORTED

CASES PER YEAR FOR MICROBIAL

HAZARDS IN JUICE (1992 TO 2000)

Hazard

Average No. of

cases reported

per year

B. cereus ........................ 2

C. parvum ....................... 3

E. coli O157:H7 .............. 10

Salmonella (non-typhi) .... 64

6. Estimates of Factors Needed To Offset

Underreporting of Foodborne Illness

It is widely recognized that the total

number of foodborne illnesses is much

greater than those numbers reported to

the CDC. In order to compensate for the

rate of underreporting, the number of

known cases associated with a hazard

(i.e., reported to CDC) is multiplied by

factors that are estimated to account for

underreporting.

One comment took issue with the

underreporting correction factors used

by FDA. The comment stated that no

underreporting correction factor should

ever exceed 100. In the analysis

accompanying the proposed rule, FDA

used two estimates of underreporting

correction factors that have been widely

cited on this issue. FDA does not agree

that underreporting correction factors

should never exceed 100. The

appropriate correction factors are those

based on the best information available,

without any limit created by a

predetermined number.

Since the PRIA, CDC has published

estimates of foodborne illness; in this

final estimate of costs and benefits, FDA

6182 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

is relying on these recent CDC estimates.

The estimates of underreporting

correction factors used in the PRIA

relied heavily on research that was over

20 years old. In some cases, the research

preceded the recognition that E. coli

O157:H7 was a pathogen. The correction

factors based on this research required

a significant amount of adaptation,

extrapolation and interpolation by FDA.

By relying on the recent CDC estimates

of foodborne illness to determine

correction factors, FDA is reducing its

reliance on dated research and its own

extrapolations. FDA believes that the

estimates of benefits based on CDC

estimates of foodborne illness should be

more objective.

The underreporting correctiion factors

calculated from the CDC reported by

Mead et al, show the relationship

between estimated total cases and

culture-confirmed total cases. The

factors are based on surveys estimating

the probability that: (1) A person who

becomes ill seeks medical care, and (2)

the probability that the physician will

obtain a stool culture from the person,

and (3) the probability that the

laboratory will test for the pathogen.

The factor for a particular pathogen is

the inverse of the multiplicative product

of those three probabilities. FDA is

relying on the CDC point estimates of

the average number of cases per year

and the CDC underreporting factor.

Because CDC did not provide ranges for

these estimates, FDA has insufficient

information to probide a range of

estimates for the benefits of this rule.

FDA’s use of a point estimate for the

number of illnesses should not,

however, be interpreted as implying the

absence of uncertainty about these

estimates.

For two of the hazards in this

analysis, E. coli O157:H7 and

Salmonella, FDA has used correction

factors based on the ratio of total

estimated cases to active surveillance

cases estimated. FDA has used these

factors for these hazards because the

juice outbreaks for these hazards

associated with this rule were

discovered through the active

surveillance of the FoodNet system. The

FoodNet system is designed to identify

interstate outbreaks and to more

thoroughly discover cases associated

with an outbreak.

For B. cereus FDA has used a

correction factor based on the ratio of

total estimated cases to reported

outbreak cases. FDA has used this factor

for this hazard because the juice

outbreaks for this hazard associated

with this rule were discovered through

the standard outbreak reporting process.

B. cereus is not a hazard tested for in the

FoodNet system, and because of its mild

symptoms is very likely to be

underreported.

For C. parvum FDA has used a

correction factor based on the ratio of

total estimated cases to 10 percent of the

estimated passive surveillance cases.

According to CDC, reported outbreak

cases account for only 10 percent of the

cases accounted for through passive

surveillance. FDA has used this factor

for C. parvum because the juice

outbreaks for this hazard associated

with this rule were discovered through

the standard passive surveillance

process. C. parvum is not a hazard

tested for in the FoodNet system, nor is

it on the list of hazards reportable to

CDC. Because of its mild symptoms it is

very likely to be underreported.

The correction factors used in this

analysis are given in table 5.

TABLE 5.—ESTIMATES OF FACTORS

NEEDED TO OFFSET UNDERREPORTING OF FOODBORNE ILLNESS

Hazard Correction factor

B. cereus ........................ 380

C. parvum ....................... 1,071

E. coli O157:H7 .............. 20

Salmonella (non-typhi) .... 38

7. Estimates of Juice-Associated Cases

Per Year

In table 6, FDA has estimated ranges

of the likely annual number of cases that

occur for each of the four pathogens

studied.

TABLE 6.—ESTIMATE OF JUICE-ASSOCIATED CASES COVERED PER YEAR

Hazard Case

B. cereus ........................ 3,420

C. parvum ....................... 3,210

E. coli O157:H7 .............. 200

Salmonella (non-typhi) .... 2,430

8. Estimate of Juice-Associated Cases

per Year Not Prevented by Labeling

Rule

FDA estimated that the juice labeling

rule would prevent up to 140 juiceassociated illnesses (10 C. parvum, 40 E.

coli, 90 Salmonella) as consumers avoid

consumption of untreated juice. This

HACCP rule will effectively supersede

the labeling rule for all those processing

establishments covered by the labeling

rule. Therefore, once it goes into effect,

the HACCP rule will be responsible for

prevented juice-related illnesses and not

the labeling rule. However, this analysis

should attribute to the juice HACCP rule

prevention of only those illnesses that

would not have been prevented by the

juice labeling rule had this rule not

superseded it. To estimate the potential

benefits of this HACCP final rule, FDA

subtracted 140 cases that were estimated

to be prevented by the labeling rule

(assuming that 16 percent of consumers

read the label and do not consume

untreated juice) from the estimates

provided in table 6. The 16 percent

consumer response estimates are the

largest estimates of consumer response

that FDA has made for the juice labeling

rule. Therefore, subtracting the 16

percent consumer response estimates

from the estimates of the total number

of juice-related illnesses yields the

lowest number of illnesses that may be

prevented by this juice HACCP final

rule. Table 7 gives estimates of the

number of juice-related illnesses per

year not prevented by the juice labeling

rule. The estimates in table 7 come from

subtracting the estimated 140 cases

prevented by the labeling rule from the

estimated cases in table 6.

TABLE 7.—THE ESTIMATED NUMBER OF JUICE-ASSOCIATED CASES NOT PREVENTED BY THE LABELING RULE DIVIDED

ACCORDING TO LEVEL OF SEVERITY

Hazard Severity Percent Cases

Mild .................................................................................. 99 3,390

Moderate ......................................................................... 1 30

Severe ............................................................................. .03 1

B. cereus .......................................................................... Total cases ...................................................................... 100 3,421

Mild .................................................................................. 90 2,890

Moderate ......................................................................... 9 290

Severe ............................................................................. .7 20

Death ............................................................................... .02 1

C. parvum ........................................................................ Total cases ...................................................................... 100 3,200

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6183

TABLE 7.—THE ESTIMATED NUMBER OF JUICE-ASSOCIATED CASES NOT PREVENTED BY THE LABELING RULE DIVIDED

ACCORDING TO LEVEL OF SEVERITY—Continued

Hazard Severity Percent Cases

Mild .................................................................................. 59 95

Moderate ......................................................................... 38 60

Severe-acute ................................................................... 3 5

Severe-chronic ................................................................ 4 10

Death ............................................................................... .0 0

E. coli O157:H7 ............................................................... Total cases ...................................................................... 100 160

Mild .................................................................................. 68 1,590

Moderate ......................................................................... 31 730

Severe ............................................................................. 1 20

ReA-short term ................................................................ 2 50

ReA-long term ................................................................. 5 120

Death ............................................................................... 5 120

Salmonella (non typhi) ..................................................... Total cases ...................................................................... 100 2,340

9. Percent of Cases Preventable by

HACCP Proposal

Table 8 indicates the percent of cases

for each hazard expected to be

prevented by the rule. In general, most

pathogens will be eliminated when a 5-

log treatment is applied. For example, E.

coli O157:H7, C. parvum and

Salmonella should all be completely

eliminated from juice by standard

methods of flash pasteurization (in the

absence of extraordinarily high counts,

detrimental human intervention, or

equipment failure). However, hazards

associated with B. cereus will not

necessarily be eliminated by heat

treatment. This bacterium forms spores

that are more difficult to kill by the

usual heat process applied to juice.

In the proposed rule, FDA tentatively

exempted certain small retail

processors. FDA estimated that the

exemption for small retail processors

would affect 14 percent of the volume

of unpasteurized juice. Therefore, the

agency estimated that though pathogen

controls may be 100 percent effective in

controlling some hazards, such controls

would only prevent 86 percent of the

cases of illness from these hazards,

because of the 14 percent of juice not

covered. The final rule covers all

processors of juice as defined in the

final rule; therefore, controls will affect

the full volume of juice made by

processors. (Retailers are not covered by

this rule. Retailers are those businesses

that sell only direct to consumers and

include grocery stores, supermarkets,

farms, roadside stands, restaurants, and

eating places.)

TABLE 8.—PERCENT OF CASES

PREVENTABLE BY HACCP PROPOSAL

Hazard

Percent of cases

preventable by

HAACP proposal

B. cereus ........................ 10

C. parvum ....................... 100

E. coli O157:H7 .............. 100

Salmonella (non typhi) .... 100

Table 9 indicates the number of cases

for each hazard expected to be

prevented by the rule.

TABLE 9.—ESTIMATES OF JUICE-ASSOCIATED CASES PER YEAR PREVENTED BY HACCP RULE

Hazard Severity Percent of

cases Cases

Mild .................................................................................. 99 340

Moderate ......................................................................... 1 0

Severe ............................................................................. .3 0

B. cereus .......................................................................... Total case ........................................................................ 100 340

Mild .................................................................................. 90 2,890

Moderate ......................................................................... 9 290

Severe ............................................................................. 7 20

Death ............................................................................... .02 1

C. parvum ........................................................................ Total cases ...................................................................... 100 3,200

Mild .................................................................................. 59 95

Moderate ......................................................................... 38 60

Severe-acute ................................................................... 3 5

Severe-chronic ................................................................ 4 10

Death ............................................................................... .08 0

E. coli O157:H7 ............................................................... Total cases ...................................................................... 100 160

Mild .................................................................................. 68 1,590

Moderate ......................................................................... 31 730

Severe ............................................................................. 1 20

ReA–short term ............................................................... 2 50

ReA–long term ................................................................ 5 120

Death ............................................................................... .04 1

Salmonella (non typhi) ..................................................... Total cases ...................................................................... 100 2,340

6184 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

10. Estimates of Annual Benefits for

HACCP Proposal

The total benefits for the categories of

severity for each hazard are derived by

multiplying the number of cases

prevented by this rule by the estimates

of the value of utility losses and medical

costs per case. The sum of those benefits

for each hazard is the total benefits of

this rule for pathogen control. Table 10

gives the estimate of benefits for each

hazard.

TABLE 10.—ESTIMATES OF JUICEASSOCIATED CASES PER YEAR PREVENTABLE BY HACCP RULE

Hazard Severity Dollars

Mild .............. $102,000

B. cereus ...... Total ............. 102,000

Mild .............. 5,780,000

Moderate ...... 1,450,000

Severe ......... 360,000

Death ........... 5,000,000

C. parvum .... Total ............. 12,590,000

Mild .............. 190,000

Moderate ...... 240,000

Severe-acute 165,000

Severechronic.12,210,000

E. coli

O157:H7.

Total ............. 12,805,000

Mild .............. 1,590,000

Moderate ...... 1,460,000

Severe ......... 320,000

ReA-short

term.

350,000

ReA-long

term.

117,120,000

Death ........... 5,000,000

Salmonella

(non typhi).

Total ............. $125,840,000

Table 11 presents the estimate of

annual benefits based on table 10.

TABLE 11.—ESTIMATES OF ANNUAL

MICROBIALLY RELATED BENEFITS

FOR HACCP PROPOSAL

Hazard Dollars

B. cereus ........................ $102,000

C. parvum ....................... 12,590,000

E. coli O157:H7 .............. 12,805,000

Salmonella (non typhi) .... $125,840,000

Total ............................ 151,000,000

11. Pesticide Residues

There are two potential benefits

associated with the regulation of

pesticides: (1) Decreases in cancer and

other illness caused by chronic

consumption of pesticide residues and,

(2) social benefits associated with

reductions in the costs of recapturing

firm goodwill. FDA cannot quantify the

cost savings that will occur because of

more vigilant monitoring of pesticide

residues by firms under a HACCP rule.

12. Summary of Benefits

Table 12 summarizes the benefits of

this rule.

TABLE 12.—BENEFITS OF JUICE

HACCP RULE

Type of benefit Annual value

Reduced illness and

death from Controlling pathogens.

$151 million.

Reduced harm from

physical and chemical hazards.

Not quantified, effects

often long-term and

probably small.

Total Quantified Benefits.$151 million

D. Costs

The costs of these rules have been

estimated by multiplying the costs for

each proposed requirement on a perplant basis by the number of plants

affected by each requirement. Cost per

plant will vary by current practice,

product, and size.

1. Coverage

In the proposal, FDA tentatively

decided that retailers would include

processors that are very small

businesses, that make juice on their

premises, and that directly sell juice or

juice products to consumers and other

retailers—provided that retail sales of

juice and juice products do not exceed

40,000 gallons per year. As noted, FDA

has decided in the final rule not to

exclude such processors from the rule’s

requirements. The final rule covers all

processors of juice except those who are

retailers. Retailers are those businesses

that sell only direct to consumers and

include grocery stores, supermarkets,

farms, roadside stands, restaurants, and

other eating places.

Since FDA published the proposed

rule, it collected data showing that 24

percent of very small apple juice

processors only sell juice direct to

consumers. FDA assumes that the same

percentage of very small orange juice

processors only sell juice direct to

consumers. Therefore, about 380 very

small apple and 70 very small orange

juice processors are exempted from the

rule as retailers.

FDA estimated that 5 percent (about

50 plants) of the 900 plants in the FDA

Official Establishment Inventory (OEI)

would have implemented HACCP as

required by this rule by the effective

date of the rule even if FDA had not

done this rulemaking. No HACCP costs

are attributable to this rule for these

plants.

Table 13 shows the estimated number

of establishments affected by the rule.

These numbers exclude the retailers and

the 5 percent of plants already doing

HACCP.

TABLE 13.—NUMBER OF PLANTS

AFFECTED BY THE RULE

Plant type

Number of

establishments

affected

Juice manufacturers in

the OEI ........................ 850

Very small apple juice

makers ........................ 1,220

Very small orange juice

makers ........................ 230

Total ............................ 2,300

2. Length of Production Period

The agency has assumed that 50

percent of the 850 plants in the OEI plus

all of the 1,450 very small juice makers

affected by the HACCP rule produce

seasonally. Table 14 shows the length of

the production period for plants

producing seasonally and year round.

TABLE 14.—PLANTS’ PRODUCTION PERIOD

Weeks of

operation

per year

Hours of

operation

per day

Number of

plants

Seasonal .................................................................................................................................................. 16 12 1,875

Year Round .............................................................................................................................................. 52 24 425

Total ..................................................................................................................................................... 2,300

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6185

3. Cost Estimates by Requirement

a. HACCP costs.

i. CGMP’s (§ 120.5)

ii. Prerequisite Program SOP’s (§ 120.6)

iii. Hazard Analysis (§ 120.7)

iv. HACCP Plan (§ 120.8)

v. Corrective Actions (§ 120.10)

vi. Verification and Validation

(§ 120.11)

vii. Process Verification for Certain

Citrus Processors(§ 120.25)

viii. HACCP Records (§ 120.12)

ix. Training (§ 120.13)

x. Imports and Foreign Processors

(§ 120.14)

b. Summary of Costs.

c. Take First Year and Recurring Cost

Per Activity.

a. HACCP costs.—i. CGMP’s (§ 120.5).

No costs are attributed to this section for

this rulemaking. In 1996, only 6 percent

of the plants inspected were cited for

official action. Thus, an overwhelming

majority of firms are complying with

part 110. Therefore, there is no

additional cost of complying with this

provision because plants are already

complying with part 110. Therefore,

FDA assumed that this rule will have no

effect on the enforcement of the CGMP’s

for juice products.

ii. Prerequisite program SOP’s

(§ 120.6).—Developing SOP’s. The cost

per plant of developing SOP’s is

approximately $260. If one half of the

850 domestic plants in the OEI and all

of the 1,450 very small juice processors

do not currently have SOP’s, then they

will have to develop them to comply

with this regulation. Under these

assumptions, the total cost for the

industry to develop SOP’s is

approximately $488,000 ($260 x 1,875

plants).

Implementing sanitation controls with

corrections of deviations from SOP’s.

Based on information from inspection

reports, FDA assumes that about 30

percent of all 2,300 covered juice plants

(about 690 plants) are likely to have

sanitation controls that are

insufficiently implemented, but which

do not warrant administrative or

regulatory action. If it costs each of

these 690 plants $500 to implement

sanitation controls and to correct

deviations from SOP’s earlier than they

would do otherwise, then the total cost

for this requirement is $345,000.

Because this cost is discounted, it is

added as a one-time expenditure in the

total costs.

Monitoring and documenting of

SOP’s. Table 15 shows the distribution

of per plant and total industry costs

based on the estimate in table 25 for

SOP monitoring and documenting

needed to comply with this rule.

TABLE 15.—TOTAL ANNUAL COST OF SOP MONITORING AND DOCUMENTING

Annual per

plant SOP

monitoring and

documenting

cost

Number of

plants

Annual SOP

monitoring and

documenting

cost

Seasonal ...................................................................................................................................... $100 1,662 $166,000

Year round ................................................................................................................................... 340 213 72,000

Totals .................................................................................................................................... 1,875 238,000

iii. Hazard analysis (§ 120.7). FDA

estimates that performing a hazard

analysis takes 20 labor hours. At $13 per

labor hour the cost of performing a

hazard analysis is about $250 per plant.

Approximately 2,300 plants will need to

perform a hazard analysis to comply

with this rule. Therefore, the total cost

to perform a hazard analysis is

approximately $575,000.

iv. HACCP plan (§ 120.8)—HACCP

plan development. FDA estimates that

developing a HACCP plan takes 60 labor

hours. At $13 per labor hour the cost of

developing a HACCP plan is about $750

per plant. Only those plants that

determine from their hazard analysis

that they have hazards that are

reasonably likely to occur will have to

develop a HACCP plan.

Processors that produce shelf-stable or

juice concentrate may conclude after

their hazard analysis that they need not

include pathogen control in any HACCP

plan as required by § 120.24(a), if they

include a copy of the thermal process in

their written hazard analysis. These

processors only need a HACCP plan if

they have other hazards that are

reasonably likely to occur.

Table 16 shows those processors

expected to develop HACCP plans.

Adding the categories of processors

that develop HACCP plans yields a total

of about 1,560 out of the original 2,300

processors that perform a hazard

analysis. This may be a small

overestimate because some of the citrus

processors that now do not make selfstable products may begin to do so

because of this rule. It also may be a

small overestimate because of the small

potential for overlap among the

categories.

TABLE 16.—NUMBER OF PLANTS WITH

HACCP PLANS

Processors with pathogen Hazards 1,460

Processors with natural toxin Hazards ............................................... 20

Processors with pesticide Hazards .. 80

Total processors with HACCP

Plans ...................................... 1,560

Approximately 1,560 plants will need

to develop a HACCP plan at a cost of

$750 each to comply with this rule.

Therefore, the total cost to develop

HACCP plans is approximately

$1,170,000.

Pathogen controls. In response to this

rule, many processors that are not now

heat-treating their products are likely to

begin doing so. Processors may choose

any lawful means to achieve the

required 5-log reduction. However, costs

here are estimated for pasteurization as

the lowest-cost technology now

available.

In the PRIA FDA estimated that costs

for initiating pasteurization range from

$18,000 for a very small seasonal

operation to $35,000 for a larger year

round operation. FDA received many

comments claiming that the initial cost

for initiating pasteurization was $30,000

even for a small operation. Because of

the number of comments claiming that

the initiation of pasteurization would

cost $30,000 for a small operation, FDA

has used a range for its estimate of the

cost of initiating pasteurization for very

small processors.

Of the 2,300 processors covered by

the HACCP rule only a portion of these

will need to initiate pasteurization. In

this final rule, processors of shelf-stable

juice and juice concentrate will not

need to incur additional costs for the

control of pathogens. FDA estimates that

this new provision in the final rule

applies to about 600 processors (70

percent of the processors listed in the

OEI) affected by this rule.

6186 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

FDA estimates that all but 20 of the

rest of the affected processors listed in

the OEI (230 plants) and 30 percent of

the 1,220 very small apple juice

processors (370 plants) are already

operating pasteurization equipment.

Therefore, 600 plants do not need to

implement additional pathogen

controls.

For the purpose of this analysis, FDA

has concluded that it is unlikely that

fresh orange juice processors will have

to pasteurize their products to achieve

a 5-log reduction when a HACCP

program is adopted because of the

nature of the fruits, the availability of

effective surface treatments and the

methods of juice extraction commonly

used by industry. However, given the

information gained from the December

1999 NACMCF meeting on citrus juice

and the several recent outbreaks

associated with fresh citrus juice, it is

clear that most fresh orange processors

will need to incur additional costs to

implement effective 5-log pathogen

reduction controls. In the PRIA, FDA

estimated that costs for these processors

were limited to the costs of creating and

operating a HACCP system with

appropriate monitoring and

recordkeeping of the necessary CCP’s,

not to purchasing pasteurizing

equipment. In this final analysis, FDA is

estimating costs for fresh orange juice

processors to improve pathogen

controls. Although the measures to

improve such controls will not

necessarily be pasteurization, FDA is

estimating these costs to be equivalent

to the costs for initiating pasteurization.

FDA only has cost data for

pasteurization which is also the only

widely-adopted commerical technology

for controlling pathogens in juice. Citrus

processors may choose to adopt a

technology more expensive that the

$18,000 to $30,000 estimated here for

the implementation of pasteurization.

However, the more expensive

technologies would likely be adopted

for reasons other than compliance with

this rule.

Therefore, 20 affected processors

listed in the OEI, 300 very small citrus

processors and 850 very small apple

juice processors (a total of 1,170 plants)

will incur costs to implement additional

pathogen controls. Table 17 shows the

first year total cost of pathogen control

attributable to the HACCP rule.

TABLE 17.—FIRST YEAR COST OF PATHOGEN CONTROL ATTRIBUTABLE TO HACCP PROPOSAL

Processor type Cost per plant Number of

plants Total

Very small apple juice processors ....................................................................................... $18,000–$30,000 850 $15,300,000–

25,500,000

Very small orange juice processors .................................................................................... 18,000–30,000 300 5,400,000–

9,000,000

Juice processors in the OEI ................................................................................................ 35,000–58,000 20 700,000–

1,160,000

Total .............................................................................................................................. .............................. 1,170 21,400,000–

35,660,000

Pasteurization will require ongoing

costs for operation and maintenance.

FDA estimates these annual costs for

labor, utilities, and materials subsequent

to the first year to be $7,000 per year for

very small processors and $8,000 per

year for processors in the OEI. The total

cost of pathogen control in subsequent

years is given in table 18.

TABLE 18.—SUBSEQUENT YEAR COST OF PATHOGEN CONTROL ATTRIBUTABLE TO HACCP RULE

Processor type Cost per plant Number of

plants Total

Very small apple juice processors ............................................................................................... $7,000 850 $5,950,000

Very small orange juice Processors ............................................................................................ 7,000 300 2,100,000

Juice processors in the OEI ........................................................................................................ 8,000 20 160,000

Total ...................................................................................................................................... ........................ 1,170 8,210,000

Other costs are related to processing

for pathogen control. The pasteurization

of juice causes changes in the

characteristics of the products,

primarily in terms of texture and taste.

Some current consumers of nonheattreated juice will bear the costs of losing

a particular product as well as costs of

searching for products with the

characteristics that they prefer. Thus,

one cost of these regulations is the

limited loss of ‘‘fresh’’ juice: that is,

juice that is not heat (or otherwise)

processed.

Some consumer comments indicated

a strong preference for fresh juice;

however, although FDA expressly asked

for comments on this issue in its

November 1999 notice, no comments

suggested any means of estimating this

cost. FDA has no information on how

readily consumers will accept

pasteurized juice in the place of fresh

juice nor does FDA have any other

information that could be used to

estimate that cost.

Glass and direct food additive HACCP

controls. FDA has not attributed any

costs for control of glass or unapproved

direct food additives although these

potential hazards are among those that

are likely to be relevant for juice. The

agency believes that even if broken glass

is determined to be a hazard to

processors packing juice in glass, these

processors are already currently

implementing every feasible control for

this potential hazard in order to limit

their liability and to provide consumer

protection. Additionally, although

approximately 25 percent of the

processing plants pack juice in glass

containers, this number is diminishing

rapidly for economic and safety reasons.

Regarding food additives, many juice

products contain food or color additives

for the purpose of coloring or extending

product shelf life. However the agency

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6187

believes that even if unapproved food

additives are determined to be a hazard,

these processors using direct food

additives in juice are already currently

implementing sufficient controls for

these potential hazards as FDA strictly

regulates them.

Natural toxin controls. FDA believes

that in most every case processors of

domestic apples should be able to

control natural toxin hazards such as

patulin, by processing controls such as

washing and culling. This can be

accomplished at no additional cost.

Processors using imported juice

concentrate are likely to need to initiate

a sampling regime for natural toxins.

FDA assumes that the 23 large plants

will randomly sample 30 shipments per

year at a cost of $150 per sample. The

total marginal cost of patulin testing is

approximately $104,000 (30 tests x

$150/test x 23 firms). Costs per plant are

$4,500. If any lots are found positive,

costs will be incurred for taking

corrective action.

Pesticide controls. FDA believes that

all 175 affected plants operated by large

firms are currently doing a sufficient

amount of sampling and monitoring (or

receiving supplier certificates) for

pesticides residues. Therefore, FDA

assumed that there are no additional

costs for large firms to control this

potential hazard. This does not mean

that FDA believes that no large firms

will identify pesticides as a hazard that

needs to be controlled under HACCP.

Large and small firms are more likely

than very small firms to use imported

produce, which may not be subjected to

as strict controls as U.S. produce in all

cases. FDA believes that 10 percent of

all large and small firms (80 plants total)

will determine that pesticide hazards

are reasonably likely to occur. However,

FDA believes that all large firms are

already sufficiently addressing this

issue with present expenditures. FDA

made this estimate based on its

knowledge of the magnitude of the

pesticide problem in juice.

If processors determine that pesticide

residues are hazards for their product,

then they must run pesticide residue

tests to ensure that there are no

pesticides either over tolerance or used

on products for which there is no

tolerance. FDA believes that 10 percent

of the shipments received by small

processors must be covered by a

sampling plan. Sixty-five small plants

are believed to cover their shipments

with a pesticide-sampling plan. Average

cost per plant is estimated to be $1,500.

The total annual marginal cost of

pesticide testing is approximately

$98,000 (10 tests x $150/test x 65 firms).

v. Corrective actions (§ 120.10).—

Corrective action plan. The

development of a corrective action plan

for juice products is less expensive than

revalidation after each deviation from a

CL. FDA estimates that a corrective

action plan for juice products can be

developed in 4 hours with a cost per

plant of approximately $50 (about 4

hours of management time).

All of the plants that develop HACCP

plans as a result of this rule will

develop corrective action plans to

comply with this rule. The total cost for

1,560 plants at $50 each to develop

corrective action plans is approximately

$78,000.

Corrective actions. Plants operating

under HACCP plans will take corrective

actions when CL’s are exceeded for

hazards such as pesticide residues,

unacceptable fruit for pathogen controls,

and presence of natural toxins. Costs of

corrective actions are expected to

decline as processors gain more

experience under a HACCP system and

as the number of corrective actions

decreases. Tables 19 and 20 show the

estimated first year and subsequent year

costs of corrective actions per plant.

TABLE 19.—COST OF FIRST YEAR CORRECTIVE ACTIONS

Plant type Cost per plant Number of

plants Total cost

Seasonal ...................................................................................................................................... $450 1,490 $671,000

Year round ................................................................................................................................... 1,460 70 102,000

Totals .................................................................................................................................... 1,560 773,000

TABLE 20.—COST OF SUBSEQUENT YEAR CORRECTIVE ACTIONS

Plant type Cost per plant Number of

plants Total cost

Seasonal ...................................................................................................................................... $110 1,490 $164,000

Year round ................................................................................................................................... 340 70 24,000

Totals .................................................................................................................................... 1,560 188,000

Verification and validation (§ 120.11).—Verification. The record verification cost per plant per production cycle is

given in table 21.

TABLE 21.—COST OF RECORD VERIFICATION

Plant type Cost per plant Number of

plants Total cost

Seasonal ...................................................................................................................................... $420 1,490 $626,000

Year Round .................................................................................................................................. 1,350 70 95,000

Totals .................................................................................................................................... ........................ 1,560 721,000

Validation. Processors with HACCP

plans must validate their HACCP plans

during the first year after

implementation and at least annually, or

whenever any changes occur that could

affect or alter the hazard analysis, or

6188 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

HACCP plan. Further, processors who

have no HACCP plans because there are

no hazards that are reasonably likely to

occur in that process (as may be the case

with processors of shelf-stable or

concentrated juice), the processor must

reassess their hazard analysis when any

significant change occurs. Examples of

things that may change include: (1) Raw

material specifications or sources of raw

materials, (2) product formulation, (3)

processing methods or systems, (4)

packaging, (5) finished product

distribution systems, or (6) intended

consumers or use by consumers.

Tables 22 and 23 give the estimated

cost for validation in the first and

subsequent years.

TABLE 22.—COST OF FIRST YEAR VALIDATION

Plant type Number of

validations

Cost per

validation

Number of

plants Total cost

Seasonal Small Business ................................................................................................ 1 $1,000 1,640 $1,640,000

Year Round Business ...................................................................................................... 2 1,000 120 240,000

Year Round Small Shelf-Stable or Concentrate Business .............................................. 1 1,000 130 130,000

Year Round Large Business ........................................................................................... 2 600 80 96,000

Year Round Large Shelf-Stable or Concentrate Business ............................................. 1 600 95 57,000

Totals ........................................................................................................................ 2,265 .................... 2,065 $2,163,000

TABLE 23.—COST OF SUBSEQUENT YEAR VALIDATION

Plant type Number of

validations

Cost per

validation

Number of

plants Total cost

Seasonal Small Business ................................................................................................ 1 $1,000 1,490 $1,490,000

Year Round Small Business ............................................................................................ 2 1,000 35 70,000

Year Round Large Business ........................................................................................... 2 600 35 42,000

Totals ........................................................................................................................ 1,630 .................... 1,560 1,602,000

vii. Process verification for certain

citrus processors (§ 120.25). Citrus

processors that decide to rely on surface

treatments of the fruit to achieve the

requisite 5-log reduction (rather than

treating the juice directly) are required

to sample their final product to verify

the effectiveness of the HACCP plan.

These processors are required to test

two 10 mL subsamples for generic E.

coli every 1,000 gallons or every 5 days

whichever is more frequent. FDA

assumes that the cost of testing two 10

mL subsamples for generic E. coli is $50.

FDA estimates that there are 240 citrus

processors that will be affected by this

section. To estimate the number of

samples, FDA began with the estimated

annual U.S. untreated orange juice

consumption estimate of 11,700,000

gallons. FDA then assumed that 10

million gallons were packaged for resale

and therefore covered by this rule. FDA

then assumed that the 180 processors

that would sample at a frequency of

once every 5 days on average process

750 gallons during that time. These

processors are assumed to be seasonal

processors operating for only 16 weeks

a year. FDA made these assumptions

based on its knowledge of microbial

testing and beliefs about the volume of

untreated packaged juice sold by small

processors. That set of processors

accounts for 2,160,000 gallons annually.

The remaining 60 processors share

production of the remaining 7,840,000

gallons resulting in about 130 samples

per year per processor.

Table 24 shows the estimated cost for

process verification sampling for these

citrus processors.

TABLE 24.—ESTIMATED COST FOR VERIFICATION SAMPLING

Sample frequency Number of

samples

Number of

processors

Cost per

sample cost Total

Every 5 days .................................................................................................................... 16 180 $50 $144,000

Every 1,000 Gallons ........................................................................................................ 130 60 50 390,000

Total .......................................................................................................................... 10,720 240 .................... $534,000

Also, any time that 2 processverification samples test positive for

generic E. coli in a series of 7 samples

there is a process verification failure.

The processor must not sell the product

without further processing and must

review its monitoring records,

reevaluate its HACCP plan, and if no

obvious deficiencies in the HACCP plan

are discovered, must revalidate its

HACCP plan. FDA estimates that even if

all citrus processors that rely on surface

treatments to achieve a 5-log reduction

are fully successful in achieving the 5-

log reduction, 2 samples in a series of

7 will test positive for generic E. coli

once in every 1,000 samples. Based on

an estimate of 10,720 samples taken per

year, this will occur about 11 times per

year. FDA assumes that the cost of

further processing of the product will be

more expensive than withdrawing and

destroying the product, which should

not exceed 1,000 gallons. FDA assumes

that the cost of withdrawing and

destroying the product plus the cost of

reviewing monitoring records,

reevaluating and revalidating HACCP

plan is $20,000. FDA made this

assumption based on its experience

with such small lot market withdrawls.

Therefore, the additional cost of a

process verification failure is $220,000

per year. The annualized cost of a

process verification failure is $320 for a

seasonal processor sampling every 5

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6189

days ((16/1,000) × $20,000 = $320) and

$2,600 for a year round processor

sampling every 1,000 gallons ((130/

1,000) × $20,000 = $2,600).

The total cost of process verification

testing for untreated citrus juice is

$764,000 per year ($534,000 + $220,000

= $764,000).

viii. HACCP records (§ 120.12).—

Monitoring and recordkeeping. The

additional monitoring and

recordkeeping that needs to be done

throughout the entire plant is estimated

to be equivalent to 5 percent of one

worker’s time (3 minutes per hour of

operation per plant). Table 25 shows the

annual cost of additional monitoring

and recordkeeping per plant. It also

shows the distribution of per plant costs

and total industry costs for the

additional monitoring and

recordkeeping needed to comply with

this final rule.

TABLE 25.—COST OF MONITORING AND RECORDKEEPING

Plant type Cost per plant Number of plants Total cost

Seasonal .................................................................................................................... $900 1,490 $1,341,000

Year Round ................................................................................................................ 5,600 70 392,000

Totals .................................................................................................................. .............................. 1,560 $1,733,000

Record maintenance and storage. The annual cost of record maintenance and storage per plant is described in

table 26.

TABLE 26.—COST OF RECORD MAINTENANCE

Plant type Cost per plant Number of plants Total cost

Seasonal .................................................................................................................... $360 1,490 $536,000

Year Round ................................................................................................................ 830 70 58,000

Totals .................................................................................................................. .............................. 1,560 $694,000

ix. Training (§ 120.13).—HACCP

coordinator training. Processors may

need to employ a HACCP coordinator to

carry out the duties specified for such

a person. FDA estimates that the cost of

HACCP coordinator training is $1,300

for each of the 2,300 processing plants,

or a total industry cost of $2,990,000.

Employee training in HACCP. Each

processor with a HACCP plan will need

to train employees in their HACCPrelated activities. This analysis assumes

that each plant must train 5 employees

or 10 percent of their employees in

HACCP-related responsibilities,

whichever is greater. Table 27 describes

the cost of training each employee for 8

hours annually (the equivalent of 40

minutes per month for 10 percent of the

employees) and the total cost of this

level of training.

TABLE 27.—COST OF EMPLOYEE TRAINING

Average plant employment

Number of

employees

trained

Cost per

employee

Number of

plants Total cost

3 ....................................................................................................................................... 3 $100 1,459 $437,700

7 ....................................................................................................................................... 5 100 10 5,000

15 ..................................................................................................................................... 5 100 19 9,500

35 ..................................................................................................................................... 5 100 28 14,000

75 ..................................................................................................................................... 8 100 29 23,200

175 ................................................................................................................................... 16 100 15 27,000

Totals ........................................................................................................................ 5,160 .................... 1,560 $516,000

x. Imports and foreign processors

(§ 120.14).—Importers. The agency

estimates that the cost of these activities

will be $10,000 for each of the 120

importers in the first year, decreasing to

$5,000 in subsequent years. Total costs

for importers is $1,200,000 in the first

year and $600,000 in subsequent years.

Foreign juice processors. The

estimated first year cost per foreign juice

exporter is approximately $26,000, and

the cost in subsequent years is $22,000.

Therefore the total cost in the first year

for 300 foreign processors is

approximately $8 million and

approximately $7 million in subsequent

years. Tables 33 and 34 in the

Regulatory Flexibility Analysis, which

follows, shows typical costs for large

plants that have not already

implemented HACCP. The agency

assumes that these costs are

representative of foreign plants

exporting to the United States.

b. Summary of Costs—The total

quantified costs are approximately $44

to $58 million in the first year and $23

million in all subsequent years. Table 28

summarizes costs of the rule by

provision.

6190 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

C. TABLE 28.—TOTAL FIRST YEAR AND RECURRING COST PER ACTIVITY

Activity First year costs Recurring costs

Develop SOP’s ............................................................................................................................................ $488,000 ..............................

Prerequisite Program SOP’s ....................................................................................................................... 345,000 ..............................

Monitoring and Documenting for SOP ........................................................................................................ 238,000 238,000

Hazard analysis ........................................................................................................................................... 575,000 ..............................

HACCP plan ................................................................................................................................................ 1,170,000 ..............................

Pathogen controls ........................................................................................................................................ 21,400,000–

35,660,000

8,210,000

Natural toxin controls ................................................................................................................................... 104,000 104,000

Pesticide controls ......................................................................................................................................... 98,000 98,000

Corrective action plan .................................................................................................................................. 78,000 ..............................

Corrective actions ........................................................................................................................................ 773,000 188,000

Verification ................................................................................................................................................... 721,000 721,000

Validation ..................................................................................................................................................... 2,163,000 1,602,000

Process verification ...................................................................................................................................... 764,000 764,000

HACCP monitoring and recordkeeping ....................................................................................................... 1,733,000 1,733,000

Record maintenance and storage ............................................................................................................... 694,000 694,000

HACCP coordinator training ........................................................................................................................ 2,990,000 ..............................

Employee training ........................................................................................................................................ 516,000 516,000

Importers ...................................................................................................................................................... 1,200,000 600,000

Foreign processors ...................................................................................................................................... 8,000,000 7,000,000

Totals .................................................................................................................................................... 44,000,000–

58,000,000

23,000,000

E. Summary of Benefits and Costs

FDA has examined the benefits and

costs of this rule as required under

Executive Order 12866. Over time, the

relationship between benefits and costs

changes, so that, to compare them

properly, benefits and costs must be

discounted to the present year (the time

at which the decisions are being made).

The quantified benefits (discounted

annually over an infinite time horizon at

7 percent) are expected to be about $2

billion ($151 million/7 percent) and the

quantified costs (discounted annually

over an infinite time horizon at 7

percent) are expected to be about $400

million.

VI. Regulatory Flexibility Analysis

FDA has examined the impact of this

rule as required by the Regulatory

Flexibility Act (5 U.S.C. 601–612). If a

rule has a significant impact on a

substantial number of small entities, the

RFA requires agencies to analyze

options that would minimize the

economic impact of that rule on small

entities. The agency acknowledges that

this rule is likely to have a significant

impact on a substantial number of small

entities.

A. Objectives

The RFA requires a succinct

statement of the purpose and objectives

of any rule that will have a significant

impact on a substantial number of small

entities. The HACCP rule is being issued

to ensure that juice processors control

all physical, chemical, and microbial

hazards in their products.

B. Definition of Small Business and

Number of Small Businesses Affected

The RFA requires a statement of the

definition of small business used in the

analysis and a description of the

number of small entities affected.

Table 29 shows the definition of small

business for each type of establishment

affected and a description of the number

of small entities affected by the rule.

The agency has accepted the Small

Business Administration (SBA)

definitions of small business for this

analysis.

TABLE 29.—APPROXIMATE NUMBER OF SMALL PLANTS COVERED BY THESE RULES

Type of establishment

North American

industry classification system codesSBA definition of small by category Category defined

as small by SBA

Percent of No. of

small businesses

covered

Juice manufacturers in the OEI ............. 311421, 311411 Less than 500 employees ..................... 75% 675

Roadside-type apple juice Makers ........ 311421, 311411 Less than 500 employees ..................... 100% 1,220

Roadside orange juice Makers .............. 311421, 311411 Less than 500 employees ..................... 100% 230

Totals ..................................................... .............................. ................................................................ .............................. 2,125

C. Description of the Impact on Small

Entities

1. Costs to Small Entities

Because there is a broad distribution

of products covered, firm types, current

processing practices and sizes, it would

be misleading to report average per firm

costs. However, some idea of the costs

can be gained from the following

examples. The impacts that the costs

will have on a firm will vary depending

on the total revenue derived from juice

by a firm and the profit (return on sales)

associated with juice production. Data

on food manufacturing firms indicates

that 75 percent of firms have return on

sales of less than 5 percent.

The first example (table 30) is of a

small seasonal apple cider plant that is

now producing nonheat-treated juice,

with fruit from a known source, and that

has not developed or implemented

sanitation SOP’s. This plant will need to

buy a pasteurizer (or find and validate

a different process that achieves a 5-log

reduction). The next example (table 31)

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6191

is a small plant that is producing orange

juice concentrate year round with fruit

from a known source, and that has

already developed and implemented

sanitation SOP’s (except that records

have not been kept on SOP’s). The third

example (table 32) is a small plant

operating year round producing

unpasteurized orange juice, using

commingled fruit, and that has not

developed or implemented sanitation

SOP’s.

These three illustrative small plants

can be compared to two illustrative

large plants. The first large plant (table

33) is a large shelf-stable apple juice

plant with many employees that

operates year round and that imports

some apples and therefore must test for

patulin, and has not developed or

implemented sanitation SOP’s. The

second large plant (table 34) is a large

shelf-stable tomato juice processor using

fruit from a known source and with

sanitation SOP’s fully implemented.

TABLE 30.—COSTS FOR ILLUSTRATIVE SMALL SEASONAL APPLE CIDER PROCESSOR

Type of cost Cost in

first year

Cost in

subsequent years

Develop SOP’s ............................................................................................................................................ $260

Sanitation SOP’s .......................................................................................................................................... 500

Monitoring and Documenting of SOP’s ....................................................................................................... 100 $100

Hazard analysis ........................................................................................................................................... 250

HACCP plan ................................................................................................................................................ 750

Pathogen controls ........................................................................................................................................ 18,000–30,000 7,900

Corrective action plan .................................................................................................................................. 50

Corrective actions ........................................................................................................................................ 450 110

Verification ................................................................................................................................................... 420 420

Validation ..................................................................................................................................................... 1,000 500

HACCP monitoring and recordkeeping ....................................................................................................... 900 900

Record maintenance & storage ................................................................................................................... 360 360

Training of coordinator ................................................................................................................................. 1,300

Employee training ........................................................................................................................................ 300 300

Totals .................................................................................................................................................... 24,700–36,700 10,600

TABLE 31.—COST FOR ILLUSTRATIVE SMALL YEAR ROUND CONCENTRATED ORANGE JUICE PROCESSOR

Type of cost Cost in first year Cost in

subsequent years

Monitoring and documenting of SOP’s ........................................................................................................ $340 $340

Hazard analysis ........................................................................................................................................... 250

Validation ..................................................................................................................................................... 1,000

Training of coordinator ................................................................................................................................. 1,300

Totals .................................................................................................................................................... 2,900 300

TABLE 32.—COST FOR ILLUSTRATIVE SMALL YEAR ROUND UNPASTEURIZED ORANGE JUICE PROCESSOR

Type of cost Cost in first year Cost in

subsequent years

Develop SOP’s ............................................................................................................................................ $260

Monitoring and documenting of SOP’s ........................................................................................................ 340 $340

Hazard analysis ........................................................................................................................................... 250

HACCP plan ................................................................................................................................................ 750

Pathogen controls ........................................................................................................................................ 18,000–30,000 7,900

Corrective action Plan ................................................................................................................................. 50

Corrective actions ........................................................................................................................................ 1,460 340

Verification ................................................................................................................................................... 1,350 1,350

Validation ..................................................................................................................................................... 2,000 1,000

Process verification testing .......................................................................................................................... 7,800 7,800

Annualized cost of Process Verification Failure .......................................................................................... 2,600 2,600

HACCP monitoring and Recordkeeping ...................................................................................................... 5,600 5,600

Record maintenance & storage ................................................................................................................... 830 830

Training of coordinator ................................................................................................................................. 1,300

Employee training ........................................................................................................................................ 500 500

Totals .................................................................................................................................................... 43,100–55,100 28,300

TABLE 33.—COSTS FOR ILLUSTRATIVE LARGE YEAR ROUND APPLE JUICE PROCESSOR

Type of cost Cost in first year Cost in

subsequent years

Develop SOP’s ............................................................................................................................................ $260

6192 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

TABLE 33.—COSTS FOR ILLUSTRATIVE LARGE YEAR ROUND APPLE JUICE PROCESSOR—Continued

Type of cost Cost in first year Cost in

subsequent years

Sanitation SOP’s .......................................................................................................................................... 500

Monitoring and documenting of SOP’s ........................................................................................................ 340 $340

Hazard analysis ........................................................................................................................................... 250

HACCP plan ................................................................................................................................................ 750

Natural toxin control ..................................................................................................................................... 4,500 4,500

Corrective action plan .................................................................................................................................. 50

Corrective actions ........................................................................................................................................ 1,460 340

Verification ................................................................................................................................................... 1,350 1,350

Validation ..................................................................................................................................................... 1,200 1,200

HACCP monitoring and recordkeeping ....................................................................................................... 5,600 5,600

Record maintenance .................................................................................................................................... 680 680

Record storage ............................................................................................................................................ 150

Training of coordinator ................................................................................................................................. 1,300

Employee training ........................................................................................................................................ 8,300 8,300

Totals .................................................................................................................................................... 24,000 20,000

TABLE 34.—COSTS FOR ILLUSTRATIVE LARGE YEAR ROUND SHELF-STABLE TOMATO JUICE PROCESSOR

Type of cost Cost in first year Cost in

subsequent years

Hazard analysis ........................................................................................................................................... $250

Validation ..................................................................................................................................................... 600

Training of coordinator ................................................................................................................................. 1,300

Totals .................................................................................................................................................... 2,000 $0

Some comments stated that the rule

would be burdensome on small juice

processors and that some processors

would have to cease producing juice.

FDA is issuing a tiered, extended

compliance period giving the smallest

firms the most time to comply with the

rule. Extending the compliance period

by 1 year for small firms could save

each one $500 to $31,600 (using a 7

percent discount rate). Extending the

compliance period by 2 years for very

small firms could save each one $900 to

$61,000 (using a 7 percent discount

rate). These savings accrue just from

delaying the time at which the

expenditures for compliance must take

place. The amount of savings increases

as the cost of compliance increases. One

effect of the cost savings will be to

reduce small firm failure. FDA believes

that this extended compliance period

will provide small firms with significant

relief in the cost of preparing for HACCP

and making necessary changes to

comply with this rule.

2. Professional Skills Required for

Compliance

The RFA requires a description of the

professional skills required for

compliance with this rule. Table 35

describes the professional skills

required for compliance with the

various activities required by this rule.

TABLE 35.—PROFESSIONAL SKILLS REQUIRED FOR COMPLIANCE

Required activity Section of

rule Professional skills required for compliance

Developing prerequisite program SOP’s ..... § 120.6 Managers familiar with incoming materials and plant sanitation.

Implementing sanitation controls with corrections of deviations from prerequisite

program SOP’s.

§ 120.6 Production workers who are able to maintain the sanitation controls as described in

the sanitation SOP’s and supervisors or managers who can determine what corrective actions are necessary for deviations from SOP’s.

Monitoring and documenting of prerequisite

Program SOP’s.

§ 120.6 Production workers who are appropriately trained to monitor and keep records on observations and measurements for prerequisite program SOP’s.

Developing hazard analysis and HACCP

plan..

§§ 120.7

and 120.8

Supervisors or managers who fulfill the role of HACCP coordinator as well as microbiologists, chemists, and attorneys.

Implementing pathogen controls ................. § 120.8 Production workers who are appropriately trained to monitor and keep records on observations and measurements at CCP’s.

Implementing pesticide controls .................. § 120.8 Production workers who are appropriately trained to carry out tests, to monitor, and to

keep records on observations and measurements at CCP’s.

Tracking corrective actions .......................... § 120.10 Production workers who are trained to take corrective action described in corrective

action plans and supervisors or managers who can determine what corrective actions are necessary for deviations from CL’s.

Verification ................................................... § 120.11 Supervisors or managers who fulfill the role of HACCP coordinator.

Validation ..................................................... § 120.11 Food scientists or food technologists who can perform a scientific review of the process.

Process verification ..................................... § 120.25 Microbiologists and production workers who are trained to take process verification

samples and food scientists or food technologists who can perform a scientific review of the process in the event of a process verification failure.

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6193

TABLE 35.—PROFESSIONAL SKILLS REQUIRED FOR COMPLIANCE—Continued

Required activity Section of

rule Professional skills required for compliance

Monitoring and recordkeeping ..................... § 120.12 Production workers who are appropriately trained to monitor and keep records on observations and measurements at CCP’s.

Record maintenance ................................... § 120.12 Clerical or production workers.

HACCP coordinator training coordinator ..... § 120.13 Supervisors or managers who fulfill the role of HACCP.

HACCP employee training .......................... § 120.13 Clerical and production workers.

Imports ......................................................... § 120.14 Clerical workers as well as supervisors or managers who fulfill the role of HACCP coordinator.

3. Recordkeeping requirements

The RFA requires a description of the

recordkeeping requirements of the

proposed rule. Table 36 shows the

provisions for which records need to be

made and kept by small businesses, the

number of small businesses affected, the

annual frequency that the records need

to be made, the amount of time needed

for making each record, and the total

number of hours for each provision in

the first year and then in subsequent

years.

TABLE 36.—SMALL BUSINESS RECORDKEEPING REQUIREMENTS

21 CFR provisions

Number of

small entities keeping

records

Annual

frequency

Hours per

record per

small entity

Total hours

first year

Total

subsequent

years

120.6 Monitoring and Recordkeeping of SOP’s .................................... 1,660 16 0.5 13,300 13,300

210 52 .................... 5,500 5,500

120.7 Hazard analysis ........................................................................... 2,125 1 20 42,500 0

120.8 HACCP plan ................................................................................ 1,930 1 60 115,800 0

120.8 Pesticide Controls by Supplier Certificate ................................... 1,700 160 .02 5,400 5,400

120.11 Verification ................................................................................. 1,450 16 2 46,400 46,400

380 52 1 8 39,500 39,500

120.11 Validation ................................................................................... 1,450 1 2 4 11,600 5,800

380 2 .................... 6,100 3,000

120.12 HACCP records ......................................................................... 1,450 1,440 .05 104,400 104,400

380 8,640 .................... 164,200 164,200

120.12 Record maintenance ................................................................. 1,450 16 1 23,200 23,200

Totals ................................................................................................ .................... .................... .................... 598,000 431,000

1First year. 2Subsequent year.

D. Minimizing the Burden on Small

Entities

The RFA requires an evaluation of

any regulatory overlaps and regulatory

alternatives that would minimize the

costs to small entities.

There are two alternatives that the

agency has considered to provide

regulatory relief for small entities. First,

FDA considered and is proposing the

option of exempting some small entities

from the requirements of these rules.

Second, FDA considered and is

proposing the option of lengthening the

compliance period for small entities.

1. Exempt Small Entities

One alternative for alleviating the

burden for small entities would be to

exempt them from the provisions of this

rule. FDA proposed to exempt retailers

who, for the purposes of this rule, the

agency tentatively decided would

include very small businesses that make

juice on their premises and whose total

sales of juice and juice products do not

exceed 40,000 gallons per year and who

sell directly to consumers or directly to

consumers and other retailers.

Revenue from sales of 40,000 gallons

of nonheat treated juice may be

approximately $160,000 with annual

profits ranging from $1,600 to $16,000

per year (1 percent to 10 percent). This

exemption covered most of the very

small businesses, although less than 15

percent of the volume of unpasteurized

juice. However, packaged products sold

by these types of processors are covered

under the labeling rule.

As detailed in response to comment

47, the comments that FDA received on

this exemption were almost entirely

critical of the exemption. Based upon

the comments and other information

available to the agency, FDA has

decided not to finalize this proposed

exemption.

2. Extend Compliance Period

FDA is issuing a tiered, extended

compliance period giving the smallest

firms the most time to comply with the

rule. Extending the compliance period

by 1 year for small firms could save

each one $500 to $31,600 (using a 7

percent discount rate). Extending the

compliance period by 2 years for very

small firms could save each one $900 to

$61,000 (using a 7 percent discount

rate). These savings accrue just from

delaying the time at which the

expenditures for compliance must take

place. The amount of savings increases

as the cost of compliance increases.

Additional savings may come as

smaller firms learn more efficient

compliance strategies from larger firms

that must comply earlier and as new,

less costly technologies that may be

employed by small firms are developed

during the extended compliance period.

FDA is unable to quantify these

additional savings of the extended

compliance period although one effect

of the cost savings will be to reduce

small firm failure.

FDA believes that this extended

compliance period will provide small

firms with significant relief in the cost

of preparing for HACCP and making

6194 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

necessary changes to comply with this

rule.

E. Summary

FDA has examined the impact of this

rule on small businesses in accordance

with the RFA. This analysis, together

with the rest of the preamble constitutes

the final RFA. FDA has determined that

this rule is likely to have a significant

impact on a substantial number of small

entities.

VII. Paperwork Reduction Act of 1995

This final rule contains information

collection provisions that are subject to

review by the Office of Management and

Budget (OMB) under the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501–

3520). A description of these

information provisions is given below

with an estimate of the annual

recordkeeping burden. Included in the

estimate is the time for reviewing

instructions, searching existing data

sources, gathering and maintaining the

data needed, and completing and

reviewing each collection of

information.

Title: Hazard Analysis and Critical

Control Point (HACCP) Procedures for

the Safe and Sanitary Processing of

Juice—Recordkeeping requirements for

processors of fruit and vegetable juices

Description: This final rule mandates

the application of HACCP procedures to

fruit and vegetable juice processing.

HACCP is a preventative system of

hazard control that can be used by all

food processors to ensure the safety of

their products to consumers. FDA is

finalizing these regulations because a

system of preventative control is the

most effective and efficient way to

ensure that these food products are safe.

FDA’s mandate to ensure the safety of

the nation’s food supply is derived

principally from the act (21 U.S.C. 321

et seq.). Under the act, FDA has

authority to ensure that all foods in

interstate commerce, or that have been

shipped in interstate commerce, are not

contaminated or otherwise adulterated,

are produced and held under sanitary

conditions, and are not misbranded or

deceptively packaged; under 21 U.S.C.

371, the act authorizes the agency to

issue regulations for its efficient

enforcement. The agency also has

authority under the Public Health

Service Act (42 U.S.C. 264) to issue and

enforce regulations to prevent the

introduction, transmission, or spread of

communicable diseases from one State

to another other State. Information

development and recordkeeping are

essential parts of any HACCP system.

The information collection requirements

of this rule are narrowly tailored to

focus on the development of appropriate

controls and documenting those aspects

of processing that are critical to food

safety. Through this final rule, FDA is

implementing its authority under

section 402(a)(4) of the act. The

information development and

recordkeeping requirements of this final

rule are likewise an implementation of

section 402(a)(4) of the act.

Description of Respondents:

Businesses and other for-profit

institutions.

In the Federal Register of April 24,

1998, the agency requested comments

on the proposed collection of

information provisions contained in the

HACCP proposal. One comment was

received. This comment asserted that

the change in sequence in the proposed

rule for the last two steps of the seven

principles of HACCP is a change that

will result in many paperwork changes.

The seven principles of HACCP have

been articulated by the NACMCF.

The agency does not agree with this

comment. Prior to 1997, the NACMCF

listed establishing recordkeeping and

documentation procedures and

establishing verification procedures as

the sixth and seventh principles of

HACCP; this is the order in which the

principles are reflected in FDA’s

seafood HACCP regulation, part 123.

When the NACMCF revised its HACCP

principles and application guidelines in

1997, it reversed the order of the last

two steps. Thus, the sequence in part

120 for the seven principles of HACCP

is identical to the sequence most

recently outlined by NACMCF. The

1997 change does not require a change

in the analytical approach or in the

information to be assembled by juice

processors as they apply the HACCP

principles to their process. The agency

does not anticipate that there will be a

need for processors to complete

additional paperwork simply because

there has been a change in the order of

the seven principles of HACCP or

because there will be a slight difference

in the juice HACCP regulation and the

seafood HACCP regulation. It is FDA’s

position that as long as all the essential

elements are present in the written

HACCP plan, the plan will be complete.

FDA estimates the burden of this

collection of information as follows:

TABLE 37.—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR sections Number of

recordkeepers

Annual

frequency of

records

Total annual

records

Hours per

record Total hours

120.6(a) & 120.12(a)(1) & (b) ............................................ 1,875 1 1,875 4 2 7,500

120.6(c) & 120.12(a)(1) & (b) ............................................ 1,875 365 684,375 0.1 68,437.5

120.7; 120.10 (a); & 120.12(a)(2), (b) & (c) ...................... 2,300 1.1 2,530 20 50,600

120.8 (except monitoring records required under

120.8(b)(7)); & 120.12(a)(3),(b)& (c) .............................. 1,840 1 1,840 60 2 110,400

120.8(b)(7) & 120.12(a)(4)(i), & (b) ................................... 1,450 14,600 21,170,000 0.01 211,700

120.10(c) & 120.12(a)(4)(ii), & (b) ..................................... 1,840 12 22,080 0.1 2,208

120.11(a)(1)(iv); 120.11(a)(2); 120.12(a)(5) ...................... 1,840 52 95,680 0.1 9,568

120.11(b) & 120.12(a)(5), & (b) ......................................... 1,840 1 1,840 4 7,360

120.11 (c) & 120.12(a)(5) & (b) ......................................... 1,840 1 1,840 4 7,360

120.14(a)(2); & 120.14 (c) & (d) ........................................ 308 1 308 4 1,232

Totals First year—476,365.5 Subsequent years—358,465.5

1There are no capital costs or operating and maintenance costs associated with this collection of information.

2First year only.

The burden estimates in table 37

above are based on an estimate of the

total number of juice manufacturing

plants (i.e., 2,300) affected by this final

rule. Included in this total are 850

plants currently identified in FDA’s OEI

plus 1,220 very small apple juice

manufacturers and 230 very small

orange juice manufacturers (see table 13

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6195

in section V). The figures in table 36 are

derived by estimating the number of

plants affected by each portion of this

final rule and multiplying the

corresponding number by the number of

records required annually and the hours

needed to complete the record. These

numbers were obtained from the

agency’s final RIA prepared for this final

rule.

Moreover, these estimates assume that

every processor will prepare SSOP’s and

a HACCP plan and maintain the

associated monitoring records and that

every importer will require product

safety specifications. In fact, there are

likely to be some small number of juice

processors that, based upon their hazard

analysis, determine that they are not

required to have a HACCP plan under

this final rule.

Table 37 provides a breakdown of the

total estimated recordkeeping burden

for the first year and subsequent years.

The estimates in this table have been

reviewed by the agency’s HACCP

experts, who have practical experience

in observing various processing

operations and related recordkeeping

activities.

The information collection provisions

of this final rule have been submitted to

OMB for review.

Prior to the effective date of this final

rule, FDA will publish a notice in the

Federal Register announcing OMB’s

decision to approve, modify, or

disapprove the information collection

provisions in this final rule. An agency

may not conduct or sponsor, and a

person is not required to respond to, a

collection of information unless it

displays a currently valid OMB control

number.

VIII. Environmental Impact

The agency has previously considered

the environmental effects of the action

being taken in this final rule. As

announced in the proposed rule

published in the Federal Register of

April 24, 1998 (63 FR 20450) (Ref. 2),

the agency determined that under 21

CFR 25.30(j) this action is of a type that

does not individually or cumulatively

have a significant impact on the human

environment. Therefore, neither an

environmental assessment nor an

environmental impact statement was

required.

(Comment 158) Two comments were

received in response to the potential

environmental impact of this rule. One

comment stated that ‘‘* * * the

extensive recordkeeping requirements

under the juice proposal will increase

paper consumption significantly, which

will not be considered ‘environmentally

friendly.’ ’’ This comment did not

provide evidence to support this

assertion.

FDA agrees that the recordkeeping

requirement in the HACCP final rule

may increase paper consumption.

However, the agency disagrees that this

increase will be significant. The agency

believes that the paper used for the

required recordkeeping will be a very

small fraction of the overall amount of

paper used in the United States.

Therefore, this use will not significantly

increase the production, use and

disposal of paper and, thus, will not

result in significant adverse impacts on

the environment. Additionally, FDA

notes that § 120.12(g) of the final rule

permits records to be maintained

electronically. When the regulated

entities maintain records electronically,

the need for paper is reduced.

(Comment 159) One comment on the

proposed rule stated that efforts to

achieve 5-log reduction will lead to

possible excessive pollution of the

environment from disposal of

unessential sanitizers. This comment

did not provide evidence to support this

assertion.

The agency has concluded that even

if some increase in the use of sanitizing

products should result, the products

used would be either registered with the

U.S. EPA or regulated by FDA for use

on food contact articles under

§ 178.1010 (21 CFR 178.1010) or both.

Environmental review is part of EPA’s

pesticide registration process and is part

of FDA’s process for listing sanitizing

solutions under § 178.1010. FDA

expects processors to use all sanitizing

products according to directions on

product labels and under the

supervision of experienced persons. Use

of the sanitizing products in this

manner should ensure that any

increased use will not result in adverse

effects on the environment.

The agency has concluded that these

comments on the potential for adverse

environmental effects will not affect its

previous determination that this action

will not have a significant impact on the

human environment and that an

environmental impact statement is not

required.

IX. Federalism

FDA has analyzed this final rule in

accordance with the principles set forth

in Executive Order 13132. FDA has

determined that the rule does not

contain policies that have substantial

direct effects on the States, on the

relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government (Ref. 75).

Accordingly, the agency has concluded

that the rule does not contain policies

that have federalism implications as

defined in the order and, consequently,

a federalism summary impact statement

is not required.

X. References

The following information has been

placed on display in the Dockets

Management Branch (address above),

and may be seen by interested persons

between 9 a.m. and 4 p.m. Monday

through Friday.

1. FDA, Department of Health and Human

Services (DHHS), ‘‘Fruit And Vegetable

Juice Beverages: Notice of Intent to

Develop a HACCP Program, Interim

Warning Statement, and Educational

Program,’’ 21 CFR part 120, 62 FR

45593–45596, August 28, 1997.

2. FDA, DHHS, ‘‘Hazard Analysis and Critical

Control Point (HACCP); Procedures for

the Safe and Sanitary Processing and

Importing of Juice,’’ proposed rule, 21

CFR part 120, 63 FR 20450–20486, April

24, 1998.

3. FDA, DHHS, ‘‘Hazard Analysis and Critical

Control Point (HACCP); Procedures for

the Safe and Sanitary Processing and

Importing of Juice;’’ extension of

comment period, 21 CFR part 120, 63 FR

37057, July 8, 1998.

4. FDA, DHHS, ‘‘Food Labeling: Warning and

Notice Statements; Labeling of Juice

Products,’’ proposed rule, 21 CFR part

101, 63 FR 20486–20493, April 24, 1998.

5. FDA, DHHS,‘‘Food Labeling: Warning and

Notice Statements; Labeling of Juice

Products,’’ 21 CFR part 101, 63 FR

37030–37056, July 8, 1998.

6. FDA, DHHS, ‘‘Preliminary Regulatory

Impact Analysis and Initial Regulatory

Flexibility Analysis of the Proposed

Rules to Ensure the Safety of Juice and

Juice Products,’’ preliminary regulatory

impact anaysis, 21 CFR parts 101 and

120, 63 FR 24254–24378, May 1, 1998.

7. FDA, DHHS, ‘‘Food Labeling: Warning and

Notice Statements; Labeling of Juice

Products; Technical Scientific

Workshops; Requests for Additional

Time to Achieve the Pathogen Reduction

Standard,’’ 21 CFR part 101, 63 FR

57594–57596, October 28,1998.

8. FDA, DHHS, ‘‘Hazard Analysis and Critical

Control Point (HACCP); Procedures for

the Safe and Sanitary Processing and

Importing of Juice: Reopening of

Comment Period,’’ 21 CFR part 120, 63

FR 69579–69580, December 17, 1998.

9. FDA, DHHS, ‘‘Apple Cider Food Safety

Control: Workshop,’’ 21 CFR part 101, 64

FR 34125–34126, June 25, 1999.

10. FDA, DHHS, ‘‘Hazard Analysis and

Critical Control Point (HACCP);

Procedures for Safe and Sanitary

Processing and Importing of Juice;

Availability of New Data and

Information and Reopening of Comment

Period,’’ 21 CFR part 120, 64 FR 65669–

65671, November 23, 1999.

11. FSIS, USDA, ‘‘National Advisory

Committee on Microbiological Criteria

6196 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

for Foods,’’ 64 FR 63281–63282,

November 19, 1999.

12. NACMCF, ‘‘National Advisory Committee

on Microbiological Criteria for Foods,

Meeting on Fresh Citrus Juice; Transcript

of Proceedings,’’ December 8 to 10, 1999,

public meeting.

13. Buchanan, R. L., S. G. Edelson, R. L.

Miller, and G. M. Sapers,

‘‘Contamination of intact apples after

immersion in an aqueous environment

containing Escherichia coli

O157:H7,’’Journal of Food Protection,

62(5):444–450, 1999.

14. Walderhaug, M. O., S. G. EdelsonMammel, A. J. DeJesus, B. S. Eblen, A.

J. Miller, and R. L. Buchanan, ‘‘Routes of

infiltration, survival, and growth of

Salmonella enterica serovar hartford and

Escherichia coli O157:H7 in oranges,’’

Abstract, Presented at International

Association for Food Protection meeting,

August 6 to 9, 2000.

15. National Academy of Sciences (NAS),

National Research Council (NCR), An

Evaluation of the Role of Microbiological

Criteria for Foods and Food Ingredients,

pp. 41–54, 308–335, National Academy

Press, Washington, DC, 1985.

16. Codex Alimentarius Commission,

Recommended International Code of

Practice: General Requirements (Food

Hygiene) [CAC/RCP 1–1969, Rev. 3

(1997), 2nd ed.], HACCP Annex. Food

and Agriculture Organization of the

United Nations, World Health

Organization, Rome.

17. NACMCF, 1998, Hazard Analysis and

Critical Control Point Principles and

Application Guidelines, Adopted August

14, 1997. Journal of Food Protection,

61(6):762–775.

18. FDA, PHS, DHHS, Grade ‘‘A’’ Pasteurized

Milk Ordinance, 1999 Revision, Public

Health Service/Food and Drug

Administration Publication No. 229.

19. FDA, 2000, Patulin in Apple Juice, Apple

Juice Concentrates and Apple Juice

Products; (Draft) Guidance for FDA

Components and Industry: Apple Juice,

Apple Juice Concentrates, and Apple

Juice Products—Adulteration with

Patulin. Web address: http://

vm.cfsan.fda.gov/∼dms/patubckg.html.

20. FDA Memorandum to Terry Troxell From

D. Jesse Wagstaff, May 5, 1994,

concerning Hazards of Patulin in Apple

Juice.

21. IARC, Patulin, International Agency for

Research on Cancer (IARC), Monographs

on the Evaluation of the Carcinogenic

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1986.

22. WHO, Patulin, World Health

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Series 26:143–165, 1990.

23. Dinovi, M., and S. Carberry, FDA

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Apple Juice, Estimate of Exposure, CSMP

Request of 6–16–93, September 3, 1993.

24. FDA, 2000, ‘‘Guidance for FDA

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Apple Juice Concentrates and Apple

Juice Products—Adulteration with

Patulin; Draft Compliance Policy Guide,’’

(also 65 FR 37791–37792, June 16, 2000)

Web Address: http://vm.cfsan.fda.gov/

∼dms/patuguid.html

25. NACMCF, National Advisory Committee

on Microbiological Criteria for Foods

(NACMCF) Recommendations on Fresh

Juice, April 9, 1997.

26. Barker, W. H., and V. Runte, ‘‘Tomato

juice-associated gastroenteritis,

Washington and Oregon, 1969,’’

American Journal of Epidemiology,

96(2): 219–226, 1972.

27. FDA Memorandum to Samuel I. Shibko

from Ivan Boyer, December 14, 1987,

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28. FDA Memorandum to the File from Mary

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Mycotoxins other than Patulin in Juices.

29. FDA health hazard evaluation,

classification, and FDA Enforcement

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and 20, 1996.

30. FDA health hazard evaluation,

classification, and FDA Enforcement

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31. FDA Enforcement Report and USDA and

Heinz news releases for recall #F–095–9

of Strained Beginner carrots, and

vegetable chicken dinner baby food,

December 23, 1998, and October 9, 1998.

32. FDA Enforcement Report for recall of

frozen carrots and mixed frozen

vegetables, April 14, 1999.

33. Government of the Federal Republic of

Germany, 1999, Comment concerning

the Codex Committee on Food Additives

and Contaminants, with reference to

Codex Document CX/FAC 99/19,

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for Lead.

34. Schmidt, R. H., C. A. Sims, M. E. Parish,

S. Pao, and M. A. Ismail, A Model

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Operations. Publication CIR 1179, Food

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35. Bolster, D., Apple Hill Quality Assurance

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36. CFSAN, FDA, Hazard Analysis and

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36a. Katz, F., and J. Giese, ‘‘Science gives

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36b. Cady, J. R., Letter from the National

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1994.

37. FDA Enforcement Report for recall #F–

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38. FDA health hazard evaluation,

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39. FDA health hazard evaluation,

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40. FDA health hazard evaluation,

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41. FDA health hazard evaluation,

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July 2, 1992.

42. CAST. 1994, Prevention of Foodborne

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122, Council for Agricultural Science

and Technology, Ames, Iowa.

43. Luedtke, A., and D. Powell, 2000, Fact

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Outbreaks, Web Address: <http://

www.plant.uoguelph.ca/safefood/microhaz/juice-outbreaks.htm>

44. Mead, P. S., L. Slutsker, V. Dietz, L. F.

McCaig, J. S. Bresee, C. Shapiro, P. M.

Griffin, and R.V. Tauxe, ‘‘Food-related

illness and death in the United States,’’

Emerging Infectious Diseases, 5(5):607–

625, 1999.

45. CFSAN, FDA Report of 1997 Inspections

of Fresh, Unpasteurized Apple Cider

Manufacturers—Summary of Results—

January 1999.

46. FDA, HHS, FDA Announces Voluntary

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Mamey Brands, HHS News, March 8,

1999, Web address: http://www.fda.gov/

bbs/topics/NEWS/NEW00676.html>

47. Anonymous, Outbreak of Salmonella

serotype muenchen infections associated

with unpasteurized orange juice—United

States and Canada, June 1999. Morbidity

and Mortality Weekly Report (MMWR),

48(27):581–585, July 16, 1999.

48. OSDH. E. coli Health Warning Issued in

Northeastern Oklahoma. Oklahoma State

Department of Health News Release,

October 13, 1999.

49. State of Florida, Food Analysis Report for

Laboratory No. 98/FO–07398, October

27, 1998; Associated Press. State issues

warning about tainted juice, 1998;

Garcia, L. M. 1998. Traces of bacteria

found in juice from local farm, October

25, 1998, The Herald (Miami).

50. FDA Enforcement Reports and HHS press

release for recall #F–660/661–9, #F–662–

9, #F–089–0. September 1 and 15, 1999,

November 16 and 19, 1999, and February

2, 2000.

51. FDA Memorandum from Robert L. Racer,

April 21, 2000, concerning April 20

Recall of All Fresh, Un-Pasteurized

Citrus Juice Products because of Possible

Health Risks.

52. CDC, An Outbreak of Norwalk-like Virus

Associated with a Juice Processor in

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Services Branch, National Center for

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Disease Control and Prevention, July 5,

2000.

53. Podoski, B.W., FDA Memorandum to the

File. Regulation of Intrastate Fresh Juice,

2000.

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6197

54. Buchanan, R.L., and M.H. Golden,

‘‘Interactions between pH and malic acid

concentration on the inactivation of

Listeria monocytogenes,’’ Journal of Food

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55. Buchanan, R.L., and S.G. Edelson, ‘‘pHDependent Stationary-Phase Acid

Resistance Response of

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the Presence of Various Acidulants,’’

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56. Dock, L.L., J.D. Floros, and R. H. Linton,

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acid, sodium benzoate, and potassium

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57. Parish, M.E., J.A. Narciso, and L. M.

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orange juice,’’ Journal of Food Safety,

17:273–281, 1997.

58. Jay, J.M. 1996, ‘‘Indicators of Food

Microbial Quality and Safety,’’ chapter

18, pp. 387–395, In Modern Food

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59. FDA, DHHS, ‘‘Guidance for Industry;

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Vegetables,’’ 1998.

60. FDA, DHEW, Fish and Seafood Products,

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61. FDA Memorandum to Patricia Spitzig

from Oliver D. Cook, July 11, 1995,

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consumer complaints and process

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62. FDA, DHHS, ‘‘Procedures for the Safe and

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Fish and Fishery Products,’’ final rule,

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63. Buchanan, R.L., FDA Memorandum to the

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64. FDA, FDA Technical Scientific Workshop

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Public Meeting, November 12, and

November 19, 1998.

65. FDA, 2000, ‘‘Compilation of Juice/Cider

Outbreaks Associated with Microbial

Hazards’’ (1974–2000), July 21, 2000.

66. Kautter, D.A., FDA Memorandum to K.

Carson, Revised Synopsis of NACMCF

Discussions, March 20, 2000 and October

24, 2000.

67. FDA memorandum to Robert Buchanan

from Sherri McGarry and John Sanders,

February 23, 2000, concerning

Salmonella outbreak associated with

orange juice. FDA memorandum from

Maxine Heinitz, August 19, 1999,

concerning update to Salmonella

database.

68. Larkin, J.W., FDA Memorandum to

OPDFB, Microbiological Critical Control

Point for Certain Shelf-stable and

Concentrated Juice Products, September

29, 2000.

69. ICMSF, 1988, Microorganisms in Foods 4:

Application of the Hazard Analysis

Critical Control Point (HACCP) System

to Ensure Microbiological Safety and

Quality, Blackwell Scientific

Publications, Boston, p. 26.

70. FSIS, USDA, ‘‘Pathogen Reduction;

Hazard Analysis and Critical Control

Point (HACCP) Systems,’’ final rule with

request for comments, 9 CFR parts 304,

308, 310, 320, 327, 381, 416, and 417, 61

FR 38806–38855, July 25, 1996.

71. Garthright, W. E., S. Chirtel, and Q.

Graves, Derivation of Sampling Plan to

Meet the Testing Requirement in the

Juice HACCP Final Rule for Citrus Juices

that Rely Solely or in Part on Surface

Treatments to Achieve the 5-Log

Reduction Standard, 2000.

72. CFSAN, FDA, Hazard Analysis and

Critical Control Point (HACCP) Pilot

Program for Selected Food

Manufacturers; Second Interim Report of

Observations and Comments, October 31,

1997.

73. Kaplan, R. M., J. P. Anderson, and T. G.

Ganiats, ‘‘The Quality of Well-being

Scale: Rationale for a Single Quality of

Life Index,’’ In Quality of Life

Assessment: Key Issues in the 1990s,

edited by Stuart R. Walker and Rachel M.

Rosser, pp. 65–94 and 442–444, The

Netherlands: Kluwar Academic

Publishers, 1993.

74. FDA, DHHS, ‘‘Irradiation in the

Production, Processing, and Handling of

Food,’’ final rule, 21 CFR part 179, 65 FR

71056–71058, November 29, 2000.

75. Bluhm, L. and B. Podoski, FDA

Memorandum to the File, ‘‘Federalism

Implications’’—Fresh and Processed

Juices/State Regulations and Practices,

May 17, 2000.

76. Anderson, S., FDA Memorandum to the

File, ‘‘Federalism Implications’’—Rule

20–49 of the Florida Department of

Citrus, January 10, 2001.

List of Subjects in 21 CFR Part 120

Foods, Fruit juices, Imports,

Reporting and recordkeeping

requirements, Vegetable juices.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, under the

Public Health Service Act, and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR chapter I is

amended as follows:

1. Part 120 is added to read as follows:

PART 120—HAZARD ANALYSIS AND

CRITICAL CONTROL POINT (HACCP)

SYSTEMS

Subpart A—General Provisions

Sec.

120.1 Applicability.

120.3 Definitions.

120.5 Current good manufacturing practice.

120.6 Sanitation standard operating

procedures.

120.7 Hazard analysis.

120.8 Hazard Analysis and Critical Control

Point (HACCP) plan.

120.9 Legal basis.

120.10 Corrective actions.

120.11 Verification and validation.

120.12 Records.

120.13 Training.

120.14 Application of requirements to

imported products.

Subpart B—Pathogen Reduction

120.20 General.

120.24 Process controls.

120.25 Process verification for certain

processors.

Authority: 21 U.S.C. 321, 342, 343, 346,

348, 371, 374, 379e, 381, 393; 42 U.S.C. 241,

242l, 264.

Subpart A—General Provisions

§ 120.1 Applicability.

(a) Any juice sold as such or used as

an ingredient in beverages shall be

processed in accordance with the

requirements of this part. Juice means

the aqueous liquid expressed or

extracted from one or more fruits or

vegetables, purees of the edible portions

of one or more fruits or vegetables, or

any concentrates of such liquid or

puree. The requirements of this part

shall apply to any juice regardless of

whether the juice, or any of its

ingredients, is or has been shipped in

interstate commerce (as defined in

section 201(b) of the Federal Food,

Drug, and Cosmetic Act, 21 U.S.C.

321(b)). Raw agricultural ingredients of

juice are not subject to the requirements

of this part. Processors should apply

existing agency guidance to minimize

microbial food safety hazards for fresh

fruits and vegetables in handling raw

agricultural products.

(b) The regulations in this part shall

be effective January 22, 2002. However,

by its terms, this part is not binding on

small and very small businesses until

the dates listed in paragraphs (b)(1) and

(b)(2) of this section.

(1) For small businesses employing

fewer than 500 persons the regulations

in this part are binding on January 21,

2003.

(2) For very small businesses that

have either total annual sales of less

than $500,000, or if their total annual

sales are greater than $500,000 but their

total food sales are less than $50,000; or

the person claiming this exemption

employed fewer than an average of 100

full-time equivalent employees and

fewer than 100,000 units of juice were

sold in the United States, the

regulations are binding on January 20,

2004.

§ 120.3 Definitions.

The definitions of terms in section

201 of the Federal Food, Drug, and

Cosmetic Act, § 101.9(j)(18)(vi), and part

110 of this chapter are applicable to

6198 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

such terms when used in this part,

except where redefined in this part. The

following definitions shall also apply:

(a) Cleaned means washed with water

of adequate sanitary quality.

(b) Control means to prevent,

eliminate, or reduce.

(c) Control measure means any action

or activity to prevent, reduce to

acceptable levels, or eliminate a hazard.

(d) Critical control point means a

point, step, or procedure in a food

process at which a control measure can

be applied and at which control is

essential to reduce an identified food

hazard to an acceptable level.

(e) Critical limit means the maximum

or minimum value to which a physical,

biological, or chemical parameter must

be controlled at a critical control point

to prevent, eliminate, or reduce to an

acceptable level the occurrence of the

identified food hazard.

(f) Culled means separation of

damaged fruit from undamaged fruit.

For processors of citrus juices using

treatments to fruit surfaces to comply

with § 120.24, culled means undamaged,

tree-picked fruit that is U.S. Department

of Agriculture choice or higher quality.

(g) Food hazard means any biological,

chemical, or physical agent that is

reasonably likely to cause illness or

injury in the absence of its control.

(h) Importer means either the U.S.

owner or consignee at the time of entry

of a food product into the United States,

or the U.S. agent or representative of the

foreign owner or consignee at the time

of entry into the United States. The

importer is responsible for ensuring that

goods being offered for entry into the

United States are in compliance with all

applicable laws. For the purposes of this

definition, the importer is ordinarily not

the custom house broker, the freight

forwarder, the carrier, or the steamship

representative.

(i) Monitor means to conduct a

planned sequence of observations or

measurements to assess whether a

process, point, or procedure is under

control and to produce an accurate

record for use in verification.

(j)(1) Processing means activities that

are directly related to the production of

juice products.

(2) For purposes of this part,

processing does not include:

(i) Harvesting, picking, or transporting

raw agricultural ingredients of juice

products, without otherwise engaging in

processing; and

(ii) The operation of a retail

establishment.

(k) Processor means any person

engaged in commercial, custom, or

institutional processing of juice

products, either in the United States or

in a foreign country, including any

person engaged in the processing of

juice products that are intended for use

in market or consumer tests.

(l) Retail establishment is an

operation that provides juice directly to

the consumers and does not include an

establishment that sells or distributes

juice to other business entities as well

as directly to consumers. ‘‘Provides’’

includes storing, preparing, packaging,

serving, and vending.

(m) Shall is used to state mandatory

requirements.

(n) Shelf-stable product means a

product that is hermetically sealed and,

when stored at room temperature,

should not demonstrate any microbial

growth.

(o) Should is used to state

recommended or advisory procedures or

to identify recommended equipment.

(p) Validation means that element of

verification focused on collecting and

evaluating scientific and technical

information to determine whether the

HACCP plan, when properly

implemented, will effectively control

the identified food hazards.

(q) Verification means those activities,

other than monitoring, that establish the

validity of the HACCP plan and that the

system is operating according to the

plan.

§ 120.5 Current good manufacturing

practice.

Part 110 of this chapter applies in

determining whether the facilities,

methods, practices, and controls used to

process juice are safe, and whether the

food has been processed under sanitary

conditions.

§ 120.6 Sanitation standard operating

procedures.

(a) Sanitation controls. Each processor

shall have and implement a sanitation

standard operating procedure (SSOP)

that addresses sanitation conditions and

practices before, during, and after

processing. The SSOP shall address:

(1) Safety of the water that comes into

contact with food or food contact

surfaces or that is used in the

manufacture of ice;

(2) Condition and cleanliness of food

contact surfaces, including utensils,

gloves, and outer garments;

(3) Prevention of cross contamination

from insanitary objects to food, food

packaging material, and other food

contact surfaces, including utensils,

gloves, and outer garments, and from

raw product to processed product;

(4) Maintenance of hand washing,

hand sanitizing, and toilet facilities;

(5) Protection of food, food packaging

material, and food contact surfaces from

adulteration with lubricants, fuel,

pesticides, cleaning compounds,

sanitizing agents, condensate, and other

chemical, physical, and biological

contaminants;

(6) Proper labeling, storage, and use of

toxic compounds;

(7) Control of employee health

conditions that could result in the

microbiological contamination of food,

food packaging materials, and food

contact surfaces; and

(8) Exclusion of pests from the food

plant.

(b) Monitoring. The processor shall

monitor the conditions and practices

during processing with sufficient

frequency to ensure, at a minimum,

conformance with those conditions and

practices specified in part 110 of this

chapter that are appropriate both to the

plant and to the food being processed.

Each processor shall correct, in a timely

manner, those conditions and practices

that are not met.

(c) Records. Each processor shall

maintain SSOP records that, at a

minimum, document the monitoring

and corrections prescribed by paragraph

(b) of this section. These records are

subject to the recordkeeping

requirements of § 120.12.

(d) Relationship to Hazard Analysis

and Critical Control Point (HACCP)

plan. Sanitation standard operating

procedure controls may be included in

the HACCP plan required under

§ 120.8(b). However, to the extent that

they are implemented in accordance

with this section, they need not be

included in the HACCP plan.

§ 120.7 Hazard analysis.

(a) Each processor shall develop, or

have developed for it, a written hazard

analysis to determine whether there are

food hazards that are reasonably likely

to occur for each type of juice processed

by that processor and to identify control

measures that the processor can apply to

control those hazards. The written

hazard analysis shall consist of at least

the following:

(1) Identification of food hazards;

(2) An evaluation of each food hazard

identified to determine if the hazard is

reasonably likely to occur and thus,

constitutes a food hazard that must be

addressed in the HACCP plan. A food

hazard that is reasonably likely to occur

is one for which a prudent processor

would establish controls because

experience, illness data, scientific

reports, or other information provide a

basis to conclude that there is a

reasonable possibility that, in the

absence of those controls, the food

hazard will occur in the particular type

of product being processed. This

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6199

evaluation shall include an assessment

of the severity of the illness or injury if

the food hazard occurs;

(3) Identification of the control

measures that the processor can apply to

control the food hazards identified as

reasonably likely to occur in paragraph

(a)(2) of this section;

(4) Review of the current process to

determine whether modifications are

necessary; and

(5) Identification of critical control

points.

(b) The hazard analysis shall include

food hazards that can be introduced

both within and outside the processing

plant environment, including food

hazards that can occur before, during,

and after harvest. The hazard analysis

shall be developed by an individual or

individuals who have been trained in

accordance with § 120.13 and shall be

subject to the recordkeeping

requirements of § 120.12.

(c) In evaluating what food hazards

are reasonably likely to occur,

consideration should be given, at a

minimum, to the following:

(1) Microbiological contamination;

(2) Parasites;

(3) Chemical contamination;

(4) Unlawful pesticides residues;

(5) Decomposition in food where a

food hazard has been associated with

decomposition;

(6) Natural toxins;

(7) Unapproved use of food or color

additives;

(8) Presence of undeclared ingredients

that may be allergens; and

(9) Physical hazards.

(d) Processors should evaluate

product ingredients, processing

procedures, packaging, storage, and

intended use; facility and equipment

function and design; and plant

sanitation, including employee hygiene,

to determine the potential effect of each

on the safety of the finished food for the

intended consumer.

(e) HACCP plans for juice need not

address the food hazards associated

with microorganisms and microbial

toxins that are controlled by the

requirements of part 113 or part 114 of

this chapter. A HACCP plan for such

juice shall address any other food

hazards that are reasonably likely to

occur.

§ 120.8 Hazard Analysis and Critical

Control Point (HACCP) plan.

(a) HACCP plan. Each processor shall

have and implement a written HACCP

plan whenever a hazard analysis reveals

one or more food hazards that are

reasonably likely to occur during

processing, as described in § 120.7. The

HACCP plan shall be developed by an

individual or individuals who have

been trained in accordance with

§ 120.13 and shall be subject to the

recordkeeping requirements of § 120.12.

A HACCP plan shall be specific to:

(1) Each location where juice is

processed by that processor; and

(2) Each type of juice processed by the

processor. The plan may group types of

juice products together, or group types

of production methods together, if the

food hazards, critical control points,

critical limits, and procedures required

to be identified and performed by

paragraph (b) of this section are

essentially identical, provided that any

required features of the plan that are

unique to a specific product or method

are clearly delineated in the plan and

are observed in practice.

(b) The contents of the HACCP plan.

The HACCP plan shall, at a minimum:

(1) List all food hazards that are

reasonably likely to occur as identified

in accordance with § 120.7, and that

thus must be controlled for each type of

product;

(2) List the critical control points for

each of the identified food hazards that

is reasonably likely to occur, including

as appropriate:

(i) Critical control points designed to

control food hazards that are reasonably

likely to occur and could be introduced

inside the processing plant

environment; and

(ii) Critical control points designed to

control food hazards introduced outside

the processing plant environment,

including food hazards that occur

before, during, and after harvest;

(3) List the critical limits that shall be

met at each of the critical control points;

(4) List the procedures, and the

frequency with which they are to be

performed, that will be used to monitor

each of the critical control points to

ensure compliance with the critical

limits;

(5) Include any corrective action plans

that have been developed in accordance

with § 120.10(a), and that are to be

followed in response to deviations from

critical limits at critical control points;

(6) List the validation and verification

procedures, and the frequency with

which they are to be performed, that the

processor will use in accordance with

§ 120.11; and

(7) Provide for a recordkeeping system

that documents the monitoring of the

critical control points in accordance

with § 120.12. The records shall contain

the actual values and observations

obtained during monitoring.

(c) Sanitation. Sanitation controls

may be included in the HACCP plan.

However, to the extent that they are

monitored in accordance with § 120.6,

they are not required to be included in

the HACCP plan.

§ 120.9 Legal basis.

Failure of a processor to have and to

implement a Hazard Analysis and

Critical Control Point (HACCP) system

that complies with §§ 120.6, 120.7, and

120.8, or otherwise to operate in

accordance with the requirements of

this part, shall render the juice products

of that processor adulterated under

section 402(a)(4) of the Federal Food,

Drug, and Cosmetic Act. Whether a

processor’s actions are consistent with

ensuring the safety of juice will be

determined through an evaluation of the

processor’s overall implementation of

its HACCP system.

§ 120.10 Corrective actions.

Whenever a deviation from a critical

limit occurs, a processor shall take

corrective action by following the

procedures set forth in paragraph (a) or

paragraph (b) of this section.

(a) Processors may develop written

corrective action plans, which become

part of their HACCP plans in accordance

with § 120.8(b)(5), by which processors

predetermine the corrective actions that

they will take whenever there is a

deviation from a critical limit. A

corrective action plan that is

appropriate for a particular deviation is

one that describes the steps to be taken

and assigns responsibility for taking

those steps, to ensure that:

(1) No product enters commerce that

is either injurious to health or is

otherwise adulterated as a result of the

deviation; and

(2) The cause of the deviation is

corrected.

(b) When a deviation from a critical

limit occurs, and the processor does not

have a corrective action plan that is

appropriate for that deviation, the

processor shall:

(1) Segregate and hold the affected

product, at least until the requirements

of paragraphs (b)(2) and (b)(3) of this

section are met;

(2) Perform or obtain a review to

determine the acceptability of the

affected product for distribution. The

review shall be performed by an

individual or individuals who have

adequate training or experience to

perform such review;

(3) Take corrective action, when

necessary, with respect to the affected

product to ensure that no product enters

commerce that is either injurious to

health or is otherwise adulterated as a

result of the deviation;

(4) Take corrective action, when

necessary, to correct the cause of the

deviation; and

6200 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

(5) Perform or obtain timely

verification in accordance with § 120.11,

by an individual or individuals who

have been trained in accordance with

§ 120.13, to determine whether

modification of the HACCP plan is

required to reduce the risk of recurrence

of the deviation, and to modify the

HACCP plan as necessary.

(c) All corrective actions taken in

accordance with this section shall be

fully documented in records that are

subject to verification in accordance

with § 120.11(a)(1)(iv)(B) and the

recordkeeping requirements of § 120.12.

§ 120.11 Verification and validation.

(a) Verification. Each processor shall

verify that the Hazard Analysis and

Critical Control Point (HACCP) system

is being implemented according to

design.

(1) Verification activities shall

include:

(i) A review of any consumer

complaints that have been received by

the processor to determine whether

such complaints relate to the

performance of the HACCP plan or

reveal previously unidentified critical

control points;

(ii) The calibration of process

monitoring instruments;

(iii) At the option of the processor, the

performance of periodic end-product or

in-process testing; except that

processors of citrus juice that rely in

whole or in part on surface treatment of

fruit shall perform end-product testing

in accordance with § 120.25.

(iv) A review, including signing and

dating, by an individual who has been

trained in accordance with § 120.13, of

the records that document:

(A) The monitoring of critical control

points. The purpose of this review shall

be, at a minimum, to ensure that the

records are complete and to verify that

the records document values that are

within the critical limits. This review

shall occur within 1 week (7 days) of the

day that the records are made;

(B) The taking of corrective actions.

The purpose of this review shall be, at

a minimum, to ensure that the records

are complete and to verify that

appropriate corrective actions were

taken in accordance with § 120.10. This

review shall occur within 1 week (7

days) of the day that the records are

made; and

(C) The calibrating of any process

monitoring instruments used at critical

control points and the performance of

any periodic end-product or in-process

testing that is part of the processor’s

verification activities. The purpose of

these reviews shall be, at a minimum, to

ensure that the records are complete and

that these activities occurred in

accordance with the processor’s written

procedures. These reviews shall occur

within a reasonable time after the

records are made; and

(v) The following of procedures in

§ 120.10 whenever any verification

procedure, including the review of

consumer complaints, establishes the

need to take a corrective action; and

(vi) Additional process verification if

required by § 120.25.

(2) Records that document the

calibration of process monitoring

instruments, in accordance with

paragraph (a)(1)(iv)(B) of this section,

and the performance of any periodic

end-product and in-process testing, in

accordance with paragraph (a)(1)(iv)(C)

of this section, are subject to the

recordkeeping requirements of § 120.12.

(b) Validation of the HACCP plan.

Each processor shall validate that the

HACCP plan is adequate to control food

hazards that are reasonably likely to

occur; this validation shall occur at least

once within 12 months after

implementation and at least annually

thereafter or whenever any changes in

the process occur that could affect the

hazard analysis or alter the HACCP plan

in any way. Such changes may include

changes in the following: Raw materials

or source of raw materials; product

formulation; processing methods or

systems, including computers and their

software; packaging; finished product

distribution systems; or the intended

use or consumers of the finished

product. The validation shall be

performed by an individual or

individuals who have been trained in

accordance with § 120.13 and shall be

subject to the recordkeeping

requirements of § 120.12. The HACCP

plan shall be modified immediately

whenever a validation reveals that the

plan is no longer adequate to fully meet

the requirements of this part.

(c) Validation of the hazard analysis.

Whenever a juice processor has no

HACCP plan because a hazard analysis

has revealed no food hazards that are

reasonably likely to occur, the processor

shall reassess the adequacy of that

hazard analysis whenever there are any

changes in the process that could

reasonably affect whether a food hazard

exists. Such changes may include

changes in the following: Raw materials

or source of raw materials; product

formulation; processing methods or

systems, including computers and their

software; packaging; finished product

distribution systems; or the intended

use or intended consumers of the

finished product. The validation of the

hazard analysis shall be performed by

an individual or individuals who have

been trained in accordance with

§ 120.13, and, records documenting the

validation shall be subject to the

recordkeeping requirements of § 120.12.

§ 120.12 Records.

(a) Required records. Each processor

shall maintain the following records

documenting the processor’s Hazard

Analysis and Critical Control Point

(HACCP) system:

(1) Records documenting the

implementation of the sanitation

standard operating procedures (SSOP’s)

(see § 120.6);

(2) The written hazard analysis

required by § 120.7;

(3) The written HACCP plan required

by § 120.8;

(4) Records documenting the ongoing

application of the HACCP plan that

include:

(i) Monitoring of critical control

points and their critical limits,

including the recording of actual times,

temperatures, or other measurements, as

prescribed in the HACCP plan; and

(ii) Corrective actions, including all

actions taken in response to a deviation;

and

(5) Records documenting verification

of the HACCP system and validation of

the HACCP plan or hazard analysis, as

appropriate.

(b) General requirements. All records

required by this part shall include:

(1) The name of the processor or

importer and the location of the

processor or importer, if the processor

or importer has more than one location;

(2) The date and time of the activity

that the record reflects, except that

records required by paragraphs (a)(2),

(a)(3), and (a)(5) of this section need not

include the time;

(3) The signature or initials of the

person performing the operation or

creating the record; and

(4) Where appropriate, the identity of

the product and the production code, if

any. Processing and other information

shall be entered on records at the time

that it is observed. The records shall

contain the actual values and

observations obtained during

monitoring.

(c) Documentation. (1) The records in

paragraphs (a)(2) and (a)(3) of this

section shall be signed and dated by the

most responsible individual onsite at

the processing facility or by a higher

level official of the processor. These

signatures shall signify that these

records have been accepted by the firm.

(2) The records in paragraphs (a)(2)

and (a)(3) of this section shall be signed

and dated:

(i) Upon initial acceptance;

(ii) Upon any modification; and

Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations 6201

(iii) Upon verification and validation

in accordance with § 120.11.

(d) Record retention. (1) All records

required by this part shall be retained at

the processing facility or at the

importer’s place of business in the

United States for, in the case of

perishable or refrigerated juices, at least

1 year after the date that such products

were prepared, and for, in the case of

frozen, preserved, or shelf stable

products, 2 years or the shelf life of the

product, whichever is greater, after the

date that the products were prepared.

(2) Offsite storage of processing

records required by paragraphs (a)(1)

and (a)(4) of this section is permitted

after 6 months following the date that

the monitoring occurred, if such records

can be retrieved and provided onsite

within 24 hours of request for official

review. Electronic records are

considered to be onsite if they are

accessible from an onsite location and

comply with paragraph (g) of this

section.

(3) If the processing facility is closed

for a prolonged period between seasonal

packs, the records may be transferred to

some other reasonably accessible

location at the end of the seasonal pack

but shall be immediately returned to the

processing facility for official review

upon request.

(e) Official review. All records

required by this part shall be available

for review and copying at reasonable

times.

(f) Public disclosure. (1) All records

required by this part are not available

for public disclosure unless they have

been previously disclosed to the public,

as defined in § 20.81 of this chapter, or

unless they relate to a product or

ingredient that has been abandoned and

no longer represent a trade secret or

confidential commercial or financial

information as defined in § 20.61 of this

chapter.

(2) Records required to be maintained

by this part are subject to disclosure to

the extent that they are otherwise

publicly available, or that disclosure

could not reasonably be expected to

cause a competitive hardship, such as

generic type HACCP plans that reflect

standard industry practices.

(g) Records maintained on computers.

The maintenance of computerized

records, in accordance with part 11 of

this chapter, is acceptable. § 120.13

Training.

(a) Only an individual who has met

the requirements of paragraph (b) of this

section shall be responsible for the

following functions:

(1) Developing the hazard analysis,

including delineating control measures,

as required by § 120.7.

(2) Developing a Hazard Analysis and

Critical Control Point (HACCP) plan that

is appropriate for a specific processor,

in order to meet the requirements of

§ 120.8;

(3) Verifying and modifying the

HACCP plan in accordance with the

corrective action procedures specified

in § 120.10(b)(5) and the validation

activities specified in § 120.11(b) and

(c); and § 120.7;

(4) Performing the record review

required by § 120.11(a)(1)(iv).

(b) The individual performing the

functions listed in paragraph (a) of this

section shall have successfully

completed training in the application of

HACCP principles to juice processing at

least equivalent to that received under

standardized curriculum recognized as

adequate by the Food and Drug

Administration, or shall be otherwise

qualified through job experience to

perform these functions. Job experience

may qualify an individual to perform

these functions if such experience has

provided knowledge at least equivalent

to that provided through the

standardized curriculum. The trained

individual need not be an employee of

the processor.

§ 120.14 Application of requirements to

imported products.

This section sets forth specific

requirements for imported juice.

(a) Importer requirements. Every

importer of juice shall either:

(1) Obtain the juice from a country

that has an active memorandum of

understanding (MOU) or similar

agreement with the Food and Drug

Administration, that covers the food and

documents the equivalency or

compliance of the inspection system of

the foreign country with the U.S.

system, accurately reflects the

relationship between the signing parties,

and is functioning and enforceable in its

entirety; or

(2) Have and implement written

procedures for ensuring that the juice

that such importer receives for import

into the United States was processed in

accordance with the requirements of

this part. The procedures shall provide,

at a minimum:

(i) Product specifications that are

designed to ensure that the juice is not

adulterated under section 402 of the

Federal Food, Drug, and Cosmetic Act

because it may be injurious to health or

because it may have been processed

under insanitary conditions; and

(ii) Affirmative steps to ensure that

the products being offered for entry

were processed under controls that meet

the requirements of this part. These

steps may include any of the following:

(A) Obtaining from the foreign

processor the Hazard Analysis and

Critical Control Point (HACCP) plan and

prerequisite program of the standard

operating procedure records required by

this part that relate to the specific lot of

food being offered for import;

(B) Obtaining either a continuing or

lot specific certificate from an

appropriate foreign government

inspection authority or competent third

party certifying that the imported food

has been processed in accordance with

the requirements of this part;

(C) Regularly inspecting the foreign

processor’s facilities to ensure that the

imported food is being processed in

accordance with the requirements of

this part;

(D) Maintaining on file a copy, in

English, of the foreign processor’s

hazard analysis and HACCP plan, and a

written guarantee from the foreign

processor that the imported food is

processed in accordance with the

requirements of this part;

(E) Periodically testing the imported

food, and maintaining on file a copy, in

English, of a written guarantee from the

foreign processor that the imported food

is processed in accordance with the

requirements of this part; or

(F) Other such verification measures

as appropriate that provide an

equivalent level of assurance of

compliance with the requirements of

this part.

(b) Competent third party. An

importer may hire a competent third

party to assist with or perform any or all

of the verification activities specified in

paragraph (a)(2) of this section,

including writing the importer’s

verification procedures on the

importer’s behalf.

(c) Records. The importer shall

maintain records, in English, that

document the performance and results

of the affirmative steps specified in

paragraph (a)(2)(ii) of this section. These

records shall be subject to the applicable

provisions of § 120.12.

(d) Determination of compliance. The

importer shall provide evidence that all

juice offered for entry into the United

States has been processed under

conditions that comply with this part. If

assurances do not exist that an imported

juice has been processed under

conditions that are equivalent to those

required of domestic processors under

this part, the product will appear to be

adulterated and will be denied entry.

6202 Federal Register / Vol. 66, No. 13 / Friday, January 19, 2001 / Rules and Regulations

Subpart B—Pathogen Reduction

§ 120.20 General.

This subpart augments subpart A of

this part by setting forth specific

requirements for process controls.

§ 120.24 Process controls.

(a) In order to meet the requirements

of subpart A of this part, processors of

juice products shall include in their

Hazard Analysis and Critical Control

Point (HACCP) plans control measures

that will consistently produce, at a

minimum, a 5 log (i.e., 105) reduction,

for a period at least as long as the shelf

life of the product when stored under

normal and moderate abuse conditions,

in the pertinent microorganism. For the

purposes of this regulation, the

‘‘pertinent microorganism’’ is the most

resistant microorganism of public health

significance that is likely to occur in the

juice. The following juice processors are

exempt from this paragraph:

(1) A juice processor that is subject to

the requirements of part 113 or part 114

of this chapter; and

(2) A juice processor using a single

thermal processing step sufficient to

achieve shelf-stability of the juice or a

thermal concentration process that

includes thermal treatment of all

ingredients, provided that the processor

includes a copy of the thermal process

used to achieve shelf-stability or

concentration in its written hazard

analysis required by § 120.7.

(b) All juice processors shall meet the

requirements of paragraph (a) of this

section through treatments that are

applied directly to the juice, except that

citrus juice processors may use

treatments to fruit surfaces, provided

that the 5-log reduction process begins

after culling and cleaning as defined in

§ 120.3(a) and (f) and the reduction is

accomplished within a single

production facility.

(c) All juice processors shall meet the

requirements of paragraphs (a) and (b) of

this section and perform final product

packaging within a single production

facility operating under current good

manufacturing practices. Processors

claiming an exemption under paragraph

(a)(1) or (a)(2) of this section shall also

process and perform final product

packaging of all juice subject to the

claimed exemption within a single

production facility operating under

current good manufacturing practices.

§ 120.25 Process verification for certain

processors.

Each juice processor that relies on

treatments that do not come into direct

contact with all parts of the juice to

achieve the requirements of § 120.24

shall analyze the finished product for

biotype I Escherichia coli as follows:

(a) One 20 milliliter (mL) sample

(consisting of two 10 mL subsamples)

for each 1,000 gallons of juice produced

shall be sampled each production day.

If less than 1,000 gallons of juice is

produced per day, the sample must be

taken for each 1,000 gallons produced

but not less than once every 5 working

days that the facility is producing that

juice. Each subsample shall be taken by

randomly selecting a package of juice

ready for distribution to consumers.

(b) If the facility is producing more

than one type of juice covered by this

section, processors shall take

subsamples according to paragraph (a)

of this section for each of the covered

juice products produced.

(c) Processors shall analyze each

subsample for the presence of E. coli by

the method entitled ‘‘Analysis for

Escherichia coli in Citrus Juices—

Modification of AOAC Official Method

992.30’’ or another method that is at

least equivalent to this method in terms

of accuracy, precision, and sensitivity in

detecting E. coli. This method is

designed to detect the presence or

absence of E. coli in a 20 mL sample of

juice (consisting of two 10 mL

subsamples). The method is as follows:

(1) Sample size. Total-20 mL of juice;

perform analysis using two 10 mL

aliquots.

(2) Media. Universal Preenrichment

Broth (Difco, Detroit, MI), EC Broth

(various manufacturers).

(3) Method. ColiComplete (AOAC

Official Method 992.30—modified).

(4) Procedure. Perform the following

procedure two times:

(i) Aseptically inoculate 10 mL of

juice into 90 mL of Universal

Preenrichment Broth (Difco) and

incubate at 35 °C for 18 to 24 hours.

(ii) Next day, transfer 1 mL of

preenriched sample into 10 mL of EC

Broth, without durham gas vials. After

inoculation, aseptically add a

ColiComplete SSD disc into each tube.

(iii) Incubate at 44.5 °C for 18 to 24

hours.

(iv) Examine the tubes under

longwave ultra violet light (366 nm).

Fluorescent tubes indicate presence of

E. coli.

(v) MUG positive and negative

controls should be used as reference in

interpreting fluorescence reactions. Use

an E. coli for positive control and 2

negative controls—a MUG negative

strain and an uninoculated tube media.

(d) If either 10 mL subsample is

positive for E. coli, the 20 mL sample is

recorded as positive and the processor

shall:

(1) Review monitoring records for the

control measures to attain the 5-log

reduction standard and correct those

conditions and practices that are not

met. In addition, the processor may

choose to test the sample for the

presence of pathogens of concern.

(2) If the review of monitoring records

or the additional testing indicates that

the 5-log reduction standard was not

achieved (e.g., a sample is found to be

positive for the presence of a pathogen

or a deviation in the process or its

delivery is identified), the processor

shall take corrective action as set forth

in § 120.10.

(e) If two samples in a series of seven

tests are positive for E. coli, the control

measures to attain the 5-log reduction

standard shall be deemed to be

inadequate and the processor shall

immediately:

(1) Until corrective actions are

completed, use an alternative process or

processes that achieve the 5-log

reduction after the juice has been

expressed;

(2) Perform a review of the monitoring

records for control measures to attain

the 5-log reduction standard. The

review shall be sufficiently extensive to

determine that there are no trends

towards loss of control;

(i) If the conditions and practices are

not being met, correct those that do not

conform to the HACCP plan; or

(ii) If the conditions and practices are

being met, the processor shall validate

the HACCP plan in relation to the 5-log

reduction standard; and

(3) Take corrective action as set forth

in § 120.10. Corrective actions shall

include ensuring no product enters

commerce that is injurious to health as

set forth in § 120.10(a)(1).

Dated: December 20, 2000.

Jane E. Henny,

Commissioner of Food and Drugs.

Donna E. Shalala,

Secretary of Health and Human Services.

[FR Doc. 01–1291 Filed 1–18–01; 8:45 am]

BILLING CODE 4160–01–P