65096 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 123 and 1240

[Docket No. 93N–0195]

RIN 0910–AA10

Procedures for the Safe and Sanitary

Processing and Importing of Fish and

Fishery Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is adopting final

regulations to ensure the safe and

sanitary processing of fish and fishery

products (hereinafter referred to as

seafood), including imported seafood.

The regulations mandate the application

of Hazard Analysis Critical Control

Point (HACCP) principles to the

processing of seafood. HACCP is a

preventive system of hazard control that

can be used by processors to ensure the

safety of their products to consumers.

FDA is issuing these regulations because

a system of preventive controls is the

most effective and efficient way to

ensure that these products are safe.

DATES: Effective December 18, 1997.

Submit written comments on the

information collection requirements by

February 16, 1996.

ADDRESSES: Submit written comments

on the information collection

requirements to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Philip C. Spiller, Center for Food Safety

and Applied Nutrition (HFS–401), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3133.

For further information concerning

the guidance entitled ‘‘Fish and Fishery

Products Hazards and Controls Guide,’’

contact: Donald W. Kraemer (address

above).

SUPPLEMENTARY INFORMATION: The

contents of this preamble are listed in

the following outline:

Table of Contents

I. Background

A. The Proposal

B. Factual Basis for the Proposal—

Summary

II. The Comments

A. Legal Basis

1. Introduction

2. General Authority

3. Insanitary Conditions

4. Records

5. Relevance of Section 404 of the Act

B. HACCP Pro and Con

1. Overview

2. The Significance of the Illness Data

3. Exempt Specific Industry Segments?

4. Would Voluntary HACCP be Superior?

5. Other Issues

C. Should Some Types of Processors be

Exempt?

1. Exempt Low Risk?

2. Exempt Small Processors?

D. Definitions

1. General

2. Cooked, Ready-to-Eat Fishery Product

3. Critical Control Point (CCP)

4. Critical Limit (CL)

5. Fish

6. Fishery Product

7. Food Safety Hazard

8. Harvester

9. Importer

10. Lot of Molluscan Shellfish

11. Molluscan Shellfish

12. Potable Water

13. Preventive Measure

14. Process Monitoring Instument

15. Processing and Processor

a. Vessels, carriers, and retail

b. Warehouses

c. Other processing operations

16. Scombroid Toxin Forming Species

17. Shellfish Control Authority

18. Smoked and Smoke-Flavored Fishery

Products

E. The HACCP Plan

1. Preliminary Steps

2. Conducting a Hazard Analysis

3. Types of Hazards

4. When is a Hazard Reasonably Likely to

Occur?

5. The Plan: Specific Considerations

6. Positive Versus Negative Recordkeeping

7. Signing the Plan

8. Relationship to Parts 113 and 114

9. Sanitation in the Plan

10. Nonsafety Issues

11. ‘‘Shall Render Adulterated’’

F. Corrective Actions

1. Should Corrective Actions be

Predetermined?

2. Assessing the Product for Safety

3. Documenting Corrective Actions

G. Verification

1. Overview and Comments

2. Need for Verification Requirement in

Regulations

3. Verifying the HACCP Plan

4. Verifying the Implementation of the Plan

5. Product Testing

6. Records Review

7. Verifying the Hazard Analysis

H. Consumer Complaints

1. Background

2. Consumer Complaints as Verification

Tools

3. Agency Access to Consumer Complaints

I. Records

1. Details and Signatures

2. Retention and Storage

3. Confidentiality of Records

4. Agency Access to Records

5. Agency Copying of Records

J. Training

1. The Need for Mandatory Training

2. Who Should Provide Training?

3. Should Training be ‘‘Grandfathered?’’

4. Course Curriculum

5. Do Importers Need Training?

6. Testing and Retraining

7. Gradations of Training

8. Duties of the Trained Individual

K. Sanitation

1. Background

2. Should the Regulations Deal with

Sanitation?

3. Why Isn’t Part 110 (21 CFR Part 110)

Adequate to Deal with Sanitation

Concerns?

4. Why Isn’t the Proposed Approach

Appropriate?

5. What is the Appropriate Approach to

Sanitation?

a. Inclusion of Sanitation Controls in

HACCP Plans

b. SSOP

6. Monitoring and Corrective Actions

7. Records

L. Imports

1. Background

2. Should Imports be Subject to These

Regulations?

3. Should Importers be Subject to These

Regulations?

4. Memoranda of Understanding (MOU’s)

5. Importer Verification Procedures

6. Affirmative Steps: General

7. Foreign Processor HACCP Plans

8. Other Affirmative Steps

9. Importer Records

10. Determination of Compliance

M. Guidelines or Regulations?

1. Background

2. Cooked, Ready-to-Eat Products and

Scombroid Species

3. Smoked and Smoke-Flavored Fishery

Products

N. Molluscan Shellfish

1. Background

2. Should There be Specific Requirements

for Raw Molluscan Shellfish?

3. Cooked Versus Raw Molluscan Shellfish

4. Shellfish Control Authorities

5. Shellfish From Federal Waters

6. Tagging and Recordkeeping

Requirements

7. Other Considerations

O. Compliance and Effective Date

1. Effective Date

2. Public Meetings

3. Penalties for Noncompliance

4. Preapproval of HACCP Plans

5. Filing Plans With FDA

6. Third Party-Approval

7. The First Inspection

8. Role of the FDA Investigator

9. Disagreements and Appeals

10. Status of the ‘‘Guide’’

11. Trade with the EU

12. Measuring Program Success

P. Other Issues

1. Relationship to Other Programs

2. ‘‘Whistleblower’’ Protection

3. Separation of Quality Control (QC) and

Production

4. Education

5. Traceback Mechanisms

6. Tribal Governments

7. HACCP System Improvements

III. Paperwork Reduction Act of 1995

IV. Economic Impact

A. Introduction
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65097

B. Costs

1. Alternative Model for Estimating the

Costs

a. Small plant cost example 1

i. Critical Control Points (CCP)

ii. Corrective Actions

b. Small Plant Cost Example 2

2. Other Cost Reports

3. Seafood Prices

C. Benefits

1. Safety Benefits

2. Summary of Safety Benefits

3. Nutrition Benefits from Mandatory

Seafood HACCP and Increased

Consumer Confidence

4. Rent Seeking

5. Export Benefits

6. Reduce Enforcement Costs

a. Seizures

b. Detentions

c. Automatic Detentions

d. Recalls

e. Injunctions

7. Other Benefits

C. Benefits

D. Costs and Benefits of Sanitation

E. Costs and Benefits Attributable to

Foreign Governments

F. Conclusion

G. Final Regulatory Flexibility Analysis

V. Environmental Impact

VI. References

List of Subjects

I. Background

A. The Proposal

In the Federal Register of January 28,

1994 (59 FR 4142), FDA published a

proposed rule to establish requirements

relating to the processing and importing

of seafood for commercial distribution

in the United States. The requirements

involved the application of HACCP

principles by processors and importers

to ensure food safety to the maximum

extent practicable. HACCP is a system

by which food processors evaluate the

kinds of hazards that could affect their

products, institute controls to keep

these hazards from occurring or to

significantly minimize their occurrence,

monitor the performance of those

controls, and maintain records of this

monitoring as a matter of routine

practice.

In addition to publishing the

proposed rule, FDA published in the

Federal Register of April 7, 1994 (59 FR

16655), a notice of availability of draft

guidelines, primarily directed toward

processors, on how to develop HACCP

controls for specific types of processing

operations. The notice of availability

requested comments on the draft.

Among other things, these draft

guidelines, which were titled the ‘‘Fish

and Fishery Products Hazards and

Controls Guide’’ (the Guide),

inventoried known likely food safety

hazards associated with many species of

seafood and many processing methods

and made recommendations on ways to

control those hazards. Comments

received by FDA on the draft Guide are

under review. The agency intends to

publish the first edition of the Guide

before the effective date of these

regulations.

FDA established on the proposed rule

a comment period of 90 days, to end on

April 28, 1994. The agency also asked

for comment on the draft guidelines by

the same date. During that comment

period, FDA held public meetings in

nine cities to help ensure that the public

was aware of the proposal, to answer

questions about its contents, and to

encourage participation in the

rulemaking process through the

submission of comments. In addition, at

these meetings, FDA staff explained to

the public how to use the draft

guidelines to develop HACCP controls

in specific processing operations.

The agency received several written

requests for an extension of the

comment period. After considering

these requests, FDA published a notice

in the Federal Register on April 7, 1994

(59 FR 16578), announcing a 30-day

extension of the comment period to May

31, 1994, for both the proposed rule and

the draft guidelines.

B. Factual Basis for the Proposal—

Summary

In the preamble to the proposed rule,

FDA stated five principal reasons for

this initiative: (1) To create a more

effective and efficient system for

ensuring the safety of seafood than

currently exists; (2) to enhance

consumer confidence; (3) to take

advantage of the developmental work on

the application of HACCP-type

preventive controls for seafood that had

already been undertaken by industry,

academia, some States, and the Federal

government; (4) to respond to requests

by seafood industry representatives that

the Federal government institute a

mandatory, HACCP-type inspection

system for their products; and (5) to

provide U.S. seafood with continued

access to world markets, where HACCPtype controls are increasingly becoming

the norm.

The preamble to the proposal cited

the conclusion of a 1991 study on

seafood safety by the National Academy

of Sciences’ (NAS) Institute of Medicine

that, while most seafoods on the market

are unlikely to cause illness to the

consumer, there are significant areas of

risk and illnesses that do occur. The

study concluded that improvements in

the current system of regulatory control

are needed and repeatedly

recommended the application of

HACCP controls where warranted.

Ensuring the safety of seafood

presents special challenges to both the

industry and the regulator. Seafood

consists of hundreds of edible species

from around the world. Depending upon

species and habitat, seafood can be

subject to a wide range of hazards before

harvest, including bacteria and viruses,

toxic chemicals, natural toxins, and

parasites. The harvesting of previously

underutilized species—a practice that is

increasing because of the depletion of

traditionally harvested species—can be

expected to create new source and

process hazards that must be identified

and controlled.

Unlike beef and poultry, seafood is

still predominately a wild-caught flesh

food that frequently must be harvested

under difficult conditions and at

varying distances from processing,

transport, and retail facilities. It is also

subject to significant recreational

harvest, some of which finds its way

into commercial channels. As fish

farming (aquaculture) increases, new

problems emerge as a result of habitat,

husbandry, and drug use.

An additional complicating factor in

ensuring the safety of seafood is the fact

that no other flesh food is imported in

the quantity, or from as many countries,

as seafood. Over 55 percent of seafood

consumed in this country is imported

from approximately 135 countries.

Several of these countries have

advanced regulatory structures for

seafood safety, but many others are

developing nations that lack

infrastructures capable of supporting

national programs for seafood

regulations comparable to those in more

developed nations.

To ensure safety, it is of utmost

importance that those who handle and

process seafood commercially

understand the hazards associated with

this type of food, know which hazards

are associated with the types of

products with which they are involved,

and keep these hazards from occurring

through a routine system of preventive

controls. For the most part, however,

seafood processors and importers are

not required, through licensure or

examination, to demonstrate an

understanding of seafood hazards as a

prerequisite to being able to do

business. In fact, there is evidence that

such an understanding does not exist in

a significant portion of the industry. A

survey conducted by FDA from 1992 to

1993 of manufacturers of ready-to-eat

seafood products revealed that, in

significant measure, firms have not been

employing the types of preventive

processing controls necessary to ensure

a safe product by design. FDA and State

surveys have also revealed that many
65098 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

processors of smoked and smokeflavored fish are operating outside of the

parameters that have been demonstrated

through scientific research to be

necessary to ensure that the hazard from

botulism is adequately controlled.

Because of seafood’s unique

characteristics (e.g., the fact that it is

predominantly wild caught and presents

a wide range of possible hazards), FDA

began to question whether the current

Federal regulatory system, which was

developed for the general food supply,

is best suited for the seafood industry.

Seafood processors are subject to

periodic, unannounced, mandatory

inspection by FDA. These inspections

provide the agency with a ‘‘snapshot’’ of

conditions at a facility at the moment of

inspection, but assumptions must be

made about conditions before and after

that inspection. Concern about the

reliability of these assumptions over the

intervals between inspections creates

questions about the adequacy of the

system.

Inspections today verify the industry’s

knowledge of hazards and controls

largely by inference. Whether a

company produces products that are

adulterated, or whether conditions in its

plant are consistent with current good

manufacturing practice (CGMP), are

measures of how well the company

understands what is necessary to

produce a safe and wholesome product.

This system places a burden on the

Government to find a problem and to

prove that it exists, rather than on the

firm to establish for itself, for the

regulator, and for consumers, that it has

adequate controls in place to ensure

safety.

Given the nature and frequency of the

current inspection system for seafood, it

has failed to produce a situation in

which the public has full confidence in

the safety and wholesomeness of these

products. There has been a similar

failure with respect to imports.

Media and other public attention on

seafood safety, and on the adequacy of

the current regulatory program for

seafood, has been substantial in recent

years. Many hearings on the sufficiency

and direction of the Federal seafood

safety program have been held in both

Houses of Congress since the late

1980’s, and numerous bills have been

considered for the stated purpose of

improving seafood safety. This public

concern has motivated representatives

of the U.S. seafood industry to request

that FDA develop a HACCP-based

program for these products.

Although not a public health issue,

international trade is also a major

consideration in determining the

advisability and benefits of a new

system of seafood regulation.

Participation in the international trade

in seafood is critical to U.S. consumers

and to the U.S. seafood industry. The

United States is the world’s second

largest seafood importing nation and the

second largest exporter of fishery

products.

The international movement toward

harmonization, coupled with the Codex

Alimentarious Commission’s adoption

of HACCP for international use, clearly

argue for the adoption of this approach

in the United States for seafood. Failure

by the United States to adopt a

mandatory, HACCP-based system could

ultimately undermine its export success,

with considerable economic

consequences. Such failure also would

undermine the United States ability to

meet growing international expectations

that it enter into mutual recognitiontype agreements with trading partners

based on HACCP.

II. The Comments

FDA received over 250 submissions

from over 200 commentors on both the

proposed regulations and the draft

Guide. Individual companies, the

majority of which are in the seafood

business, submitted slightly over half of

the comments. Nearly 40 trade

associations submitted comments. As

with the companies, the majority of

these associations represent seafood

interests, but a significant minority have

memberships reflecting a range of food

products.

Comments were also received from

consumer advocacy and similar groups,

and coalitions of such groups. All

totaled, the views of over 50

organizations were represented in these

comments.

Other commenters included State

agencies, the Association of Food and

Drug Officials (AFDO), the Interstate

Shellfish Sanitation Conference (ISSC),

several scientific associations and

bodies, departments of three

universities, foreign governments, and

about 25 individuals.

Overall, the comments covered

virtually every aspect of the proposal

and guidelines. FDA appreciates the

effort, interest, and thoughtfulness

reflected by these comments.

The following materials address the

significant comments that were received

on the proposed regulations, both on the

specific provisions of the proposal and

on related matters. The materials on the

provisions of the proposed regulations

explain, among other things, why the

agency did or did not modify the

provisions based on the comments. Any

provisions not addressed below were

not changed substantively or were not

the subject of significant comment.

FDA will respond to those comments

that relate solely to the draft Guide

when the first edition of that document

is completed and made available to the

public. The agency intends to address

those comments in a notice of

availability to be published in the

Federal Register.

A. Legal Basis

1. Introduction

About 25 comments addressed the

legal basis for these regulations. Nearly

half of these comments were either

companies that process foods other than

seafood or trade associations that

represent such companies, some of who

indicated that they were motivated to

comment, at least in part, by the

possible precedent that these

regulations could set for HACCP

programs beyond seafood. Some of these

comments deferred comment on the

legal basis for the HACCP regulations

for seafood but commented on whether

the legal basis that FDA was proposing

for seafood would be appropriate for

mandatory HACCP programs for other

kinds of foods.

FDA is issuing these HACCP

regulations for seafood under various

sections of the Federal Food, Drug, and

Cosmetic Act (the act), including, most

significantly, sections 402 (a)(1) and

(a)(4) and 701(a) (21 U.S.C. 342 (a)(1)

and (a)(4) and 371(a)). Section 402(a)(1)

of the act states that a food is

adulterated if it bears or contains any

poisonous or deleterious substance that

may render the food injurious to health.

Section 402(a)(4) of the act states that 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). The question is thus

whether the conditions in a plant are

such that it is reasonably possible that

the food may be rendered injurious to

health. The agency believes that, if a

seafood processor does not incorporate

certain basic controls into its procedures

for preparing, packing, and holding

food, it is reasonably possible that the

food may be rendered injurious to

health and, therefore, adulterated under

the act. Section 701(a) of the act
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65099

authorizes the agency to adopt

regulations for the efficient enforcement

of the act.

2. General Authority

1. One comment stated that FDA had

not met its responsibility to present the

shortcomings in the existing law when

demonstrating the need for these

regulations.

FDA believes that this comment is

misguided. The agency’s statutory

authority is not deficient in this area.

FDA does have a responsibility,

however, to demonstrate that there is a

need for the regulations, and that the

regulations are reasonably related to the

purposes of the act that they are

designed to advance. FDA has fulfilled

this responsibility.

As outlined above, the act provides a

broad statutory framework for Federal

regulation to ensure human food will

not be injurious to health and to prevent

commerce in adulterated foods. As the

record in this proceeding amply

demonstrates, there is a range of

circumstances and conditions that have

raised concerns about how the safety of

seafood sold in this country is ensured.

Given these concerns and its

responsibility under the act, FDA has

concluded that it is necessary to require

that firms incorporate certain basic

measures into how they process

seafood. The agency also concludes that

failure to incorporate these measures

into a firm’s processing procedures

would mean that the firm would be

producing the product under insanitary

conditions whereby it may be rendered

injurious to health. (See United States v.

Nova Scotia Food Products Corp., 568

F.2d 240, 247 (2d Cir. 1977).)

2. A few comments took the view that

FDA lacked the authority to issue these

regulations because Congress had

considered legislation relating to

seafood safety in recent years but had

not enacted it. Much of this legislation

contained provisions authorizing the

establishment of a mandatory Federal

inspection program based on HACCPtype principles. According to the

comments, Congress’ failure to

authorize this program after considering

doing so indicated that the contents of

FDA’s seafood HACCP regulations

remain within the domain of Congress

and have not been delegated to FDA to

implement.

FDA does not agree with this

contention. Unquestionably, seafood

safety has received considerable

attention from Congress in recent years,

most notably in the late 1980’s through

the early 1990’s. Many hearings were

held on the subject in both the House of

Representatives and the Senate during

this period, and several bills were

introduced in both chambers. The high

water mark for this activity occurred at

the end of the 101st Congress when

differing seafood safety bills passed both

chambers. These bills could not be

reconciled before the end of the term,

however, so nothing was enacted.

Legislation introduced in the 102d

Congress did not pass either chamber.

The fact that Congress has considered

the issue of seafood safety, however,

does not preclude FDA from

implementing a mandatory seafood

HACCP program. The effect of

legislation that was never enacted on a

Federal agency’s initiatives was

considered in National Confectioners

Association v. Califano, 569 F.2d 690,

693 n.9 (D.C. Cir. 1978), a case involving

a challenge to FDA’s statutory authority

to issue good manufacturing practice

regulations for candy making. The court

rejected an argument that the existence

of legislation that was not enacted that

would have given FDA express

authority to require some of the things

that the agency included in its

regulations indicated that Congress

intended to exclude such authority from

the act as it was then written. Instead,

as will be discussed below, in

upholding the validity of the

regulations, the court looked at whether

the statutory scheme as a whole justified

the promulgation of the regulations.

It is true that a deliberate refusal by

Congress to authorize a specific program

would at least be one factor to be

weighed in determining the validity of

a regulation. See Toilet Goods

Association v. Gardner, 387 U.S. 158

(1967). The expiration of the 101st

Congress before competing seafood bills

could be reconciled did not, however,

amount to a refusal on the part of

Congress to authorize a mandatory

HACCP program, including HACCPbased inspections for seafood. Thus,

FDA concludes that there is no merit to

the comments’ assertion.

3. Insanitary Conditions

3. Several comments, most of whom

were trade associations or companies

involved in the processing of products

other than seafood, questioned whether

section 402(a)(4) of the act was an

appropriate authority upon which to

base a mandatory HACCP program.

Most of the concern hinged on whether

a failure to have a HACCP plan, or to

keep HACCP records, could really be

considered an ‘‘insanitary’’ condition

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

questioned whether safety issues

relating to chemical or physical hazards,

or to pesticides, unapproved additives,

and drug residues, as included in the

proposed regulations, could be deemed

to have been the result of insanitary

conditions. Two comments expressed

the view that section 402(a)(4) of the act

does not concern food safety generally

but only safety problems caused by

insanitary conditions.

The relevant case law supports a

broad reading of ‘‘insanitary.’’ In Nova

Scotia, supra, 568 F.2d at 247, the court

read ‘‘insanitary’’ to cover a wide set of

circumstances necessary to ensure that

food was not produced under

conditions that may render it injurious

to health. Specifically, the court

concluded that FDA’s regulations

mandating time-temperature-salinity

requirements for smoked fish products

were within the agency’s statutory

authority under section 402(a)(4) of the

act. The court rejected the argument that

‘‘insanitary’’ limited coverage under

section 402(a)(4) of the act only to

bacterial hazards that could enter the

raw fish from equipment in the

processing environment and not to

proper processing to kill bacteria that

entered the processing facility in the

raw fish itself.

Acceptance of a restrictive reading of

section 402(a)(4) of the act, the court in

Nova Scotia noted, would probably

invalidate several existing FDA

regulations, including those relating to

the thermal processing of low-acid

canned foods in part 113 (21 CFR part

113). When dealing with the public

health, the court concluded, the statute

should not be read too restrictively but

consistent with the act’s overall purpose

to protect the public health. (See also

United States v. Bacto-Unidisk, 394 U.S.

784, 798 (1969); United States v.

Dotterweich, 320 U.S. 277, 280 (1943).)

4. Notwithstanding these cases, one

comment cited the case of United States

v. General Foods Corp, 446 F. Supp 740

(1978), aff’d 591 F.2d 1332 (2d Cir.

1978), for the proposition that a failure

to have a HACCP plan could not alone

be a violation of section 402(a)(4) of the

act because it would not constitute

insanitation.

FDA does not agree that the General

Foods case stands for this proposition.

Rather, the court in General Foods

explicitly recognized that ‘‘[b]ecause the

purpose of 402(a)(4) is to prevent

contamination, or nip it in the bud,

actual contamination of the finished

product need not be shown.’’ Id. at 752.

Significantly, the court appeared to be

impressed with the preventive controls

that were in place in the defendant’s

plant and took these into consideration

in deciding that the agency had failed to

prove that section 402(a)(4) of the act

had been violated. However, the court

did not deal at all with the limits on
65100 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

FDA’s authority to do rulemaking under

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

to establish standards for such

preventive controls.

Thus, it is not inconsistent with

General Foods for FDA to adopt HACCP

regulations that are designed to define

the minimum steps that a seafood

processor must take to ensure that the

food that it produces is not prepared

under conditions that may render it

injurious to health. Clearly, given the

risks inherent in many seafood

operations, if a processor does not

identify the critical control points in its

process, and does not monitor what goes

on at those points, there is a reasonable

possibility that the food that it produces

will be injurious to health.

A primary objective of the seafood

HACCP regulations is to establish a

system of preventive controls for human

food safety. The HACCP plan is a

fundamental step in the development of

these controls. It is the step in which the

manufacturer analyzes its process,

identifies the points at which problems

may occur, and establishes the

parameters that must be met if those

problems are to be avoided. Thus,

failure to have a HACCP plan would, in

fact, constitute an ‘‘insanitary

condition’’ as this term must be

understood in light of the relevant case

law.

Section 402(a)(4) was added to the act

to ensure ‘‘the observance of those

precautions which consciousness of the

obligation imposed upon producers of

perishable food products should require

in the preparation of food for

consumption by human beings.’’

Hearings before the Senate Committee

on Commerce, S. 2800, 73d Cong., 2d

Sess., Mar. 1934, as cited in United

States v. 1,200 Cans, Pasteurized Whole

Eggs, Etc., supra, 339 F. Supp. 140–141.

Clearly, HACCP reflects the emerging,

internationally recognized

understanding of the precautions

necessary to produce safe food. These

regulations embrace HACCP and

provide processors with directions for

establishing HACCP systems and

operating them as a matter of routine

custom and habit that will ensure the

safety of the food that they produce.

Thus, FDA finds that operation under

an effective HACCP system is necessary

to meet a processor’s obligation under

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

4. Records

In Confectioners, the court upheld

FDA’s authority to issue regulations

under section 402(a)(4) of the act that

included recordkeeping requirements.

The recordkeeping provisions of the

regulations were challenged on the

grounds that they would permit

prosecution where processing

conditions were completely sanitary,

but the records were deficient. Such an

outcome, it was argued, would be

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

the act.

Citing Toilet Goods, the court rejected

this argument and held that the primary

consideration was whether the statutory

scheme as a whole, not just section

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

agency’s regulations. The court pointed

out that this consideration involved an

inquiry into practicalities as well as

statutory purpose, i.e., enforcement

problems encountered by FDA and the

need for various forms of supervision in

order to accomplish the goals of the act.

5. Two comments expressed the view

that the holding in Confectioners should

be limited to the specific facts in that

case. One comment stated that the case

only upheld FDA’s authority to impose

recordkeeping requirements on firms to

facilitate recalls of potentially

dangerous products. The other comment

noted that the case only granted FDA

access to shipping records. The

comment pointed out that FDA already

has access to such records from carriers

under section 703 of the act.

While it is true that the records that

FDA was requiring, and to which the

agency claimed access under the

regulations involved in Confectioners,

were source coding and distribution

records in order to facilitate recalls, the

court’s ruling involved broad principles

relating to the validity of the regulations

generally and was not limited to recalls

or shipping records. The court stated

that in light of the statutory scheme as

a whole, ‘‘we find no basis for the

Association’s distinction between the

FDA’s role in preventing and remedying

commerce in adulterated foods. The

agency believes that the Act imposes on

the FDA an equal duty to perform each

role.’’ Id. at 694. This statement simply

is not consistent with the narrow

reading suggested by the comment.

Rather, it fully supports FDA’s authority

to adopt regulations to prevent the

introduction of adulterated foods into

interstate commerce. Clearly,

compliance with FDA’s seafood HACCP

regulations will help to achieve that

end.

It is also true, as one comment

pointed out, that section 703 of the act

expressly grants FDA access to shipping

records and not to the kinds of

processing records required in these

regulations. FDA cannot agree, however,

that Confectioners stands for the

proposition that FDA should have

access only to food manufacturers’

shipping records because those are the

only kinds of records to which FDA has

access under section 703 of the act. The

court concluded that the narrow scope

of section 703 of the act is not a

limitation on the right of the agency to

require recordkeeping and have access

to records that are outside the scope of

section 703 of the act, so long as the

recordkeeping requirement is limited,

clearly assists the efficient enforcement

of the act, and the burden of

recordkeeping is not unreasonably

onerous (569 F.2d at 693 n.9).

The recordkeeping required under

these regulations passes the

Confectioners test. First, the

recordkeeping requirements are limited.

The HACCP recordkeeping and record

access requirements in the final rule are

tied specifically to the critical control

points (CCP’s) in the manufacturing

process. In other words, the

recordkeeping requirements are limited

to those points in the process at which

control is essential if assurance that the

resultant product will not be injurious

to health is to be achieved.

Second, the recordkeeping assists in

the efficient enforcement of the act. The

recordkeeping requirements, by

focusing on the CCP’s, ensure that the

processor and the agency focus on those

aspects of processing that most

jeopardize food safety. Unlike the

current inspection system,

recordkeeping in a HACCP-type system

documents that preventive controls are

being followed and enables the regulator

to verify this fact. Such a system,

therefore, assists in effective and

efficient enforcement of the act.

Finally, the HACCP-recordkeeping

burden is not unduly onerous. It is

limited to those aspects of processing

that are critical to food safety.

Documentation that control is being

maintained over these aspects of

processing need only be a minor

additional step in most instances. The

documentation required in the final rule

is narrowly tailored to ensure that only

essential information needs to be

recorded.

6. Several comments questioned

whether FDA may have access to

HACCP records and plans on the

grounds that the act does not explicitly

authorize such access. Some of these

comments pointed to the lack of

authorization in section 704 of the act

(21 U.S.C. 74), the provision that

authorizes the inspection of food

processors and other types of

establishments. The comments pointed

out that section 704 of the act authorizes

agency access to certain records relating

to prescription drugs and medical

devices during the course of those

inspections but not to records relating to
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65101

foods. One comment felt that the

specific grant of records access for drugs

and devices in section 704 of the act

precluded expansion of access to

records not specifically mentioned in

the act. Other comments felt that FDA

was barred from access simply because

the act does not expressly grant it.

FDA does not agree, as the agency’s

authority under sections 402 and 701(a)

of the act to issue these regulations

provides ample authority for records

access. The line of cases cited above

stands for the proposition that a lack of

explicit delegated authority does not

invalidate agency regulations so long as

the regulations are consistent with the

act’s overriding purpose. In

Confectioners, the court upheld FDA’s

authority to adopt recordkeeping

requirements in the absence of an

explicit delegation of authority. In that

case, moreover, the court found no

evidence that Congress intended to

immunize food processors from limited

recordkeeping (569 F.2d at 695).

Similarly, the court in Nova Scotia

concluded, in the absence of such

evidence, that there was no impediment

to a broad reading of the statute based

on the general purpose of the Congress

in protecting public health (568 F.2d at

248).

FDA has concluded, therefore, that

these regulations are consistent with

section 704 of the act and with the act

as a whole. 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. The case law supports FDA’s

authority to require such recordkeeping

and to have access to such records.

Other countries, including Canada,

the European Union (EU) Norway,

Australia, and New Zealand, which

have already implemented HACCP-type

systems, have deemed it necessary to

the success of their systems to provide

for recordkeeping and record access

along the lines of this regulation (for

either their entire seafood industries or

seafood export industries). Thus, it is

widely accepted that recordkeeping and

inspectional access are essential

components of a HACCP-type seafood

system. In addition, in order to maintain

other countries’ faith in the safety

standards of U.S. seafood exports, FDA

needs similar access to records showing

HACCP implementation.

7. One comment expressed the view

that the copying of records by FDA, as

authorized by these regulations, is

beyond the scope of section 704 of the

act.

FDA points out that it is not acting

under section 704 of the act. To

effectuate the broad purposes of the act,

there may be some circumstances in

which access to the records would be

meaningless without the opportunity to

copy them. While the agency does not

anticipate that copying will be

necessary in most instances, perhaps the

most readily predictable circumstance

in which copying would be necessary is

when an investigator needs assistance

from relevant experts in headquarters to

evaluate the record. Without copying, it

would be necessary for the agency to

rely solely on the notations and report

of the investigator.

This reliance may not be adequate in

many circumstances. For example, there

may be a deviation from a critical limit

(CL) that poses no health risks. Without

the ability to show a copy of the records

to someone within the agency with the

necessary expertise in the area, an

investigator would have to cite the

company for a violation. If, however, an

agency expert determined that the

deviation posed no safety risks, the

agency could use its enforcement

discretion not to pursue a violation.

8. One comment expressed the view

that the act does not support a

mandatory HACCP program that

includes access to records for the entire

seafood industry. According to the

comment, the act permits FDA access to

records only under extreme conditions

where there is a potential for injury, but,

the comment noted, hazards are only

associated with a small percentage of

fish.

FDA cannot agree. While it is true that

those seafood-related illnesses that are

reported to public health authorities

tend to be associated with a limited

number of species, potential hazards are

much broader. As indicated above, the

1991 NAS report on seafood safety

provides an extensive inventory of

hazards.

For the benefit of the commentor it is

worth noting that if a processor is

involved with species and processes for

which there are no food safety hazards

that are reasonably likely to occur, a

HACCP plan will not be necessary

under these regulations. As will be

discussed later in this preamble, the

agency anticipates a postimplementation dialog with firms on

whether they have hazards that must be

controlled in accordance with these

regulations and, if so, how many.

9. One comment expressed the view

that the authority to inspect ordinary

food records has not been asserted

before. This statement was made in

support of the contention that there is

no statutory basis for FDA access to

ordinary food records.

The legal basis for FDA’s access to

records has already been fully addressed

in this preamble. It is important to note

that the agency is not claiming a right

of access to food records coextensive

with that for drugs and devices under

section 704 of the act. Rather, FDA is

asserting a right to access to records that

is narrowly tailored to advance the

purposes of the sections of the act that

it is implementing here, i.e., records

relating to the CCP’s in a firm’s process.

While the agency is not sure what the

comment meant by ‘‘ordinary’’ food

records, it is worth pointing out that the

position in this regulation on agency

access to records is a longstanding

interpretation for regulations of this

type. Agency access to processing and

production records has been required

since the early 1970’s in FDA’s

regulations for thermally processed lowacid foods packaged in hermetically

sealed containers (part 113) and for

acidified foods part 114 (21 CFR 114).

As discussed in the new section, these

regulations were issued primarily under

the authority of both sections 402(a)(4)

and 404 of the act (21 U.S.C. 344),

neither of which specifically mention

access to records.

5. Relevance of Section 404 of the Act

10. Several comments expressed the

view that FDA should base HACCP

regulations on section 404 of the act

rather than on section 402(a)(4) of the

act. Some of these comments were

referring to these seafood HACCP

regulations, while others were primarily

concerned with any HACCP regulations

that FDA might issue for other foods.

Other comments expressed the view

that FDA’s existing low-acid canned

food regulations should serve as a

model for new HACCP programs.

Because some of the low-acid canned

food regulations have been issued under

section 404 of the act, all of these

comments may have been making the

same general point.

Most of those that advocated use of

section 404 of the act as the legal basis

expressed concerns about the

appropriateness of relying on section

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

grants of access to records in the act,

especially in section 704 of the act, and

concluded that the act only grants the

agency access to records under extreme

situations. One comment urged that

FDA issue the seafood HACCP

regulations under the authority of

section 404 of the act in order to

enhance the agency’s ability to achieve

compliance through the permit system.
65102 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

Section 404 of the act is entitled

‘‘Emergency Permit Control.’’ It

authorizes FDA to establish a permit

system for processors of food that may

be injurious to health when two

conditions are met: (1) Contamination is

with microorganisms, and (2) the

injurious nature of the product cannot

be adequately determined after the

product enters interstate commerce.

Section 404 of the act authorizes FDA to

inspect firms that operate under this

permit system but does not mention

records or FDA access to records.

As indicated previously, FDA has

issued regulations under this authority.

Regulations at part 108 (21 CFR part

108) subpart A establish the permit

system generally. Regulations at part

108 subpart B establish that acidified

foods and thermally processed low-acid

foods in hermetically sealed containers

(i.e., low-acid canned foods, or ‘‘LACF’’)

meet the criteria in section 404 of the

act and are therefore subject to the

permit system. Subpart B requires

processors of these foods to register with

FDA and to submit detailed information

to FDA on their manufacturing

processes.

As an adjunct to these regulations,

FDA has also issued the regulations,

referred to previously, at part 113 and

part 114 for these products. These latter

regulations require the maintenance of

day-to-day processing records that are

retained by the processor and are in

addition to the processing information

that must be sent to FDA. FDA

investigators have access to, and may

copy, these records (§§ 108.25(g) and

108.35(h)).

While the permit system may have

some compliance advantages, as pointed

out by one comment, there are other

considerations in this case that are more

important. The permit system is, as the

title of section 404 of the act declares,

an ‘‘emergency’’ system. Because it is an

extreme remedy for extreme situations,

FDA has used section 404 of the act

relatively sparingly.

In the case of seafood, although FDA

strongly believes that a HACCP system

will correct deficiencies in the current

system and provide significant further

assurance of safety, the agency cannot

conclude that seafood is in an overall

state of emergency from a public health

standpoint. This conclusion is

consistent with the position taken by

the NAS. The NAS’ Institute of

Medicine, in its 1991 report entitled

‘‘Seafood Safety,’’ devoted hundreds of

pages to areas of risk and made

numerous recommendations about

control measures, including the

application of HACCP where

appropriate. However, the NAS also

concluded that most seafood in the U.S.

marketplace is unlikely to cause illness.

FDA believes that, for seafood at least,

HACCP should be the norm rather than

an exceptional remedy for an extreme

situation. A functioning HACCP system

reflects an understanding of the wide

range of hazards to which seafood may

always be subject and provides for a

systematic application of the preventive

controls necessary to minimize the

occurrence of those hazards. It is the

most effective and efficient way known

of ensuring food safety as a matter of

design. In this regard, FDA has

concluded that, for seafood, the efficient

enforcement of the act should not have

to depend on a finding of an emergency

under section 404 of the act.

It is also worth noting that section 404

of the act would limit the application of

HACCP to hazards by reason of

contamination from microorganisms.

FDA is not aware of any HACCP expert

or authoritative body, including the

National Advisory Committee for

Microbiological Criteria for Foods

(NACMCF), which advocates limiting

HACCP to these hazards only. A full

discussion of hazards to which seafood

HACCP should apply appears later in

this preamble.

FDA does not agree that section 404

of the act is the only basis for these

seafood HACCP regulations, or that it

would be a more appropriate basis. It is

not clear, moreover, how section 404 of

the act can be cited as supporting the

proposition that the agency only has

access to records in extreme situations.

As indicated earlier, section 404 of the

act contains no express grant of access

to records. Again, FDA has concluded

from the case law that, under

appropriate circumstances, the agency

has access to specific types of records

on foods and food processing for

specific purposes, where such access is

not expressly provided for in the act,

but the agency cannot conclude that this

right is limited to extreme situations.

Some of the comments provided

examples of extreme situations to which

HACCP regulations should be limited

from their standpoint. These examples

raise important issues that will be

addressed elsewhere in this preamble.

11. Two comments expressed the

view that the LACF regulations should

serve as a model for the types of records

that would be accessible under HACCP

regulations.

FDA did in fact use the LACF

regulations as a model in that regard.

The HACCP plan required here is

similar to the scheduled processes that

processors must submit in the LACF

regulations. Likewise, there is little

difference between the HACCPmonitoring records required here and

the day-to-day processing records that

are required in LACF regulations.

B. HACCP Pro and Con

1. Overview

Nearly half of the comments included

specific statements of support or

opposition for the concept of a

mandatory HACCP program to ensure

the safety of seafood. The supporters

outnumbered the opponents by over 10

to 1.

Nearly all of those who supported the

approach also had technical comments

on various provisions in the proposal.

Some conditioned their support on the

availability of additional enforcement

authorities or resources for FDA. These

aspects of their comments will be

responded to elsewhere in this

preamble. A small number of these

comments supported the concept of a

mandatory HACCP program for seafood

but opposed the proposal as drafted.

The supporters of the concept

included most of the seafood trade

associations that commented,

businesses, consumer advocacy

organizations, Federal and State

agencies, professional societies,

academics, and a member of Congress.

The reasons for this support included:

Enhancement of consumer confidence,

the superiority of HACCP-type

preventive controls over traditional

CGMP-type controls and end-product

sampling, the view that HACCP is the

most efficient and effective way to

ensure safety, and the view that a

mandatory HACCP system reflects an

appropriate assigning of primary

responsibility to industry for producing

safe food. Other reasons included a

leveling of the competitive playing field,

both domestically and internationally;

the need for prompt adoption of a

mandatory HACCP program by FDA to

enable the seafood industry to maintain

its market position in Europe and

elsewhere throughout the world; greater

productivity; and increased industry

control over processing.

One large seafood trade association

stated:

[The association] strongly supports the

adoption of a comprehensive regulatory

program by the FDA which is designed for

fish and seafood using HACCP principles.

HACCP systems have been applied

successfully by individual firms in our

industry, and they have been shown to be a

very cost-effective way of controlling safety

hazards. Of equal importance, the adoption

of a HACCP-based regulatory program should

lead to more effective and efficient use of

FDA resources, and less disruption of the

processing and importing of seafood for

consumers.
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65103

A small number of comments

expressed opposition to the mandatory

HACCP approach for seafood, however.

One State comment expressed the view

that HACCP would not have any

significant effect on reducing illnesses

from molluscan shellfish. Another

comment stated that, overall, seafoodrelated illness data do not justify

mandatory HACCP for seafood. (Several

other comments questioned the need for

these regulations in light of the NAS’

conclusion that commercial seafood is

generally safe. These comments either

generally opposed the proposed

regulations as drafted, or opposed its

application to the comments’ segments

of the seafood industry, but did not

express opposition to mandatory

HACCP as a concept.) None of these

comments supplied any new seafoodrelated illness data.

2. The Significance of the Illness Data

The preamble to the proposed

regulations described broadly what is

known and not known about the extent

of seafood-related illness in the United

States. Foodborne illnesses tend to be

significantly underreported to public

health authorities. Consequently,

precise data on the numbers and causes

of foodborne illness in this country do

not exist. FDA does know, however, that

illness from seafood does occur, and

that a wide variety of hazards have been

identified that could cause illness from

seafood (see Ref. 7, pp. 1–13). The

overwhelming majority of these hazards

are amenable to preventive controls.

FDA’s draft Guide addresses controls for

over 20 specific types of safety hazards.

The primary purpose of these

regulations is to ensure that preventive

controls are systematically applied in

seafood processing as a matter of routine

custom and usage, and in a way that can

be verified by company management as

well as by regulatory authorities. Thus,

while the reported illness data are

highly relevant to whether these

regulations should be issued, they are

not the sole basis for the regulations.

For molluscan shellfish in particular,

FDA agrees with the commenters who

believe that the principles of the

National Shellfish Sanitation Program

(NSSP) should continue to form the

basis for the molluscan shellfish safety

program in this country. There is no

clear alternative to proper water

classification and patrol by State

authorities as the basis for molluscan

shellfish safety. HACCP provides

processors with an excellent system for

ensuring that these preventive-type

controls are adhered to in a systematic

way.

It may be argued—and some

comments made the point—that the best

way to reduce the overall number of

illnesses from raw molluscan shellfish

is to provide additional resources to the

States to enhance their water

classification and monitoring abilities.

Classifying and patrolling shellfish

harvesting waters are important means

of preventing molluscan shellfish that

have been contaminated from sewage

from entering the marketplace.

However, additional Federal resources

will probably not be available for this

purpose in the foreseeable future. It is

imperative, therefore, that the system

that is in place be made as efficient as

possible.

It would be incongruous to exempt

from a national system of preventive

controls the processors of products

identified by the NAS as the source of

the greatest numbers of seafoodassociated illnesses. FDA strongly

believes that HACCP controls will help

shellfish processors and regulators alike

to better focus on potential safety

problems and less on tangential matters

than historically has been the case. A

full discussion of the application of

HACCP to raw molluscan shellfish

appears later in this preamble.

3. Exempt Specific Industry Segments?

12. Comments stating that HACCP

systems should not be mandated for

specific industry segments usually

referred to either the crab processing or

the catfish industries. These comments

generally expressed the view that

HACCP requirements for these

industries were not necessary.

FDA advises that these regulations are

flexible enough so that HACCP-type

controls are not required where they are

not necessary, i.e., where it is

reasonably likely that hazards do not

exist. It is the agency’s experience,

however, that there are reasonably likely

hazards associated with crabmeat as a

cooked, ready-to-eat product, including

the growth of pathogens as a result of

time-temperature abuse of the product

and the potential for pathogen survival

from inadequate pasteurization. There

are reasonably likely hazards associated

with the processing of catfish (e.g.,

contamination from agricultural

chemicals, improperly used aquaculture

drugs, and a variety of hazards resulting

from the in-plant processing

operations). It is incumbent on

processors of these products to know

and control such hazards.

The agency recognizes that whether

reasonably likely hazards exist involves

case-by-case determinations. As will be

discussed in the ‘‘HACCP plan’’ section

of this preamble, processors will be

given every opportunity to demonstrate

why no hazards exist in their

operations.

4. Would Voluntary HACCP Be

Superior?

13. Some comments believed that a

voluntary approach to HACCP for

seafood would be preferable to a

mandatory approach. One reason given

for this view was that, under a

mandatory system, the risk of regulatory

action by FDA would compel processors

to design HACCP controls that were the

minimum necessary to comply with the

rule. There would be a significant

disincentive for processors to design

HACCP plans that have the greatest

practical impact on food safety out of

fear that occasional failure to meet those

higher standards would trigger a

regulatory response.

If voluntary HACCP systems were

already universal, or nearly so in the

seafood industry, and they generally

applied safety controls that were beyond

the minimum needed for safety, FDA

would see little reason to establish a

mandatory system. However, HACCP is

not the norm, and given the current

situation in the seafood industry, FDA

finds that making HACCP mandatory is

necessary to ensure that safe,

wholesome, and unadulterated product

is produced. Thus, FDA is adopting part

123 (21 CFR part 123).

The agency acknowledges the

possibility that, under a mandatory

system, firms will perceive that they are

on safer ground with FDA if they

establish minimum acceptable controls

that are more easily met, rather than

more stringent controls that are beyond

the minimum necessary to ensure safety

and, therefore, are harder to meet. For

example, in deciding what CCP’s to

identify in a HACCP plan, a processor

might err on the side of inclusion under

a voluntary plan but keep the number of

CCP’s down to the minimum acceptable

to FDA if having a plan is mandatory.

It remains to be seen whether

processors will really choose to behave

this way under a mandatory system. The

choices that processors will make may

depend, in part, on FDA policy toward

HACCP plans that are beyond the

minimum. The logic in favor of the

agency initiating regulatory action when

a processor fails to meet its own CL but

succeeds in meeting a minimum level

that would have been an acceptable CL

to FDA, would be that the firm is out of

control vis a vis its own preventive

process. The logic against initiating

regulatory action would be that the

processor is still in control in terms of

meeting minimum necessary safety

parameters, and that the product is, in
65104 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

FDA’s opinion, safe to eat. As an

additional factor, FDA does not want to

discourage firms from establishing

preventive controls for themselves that

are beyond the minimum necessary to

ensure safety.

In evaluating monitoring records,

FDA will first determine whether the

recorded values are within the

processor’s critical limits as set out in

its HACCP plan. Where values are found

that are outside the CL’s, the agency will

determine the cause and extent of such

occurrences, and what corrective action,

if any, the processor has taken. Where

product that was involved in a CL

deviation was distributed without first

being subjected to appropriate

corrective action, FDA will determine

the cause and extent of the control

failure.

In determining the appropriate agency

regulatory response to CL deviations,

FDA will assess the public health risk

that the product poses. This assessment

will, in part, involve a determination of

whether the minimum limit necessary

to ensure safety was breached. FDA

acknowledges that this level and the

processor’s CL may not always be the

same. The agency is not likely to take

action against a product that it finds

poses no significant public health risk,

regardless of whether it has or has not

met the processor’s CL.

Nonetheless, processors must

establish controls to ensure that

appropriate corrective actions are taken

when their CL’s are breached. Where

such controls fail, FDA expects

processors to redesign their control

mechanisms as necessary. Chronic

failure to appropriately respond to CL

deviations demonstrates that a

processor’s HACCP system is

inadequate, and that fact could cause

FDA to have some regulatory concern.

14. Another comment urged that

HACCP for seafood should be voluntary

on the grounds that FDA lacks the

resources and statutory enforcement

authorities to operate a mandatory

system. Other comments expressed the

same types of concerns about FDA

resources and enforcement authorities

without concluding that a voluntary

system would be preferable. One

comment, from a consumer advocacy

organization representing several other

organizations, supported the concept of

a mandatory HACCP system but

expressed reservations about FDA’s

ability to adequately perform HACCPbased inspections of processors without

additional resources. Other commenters

expressed the same kinds of concerns.

The comment pointed out that because

HACCP inspections will take longer

than current inspections, the intervals

between inspections will increase

significantly, creating ‘‘an unenforced

industry honor system.’’ The

commenter, and some others, also

advocated additional enforcement

authorities.

The success of this program will

depend on a number of factors. One of

these factors, unquestionably, will be

the ability of a regulatory authority, or

authorities, to adequately monitor

processors’ HACCP systems through

inspections. If the frequency of

inspections is too low, safety may not be

ensured, consumer confidence may be

eroded, and the accusation that the

program is self-regulatory may have

merit, even though a HACCP-based

inspection allows the investigator to

view a firm’s critical operations over

time, not just at the moment of the

inspection.

The use of a HACCP-based system

bears on the adequacy of FDA’s

inspection resources in two important

respects. The first is the effect of the use

of HACCP-based inspections on

inspection frequencies. The time needed

to conduct a HACCP-based inspection

will undoubtedly vary depending on the

number of hazards, complexity of the

operation, and other factors. The first

round of HACCP inspections will likely

take longer—possibly as much as twice

as long in high-risk and complex

operations—as the CGMP-based

inspections FDA presently conducts,

but the time-per-inspection is likely to

drop significantly thereafter. It remains

to be seen whether inspection times will

eventually shorten to current times, or

whether HACCP-based inspections will

always take longer on average. In any

event, FDA finds some merit in the

comments’ basic concerns about

inspection frequencies.

Second, as a countervailing matter, a

HACCP-based inspection can be a more

efficient and effective inspection than a

CGMP-based inspection, largely because

it can be highly focused on matters that

are critical to safety, and because access

to key safety monitoring records allows

the investigator to evaluate the process

over time. Thus, some compensation for

increased intervals between inspections

will be provided by the fact that the

investigator gets not merely a snapshot

of the operation of the plant in time but

a broad view of how the plant has been

operated over the preceding months or

even years, as reflected in the plant’s

records. Thus, FDA concludes that, on

balance, the somewhat longer

inspection intervals that might occur

under a HACCP-based system would be

fully compensated for by the broader

view provided by a HACCP-based

inspection.

In addition, FDA intends to increase

the frequency and improve the

consistency of processor inspections

through HACCP-based work sharing

partnerships with the States. One of the

agency’s goals is for these regulations to

serve as a basis for partnerships that

involves a pooling of resources.

While FDA acknowledges the

comments’ concerns about resources,

the agency would not agree that the

HACCP program should be abandoned

because of resource constraints. Quite

the contrary, resource constraints make

it imperative that FDA seafood

inspections be based on the most

effective and efficient system devised to

date. HACCP is that system. Moreover,

the agency believes that there is enough

flexibility in a HACCP-based inspection

system to permit gradations in

implementation (e.g., focusing on the

most extreme hazards; selectively

reviewing records) to accommodate

whatever resource situation exists at any

given moment.

With regard to enforcement

authorities, as made clear above, the act

provides ample authority for the

establishment and implementation of a

HACCP-based system by FDA.

Regardless of whether additional

authorities might be desirable, there

simply is no reason for FDA not to

proceed to establish and implement a

HACCP-based system forthwith.

15. Another comment expressed

opposition to mandatory HACCP for the

seafood industry on the grounds that

HACCP diverts the responsibility for

ensuring a safe product from the

government to the fish processors.

FDA’s intent is not to transfer its

legitimate responsibilities with regard to

food safety to the regulated industry. In

point of fact, the industry already has

responsibility under the law to produce

a safe product. HACCP helps to clarify,

however, how responsibility for human

food safety is divided between industry

and the regulator.

Industry, as stated above, must take

primary responsibility for the

production of safe food, while the

regulator must be responsible for setting

standards (including program

regulations such as these), verifying that

the industry is doing its job, and taking

remedial action when it is not. HACCP

requires that the industry be aware of

the human food safety hazards that are

reasonably likely to occur, and that

industry operate under a system that is

designed to ensure that those hazards

are not realized. Thus, HACCP enables

the industry to demonstrate that it is

meeting its legitimate responsibilities.
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65105

5. Other Issues

16. One comment supported the

concept of HACCP but expressed the

view that the regulation drafting process

should be started over by forming a

committee consisting of representatives

from various segments of the seafood

industry, and appropriate government

and university personnel. A few other

comments expressed the view that FDA

had acted too quickly in issuing the

proposed regulations and also requested

that FDA start over by engaging in

discussions with industry, foreign

regulatory agencies, academia, and

consumers. These latter comments,

which were mostly from companies not

primarily involved in the processing of

seafood, preferred a voluntary approach

to HACCP, with mandatory applications

only in exceptional situations. FDA did

not act too quickly, or without

appropriate consultation, in issuing the

proposal in this proceeding. As the

preamble to the proposed rule

documented at some length, the

proposal was the culmination of an

extensive process by FDA and others,

including the seafood industry itself,

that led major representatives of that

industry to request the issuance of the

proposal. Before that, industry trade

associations testified repeatedly before

Congress in the late 1980’s through the

early 1990’s in support of legislation

that would have required a mandatory

inspection system for seafood based on

HACCP principles.

FDA participated in pilot programs in

the past such as the seafood HACCP

pilot conducted jointly by FDA and the

National Marine Fisheries Service

(NMFS) of the Department of Commerce

(DOC) in 1990 to 1991. In addition, FDA

ran programs with seven other

countries. In developing these

regulations, the agency also took

advantage of information from the

Model Seafood Surveillance Project

(MSSP). The MSSP was conducted by

the DOC at the request of Congress in

1986 to design an inspection system for

seafood consistent with HACCP

principles. As part of the MSSP project,

49 workshops were conducted involving

1,200 industry, State, and university

participants. Canada currently has a

HACCP system, and the EU has issued

directives that move in that direction.

The agency has concluded that

sufficient field trials have already taken

place to conclude that HACCP is a

viable method of hazard control for the

seafood industry.

Public input into the development of

the HACCP approach contained in these

regulations has been substantial. As

described earlier in this preamble, FDA

engaged in a series of ‘‘town meetings’’

in nine cities across the country shortly

after the proposal was published in

order to answer questions about the

proposed regulations and encourage

comments. The public response to

FDA’s proposal contributed

substantially to the contents of the final

regulations.

C. Should Some Types of Processors Be

Exempt?

In the preamble to the proposed

regulations FDA asked for comment on

whether either processors of ‘‘low-risk’’

products or small processors, or both,

should be exempted from the

requirements of the final regulations.

The agency asked for information on

whether the regulatory burden could be

reduced without compromising the

public health protection goals of the

regulations, and whether there exists a

rational way to distinguish ‘‘high risk’’

from ‘‘low risk,’’ and big processors

from little processors, for purposes of

HACCP.

1. Exempt Low Risk?

The most obvious way of

distinguishing high-risk products from

low-risk products would be on the basis

of reported, confirmed, seafood-related

illnesses. The preamble to the proposed

regulations pointed out some problems

with this approach. First, the agency

pointed out that the underreporting and

skewed reporting that occurs with

respect to foodborne illness creates

significant concern as to whether

reported illnesses represent a reliable

enough factor to serve as the basis for

an exemption to these regulations.

Second, FDA stated that it was

concerned that there could be a

significant potential for harm that could

be controlled by HACCP but that would

not have shown up in the data that is

relied on to establish risk. For example,

while there may be no reported cases of

botulism associated with some products

that have the potential for Clostridium

botulinum toxin, the severity of the

consequences of the hazard warrant

preventive controls. Likewise, while

there may be no reported cases of

domoic acid intoxication associated

with shellfish from a particular area,

preventive controls are warranted as

soon as a such a case is made public.

Thus, the preamble asked whether

potential for harm might be a reasonable

way to distinguish high-risk from lowrisk products for purposes of an

exemption. FDA was interested in

whether comments could provide

usable criteria for such an exemption.

About 45 comments addressed the

question of whether the regulations

should apply to high-risk products only.

Roughly two-thirds of these comments

preferred a high-risk approach. For the

most part, they either did not define

‘‘high risk,’’ or defined it as including

essentially the top three reported

seafood- related illnesses (virus-related

from raw molluscan shellfish,

scombrotoxin, and ciguatoxin). For the

most part, other hazards were assumed

to represent a low risk.

17. One comment recommended that

the regulations initially cover the

hazards reported at the highest levels of

to the Centers for Disease Control and

Prevention (CDC) because these hazards

are at least known to be causing illness,

and that the agency should phase in

other hazards as appropriate if the

foodborne-illness reporting system were

to reveal a need to do so.

Few comments were received on

whether there could be a basis for

distinguishing high risk from low risk

other than reported illnesses. Some

comments suggested that the agency

should consider severity of illness as a

criterion. Some of these comments

specifically cited smoked and smokeflavored fish as products that should be

covered on this basis because of the

devastating effects of botulism. A few

comments expressed the view that

mandatory HACCP should be limited to

hazards that can cause loss of life or

irreversible injury.

Several comments objected to a ‘‘low

risk’’ exemption in any form. Some

pointed out that, given the

underreporting and skewed reporting

that exists, the CDC foodborne-illness

reporting system does not provide a

suitable basis for making determinations

of comparative risk (i.e., high risk versus

low risk). These comments expressed

concern that linking the requirements of

these regulations to illness reporting

that has already occurred would have

the effect of exempting emerging

hazards, at least until they caused

reported illness.

Other comments stated that there is

no significant advantage to exempting

low-risk products because processors of

these products will have simpler

HACCP plans than those who process

products with more potential safety

hazards. One comment stated that a

high risk-only approach made some

sense but, as a practical matter, would

negate the added assurance to

consumers from HACCP that seafood is

safe and processed under some form of

regulation. According to this comment,

from a large seafood trade association, it

is more important that the entire food

category be recognized as having been

subjected to modern safety assurance
65106 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

procedures than that the regulations

exempt the low risk end of the industry.

FDA has considered these points of

view and has concluded that, at least for

now, there is no reasonable way to

divide seafood products into high risk

and low risk for purposes of these

regulations. The comments that

suggested defining ‘‘high risk’’ in terms

of the most frequently reported illnesses

are correct that the volume of reporting

tends to concentrate substantially in the

three hazard areas mentioned above.

Because illnesses that are confirmed and

reported tend to be those that are the

most easily traced or diagnosed,

however, the relative significance of the

high level of reporting in these three

areas—as well as the drop-off in

reporting in other areas—is not fully

known. Moreover, illnesses associated

with chronic hazards are virtually

unreported because of the difficulties in

associating such illnesses to specific

food sources.

The comments did not include any

new data that would reveal whether the

risks associated with the most reported

illnesses are actually the highest risks or

only the most apparent. No new

information was provided to allow FDA

to determine whether distinguishing

high risk from low risk on the basis of

reported illnesses would constitute a

rational division for purposes of these

regulations. Nor has FDA been supplied

with information that would allow it to

conclude whether other valid criteria

exist.

FDA agrees with the comments that

pointed out that the requirements of

HACCP are less when risks are low.

Moreover, as will be discussed later in

this preamble, FDA has revised the final

regulations to provide that HACCP

plans are not required when there are no

reasonably likely safety hazards to

control. Thus, HACCP inherently tends

to distinguish between high- and lowrisk products without the need for

explicit exemptions.

FDA also agrees that broad

exemptions would put at risk some of

the principal objectives of these

regulations. Explicit exemptions make

the system less flexible and might not

cover emerging situations for which

preventive controls are necessary to

keep illnesses from occurring in the first

place. A system that includes such

exemptions would likely not provide as

much consumer confidence as would a

complete HACCP system. In addition,

FDA notes that the benefits to the

industry in international trade from

adopting a HACCP system might be

minimized if such exemptions were

adopted because the United States’

international trading partners are opting

for complete systems.

2. Exempt Small Processors?

18. Over 60 comments addressed the

question of whether the regulations

should exempt small businesses. About

five out of six of these comments

opposed an exemption.

Those that supported an exemption

for small businesses expressed concern

about the effect of the general costs of

implementation, particularly the costs

of training and recordkeeping. One

comment observed that many small

businesses are economically-strapped,

old, family enterprises that support an

often fragile local economy. Another

comment expressed the view that small

businesses should be exempt because

they are not involved in international

trade. One comment noted that the

highest volume producers (i.e., large

businesses) are where a mistake affects

the most consumers.

One comment recommended that

FDA develop exemption procedures to

relieve small companies of paperwork

and training requirements, especially if

they produce low-risk products. A few

comments suggested that small

businesses, or at least small businesses

with good records, be exempt from

‘‘positive’’ recordkeeping, i.e., recording

the results of each monitoring. Under

this kind of exemption, small businesses

would only record unusual occurrences

and corrective actions.

The majority of comments that argued

against exempting small businesses

provided a number of reasons. One

comment pointed out that as much as

half of seafood consumed in the United

States is from small firms. Several

comments stated that size is not related

to risk. Small firms are the major

producers of many high-risk products

(e.g. cooked, ready-to-eat and raw

molluscan shellfish). Thus, according to

the comment, the final regulations

would represent a futile exercise if

small firms were not included. One

comment observed that small

companies sometimes represent more of

a risk potential than large companies

due to lack of enough trained quality

control personnel. Other comments

pointed out that small businesses with

simple operations would have simple

plans and a minimum of recordkeeping.

One comment pointed to difficulties

that FDA would have in administering

exemptions to the regulations,

particularly in distinguishing between

firms that were and were not entitled to

an exemption. Another concern

expressed by comments was the

potential unfairness of exempting some

companies while requiring HACCP of

others.

One State that has implemented

mandatory HACCP for seafood

processors observed that HACCP

requirements had not proven to be an

excessive burden to small businesses in

that State.

Some comments that supported

including small businesses in the

coverage of the HACCP requirement

recommended, nonetheless, that FDA

should provide assistance to small

businesses through guidelines, model

plans, and technical and financial

assistance. Some comments

acknowledged that small firms can work

through trade groups on common plans

and training.

Other comments felt that dropping

small firms from the final regulations

would adversely affect consumer

confidence. One comment expressed

fear that the international standing of

FDA’s seafood safety program would be

in jeopardy if the regulations were to

exempt some firms.

FDA does not know how to exempt

small business without jeopardizing the

public health objectives of the

regulations. An exemption for small

processors of ‘‘low-risk’’ products

would run into the difficulties

explained above in the discussion of

whether these regulations should only

apply to ‘‘high-risk’’ products. FDA

agrees with the comments that, in the

seafood industry, the size of the

operation often does not coincide with

the number or type of hazards that must

be controlled in order to ensure a safe

product (i.e., small size does not

automatically mean minimal hazards).

For example, cooked, ready-to-eat

seafood processing, a relatively complex

manufacturing operation, typically

requiring a larger than average number

of CCP’s, is concentrated in the small

business portion of the seafood

industry. Additionally, the processing of

raw molluscan shellfish, a product

identified by NAS as being associated

with a disproportionately large

percentage of the seafood-borne

illnesses, is most commonly performed

by small firms. FDA also agrees that,

because seafood businesses tend to be

small, an exemption for small

businesses could make HACCP the

exception, rather than the rule, in this

industry.

The concerns expressed in the

comments about the possible adverse

consequences of these regulations on

small business, however, should not be

taken lightly, and the agency has not

done so. FDA has no desire to establish

a mandatory regime that cannot be met

by otherwise responsible companies,
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65107

small or otherwise, that are producing

safe food. Indeed, these regulations are

based on the premises that: (1)

Preventive controls for safety should be

within the reach of anyone who is

producing seafood for commerce (i.e.,

preventive controls should not be

prohibitively burdensome, either

financially or conceptually); and (2) it is

in the public interest that everyone who

is producing seafood for commerce

should practice preventive control for

human food safety. The fundamental

question that the issue of whether to

exempt small business raises is whether

these premises are valid.

Having fully considered the

comments on this issue, FDA is not

persuaded that awareness of likely food

safety hazards would cause financial

hardship to small businesses, or that

having reasonable, practical controls for

those hazards will cause undue harm.

As will be discussed in the ‘‘Records’’

section of this preamble, the costs

associated with the recordkeeping

requirements of HACCP are really

incidental to the cost of monitoring and

need not place a significant burden on

small businesses. For example, after

checking the temperature of a

refrigerator, the observer need only take

an additional moment to document the

result of the observation. The agency

cannot emphasize too strongly that, in

most instances, only very simple

recordkeeping is needed to adequately

serve the purposes of the system. The

question from the agency’s standpoint,

therefore, is whether the actual

monitoring of critical operations, at

reasonable frequencies, would be

prohibitively expensive to the small

operator. FDA has not been provided

with a basis for such a conclusion.

This leaves plan development and

training as costs. The guidelines that

FDA is making available on plan

development should help substantially

to keep development costs down. FDA

is also aware that trade associations and

others are interested in developing

model plans that, when used in concert

with the guidelines, should further

reduce the resources that a firm will

need for plan development. The

creation of a HACCP plan does require

some thought and effort by the

processor to ensure that hazards and

controls are understood and identified.

Nonetheless, the guidelines and model

plans will enable small processors to be

able to apply the thought and effort

necessary to create a HACCP plan with

maximum efficiency and minimum cost.

FDA is requiring that all processors

either employ at least one trained

individual or contract for services from

at least one trained individual, as

needed. There are unavoidable costs

associated with this requirement. It is

imperative that these costs be affordable

to small business and be no greater than

necessary. As discussed at length in the

‘‘Training’’ section of this preamble,

FDA has been extensively involved with

a consortium called the ‘‘Seafood

HACCP Alliance’’ (the Alliance)

consisting of representatives from

Federal and State agencies, industry,

and academia, to create a uniform, core

training program that will meet the

requirements of these regulations and

will cost very little. The agency is also

aware of HACCP training that has been

provided for years for members of

industry by NMFS and others. As an

additional matter, FDA is allowing job

experience to serve as a form of training

in order to avoid the unnecessary

expense to a processor of having to pay

for a HACCP course when at least one

employee already has knowledge that is

equivalent to that provided by the

course.

These efforts should alleviate the

concerns of those who believe that the

training requirement will be too

burdensome on small business. The

agency will monitor the situation

closely once this training gets

underway. If costs turn out to be

significantly higher than FDA

anticipates, the agency will consider

some modification to the requirement.

While the agency regrets that grant

monies are not available to small

businesses from FDA, the effort that the

agency is investing in guidelines and

training development is a form of

subsidy that should keep costs down

generally.

D. Definitions

1. General

In addition to relying on the

definitions contained in the act and

those in the umbrella good

manufacturing practice regulations at

part 110 (21 CFR 110), FDA proposed at

§ 123.3 (a) through (t) to define 20 terms

that are essential to the interpretation of

part 123. Approximately 100 comments

addressed various aspects of the

proposed definitions at § 123.3.

The majority of the comments on

definitions were concerned with the

meanings that FDA proposed for

‘‘processor’’ (§ 123.3(n)) and

‘‘processing’’ (§ 123.3(m)). These

comments generally asked for

clarification about the applicability of

the definitions to a given commercial

activity, or contended that the

definitions should be amended to either

include or exclude certain activities.

Most of the other comments that

addressed the definitions were

primarily concerned with the meanings

proposed for ‘‘fish,’’ fishery product,’’

‘‘critical control point,’’ ‘‘cooked readyto-eat,’’ and ‘‘importer.’’ As a result of

the comments as well as agency

decisions to modify other provisions in

part 123, FDA has deleted, revised, and

added definitions to those proposed at

§ 123.3.

2. Cooked, Ready-To-Eat Fishery

Product

19. The proposed regulations

contained a definition for ‘‘cooked,

ready-to-eat fishery product’’ at

§ 123.3(b). The term was used at

proposed § 123.10(a) and in the

appendices to the proposed regulations.

The final regulations no longer contain

this term, and the appendices are not

being codified. For these reasons, FDA

has eliminated the definition of

‘‘cooked, ready-to-eat fishery product’’

from the final regulations.

Nonetheless, a large number of

comments expressed concerns about the

definition as it was proposed. In

general, the comments urged that

certain products be excluded from the

definition of ‘‘cooked, ready-to-eat

fishery products;’’ those that are not

fully cooked by the processor or that

will be recooked by the consumer, and

low-acid canned foods subject to the

provisions of part 113.

FDA recognizes the significance of the

use of the term. Because the agency has

excluded use of the term in these final

regulations, it will defer consideration

of the comments until drafting of the

Guide.

3. Critical Control Point (CCP)

FDA proposed at § 123.3(c) to define

a critical control point as ‘‘a point in a

food process where there is a high

probability that improper control may

cause, allow, or contribute to a hazard

in the final food.’’ The word ‘‘hazard’’

in this definition was intended to refer

primarily to food safety hazards. It

could also have applied to quality and

economic hazards, however, because the

agency was proposing at § 123.6(c) to

encourage processors to apply HACCP

to these hazards as well.

20. A significant number of comments

urged the agency to modify the

definition so that it clearly addresses

only food safety. These comments

recommended that the word ‘‘hazard’’

should be prefaced with either ‘‘food

safety’’ or ‘‘health,’’ or that FDA should

codify the definition for ‘‘hazard’’ that

has been recommended by the

NACMCF.

Several of the comments urged FDA

to adopt the NACMCF definition for
65108 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

‘‘critical control point’’ so that the

agency’s regulations would be

consistent with nationally and

internationally agreed upon HACCP

definitions. One objected to the phrases:

‘‘high probability,’’ because of its

connotation in statistical applications;

‘‘improper control,’’ because of a lack of

a standard for proper control; and

‘‘cause, allow, or contribute,’’ because it

could allow the elevation of trivial

concerns to critical control point status.

FDA is persuaded by those comments

that urged consistency with the

NACMCF definition for ‘‘critical control

point.’’ The agency has, therefore,

modified proposed § 123.3(c)

(redesignated as § 123.3(b)) to read,

‘‘Critical control point means a point,

step, or procedure in a food process at

which control can be applied, and a

food safety hazard can as a result be

prevented, eliminated, or reduced to

acceptable levels.’’ The modified

language is consistent with the agency’s

decision to limit the HACCP provisions

of part 123 to the avoidance of food

safety hazards (see the ‘‘HACCP Plan’’

section of this preamble for discussion).

It is also compatible with modifications

described elsewhere in this preamble

aimed at greater consistency with the

NACMCF recommendations. The

wording change will not have any

practical impact on the requirements of

the regulations because the definition

still reflects the agency’s intent to

require that seafood be processed in a

way that eliminates, to the extent

possible, the chance that it will be

rendered injurious to health by

procedures that are under the control of

the processor.

The NACMCF definition does not

contain the phrases that were objected

to by one of the comments as described

above. Thus, the concerns raised by this

comment have been resolved.

21. A few comments, however, stated

that the definition should also apply to

the control of all decomposition because

it is a major problem associated with

seafood.

FDA acknowledges that, because of

the highly perishable nature of fish,

decomposition is probably the most

common problem associated with

seafood. The agency further

acknowledges the comments that

expressed concern that failure to control

this problem will continue to adversely

affect consumer confidence. The

industry especially should heed this

concern and consider the application of

HACCP principles to decomposition, if

necessary, to help maintain the quality

of its products.

Nonetheless, decomposition that is

not associated with safety is not

appropriately a part of these mandatory

HACCP regulations but should remain

subject to traditional good

manufacturing practices controls (see,

e.g., § 110.80(b) (21 CFR 110.80(b))). As

discussed earlier, these regulations are

being issued, in part, under section

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

provides that a food is adulterated if it

is prepared, packed, or held under

insanitary conditions whereby it may

have been rendered injurious to health.

While decomposition in some species

can be injurious to health and is

therefore within the scope of section

402(a)(4) of the act, most decomposition

affects the quality of seafood but not its

safety. Decomposition that affects

quality but not safety is subject to

section 402(a)(3) of the act. Therefore,

FDA is not subjecting decomposition

that is not safety related to the

requirements of these final regulations

but will continue to regulate

decomposition under traditional CGMP

control.

FDA points out that it has defined

‘‘food safety hazard,’’ a term that the

agency uses in the definition of ‘‘critical

control point,’’ in § 123.3(f). The agency

discusses this definition, which is

consistent with the NACMCF

recommended definition, later in this

section.

4. Critical Limit (CL)

FDA proposed in § 123.3(d) to define

a ‘‘critical limit’’ as ‘‘the maximum or

minimum value to which a physical,

biological, or chemical parameter must

be controlled at a critical control point

to minimize the risk of occurrence of the

identified hazard.’’ In the preamble to

the proposed regulations, the agency

explained that the proposed definition

was intended to be consistent with the

concept of the NACMCF recommended

definition, which reads, ‘‘a criterion that

must be met for each preventive

measure associated with a critical

control point.’’ However, the proposed

definition was also intended to be more

explanatory than is the NACMCF

definition, especially as it relates to the

assignment of a minimum or maximum

value and in the relationship of these

values to a minimization of the risk,

rather than to an absolute elimination of

risk.

22. Several comments stated that the

proposed definition of a ‘‘critical limit’’

should be modified to be the definition

recommended by the NACMCF. The

comments asserted that the NACMCF

definition is the internationally

accepted standard, and that its use in

the regulations would avoid confusion.

A few comments argued that FDA’s use

of the phrase ‘‘minimize the risk’’

implies that the CL must be set to attain

the lowest possible risk, unlike the

‘‘reduce to an acceptable level’’ standard

in the NACMCF definition for CCP.

Although FDA agrees that the

definitions in these regulations should

closely adhere to the NACMCF’s

recommended definitions, the agency

concludes that, in this instance, FDA’s

wording is more descriptive for

regulatory purposes and more useful to

processors. However, FDA has been

persuaded that the phrase ‘‘minimize

the risk’’ may be misinterpreted as

requiring outcomes that are not

realistically achievable by a processor.

To provide clarification and consistency

with the revised definition of ‘‘critical

control point,’’ FDA has replaced the

phrase ‘‘minimize the risk’’ with the

phrase ‘‘prevent, eliminate, or reduce to

an acceptable level’’ in the final

regulation (now codified as § 123.3(c)).

As noted previously, this language also

appears in the NACMCF definition of

‘‘critical control point.’’ The new

language correctly provides for the

making of scientific judgments about

appropriate degrees of hazard reduction,

based on the nature of the hazard and

the availability of controls, and is more

consistent than the proposed language

with accepted HACCP convention.

23. One comment stated that the word

‘‘identified’’ should be deleted from the

proposed definition.

FDA is not persuaded to make any

modification to the definition in

response to this comment. The

‘‘identified hazard’’ refers to the hazard

identified in the HACCP plan.

24. One comment stated that the

phrase ‘‘in the end product’’ should be

added following the word ‘‘hazard’’ in

the proposed definition.

FDA is not persuaded to make any

modification to the definition in

response to this comment. Food safety

hazards are, by definition, those that

cause ‘‘a food to be unsafe for human

consumption.’’ This definition implies a

consideration of the end product that

will be offered for human consumption.

25. One comment objected to the

phrase ‘‘the maximum or minimum

value’’ in the definition, stating that, as

in the case of certain food additives,

there are situations where both a

maximum and a minimum value exist,

and a processor is required to maintain

the process between these values.

FDA is not persuaded to make any

changes to the proposed language in

response to this comment. The word

‘‘or,’’ which the agency uses in the

definition, is inclusive. Thus, properly

read, § 123.3(c) states that a CL is the

maximum value, the minimum value, or

both the maximum and minimum
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65109

values within which the parameter must

be controlled to protect against the

occurrence of a food safety hazard.

For consistency with the definition of

‘‘critical control point,’’ FDA has added

the phrase ‘‘food safety’’ before the word

‘‘hazard’’ in the text of § 123.3(c). The

language in the final regulation now

reads, ‘‘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 safety hazard.’’

5. Fish

26. FDA proposed to define ‘‘fish’’ as

‘‘fresh or saltwater finfish, molluscan

shellfish, crustaceans, and other forms

of aquatic animal life other than birds or

mammals.’’ A significant number of

comments suggested that FDA should

modify this definition to clarify whether

it includes species such as sea snails,

abalone, frogs, alligators, turtles, other

reptiles, amphibians, sea cucumbers,

plants, or algae.

FDA agrees that this type of

clarification would be helpful and has

modified the definition at § 123.3(d) to

read:

Fish means fresh or saltwater finfish,

crustaceans, other forms of aquatic animal

life (including, but not limited to, alligator,

frog, aquatic turtle, jellyfish, sea cucumber,

and sea urchin) other than birds or mammals,

and all mollusks, where such animal life is

intended for human consumption.

The term ‘‘mollusks’’ includes

abalone, sea snails, and land snails (e.g.,

escargot and any other terrestrial

gastropods, such as the giant African

land snail (Achatina fulica)). The

addition of examples of aquatic animal

life and the mention of mollusks are

intended to make clear which species

are covered by the term ‘‘fish.’’ Waterdwelling reptiles and amphibians other

than alligators, turtles, and frogs have

not been specifically listed because they

are not significant commercial food

sources in the United States. Finally,

FDA notes that, consistent with the

proposed definition, aquatic plants

(including algae) are excluded. This

definition is consistent with the

traditional treatment of these products

by FDA.

The new language also serves to

emphasize that these regulations apply

only to those products that are intended

for human consumption. This point was

explicit in the proposed definition for

‘‘fishery product’’ but was inadvertently

not mentioned in the proposed

definition of ‘‘fish.’’

27. Two comments contended that

there should be separate definitions for

finfish and shellfish, to differentiate

between relative levels of safety

concerns (e.g., high and low risk).

FDA disagrees with this comment.

Such a differentiation would serve no

purpose in these regulations. The

purpose of these regulations is to set up

a unitary system that responds to a

particular product based on the risks it

presents, not to establish a system that

is divided up based on risk presented.

The merits of differentiating between

products on the basis of risk is

addressed in the section of the preamble

entitled ‘‘Should Some Types of

Processors be Exempt?’’

6. Fishery Product

FDA proposed to define ‘‘fishery

product’’ as ‘‘any edible human food

derived in whole or in part from fish,

including fish that has been processed

in any manner.’’ The preamble to the

proposed regulations stated that the

intent of the definition was to include

products that contain seafood as an

ingredient as well as those products that

are comprised of seafood alone, because

hazards derived from seafood are

reasonably likely to occur in both types

of products.

28. A few comments urged that FDA

exclude from the meaning of ‘‘fishery

product’’ any product that is made in

whole or in part from commercially

sterilized fishery products subject to the

requirements of parts 113 and 114, (i.e.,

thermally processed low-acid canned

foods and acidified foods).

FDA disagrees with this comment.

Although such foods are required to be

produced in accordance with certain

HACCP-type control procedures to

reduce the risk of the hazard of C.

botulinum toxin production, these

control measures do not address other

potential hazards. For example, part 113

provides no assurance that the raw

material used in the canning of tuna

will be free from contamination with

dangerous levels of histamine. Likewise,

products made in part from low-acid

canned foods and acidified foods can

also present hazards that must be

addressed. For example, a salad made in

part from canned tuna can be subjected

to recontamination with pathogenic

microorganisms and time-temperature

abuse during preparation.

Although FDA cannot exclude those

products made in whole or in part from

low acid canned foods or from acidified

foods from the definition of a ‘‘fishery

product,’’ it is worth noting that the

agency has exempted processors who

are following the requirements of part

113 or part 114 from having to include

controls for C. botulinum in their

HACCP plans. This hazard is already

addressed by the requirements in those

parts (see § 123.6(e) of these regulations

and the ‘‘HACCP Plan’’ section of this

preamble).

29. One comment suggested that the

language of the proposed definition

inappropriately excludes fish roe.

FDA points out that the phrase ‘‘any

edible human food product derived in

whole or in part from fish,’’ in the

proposal was intended to cover these

products. FDA, however, has modified

the definition of ‘‘fishery product,’’ and

it no longer includes this language.

Therefore, to make clear that roe are

covered, FDA has made explicit in the

definition of ‘‘fish’’ that the roe of the

covered animals are included.

30. A significant number of comments

urged that the definition exclude

products that contain only a minimal

amount of fish. These comments

suggested various standards that FDA

should apply to exclude such foods

from the definition. These included:

Products that contain less than 50

percent fish; products that contain less

than 10 percent fish; products that

contain 2 percent or less of cooked, or

3 percent or less of raw, fish; products

in which fish is not a characterizing

ingredient; and products that contain

any nonfish ingredient unless a hazard

analysis identifies a significant hazard

associated with the fish ingredient. The

comments provided no justification for

the percentages suggested.

FDA agrees that foods that contain

inconsequential amounts of fish, such as

Worcestershire sauce, are not the types

of foods that should come under the

purview of these regulations. It is

doubtful that they pose reasonably

likely hazards associated with their fish

components. Moreover, these products

are neither represented nor perceived as

being fish-based foods.

The comments provided FDA with no

basis, however, upon which to select a

specific minimum content of fish

ingredient for the definition of ‘‘fishery

product.’’ There is no obvious minimum

percentage of fish on which to exempt

a food that contains only a small

amount of fish from the provisions of

these regulations.

Instead, the agency accepts the

comment that, to meet the definition of

a ‘‘fishery product,’’ a food should be

characterized by the qualities of the fish

that it contains. Thus, these regulations

will apply to those foods whose basic

nature is defined by the fish that they

contain. Accordingly FDA has modified

the proposed definition (§ 123.3(e)) to

read in part, ‘‘Fishery product means

any edible human food product in
65110 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

which fish is a characterizing

ingredient.’’ This revision will serve to

ensure that mandatory HACCP

requirements do not apply to products

that contain inconsequential amounts of

fish from a public health standpoint.

31. One comment stated that fish oil

that is intended for use in human food

should not be subject to the

requirements of these regulations until

it has been separated, through initial

processing, from the oil that will be

used for animal feeds and other

industrial purposes. FDA does not find

that the comment provided sufficient

justification to treat this product

differently from other human food

products processed from fish. The

agency acknowledges that the hazards

associated with these products may be

minimal. If that is the case, the fish oil

processor’s burden will also be minimal,

perhaps limited to training expenses

and the performance of a hazard

analysis. Moreover, these regulations do

not apply to products that are not for

human consumption and fish oil

processors that are confident that their

production will not be used for human

consumption need not apply the

requirements of these regulations.

7. Food Safety Hazard

32. A number of the comments

recommended that FDA define ‘‘safety

hazard’’ or ‘‘food safety hazard.’’ Several

of these comments recommended that

FDA adopt a definition that is consistent

with the NACMCF recommended

definition for ‘‘hazard.’’ The comments

were primarily concerned with the

coverage of these regulations. They

urged that the regulations be clear that

only food safety hazards need be

addressed by the HACCP plan and

argued that a definition would help to

accomplish that.

The NACMCF definition of ‘‘food

safety hazard’’ reads, ‘‘A biological,

chemical, or physical property that may

cause a food to be unsafe for

consumption.’’ While FDA provided no

definition of ‘‘food safety hazard’’ in the

proposed regulations, it did raise the

issue of the coverage of the regulations

in proposed § 123.6(b) (redesignated as

§ 123.6(c)), which mandated coverage of

food safety hazards only and listed nine

types of food safety hazards posed by

the various types of fish and fishery

products. This list included examples of

biological, chemical, and physical

hazards. Additionally, the preamble to

the proposed regulations discussed at

length the significance of a number of

these types of hazards.

FDA agrees that the meaning ascribed

by the agency to a food safety hazard

should be as clear as possible in these

regulations. The examples of hazards in

the proposed regulations—and codified

in these final regulations—are

consistent with the NACMCF definition

for a food safety hazard. Therefore, for

the sake of clarity, FDA has decided to

characterize these examples in a

definition § 123.3(f), which reads, ‘‘Food

safety hazard means any biological,

chemical, or physical property that may

cause a food to be unsafe for human

consumption.’’ The only difference

between this definition and the

NACMCF recommendation is the

addition of the word ‘‘human.’’ FDA has

included this word to prevent confusion

about the application of these

regulations to pet or animal feed.

In keeping with the new definition,

and to provide further clarification

about the nature of the hazards that are

required to be addressed by these

regulations, the term ‘‘hazard’’ has been

changed to ‘‘food safety hazard’’ where

it appears throughout the codified

portion of this document.

8. Harvester

FDA proposed to define ‘‘harvester’’

as ‘‘a person who has an identification

number issued by a shellfish control

authority for commercially taking

molluscan shellfish by any means from

a growing area.’’ After review, the

agency has concluded that it was not

necessary to limit ‘‘harvesters’’ to those

persons who have an identification

number, primarily because in some

jurisdictions, identification numbers

may not be issued by a shellfish control

authority. Without this limitation, FDA

has concluded that there is no need to

establish a particular meaning for this

term for the purposes of these

regulations. Therefore, the agency has

removed this definition from the final

regulations.

9. Importer

FDA proposed to define ‘‘importer’’ as

‘‘a person, or his representative in the

United States, who is responsible for

ensuring that goods being offered for

entry into the United States are in

compliance with all laws affecting the

importation.’’ The preamble to the

proposed regulations explained that the

importer is the owner of the imported

goods or the owner’s representative in

the United States. The preamble further

noted that freight forwarders, food

brokers, food jobbers, carriers, and

steamship representatives would not

usually be considered to be the importer

of the product for the purposes of these

regulations because they are not usually

in a position to make decisions that can

ensure the safety of the product.

However, the preamble did not

categorically rule out that these

individuals could be the importer

because sometimes they may be in a

position to make decisions relevant to

safety.

33. Several comments stated that FDA

should modify the definition of

‘‘importer’’ to specifically exclude

intermediary agents involved in the

importing process, such as freight

forwarders, licensed U.S. customs

brokers, food brokers, food jobbers,

carriers, and steamship representatives.

These comments noted that, although

imported products may enter the United

States under the name of an

intermediary, this practice is done for

convenience in handling the paperwork

at the port of entry. The comments

stated that the intermediary has little

responsibility for conducting the

negotiations with an overseas producer

and rarely takes possession of the

products. Therefore, the comments

stated, the intermediary has limited

influence on the safety of the imported

goods. Two comments pointed out, for

example, that customs brokers that

provide their clients with the service of

using the broker’s customs bond are

listed as the ‘‘importer of record’’ and

may thereby, unintentionally, be

regarded as importers under the

proposed definition, even though they

do not own or control the product being

imported.

Conversely, two comments argued

that agents, such as food brokers, should

be included in the definition of an

‘‘importer’’ because they bring product

into the United States and sell it. The

comments argued that the brokers

should, therefore, be held responsible

for ensuring that the foreign processor

complies with the provisions of these

regulations, to avoid an unfair

advantage over domestic processors.

FDA concludes, based on the

information provided in the comments,

that these intermediaries can neither be

categorically included or excluded.

However, the agency recognizes that the

number and type of comments on this

issue demonstrate that the language of

proposed § 123.3(h) was inadequate to

convey the agency’s intent, as

articulated in the preamble. For this

reason, FDA has clarified the definition

of ‘‘importer’’ in § 123.3(g) to read, in

part:

Importer means either the U.S. owner or

consignee at the time of entry 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, who is

responsible for ensuring that goods being

offered for entry into the United States are in

compliance with all laws affecting the

importation.
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65111

Reference to the owner or consignee of

the imported goods parallels the

language in section 801 of the act (21

U.S.C. 381).

Because the ownership of imported

products can change many times in a

relatively short period of time after

entry, the party who is the owner or

consignee at the time that these

products are offered for entry must be

identified as the importer. As the person

that has the ability to decide whether to

offer the product for entry, this person

is in a position to ensure that the

product is processed under appropriate

controls and to demonstrate this fact to

FDA.

FDA must be able to verify the

existence of the evidence of compliance

by the foreign processor. This evidence,

according to the provisions of § 123.12,

is to be in the possession of the

‘‘importer.’’ It must be available in the

United States, however, if FDA is to

consider the information in deciding

whether to admit the products. Thus,

where products are offered for entry by

a U.S. owner or consignee, that owner

or consignee will, for purposes of these

regulations, be considered the importer

because it will have control of this

evidence. Where products are often

offered for entry without a U.S. owner

or consignee, the U.S. agent of the

foreign owner or consignee will be

considered the ‘‘importer’’ for purposes

of these regulations to make clear who

will be expected to have this evidence

for such products.

FDA recognizes that the U.S. owner or

consignee of the product, or the U.S.

representative of the foreign owner or

consignee, at the time of entry into the

United States may also serve other

functions. For example, it may also be

a food broker for, or warehouser or

processor of, the product. It may, in

some instances, also be the freight

forwarder, customhouse broker, or

carrier for the product. These other

functions will not matter, however, if

the person is the U.S. owner or

consignee of the product, or the U.S.

representative of the foreign owner or

consignee, at the time of entry into the

United States. From FDA’s experience,

while certainly not impossible, it is at

least unlikely that this qualification will

be met by the customhouse broker, the

freight forwarder, the carrier, or the

steamship representative.

The agency has attempted to clarify

this definition by including a sentence

that reads, ‘‘For the purposes of this

definition, ordinarily the importer is not

the custom house broker, the freight

forwarder, the carrier, or the steamship

representative.’’ Further, FDA does not

intend to rely exclusively upon the

assignment of the ‘‘Importer of Record’’

or the holder of the U.S. Customs Surety

Bond in determining the ‘‘importer’’ for

the purposes of these regulations, as was

suggested in the preamble to the

proposed regulations. In some instances

the ‘‘Importer of Record’’ or the holder

of the U.S. Customs Surety Bond will

not meet the qualifications of an

importer that are set out in § 123.3(g).

10. Lot of Molluscan Shellfish

FDA proposed to define a ‘‘lot of

molluscan shellfish’’ as ‘‘a collection of

shellstock or containers of shellstock of

no more than 1 day’s harvest from a

single, defined growing area harvested

by one or more harvesters.’’ Because of

language changes that FDA has made in

subpart C of part 123, this term isno

longer used in the regulations.

Consequently, FDA has decided that

there is no need to define this term and

has eliminated the definition.

11. Molluscan Shellfish

34. Comments from a number of State

agencies, trade associations, seafood

processors, and the ISSC objected to the

use of the term ‘‘fresh or frozen’’ in the

proposed definition of ‘‘Molluscan

shellfish.’’ The comments were

concerned because this definition

would have the effect of exempting

canned and any other heat-processed

molluscan shellfish from the source

control, recordkeeping, and tagging

provisions of proposed subpart C of part

123 and proposed § 1240.60(b).

The comments stated that limiting

these provisions to raw products would

allow foreign firms to continue to heattreat or can molluscan shellfish that are

harvested from foreign waters that do

not meet National Shellfish Sanitation

Program (NSSP) standards and to export

them to the United States. The

comments stated that this situation was

not in the best interest of the public

health because of the potential for the

presence of heat-stable natural toxins,

such as paralytic shellfish poison or

amnesiac shellfish poison, as well as

chemical contaminants. The comments

also complained that, because State

laws and regulations require that all

molluscan shellfish harvested in the

United States come from waters

approved by a shellfish control

authority regardless of whether they are

to be consumed raw or

cooked,continuing to allow foreign

processors who export cooked shellfish

to the United States to use molluscan

shellfish from unapproved growing

waters places the domestic shellfish

industry at a competitive disadvantage.

FDA believes that these comments are

generally valid but are beyond the scope

of this rulemaking. The point of this

rulemaking it to determine whether

FDA should require that HACCP be

followed in the processing of seafood.

The question of whether cooked

molluscan shellfish that is being offered

for import into this country is being

harvested in a manner that creates

public health concerns and unfair

competitive advantages is a separate

matter that the agency will address, if

necessary, in the future.

Similar issues with respect to the use

of the term ‘‘fresh or frozen’’ and the

term ‘‘raw’’ in proposed subpart C of

part 123 of these regulations and in

proposed part 1240 are discussed in the

‘‘Molluscan Shellfish’’ section of this

preamble (see comment 144).

12. Potable Water

FDA proposed to define ‘‘potable

water’’ as ‘‘water which meets the U.S.

Environmental Protection Agency’s

Primary Drinking Water Regulations as

set forth in 40 CFR part 141.’’ Because

of changes that the agency has made in

proposed § 123.10 (redesignated as

§ 123.11), the term is no longer used in

these regulations. Consequently, FDA

has eliminated the definition.

Nonetheless, a significant number of

comments questioned when it would be

necessary for processing water to meet

the definition of ‘‘potable water.’’

Because it is likely that both terms (i.e.,

processing water and potable water) will

be used in the first edition of the Guide,

FDA will consider these comments

during the redrafting of the Guide.

13. Preventive Measure

FDA has added a definition for the

term ‘‘preventive measure’’ at § 123.3(i).

Although the term was not used in the

proposal, the concept of preventive

measures was a fundamental part of the

hazard analysis that was implicit in

proposed § 123.6(b). ‘‘Preventive

measure’’ is used in the final regulations

in § 123.6(a) in the description of a

hazard analysis.

FDA proposed to require that all

processors create a HAACP plan. Based

on comments received, however, as

explained below, FDA has decided to

require that processors conduct hazard

analyses to determine whether they

need to develop a HACCP plan. This

decision necessitates that FDA define

‘‘preventive measure.’’ In accordance

with the recommendations of the

NACMCF (see Ref. 34, p. 189), a hazard

analysis must identify both the food

safety hazards that are reasonably likely

to occur and the preventive measures

that are available to the processor to

control such hazards.
65112 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

Identifying the preventive measures is

necessary in order to determine whether

a processing step is a CCP for that

hazard. A processing step cannot be a

CCP for a hazard if no preventive

measure is available at that step to

control the hazard. The definition of

‘‘preventive measure’’ in these

regulations is essentially the same as

that recommended by the NACMCF.

14. Process Monitoring Instrument

The term ‘‘process control

instrument’’ was used in the proposal

for consistency with the phrase ‘‘the

procedures * * * that will be used to

control and monitor each of the critical

control points.’’ For consistency with

the NACMCF principles of HACCP,

FDA has modified the language of

§ 123.6(c)(4) to eliminate the word

‘‘control.’’ In order to achieve

consistency within these regulations,

the agency has concluded that the

appropriate term for such instruments

is, therefore, a ‘‘process monitoring

instrument.’’

15. Processing and Processor

Along with the term ‘‘importers,’’ the

terms ‘‘processor’’ and ‘‘processing’’

collectively define who is subject to

these regulations.

FDA proposed to define ‘‘processing’’ as:

[W]ith respect to fish or fishery products,

handling, storing, preparing, heading,

gutting, shucking, freezing, changing into

different market forms, manufacturing,

preserving, packing, labeling, or holding.

Practices such as heading or gutting intended

solely to prepare a fish for holding on board

a harvest vessel are excluded. This regulation

does not cover the operation of a retail

establishment.

FDA proposed to define ‘‘processor’’ as:

[A]ny person engaged in commercial,

custom, or institutional processing of fish or

fishery products, either in the United States

or in a foreign country. Persons engaged in

the production of foods that are to be used

in market or consumer tests are also

included. Persons who only harvest or

transport seafood, without otherwise

engaging in processing, are not covered by

these regulations.

a. Vessels, carriers, and retail. As

explained in the preamble to the

proposed regulations, the definitions of

‘‘processor’’ and ‘‘processing’’ excluded

fishing vessels that essentially only

harvest, transportation companies that

carry but do not otherwise process fish

and fishery products, and retail

establishments. FDA invited comment

on these exclusions.

In the preamble, FDA acknowledged

that food safety hazards can be

introduced at these three points in the

commercial distribution chain.

However, FDA tentatively decided to

exclude fishing vessels, carriers, and

retailers from the definition of

‘‘processor’’—and thus from direct

coverage under these regulations—

because of practical considerations,

such as the fact that the large size of the

U.S. fishing fleet and the large numbers

of carriers and retailers would

overwhelm any rational Federal

inspection system, and because the

agency believed that the public health

goals of the regulations could still be

met.

FDA expressed its tentative view that

the HACCP regulations would affect

fishing vessels and carriers indirectly

though the controls that processors

impose to meet their obligations under

HACCP. As for retail establishments, the

preamble explained that, historically,

they have been the regulatory

responsibility of State and local

governments. FDA traditionally has

provided support through training,

technical assistance, and the

development of model codes. Since the

issuance of the proposal, FDA has

published its retail and institutional

‘‘Food Code,’’ with the recommendation

that it be adopted by State and local

jurisdictions. The Food Code covers

handling and receiving practices at

retail, and its most recent version

includes HACCP elements.

FDA’s approach to these issues is

based on agency discretion and does not

derive from a lack of statutory authority.

FDA has broad authority to regulate

Food that is shipped in interstate

commerce. While carriers are exempt

from most direct FDA regulation in

accordance with section 703 of the act

(21 U.S.C. 373), the food being

transported is not exempt. Moreover,

FDA has authority under the Public

Health Service Act (the PHS Act) (42

U.S.C. 264) to take such measures as it

deems necessary to prevent the

introduction, transmission, or spread of

communicable disease from foreign

countries into the States or from one

State or possession into any other State

or possession.

FDA received a significant volume of

comment on the question of coverage by

these regulations of fishing vessels,

carriers, and retail establishments. The

majority of comments strongly favored

inclusion of these entities within the

scope of the these regulations.

35. The arguments relating to vessels

and carriers tended to overlap. Those

who favored inclusion noted that

hazards—particularly those associated

with time-temperature abuse and

insanitation—can originate with fishing

vessels and carriers. The comments

argued that not controlling the

conditions under which seafood is

harvested and transported would

amount to leaving CCP’s unregulated.

One comment observed that carriers

have an incentive to turn off

refrigeration units to save gas.

Several comments expressed the view

that exclusion of vessels and carriers

from the coverage of these regulations

unfairly makes processors responsible

for these aspects of seafood production.

One comment pointed out that vessels,

especially those that harvest scombroid

toxin-forming species, should be legally

responsible for any safety hazards that

they cause through improper handling.

Some comments asserted that HACCP

can be practiced on fishing vessels and

by carriers, at least with regard to

temperature controls.

One State agency expressed the view

that holding processors responsible for

the behavior of fishing vessels has, in its

experience, not worked, nor has

education of fishing vessel owners or

voluntary compliance by owners. The

comment did not document the basis for

these conclusions, however. Some

comments argued that, while it would

be difficult to include all vessels and

carriers, those involved with high-risk

products should be included.

Comments in favor of excluding

vessels and carriers from these HACCP

regulations noted that FDA’s rationale

for exclusion was prudent given the

number, location, and diversity of the

U.S. fishing fleet and the complexity of

transport arrangements. For carriers, one

comment noted that partial loads that

are dropped off in different locations

would be especially difficult to control.

Some comments asserted that direct

regulation of these entities was not

necessary because processors could

establish minimum requirements as a

condition of purchase, as part of their

HACCP systems. Some comments urged,

however, that fishing vessels be subject

to HACCP requirements when they

deliver directly to an entity that is not

subject to these regulations (e.g., a

restaurant). One comment argued that

receiving firms should require that

product be in the same condition that it

was in when it left the previous

processor.

Some comments questioned the

ability of fishing vessels and carriers to

comply with HACCP requirements. A

number of comments favored

alternatives to HACCP, such as

guidelines and standard operating

procedures (SOP’s).

FDA is impressed by the strong

support for inclusion, of fishing vessels

and carriers in the coverage of these

regulations. Some of this support was

based on concern over the loss of

quality because of poor handling
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65113

practices (e.g., the effect of timetemperature abuse on shelf life and

spoilage unrelated to safety) rather than

on food safety considerations.

Nonetheless, members of these two

industries should be aware that

significant concerns have been

expressed with regard to their practices.

For some species and products, the

practices of fishing vessels and

transporters can have significant public

health consequences. These practices

can put pressure on a processor who is

receiving these products to carefully

scrutinize the condition of incoming

materials. The practices can also put

pressure on a processor to determine

whether carriers are suitable to transport

their finished products (e.g., that

carriers have proper refrigeration).

The agency appreciates the argument

that all entities that can affect safety in

the distribution chain should accept and

share this responsibility. These points

notwithstanding, FDA received no

comment that provided information

about how the agency could operate an

inspection program for carriers and

harvest vessels with its current

resources. For this reason, the agency

concludes that such a program is

impractical at this time.

When processors accept raw materials

for processing, especially from vessels,

they assume some responsibility for the

condition of the incoming materials,

regardless of how others are regulated.

This is true under both general

commercial law and the laws

administered by FDA. Carriers likewise

have responsibilities. If a carrier fails to

exercise such controls as are necessary,

food that it carries may be rendered

adulterated and the owner of the

product, i.e., the processor, could suffer

product loss. Food handlers generally

should exercise sufficient control over

the products in their custody to ensure

that any food safety hazards that are

reasonably likely to occur during that

period are being addressed.

As an additional matter, FDA agrees

with those comments that advocated a

step-wise regulatory approach to these

entities.

Mandatory HACCP for seafood is a

pioneering venture. While the

groundwork has been prepared for it

through pilot projects and other efforts

over the years, there is no substitute for

actual experience once it is operating.

The agency would prefer, therefore, to

construct the system through a series of

manageable steps if it needs to do so,

rather than to risk overextending itself

and the system initially. While these

regulations exempt carriers and harvest

vessels from direct coverage, experience

with the application of a mandatory

HACCP program may, at some later

date, cause the agency to reconsider its

approach.

For fishing vessels, FDA intends, for

the time being, to issue good handling

practice guidelines. To that end, the

agency is studying those issued by the

State of Alaska and by the Codex

Alimentarius Commission of the Food

and Agriculture Organization/World

Health Organization, among other such

available guidance. FDA will evaluate

the effect of these guidelines, in

addition to any requirements that States

have or may adopt regarding fishing

vessel practices, and reassess at a later

date whether there is a need for

mandatory Federal controls. The agency

invites continued correspondence and

the sharing of views on this matter.

The comments that recommended

that vessels that sell directly to ‘‘nonHACCP’’ establishments (e.g.,

restaurants) should be required to have

HACCP plans are advised that the Food

Code addresses the subject of source

control for retail establishments and

recommends the requirement of HACCP

plans for retail establishments in some

circumstances. This matter relates

principally to State and local laws and

is addressed below in the discussion of

retail establishments.

For carriers, the situation is

complicated by the restriction in section

703 of the act that was described

previously. As one comment

recommended, FDA has had

conversations with other Federal

agencies on the subject of transportation

of food and will continue to do so. In

the meantime, FDA strongly

recommends that processors review the

material in the Guide on how they can

exercise control over incoming raw

materials as well as over shipments of

their own products. One emerging area

that the agency is monitoring—and

processors should consider also—is the

development of inexpensive timetemperature sensors that indicate

whether proper temperatures have been

maintained over a period of time.

36. The question of the inclusion of

retail establishments within the

mandatory seafood HACCP system

involves some different considerations.

Processors have less influence, if any,

over how their products are handled at

retail than they do over how their

products are handled by vessel

operators or carriers. Some comments

pointed out, for example, that a

processor’s best efforts could be for

naught if the product is subsequently

mishandled at retail.

Several comments pointed out that

many retail establishments carry out

activities that meet the definition of

‘‘processing.’’ According to these

comments, such establishments should

not be exempt from HACCP

requirements.

Other comments took the view that

these regulations should not apply to

retail establishments, primarily for the

reasons provided in the preamble to the

proposal. Some recommended that retail

establishments should not be subject to

the regulations so long as the Food Code

applies to them. Others suggested that

HACCP should apply if the retail

establishment buys directly from a

fishing vessel or from sport fishermen.

Some suggested better consumer

education and voluntary HACCP-type

programs.

FDA agrees that there are hazards that

occur at the retail level that can render

meaningless the controls that may have

been in place elsewhere in the chain of

production and distribution. The NAS

has cited retail and food service

establishments as sources of seafoodrelated illnesses (see Ref. 7, p. 27). FDA

is convinced—and the comments

support—that proper controls at the

retail level are imperative to ensuring a

safe product.

Nonetheless, FDA’s observation in the

preamble to the proposed regulations

remains valid that retail establishments

pose an inspection burden well beyond

the capacity of FDA. No comments have

provided any basis for the agency to

conclude otherwise or would justify the

significant shift of resources that would

be necessary for FDA to even begin to

address the retail sector in a meaningful

way. FDA notes that State and local

governments provide significant

regulation of the retail food sector. FDA

has committed the resources that it has

available for addressing retail problems,

by providing training and technical

assistance to State and local

governments. Most significantly, FDA

has provided guidance in the form of

the Food Code, which provides the

latest and best scientifically based

advice about preventing foodborne

illness for adoption by those

jurisdictions that have regulatory

responsibility for food service, retail,

and vending operations.

It is worth noting that the Food Code

suggests the use of HACCP controls at

retail in some circumstances where

comments argued for such controls as

part of these regulations. Under the

regulatory controls suggested in the

Food Code, a retail establishment that

purchases a scombroid toxin forming

species of fish from a recreational

harvester, for example, would need a

HACCP plan relating to how it will

ensure that fish had been handled so as

to avoid time-temperature abuse. Under
65114 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

the Food Code, fish caught

recreationally generally require the

approval of a regulatory authority in

order to be sold to a retail

establishment. The States should be

aware that the Food Code is responsive

to concerns raised by comments in these

respects. FDA urges the States to

consider adopting the Food Code for

retail and institutional operations.

It is worth noting that the Food Code

applies HACCP requirements to retail

establishments as an exception for

extreme situations, rather than as the

rule. There is still much to be learned

about the application of HACCP to retail

establishments. Also, it may not be wise

to single out seafood for the application

of HACCP at retail. Retail operations can

be complex and involve the handling of

many types of foods. Trying to operate

a HACCP system solely for seafood

could divert attention away from

important safety practices for high-risk

products other than seafood.

For all these reasons, therefore, the

agency concludes that FDA should not

mandate HACCP systems for the seafood

component of retail establishments at

this time. Also, the agency has not been

provided with any information on how

an FDA inspection program for such

establishments would be feasible.

Nonetheless, the agency will take all

comments on retail establishments

under advisement for future

consideration as the system evolves.

It is important to note, however, that

where a processor engages in mixed

operations (i.e., some retail and some

wholesale), as in the case of cash-andcarry warehouses noted by one of the

comments, the wholesale portion of the

operations will be subject to the

provisions of these regulations. As a

further point of clarification in response

to one comment, FDA has traditionally,

and will continue to, classify central

kitchens that distribute product to retail

outlets that are owned by the same firm

as a retail operation.

b. Warehouses. In the preamble to the

proposed regulations FDA stated that

the definition of ‘‘processor’’ included

warehouses. Warehouses store fish and

fishery products, one of the operations

included in the proposed definition of

‘‘processing.’’ A ‘‘processor’’ is simply

an entity that engages in processing.

There are food safety hazards that can

be introduced while storing a product

(e.g., in a warehouse). These hazards

include, among other things, pathogen

growth in cooked, ready-to-eat products

and histamine development in

scombroid toxin-forming species, as a

result of improper storage temperatures.

Nonetheless, the warehouse

environment usually has few hazards

compared to complex processing

operations. Consequently, the preamble

to the proposed regulations invited

comment on whether warehouses

should be exempted from the definition

of ‘‘processor’’ and, by implication,

whether ‘‘storing’’ should not be

included in the definition of

‘‘processing,’’ as one way of scaling the

regulations back in terms of cost and

burden.

37. The comments split about evenly

on this subject. Those that gave a reason

for including warehouses cited the need

to monitor storage temperatures for

species that are prone to safety hazards

if they are temperature abused. Those

that opposed and provided a reason

tended to argue that storage alone

should not subject an establishment to

the requirements of the regulations. A

related concern was the view that

warehouse operators do not have a

thorough knowledge of the products

that they handle and only store products

that are provided to them by others.

This concern was expressed both by

those who objected to the inclusion of

warehouses and those who simply

asked for clarification about the role of

warehouses. Others who asked for

clarification expressed the view that

warehouses could be responsible for

conditions during storage.

After consideration of these

comments, FDA has decided to retain

warehouses (e.g., public storage

warehouses, foodservice distribution

warehouses, and wholesale grocers)

within the definition of ‘‘processor’’ and

to retain ‘‘storing’’ within the definition

of ‘‘processing.’’ It is important to

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

act covers storage along with other

forms of processing. It states that a

product is adulterated if it is ‘‘prepared,

packed, or held under unsanitary

conditions * * * whereby it may have

been rendered injurious to health.’’

These regulations are being issued for

the efficient enforcement of section

402(a)(4) of the act. Moreover, as

described above, hazards can be

introduced as well as controlled during

storage. HACCP is an appropriate

system for the control of these hazards.

FDA believes that the burden on

warehouses will be minimal given the

simplicity of the operation and the fact

that, in most cases, a warehouseman’s

responsibility under HACCP will only

extend to conditions within the

warehouse that could cause a safety

hazard to occur.

For the most part, hazards deriving

from the environment (pesticides, etc.)

will be controlled during the initial

processing of the product (i.e., by the

first processor to take possession). As a

result, subsequent processors will

receive products that are generally free

of environmental hazards and thus will

not need to establish HACCP controls

for them. More often than not, storing

will not be the first processing

operation. Thus, a warehouse will not

usually be responsible for

environmental hazards. The same

principle holds true for hazards arising

during processing operations that occur

before storage in a warehouse. Those

hazards must be controlled during the

prior processing and generally not

during storage.

There may be occasions, however,

when storage is the first processing

operation (e.g., when a warehouse will

be the first processor to receive raw

material fish from a fisherman or

aquacultural producer). Under these

circumstances, the warehouse, rather

than a distant owner of the product,

may be in the best position to obtain

information that may be needed about

harvest site, fishing practices, and

transportation to the dock that would be

germane to safety. There should be some

arrangement between the warehouse

and the owner on this matter to ensure

that environmental hazards are properly

addressed.

38. One comment objected to the

inclusion of storage within the

definition of processing on the grounds

that FDA should not dictate where

CCP’s should be.

The agency is not attempting to do so.

FDA acknowledges that whether storage

is a CCP will depend on the

circumstances. For example, refrigerated

storage of a scombroid species will

likely be designated as a CCP, whereas

dry storage of canned fish will not likely

be considered as such.

39. Another comment objected to

including ‘‘airline warehousing’’ within

these regulations.

If airlines hold product as part of their

usual course of business as carriers, they

are exempt from having HACCP plans in

accordance with section 703 of the act.

c. Other processing operations. 40. A

few comments requested clarification on

whether waterfront facilities that unload

vessels and pack the catch for shipment

to buyers are engaging in processing and

thus meet the definition of ‘‘processor.’’

These firms perform activities such as

handling and storing that are included

in the definition of processing and fall

within the purview of the ‘‘prepared,

packed, or held’’ clause of section

402(a)(4) of the act. Additionally, these

activities warrant coverage under these

regulations because of their relationship

to reasonably likely hazards. For

example, these firms are, by design,

usually the first processors to receive
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65115

the product from the fisherman or

aquacultural producer. As such, they are

often in the best position to control

environmental hazards, as was

previously discussed. They also often

store the product, at least for short

periods of time. In this capacity, they

may be responsible for ensuring that the

product is not exposed to timetemperature abuse, a phenomenon that

critically affects the safety of some

products.

For these reasons, FDA has clarified

the definition of ‘‘processing’’ at

proposed § 123.3(m) (redesignated as

§ 123.3(k)) to specifically include

dockside unloading.

41. One comment took the view that

only processors who own the products

that they are processing should be

subject to these regulations and

suggested that the term ‘‘processorowner’’ be substituted for ‘‘processor.’’

Several other comments questioned

whether custom processors that do not

own the product, should be subject to

the provisions of these regulations.

The definition of ‘‘processor’’ does

not hinge on ownership. As indicated

earlier, whether a product is adulterated

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

depends on the condition under which

it was ‘‘prepared, packed, or held.’’

Ownership is not a relevant factor.

Consistent with this principle, these

regulations define a processor as simply

an entity that engages in processing.

‘‘Processing’’ is defined as including a

number of activities, such as

manufacturing and packing, that are

normally performed by a custom packer.

Like warehouses that store products

for distant owners, custom packers are

often in the best position to exercise

HACCP controls for the products that

they process. Because of the real-time

nature of HACCP (i.e., because

monitoring provides immediate

feedback as to whether a hazard is being

controlled), the processor can most

effectively apply HACCP monitoring

controls to a food being processed,

regardless of whether the processor is

the actual owner of the food. FDA

recognizes that it will often be beneficial

for the custom processor and the owner

of the product to fully discuss and agree

upon the HACCP controls that will be

effected by the custom processor while

the product is in its possession.

42. One comment argued that custom

packers should be included within the

scope of these regulations because these

processors often can or smoke

recreationally caught products and are

often the only commercial entity that

can assure the safety of such products.

While the definition of ‘‘processing’’

clearly covers the kinds of activities

performed by custom packers, it is not

the intent of these regulations to address

arrangements between a recreational

fisherman and a custom packer for the

processing of fish for the personal use

of the fisherman. The regulations only

cover custom packing that is performed

on behalf of an owner who intends to

introduce the fish into interstate

commerce. Nonetheless, the agency

does not believe that clarification to the

regulations is needed on this point.

43. One comment urged that

aquacultural producers that also

eviscerate the fish before delivery to a

processing plant be required to comply

with the requirements of these

regulations.

FDA agrees with the comment and

further states that the process of

eviscerating is specifically included in

the definition of ‘‘processing.’’

Eviscerating is excluded from the

definition only when it occurs on a

harvest vessel for the purpose of

preparing the fish for holding en route

to the processor.

44. A few comments objected to FDA

including labeling in the definition of

‘‘processing.’’ The comments argued

that labeling operations are unlikely to

introduce hazards to the product. FDA

has considered these comments but

finds that there is potential during some

labeling operations for the development

of hazards. For example, improperly

controlled labeling operations for

scombroid species could result in timetemperature abuse of the product,

increasing the risk of histamine

contamination. Cooked, ready-to-eat

products could similarly be subjected to

time-temperature abuse, resulting in the

potential for pathogen growth. The

inclusion of labeling in the list of

processing operations is not intended to

imply that this step should always, or

even frequently, be considered a CCP.

That can only be determined through

the conduct of a hazard analysis.

FDA proposed to exempt ‘‘heading or

gutting intended solely to prepare a fish

for holding on board a harvest vessel’’

from the definition of ‘‘processing.’’ In

drafting the proposed regulations, FDA

was concerned that, in the absence of

such an exemption, harvest vessels that

are presently heading or gutting fish

would stop the practice to avoid being

subject to the requirements of these

regulations. FDA did not want an

inadvertent consequence of these

regulations to be a reduction in product

quality. In addition, FDA tentatively

concluded that safety hazards

introduced by these operations are

generally minimal.

45. One comment noted that FDA

should include the practice of freezing

fish on harvest vessels in the list of

exempted operations.

FDA agrees that freezing is an

operation that is routinely used onboard

a harvest vessel in order to preserve the

quality of the fish until it is landed for

further processing (e.g., freezing

performed onboard tuna harvesting

vessels). For this reason, the agency has

revised the definition of ‘‘processing’’ to

include an exemption for onboard

freezing.

46. One comment suggested that FDA

also exempt onboard scallop shucking

operations.

Unlike shucking other molluscan

shellfish, shucking scallops involves

eviscerating, a procedure that falls

within the exemption in § 123.3(k).

Consequently, onboard shucking of

scallops does not constitute processing

for purposes of these regulations. The

agency does not believe that a change in

the definition is necessary in this

regard.

47. One comment suggested that, with

respect to molluscan shellfish,

‘‘processors’’ should include shellfish

shippers, reshippers, shucker-packers,

repackers, and depurators.

The persons that perform all of these

types of operations are ‘‘processors’’

under § 123.3(k)(1) and subject to the

provisions of these regulations. Thus,

the agency has concluded that no

change in the definition is necessary.

16. Scombroid Toxin-Forming Species

The term ‘‘scombroid toxin-forming

species’’ appears in § 123.6(c)(1)(vi) of

this final rule. While FDA did not

propose to define this term in the

codified portion of the proposed

regulations, it did propose to define it

in part 123 appendix B as:

[T]una, bluefish, mahi mahi, mackerel,

sardines, herring, kahawai, anchovies,

marlin, and other species, whether or not of

the family Scombridae, in which significant

levels of histamine may be produced in the

fish flesh by decarboxylation of free histidine

as a result of exposure of the fish after

capture to temperatures that permit the

growth of mesophilic bacteria.

Appendix B of part 123 is no longer

included in these regulations, as is

discussed elsewhere in this preamble.

Consequently, FDA is transferring the

definition from part 123 appendix B to

§ 123.3(m) to clarify the meaning of

§ 123.6(c)(1)(vi).

48. A number of comments objected

to the inclusion of herring in the list of

scombroid toxin-forming species,

arguing that there has been no

association between herring and cases of

histamine poisoning.

In response to the comments, FDA has

modified the definition of scombroid
65116 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

toxin forming species to make specific

reference to only tuna, bluefish, and

mahi mahi, since the overwhelming

majority of scombroid poisonings are

associated with these types of fish.

Processors should assess the potential of

other species to product histamine. The

key to the definition is whether

significant levels of histamine may be

produced in the flesh of the fish.

17. Shellfish Control Authority

FDA proposed to define ‘‘shellfish

control authority’’ as ‘‘a Federal or State

health authority, or foreign government

health authority, legally responsible for

the administration of a program that

includes classification of molluscan

shellfish growing areas, enforcement of

harvesting controls, and certification of

molluscan shellfish processors.’’

49. A few comments pointed out that

the definition should not require that a

shellfish control authority be a State

‘‘health’’ authority because in some

States the responsibility is vested in

other than a health agency, such as a

resource management agency.

FDA recognizes that these comments

are correct. For this reason, the agency

has modified the language in § 123.3(o)

to read, in part, ‘‘State agency.’’ FDA

believes that this term is sufficiently

broad to encompass any of the present

State arrangements. FDA has made a

parallel change with respect to foreign

government authorities, in order to

accommodate the same kind of

variations in regulatory arrangements.

These final regulations similarly refer to

a ‘‘foreign agency.’’

50. One comment, from a State

regulatory agency, stated that within the

United States, FDA should be the

responsible shellfish control authority

and should mandate that processors

register with FDA, much as it has done

with low-acid canned foods and

medical devices. The comment further

stated that a requirement in Federal

regulations that State agencies perform

this function may be unconstitutional.

The comment misconstrued the

provision. The provision is intended to

define the term ‘‘shellfish control

authority’’ rather than to provide

substantive requirements. Furthermore,

these regulations at no point mandate

that States perform certain functions.

51. Some comments expressed

concern that the proposed definition of

‘‘shellfish control authority’’ was too

narrow in that it did not include any

entities that could serve the function of

a shellfish control authority for Federal

waters. The effect of the proposal, the

comments pointed out, would be to

close unnecessarily all molluscan

shellfish harvesting in Federal waters.

It was never FDA’s intent to close

Federal waters to molluscan shellfish

harvesting. These waters are beyond the

jurisdiction of State shellfish control

authorities, and no Federal agency

classifies them in the same way that

States classify their own waters. FDA is

seeking a means to classify Federal

waters. An agreement with NMFS

relating to the classification of Federal

waters is one possible solution. For this

reason, FDA has modified proposed

§ 123.3(o) to state that a shellfish control

authority may be ‘‘a Federal agency.’’

This subject is also discussed in the

‘‘Molluscan Shellfish’’ section of this

preamble.

52. One comment urged that FDA

provide for the possibility of sovereign

tribal governments serving as shellfish

control authorities.

FDA recognizes that the proposed

definition was deficient because it failed

to include tribal governments in the list

of possible shellfish control authorities.

The agency, the State of Washington,

and 19 Indian tribes have recently

entered into a settlement that will likely

result in such an arrangement in the

State of Washington (Ref. 202). When

such governments meet the necessary

criteria, it is the intent of the agency to

formally recognize them for purposes of

classifying shellfish growing waters and

certifying shellfish processing plants for

inclusion on the Interstate Certified

Shellfish Shippers List. To provide for

this situation, FDA has modified the

definition of ‘‘shellfish control

authority’’ to include ‘‘sovereign tribal

governments.’’

FDA has also recognized that in many

cases the functions of ‘‘classification of

molluscan shellfish growing areas,

enforcement of harvesting controls, and

certification of molluscan shellfish,’’ as

listed in the proposed regulations, are

not carried out by a single agency. To

provide for such a situation, FDA has

modified the proposed language at

§ 123.3(o) to read, ‘‘program that

includes activities such as,’’ rather than

simply ‘‘program that includes.’’

18. Smoked and Smoke-Flavored

Fishery Products

The terms such as ‘‘smoked fishery

products,’’ ‘‘smoked fish,’’ ‘‘smoked and

smoke-flavored fishery products’’ were

used in the proposed regulations and

throughout appendix 1 to the proposal.

As a result of decisions discussed

elsewhere in this preamble, reference to

‘‘smoked and smoke-flavored fishery

products’’ has been eliminated in these

regulations except in part 123, subpart

B.

While no definition of ‘‘smoked and

smoke-flavored fishery products’’ was

included in the definitions section of

the proposed regulations, the terms

‘‘smoke-flavored fish’’ and ‘‘smoked

fish’’ were separately defined in

appendix 1 to the proposal as:

‘‘Smoked-flavored fish means fish that

is prepared by treating it with salt

(sodium chloride) and then imparting to

it the flavor of smoke by other than the

direct action of smoke, such as

immersing it in a solution of liquid

smoke,’’ and ‘‘Smoked fish means fish

that is prepared by treating it with salt

(sodium chloride) and then subjecting it

to the direct action of smoke from

burning wood, sawdust, or similar

material.’’ FDA solicited comment on

the materials in appendix 1. Because the

term is used in these final regulations

and FDA is concerned that there may be

confusion about its application, the

agency has determined that a definition

of ‘‘smoked and smoke-flavored fishery

products’’ is needed in the codified

portion of these regulations. FDA has

included one at § 123.3(s) that is

consistent with those proposed in the

appendix 1 to the proposal. Section

§ 123.3(s) reads:

Smoked or smoke-flavored fishery products

means the finished food prepared by: (1)

Treating fish with salt (sodium chloride), and

(2) subjecting it to the direct action of smoke

from burning wood, sawdust, or similar

material and/or imparting to it the flavor of

smoke by a means such as immersing it in

a solution of wood smoke.

FDA received numerous comments on

the regulatory treatment of smoked and

smoke-flavored fishery products, but

none that would affect this definition.

E. The HACCP Plan

Approximately 100 comments

addressed one or more of the provisions

of proposed § 123.6. This section of the

proposed regulations set out who must

write and implement a HACCP plan,

and what the HACCP plan must

include.

1. Preliminary Steps

FDA proposed in § 123.6 to require

that all processors of fish and fishery

products prepare and implement a

HACCP plan that identifies the hazards

that are reasonably likely to occur and

thus that must be controlled for that

product. In the proposal, FDA

acknowledged the process

recommended by the NACMCF for

developing a HACCP plan but did not

propose to require that processors

follow it. The process recommended by

the NACMCF includes: Assembling a

HACCP team, describing the food and

its distribution, identifying the intended

use and consumers of the food,

developing a flow diagram, verifying the
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65117

flow diagram, and performing a hazard

analysis (Ref. 34, pp. 187–188). All but

the last of these have been identified by

NACMCF as the ‘‘five preliminary

steps’’ of HACCP.

It was, and still is, the agency’s belief

that processors would benefit from a

process that included these five steps as

well as a hazard analysis in order to

successfully arrive at an appropriate

HACCP plan. Nonetheless, the agency

did not propose to require adherence to

the ‘‘five preliminary steps,’’ or

explicitly propose to require that a

hazard analysis be performed. So long

as the processor had, in the end, a

HACCP system that was appropriate for

species and process, and was being

implemented effectively, the agency

tentatively concluded that these

regulations did not need to manage the

process any further.

53. A number of the comments

contended that FDA should require that

firms adhere to these procedures in

preparing a HACCP plan. Specifically, a

few comments argued that the proposed

rule significantly diminished the

potential effectiveness of HACCP by not

requiring that processors engage in the

‘‘five preliminary steps.’’ The comments

argued that inclusion of the preliminary

steps would facilitate international trade

and reduce confusion on the part of

seafood importers and exporters through

consistency with an internationally

recognized standard for HACCP.

Several other comments urged that

the NACMCF recommendation for the

development of a process flow diagram,

in particular, by a processor be made

mandatory. These comments identified

several benefits from such a

requirement: To facilitate employee

implementation of the plan, to facilitate

processor verification activities, to

reduce the time needed for regulators to

review the manufacturing process, and

to enable the regulator to determine

whether the processor properly

considered the entire manufacturing

process. One comment stated that FDA’s

assumption that flow diagrams are

burdensome or unnecessary is contrary

to the 1992 NACMCF Report which

notes that flow diagrams could be

simple representations that accurately

depict the steps in a process, rather than

detailed, technical drawings.

FDA acknowledges that, for the

reasons stated in the comments, many

processors will find that the

development of a flow diagram is a

useful preliminary step to the

preparation of a HACCP plan. Other

processors may find, however, that,

because of the simplicity of their

operations, the preparation of a written

flow diagram is an unnecessary step. In

either case, FDA is convinced that a

processor’s decision to develop or not to

develop a flow diagram will be, and

should be, driven by its perception of

the benefits of doing so. The comments

received on this subject were not

sufficiently persuasive for the agency to

conclude that a flow diagram should be

made mandatory. The comments

provided no basis to find that in the

absence of a flow diagram, a processor

could not properly develop a HACCP

plan, or that a plan, so developed,

would likely cause the HACCP program

to fail.

As some of the comments pointed out,

there may be some benefit to the

regulator to have access to a flow

diagram during an inspection, but this

convenience is not a sufficient reason to

mandate it. FDA investigators will likely

develop their own flow diagrams during

their in-plant inspections and compare

them with the decisions reached by the

processor in the development of the

HACCP plan (e.g., the identification of

hazards and CCP’s). While it may be

beneficial for the investigator to be able

to compare his or her flow diagram with

that of the processor, it is not essential

to the conduct of the inspection.

FDA agrees with the comments that

stated that the other four elements of the

‘‘five preliminary steps’’ are desirable

attributes of the HACCP development

process. However, the agency has not

been persuaded that, in the absence of

a regulatory requirement that they be

followed, the HACCP program is

unlikely to succeed. In order to write an

appropriate plan some or all of these

steps will likely have to be performed,

even without a regulatory requirement

to do so. However, if a processor can

write a plan without these steps, the

goals of the regulations will still have

been met. For FDA to require them to

be performed and documented in every

case would add burden and reduce

flexibility unnecessarily. Moreover,

FDA is unconvinced that any inhibition

to foreign trade is likely to occur if

adherence to these steps is not required.

FDA believes that foreign trading

partners will be satisfied by the

presence of a successful HACCP system

and will not reject U.S. exports because

steps preliminary to HACCP were not

documented.

Even without a requirement

mandating specific preliminary steps,

FDA believes that most processors will

follow the spirit, if not the exact letter,

of the recommended procedures. These

procedures provide the processor with a

recognized method of plan development

that will help lead to a successful

outcome. FDA is primarily interested in

that outcome. The NACMCF

recommendation for the assembly of a

HACCP team, in particular, could be a

significant burden for the many small

businesses operating in the seafood

industry. For these reasons, the final

regulations do not mandate any

preliminary steps that processors must

perform as a prerequisite to conducting

a hazard analysis or drafting a HACCP

plan.

2. Conducting a Hazard Analysis

54. A number of comments from trade

associations and processors objected to

the requirement in the proposal that

every processor have and implement a

written HACCP plan. These comments

contended that FDA should revise this

provision to require that a processor

first conduct a hazard analysis to

determine whether any food safety

hazards exist that can be controlled

through HACCP and then prepare and

implement a HACCP plan only when

the hazard analysis identifies at least

one such food safety hazard. One

comment stated that conducting a

hazard analysis is the first step in a twostep process, with developing a HACCP

plan being the second step. The

comments urged consistency with the

NACMCF recommendations in this

regard.

FDA agrees with the approach

suggested by the comments and believes

that it is essentially consistent with

what the agency proposed. Although

FDA did not explicitly propose to

require that every processor conduct a

hazard analysis, completion of such an

analysis by every processor was implicit

in the requirement in proposed

§ 123.6(b)(1) and (b)(2) that processors

identify both the hazards that are

reasonably likely to occur and the CCP’s

for each of these hazards.

In response to the comments, FDA has

decided to clarify its regulations to

make the requirement that a hazard

analysis be conducted explicit rather

than implicit in order to clarify the steps

that are required as part of a HACCP

system. Moreover, this change allows

the agency to make clear that

conducting the analysis may or may not

lead to the preparation of a HACCP

plan.

Thus, FDA is providing in § 123.6(a)

that processors shall conduct a hazard

analysis or have one conducted on their

behalf. It is the agency’s expectation that

most seafood processors will, after

performing a hazard analysis, find it

necessary to control for at least one

hazard and, therefore, be obligated to

prepare a HACCP plan. However, when

no hazard is reasonably likely to occur,

there is no reason to prepare a HACCP

plan. Therefore, § 123.6(b) states, in
65118 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

part, ‘‘(b) The HACCP plan. Every

processor shall have and implement a

written HACCP plan whenever a hazard

analysis reveals one or more food safety

hazards that are reasonably likely to

occur, as described in paragraph (a) of

this section.’’

The agency does not believe that the

methodology of conducting hazard

analyses is sufficiently standardized at

this time to justify mandating what the

analysis must include. FDA encourages

processors to utilize the NACMCF

document as guidance in performing

this activity. In addition, the agency

recognizes that the best way for it to

verify a processor’s hazard analysis is

indirectly, through its own evaluations

of whether a processor ought to have a

HACCP plan, and whether a HACCP

plan appropriately identifies the food

safety hazards and CCP’s that are

reasonably likely to occur. In other

words, it is the end product of the

hazard analysis, the HACCP plan and its

implementation, that should be judged

by the regulator. For this reason, the

agency is not requiring that hazard

analyses be performed according to a

standardized regimen, or that they be

documented in writing for FDA review.

Even though FDA is not requiring that

the hazard analysis be available to the

agency, there may be cases in which it

would be to the processor’s advantage to

have a carefully documented written

hazard analysis to show to FDA. Such

documentation may prove useful in

resolving 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.

Written hazard analyses may also be

useful to processors in that they may

help provide the rationale for the

establishment of critical limits and other

plan components. Having the basis for

these decisions available may be helpful

when processors experience changes in

personnel, especially those associated

with the HACCP process, and in

responding to unanticipated CL

deviations.

3. Types of Hazards

FDA received a number of comments

on the types of hazards that a mandatory

HACCP system should control, and that

the hazard analysis should examine.

The proposed regulations did not

distinguish among hazards but proposed

to require that HACCP plans identify all

food safety hazards that are reasonably

likely to occur. The comments that

addressed the question of what types of

hazards mandatory HACCP should

address generally preferred that its focus

be on some subset of hazards, rather

than on the entire spectrum that could

cause seafood to be adulterated. The

comments argued that the hazards that

were not the focus of the HACCP regime

established by the regulations could be

covered by more traditional food safety

mechanisms. A review of these

comments follows.

55. Several comments, from

processors and trade associations, stated

that the hazard analysis should only be

used to identify those food safety

hazards that have the potential to cause

‘‘serious adverse health consequences.’’

These comments stated that such

consequences included those that

would trigger a ‘‘Class I’’ recall as

defined by FDA, particularly those that

involve contamination of the food with

pathogenic microorganisms. A Class I

recall involves a situation in which

there is a reasonable probability that the

use of, or exposure to, a violative

product will cause serious adverse

health consequences or death and

would not be used to respond to

situations in which the health

consequences are temporary, medically

reversible, or remote (21 CFR 7.3(m)(1)

and (m)(2)). Other processor comments

suggested the use of the phrase

‘‘significant food safety hazard’’ to limit

the scope of the HACCP regime without

proposing a definition for the phrase.

One comment stated that focusing on

truly serious hazards is the only way to

keep the number of CCP’s to a

minimum, so that a HACCP plan can

realistically be implemented. The

comment also stated that having too

many CCP’s, or CCP’s that are not

related to serious health risks, would so

burden food processing personnel that

effective compliance with the HACCP

plan would be undermined, and it

would be significantly more difficult to

control truly critical processes.

Several of these comments argued that

hazards should have immediate, as well

as serious, health consequences before

being required to be identified in a

HACCP plan. These and several other

processor comments generally

expressed the view that hazards that can

cause a food to be adulterated under the

act, but that do not have the potential

to cause acute illness, should not be

required to be included in a HACCP

plan. For example, two of the comments

stated that FDA should not use the

HACCP regulations to ensure

conformity with food additive

regulations, pesticide residue

tolerances, or action levels for

environmental contaminants. One

comment stated that although process

controls that are similar to HACCP

controls are often used by food

manufacturers to monitor these kinds of

contaminants, the controls should not

be regarded as part of HACCP because

they do not address acute health

hazards. A few comments suggested that

existing regulatory programs are

adequate to address these types of

hazards.

On the other hand, comments from

one trade association and a number of

individuals acknowledged that drug

residues and pesticide residues should

be addressed by HACCP plans; where

they are likely to occur at levels over

tolerance. Comments from a number of

processors of aquaculture-raised finfish

acknowledged that drug and pesticide

residues are food safety hazards that

affect their industry, but these

comments questioned the

appropriateness of the control

mechanisms provided in FDA’s draft

Guide. Finally, comments from several

consumer advocacy groups expressed

continued concern for the hazards

posed by environmental contaminants.

Having considered these comments,

FDA confirms its tentative view,

reflected in the proposal, that HACCP

should be the norm, rather than the

exception, for controlling safety related

hazards in the seafood industry.

Existing standards for such

contaminants as drug residues,

pesticides, and industrial contaminants,

are established to ensure that their

presence in foods does not render the

food unsafe. Processors of fish and

fishery products are obliged to produce

foods that meet these standards.

Processors are obliged to exercise

control over all food safety hazards that

are reasonably likely to occur. A failure

to do so would mean that the food was

prepared under insanitary conditions

whereby it may have been rendered

injurious to health or is otherwise

adulterated. The criteria for including a

food safety hazard in a processor’s

HACCP plan should be the degree to

which the hazard is likely to develop in

that product (e.g., based on the

processing technique, the harvest

location, the species) and not the nature

or immediacy of the illness or injury

that it is likely to cause.

FDA views as highly speculative the

concerns, expressed by a few comments

from the food industry, that inclusion in

HACCP of those hazards that generally

require chronic exposure to produce

disease will dilute HACCP systems to

the point of shifting industry resources

away from acute toxicity hazards. No

evidence was submitted to support such

claims. The pilot HACCP program

conducted jointly by FDA and NMFS,

the current NMFS voluntary HACCP

program, and the NMFS Model Seafood

Safety Program all included controls for

food additives, primarily a nonacute
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65119

food safety hazard, and there has been

no diminution of control of acute

hazards as a result. Moreover, the

agency is convinced that when

determining, in accordance with

§ 123.6(a), what contaminant hazards

are ‘‘reasonably likely’’ to occur in a

particular type of product, most

processors will have very few, if any, of

these chronic exposure-type hazards to

manage through HACCP as opposed to

through some other method of control.

FDA intends to monitor the progress

of the seafood HACCP program to judge,

among other things, whether the

application of HACCP to food safety

hazards generally, rather than to the

most extreme acute hazards, overloads

the HACCP system and dilutes its

effectiveness for all hazards. Until such

an effect is actually found to occur, FDA

is persuaded that the systematic

application of preventive controls to

food safety hazards generally will

provide the American consumers with

the most effective and efficient food

safety system that has been devised to

date. If FDA were to determine that

HACCP needs to be scaled back in order

to make it work, the agency will take

appropriate steps to make such a

change.

One other factor bears mention in this

regard. FDA has long been aware of

consumer concern about environmental

contaminants in fish and fishery

products. As previously mentioned, this

concern was expressed in the comments

to the proposed regulations. The chance

that these regulations will increase

consumer confidence in the safety of

seafood products would be greatly

diminished if these regulations did not

require processors to consider the risks

from these contaminants as part of their

hazard analysis.

56. A comment from a trade

association stated that, while there is

potential for an unapproved direct or

indirect food or color additive to be a

health hazard, the use of an additive

that has not been listed for use in fish

but is routinely used throughout the

food industry would not necessarily be

likely to cause harm to human health.

The comment said that a control for use

of the additive should not be required

to be included in a HACCP plan.

Under the act, certain products, such

as food additives, new animal drugs,

including new animal drugs intended

for use in aquaculture, and pesticides,

require premarket approval before they

may be legally used. Moreover, this

approval can be limited so that the

product may only be used legally on or

with specific foods, or for specific

purposes, for which approval has been

obtained. This limitation reflects a

longstanding realization that the safety

of these types of products is variable

and must be established on a use-by-use

basis. Whether an additive, drug, or

pesticide is safe for a particular use, in

a particular food, at a particular level,

depends on factors such as the amount

of the food that is consumed and, if the

additive, drug, or pesticide is ingested

in a living animal before capture, how

the product is metabolized in that

animal.

Therefore, a food additive that has

been approved for use in some foods,

but not fish and fishery products, is

deemed by the act to be unsafe for use

with fish and fishery products. FDA is

not in a position to change this aspect

of the law through regulations.

Consequently, the agency has not

created an exemption from the

requirement for HACCP controls for

safety hazards caused by the presence of

unapproved additives or other products

that lack premarket approval for fish or

fishery products.

The agency is aware that it is possible

that some of these products may pose no

meaningful risk in fish and fishery

products at levels approved or allowed

in other foods. It is the obligation of the

proponent of the use of the substance to

follow applicable statutory procedure to

establish this fact to FDA’s satisfaction.

57. In the preamble to the proposed

regulation, FDA specifically invited

comment on whether, in order to reduce

the burden of HACCP on the industry,

as in the Canadian fishery products

HACCP regulation, the agency should

limit its HACCP approach to cover only

those hazards that are introduced within

the confines of the processing plant.

This type of limitation would eliminate

mandatory control of environmental

hazards such as pesticides, natural

toxins, industrial contaminants, and

aquaculture drugs through the HACCP

system.

One comment contended that a

processor of fishery products would be

in a difficult position attempting to

exercise control over problems that

occur during harvesting. The comment

stated that the purpose of HACCP is to

require that each processor be

responsible for minimizing those

serious hazards that it is in the best

position to control, but that the

proposed regulations would force the

processor to take responsibility for

hazards that it may be poorly suited to

control. The comment argued that

FDA’s intent was to deploy HACCP

solely as a way of reducing the agency’s

inspectional burden. The comment

further stated that the focus should be

on finding those few CCP’s within a

specific process where a serious hazard

can best be controlled. Several other

comments expressed confusion about

the application of HACCP to

environmental hazards.

The preamble to the proposed

regulations described the link between

environmental hazards, such as natural

toxins (e.g., ciguatera toxin, domoic

acid, and saxitoxin), histamine, and

various viral and bacterial pathogens,

and human disease. The NAS’ ‘‘Seafood

Safety’’ report (Ref. 7, p. 1) suggested

that the most significant reduction in

illness from seafood would come from

the control of environmental hazards.

To eliminate coverage of such hazards

from these regulations would be to

eliminate the greatest share of

anticipated benefits.

The preamble to the proposed

regulations provided a number of ways

in which the processor can exercise

control over environmental hazards.

This control derives from the fact that

responsible processors already exercise

discretion in obtaining their raw

materials. Control is achieved by

checking tags on containers of

molluscan shellfish to ensure that they

are harvested only from approved

waters, checking with fishermen to

ensure that finfish do not originate from

harvest areas that are closed due to the

presence of excessive agricultural or

industrial contaminants, and physically

examining incoming histamine-forming

species for evidence of decomposition

and insisting that harvest vessels

exercise control over the time and

temperature of storage for these species.

Similarly, processors of aquacultureraised species can audit or otherwise

insist on a producer controls over the

use of animal drugs or other hazards

resulting from inappropriate husbandry

practices. In a HACCP system, these are

examples of controls that can be applied

at the first CCP, i.e., at the receipt of raw

materials.

FDA concludes that the measures that

a processor takes to ensure that its raw

materials are free of environmental

hazards are a critical part of a seafood

HACCP program. Responsible

processors already exercise the kind of

control necessary to ensure that their

raw materials do not present such a

hazard. If a likely hazard exists, it

would not be sufficient to use the price

offered for raw materials to be the only

measure to protect against the hazard.

For these reasons, FDA has retained

environmental hazards in the list of

food safety hazards that processors

should consider in § 123.6(c)(1). To

clarify that there are hazards that occur

before receipt of raw materials that can

be controlled nonetheless by

examination or discretion at the
65120 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

receiving CCP, FDA has modified

§ 123.6 by including the following

sentence in § 123.6(a), ‘‘Such food safety

hazards can be introduced both within

and outside the processing plant

environment, including food safety

hazards that can occur before, during,

and after harvest.’’

For consistency, § 123.6(c)(2) needs a

space here provides for both types of

CCP’s, and now reads:

(2) List the critical control points for each

of the identified food safety hazards,

including, as appropriate: (i) Critical control

points designed to control food safety

hazards that could be introduced in the

processing plant environment, and (ii)

Critical control points designed to control

food safety hazards introduced outside the

processing plant environment, including

food safety hazards that occur before, during,

and after harvest.

Because most of the environmental

hazards to which fish are exposed will

be controlled by the first processor to

take possession of the fish from the

fisherman or aquacultural producer,

whether that processor is located in the

United States or in another country,

subsequent processors need not focus

on these hazards in their HACCP plans.

For example, pesticide contamination of

inland and near shore finfish can be

effectively controlled by the first

processor by purchasing from fishermen

who do not harvest in areas that have

been closed by regulatory authorities,

and drug residue contamination can be

effectively controlled by the first

processor by purchasing from

aquaculture producers who use animal

drugs properly.

4. When Is a Hazard Reasonably Likely

To Occur?

In the proposal, FDA identified nine

categories of safety hazards that might

occur in fishery products. The agency

tentatively concluded that a processor

must establish HACCP controls when

one or more of the listed hazards is

reasonably likely to occur.

58. A number of comments, from

processors and a trade association,

questioned whether certain of these

nine hazard categories by themselves

justify a HACCP plan. The comments

challenged the likelihood that some of

these hazards would cause harm and

asked for clarification on how a

processor is to determine whether a

hazard is ‘‘reasonably likely to occur.’’

One comment held that, if the term

‘‘reasonably likely to occur’’ is linked to

actual incidents of illness caused by a

given hazard, it would be inappropriate

to define some of the listed hazard

categories as reasonably likely to occur.

This comment also requested that FDA

clarify whether the hazards identified in

its draft Guide are those that the agency

believes are reasonably likely to occur

under all conditions for the listed

species and processing methods. The

comment further noted that residues of

industrial or agricultural chemicals

present in seafood are usually not

present at levels that are reasonably

likely to be a safety hazard, even in

many of those species that are listed in

the Guide as presenting that hazard.

As discussed in the preamble to the

proposed regulations, FDA recognizes

that HACCP need not be used to control

every theoretical hazard, no matter how

remote the likelihood of its occurrence.

Moreover, as discussed earlier in this

preamble, case law interpreting section

402(a)(4) of the act has held that

conditions must be such as to create a

reasonable possibility that a hazard will

occur in order for product to be

adulterated under that section of the

law. (See United States v. 1,200 Cans,

Pasteurized Whole Eggs, Etc., 339 F.

Supp. 140–141.)

Unquestionably, historical occurrence

of reported illness is an appropriate

starting place for the identification of

food safety hazards that are reasonably

likely to occur in the absence of

controls. For example, illness from

scombrotoxin in those species that form

the toxin if subjected to time and

temperature abuse after harvest is one of

the most frequently reported illnesses

from seafood. Moreover, the

relationship between abuse after harvest

and the formation of the toxin is well

established. FDA can say with comfort,

therefore, that scombrotoxin poisoning

is a hazard that is reasonably likely to

occur in the absence of appropriate

controls for scombrotoxin-forming

species of fish.

For some hazards, however, the

incidence of reported illness is very

low. A good example is illness from the

consumption of raw fish species that are

prone to parasites. The low number of

reported illnesses is probably

attributable to underreporting and to the

fact that controls for this hazard (e.g.,

commercial blast freezing that kills

parasites) generally exist. However, it is

well established that in the absence of

controls, infection from parasites is a

hazard that is reasonably likely to occur

when a species that is prone to parasites

is consumed raw.

The incidence of reported illness that

is linked to a specific food is virtually

nonexistent when the illness is the

result of chronic exposure to a chemical

contaminant. It is extremely difficult,

for example, to link a specific case of

cancer to a specific contaminant in food.

However, where public health officials

have determined that a contaminant

represents a chronic health hazard, the

standard control strategy to be

employed by processors for such

contaminants is to ensure that their

presence in food remains below specific

levels.

Processors are advised of such

chronic health hazard determinations

through FDA action levels, publications

(e.g., Federal Registers at 55 FR 14359,

April 17, 1990; 58 FR 11609, February

26, 1993; and 58 FR 48368, September

15, 1993), or other similar guidance

documents. If the contaminant is

present in food in an amount that is

above that level, the food represents a

hazard to health that the evidence from

the chronic studies shows is reasonably

likely to occur. The question, then, is

whether the likelihood of finding a fish

in which the contaminant is at a higher

than acceptable level is an event that is

reasonably likely to occur. For open

ocean species of fish, for example, a

finding of pesticide residues above

nationally established tolerances can be

a very rare event. For near shore species

in certain locations, however, a finding

above tolerance can occur often enough

so as to warrant controlling for it as a

matter of reasonable prudence.

The incidence of reported illness for

a particular hazard may also be

nonexistent or very low because the

hazard may be too new to have

generated reported illnesses. The

emergence of natural toxins harmful to

humans in species or in locales where

the toxin has not been found before is

a well known phenomenon in seafood.

While FDA does not expect that HACCP

controls should be in place to control

for the possibility of such hazards—the

hazard may or may not ever occur—the

agency strongly believes that once a

hazard does emerge and is identified,

HACCP controls are highly appropriate

to keep illnesses from occurring. For the

duration of the a hazard, it must be

treated as one that is reasonably likely

to occur.

To provide clarification on the above

points, FDA has modified § 123.6 by

including the following sentence in new

§ 123.6(a):

A food safety 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 it will occur in the particular type of fish

or fishery product being processed in the

absence of those controls.

To reinforce that it was not FDA’s

intent to suggest that all of the nine

hazard categories that it listed in

§ 123.6(c)(1) are reasonably likely to
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65121

occur in all circumstances, the agency

has modified the language in this

provision to read in part,

‘‘Consideration should be given to

whether any food safety hazards are

reasonably likely to occur as a result of

the following:’’ (the list of nine

categories follows in the text).

The Guide is not intended as a

definitive list of the hazards that are

reasonably likely to occur, under all

conditions, for those species and

processing methods listed.

HACCP is a operation-specific

process. For this reason, the processor

must decide on a case-by-case basis

what hazards it needs to address; that is,

what hazards are reasonably likely to

occur. The purpose of the hazards

portion of the Guide is to provide a

listing of hazards, by fish species and by

finished product type, that FDA knows

to have a reasonable potential for

occurrence in the product.

FDA encourages processors to use the

Guide, as well as any other available

information, to decide what hazards

need to be addressed in any particular

plan. Processors need to recognize that

they need to use judgment in applying

the Guide to their own particular

circumstances. For example, a processor

of one species of fish may find that

pesticide contamination is listed as a

hazard for the species, but may be aware

of credible data that demonstrate that

the water from which it obtains its fish

is free of such contamination. In that

case, the processor is free to deviate

from the guidance. FDA intends to

clarify the Guide on this point by

distinguishing between hazards that are

reasonably likely to occur all of the time

(e.g., histamine in species that are prone

to it) and hazards that are reasonably

likely to occur under certain

circumstances (e.g., certain toxins when

a ‘‘bloom’’ is occurring).

5. The Plan: Specific Considerations

59. FDA proposed that HACCP plans

be specific to each processing location

and to each kind of fish and fishery

product processed by a processor,

except that the plan may group kinds of

fish and fishery products together if the

hazards, CCP’s, CL’s, and procedures

required to be included in the plan are

identical. A few comments from

processors and trade associations

suggested that production methods

should also be allowed to be grouped

together so long as the hazards and the

control procedures for the production

methods are identical. The comments

suggested that grouping would reduce

the paperwork burden on some

processors without altering the benefits

attainable through HACCP.

FDA agrees with the suggestion for

the reason presented by the comments

and has modified § 123.6(b) accordingly,

to read, in part:

A HACCP plan shall be specific to: (1) Each

location where fish and fishery products are

processed by that processor; and (2) Each

kind of fish and fishery product processed by

the processor. The plan may group kinds of

fish and fishery products together, or group

kinds of production methods together, if the

food safety hazards, critical control points,

critical limits, and procedures required to be

identified and performed in paragraph (c) of

this section are identical for all fish and

fishery products so grouped or for all

production methods so grouped.

60. In the proposal, FDA specified

that a HACCP plan must identify: The

applicable food safety hazards; the

CCP’s; the CL’s; the control and

monitoring procedures; and the

recordkeeping procedures. A few

comments suggested that FDA use the

word ‘‘list’’ or ‘‘include’’ rather than

‘‘identify’’ to describe a requirement for

an item to appear in the HACCP plan.

The comments suggested that it is not

clear from the word ‘‘identify’’ whether

the regulations are intended to require

that the plan contain or include the

actual values (e.g., the temperature of a

refrigerator) or a description of the

procedures, or whether it is permissible

simply to make reference to their

existence in a guideline or other source.

FDA’s intent is that a HACCP plan

explicitly include the value or a

description of the procedures for each of

the required HACCP elements. FDA

agrees that a word such as ‘‘list’’ would

be less ambiguous. Therefore, FDA has

revised § 123.6 (c)(1), (c)(2), (c)(3), and

(c)(4) by substituting the word ‘‘list’’

where the word ‘‘identify’’ appeared in

the proposed regulations.

FDA has also revised § 123.6(c) by

making another clarifying change. The

agency has added the phrase ‘‘at a

minimum’’ to the introductory

statement to make clear that the

required plan contents do not restrict a

processor from including additional

information in the plan, where it may be

appropriate.

61. Two comments requested that

FDA specify that decomposition, listed

as one of the hazard categories in the

proposal, is a hazard only in scombroid

toxin-forming species.

These comments stated that

decomposition in other species is not a

safety hazard but is an economic and

aesthetic problem.

FDA agrees with the comments in

part. FDA’s intent was to require control

of decomposition in a HACCP plan only

when it represents a food safety hazard.

As described in the preamble to the

proposed regulations, histamine

(scombroid toxin) development as a

result of microbiological decomposition

in certain species of fish is a well

recognized food safety hazard (Ref. 5, p.

24). There are some early indications,

however, that the development of

putrescine and cadaverine, also

byproducts of decomposition of fish,

under certain circumstances, may also

represent food safety hazards (Ref. 203,

p. 240). For this reason, FDA is hesitant

to limit the safety concern associated

with decomposition to the production of

histamine. Accordingly, FDA has

modified § 123.6(c)(1)(vi) to read,

‘‘Decomposition in scombroid toxinforming species or in any other species

where a food safety hazard has been

associated with decomposition.’’

62. Comments from two State

government agencies and a trade

association stated that FDA should

eliminate parasites as a safety hazard

that must be considered for inclusion in

a processor’s HACCP plan. The

comments noted that, with respect to

pathogens, FDA makes the assumption

that raw fish will be further processed

by cooking, and that, therefore, that the

pathogens will be destroyed and not

pose a health hazard. The comments

urged that the same rationale be applied

to raw fish that may contain parasites.

The comments further suggested that

the retail level is appropriate point of

control for parasites, and that the

provisions of the Food Code are

adequate to address this issue.

The comments further argued that

parasites pose a hazard only in certain

species that are consumed raw, and that

mandatory control procedures for all

fish that are consumed raw would create

an enormous economic hardship for

some segments of the industry. In

particular, one of the comments

contended that parasites have never

been a problem in the large tunas that

are eaten raw, and that it should not be

necessary to freeze such fish before they

are sold for raw consumption.

FDA’s intent is to require control of

parasites in a HACCP plan only in those

instances when parasites are reasonably

likely to occur in the portion of the flesh

that is consumed, and the presence of

the parasites will present a food safety

hazard (e.g., where the fish is offered for

raw consumption). To clarify this intent,

FDA has modified § 123.6(c)(1)(vii) to

read:

Parasites, where the processor has

knowledge or has reason to know that the

parasite-containing fish or fishery product

will be consumed without a process

sufficient to remove the hazard, or where the

processor represents, labels, or intends for

the product to be so consumed.
65122 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

With regard to the comparison made

by comments that FDA is requiring

control of parasites in raw fish but not

pathogens in raw fish, the

characterization of FDA’s policy

towards pathogens is inaccurate. The

sanitation provisions of these

regulations are designed, in large part,

to minimize the presence of pathogens

in fish and fishery products, whether

they are raw or further processed. The

major opportunity for the introduction

of enteric pathogens to processed fish

and fishery products is from the

processing environment as a result of

insanitary practices rather than by the

carcass of the animal (Refs. 3, p. 267;

and 7, p. 33). For this reason, sanitation

controls designed to prevent

contamination of fish flesh are

important to minimize the levels of

enteric pathogens found on processed

fish (Refs. 3, p. 10; 7, p. 27; 204; and

205). The agency is convinced that, if

followed, these controls will be effective

in minimizing the presence of such

pathogens. Moreover, FDA has long

enforced a zero tolerance for the

presence of Salmonella on raw fish,

based, in part, on the avoidability of

such contamination through the

application of CGMP’s.

63. One comment stated that the term

‘‘physical hazards’’ in the proposal

could be interpreted to include

nonsafety related hazards.

In § 123.6(c), physical hazards are one

of nine listed causes of ‘‘food safety

hazards’’ that processors should

consider for listing in their HACCP

plans (§ 123.6(c)(1)(ix)). Thus, the

agency believes that the language of this

section clearly applies to food safety

hazards only, and no modification of the

provision is necessary in response to

this comment.

FDA proposed that HACCP plans

include the CL’s that must be met at

each CCP. FDA received no significant

comment on this section (§ 123.6(c)(3))

and has made no substantive changes to

it.

FDA proposed to require that HACCP

plans include the procedures for both

‘‘monitoring’’ and ‘‘controlling’’ the

CCP’s. FDA recognizes that monitoring

and controlling serve different purposes,

and that the appropriate HACCP

principle is the monitoring of CCP’s to

ensure conformance with the CL (Ref.

34, p. 197). How a processor exercises

control is not critical to product safety

so long as the CL is not exceeded. There

are many ways to maintain control. No

one way or list of ways needs to be

stated in the plan so long as monitoring

is taking place at an appropriate

frequency to ensure that control is

occurring and to detect CL deviations

when they occur. For this reason, FDA

has modified § 123.6(c)(4) to read, ‘‘(4)

List the procedures, and frequency

thereof, that will be used to monitor

each of the critical control points to

ensure compliance with the critical

limits.’’

FDA has also eliminated the reference

in § 123.6(c)(4) to consumer complaints

as a monitoring tool. As explained in

more detail in the ‘‘Consumer

Complaints’’ section of this preamble,

FDA has concluded in response to

comments that consumer complaints

generally do not provide the processor

with the kind of immediate feedback

about whether the process is under

control that monitoring should provide

in a HACCP system. Consumer

complaints may provide the processor

with information that would be useful

for verification purposes, however.

These regulations therefore require

processors to take consumer complaints

into account as verification tools

(§ 123.8(a)(2)(ii).

Likewise, FDA has moved the

reference in the proposed regulations to

the calibration of process monitoring

instruments to the new ‘‘Verification’’

section of these regulations (§ 123.8),

and it has eliminated the specific

reference to computer software

validation. As explained in more detail

in the ‘‘Verification’’ section of this

preamble, FDA has concluded in

response to comments that calibration is

a verification function that provides the

processor with information about

whether its monitoring equipment is

functioning properly. Computer

software validation is a form of

calibration and need not be addressed

separately in these regulations.

64. In the preamble to the proposed

regulations, FDA asked for comment on

whether guarantees from suppliers

should be considered as an acceptable

way of meeting the proposed monitoring

requirement. Comments from a number

of processors responded that a

certificate from a producer that a lot of

raw material fish is free from

unacceptable levels of pesticide and

drug residues should be an acceptable

means of monitoring the hazards of

animal drug and pesticide residues in

aquaculture-raised fish. The comment

held that reliance on suppliers’

certificates may be necessary because of

the logistical problems that could be

associated with analyzing raw materials

for pesticides and drug residues. Of

particular concern, the comments said,

is the time necessary to analyze the

samples. The comments further stated

that the certificates should be based on

participation in an industry-wide

quality assurance program designed to

ensure that the raw materials are free

from these hazards.

FDA believes that caution is

warranted on the subject of supplier

guarantees. Where more direct controls

are available, they should be used. In

the case of aquaculture-raised fish, more

definitive controls than the acceptance

of a certificate attesting to the absence

of unapproved drug residues alone are

available to a processor, and these

controls are not unduly burdensome.

They include the review of the

supplier’s animal drug control records

when the lot is offered for sale and a

system of onsite audits of the supplier,

either by the processor or by a third

party. Such alternatives are also

available for most raw material hazards

(e.g., checking container tags and

harvester licenses as a means of

controlling microbiological

contamination in molluscan shellfish,

and checking vessel storage records as a

means of controlling histamine

development in scombroid species).

However, the agency recognizes that

there may be some instances in which

such controls are not possible, and

suppliers’ certificates or guarantees are

the only available monitoring tool. In

those cases, verification of the

effectiveness of the certificates may be

critical. Thus, the extent to which

suppliers’ guarantees can be relied upon

will have to be considered on a case-bycase basis. However, FDA has made no

change in § 123.6(c)(4) in response to

the comments.

FDA has added § 123.6(c)(5) that

describes requirements of the HACCP

plan with regard to corrective actions.

As explained in more detail in the

‘‘Corrective Actions’’ section of this

preamble, FDA has concluded in

response to comments that these

regulations should provide the

processor with the option of

predetermining corrective actions.

Predetermined corrective action

procedures have the potential to enable

a processor to take faster action when a

deviation occurs than would be possible

in the absence of such procedures, and

to make a more timely response to the

deviation when trained or otherwise

qualified individuals are not readily

available.

FDA has also added § 123.6(c)(6),

which describes the requirements of the

HACCP plan with regard to verification.

As explained in more detail in the

‘‘Verification’’ section of this preamble,

FDA has concluded in response to

comments that a processor needs to

specifically include in its HACCP plan

the verification procedures that it will

use and the frequency with which it

will use those procedures. FDA finds
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65123

that inclusion of this information in the

plan is necessary to underscore that a

processor has an ongoing obligation to

be sure that the verification steps that it

has determined are necessary are readily

ascertainable by the processor and its

employees as well as by regulatory

officials.

FDA proposed to require that HACCP

plans provide for a recordkeeping

system that documents the monitoring

of CCP’s. The proposed regulations also

provided that the records must include

the actual values obtained during

monitoring and any consumer

complaints that relate to the operation

of CCP’s or possible CL deviations. FDA

has removed the latter provision,

relating to consumer complaints, from

§ 123.6(c)(7). As explained above, these

final regulations treat consumer

complaints as verification tools rather

than monitoring tools. Consequently,

consumer complaints need not be

included in a recordkeeping system that

documents the monitoring of CCP’s. A

full discussion of issues relating to

consumer complaints is presented in the

‘‘Consumer Complaint’’ section of this

preamble.

6. Positive Versus Negative

Recordkeeping

The preamble to the proposed

regulations invited comment on

whether it was necessary for the results

of monitoring (i.e., the actual values) to

be recorded regardless of whether a CL

was met (positive recordkeeping), or

whether it was only necessary to record

information when a CL was not met

(negative recordkeeping). The agency

noted that negative recordkeeping is

presumably less expensive than positive

recordkeeping.

65. A substantial number of

comments addressed this issue.

Approximately two-thirds of these

comments, including those from trade

associations, processors, Federal, State,

and foreign government agencies,

consumer advocacy groups, and a

professional society, supported

requiring positive records. The

remaining one-third of the comments

that addressed this issue, from trade

associations, processors, and Federal

and State government agencies, argued

that records should only be required

when a CL deviation occurs, or that

positive records should be required or

encouraged, but that FDA should be

granted access to only the negative

records.

In general, the comments supporting

the need for positive records recognized

that monitoring records serve two major

purposes: To facilitate the identification

of trends that would lead to a loss of

control if not caught in time and to

document compliance with, or

deviations from, CL’s. Comments from a

large processor and a trade association

stated that, based on their extensive

experience with HACCP, positive

monitoring records provide a pattern of

results and values that is much more

meaningful than sporadic negative

records alone. Several comments stated

that positive recordkeeping facilitates

the taking of corrective action before the

CL’s are exceeded.

Several comments stated that a

provision that required only negative

records would penalize the firms that

already maintain records of all CCP

observations. A few comments

suggested that neither firm management

nor FDA could verify that the

monitoring procedures specified in a

processor’s HACCP plan are being

carried out if only records of deviations

from CL’s are kept, because there would

be no records to indicate that the other

checks were actually being made. A

comment from a consumer group further

argued that allowing the use of negative

records alone could create the

opportunity for processors to limit their

monitoring, because no records would

be needed to demonstrate that such

monitoring was performed.

Most comments that supported the

use of negative records alone stated that

positive recordkeeping and the review

of positive records was overly

burdensome for both the industry and

the regulator. A few comments stated

that positive records generate massive

databases that disguise CL deviations,

rather than illuminate them. No

examples of this phenomenon were

provided, however. One comment

suggested that since FDA inspects most

processors once a year or less, it is

questionable whether the agency would

be in a position to pick up trends in the

data from a review of all the positive

records that would be retained. Another

comment stated that it is just as

unrealistic to expect FDA investigators

to review all positive records as it is for

FDA to inspect all fish. A few comments

argued that the sheer volume of the

paperwork produced with positive

recordkeeping would result in technical

or clerical errors by processors that

could result in products being deemed

by FDA to be adulterated.

Several comments suggested that a

system where CL deviations trigger

remedial actions, which are properly

documented, should be sufficient for

FDA’s verification purposes. One

comment suggested that because

processors can falsify positive records as

well as negative records, FDA was

mistaken if its motive for proposing to

require positive records over negative

records was to help prevent

unscrupulous processors from

circumventing the system. An

additional comment supported limiting

mandatory HACCP recordkeeping to

negative records because FDA could not

rule out the possibility that future court

decisions or changes in FDA policy

might permit the disclosure of HACCP

records in FDA’s possession, and

negative recordkeeping would reduce a

company’s potential exposure.

FDA’s reasons for proposing positive

records match those in the comments

that support these kinds of records. As

the preamble to the proposed

regulations noted, recordkeeping is the

key to HACCP, enabling the processor

and the regulator to see the operation

through time. Negative records alone do

not allow this assessment over time and

do not provide assurance that the

appropriate monitoring was even

performed.

FDA cannot conclude from the

comments that supported negative

records that the burden of positive

recordkeeping is excessive or otherwise

outweighs the benefits. The agency

acknowledges that a requirement for

positive records may be more

burdensome than one that only requires

negative records. However, FDA

received no new data on this issue.

Positive recordkeeping can be extremely

simple and need not take much longer

to perform than the monitoring

necessary to determine whether the

process is in control (e.g., noting the

temperature of a refrigerator in a

logbook located next to the refrigerator).

The agency is convinced that this

minimal additional effort greatly

increases the chances that a processor’s

HACCP program will be successful.

Based largely on FDA’s experience

with the positive recordkeeping

requirements in the low-acid canned

food and the acidified food industries,

FDA does not agree that the volume of

positive records that a system will

generate will defeat the system by

hiding CL deviations or trends toward

such deviations. FDA’s regulations at

parts 113 and 114 require that these

industries perform positive

recordkeeping at identified CCP’s. The

industry itself requested this

requirement.

FDA has found that these processors

have no trouble making positive

records, and that both the processors

themselves and the regulators become

adept at reviewing them and deriving

benefits from them that would not have

been available from negative records.

These benefits have included being able

to pinpoint with confidence when a
65124 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

deviation began and ended, being able

to react to trends toward a loss of

control, and being able to prove that

CCP’s were actually being monitored as

often as necessary to ensure control. The

relative volume of records has not

served as a roadblock in this regard.

It is unlikely that FDA investigators

will review all monitoring records

during routine inspections, except in

highly unusual circumstances. As has

been the case with FDA inspections of

low-acid canned foods and acidified

foods, the agency will, in most cases,

select records to represent the

production since the last inspection.

This technique has proven to be both

effective and efficient.

As for the concern that the agency

will declare product adulterated on the

basis of technical or clerical errors in

positive-type records, the agency

advises that it is not its intent to pursue

regulatory action against product solely

because of clerical or related errors in

mandatory records. FDA does not take

such actions against processors of lowacid canned foods or acidified foods,

and it will not do so against seafood

processors. FDA will consider the entire

situation, and its potential for impact on

human health, in formulating a response

to deviations from these regulations.

As for the comment that FDA might

as well mandate negative records

because positive records can be

successfully falsified, FDA advises that

the possibility that records will be

falsified—and that falsifiers will get

away with it—is an issue that involves

the fundamental credibility of the

system. From FDA’s standpoint, the

agency’s decades-long experience

reviewing positive records on low-acid

canned foods and acidified foods gives

it confidence that its investigators can

detect falsifications. However, FDA did

not propose positive records for the

purpose of catching falsifiers. FDA

proposed positive records because this

approach confers benefits on both the

industry and the regulator that outweigh

the additional work of maintaining

them. Aside from the view, to which

FDA strongly adheres, that most

processors are honest and will not

falsify records, the agency strongly

believes that most processors will

quickly see the benefits to themselves of

a properly operating HACCP system

based on positive records and will insist

that their records be accurately

completed.

One such benefit should be a more

motivated workforce. HACCP

monitoring and recordkeeping can and

should be done by the workers who

operate the system at the CCP’s, not by

quality control personnel. To the extent

that these workers experience a sense of

responsibility and pride associated with

making accurate daily notations, the

processor can expect to benefit.

Regarding public disclosure of records

as mentioned by one of the comments,

FDA continues to believe that

possession of monitoring records by the

agency will be more the exception than

the rule, and that these kinds of records

are protected from public disclosure in

any event. The protection of records is

addressed in detail in the ‘‘Records’’

section of this preamble.

FDA has therefore not modified the

requirement that processors’ monitoring

records include the actual values

obtained during the monitoring.

7. Signing the Plan

66. In the preamble to the proposed

regulations, FDA specifically invited

comment on whether HACCP plans

should be required to be signed by a

representative of the firm and, if so, by

whom. Approximately 30 comments

responded to the inquiry. About twothirds of these comments, from

processors, trade associations,

professional associations, and Federal,

State, and foreign national governmental

agencies, supported the need for a

signature. The remaining comments,

mostly from processors and trade

associations, argued that a signature was

unnecessary.

Those that favored a requirement for

a signature on HACCP plans stated that

the signature does the following:

Demonstrates formal adoption of the

HACCP plan, solidifies responsibility

for adherence to the plan, and fosters a

sense of management ownership. The

comments made the following

suggestions with regard to who should

be the signatory (in order of preference):

Onsite manager, most responsible

individual of the firm, any senior

manager, HACCP coordinator, and all

HACCP team members. Those

comments that argued against a

mandatory signature on the plan stated

that the existence of a HACCP plan itself

constitutes management support for the

plan.

FDA agrees with the comments that

recommended a requirement for HACCP

plans to be signed by a representative of

the firm. As suggested by the comments,

such a signature will provide direct

evidence of management’s acceptance of

the plan for implementation. FDA

cannot stress enough that for HACCP to

succeed, there must be a clear

commitment to it from the top of the

firm on down. Management must set a

strong example in this regard. A

signature requirement will remind

management of this important

responsibility and will signal to all

employees that the firm regards the

HACCP plan as a document to be taken

seriously. Additionally, the

representative’s signature, along with

the date of signing, would serve to

minimize potential confusion over the

authenticity of any differing versions or

editions of the document that might

exist. FDA has concluded that the

burden of such a requirement would be

minimal, and has added a new

paragraph at § 123.6(d), that reads:

(d) Signing and dating the HACCP plan. (1)

The HACCP plan shall be signed and dated,

either by the most responsible individual

onsite at the processing facility or by a higher

level official of the processor. This signature

shall signify that the plan has been accepted

for implementation by the firm. (2) The

HACCP plan shall be dated and signed: (i)

Upon initial acceptance; (ii) Upon any

modification; and (iii) upon verification of

the plan * * *.’’

As will be discussed fully in the

‘‘Verification’’ section of this preamble,

the adequacy of the HACCP plan must

be reassessed, and modified as needed,

whenever significant changes in the

firm’s operations occur, but no less than

once per year. These reassessments and

modifications are necessary to ensure

that the plan remains current and is

responsive to emerging problems. The

signature of the firm representative will

be valuable in documenting that these

reassessments and modifications are

performed as required. Particularly if no

modification of the plan is needed,

reassessment can be verified by FDA

only if documentation, such as a

signature, is maintained by the firm.

8. Relationship to Parts 113 and 114

67. A few comments urged that the

final regulations provide that if a

processor of low-acid canned fishery

products is in compliance with FDA’s

regulations for these products under

part 113, it would also be in compliance

with these HACCP regulations with

respect to the control of the hazard of

C. botulinum toxin production. The

regulations at part 113 establish

HACCP-type controls for this hazard.

FDA agrees that there is no need for

a processor to restate in its HACCP plan

the requirements of part 113 or 114. It

is also not necessary for such a

processor to institute controls in

addition to those specified in parts 113

and 114 in order to control the hazard

of C. botulinum toxin production.

Consequently, processors who must

comply with the requirements of part

113 or 114 need not address this hazard

at all in their HACCP plans. However,

it is important to note that other hazards

may be reasonably likely to occur in an
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65125

acidified or low-acid canned fishery

product. These hazards must be

addressed in the HACCP plan, as

appropriate. For example, processors of

canned tuna will likely need to identify

in their HACCP plans how they will

control the development of histamine

before the canning process.

Accordingly, to clarify what is required

of processors of acidified and low-acid

canned fishery products, FDA has

added § 123.6(e), which reads:

For fish and fishery products that are

subject to the requirements of part 113 or 114

of this chapter, the HACCP plan need not list

the food safety hazard associated with the

formation of Clostridium botulinum toxin in

the finished, hermetically sealed container,

nor list the controls to prevent that food

safety hazard. A HACCP plan for such fish

and fishery products shall address any other

food safety hazards that are reasonably likely

to occur.

9. Sanitation in the Plan

The question of the role of processing

plant hygiene (i.e., traditional sanitation

controls) in HACCP is addressed at

length in the ‘‘Sanitation’’ section of this

preamble. As explained in that section,

FDA is requiring that processors address

plant sanitation by monitoring for

certain key sanitation conditions and

practices apart from critical control

point monitoring activities, or by

including sanitation controls as part of

the HACCP plan, or by adopting some

combination of these two approaches, at

the option of the processor. To reflect

this approach, in paragraph (f) in § 123.6

on the inclusion of sanitation controls

in the HACCP plan FDA has stated: ‘‘(f)

Sanitation controls may be included in

the HACCP plan. However, to the extent

that they are monitoring in accordance

with § 123.11(b), they need not be

included in the HACCP plan and vice

versa.’’

FDA recognizes that, in many

processing operations (e.g., cooked,

ready-to-eat fishery products, smoked

fishery products, and molluscan

shellfish) sanitation controls, such as

hand and equipment washing and

sanitizing, are critical to the safety of the

food because they serve to minimize the

risk of pathogen introduction into

finished products that may not be

further cooked before consumption (Ref.

3, p. 267). For this reason, some

processors may elect to include the

control of sanitation conditions and

practices in their HACCP plan in

addition to, or in place of, monitoring

for such conditions and practices apart

from the HACCP plan. Based in part on

experience gained from the seafood

HACCP pilot project operated jointly by

FDA and DOC, however, FDA also

recognizes that sanitation controls may

be difficult to fit in HACCP plans, with

appropriate CL’s and corrective actions

sometimes being elusive. For this

reason, some processors may elect to

rely exclusively on sanitation controls

that are not part of the HACCP plan.

FDA considers either approach to be

acceptable, so long as whatever

approach is chosen is fully

implemented and followed.

10. Nonsafety Issues

68. FDA proposed in § 123.6(c) to

recommend, but not to require, that

HACCP plans include controls for such

nonsafety hazards as economic

adulteration and decomposition that are

not related to safety. Additionally, FDA

proposed to append to the regulations at

Appendix D guidance on how a

processor can use a HACCP-based

approach to ensure that fish and fishery

products are in compliance with the

economic adulteration and misbranding

provisions of the act. Approximately 75

comments addressed these proposed

provisions. The vast majority of these

comments urged that proposed

§ 123.6(c) and proposed Appendix D of

part 123 be eliminated from the

regulations. Some of these comments

suggested that it might be appropriate

for the contents of proposed Appendix

D to be included in the Guide.

Those that argued for removal of the

recommendation that HACCP be used to

control nonsafety hazards from the

regulations stated that: (1) HACCP for

safety purposes will be a big enough

challenge for both the industry and

regulators, and that inclusion of

nonsafety hazards might be

overwhelming; (2) nonsafety hazards,

such as economic fraud and

decomposition, are covered adequately

by existing FDA regulations and

standards and by industry quality

control programs; (3) inclusion of

nonsafety hazards deviates from the

internationally recognized NACMCF

recommendations; and (4) inclusion of

nonsafety hazards, even as a

recommendation, would dilute and

jeopardize a desirable industry focus on

safety. One comment stated that

processing plant personnel and

supervisors should be trained to expect

serious consequences when CL

deviations occur because this heightens

their attention to monitoring and

control. However, the comment further

argued, the consequence of violating a

nonsafety CL is likely to be relatively

minor. The comment argued that, as a

result, plant personnel and supervisors

will become confused about the

significance of CL deviations.

A significant minority of the

comments favored the treatment of

nonsafety hazards such as economic

fraud and decomposition in the same

manner in which safety hazards are

treated in these regulations, with

mandatory HACCP controls. These

comments argued that: the same

conditions of processing that affect the

occurrence of safety hazards affect the

occurrence of such nonsafety hazards as

decomposition and economic fraud,

making the two control systems

compatible; an improvement in

consumer confidence in seafood cannot

be achieved without improvements

relative to economic deception and

decomposition; decomposition is the

number one cause of FDA legal action

with respect to seafood; decomposition

is a good indication of time and

temperature abuse, which has a

significant impact on the growth of

pathogens; the seafood industry

considers economic fraud to be the most

significant hazard affecting the

marketing of its products; species

substitution can be safety related, as in

the case of the substitution of a

scombroid species for a nonscombroid

species; HACCP controls would likely

enhance compliance with existing

nonsafety standards; and inclusion of

controls for economic fraud and

decomposition would not significantly

increase the costs to industry.

FDA concludes that the HACCP

system will have to mature, and much

will have to be learned, before it can be

determined whether a mandatory

HACCP program should include

nonsafety matters. Because these

regulations reflect a first step in terms

of mandating HACCP, the agency is

comfortable as a matter of policy that

they should initiate a system that

focuses on food safety. Additionally, the

statutory provisions that form the basis

for these regulations are safety

provisions. FDA’s application of HACCP

is intended for the effective enforcement

of sections 402(a) (1) and (a)(4) of the

act, which apply to products that

contain substances that may render the

product injurious to health and to

processing conditions that are insanitary

and that could render a product

injurious to health. Thus, the only real

issue is whether the final regulations

should retain the recommendations

with regard to the application of HACCP

to nonsafety matters.

FDA is persuaded by the comments

that the proposed recommendations for

HACCP controls of nonsafety matters,

coupled with the presence of proposed

Appendix D of part 123, have the

potential for causing confusion about

the agency’s expectations and
65126 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

enforcement policies. FDA recognizes

the point raised by a number of

comments that advisory provisions are

often confused with or misapplied as

requirements. Given this fact and the

emerging nature of HACCP, FDA has

decided to eliminate proposed § 123.6(c)

and Appendix D of part 123. FDA will

consider including the concepts that

underlay these provisions in the first

edition of the Guide, however, because

the Guide is understood as being the

repository for recommendations relating

to seafood HACCP.

The agency’s decision to eliminate

reference to nonsafety hazards from

these regulations notwithstanding, such

hazards as economic adulteration,

decomposition not normally associated

with human illness, general unfitness

for food, and misbranding constitute

violations of the act and are subject to

regulatory action by FDA (see sections

402(a)(3) and 403 of the act (21 U.S.C.

343)). When inspections by FDA

investigators reveal violations of these

provisions of the act, FDA will take

enforcement action as it deems

appropriate. Processors who are able to

accommodate a HACCP system that

covers both safety and nonsafety

hazards may find advantage in doing so,

in order to better ensure compliance

with existing nonsafety regulations and

standards.

11. ‘‘Shall Render Adulterated’’

FDA proposed to provide that: Failure of

a processor or importer to have and

implement an HACCP plan that complies

with this section or to operate in accordance

with the requirements of this part, shall

render the products of that processor or

importer adulterated under section 402(a)(4)

of the act.

The preamble to the proposed

regulations explained that the proposed

regulations set out those requirements

that the agency had tentatively

concluded are the minimum necessary

to ensure that the processing of fish and

fishery products will not result in

product that is injurious to health. FDA

tentatively determined that such

minimum requirements include the

establishment of HACCP preventive

controls. The preamble further

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

act, among other things, deems a food to

be adulterated if it is prepared, packed,

or held under insanitary conditions

whereby it may have been rendered

injurious to health.

69. A significant number of

comments, primarily from processors

and trade associations, opposed the

proposed language of this provision.

The comments urged that the word

‘‘may’’ replace the word ‘‘shall’’ in order

to establish that instances of

noncompliance with the regulations do

not automatically constitute

adulteration. They contended that,

because FDA will not be preapproving

HACCP plans, a negative finding on the

first FDA inspection could, under the

language that was proposed, cause the

agency to consider all product produced

to that point to be adulterated. The

comments stated that each case of

noncompliance should be evaluated on

its own merits.

FDA fully agrees that each case

should be judged on its merits but does

not agree that it is necessary to change

the regulations in order to establish this

principle. The purpose of § 123.6(g),

which sets out this language, is not to

create a legal presumption that food is

adulterated if there is not perfect

adherence to these regulations but to

make clear that certain types of

preventive controls are so fundamental

to ensuring the safety of seafood that if

there is not adherence to them, the food

cannot be considered to have been

produced in accordance with section

402(a)(4) of the act.

As a practical matter, FDA expects to

exercise broad regulatory discretion in

deciding when violations of these

regulations warrant regulatory action,

just as it does now for other situations.

The agency will analyze each case on its

merits, based at least in part on the

potential for harm that exists.

The agency’s primary concern is that

processors develop HACCP plans that

address the hazards that are reasonably

likely to occur. When deficiencies in

HACCP plans are detected during FDA

inspections, the agency usually will first

attempt to seek voluntary correction of

the situation. Only when such voluntary

correction is not forthcoming is it likely

that FDA will elect to pursue regulatory

action. It must be noted, however, that,

where HACCP plan deficiencies result

in significant potential for consumer

harm, the agency will evaluate the need

for corrective action with respect to the

product that has been produced as well

as to the HACCP plan itself.

In this regard, FDA notes that a

change from ‘‘shall’’ to ‘‘may’’ in the

provision would be more compatible

with guidelines than with regulations.

Consequently, the agency has retained

the term ‘‘shall’’ in § 123.6(g). However,

to clarify that a decision on whether to

take regulatory action will involve

discretion based on the public health

significance of the violation, a sentence

has been added to indicate that when a

violation occurs, FDA will evaluate the

processors overall implementation of its

HACCP plan in deciding how best to

remedy the violation.

Consistent with the revisions to the

requirements for imported products

contained in § 123.12, the word

‘‘importers’’ has been eliminated from

§ 123.6. As described in the ‘‘Imported

Products’’ section of this preamble, the

proposed requirement that an importer

develop a HACCP plan (§ 123.11) has

been eliminated in favor of a

requirement for importer verification

procedures. This change eliminated the

relevance of § 123.6 to importers.

Consistent with the revision to

§ 123.6(a) and (b) that processors have

HACCP plans only when a hazard

analysis reveals one or more food safety

hazards that are reasonably likely to

occur, § 123.6(g) has been amended to

state that a processor’s failure to have a

HACCP plan shall render the fish or

fishery products adulterated only when

a HACCP plan is necessary.

F. Corrective Actions

The fifth HACCP principle, as

articulated by the NACMCF, is that

processors establish the corrective

actions that they will take should

monitoring show that a CL has been

exceeded. The NACMCF’s expectation

is that these corrective actions should be

predetermined and written into the

processor’s HACCP plan.

In the proposed regulations, FDA

tentatively chose to incorporate the

principle of corrective action without

requiring predetermined corrective

action plans in the processor’s HACCP

plan. Instead, FDA proposed minimum,

generic corrective action procedures for

processors to follow. In so doing, FDA

was trying to minimize the burden of

the mandatory requirements of HACCP,

especially for small processors. FDA

tentatively concluded that the

procedures set out in proposed § 123.7

represented the minimum requirements

necessary to ensure that processors

respond effectively to deviations that

could affect safety, and that if those

procedures were followed, specific

corrective action plans, although

desirable, would not be necessary.

FDA proposed in § 123.7 to require

that deviations from CL’s trigger a series

of actions, including: Segregating and

holding the product, making a

determination of the acceptability of the

product for distribution, taking

appropriate remedial action with

respect to the product and the cause of

the deviation, and documenting the

actions taken. In the preamble to the

proposed regulations, FDA invited

comment on the wisdom of this

approach as opposed to requiring that

predetermined corrective action plans

be made part of the HACCP plan. A

large number of comments responded to
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65127

that request. Additional comments

addressed the specifics of the proposed

generic-type requirements in § 123.7.

1. Should Corrective Actions Be

Predetermined?

70. Approximately half of the

comments supported the corrective

action system proposed by the agency or

a variation of it, and the other half

called for mandatory predetermined

corrective action plans. Many of those

that supported mandatory corrective

action plans urged consistency with the

HACCP recommendations of the

NACMCF. These comments noted that

the NACMCF recommendations are

consistent with Codex Alimentarius

Commission standards. They predicted

that compatibility of the final

regulations with such international

standards would minimize confusion

for processors and importers, smooth

international adoption of HACCP

principles, and facilitate trade. The

comments stressed that predetermining

corrective action is an essential

component of a processor’s HACCP

program, with the seven principles

being so closely intertwined that overall

success is probable only if all are intact.

A number of comments argued that a

processor’s implementation of a

corrective action plan would eliminate

indecision and confusion about what

corrective action should be taken in the

event of a deviation from a CL. For

example, one comment pointed out that

corrective actions written into the

HACCP plan would eliminate the need

for employees to substantiate to

management the correctness of their

response to a deviation, because the

corrective action plan would provide

the right actions to be taken for each

particular deviation. A few comments

stated that, if the appropriate corrective

actions are detailed in the HACCP plan,

responses by employees to CL failures

are more likely to be immediate

(reducing product losses) and effective

(reducing wasted effort). These

comments further noted that corrective

action plans are particularly necessary

when individuals qualified to make

product safety evaluations are not

readily available.

One comment asserted that the

strength of the HACCP system is that it

is preventive, and that corrective action

plans are fundamental in preventing a

product, for which there is a safety

concern, from reaching the consumer.

The comment further stated that written

corrective action plans should provide

for the documentation of the following:

(1) The cause of the deviation, (2) the

action taken to ensure that the deviation

does not reoccur, (3) the results of the

risk evaluation, and (4) product

disposition.

Many comments did not agree that

corrective action plans should be

required. A few comments argued that

developing a corrective action plan is

impractical and can be unduly

restrictive because of the diversity and

complexity of seafood products and of

seafood processing operations. One

comment noted that many situations

exist in which the appropriate response

to a CL failure is not apparent until the

details of the particular situation are

known. Several stated that a corrective

action plan is less preferable than

having responsible and knowledgeable

personnel, adequately trained in

HACCP, available to evaluate a

deviation from a CL. If such personnel

are available, one comment noted,

deviations can be handled on a case-bycase basis, with appropriate

documentation of the disposition of the

affected product.

Several comments argued that the

lack of a corrective action plan is not

sufficient evidence to demonstrate that

a product is adulterated. The comments

argued that the proposed requirement

that a processor establish CL’s and

perform and record appropriate

corrective actions when these limits are

exceeded, provides sufficient

demonstration of hazard control.

A number of comments that

advocated the concept of predetermined

corrective action plans urged that

processors be given the option of

writing such plans or of following a

series of minimum mandatory actions,

like those proposed by FDA, when CL

failures occur. In the preamble to the

proposed regulations the agency did, in

fact, encourage processors to

predetermine corrective actions as part

of the preparation of a HACCP plan.

On this issue, the merits of the

various approaches tend to balance.

Consequently, FDA agrees with those

comments that urged that the

regulations provide processors with the

option of developing their own

corrective action plans as part of their

HACCP plans or of following a generic

model corrective action plan, provided

in the regulations, should a deviation

occur.

The agency accepts the view that

predetermined plans have the potential

to provide processors with benefits, as

pointed out by the comments, such as

faster action when a deviation occurs,

less need to justify to management the

appropriateness of the corrective action

after it has been taken, and a more

timely response to the deviation when

trained or otherwise qualified

individuals are not readily available to

make determinations. On the other

hand, FDA has not been provided with

information on which it can conclude

that these benefits—as desirable as they

may be—need to be mandated in order

to protect the public health. Processors

can build them into their HACCP

systems if they so choose, but the public

health will be protected so long as

shipment of the affected product into

commerce does not occur until the

significance of the deviation has been

assessed and appropriately resolved.

This outcome is assured both with

specific predetermined corrective action

plans and with the minimum generic

model that FDA is requiring as an

alternative. Without additional evidence

from actual experience, which was not

provided by the comments, FDA cannot

conclude that the overall success of

HACCP depends on whether processors

have specific predetermined plans for

events that might not necessarily occur.

Consequently, FDA has revised

§ 123.7 to permit, but not to require,

processors to include in their HACCP

plans any written corrective action

plans that they develop. When a

deviation from a CL occurs, § 123.7(a)

requires that processors either: (1)

Follow a corrective action plan that is

appropriate for the particular deviation,

or (2) follow the series of actions

provided in § 123.7(c). The steps in

§ 123.7(c) constitute a minimum generic

model for corrective actions and, as will

be explained below, closely match those

that were contained in the proposed

regulations.

The final regulations at § 123.7(b)

define an appropriate corrective action

plan as one that addresses both the

safety of the product that was being

processed when the CL failure occurred

and the cause of the deviation. In this

respect, the contents of the corrective

action plan are consistent with the

views of the NACMCF (Ref. 34, pp. 199–

200). The corrective action must ensure

that any unsafe product is not

distributed.

FDA advises that action necessary to

correct the product may involve any one

or more of the following steps:

Immediately reprocessing the product;

diverting the product to another use

where it can be used safely; segregating

the product, holding it, and having it

evaluated by a competent expert; or

destroying the product. In order to

ensure that subsequent product is not

subjected to the same deviation, the

corrective action must be sufficient to

bring the process back under control

(Ref. 34, pp. 199–200). FDA advises that

such action may involve, where

appropriate: adjustments to those

process parameters that have an effect
65128 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

on the relevant CL (e.g., flow rate,

temperature, source of raw materials);

temporarily diverting product around a

point in the process at which problems

are being encountered; or temporarily

stopping production until the problem

can be corrected.

Section 123.7(c) describes the steps

that a processor must take whenever

there is a deviation from a CL but no

corrective action plan to follow. As

stated above, these steps constitute a

minimum generic-type corrective action

plan. The objectives of these steps are

the same as those of a preconceived

plan: To ensure that adulterated product

does not enter commerce and to correct

the cause of the deviation. Because it is

a generic-type plan that is intended to

be applicable to any situation, some of

the steps, such as segregating and

holding the affected product

(§ 123.7(c)(1)), might not be necessary if

the corrective action had been

predetermined. This aspect of the

generic-type plan may provide

processors with an incentive to

predetermine corrective actions

whenever practical.

Another such incentive is the

requirement, at § 123.7(c)(5), that the

processor reassess the adequacy of its

HACCP plan when a deviation occurs.

This requirement does not exist where

a corrective action plan exists. The

reason for the distinction is that, on one

hand, if a processor has assessed its

process and decided that CL failures are

likely to occur from time to time at

particular points, those failures, when

they occur, do not represent a failure of

the plan but a foreseeable occurrence.

On the other hand, if the processor has

not made such an assessment, and a

failure occurs, it is not possible to say

what the failure means. The processor

must assess whether the deviation is the

result of a system-wide problem that is

not being properly addressed by the

plan or simply a failure that could be

expected to occur in the normal course

of things. The failure must be fully

assessed, and if it represents a failure of

the plan, the plan must be modified to

reduce the risk of reoccurrence.

The agency is convinced that the

corrective action approach contained in

the final regulations (i.e., predetermined

corrective action plans at the option of

the processor) adheres to the principles

of HACCP as recommended by

NACMCF (Ref. 34, pp. 199–200) and

will not result in undue burden,

confusion, or trade difficulties. At the

same time, these regulations will

provide the flexibility needed to

accommodate the varying levels of

HACCP sophistication within the

industry. FDA is satisfied that employee

indecision in responding to CL

deviations will not result in a public

health problem in the absence of

corrective action plans because the final

regulations contain a set of well defined

actions that are to be followed if a

deviation occurs and no predetermined

plan exists. The actions outlined in

§ 123.7(d) ensure that no unsafe product

will enter commerce, and that a

normalization of processing conditions

will be effected as quickly as possible.

While the agency sees merit in the

argument that predetermined corrective

action plans will, in many cases, be

economically beneficial to a processor

(e.g., minimize product loss and wasted

effort), such economic factors will, in

and of themselves, motivate processors

to predetermine appropriate corrective

actions, but they do not mean that the

agency needs to require the adoption of

predetermined plans.

71. A few comments recommended

that FDA review corrective action plans

for adequacy during, or in advance of,

the first regulatory visit. This review,

the comments asserted, would help to

avoid a situation in which the processor

takes a corrective action in conformance

with its HACCP plan, but the agency

later determines that the action was

inadequate.

FDA agrees that these comments

reflect a desirable ideal but must

acknowledge that such a review

ordinarily will not be feasible. If

processors complete their HACCP plans,

including any corrective action plans

that they choose to develop, before the

effective date of these regulations, they

may be able to obtain a review of those

plans as part of a routine FDA

inspection.

In any event, the agency intends to

review corrective action plans that a

processor includes as part of its HACCP

plan during routine regulatory

inspections. Where the investigator

finds a shortcoming in the corrective

action plan, the investigator will discuss

it with the processor. As with a failure

to meet any other provision of these

regulations, in determining its response

to such a shortcoming, the agency will

consider the totality of the situation and

the likelihood that the shortcoming will

have an adverse impact on the safety of

the product. If a corrective action plan

has not actually been used as of the time

of the investigator’s review, and as a

consequence of its review the agency

advises the processor that the corrective

action plan needs to be improved, it is

likely that FDA will advise the

processor to follow the alternative

procedure in these regulations until the

upgrade occurs.

2. Assessing the Product for Safety

72. FDA received comments on

specific aspects of the generic-type

corrective action plan provided in

proposed § 123.7(a). A significant

number of comments opposed the

provision that would have required an

‘‘immediate’’ safety assessment when a

CL deviation occurs. One comment

stated that, because an appropriately

trained individual may not be

immediately available to make a

determination of the acceptability of the

lot, the provision should be modified to

require segregation and holding of the

affected product until either a timely

safety review by a properly trained

individual has been completed, or a

determination has been made that the

appropriate predetermined corrective

action plan has been followed. A

number of other comments also

suggested that the phrase ‘‘immediate

review’’ be revised to ‘‘timely review.’’

One comment recommended that FDA

specify a maximum amount of time in

which to evaluate the product, for

example within 24 hours. Another

comment advised that FDA permit

processors to cook or freeze fresh

product involved in a CL deviation,

until an evaluation can be completed.

FDA agrees that immediate review is

not necessary. As long as the review

occurs before the product is distributed,

the public health will be sufficiently

protected. Consequently, while

§ 123.7(c)(2) requires a review to

determine the acceptability of the

affected product for distribution, it does

not require that the review be

immediate, nor does it otherwise specify

a timeframe for review. If there is a

chance that the product is still fit for

commerce, FDA expects that economic

considerations will dictate the timing of

the review. FDA agrees that, in many

cases, it would be advantageous for a

processor to cook or freeze a product

pending results of a safety evaluation.

The agency has no objection to such an

action as long as the processor

maintains the identity of, and its control

over, the lot.

FDA has also modified § 123.7(c)(2)

from the proposal to require that the

review of the product be conducted by

someone with adequate training or

experience, although FDA is not tying

adequate training to training in HACCP

(see § 123.10) as it did in the proposal.

FDA made this change because, as

comments pointed out, a 3-day course

in HACCP would not necessarily qualify

someone to make many public health

determinations of this nature. The basis

for this modification is more fully
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65129

described in the ‘‘Training’’ section of

this preamble.

3. Documenting Corrective Actions

In § 123.7(d), FDA is retaining the

proposed requirement that records of

corrective actions be kept. As with the

proposal, such records are subject to the

general recordkeeping requirements of

§ 123.9. The records must document the

actions taken in following either a

predetermined corrective action plan or

the corrective action procedures

specified in § 123.7(c).

73. One comment suggested that the

absence of written corrective action

plans would make it more difficult to

document a response to a deviation. It

went on to explain that, with a plan, the

processor could simply note, for

example, that ‘‘the product was

recooked in accordance with ‘Section B

of the Plan.’’’ It pointed out that more

extensive documentation would be

necessary if a processor did not have a

predetermined plan.

FDA does not agree with this

comment. Section § 123.7(d) requires

that the corrective action taken by a

processor be fully documented. It is the

agency’s intent that such documentation

provide the specifics about the actions

that were taken and not simply refer to

a written procedure. In the example

given, records of the recooking

operation, equivalent to monitoring

records for such an operation, i.e.,

cooking, would be necessary to

document that the operation was

performed in a manner that would

render the product safe. Thus, similar

documentation would be necessary

whether a plan exists or not.

It is worth noting that § 123.7(d) now

states that corrective action records are

subject to verification in accordance

with § 123.8(a)(3)(ii). This requirement

is not new but reflects the fact that

record review is deemed to be a

verification activity in the final

regulations but was not classified as

such in the proposal. A further

discussion of this matter can be found

in the section of this preamble that

follows.

G. Verification

1. Overview

Verification is one of the seven

commonly recognized principles of

HACCP. In the preamble to the

proposed regulations, FDA

acknowledged and discussed the

recommendations of the NACMCF as

they relate to verification. According to

the NACMCF, verification essentially

involves: (1) Verifying that the CL’s are

adequate to control the hazards; (2)

ensuring that the HACCP plan is

working properly, e.g., that it is being

followed, and that appropriate decisions

are being made about corrective actions;

and (3) ensuring that there is

documented, periodic revalidation of

the plan to make sure that it is still

relevant to raw materials as well as to

conditions and processes in the plant.

2. Need for Verification Requirement in

Regulations

In the preamble to the proposed

regulations, FDA encouraged processors

to adopt verification practices but did

not propose to require that a processor’s

HACCP plan specify the verification

procedures. Rather, the agency

tentatively concluded that verification

of a HACCP plan would effectively

occur through: (1) Comparison of the

plan to guidance documents such as

FDA’s draft Guide; (2) technical

assistance provided through trade

associations, universities, and

government agencies; (3) mandatory

review of monitoring and corrective

action records by trained individuals

before product distribution; (4)

mandatory reassessment of the

adequacy of the HACCP plan as a

consequence of CL deviations; (5)

reliance on the recommendations in

FDA guidelines that processors of

cooked, ready-to-eat seafood products

use the expertise of ‘‘processing

authorities,’’ i.e., third-party experts; (6)

mandatory training; and (7) investigator

review of the entire HACCP system

during routine agency inspections. FDA

requested comment on whether this

approach is adequate to ensure that the

verification principle was being

properly addressed.

74. A large number of comments

responded to this request.

Approximately one-third of these

comments stated that FDA’s proposed

approach to HACCP verification was

adequate. The other comments argued

that verification should be specifically

mandated as a part of a firm’s HACCP

program.

A few of the comments favoring the

proposed approach contended that a

HACCP plan lacking verification

procedures should not be grounds for

FDA to consider a product to be

adulterated. Several comments stated

that processors will engage in

verification activities without a

requirement, as a natural outgrowth of

a HACCP program, because without

such activities, HACCP will not work.

For this reason, they argued, it is not

necessary to mandate that verification

procedures be included in processor’s

HACCP plans.

Of the comments that supported the

need for specifically-mandated

verification activities, a significant

number urged the agency to adopt such

a requirement to be consistent with the

HACCP recommendations of the

NACMCF. These comments noted that

the NACMCF recommendations are

consistent with Codex Alimentarius

Commission standards. They predicted

that compatibility of the final

regulations with such international

standards would minimize confusion

for processors and importers, smooth

international adoption of HACCP

principles, and facilitate trade. The

comments stressed that verification is

an essential component of a processor’s

HACCP program, and that the seven

principles are so closely intertwined

that overall success is probable only if

all are intact.

One of the comments stated that

verification should involve a continual

review and improvement of the HACCP

system. The comment added that

verification is a primary responsibility

of processors, one that is equivalent in

importance to plan development.

Several comments stated that the

benefits of HACCP verification include:

Assurance that all CCP’s are identified,

assurance that the plan is being

followed, a mechanism for third party

oversight of the plan development

process, a means of measuring the

success of a HACCP system, and

information on trends in the frequency

and reasons for CL deviations. One

comment suggested that firms should be

required to perform verification

activities at least annually.

A few comments stated that although

the proposed regulations included some

required practices that could be deemed

to be verification, such as the calibration

of process-monitoring instruments and

plan reassessment and modification in

response to a CL failure, the entire

concept of verification should be

addressed more fully in a separate

section of the final regulations. One of

these comments suggested that the

following verification activities be

specifically mandated: Calibration of

process control instruments, validation

of software for computer control

systems, and daily review of monitoring

records.

One comment stated that, without a

requirement for specific verification

activities, processors would rely strictly

on end-product testing to evaluate the

success of the HACCP plan, and that

such an approach would diminish the

effectiveness of the entire HACCP

system. Several comments stated that

HACCP plan verification procedures
65130 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

should include detailed government and

industry audits and product analyses.

One comment, from a consumer

advocacy organization, challenged

whether effective verification would

really occur through the measures cited

in the preamble. The comment stated

that ‘‘third-party technical assistance’’ is

not a mandatory part of the HACCP

program and, therefore, can not be

counted on as a verification procedure.

It added that such technical assistance

would tend to be performed during plan

development, and that verification must

be an ongoing procedure. The comment

stated that a ‘‘review of all HACCPmonitoring records by trained

individuals before distribution of

product’’ is not verifiable by the agency

because a firm can cut corners by having

their employees sign the records

without reviewing them. The comment

argued that FDA auditing of consumer

complaints and mandatory in-process

and end-product testing are important

verification procedures.

A few comments suggested that FDA

should include a requirement that

written verification procedures be in

place, but that the agency need not

prescribe specific verification activities,

or should do so only sparingly.

FDA notes that the proposed

regulations contained specific

provisions identified by many of the

comments as appropriate verification

steps. For example, the proposed

requirement that the HACCP plan

adequately address the food safety

hazards that are reasonably likely to

occur (§ 123.6(c) in this final rule) is a

continuing, rather than a one-time

requirement. Thus, to continually be in

compliance with it, a responsible

processor would have to engage in some

form of reassessment. Other provisions

in the proposal that comments

identified as verification steps included:

The required calibration of process

monitoring instruments; the required

validation of computer software; the

requirement that consumer complaints

be reviewed to assess whether they

indicate a problem at a CCP; and the

requirement that HACCP-monitoring

and corrective action records be

reviewed before distribution of the

product. FDA now realizes, however,

that by not specifically requiring

verification as such, the proposal

generated considerable confusion about

whether FDA intended to include or

exclude the principle of verification

from processors’ HACCP programs. FDA

has concluded, therefore, that

verification is important enough to be

an explicit part of the regulations. FDA

has made it such in the final rule at

§ 123.6(c)(6) and in a new section for

verification, § 123.8.

Section 123.6(c)(6) requires that

processors include in their HACCP

plans a list of the verification

procedures that they will use and the

frequency of those procedures. This

provision is consistent with the view of

the NACMCF that a processor’s

verification procedures should be

addressed in the HACCP plan (Ref. 34,

pp. 200–202). FDA does not expect that

this requirement will be particularly

burdensome for the processor for two

reasons. First, the requirement that

verification procedures be listed in the

HACCP plans is really only a variation

of the proposal in that FDA proposed to

require a number of the activities that it

is now designating as verification

activities in § 123.6(b)(4) (e.g.,

calibration of monitoring instruments

and review of consumer complaints).

Second, a list of the steps that a

processor determines are appropriately

a part of the annual reassessment of the

HACCP plan need not be extensive or

detailed. FDA recognizes that, at least

initially, much of the annual

verification procedure could take the

form of meetings and discussion, and

may not lend itself well to a detailed

listing of steps. FDA believes that the

annual verification procedure should be

allowed to evolve, and that a

requirement that the listing of steps in

the plan be detailed before an annual

verification ever occurs could adversely

affect that evolution.

The new section on verification,

§ 123.8, describes the minimum

components of a processor verification

program. Among other things, the

agency has consolidated there those

aspects of the proposal that, according

to comments, should be designated as

verification activities. Section § 123.8

contains little in the way of detail that

was not included in the proposed

regulations. In addition, it is designed to

be generally consistent with the

verification concepts expressed by the

NACMCF, as requested by comments,

and at the same time, not unduly

burdensome.

3. Verifying the HACCP Plan

Section 123.8(a) requires that

processors with HACCP plans verify

two aspects of their HACCP systems: (1)

That their HACCP plans are adequate to

control food safety hazards that are

reasonably likely to occur, and (2) that

their plans are being effectively

implemented. Verifying these two

aspects is, essentially, what the

NACMCF refers to as the first and

second of the four processes of

verification (Ref. 34, p. 201).

Second, § 123.8(a)(1) requires that a

reassessment of the HACCP plan occur

whenever there are any changes of the

type listed in these regulations that

could alter the plan, or at least annually.

The NACMCF takes the view that

verification must occur on a periodic,

regular basis (Ref. 34, p. 202), although

no specific timeframes are suggested.

FDA agrees with the NACMCF and the

comments that verification of the

adequacy of the HACCP plan should be

conducted on a regular basis, even in

the absence of a recognized change, to

ensure that the plan continues to

address all of the reasonably likely food

safety hazards with appropriate CL’s

and monitoring procedures. It is

essential that processors verify the

adequacy of their plans and that this

verification occur on a periodic basis.

Processors should conduct the review at

intervals that are appropriate for their

processes. FDA agrees with one of the

comments, however, that this interval

be no more than a year in order to

ensure that the plan remains adequate to

address the hazards associated with the

species and processes (Ref. 206, p.

1084).

The regulations at § 123.8(a)(1)

provide examples of changes that could

trigger a reassessment. These include

changes in raw materials, product

formulation, processing methods or

systems, finished product distribution

systems, or the intended use or

consumers of the finished product.

These examples are derived from the

NACMCF materials on the ‘‘five

preliminary steps’’ that form the basis

for the HACCP plan (Ref. 34, pp. 188

and 201). A change in any of these areas

could necessitate a change in the plan

in order to respond to any new hazards

that may have been introduced or to

maintain preventive control over

existing ones. It is important to

recognize that this list is not all

inclusive.

Section 123.8(a)(1) requires that the

plan reassessment be performed by an

individual that has been trained in

HACCP in accordance with § 123.10.

This requirement is a logical outgrowth

of the proposed requirement in § 123.9

that a HACCP-trained individual be

responsible for the initial development

of, and subsequent modifications to, the

HACCP plan. These kinds of activities

require an understanding of the

principles of HACCP and plan

development as obtained through

training that is at least equivalent to the

course required in § 123.10.

Section 123.8(a)(1) also requires that,

where a reassessment reveals that the

HACCP plan is inadequate, the

processor shall immediately modify the
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65131

plan. Failure of a processor to

immediately modify its HACCP plan

after it has determined that the plan is

inadequate would result in the

processor operating under a plan that is

not in conformance with these

regulations.

FDA recognizes that the methods that

processors will use to verify that the

plan is still adequate will vary, based on

individual preferences and past

experience. FDA agrees with comments

that urged the agency to permit

maximum flexibility in the development

of verification procedures that are

tailored to individual operations.

Nonetheless, the agency encourages

processors to consider the guidance in

the March 20, 1992, NACMCF

publication, ‘‘Hazard Analysis and

Critical Control Point System.’’

Moreover, FDA believes that the best

way for the agency to judge the merits

of a processor’s annual verification will

be through its own continuing

determinations of whether the

processor’s overall HACCP system

remains appropriate for the

circumstances. These determinations

will occur as a product of the agency’s

ongoing inspection program.

On this subject, FDA is sensitive to

the comment that the absence of

verification procedures from a HACCP

plan should not, in and of itself, cause

a food to be deemed adulterated under

402(a)(4) of the act. Nonetheless, the

absence of verification could jeopardize

the likelihood of success of the overall

program. For example, monitoring a

critical cooking step with a thermometer

that has not been calibrated provides

little assurance that the CL is actually

being met, and failure to review records

may allow the absence of monitoring or

improper corrective action to go

unnoticed for extended periods of time.

Should the agency find itself in the

position of having to react to the

absence of adequate verification

procedures in a processor’s HACCP

plan, in deciding whether to bring

regulatory action, the agency will

consider the totality of the situation,

and the likelihood that it would have an

adverse impact on the final food, as it

would in considering a processor’s

failure to meet any specific provision.

4. Verifying the Implementation of the

Plan

The regulations at § 123.8(a)(2) and

(a)(3) require ongoing verification

activities in addition to the annual

reassessment. These ongoing activities

are in keeping with the NACMCF’s view

that verification must also take the form

of ‘‘frequent reviews’’ (Ref. 34, p. 201).

Frequent reviews relate primarily to

whether the HACCP plan is functioning

effectively on a day-to-day basis. It is

important to note that, for the most part,

the requirements in these sections were

proposed in other parts of the

regulations and are now being compiled

in § 123.8(a)(2) and (a)(3). Several

comments on these provisions pointed

out that they were verification steps and

should be referred to as such. FDA

agrees and has brought them together in

this new verification section of the final

regulations. Section 123.8(a)(2) requires

that processors review consumer

complaints (proposed at § 123.6(b)(4)),

calibrate process monitoring

instruments (proposed at § 123.6(b)(4)),

and perform periodic end-product or inprocess testing, as appropriate, in

accordance with written procedures for

these activities in the HACCP plan.

Section II H. of this preamble

addresses the review of consumer

complaints at some length.

The provision on the calibration of

monitoring instruments

(§ 123.8(a)(2)(ii)) is brought forward

with no substantive change from the

proposal. Calibration is an important

activity and involves readily defined

procedures that can easily be provided

in the plan.

Calibration can include the validation

of computer hardware and software.

FDA proposed to require that the

HACCP plan detail the methods of

computer software validation to be used

by the processor. FDA received a small

number of comments both for and

against computer software validation as

a worthwhile part of verification. Two

comments supported the need for

consumer software verification. But two

comments suggested that computer

software verification would be an

unnecessary expense because it would

result in only marginally improved

reliability.

The agency has worked extensively

with the low-acid canned food industry

to verify computer hardware and

software that the industry is now using

to operate or control various processing

functions. That experience has

demonstrated to FDA both the

desirability and the feasibility of

verifying computer hardware and

software. For low-acid canned foods, the

industry is using computers to perform

several functions, including monitoring

compliance with CL’s, controlling the

processing operations, taking corrective

actions, and recordkeeping (Ref. 221).

In a HACCP system such as that being

established for seafood by these

regulations, FDA is interested in

ensuring that hardware and software for

computers that monitor compliance

with a CL be verified. However, when

computers are used as processmonitoring instruments, they must be

calibrated in accordance with

§ 123.8(a)(2)(ii). The other functions that

a computer can perform, as listed above,

can be verified through procedures

required elsewhere in these regulations

(e.g., recordkeeping can be verified

through the review of records by a

trained individual in accordance with

§ 123.8(a)(3)). Consequently, the agency

has concluded that it is not necessary

for these final regulations to include a

specific requirement for computer

validation.

Instead, the agency acknowledges that

the proper frequency of equipment

calibration is entirely dependent upon

the type of instrument and the

conditions of its use. Therefore, FDA is

not being prescriptive in this regard.

FDA has, however, provided guidance

on the subject in the draft Guide.

Additional guidance should be

obtainable from the manufacturer of the

instrument. The nature and frequency of

the calibration effort should be

determined at the time of HACCP plan

development and should be included in

the plan to ensure that it is regularly

and appropriately done. The agency is

convinced that without such

formalization, calibration, which, for

some instruments, may be done as

infrequently as once per year, may be

overlooked.

5. Product Testing

75. Section 123(8)(a)(2)(iii), which

lists the performing of end-product or

in-process testing, is a new provision.

FDA requested comment on what tests,

including or in place of end-product

testing, should be used to measure the

success of the HACCP program, both in

terms of individual firms and the

national program as a whole, and how

frequently such tests should be

administered (Ref. 208 at 4183). A large

number of respondents addressed FDA’s

request for comment. Approximately

half of these comments supported the

need for an end-product testing

requirement. The other half objected to

such a requirement or suggested that the

need should be determined on a caseby-case basis.

A number of consumer advocacy

organizations suggested that end

product testing is essential because no

other verification mechanism provides

public confidence that HACCP programs

are actually resulting in a safer product.

Several comments stated that regular

microbiological testing would help a

processor determine whether there are

sources of contamination that are not

being controlled.
65132 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

A few comments suggested that such

testing should be performed more

frequently during plan development and

validation, and then reduced to some

lower level as part of a firm’s

verification efforts. Another comment

suggested that testing should be

performed quarterly by those processors

with a poor record of compliance and

annually by those with a good record.

Several comments suggested that the

need for and frequency of product

analysis should be established as part of

the HACCP plan development process.

One of these comments noted that the

frequency of testing may fluctuate

depending, in part, upon changes in

personnel, raw materials, equipment,

and product formulation.

A number of comments stated that

end-product testing is a questionable

method for measuring the success of a

HACCP system. One of these comments

stated that end-product testing measures

the effectiveness of the plan for a small,

finite portion of production and has

limited value in measuring the success

of the HACCP plan overall.

One comment stressed that finished

product testing is contrary to the

concept of HACCP, i.e., a reliance upon

preventive controls at critical points

throughout the system. Another

comment contended that mandatory

microbiological analysis of foods would

be inappropriate because: (1)

Statistically valid sampling programs for

pathogens are not economically feasible

because of the low incidence of

pathogens in most foods; (2) the use of

indicator organisms to predict the

presence of pathogens is not always

reliable and, where it is not, can become

merely a test for aesthetics; and (3)

microbiological analysis of foods is

often costly, imprecise, and slow, and,

therefore, not suitable for real time data

generation.

The agency acknowledges the

shortcomings of product testing,

especially microbiological testing, used

for process control as pointed out by the

comments. The NACMCF, in its

comments in response to FDA’s

questions about product testing,

reiterated its view that, while

verification is essential to the success of

HACCP, end-product testing has limited

value for measuring the success of a

HACCP system. Comments also noted

that in-process or finished product

testing should not normally be a

prerequisite for lot release under a

HACCP program.

However, FDA recognizes that many

processors will find that product testing

has a role to play in the verification of

HACCP systems, and the agency wishes

to encourage incorporation of testing

into HACCP plans, where appropriate.

Consequently, the regulations at

§ 123.8(a)(2)(iii) list end-product and inprocess testing as a verification activity

at the option of the processor.

The agency provided guidance

concerning appropriate attributes for

product testing in the draft Guide and

intends to elaborate on it in the first

edition of the Guide.

6. Records Review

Section § 123.8(a)(3) requires that a

trained individual review all records

that document monitoring of CCP’s, the

taking of corrective actions, the

calibrating of any process control

instruments, and the performing of any

end-product or in-process testing. The

review of HACCP records by a trained

individual was included in the

proposed regulations at § 123.8(b). In

response to comments that urged

consistency with the recommendations

of the NACMCF, FDA has designated

this review a verification function for

purposes of the final regulations and has

included it in the section on

verification. Specifically, the proposed

regulations provided that a HACCPtrained individual review the

monitoring records, sanitation control

records, and corrective action records

before distribution of the product to

which the records relate. Under the

proposal, the individual’s review would

include records of process monitoring

instrument calibration, because the

agency characterized these records as

monitoring records.

The comments that FDA received on

these provisions focused on the

proposed requirement that the review

by the trained individual occur before

the product could be shipped. Several

comments objected, stating that such a

review before shipment was

unnecessary, because under the

corrective action provisions of the

proposed regulation, any CL deviation

caught by the observer/operator would

necessitate the segregation and holding

of the affected product before shipment

until the safety of the product could be

assured. One comment further stated

that linking lot release to record review

before shipment underestimates the

level of control attainable through the

monitoring and corrective action

principles of HACCP.

Comments from several processors

and trade associations stated that, for

some processors, it would be

impractical to withhold the shipment of

every lot until HACCP records could be

verified and signed. These comments

noted that, with the use of today’s high

speed processing lines, it is normal

practice for some processors to begin

shipping products before the end of the

shift (lot). Several comments also stated

that holding a product until the HACCP

records could be reviewed could result

in a product being subjected to

unfavorable conditions during storage,

which could compromise both quality

and safety.

Several comments urged that

processors be permitted to review the

HACCP records at the end of the day or

at the end of the shift, even if this

review occurred after distribution.

Others suggested that record review

should be performed within a

‘‘reasonable time’’ of production of the

record.

The agency remains convinced that

the coupling of lot release with

verification-type record review provides

a valuable added level of safety

assurance. This kind of record review

before shipment is a regulatory

requirement for low-acid canned foods

and acidified foods. FDA’s experience

with these industries is that record

review before distribution has been

instrumental in preventing the

introduction of potentially hazardous

foods into commerce (Ref. 221). The

agency encourages processors to

institute such a program whenever

possible.

However, FDA accepts from the

comments that the proposed

requirement would cause certain

processors to delay shipping perishable

products and thus present an

unacceptable burden to them. The

agency therefore is not requiring that

record review occur before shipment.

Uncoupling record review from lot

release leaves as the primary purpose

for record review the periodic

verification that the HACCP plan is

appropriate and is being properly

implemented. Record review needs to

occur with sufficient frequency so as to

ensure that any problems in the design

and implementation of the HACCP plan

are uncovered promptly and to facilitate

prompt modifications. The concept is

roughly that of a ‘‘feedback loop,’’ with

information coming out of the record

review process in such a timely manner

that it can have impact on the

production of subsequent lots of the

product.

FDA is convinced that a weekly

review of HACCP monitoring and

corrective action records would provide

the industry with the necessary

flexibility to handle highly perishable

commodities without interruption,

while still facilitating speedy feedback

of information. FDA is reluctant to

allow the level of flexibility provided by

such language as ‘‘reasonable time,’’ out

of concern for the confusion that it
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65133

would generate. FDA’s experience with

low-acid canned foods and acidified

foods has demonstrated that review of

these kinds of records is a critical

verification tool. FDA is, therefore,

adopting the proposed provision as

§ 123.8(a)(3) with one revision. As set

out in the final rule, it requires that the

HACCP-trained individual review the

monitoring records of CCP’s and the

records that document the taking of

corrective actions within 1 week of the

making of the records, rather than before

shipment, as a part of a processor’s

verification activities (§ 123.8(a)(3) (i)

and (ii)).

FDA agrees, on the other hand, that

this principle need not apply to the

review of records of such verification

activities as process control instrument

calibration and product testing. The

frequency of these activities will be

variable and dependent upon the

HACCP plan development process.

Consequently, setting a specific review

frequency for these records is not

warranted. Section 123.8(a)(3)(iii)

reflects this conclusion. It requires that

the HACCP-trained individual review

the calibration records within a

reasonable time after the records are

made, rather than before any additional

products are shipped. It also applies the

same ‘‘reasonable time’’ standard to any

end-product testing records that are

made.

The proposed regulations did not

address the review of end-product

testing records by a trained individual.

The requirement in these final

regulations for a review of such records

reflects the principle contained in the

proposal that there be a verification-type

review by a trained individual of the

HACCP records that are being created by

the processor. In this respect, the

responsibilities of the trained individual

are unchanged from those that were

contemplated in the proposal, although

details relating to those responsibilities

have been modified based on the

comments.

Section § 123.8(b) requires that

processors take appropriate corrective

action whenever a review of a consumer

complaint, or any other verification

procedure, reveals the need to do so.

This provision is essentially a

restatement of the proposal regarding

consumer complaints, expanded to

include the results of verification

procedures for purposes of emphasis.

Verification was not specifically

included in the proposal. FDA is

including a reference to it here to

remind processors not to preclude the

possibility that information obtained

through verification could lead to the

taking of a corrective action. This

possibility exists even though, more

often than not, verification will not

provide the kind of immediate feedback

that the processor will receive from

monitoring. Corrective actions based on

information received through

verification will be exceptions to the

rule. However, processors should be

mindful of the possibility.

7. Verifying the Hazard Analysis

Section 123.8(c) requires that,

whenever a processor does not have a

HACCP plan because a hazard analysis

has not revealed any food safety hazards

that are reasonably likely to occur and

that can be controlled through HACCP,

the processor must reassess the hazard

analysis whenever a change occurs that

could reasonably affect whether such a

hazard exists. FDA has included

examples of such changes in § 123.8(c).

The list is identical to that provided in

§ 123.8(a)(1), for when a plan must be

reassessed. Consequently, any change in

these factors should warrant a

reassessment to be certain that a plan is

still not needed.

FDA has concluded that, under a

mandatory HACCP system, the principle

of verification applies equally to a

decision that a HACCP plan is not

necessary as it does to a decision that

the plan continues to be adequate.

Circumstances change, and processors

must be alert to whether the exemption

from the requirement to have a plan

continues to apply to them.

Section 123.8(d) requires that

processors document calibration and

product testing in records that are

subject to the recordkeeping

requirements of the regulations at

§ 123.9. The requirement that records be

kept of process monitoring instrument

calibration was included in the

proposed regulations at § 123.6(b)(5).

The requirement that records of endproduct testing be kept is consistent

with the general recordkeeping

principles of HACCP. The one exception

is that FDA is not requiring records that

document the review of consumer

complaints. The agency is satisfied that

the requirement for a processor to

review consumer complaints relating to

potential safety concerns will be

sufficient for this kind of verification

activity. Moreover, as explained in the

discussion of consumer complaints

elsewhere in this preamble, FDA is

persuaded that most consumer

complaints will involve matters

unrelated to the mandatory HACCP

system.

H. Consumer Complaints

1. Background

In the proposed regulations, FDA

tentatively concluded that each

processor’s HACCP system had to

utilize any consumer complaints that

the processor receives that allege a

problem with product safety. Several

provisions described how consumer

complaints were to be used. In one, FDA

proposed to require that a processor’s

monitoring efforts include the use of

consumer complaints, and that its

HACCP plan reflect how they will be

used. In a second provision, FDA

proposed to require that, when a

processor receives a consumer

complaint that may be related to the

performance of a CCP or that may reflect

a CL deviation, the processor determine

whether a corrective action is

warranted, and, if so, take one in

accordance with the specified corrective

action procedures. FDA also proposed

to require that the taking of such

corrective actions be fully documented

in records. Finally, FDA proposed to

require that consumer complaints that

relate to the operation of a CCP or to a

possible CL deviation be included as

part of the processor’s HACCP records

and be available for agency review and

copying.

FDA’s rationale for proposing these

requirements was that consumer

complaints may be the first alert that a

processor has that problems are

occurring that are not being detected or

prevented by the processor’s HACCP

controls. While the goal of a HACCP

system is to prevent all likely hazards

from occurring, no system is foolproof.

The agency tentatively

concluded,therefore, that each HACCP

system should take advantage of

consumer complaints as they relate to

the operation of CCP’s. FDA also

tentatively concluded that it might be

necessary for the agency to review those

complaints in order to be able to verify

whether a processor is taking necessary

steps to review its HACCP controls and

take corrective actions as necessary in

response to consumer complaints. The

agency emphasized that it was referring

solely to complaints relating to the

operation of the HACCP CCP’s (i.e.,

those that allege a problem with human

food safety) and not to consumer

complaints generally.

2. Consumer Complaints as Verification

Tools

76. FDA received a large number of

comments on the advisability of

handling consumer complaints in the

manner that the agency proposed.

Generally speaking, the comments
65134 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

addressed two broad issues: Whether

consumer complaints are relevant to a

HACCP system, and if they are relevant,

how they should be used. The question

of whether FDA should have access to

consumer complaints was a significant

concern that comments found germane

to both issues. Approximately one-fifth

of the comments supported the

proposed system or a variant of the

system (i.e., they believed that

consumer complaints are relevant to a

HACCP system). Some of those who

voiced general support urged more

comprehensive agency access to

consumer complaints, and others urged

that some restriction on agency access

be put in place. The remaining

approximately four-fifths of the

comments, principally from seafood and

other food processors and trade

associations, argued that consumer

complaints have no place in a HACCP

system.

Those comments that opposed the

mandatory use of consumer complaints

in a HACCP system provided a variety

of reasons. The comments argued that

consumer complaints are generally: (1)

Unrelated to the safety of the product;

(2) not received in a timely manner that

would facilitate control of the process

and are, in this way, akin to finished

product testing; (3) erroneous and

sometimes exaggerated or fraudulent; (4)

vague; (5) subjective and nonscientific;

(6) associated with hazards that develop

during transportation, storage, and retail

marketing, rather than processing, if

they identify food safety hazards of any

kind; (7) not traceable to a specific

processing plant or lot of product; and

(8) not readily associated with a specific

CCP or CL failure, even where it is

likely that they are the result of a

problem during processing. These

comments asserted that, therefore,

consumer complaints are not an

appropriate monitoring tool.

A number of these comments

suggested that, given the problems listed

above, sorting through the large volume

of consumer complaints that are

received by most large firms to identify

those few that might be able to be linked

to the performance of a specific CCP

would be a waste of both the processor’s

and the agency’s time. These comments

stated that such a review of consumer

complaints would divert their efforts

from more productive tasks.

Several comments raised additional

questions about consumer complaints as

a HACCP verification tool. They

suggested that there are better, more

effective means of verifying that the

HACCP plan is working properly. These

suggestions are covered in the

‘‘Verification’’ section of this preamble.

These comments further argued that

consumer complaints are not identified

in the NACMCF recommendations as a

useful verification tool.

A relatively small, diverse group of

comments, including those from a

seafood processor, a seafood trade

association, a State regulatory agency,

an individual, and a professional

organization, supported the handling of

consumer complaints as proposed. One

of these comments suggested that

consumer complaints could be useful in

FDA’s efforts to verify that processors’

HACCP programs are effective.

Another group of comments, from

consumer advocacy organizations and a

State regulatory agency, agreed that

consumer complaints are an appropriate

part of HACCP. One of the comments

noted that the consumer performs the

final quality control check, and that if

a consumer finds a problem egregious

enough to take the time to write a letter,

the information contained in that letter

should be considered in any evaluation

of the adequacy of the relevant HACCP

plan. The comment further argued that

consumer complaints could bring to

light unidentified CCP’s. This benefit,

the comment contended, would not be

possible under the proposed regulations

because the agency limited consumer

complaints in a HACCP system to those

that may be related to a CL deviation at

an existing CCP. Finally, one of the

comments noted that the inclusion of

consumer complaint access in the

proposed regulations is the one area in

which the agency delivers on its ‘‘water

to table’’ commitment.

FDA is persuaded that consumer

complaints generally will not make an

effective monitoring tool in a HACCP

system, primarily because they tend not

to provide the kind of immediate,

reliable feedback expected of a HACCPmonitoring system. FDA agrees with the

comments that suggested that

monitoring procedures under HACCP

must provide the processor with

immediate feedback on whether the

process is under control and be

scientifically sound.

FDA is not persuaded, however, that

consumer complaints are irrelevant to

HACCP systems. The agency received

no comments that were able to

demonstrate that outside sources of

information should not, where

appropriate, supplement a processor’s

own monitoring as a way of determining

whether the process is in control.

Moreover, a number of comments stated

that they go to some lengths to examine

the consumer complaints that they

receive. The question, then, is whether

consumer complaints can serve some

legitimate verification purpose in a

HACCP system.

While consumer complaints are not

specifically addressed in the NACMCF

HACCP recommendations, the

verification portion of that document

states, in part, that verification

inspections should be conducted,

‘‘When foods produced have been

implicated as a vehicle of foodborne

disease.’’ This statement is a recognition

that information from sources outside

the processing plant can and should be

considered in the verification of a

HACCP plan. In fact, it is FDA’s

experience that consumer injury or

illness complaints to the agency

occasionally point out problems

traceable to defective controls at the

food processing facility (Ref. 207).

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 accepts the possibility that many,

if not most, consumer complaints that a

processor receives will not be germane

to safety, that many will turn out not to

be valid, and that others will relate to

events at retail or that are otherwise

beyond the ability of the processor to

control. Nonetheless, FDA strongly

believes—and the comments support

this view—that a responsible processor

will at least review consumer

complaints to determine their potential

value and take steps to correct the

product or the process, when such stops

are warranted.

FDA has concluded, therefore, that

processors should evaluate the

consumer complaints that they receive

to determine whether the complaints

relate to the performance of CCP’s, or

reveal the existence of unidentified

CCP’s, as part of their HACCP

verification procedures. The agency

acknowledges that the absence of

consumer complaints does not, by itself,

verify the adequacy of a HACCP system.

However, after taking into account all

the concerns raised by the comments,

the agency is of the view that those

consumer complaints that a processor

does receive, and that allege a safety

problem, can be of value as a

verification tool and should serve that

purpose. This conclusion is reflected in

the requirements of § 123.8 of these final

regulations (see discussion in the

‘‘Verification’’ section of this preamble),

which lists the review of consumer

complaints as an appropriate

verification activity (§ 123.8(a)(2)(i)).

As explained earlier in this preamble,

because the agency regards consumer
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65135

complaints as a verification tool rather

than a monitoring tool, FDA has

modified § 123.6(c)(4) to eliminate the

proposal requirement that the HACCP

plan describe how consumer complaints

will be used in the monitoring of CCP’s.

The agency has also modified

§ 123.6(c)(7) to eliminate the proposed

requirement that consumer complaints

be part of a processor’s HACCPmonitoring records.

FDA has concluded that when a

review of a consumer complaint reveals

a need for the processor to take

corrective action (e.g., recall,

destruction, or reprocessing of the

product or modification of the process

to reduce the risk of reoccurrence of the

problem), such action must be taken in

conformance with the applicable

corrective action procedures of these

regulations. This conclusion is reflected

in of § 123.8(b) which states that

processors shall immediately follow the

procedures in § 123.7 whenever a

review of a consumer complaint, or any

other verification procedure, reveals the

need to take a corrective action. The

corrective action provisions are

discussed in the ‘‘Corrective Actions’’

section of this preamble.

As suggested by several of the

comments, records of corrective action

relative to consumer complaints need

not include the original consumer

complaint. However, it is unlikely that

a comprehensive record of the

corrective action taken could be

generated without at least the critical

information contained in the complaint,

such as the nature of the complaint and

identification of the product in

question. Identification of the

complainant is not likely to be critical.

3. Agency Access to Consumer

Complaints

77. Many comments questioned

whether FDA should have access to

consumer complaints. Several

comments argued that no other food

industry is required to provide access to

consumer complaints. A few

specifically cited the absence of such a

requirement in the low-acid canned

foods regulations (part 113).

One comment noted that FDA has

methods other than access to a

company’s consumer complaint file to

obtain information about product

defects that affect safety, including

direct calls from consumers and health

professionals, MedWatch, and reporting

to the Center for Disease Control and

Prevention (CDC). Another comment

suggested that it would be more efficient

to devise a system whereby consumers

are encouraged to submit complaints

about product safety directly to FDA

rather than to mandate access to

corporate files.

Several comments suggested that

consumer complaint files should remain

a private company matter, and that open

access to these files is likely to result in

regulatory abuse. A few comments

further argued that, by mandating

complaint file access, the agency would

penalize those firms with good

consumer complaint gathering systems

and possibly deter others from

developing such systems.

A relatively small, diverse group of

comments, including seafood

processors, a seafood trade association,

and a Federal government agency,

submitted that, while it is appropriate

for FDA to mandate that processors

utilize consumer complaints in

assessing the effectiveness of their

HACCP program, it is not necessary for

the agency to have direct access to the

firms’ complaint files. The comments

suggested two alternatives to providing

direct access to complaint files: (1)

Allowing processors to prepare Notices

of Unusual Occurrence and Corrective

Action (NUOCA) that described the

action taken in response to consumer

complaints that relate to product safety;

or (2) allowing processors to prepare a

matrix of complaints, as is currently

used in the voluntary, fee-for-service

HACCP program being operated by

NMFS.

Others in this group suggested that

FDA have access only to written

complaints, or only to consumer

complaints, as opposed to trade

complaints, which the comment argued

are often submitted for commercial

advantage only. One comment noted

that it would be impossible for

processing vessels to retain consumer

complaints on board the vessel, and that

provision should be made for these to be

stored at the corporate office. Other

comments urged that FDA access to

consumer complaints not include the

right to copy them, or that, in some

other way, they be protected from

public disclosure.

Another group of comments,

composed of consumer advocacy

organizations and a State regulatory

agency, urged that all consumer

complaints, regardless of their potential

relationship to product safety, be

included in a processor’s HACCP

records and be available for FDA

review. These comments suggested that

the FDA investigator should make the

determination of which complaints are

relevant for follow up rather than the

firm. They further suggested that the

investigator can ignore any complaints

that are not relevant to safety controls at

the processing facility.

Unquestionably, FDA has an essential

role to play as a regulatory verifier of

HACCP. As described earlier, the agency

received a number of comments that

raised concerns about the veracity of a

mandatory HACCP system in the

absence of adequate regulatory review.

Moreover, FDA has concluded that this

role cannot be carried out without the

ability to review HACCP plans and a

narrow category of processor’s records

(i.e., those that relate to how a processor

is controlling the critical safety aspects

of its operations). The agency is not

interested in expanding this access

beyond those records that are the

minimum necessary to carry out this

responsibility.

With regard to consumer complaints,

FDA is persuaded by the comments that,

especially when used as HACCP

verification records rather than HACCPmonitoring records as originally

proposed, the public health benefits that

may accrue from agency access to these

kinds of records would probably be

minimal and are outweighed by the

concerns that have been expressed.

FDA is satisfied that agency review of

a processor’s overall verification

scheme, plus access to records that

document any corrective actions that

were taken as a result of information

obtained through consumer complaints,

review of those complaints that

consumers regularly send to the agency,

the ability to conduct unannounced

inspections, and access to monitoring

records and plans, should be enough for

FDA to adequately verify processor’s

HACCP systems.

FDA also accepts that the burden on

processors if they had to segregate

complaints that have a potential

relationship to product safety from

those that relate to product quality,

economic issues, customer satisfaction,

and other nonsafety issues, would be

great and is not warranted by any

potential gain in product safety. Many

firms would have to take this step to

make safety-related complaints available

to FDA. Similarly, the agency recognizes

that a significant burden would be

placed upon its inspectional force if it

had to verify that a processor had

properly categorized its complaints.

The alternative of FDA having access

to all consumer complaints and making

its own determinations about which

relate to safety, as some comments

suggested, is simply not practicable. In

addition, it is not the desire of FDA to

penalize those firms that have large,

expensive complaint gathering systems,

by mandating that they provide all

information so gathered for agency

review, or to discourage others from

developing such systems.
65136 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

In the preamble to the proposed

regulations, FDA stated that more than

half of the seafood-related consumer

complaints that it receives relate to

product quality, filth, and economic

deception concerns. Access to all

consumer complaints is, therefore,

unnecessary to ensure product safety.

FDA has, therefore, removed from

what is now § 123.9(c) the requirement

that consumer complaints relating to

safety be available to the agency. The

agency reiterates, however, that

processors should utilize all available

information as they evaluate the

adequacy of their HACCP plans and

their implementation. Consumer

complaints are one potential source of

information, and a significant group of

comments recognized the value of

consumer complaints in the verification

process.

I. Records

FDA proposed that records required

by the regulations: (1) Contain certain

information, (2) be completed at the

time of the activity, (3) be signed by the

operator or observer, (4) be reviewed for

completeness and compliance with the

HACCP plan and signed and dated by

the reviewer, (5) be retained for

specified periods of time, and (6) be

available for review and copying by

FDA.

FDA received a large number of

comments that addressed these

proposed recordkeeping requirements.

These comments were from a diverse

group of commenters, including large

and small processors, trade associations,

individuals, Federal, State, and foreign

government agencies, consumer

advocacy groups, professional societies,

and academics. Several comments

provided arguments that support the

need in a mandatory HACCP program

for records in general, and none

specifically argued in opposition to that

concept. Most of the comments

addressed specific issues that relate to

recordkeeping.

Those comments that supported the

need for records stated that

recordkeeping is a key component of

HACCP. One processor’s comment

noted that HACCP records must be kept

in good order so that problems can be

easily tracked to their root cause. One

comment stated that HACCP records

facilitate an evaluation of safety

conditions over time, rather than

through a ‘‘snap shot’’ inspection.

Another processor noted that HACCP

recordkeeping is not overly

burdensome, and that the proposed

regulations would not require it to

maintain any records in addition to

those that it already maintains.

1. Details and Signatures

78. FDA proposed that all HACCPmonitoring records (including records of

process-monitoring instrument

calibration), sanitation control records,

and corrective action records identify

the date of the activity that the record

reflects. One comment recommended

that the final regulations should also

require that the time of each observation

be recorded, to make it easier to link

records to specific lots of product. A

comment from a trade association

requested that the records be required to

identify the establishment where the

activity occurred to reduce the potential

for confusion in firms with multiple

processing facilities.

FDA agrees with both comments that

the date and time on records will help

to connect information on the records to

specific lots of product, and that the

name and location of the processor will

help link information to a specific

processing facility.

The agency has, therefore, modified

§ 123.9(a)(1) and (a)(2) to state, in part,

that the required records must include:

‘‘(1) The name and location of the

processor or importer; (2) The date and

time of the activity that the record

reflects.’’

79. FDA proposed to require that

HACCP-monitoring records (including

records of process-monitoring

instrument calibration) and sanitation

control records be signed by the

observer/operator. A few comments

supported the proposed requirement on

the grounds that it fosters accuracy and

accountability in the recordkeeping

process. One comment opposed the

proposed requirement, raising concern

about the legal liability that it imposed

upon the workers that sign the records.

A few comments suggested that the

observer/operator be allowed to initial,

instead of sign, the records.

FDA agrees with the comments that

suggested that a signature on monitoring

and sanitation control records is

necessary to ensure accountability in

the recordkeeping process. FDA also

hopes that it will enhance workers’

sense of responsibility and pride in their

participation in the HACCP system of

preventive controls. Regarding worker

liability, those that deliberately falsify

records are liable whether they sign the

records or not. In any event, the

falsification of records cannot be

condoned and should not be tolerated

by processors.

FDA further agrees that the purpose

for the observer/ operator’s signature is

achieved if the observer/operator either

signs or initials the monitoring records.

FDA proposed to require the signature

of the observer/operator on all records

involving observations or measurements

made during processing or related

activities. This specification of the kinds

of records in which signatures were

required would have had the effect of

exempting consumer complaints, which

were considered to be monitoring

records in the proposal from this

requirement. However, the use of

consumer complaints as monitoring

records has not been carried forward to

these final regulations. Consequently,

limiting the records that must be signed

to involving observations or

measurements is no longer necessary,

and FDA has deleted it for purposes of

clarification (see § 123.9(a)).

FDA has also deleted the proposed

provision that the observer/operator

need not sign corrective action records.

The agency proposed to require that

only a trained individual sign these

records. FDA is requiring the signature

or initials of the observer/operator on

corrective action records in order to be

consistent with the corrective action

provisions of these regulations. In

§ 123.7, for example, processors may

now predetermine their corrective

actions in ways that empower observer/

operators to take corrective measures,

especially in the absence of a trained

individual. The likelihood that a trained

individual might not be present at the

moment when a corrective action must

be initiated is enhanced by the fact that

such an individual need not be an

employee of the processor (see

§ 123.10). Conversely, the presence of a

trained individual during the initiation

of a corrective action need not preclude

the observer/operator from taking

corrective steps, as appropriate. Finally,

the agency has concluded that the

burden imposed by requiring the

signature or initials of the observer/

operator whenever that individual

participates in the making of a

corrective action record is

inconsequential.

80. Several comments questioned

whether the proposed requirement that

monitoring records include the

‘‘identity of the product, product code

* * *,’’ meant that all fish and fishery

products were required to bear a

product code.

It was not the intent of the agency to

require product codes on such products,

only to require that they be listed on

appropriate records when they are used.

The purpose of the proposed

requirement was to facilitate linkage

between records and product. To clarify

this point, FDA has modified what is

now § 123.9(a)(4) to read, ‘‘(4) Where
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65137

appropriate, the identity of the product

and the production code, if any.’’

81. Several comments suggested that

FDA not specify the components of

required records. These comments

argued that many processors have

existing forms that can appropriately be

used as HACCP records.

It is not FDA’s intent in § 123.9(a) to

specify record format or content, beyond

certain minimum, essential

components. Processor’s are encouraged

to use existing records, making

modifications only as necessary to meet

the previously described requirements.

2. Retention and Storage

FDA proposed to require that

processors retain monitoring (including

process monitoring instrument

calibration), sanitation control, and

corrective action records for 1 year after

the date that they were prepared for

refrigerated products and for 2 years for

frozen or preserved products. FDA also

proposed that records used to

substantiate the adequacy of equipment

or processes be retained for 2 years after

the date that they apply to products

being processed.

82. Several comments stated that

these proposed retention times were too

long. Most of these comments suggested

record retention times of from 90 days

to 1 year for refrigerated products and

from 6 months to 1 year for frozen

products. One comment argued that 1

year is a sufficient period for record

retention unless the records relate to a

CL deviation, in which case they should

be held for 3 years. Another comment

urged that the agency not mandate

record retention times but require

processors to identify appropriate

retention time requirements in their

HACCP plans.

FDA rejects those comments that

requested a reduction in the proposed

mandatory record retention period.

While it may be true that most

refrigerated products will be unusable

within 90 days, as suggested by one of

the comments, retention times of less

than 1 year do not provide for sufficient

access for the processor’s or FDA’s

verification activities. (See revised

§ 123.8(a)(1) and the accompanying

preamble discussion of the minimum 1-

year frequency of plan reassessment.)

No new, substantive comment was

provided relative to record retention

times for frozen or preserved products

that would warrant a reduction for those

products.

Thus, FDA has made no changes to

§ 123.9(b).

83. FDA proposed that, in the case of

processing facilities that close between

seasonal packs, records could be

transferred to another accessible

location between seasonal packs, as long

as they were returned during the next

active season. Comments from several

processors and trade associations urged

the agency to modify the requirement to:

(a) Allow for permanent transfer from

the facility and (b) include both remote

processing sites and processing vessels

regardless of whether they close

seasonally. Comments from operators of

processing vessels and remote

processing sites and from a trade

association requested that FDA allow

HACCP records to be kept on the

processing vessel or remote site for a

period of time and then be transferred

permanently to the processor’s

corporate, or closest business office. The

comments argued that the records in

those locations would be more easily

stored, safer, and more readily

accessible to regulators than they would

be at remote sites and on processing

vessels. Additionally, they argued that

corporate verification activities often

would be performed at the land-based

facilities. Transfer of the records to

these facilities would promote

verification in these circumstances.

Comments opposing the requirement

that the records be returned to a

seasonally closed facility once the

facilities reopened expressed concern

that return of the records to the

reopened locations could result in lost

records.

FDA has been persuaded to

accommodate the difficulties associated

with record storage on processing

vessels and remote processing sites by

allowing HACCP records to be moved

from such facilities to another

reasonably accessible location at the end

of the seasonal pack without requiring

that the records all be returned for the

following season (§ 123.9(b)(3)).

Additionally, the agency will, as

proposed, allow HACCP records from

any facility that is closed between

seasonal packs to be permanently

transferred to another reasonably

accessible location. However, FDA

points out that, in most instances, the

agency will need to examine processing

records onsite in order to conduct an

effective verification inspection. For this

reason, records must be so stored that

they can be promptly returned to the

processing facility upon demand by

FDA. In order to maintain inspectional

efficiency, the time period between an

FDA request for the records and their

arrival should not ordinarily exceed 24

hours.

84. Several comments urged FDA to

provide for the use of computers to

maintain HACCP records.

It was not the intent of the agency to

preclude such records. To make this fact

clear, FDA has added a new paragraph,

§ 123.9(f), to the final regulation, which

reads, ‘‘(f) Records maintained on

computers. The use of records

maintained on computers is acceptable,

provided that appropriate controls are

implemented to ensure the integrity of

the electronic data and signatures.’’

In the Federal Register of August 31,

1994 (59 FR 45160), FDA proposed

separate regulations at 21 CFR 11 that,

if adopted, will become the standard for

determining what constitutes

appropriate controls for electronic

records, electronic signatures, and

handwritten signatures executed to

electronic records. In the interim,

processors are encouraged to look to

industry standards for guidance.

3. Confidentiality of Records

85. In the preamble to the proposed

regulation, FDA stated that, as a

preliminary matter, HACCP plans and

monitoring records appear to fall within

the bounds of trade secret or

commercial confidential information

and would, therefore, be protected from

public disclosure by section 301(j) of the

act (21 U.S.C. 331) and by the Freedom

of Information Act (FOIA) and the

Department of Health and Human

Services (DHHS) and FDA regulations

promulgated pursuant to these laws.

FDA specifically invited comment on

the issue of public disclosure of HACCP

records and on whether FDA has any

discretion about the releasability of any

HACCP records that it may eventually

have in its possession. A large number

of comments responded to FDA’s

request for comment, especially in the

context of the provision in the

regulations (§ 123.9(c) in this final rule),

that provides that all required records

and plans must be available for review

and copying.

A large number of comments, from

processors, trade associations,

professional associations, State and

Federal agencies, and individuals,

contended that HACCP records and

plans are trade secrets and should under

no circumstances be released to the

public. Comments from several

consumer advocacy groups countered

that in many cases HACCP records and

plans will not contain trade secret

information or will contain only limited

trade secret information, and that the

nonsecret parts (i.e., most of their

contents) should, therefore, be available

to the public.

Many of the comments that supported

protection from public disclosure urged

that the final regulations contain

controls over the agency’s access to, and
65138 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

copying of, HACCP plans and records as

the only guaranteed way to ensure

confidentiality. The comments argued

that the potential harm from exposure of

HACCP plans and records to

competitors or to the public is

considerable and carries the threat of

increased costs, misuse, and damage to

the integrity of a firm and its products.

Several comments contended that

HACCP records will be trade secret

because they will be process-specific

and, therefore, will contain such

information as processing times and

temperatures. They stated that these

processing parameters may differ from

company to company based on product

formulas.

A few comments argued that there is

no precedent for public access to

industry-generated records. Some of

these comments stated that processing

records are regarded as trade secret

under the LACF regulations, and they

noted that § 108.35(d)(3)(ii) deems

processing information submitted to

FDA to be trade secret within the

meaning of 301(j) of the act and within

the meaning of the FOIA. Other

comments asked that FDA protect

HACCP plans and records in the same

way that the agency protects processing

and quality control data that are

submitted to FDA under cooperative

quality assurance agreements (i.e.,

manufacturing methods or processes,

including quality control procedures,

are deemed not to be releasable unless

the information that they contain has

already been released or is otherwise no

longer trade secret or confidential

commercial per §§ 20.111(d)(2) and

20.114 (21 CFR 20.111(d)(2) and

20.114)).

Several comments suggested that FDA

specifically declare that: (1) HACCP

plans and records are trade secrets; (2)

section 301(j) of the act and the FOIA

prohibit disclosure of trade secret or

confidential commercial information

and give the agency no discretion

whether to release these types of

records; and (3) § 20.81 provides for

disclosure of trade secret or confidential

commercial information only if the

information has been previously

disclosed to the public.

One comment proposed that, if FDA

felt obliged to release some HACCPrelated information pursuant to FOIA

requests, reports of regular inspections

be released instead of HACCP plans and

records, because such reports are likely

to contain less sensitive information.

Another comment suggested that, to

avoid releasing proprietary information,

the agency should describe or explain

information that is contained in HACCP

plans and records in general terms

rather than release the records

themselves. The comment asserted that

this step would serve to inform

consumers about the relative safety of

the product and the effectiveness of the

HACCP system, while not divulging

specific process parameters that are

trade secret or confidential commercial.

Conversely, comments from consumer

advocacy groups argued that, for the

most part, HACCP plans and records are

not trade secret or confidential

commercial. The comments asserted

that much of the information contained

in these plans and records involves the

application of basic sanitary engineering

and is already in the public domain, as

evidenced by the draft FDA Guide.

The consumer advocacy groups

argued that, given the limited resources

that FDA can devote to monitoring

HACCP compliance, public access to

HACCP records should be as broad as

allowed under the law, so that

consumer confidence in, and

understanding of, the seafood supply

can be fostered. One comment asserted

that the public’s right and need to know

about matters involving public health

should be the basis from which the

agency formulates public access policy.

Another comment stated that consumers

are the intended beneficiaries of the

HACCP seafood proposal and therefore

should have the right to determine

through record inspection whether

processors are properly implementing

the HACCP requirements. These

comments urged FDA to routinely

collect HACCP plans and records from

processors to facilitate agency

verification activities and public review

of the effectiveness of the HACCP

system. One comment from a consumer

advocacy group asserted that Public

Citizen Health Research Group v. FDA,

704 F.2d 1280 (D.C. Cir. 1983) narrowly

defined trade secrets in such a way that

HACCP plans and the records at issue

in this rulemaking could not be

considered trade secret.

Unquestionably, adoption of a

mandatory HACCP system will place

significant documentation requirements

on seafood processors. As a result, they

will produce records that reflect

processing designs and equipment and

certain types of day-to-day operations.

They will be available to FDA. FDA

strongly believes that it is in the public

interest to require that these records be

maintained, and that the agency have

access to them. Such records and access

are necessary to effectuate a mandatory

system of preventive controls for safety.

As stated in the preamble to the

proposed regulations, FDA expects to

take possession of records on a case-bycase basis, and only when there is a

specific need to do so. The agency

categorically rejects the view that FDA

should be a collection point for HACCP

records and plans so that they may be

made publicly available. Nevertheless,

the apprehension expressed by many

comments about the consequences of

public disclosure of these new types of

records is certainly understandable.

FDA agrees with the views expressed

by consumer advocacy organizations

that the public needs ways to be able to

judge how and whether it is benefiting

from a HACCP system. Neither the

agency nor the industry can reasonably

expect that the public will simply take

the government’s word for it. It remains

to be seen, however, whether public

access to information about processors

that processors have traditionally held

as protected is the only way, or the best

way, to provide the public with

information about this system.

FDA is considering how meaningful

data can be extracted from the

inspectional process and prepared in

such a manner that it could be released

without jeopardizing trade secret and

confidential commercial information

and yet be useful to both FDA and the

public in evaluating this program. FDA

is considering developing standardized

reports that would be completed by

investigators at the conclusion of

routine HACCP-based inspections and

become part of agency files. As

presently conceived, these reports

would contain a summary of the status

of the HACCP program in effect at the

firm, similar to the suggestion of two of

the comments.

Nonetheless, the question is whether,

as FDA preliminarily concluded, most

plans and records to be generated under

this program will be subject to

protection under existing law and FOIA

regulations. FDA’s experience in

seafood processing plants, its

experience with HACCP, and its

understanding from the cost-benefit

modeling that has been done in the

preparation of these regulations is that

HACCP plans will take each processor

some time and money to develop. Thus,

the agency concludes that HACCP plans

generally will meet the definition of

trade secret, including the court’s

definition in Public Citizen Health

Research Group v. FDA, supra. Plans

that incorporate unique timetemperature regimens to achieve

product safety, or other parameters that

are processor-specific and that are the

result of considerable research and

effort, will surely meet this definition.

Moreover, there is value in a plan to

a company that produces it for no other

reason than that it took work to write.

The equity in such a product is not
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65139

readily given away to competitors. FDA

knows from its own experience that

plant configurations tend to be unique

to individual processors, or at least have

unique features (Ref. 222). While

generic plans will have great utility in

many circumstances, they serve

primarily as starting points for

processors to develop their own plans.

FDA expects that its Guide will help

serve that purpose, but firms will still

need to expend time and money to tailor

HACCP to their individual

circumstances.

Additionally, the agency has come to

the conclusion, as a matter of policy,

that records and plans should be

protected to the extent possible in order

to promote the implementation of

HACCP across the seafood industry.

FDA has concluded that the public will

benefit from the protection of records

because it will actually strengthen the

HACCP system. So long as the

legitimate public need to be able to

evaluate the system can be met through

other means, the confidentiality of

HACCP records and plans generally will

foster the industry’s acceptance of

HACCP. Even though HACCP may be

mandatory under these regulations, in

order for it to succeed, processors must

be committed to it because they see

value in it for themselves. Fear of public

disclosure of matters that have long

been regarded as confidential business

matters could significantly undermine

that commitment. FDA concludes,

therefore, that it is in the public interest

to foster tailored HACCP plans that

demonstrate understanding and

thought, rather than promote the use of

rote plans and minimally acceptable

standards due to fear of public

disclosure.

FDA understands that it cannot make

promises of confidentiality that exceed

the permissible boundaries established

under FOIA, nor does the agency wish

to do so in this case. The agency still

does not expect that it will be in

possession of a large volume of plans

and records at any given moment.

However, given the significant interest

in this subject as conveyed by the

comments, FDA has concluded that the

final regulations should reflect the fact

that the HACCP plans and records that

do come into FDA’s possession will

generally meet the definition of either

trade secret or commercial confidential

materials. A statement to this effect in

the final regulations will help to make

this fact as widely understood as

possible and will clarify the agency’s

position on this matter. This fact is

codified at § 123.9(d)(1), which reads as

follows:

(d) Public disclosure. (1) Subject to the

limitations in paragraph (d)(2) of this section,

all plans and 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 they relate to a product or ingredient that

has been abandoned and they no longer

represent a trade secret or confidential

commercial or financial information as

defined in § 20.61 of this chapter.

The agency acknowledges that there

could be exceptions to this general rule.

The nature of information in HACCP

plans and records varies. Some of it

could be generally available processing

methodology or procedures, based on

generic or model HACCP plans or

guidelines developed by the agency or

some other public source, that is

sufficiently reflective of an industry

standard that it has little if any

proprietary value. In such a case, in

response to an FOIA request, there may

not be a valid reason for protecting this

information. The agency has concluded

that there should be a provision that

makes clear that it will make

information available in appropriate

circumstances. Consequently, the final

regulations in § 123.9(d)(2), state:

(2) However, these records and plans may

be subject to disclosure to the extent that

they involve materials that 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.

There is precedent for describing in

regulations the records that have

protected status. The low-acid canned

food regulations at § 108.35(l) provide

that, except under certain limited

situations, filed scheduled processes

submitted to FDA are not available for

public disclosure. Additionally,

§ 108.35(d) provides that data submitted

to the agency to support these processes

are to be treated as trade secret. These

materials are analogous to HACCP

plans, and their treatment is consistent

with the agency’s views relative to the

protected status of HACCP plans. The

comments that suggested that the lowacid canned foods regulations grant

trade secret status to the monitoring

records that are required to be kept by

part 113 are incorrect. These records are

not provided any special status in those

regulations.

4. Agency Access to Records

86. Several comments suggested that

the final regulations should require

processors to provide access by FDA to

HACCP records only after the

submission by the agency of a written

request for specific records it deems

necessary to review. The comments

noted that this approach would be

similar to § 108.35(h) in the LACF

regulations, because processors are

familiar and satisfied with such

procedures.

FDA remains convinced that access to

HACCP documents is essential to the

agency’s verification of a firm’s HACCP

system. A key feature of the HACCP

verification process is access by

government investigators to the HACCP

plan, to monitoring records kept

according to the plan, and to records of

corrective actions that were taken in

response to CL deviations. Examination

of HACCP records enables an

investigator to see how the processing

facility or the importer operates over

time rather than how it is functioning at

one particular moment in time.

Additionally, it will enable the regulator

to review the adequacy of the

processor’s or the importer’s preventive

control system itself.

FDA rejects the idea of being required

to request in writing access to HACCP

plans and records. The agency is

convinced that it has sufficiently

limited its access to those records and

plans that are minimally necessary to

adequately evaluate the adequacy of a

firm’s HACCP system. Section 123.9(c)

has been modified slightly to clarify to

which records FDA is required to be

granted access.

The comments are correct that the

emergency permit regulations for lowacid canned foods at § 108.35 require

that FDA issue a written request for

access to monitoring records. However,

the written request has proven to be

merely a mechanical exercise. It has not

in any way served to affect the outcome

of FDA access to records, nor is it

associated with any managerial control

over the activities of FDA investigators,

with respect to the kind or numbers of

records to which they seek access.

Moreover, the bottled water regulations

at § 129.80(h), promulgated subsequent

to the low-acid canned food regulations,

do not contain a requirement for the

issuance of a written request for records.

FDA is not aware of any undue concerns

expressed by the bottled water industry

relative to agency abuse of its records

access authority as a result of the lack

of a written request requirement in

those regulations. FDA further notes

that its investigators are required to

present a written notice of inspection to

management of the firm at the start of

each inspection. The notice explains the

authority of the investigator to conduct

an inspection of the facility. The agency

has concluded that there is no need to

further encumber the efficient

enforcement of these regulations with a
65140 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

written request for those records to

which it is entitled to have access. It has

chosen to use the more recent

regulations, bottled water, as the model

for these regulations with respect to

records access.

5. Agency Copying of Records

87. A large number of comments

opposed the provision in the proposal

that provided for FDA copying of

HACCP plans and records, mostly

because of concern about public

disclosure. Several comments stated

that the agency should be permitted to

obtain copies only to support a

regulatory action and only after FDA has

obtained a subpoena. Several other

comments suggested that FDA be

permitted to copy only those records

that relate to a CL failure.

Several comments requested that FDA

provide safeguards to control potentially

abusive regulatory practices by

establishing rules to be followed when

copying records. The comments stated

that the rules should accomplish the

following: Identify investigators

authorized to copy records, limit

copying to records pertaining directly to

CCP’s, require prior written

authorization for copying from the

investigator’s supervisor, require that

the authorization identify the specific

records to be copied and the reason that

they are needed, require that a

responsible company executive receive

each request before any copying is

permitted, and permit the company to

question the purpose for the request

before records are copied.

Comments from several consumer

advocacy groups, on the other hand,

supported the agency’s need to copy

records.

There are two primary reasons for the

agency to copy HACCP plans and

records: (1) To facilitate expert review of

such issues as the identification of

appropriate hazards and CL’s in HACCP

plans and the evaluation of the

adequacy of corrective actions taken in

response to CL failures; and (2) to

document suspected inadequacies of the

HACCP plan or the firm’s

implementation of the plan for possible

regulatory followup.

Limiting the copying of records to

those situations in which regulatory

action is contemplated or in which a

subpoena could be obtained would

serve neither the needs of the industry

nor the agency. Resolution of

differences in food safety control

strategies through scientific review and

dialog, where possible, is superior to

reliance solely upon the legal system for

such resolution. Similarly, limiting the

copying of records to instances

involving CL deviations would

inappropriately restrict the agency’s

ability to evaluate potential problems in

the identification of CCP’s, the

establishment of CL’s, and other

scientific issues, which, in some cases,

may be beyond the expertise of agency

investigators.

Industry comments have expressed

considerable concern, as discussed in

the ‘‘Compliance’’ section of this

preamble, that there will be no

mechanism for dialog with the agency if

a firm disagrees with an investigator’s

findings with regard to the sufficiency

of HACCP plans and records. The

agency is strongly committed to dialog

whenever possible. Provision of a means

by which senior reviewers at agency

headquarters will have access to HACCP

plans and records will facilitate that

process.

FDA has concluded that the

restrictions on copying of records

suggested by the comments would

significantly interfere with that access.

It would be highly inefficient for FDA

to identify a special class of

investigators that are permitted to copy

HACCP records and plans. FDA

investigators are responsible for

conducting inspections and

investigations to enforce a wide array of

regulations, and FDA field managers

need the flexibility to assign work in an

efficient and effective manner. Copying,

like record access, is limited to the

records specified in § 123.9(c). It would

be highly impractical for supervisory

preapproval to be accorded to an

investigator for the copying of specific

records. Until an investigator has

evaluated a HACCP plan and validated

the operations of the plant, it is not

likely that the investigator will know

with any certainty what HACCP records

are appropriate for review. Additionally,

inspections are often done in remote

locations and under highly flexible

itineraries that preclude close contact

between the investigator and particular

supervisor. Certainly, FDA investigators

will make every effort to obtain HACCP

plans and records from responsible

individuals of the firm and will, if

necessary, explain the relevance of the

requested records to the recordkeeping

requirements of these regulations.

The agency is unconvinced of the

need to modify § 123.9(c) in response to

the aforementioned comments, except

that reference to consumer complaints

in this section has been eliminated as

discussed in the ‘‘Consumer

Complaints’’ section of this preamble.

88. Several comments questioned the

phrase ‘‘duly authorized officers and

employees’’ used in this section. Some

felt that it referred, at least in part, to

employees of the firm, and others felt

that it excluded officials of State

regulatory agencies that may adopt these

regulations by reference.

The intent of the proposed regulations

was to grant records access to regulatory

agency officers and employees, not

officers or employees of a firm. The

language was intended to be flexible

enough to cover State officials if their

agency adopted the regulations by

reference. FDA has changed the wording

of the regulations to address these

concerns.

The modified paragraph in § 123.9(c)

reads:

(c) Official review. All records required by

this part and all plans and procedures

required by this part shall be available for

official review and copying at reasonable

times.

J. Training

A large number of comments

addressed the proposed training

requirements. FDA proposed to require

that each processor and importer

employ at least one individual who has

successfully completed a training course

that has been approved by FDA on the

application of HACCP to fish and

fishery products processing. FDA also

proposed that the trained person or

persons be responsible for, at a

minimum, developing and modifying

the HACCP plan, evaluating the

adequacy of corrective actions taken in

response to CL deviations, and

reviewing monitoring records before

shipment.

In the preamble to the proposed

regulations, FDA specifically requested

comment on: (1) Whether the need for

training could be satisfied by different

gradations of training (e.g., based on

complexity or size of operation or on the

degree of risk posed by the products

being produced); (2) whether other

training formats, such as video tapes,

might be effective, at least under some

circumstances (e.g., a small business

whose processing involved few

hazards); (3) whether, assuming the

regulations are adopted by FDA,

training in HACCP received before they

are effective should be ‘‘grandfathered’’

as fulfilling the training requirement;

and (4) whether some or all of the

training requirements should be deleted

or modified as a means of reducing the

burden on the industry.

1. The Need for Mandatory Training

89. Most of the comments that

addressed the question of whether there

should be a mandatory training

requirement expressed support for it. A

significant portion of these comments

acknowledged the need for at least one
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65141

trained individual at each processing

facility. Those that provided reasons for

their support contended that properly

trained personnel are essential to the

development and effectiveness of

HACCP controls, and that training is

necessary to ensure consistency of

approach.

Those few comments that expressed

reservations about the overall HACCP

training requirement generally

acknowledged the need for a trained

individual in the plant but opposed a

compulsory training program. Two

comments, from State governments,

expressed concerns about the financial

burden of training on small businesses

and questioned the need for making

such a provision mandatory.

The overwhelming support in the

comments for HACCP training is

indicative of the nearly universal view

that training is essential to the effective

implementation of a HACCP system. As

stated in the preamble to the proposed

regulations, this view is shared by the

NAS based on the success of the

training requirement in FDA’s HACCPbased regulations for low-acid canned

foods at part 113 (Ref. 54). The primary

concern expressed about mandatory

training is the cost.

The agency is convinced that its

efforts with the Alliance will facilitate

the development and implementation of

a low cost training program. As

mentioned above, the Alliance is a

cooperative effort between Federal and

State food regulatory agencies,

academia, and the fish and fishery

products industry to provide support to

the industry in meeting its needs

relative to HACCP training, technical

assistance, and research. Presently, the

Alliance Steering Committee is

comprised of representatives of FDA,

the U.S. Department of Agriculture

(USDA), NMFS, AFDO and its six

regional affiliates, the Sea Grant

Colleges, the ISSC, the National

Fisheries Institute, and the National

Food Processors Association (NFPA).

The goals of the Alliance are to

develop: a HACCP training course that

will meet the requirements of these

regulations, a mechanism for delivering

the training to the fish and fishery

products industry, a compendium of

established methods for controlling

hazards in the fish and fishery products

industry, and a mechanism for

coordinating the research efforts of the

participating agencies to facilitate the

development of improved methods of

hazard identification and control.

The training course materials are in

an advanced stage of development and

are expected to be publicly available

shortly after the publication of these

regulations. The AFDO regional

affiliates have agreed to work within

their regions to identify regulatory and

industry training needs and qualified

trainers who are interested in

participating in the Alliance-sponsored

training. They have also agreed to serve

as the course coordinators for the

Alliance-sponsored training, which will

be conducted on a cost-recovery basis.

The Alliance is developing a 3-day

course, divided about equally among:

(1) The fundamentals of HACCP, based

on the recommendations of the

NACMCF; (2) the requirements of these

regulations and the recommendations of

the Guide; and (3) a practical exercise in

HACCP plan development.

FDA is sensitive to the concerns

expressed about the cost of training but

is optimistic that training will not be

unnecessarily burdensome on small

business, either in actual out- of-pocket

expenses or in lost productivity. As was

previously mentioned, FDA is working

with the Alliance to produce a low cost,

3-day HACCP-training course for the

seafood industry, that is intended to

meet the requirements of these

regulations. Current plans are for the

course to be offered through a variety of

public institutions, including Sea Grant

colleges. As indicated earlier, in this

setting the course is expected to be

offered on a cost recovery basis. It is

likely that the course will also be

offered by private institutions, using

their own fee structure.

The other cost associated with the

training requirement is the lost

productivity for the duration of the

course. FDA is convinced that, with the

flexibility in course structure, described

elsewhere in this section, training can

be taken at times when it would least

affect the operations of the firm (e.g.,

during an off-season, at night).

Moreover, FDA is convinced by the

comments that, as a general rule, the

benefits of training will significantly

outweigh the burden. The agency has

concluded that with certain

modifications from the proposal as

described below, training should remain

a feature of these regulations.

The agency has made one

modification in response to requests

that it modify the training requirement

to reduce financial burden, especially

on smaller processors. FDA

acknowledges that a short course in

HACCP has its limitations. For example,

a 3-day course might not have anything

important to offer to an individual who

has significant job experience working

with or for an individual who is wellversed in HACCP. In such a situation, if

the processor loses the trained

individual, it should be able to replace

him or her with the individual who has,

in effect, apprenticed with the trained

individual without having to send the

apprentice to a course in HACCP

training, assuming, of course, that the

apprenticeship has imparted a level of

knowledge at least equivalent to that

that could be provided by the training.

The agency has modified the regulations

to provide for this kind of situation by

permitting adequate job experience to

qualify and individual to perform the

functions of the trained individual.

Note that all references in this

preamble to a trained individual mean

an individual who meets the

requirements of § 123.10 through either

completion of a course or job experience

that provides an equivalent level of

knowledge.

2. Who Should Provide Training?

90. A significant number of comments

identified organizations or individuals

that they considered to be qualified to

conduct or develop HACCP-training

courses. The majority of the comments,

which included remarks from

processors, trade associations, and State

governments, suggested that FDA

should either conduct such training or

at least approve the relevant course

material. A few of the comments that

recommended that FDA conduct the

courses also recommended that FDA

provide the courses at no cost or

financially support the training. The

comments that endorsed FDA approved

courses asserted that this approach

would result in a standardized,

comprehensive training program that

emphasizes the minimum acceptable

HACCP requirements.

Other comments recommended that

training programs could be conducted

by NFPA or other trade associations,

ISSC, Sea Grant colleges and other

academic institutions, consultants, and

State and local regulatory agencies. The

comments acknowledged the cost

savings that could be realized with trade

association- provided training and

through the HACCP training experience

already possessed by the NFPA. One

comment suggested that allowing many

training programs would offer hundreds

of professionals the opportunity to

contribute to the development of

HACCP. A few comments suggested that

FDA publish a listing of approved

training courses.

A comment from the ISSC cautioned

that organization does not support the

shifting of public health training in the

area of molluscan shellfish away from

itself. The comment further stated that

the organization would work

cooperatively with the Alliance in the

development of a HACCP-training
65142 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

course, which it suggested should be

Federally subsidized and ISSC

endorsed.

A few comments suggested that the

Alliance be permitted to develop the

standard for HACCP training, and that

the results be shared with all

prospective trainers. A few additional

comments urged that HACCP training be

based on the recommendations of

NACMCF, because such efforts would

result in a training program that was

well defined.

FDA generally agrees with these

comments. The agency does not intend

to run HACCP-training courses for the

industry. Rather, FDA must, of

necessity, focus its HACCP training on

government investigators. The agency

anticipates that industry training will be

conducted privately and through

academia. This division of labor is

based on the model that has worked

well for the training requirement for

low-acid canned foods.

FDA agrees, moreover, that there

should be widespread opportunity for

conducting HACCP training. It is not the

agency’s intent to specify or limit the

field of qualified trainers.

The training course that is under

development by the Alliance is based on

the recommendations of the NACMCF.

After reviewing the final draft of the

Alliance training materials, FDA intends

to publish a notice of availability of the

documents in the Federal Register. It is

the agency’s intent to utilize the

Alliance materials as the standard

against which other course materials

may be judged.

The agency strongly encourages

trainers to evaluate their courses, past,

present, and future, against the Alliance

materials when they become available

and to modify or adapt curricula, where

necessary, to ensure that they are

consistent with, and provide at least an

equivalent level of instruction to, the

Alliance course. Where previously

conducted training fails to meet this

standard, it may suffice to provide

supplemental materials or instruction so

that the cumulative training is at least

equivalent to the Alliance course. FDA

also encourages the fish and fishery

products industry to confirm with past

or prospective trainers that a particular

course is equivalent to and consistent

with the Alliance materials. The agency

has no plans to publish a list of

‘‘approved’’ courses other than the

Alliance course materials.

Finally, it should be noted that FDA

resources will not be sufficient to fund

the training of all appropriate regulators

(i.e., State or local regulators). The

agency is confident, however, that

Alliance training will provide a low cost

opportunity for high quality HACCP

training for State or local regulators as

well as for processors.

Because FDA will not be approving in

advance specific courses other than the

Alliance curriculum, and in response to

comments, the final regulations have

been modified at § 123.10 to require that

training courses be ‘‘at least equivalent

to the standardized curriculum

recognized as adequate by the U.S. Food

and Drug Administration.’’ FDA had

proposed to require that training courses

be ‘‘approved by the Food and Drug

Administration.’’

3. Should Training Be ‘‘Grandfathered?’’

91. A large number of comments

addressed the question of whether

training in HACCP received before the

effective date of these regulations

should be ‘‘grandfathered’’ as fulfilling

the training requirement. All of these

comments supported the grandfathering

of such training. Many of the these

comments recommended specific

training courses that FDA should

grandfather. Approximately half of these

comments requested that those trained

under NMFS’ HACCP training program

be grandfathered. Those that provided

reasons referenced the large number that

had been trained at the time of the

writing of the comment (1,310

domestically and 394 overseas) and

stressed that NMFS’ training was more

comprehensive than that which would

be necessary under FDA’s HACCP

approach, especially because the NMFS

program covers nonsafety hazards in

addition to safety hazards.

Other comments supported

grandfathering HACCP courses

conducted by NFPA, Sea Grant colleges,

State regulatory agencies and those

organizations sanctioned by such

agencies to provide HACCP training,

and Pacific Fisheries Services. One

comment suggested that graduation

from a Better Process Control School, as

required by parts 113 and 114 for

processors of acidified and low-acid

canned foods, should be considered to

meet the requirements of these

regulations. Another comment urged

that any training program based on the

HACCP principles recommended by the

NACMCF should be grandfathered.

One comment suggested that, in order

to grandfather courses, FDA would need

to develop a system to determine the

effectiveness of the training that has

been conducted. The comment

recommended the use of testing or

curriculum review as evaluation tools.

The comment further encouraged the

development of a formal approval

process for previously conducted

training.

FDA has concluded that it is not in a

position to grandfather HACCP training

received before the issuance of these

regulations. Blanket grandfathering

would pose the risk of sanctioning

training that does not fully prepare

processors for operating under these

regulations, and case-by-case

grandfathering would be unduly

demanding on agency resources.

On the other hand, the agency will

not presume that HACCP training

received prior to the issuance of these

regulations will have to be repeated.

FDA will challenge the adequacy of

prior training only when a processor’s

performance demonstrates a lack of

understanding of HACCP principles.

Nonetheless, FDA encourages

processors to update any prior training

to ensure that they have a thorough

understanding of the requirements of

these regulations. It may well be that

many traditional HACCP courses will

need only minimal supplementation to

accommodate them to the provisions of

these regulations, and that there will be

no need for a processor to repeat an

entire course. As mentioned above,

partial, supplemental courses may be

offered, or reading materials developed

by the course offerer and sent to the

processor may suffice. There are

numerous possibilities.

FDA is also not in a position to make

determinations in advance about the

acceptability of courses that will be

offered after the issuance of these

regulations. FDA agrees with the

comment that, in order to do so, the

agency would have to develop a system

for course evaluation. Review of course

materials, auditing of course

presentations, testing, and other

evaluation tools that FDA might have to

employ are labor intensive and are not

the most efficient use of agency

resources. Rather, the adequacy of

courses will have to be evaluated by

FDA on a case-by-case basis, when

inspectional or other evidence causes

the agency to question whether the

course meets the requirements of

§ 123.10.

The ultimate determination of the

success of training is whether

processors are operating effective

HACCP systems. In the initial stages of

the program, at least, FDA’s primary

focus will have to be on whether

HACCP plans are adequate, and the

systems are being effectively

implemented. FDA’s interest in the

adequacy of training will increase when

plans and systems fail to demonstrate an

adequate understanding of HACCP and

its application to seafood.

Nonetheless, FDA can state that the

Better Processing School curriculum for
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65143

acidified and low-acid canned foods

will not be adequate to meet the training

requirement of these regulations. The

Better Processing School was developed

to instruct acidified and low-acid

canned food processors in how to safely

process such products to control the

hazard of the development of botulinal

toxin in accordance with the

requirements of parts 113 and 114. The

course does not provide instruction in

the principles of HACCP or address

other hazards (e.g., histamine

development) to which these products

might also be exposed.

4. Course Curriculum

92. A few comments suggested that

the training be divided into a basic

HACCP core and interchangeable

segments based on the portions of the

industry of interest to the students (e.g.,

vessels, cooked, ready-to-eat fishery

products, molluscan shellfish, and

smoked fish).

As mentioned previously, the

Alliance course includes three

segments: A basic HACCP core, the

requirements of these regulations, and

the development of a HACCP plan. The

first two segments are applicable to the

entire fish and fishery products

industry. The Alliance has

acknowledged the need to develop

industry-specific features for the third

segment. The agency is in agreement

with the Alliance and with the comment

in this regard and would encourage the

development of such directed courses.

93. In response to FDA’s invitation to

comment on the advisability of alternate

training formats, several comments

expressed support for the use of video

tapes by small processors of low-risk

products. A few additional comments

did not specifically address video taped

training but stated that, while it is

desirable to have uniform training,

ultimately training should involve

‘‘whatever it takes.’’ One comment

suggested that home study courses and

education via television might be

acceptable alternatives to more formal,

for-fee training mechanisms. A few

comments opposed courses that consist

exclusively of video tapes, based on

concern for a potential limitation in the

level of understanding that could result

from this type of noninteractive training

method.

FDA agrees with the comments that

expressed concern with teaching

methods, such as video tapes, that lack

instructor/student interaction. However,

in the interest of providing flexibility in

meeting the training requirement of

these regulations, the agency has

concluded that any teaching format is

acceptable so long as it provides a level

of understanding at least equivalent to

that provided by the Alliance training

program. FDA is aware that video tape

training is widely used for a variety of

purposes. The agency cannot conclude

that video-based HACCP training will

not accomplish the purposes of the

training requirement. For remote site

processors, video-based training may be

the only practical method available.

It is unlikely, however, that two or

three 2-hour video tapes, as one

comment suggested, will provide an

equivalent level of training to the 3-day

Alliance course under development. On

the other hand, a series of video

presentations, perhaps in conjunction

with a 1-day workshop, may be

adequate.

94. A few comments addressed the

length of the training course. One

suggested that 3 days would be overly

burdensome on small businesses

because of the loss of manpower during

the course. Another suggested that 3

days was not long enough to furnish the

needed information. One comment

suggested that the length of training

should be based on the level of

experience of the student and the level

of complexity of the processing

operation.

FDA has concluded, based, in part, on

its participation in the Alliance, that the

3-day Alliance curriculum is the

minimum necessary to develop an

adequate understanding of HACCP

principles and essentials of HACCP plan

development. If the curriculum were

reduced any further, processors would

risk having to take more time later to

implement their HACCP systems as a

result of trial and error, and as a result,

the quality of their HACCP programs

would be jeopardized.

Nonetheless, FDA is not specifying in

the regulations how long the course

must take, only that it be equivalent in

terms of curriculum to the standardized

curriculum recognized as adequate by

the agency. If true equivalency can be

achieved in less time, FDA would have

no objection. Moreover, depending

upon the circumstances, FDA would

have no objection to training that can be

imparted in segments at convenient

times so as to cause only a minimal

disruption to the work schedule.

Section 123.10, therefore, states that

the training must be ‘‘at least equivalent

to the standardized curriculum

recognized as adequate by the U.S. Food

and Drug Administration.’’ This

provision will also accommodate the

use of food processing experts, who

have received training in HACCP that is

far more extensive than that planned by

the Alliance. FDA recognizes that it

would be inappropriate to limit the

universe of experts to those who have

taken a course based on the Alliance 3-

day curriculum. The issue of the use of

consultants and other experts will be

further discussed later in this section.

5. Do Importers Need Training?

95. A few comments suggested that

FDA should provide separate or

specialized training aids for importers.

Two of these comments noted that

importers have not, historically, been

involved with the processing of seafood

commodities. The comments requested

that FDA work with trade associations

that represent importers in setting up

workshops, developing specialized

training materials for importers, and

recognizing training provided by foreign

institutions.

FDA has reassessed the need for

training to accomplish the HACCP

functions assigned to importers,

especially in light of changes in the

imports provisions of these final

regulations. These changes are fully

discussed in the ‘‘Imports’’ section of

this preamble. In summary, importers

are now required to conduct verification

activities but are no longer required to

have full HACCP plans of their own

unless they also meet the definition of

a ‘‘processor.’’ FDA has concluded that

HACCP training, while desirable, is not

essential to the preparation of importers’

verification procedures, as specified at

§ 123.12(a)(2). For this reason, training

is not required for importers, and all

reference to required training for

importer functions has been dropped

from § 123.10.

Nonetheless, the agency is aware that

importers may be unfamiliar with the

technical aspects of fish and fishery

product processing and HACCP control

procedures. Knowledge about these

matters would be helpful for purposes

of verification. To meet this need, FDA

plans to include in the Guide specific

materials relating to importers’

verification procedures. In addition, as

has traditionally been the case, the

agency intends to continue to interact

with, and provide information to, the

import industry through trade

associations and other forums, within

the limits of budget constraints.

Moreover, importers may want to

participate in the training courses that

are offered by the Alliance.

Finally, the agency agrees with the

comment that suggested that training

overseas should be conducted by foreign

institutions recognized for their

expertise in seafood processing and

HACCP control. This issue will be

further discussed in the ‘‘Imports’’

section of this preamble.
65144 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

6. Testing and Retraining

96. Several comments supported the

mandatory use of testing to assess

whether an individual has successfully

completed HACCP training. Two

comments further recommended that

the agency could consider the training

requirement to be met if a person

successfully passes an examination.

The agency is not opposed to testing

at the end of a course but prefers not to

mandate that courses include tests.

Trainers will be free to include or not

include testing as part of their training

efforts. The issue of student evaluation

is one that is still being debated in the

Alliance relative to Alliance-sponsored

training courses.

However, testing alone does not

provide the kind of exposure to the

concepts of HACCP that is necessary to

result in company understanding and

commitment. The function of training is

to prepare industry to meet the

requirements of the regulations, not to

test competency. The true test will be

whether processors are able to

implement their HACCP systems.

Processors will be judged as plans are

reviewed, and plant operations are

evaluated, during inspections.

97. A few comments recommended

mandatory retraining or continuing

education. The comments stated that as

new information about the science of

fish and fishery products hazards and

the technology of their control becomes

available, there will need to be some

method for introducing this information

to previously trained individuals. One

comment, on the other hand, urged that

training be limited to a single event and

not be subject to periodic renewal.

The primary purpose of the training is

to teach the fundamentals of HACCP.

These are unlikely to change over time.

A comprehensive discussion of seafood

hazards and controls is far too extensive

for inclusion in a 3-day training session.

The agency has concluded that

information about the technology that is

available to control hazards should be

made available to the industry through

the Guide, the Alliance Compendium of

Established Processes, and other modes

of technical assistance. FDA supports

the idea of continuing education and

will encourage it, but the agency is not

prepared to mandate it in these final

regulations.

98. A comment suggested that the

regulations mandate remedial or

enhanced training for a first time

violator whose infractions have resulted

from a misunderstanding of HACCP

principles.

Whenever an infraction occurs, the

nature of the remedy that is warranted

depends on factors such as the public

health significance of the infraction. The

agency has administrative warnings

and, when necessary, a range of

regulatory actions available to it. (See

the ‘‘Compliance’’ section of this

preamble for a more thorough

discussion of compliance philosophy

under HACCP and available remedies.)

Ultimately, however, it will be the

processor who will be responsible for

correcting the deficiencies in its HACCP

system. Part of that responsibility will

be determining the most appropriate

method of resolving any failure to fully

understand HACCP principles, whether

through remedial training, hiring a

consultant, or taking some other step. So

long as an appropriate outcome can be

obtained, FDA would prefer not to

mandate any particular method of

remediation in these regulations.

Processors certainly may wish to

consider additional education as an

option, however.

7. Gradations of Training

99. Several comments addressed

whether the HACCP training

requirement could be satisfied by

different gradations of training,

depending on the complexity or size of

the operation or on the degree of risks

posed by the product being produced.

The majority of these comments

supported the concept of variable levels

of HACCP training. Most did not

provide the basis of their support. Those

that did suggested that small or large

scale processing of low-risk products

would not likely require any special

training, and that small scale processing

of even high-risk products would allow

for individual examination of every fish,

an option that is not possible in large

scale processing. One comment further

suggested the use of variances to

exclude certain industry members from

the training requirement, rather than

providing a blanket exemption for a

segment of the industry.

A minority of the comments on this

subject opposed any variations in the

level of training. Several of these

comments stated that the necessity for

HACCP education and training does not

vary based on the size of a company,

and that a standard training curriculum

should be developed for all companies,

regardless of their size. Some of these

comments stated that smaller processing

operations may be inherently less safe,

and that, cumulatively, they represent a

large amount of the seafood making its

way to the consumer. One comment

stated that smaller processing

operations may actually have a greater

need for employee training, compared to

some larger processing operations that

may already have trained staff.

The agency agrees with the comments

that suggested that the need for HACCP

training does not vary solely by the size

of the processor. An understanding of

the principles of HACCP is essential for

the successful implementation of a

HACCP program, regardless of

establishment size. The agency agrees

with the assertion that, in many cases,

the training needs of small businesses

may, in fact, be greater than those of

large firms, because they frequently lack

the trained quality control and research

and development staffs that are common

in large firms. Moreover, small

businesses comprise a significant

portion of certain high-risk segments of

the fish and fishery products industry,

such as processors of molluscan

shellfish and cooked, ready-to-eat

products. Training will be critical to

ensure the success of HACCP in these

segments.

Although the agency expects that the

complexity of HACCP plans will vary

with the number and type of hazards

associated with a processing operation,

an understanding of the basic principles

of HACCP, and how to apply those

principles to the processor’s operations,

will remain essential. The curriculum

under development by the Alliance is

designed to provide a very basic

grounding in these matters. As stated

earlier, the Alliance has acknowledged

a need to tailor part of the course so that

it can be directed toward specific

industry segments. This approach may

be the best way to provide flexibility in

the program, so that training can match

the degree of complexity and risk that

is encountered by the processor. FDA

will continue to encourage the

development of industry-specific

training features.

The agency is not persuaded that the

ability of a processor to individually

examine all fish because of the small

scale of operations will reduce the

processor’s need to understand the

hazards associated with seafood and the

specifics of a systematic approach for

controlling them. FDA has long taken

the position that observing each fish on

an assembly line is an inappropriate

way to ensure seafood safety (Ref. 208,

p. 4146). While matters relating to the

quality of the fish can be observed in

this manner, safety matters often cannot.

8. Duties of the Trained Individual

100. Several comments suggested that

a firm be permitted to hire a consultant,

or an outside expert, who is not an

employee of the firm, to perform the

functions required of a trained

individual. Two trade associations
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65145

argued that contracting for the

development of a HACCP plan by a

professional consultant could be more

efficient and cost effective, especially

for many small companies. Related

comments pointed out that some of the

proposed functions of the trained

individual either did not require a

person to be onsite continually (e.g.,

plan development) or required expertise

that could not realistically be obtained

in a 3-day course (e.g., making decisions

about whether product that has been

subject to a deviation is safe to release

into commerce).

While the agency considers training

employees to be preferable to hiring

outside consultants in terms of fostering

the appropriate corporate culture and

commitment to HACCP, FDA recognizes

the importance of ensuring the

flexibility that firms, especially small

businesses, may need to comply with

the regulations in a cost-effective

manner. The agency also accepts that for

some processors, the expertise that may

be needed from time to time could best

be provided by an expert consultant.

Consequently, the agency is modifying

§ 123.10 to read as follows: ‘‘* * * the

following functions shall be performed

by an individual who has successfully

completed a course of instruction

* * *.’’ The requirement that

processors employ a trained individual

has been eliminated. Moreover, FDA has

modified § 123.10(c) to state, ‘‘The

trained individual need not be an

employee of the processor.’’

101. A number of comments asked

whether the regulations would require a

separate trained individual for each

processing location of each company or

just one per company.

FDA intends that the functions

enumerated in § 123.10 be performed by

a trained individual. The number of

employees a processor must train, or the

consultants that must be hired, in order

to ensure that trained individuals

perform these functions is left to the

judgment of the processor. For some

firms, one individual will be sufficient.

Others will need to secure the services

of more than one such individual, either

as employees or as consultants. Whether

these individuals are located at each

facility, at a corporate headquarters, at

a consulting firm, or at some

combination of these arrangements is to

be determined by each individual

processor.

102. A few comments were concerned

about the logistics of the routine

functions that the agency proposed must

be performed by someone with HACCP

training (i.e., record review and

deviation handling). Specifically, they

argued that the proposed requirements

would actually require each firm to have

more than one trained individual

because of work weeks that routinely

exceed 40 hours, vacations, illnesses,

and employee turnover. The

consequence, the comments suggested,

would drive up the cost of training.

FDA acknowledges that, for certain

situations, these comments may be

correct. However, the agency has made

three changes in the final regulations to

minimize this possibility. First, as stated

above, a processor may hire trained

consultants on an as-needed basis.

Second, as discussed in the

‘‘Verification’’ section of the preamble,

the regulations do not include the

proposed requirement that a trained

individual review monitoring records

before the product to which the records

relate is shipped. These final regulations

require only a weekly review. As a

result, the need to have a trained

individual onsite every day has become

substantially reduced. Third, as

described below, FDA has decided not

to require that the trained individual

evaluate CL deviations and corrective

actions. This modification reduces still

further the need to have a trained

individual onsite at all times. In

addition, as described previously, the

agency is allowing processors to employ

individuals whose training has been

obtained through on-the-job experience.

Thus, for example, a processor that

needs the services of two trained

individuals could satisfy the

requirements of these regulations by

employing an individual who has been

trained in an adequate course and a

second individual who has apprenticed

sufficiently with the first individual to

have mastered the subject.

As a related matter, the provision in

the final regulations that provides for

the development of corrective action

plans (see the ‘‘Corrective Actions’’

section of this preamble) could

eliminate the need to bring an expert

onto the scene in many instances in

which corrective action is necessary.

The processor may be able to follow the

corrective action plan without having to

rely on an expert or trained individual.

This procedure could permit further

savings.

103. Some comments suggested that

there should be different categories of

trained individuals, with different

responsibilities. These comments, from

individuals, processors, and trade

associations, asserted that a firm should

have one HACCP trained person capable

of conducting or overseeing the routine

operation of the HACCP program, but

that this individual should not

necessarily be responsible for designing

a firm’s HACCP plan or making complex

scientific evaluations.

Another comment suggested that it

was unrealistic to expect that a training

program would provide the level of

expertise necessary for a person to make

a determination on whether a deviation

may have rendered a product injurious

to health or otherwise adulterated.

FDA generally agrees with these

comments. It was never the agency’s

intent to limit the processor’s use of

experts to employees whose training

included the course prescribed by these

regulations, especially in the areas of

HACCP plan development and the

evaluation of CL deviations and

corrective actions (i.e., making

evaluations about whether product that

has been subject to a deviation is safe to

ship). While FDA is convinced that a

short course in HACCP principles is

important to the success of the overall

program, the agency also recognizes that

such a course has its limitations.

FDA has deleted the proposed

requirement that the HACCP-trained

individual be required to evaluate CL

deviations and corrective actions to

allow for the use of experts in other

appropriate scientific disciplines that

have not been trained in accordance

with these regulations. For example, the

agency does not expect that a processor

will be able to determine the public

health consequences of every possible

deviation without the assistance of

experts. The kind of expertise necessary

would likely involve disciplines other

than HACCP. Moreover, the agency

agrees that it is unreasonable to expect

that successful completion of a 3-day

HACCP course alone would qualify an

individual to make determinations

about the safety of products involved in

a CL failure. HACCP training in such a

situation could only reasonably be

expected to help ensure that appropriate

corrective action measures are taken and

recorded from a HACCP perspective.

Consistent with this change, FDA has

modified § 123.7(c)(2) to state that a

determination of acceptability for

distribution into commerce of products

that may have been affected by a

deviation must be made by individuals

with the expertise to make such a

determination, and that such

individuals need not be those who meet

the requirements of § 123.10.

Nonetheless, FDA expects that, at a

minimum, an individual trained in

accordance with these regulations will

perform the verification function of

reviewing records of corrective actions

to ensure that they are complete, and

that an appropriate corrective action

was taken (i.e., one that was

predetermined in the HACCP plan, or
65146 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

one that was determined by a qualified

expert to be sufficient to render the

product safe). Section 123.10(c) requires

that the trained individual perform

certain record reviews associated with

the verification principle of HACCP,

including reviews of corrective action

records (see § 123.8(a)(3)(ii)).

FDA has modified § 123.10 from the

proposal to clarify and to conform this

section to other features of the

regulations. A summary of these

modifications follows.

FDA has revised § 123.10(a) to clarify

that when a trained individual develops

an HACCP plan for a processor, this

effort may involve adapting a model or

generic-type plan for use by that

processor. FDA received a significant

number of comments on the pros and

cons of model or generic-type HACCP

plans. This subject is addressed in

various places in the preamble, most

notably in the section entitled ‘‘Other

Issues.’’ In summary, the development

of model plans can be of great benefit

to the industry, especially small

businesses, so long as the model plans

are tailored by processors to meet their

individual situations and are not simply

copied verbatim. The agency is

convinced that, in most cases, generic or

model plans will need to be modified to

some extent to fully accommodate the

specifics of the processor’s operations.

Section 123.10(b) provides, in part,

that the trained individual is

responsible for reassessing and

modifying the HACCP plan in

accordance with corrective action

procedures specified in § 123.7(c)(5).

This requirement is not new. It should

be noted, however, that, unlike the

proposal, the final rule requires the

trained individual to perform these

functions only when the processor does

not have a predetermined corrective

action plan that addresses the specific

deviation. As explained in the

‘‘Corrective Action’’ section of this

preamble, a review and reassessment of

the plan should not ordinarily be

necessary when a corrective action was

anticipated, as reflected by the existence

of a predetermined corrective action

plan.

Section 123.10(b) also requires that a

trained individual perform the annual

reassessment of the processor’s HACCP

plan as required by § 123.8(a)(1). A new

feature of the regulations, this

requirement parallels the mandate that

each processor engage in verification

activities (see § 123.8(a)). It is a logical

outgrowth of the principle, central to

both the proposal and this final rule,

that plan development be performed by

individuals who possess the knowledge

and skills that are obtained through

training in HACCP.

Section 123.10(c) requires that a

trained individual perform certain

record reviews as enumerated in

§ 123.8(a)(3). This requirement is not

new except for the review of records of

end-product testing, if any. End-product

testing was not addressed in the

proposal but, as explained in the

‘‘Verification’’ section of the preamble,

has been added as an optional

verification activity. The review of endproduct testing records by a trained

individual is a logical outgrowth of the

principle that was reflected in the

proposal in § 123.8(b) that a trained

individual review all HACCP records for

completeness and consistency with

written HACCP procedures.

Finally, it should be noted that the

requirement in the proposed regulations

that trained individuals perform certain

functions for importers has been

dropped entirely. This deletion is

consistent with the changes that FDA is

making in the provisions that applied to

importers in this final rule. These

revisions are described elsewhere in this

preamble. In summary, importers are

given alternatives to having HACCP

plans and are not required to take the

kinds of actions for which a trained

individual has been determined to be

essential.

K. Sanitation

1. Background

FDA proposed to require that

processors conduct sanitation

inspections at specified frequencies to

ensure that each of up to 18 specified

sanitation conditions are maintained in

the processing facility where they are

relevant to the type of processing being

performed. The agency also proposed to

require that processors maintain

sanitation control records, and that they

take and document corrective actions

when the specified conditions were not

met. In addition, FDA encouraged, but

did not propose to require, processors to

make use of written SSOP’s to ensure

that the necessary sanitation measures

were implemented.

FDA tentatively concluded that

sanitation controls are necessary in

these regulations because: (1) Sanitation

practices directly affect the

microbiological safety of seafood

products that are not further cooked by

the consumer, such as cooked, ready-toeat products, smoked products, raw

molluscan shellfish, and other fish that

are consumed raw; (2) sanitation

practices are relevant to the

microbiological safety of seafood

products even where these products are

to be cooked by the consumer; (3)

sanitation practices directly affect the

chemical and physical safety of seafood

products; (4) nearly half the consumer

complaints relating to seafood that FDA

receives in a typical year are related to

plant or food hygiene; and (5)

inspections conducted by FDA and

NMFS demonstrate that a significant

portion of seafood processors operate

under poor sanitation conditions.

The MSSP, conducted by NMFS,

concluded that sanitation controls could

be included in HACCP plans without

overloading HACCP. Moreover, the

FDA/NMFS HACCP-based seafood pilot

program included sanitation CCP’s.

Nonetheless, FDA tentatively concluded

that monitoring and recordkeeping for

the 18 specific sanitation conditions

specified in the proposal should be

permitted to occur outside of a

processor’s HACCP plan so as not to

overload it. Because these sanitation

controls relate to an entire facility, not

just to a limited number of CCP’s, FDA

felt that they would not all fit well

within an HACCP plan.

FDA took this prescriptive approach

to sanitation to assist processors so that

they would not have to figure out how,

or whether, to include sanitation in

their HACCP plans and to help them

resolve the sanitation problems that the

seafood industry has chronically

experienced. By requiring a specific,

daily sanitation regime that incorporates

HACCP-type features (i.e., monitoring

and recordkeeping) to help the

processor track sanitation in its plant,

FDA hoped to foster a culture of, and

commitment to, good sanitation

practices that has been lacking in a

significant portion of the industry.

2. Should the Regulations Deal With

Sanitation?

FDA requested comment on whether

sanitation control measures should be

addressed by processors in accordance

with the proposed approach, or whether

the regulations should require that

processors address sanitation in their

HACCP plans.

More than 250 comments addressed

various aspects of the proposed

sanitation requirements, more

comments than addressed any other

aspect of the proposed regulations.

Approximately 100 of these comments

addressed FDA’s questions about the

approach to sanitation control in these

regulations. The remaining comments

focused on specific sanitation

provisions.

104. Approximately 10 percent of

those that responded to the requests

supported the proposed approach.

These comments were from processors,
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65147

consumer advocacy groups, State,

Federal, and foreign government

agencies, and a trade association.

Approximately five percent of the

comments, from processors, trade

associations, and State government

agencies, objected to the inclusion of

any explicit sanitation controls in these

regulations. It is not clear, however,

whether the latter comments were

objecting to sanitation controls as part of

HACCP where appropriate for safety or

to any sanitation approach beyond

HACCP. The remaining approximately

85 percent of the comments, principally

from processors, trade associations, and

State and Federal government agencies,

generally acknowledged the need for

these regulations to address sanitation

in seafood processing plants but

objected to one or more of the specifics

of the proposal.

Those that supported the proposed

approach argued that sanitation controls

are a critical component of the

regulations because: (1) Addressing the

insanitary practices in the seafood

processing industry is essential to

improved consumer confidence; (2)

effective sanitation controls are a

prerequisite to the proper functioning of

a HACCP system; and (3) sanitation

controls are critical to the management

of microbiological hazards in both

products that will not be cooked by the

consumer and those that will be cooked,

the latter because of the potential for

cross-contamination in the kitchen. The

comments suggested that a prescriptive

approach to sanitation is warranted

because the FDA and NMFS inspection

results cited in the preamble to the

proposal documented the failure of a

significant percentage of the industry to

control key sanitation conditions and

practices. Moreover, these comments

continued, the enumeration of specific

controls relieves the industry of the

burden of identifying the most

significant areas of concern.

Several comments stated that

sanitation requirements for seafood

processors are necessary because

guidelines do not have the force of

regulation and therefore are more

difficult to enforce. One comment stated

that including sanitation requirements

in these regulations would simplify

compliance for seafood processors

because the HACCP and sanitation

requirements would be in one place.

One comment stated that some

processors would be more inclined to

implement sanitation control measures

if all processors were subject to the

same mandatory requirements.

Many of the comments that objected

to the manner in which FDA proposed

to treat sanitation acknowledged that

effective sanitation controls are essential

to the proper functioning of a HACCP

system. As with comments that

supported the proposed approach, a few

of these comments identified sanitation

as a prerequisite to HACCP.

The comments that objected to the

inclusion of any sanitation requirements

in these regulations provided reasons

that the agency believes are more

relevant to the question of how these

regulations should address sanitation

than to whether they should address the

issue. For this reason, the arguments

presented in these comments are

addressed later in this section.

FDA accepts the view expressed by

the overwhelming majority of comments

(i.e., those that advocated the proposed

approach and those that advocated other

sanitation control mechanisms) that

sanitation is relevant to the goals of

these regulations and should be

addressed in them. The primary source

of pathogenic microorganisms for most

fish (i.e., wild-caught fish) is the

processing plant environment (Ref. 3, p.

267). The control of sanitation in the

plant is the most effective way to

minimize pathogens, and, for products

that are not given a final heat treatment

after packaging, it is the only way to

minimize them at that stage in the chain

of distribution (Refs. 3, p. 10; 7, p. 27;

204; and 205). This situation is nearly

the reverse of that for red meat and

poultry, where pathogens are likely to

have originated from the raw materials

before they enter the plant (Refs. 36, p.

197; 209; and 210, p. 1).

A significant body of opinion holds,

moreover, that good sanitation is a

necessary foundation for HACCP. This

view was articulated in comments to

this rulemaking and in the proposed

rule to establish HACCP and other

requirements for the beef and poultry

industries issued by USDA (Ref. 211).

USDA proposed both SOPs for

sanitation as a prerequisite to a HACCP

plan and sanitation as part of HACCP

where critical for safety (Ref. 211, p.

6789).

FDA concludes, therefore, that these

regulations cannot fully address all

matters relevant to safety, or

significantly contribute to the

restoration of consumer confidence in

seafood without providing for major

improvements in sanitation. Therefore,

these regulations address sanitation.

3. Why Isn’t Part 110 (21 CFR Part 110)

Adequate To Deal With Sanitation

Concerns?

105. Some comments asserted that it

would be adequate to rely on the

existing CGMP’s in part 110, which

provide guidance of general

applicability to all foods. A variation on

that concern was the view that the

sanitation standards in part 110 need

not be codified in these regulations

because they are adequately expressed

in that part. The NACMCF pointed out

that the CGMP’s have proven adequate

for a wide variety of processed foods

under FDA’s jurisdiction. Some

comments stated that part 110 should be

made mandatory for seafood and fully

enforced.

Good sanitation is already mandatory

for all foods. Section 402(a)(4) of the act

deems food to be adulterated if

processed under insanitary conditions.

The CGMP’s in part 110 articulate the

kinds of conditions and practices that

need to be followed in order to avoid

producing an adulterated product under

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

Nevertheless, while FDA has been

enforcing the sanitation standards

contained in part 110 for many years, as

indicated earlier, it has not succeeded in

developing a culture throughout the

seafood industry in which processors

assume an operative role in controlling

sanitation in their plants. The statistics

relating to the incidence of insanitation

cited in the preamble to the proposed

regulations (Ref. 208 at 4161–4162)

clearly demonstrate that such a culture

is not adequately in place. The

following observation about culture in

the preamble to USDA’s proposed

HACCP rules for beef and poultry is

applicable here as well:

* * * Identification of sanitation

requirements has been viewed by some

establishment owners and personnel as the

inspector’s responsibility. Such

establishments often fail to take the initiative

to find and remedy insanitary conditions,

relying instead on the inspector to find

deficiencies. (Ref. 211, p. 6788)

Moreover, FDA points out that while

the CGMP’s state that sanitation controls

should occur as frequently as necessary,

they are silent with regard to monitoring

by the processor to ensure for itself that

sanitation controls are being followed.

For these reasons, FDA concludes that

part 110 alone has not proven to be

adequate for the seafood industry. In

order to ensure that firms take full

responsibility for sanitation in their

plants, which is strongly related to the

production of safe and wholesome

seafood, FDA has concluded that it is

necessary to include sanitation

requirements in these regulations.

4. Why Isn’t the Proposed Approach

Appropriate?

106. Many comments that agreed that

sanitation should be addressed in the

regulations, as well as some that

opposed addressing it, objected that the
65148 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

proposal was too prescriptive. These

comments asserted that: (1) The

proposed 18 sanitation controls are

overly prescriptive and inflexible and

are not appropriate for all processors; (2)

the codification of prescriptive

sanitation requirements as regulations

limits the ability of processors to keep

pace with advances in science and

technology; (3) the proposed sanitation

controls have the effect of establishing

eighteen CCP’s, which are not always

appropriate; and (4) the proposed

sanitation provisions duplicate or

contradict existing State or NSSP

requirements. FDA will respond to these

criticisms.

Many comments that argued that the

18 specific sanitation controls that FDA

proposed were too prescriptive

provided examples of how this

approach could deny processors the

flexibility necessary to develop and

implement sanitation programs that are

effective for the specific conditions in

which they are to be used. Some of

these examples are as follows:

(1) A few comments challenged the

proposed ‘‘easily cleanable’’ standard

for equipment, suggesting that in some

applications (e.g., at sea processing and

old equipment) this standard may not be

attainable and may not be necessary as

long as the equipment is, in fact,

cleaned;

(2) A large number of comments

challenged the proposed 4-hour

equipment cleaning frequency,

suggesting that it is unwarranted in

some situations (e.g., refrigerated

processing facilities) because it is

inconsistent with actual microbiological

growth rates. It is unduly burdensome

in other situations (e.g., surimi

processing facilities), according to the

comments, because it would limit shifts

to 4 hours, would interrupt production,

and would require hours of equipment

breakdown time;

(3) A few comments challenged the

proposed ‘‘impermeable’’ standard for

gloves and outer garments that contact

food or food contact surfaces, suggesting

that in some instances it was

impractical (e.g., filleting fish);

(4) A significant number of comments

challenged the proposed 4-hour hand

sanitizer strength test frequency,

suggesting that replacement of dips

rather than checking concentration may

be appropriate, as may be the use of

automated hand washing and sanitizing

systems; and,

(5) A number of comments challenged

the proposed requirement that hand

washing and sanitizing stations be

located in processing areas, suggesting

that they need only be easily accessible.

These comments have general merit

and have persuaded the agency that a

less prescriptive approach is

appropriate to ensure that the

regulations do not impose impractical,

unduly burdensome, or excessively

rigid requirements.

107. Another concern with FDA’s

approach was that codifying specific

sanitation control procedures would not

enable processors to keep their

sanitation programs updated with

advances in science and technology. As

an example, the NACMCF comment

cited recent industry experience with

other foods that has shown that the

proposed requirement of midshift

cleaning and sanitizing in packaging

rooms for ready-to-eat foods, may with

many current sanitation practices

actually be counterproductive to the

control of Listeria monocytogenes. The

NACMCF advised that codification of a

midshift cleaning requirement would

have prevented these industries from

modifying their cleaning procedures to

adjust to the new information.

FDA agrees that sanitation

requirements should be sufficiently

flexible to permit the incorporation of

new information and better procedures.

108. A number of the comments,

including more than half of those that

opposed any new form of sanitation

controls, argued that the sanitation

control approach proposed by FDA

would effectively establish eighteen

mandatory sanitation CCP’s that may

not always be appropriate.

These comments may have been the

result of a misunderstanding of the

relationship between processor HACCP

plans and the proposed sanitation

controls. While the proposed controls

involved monitoring and recordkeeping,

they were not proposed as part of a

processor’s HACCP system. FDA did not

intend to designate them as CCP’s. FDA

believes that the provisions of these

final rules make clear that the necessary

sanitary controls need not be considered

to be CCP’s.

109. A large number of the comments

that objected to the manner in which

FDA proposed to handle sanitation

argued that the proposed sanitation

provisions are redundant with State and

local regulations and, with respect to

molluscan shellfish, with the NSSP.

FDA acknowledges that the NSSP and

most State seafood control programs

include provisions, much like FDA’s

CGMP’s, that are designed to control

processing plant sanitation. These other

provisions, like the CGMP’s, serve as

baseline standards for sanitation.

However, the rates of noncompliance

with existing CGMP standards, as

detailed in the preamble to the proposed

regulations (Ref. 208 at 4161–4162),

demonstrate a need for a system in

which processors are responsible for not

only meeting these baseline standards

but also routinely auditing their

facilities and operations to ensure that

they are meeting them. In this way, the

sanitation requirements of these

regulations build upon existing

sanitation requirements, at the Federal,

State, and local levels.

The more generalized nature of these

final regulations with respect to

sanitation should mitigate the concerns

of the comments that complained about

the conflict between, and duplication

with, existing sanitation standards.

As discussed elsewhere in this

preamble, FDA encourages adoption of

these regulations by State and local

regulatory agencies. FDA is convinced

that, in many cases, the regulations can

be quite easily overlaid on existing

State, local, and NSSP requirements.

5. What Is the Appropriate Approach to

Sanitation?

Based on its review of the comments,

FDA has been convinced that a

modification of its approach to

sanitation is appropriate. FDA

concludes that its approach in the

proposal was too inflexible and could

have made it more difficult in certain

circumstances to incorporate new

technologies and information.

The comments argued for one or more

of several approaches that they

identified as being more appropriate

than FDA’s proposed approach: (1)

Requiring that each processor develop

and follow a SSOP that is specifically

tailored to a processing operation; (2)

including sanitation controls in the

HACCP plan where they are critical to

product safety; and (3) retaining the

general approach of the proposed

regulations but somehow reducing the

number of specific requirements.

Approximately 85 percent of those that

opposed the way that sanitation was

treated in the proposal advocated one or

a combination of the first two of the

approaches, with the recommendations

evenly split between the two. The small

number of comments that objected to

including any specific sanitation

requirements in the regulations may

also have been arguing that sanitation

should not be part of HACCP but should

be controlled solely through CGMP’s.

a. Inclusion of sanitation controls in

HACCP plans.

110. There was strong support in the

comments for the inclusion of sanitation

controls in HACCP plans, particularly

where the controls are necessary to

protect the safety of the product. The

comments stated that a processor’s
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65149

hazard analysis may reveal the need to

control certain aspects of sanitation in

the HACCP plan, especially to control

hazards involving microbiological

contamination. One comment noted that

sanitation controls are likely to be

components of the HACCP plans of

molluscan shellfish processors.

Given the strong support that

sanitation controls should be included

in HACCP plans where they are critical

to safety, FDA has no objection to

processors including sanitation controls

in their HACCP plans. Consequently,

these final regulations state in § 123.6(f)

and § 123.11(d) that sanitation controls

for safety may be included in HACCP

plans.

The agency has concerns, however, as

to whether including sanitation controls

in a HACCP plan will be adequate to

ensure that appropriate conditions exist

in a plant. The conditions that would be

addressed in the HACCP plan will likely

be those that are most critically and

directly related to product safety. Other

situations that are relevant to safety, but

in a less direct way, would probably not

be controlled through HACCP. For

example, following the NACMCF

recommendations for hazard analysis

and HACCP plan development would

likely result in the identification of a

number of equipment and hand washing

controls at CCP’s in the HACCP plan for

the processing of a cooked, ready-to-eat

product to minimize the risk of

microbiological contamination but not

in the identification of these same

controls in the HACCP plan for a raw

finished product that would normally

be cooked before consumption. In the

latter case, however, attention to

sanitation would still be important in

the processing plant to prevent

contamination of the product, given that

the ultimate consumer cook may be

inadequate, or that the product, once

contaminated, could be a source of

cross-contamination to other foods.

Likewise, the potential for

contamination of either a cooked, readyto-eat product or a raw product as a

result of rodent activity in a processing

plant, or as a result of improper use of

pesticides on or near the product, would

not likely be identified in a HACCP

plan. All of these conditions are

relevant to the safety of the product and

should be addressed by processors. It is

not clear whether HACCP can fully

succeed in plants that are not in control

of general sanitation practices.

The inclusion of sanitation in HACCP—

as desirable as it may be—will not fully

resolve this problem.

b. SSOP.

111. As indicated above, a significant

number of comments that addressed

alternatives to the prescriptive approach

to sanitation in the proposal preferred a

SSOP, either alone or in combination

with critical sanitation controls in

HACCP. Significantly, the NACMCF

was among those that made this

suggestion. NMFS’ comment stated that,

in its experience, the development of

SSOP’s by processors in its voluntary

program has been associated with

marked improvement in sanitation.

Many comments stated that much of the

seafood processing industry already has

SSOP’s, and that those that do not

should develop them.

FDA agrees that the development by

processors of an SSOP would be a

beneficial step. FDA therefore is

recommending in § 123.11(a) that:

Each processor should have and

implement a written sanitation standard

operating procedure (herein referred to as

SSOP) or similar document that is specific to

each location where fish and fishery products

are produced.

An SSOP places the primary burden

for identifying relevant controls on the

food processor. To meet this burden, it

will be necessary for the processor to

think through each operation and

identify where, and how frequently,

appropriate sanitation measures are

necessary. The process of doing so will

foster the type of culture that FDA is

trying to promote, in which processors

assume an operative role in controlling

sanitation in their plants.

FDA is adopting § 123.11 pursuant to

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

to ensure that seafood is not produced

under insanitary conditions whereby it

may be rendered injurious to health. It

grows directly out of proposed § 123.10,

but, as stated above, it reflects the

agency’s efforts to make the sanitation

requirements more flexible.

FDA has not elected to make the

development of an SSOP mandatory

because it recognizes that some

processors may be able to achieve

satisfactory sanitation conditions and

practices without having to commit

their sanitation control procedures to

writing. The agency remains convinced

however, that such satisfactory

conditions are unlikely to be achieved

without periodic monitoring of the

operations. For this reason the agency

has retained at § 123.11(b) the

mandatory sanitation monitoring

requirements proposed at § 123.10(c).

Sanitation monitoring will be further

discussed in the next section of this

preamble.

Where a processor elects to develop

an SSOP it should specify how it will

meet those sanitation conditions and

practices that are to be monitored in

accordance with § 123.11(b). These

conditions and practices will also be

discussed in the next section.

Both § 123.11(d) and § 123.6(f)

provide that sanitation controls that are

monitored in accordance with

§ 123.11(b) need not be included in the

HACCP plan and vice versa. The

purpose of these provisions is to allow

processors to incorporate those

sanitation controls into their HACCP

plans that they believe are appropriately

addressed through HACCP, without

having to duplicate those controls in a

separate sanitation program.

6. Monitoring and Corrective Actions

The regulations no longer contain

specific monitoring frequencies to

ensure that proper sanitation conditions

are being met, as was proposed at

§ 123.10(c). In keeping with the agency’s

decision to reduce the prescriptive

nature of the sanitation requirements,

§ 123.11(b) now requires that each

processor monitor the conditions and

practices during processing with

sufficient frequency to ensure, at a

minimum, conformance with certain

key sanitation conditions and practices

as specified in part 110.

112. The agency arrived at this

approach in response to the comments.

As part of the agency’s efforts to achieve

flexibility, it examined the 18 sanitation

controls that it proposed at § 123.10(a)

in light of the comments that argued

that they were overly prescriptive. FDA

proposed the 18 sanitation controls to

ensure that, where relevant to the

processing operation, important areas of

concern were addressed in each plant.

The preamble addressed at some length

why each of them was significant and

relevant to safety. Moreover, although

considerable comment was received that

challenged the manner in which a

particular processor should address

these sanitation conditions and the

situations in which they should be

considered applicable, only two

comments challenged the significance of

these conditions or the need for them to

be controlled when they are determined

to be germane, and neither comment

provided a basis for doubting the

significance of these controls.

FDA concludes that, where relevant to

a processor’s operation, the processor

should monitor sanitation conditions

and practices relating to the general

subject areas reflected by the 18 specific

sanitation controls because they are

important for ensuring the safety of the

product. As in the proposal, each

processor will be responsible for

determining which of the subject areas

are relevant to its plant and process.

However, unlike the proposal, the
65150 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

processor will be free to tailor the

sanitation controls to the circumstances

of its operation, as long as it does so in

a manner that ensures the effectiveness

of those controls. The regulations do not

specify the manner in which control

must be achieved. FDA will provide

guidance on how to ensure appropriate

sanitation control in the Guide. FDA is

deferring consideration of the comments

that it received on the specific

sanitation control measures that it

described in the proposal until it

prepares the Guide.

In order to ensure that processors

monitor the general subject areas

reflected by the 18 specific sanitation

controls listed in the proposal, FDA has

concluded that it is appropriate to list

in the regulations the sanitation controls

that should be considered. This list will

ensure that the most significant

sanitation controls are considered by the

processor in formulating the measures

that it will institute in its plant.

The controls that FDA is listing in

§ 123.11(b) no longer contain sanitation

standards that are beyond part 110 or

repeat specific standards that are

contained in that part. Instead,

§ 123.11(b) now states that the processor

shall ensure that actions are taken to

ensure that those sanitary conditions

that are contained in part 110 and that

are relevant to the plant are maintained

in eight general areas:

(1) The safety of the water that comes

into contact with food or food contact

surfaces or is used in the manufacture

of ice (§ 123.11(b)(1)). This control

derives from proposed § 123.10 (a)(1)

and (a)(2) relating to water quality and

treatment and to cross connections

between potable and nonpotable water

systems.

Water is used in virtually all seafood

processing facilities for washing

product, equipment, and employees’

hands, for transporting fish in flumes,

and as an ingredient. Contaminated

water can serve as a vehicle for

contamination of the product, both

directly and indirectly (Refs. 63; 64; 65,

p. 49; 66; 67; and 68, pp. 1 and 2). Cross

connections, which include situations

that allow for back siphonage into a

potable system from a nonpotable

system under negative pressure

conditions, can result in the chemical or

microbiological contamination of the

potable water system (Refs. 64; 65, pp.

50 and 51; 68; 71; and 72).

This matter was one of the two, as

indicated above, about which FDA

received a comment that challenged the

need for a sanitation control. A

comment suggested that the safety of the

water supply is within the jurisdiction

of local health authorities, and that a

processor should not have to deal with

that issue.

FDA acknowledges that many State

and local jurisdictions exercise control

over both public and private water

supplies. In the case of private wells,

they often permit and inspect the

construction of the well and collect

periodic water samples for

microbiological and chemical attributes.

Where such is the case, it may be

reasonable for the processor to rely

upon these measures. However, in the

absence of appropriate controls by a

public authority, FDA has concluded

that the processor must exercise

whatever control is necessary to ensure

that the water supply is safe. To do

otherwise would be to subject the

product to an unacceptable safety risk

from the contaminants that may be

introduced by the water.

(2) The condition and cleanliness of

food contact surfaces, including

utensils, gloves, and outer garments

(§ 123.11(b)(2)). This control derives

from proposed § 123.10 (a)(3) through

(a)(5) relating to the design,

workmanship, materials, and

maintenance of food contact surfaces;

the cleaning and sanitizing of these

surfaces, including the frequency of

cleaning and sanitizing; the

impermeability of gloves and outer

garments that contact food; and the

maintenance of gloves and outer

garments.

Utensils, equipment, aprons, gloves,

outer garments, and other food contact

surfaces can be vehicles for microbial

contamination of both the raw and

finished products. Food contact surfaces

that contain breaks, pits, cuts, or

grooves, or that are porous or corroded,

may harbor pathogenic microorganisms

that can migrate to the product and

contaminate it. These kinds of surfaces

are difficult to clean (Refs. 65, pp. 20,

and 36–48; 72, pp. 166–167; 73; and 83).

Where food contact surfaces are

constructed of toxic materials, the

product may be directly contaminated

(Ref. 74). Inadequately cleaned food

contact surfaces can serve as a reservoir

for pathogenic microorganisms,

especially if biofilms are allowed to

form, in which microorganisms can be

entrapped and shielded from the action

of cleaning and sanitizing compounds.

(3) The prevention of crosscontamination from insanitary objects to

food, food packaging material, and other

food contact surfaces, including

utensils, gloves, and outer garments,

and from raw product to cooked product

(§ 123.11(b)(3)). This control derives

from proposed § 123.10 (a)(6), (a)(7),

(a)(13), and (a)(18), relating to employee

practices to prevent contamination, to

physical separation of raw and cooked

product, and to plant design to prevent

contamination.

Employees and food contact surfaces

can serve as vectors in the transmission

of pathogenic microorganisms to the

food. These microorganisms can be

introduced to the product from outside

areas, rest rooms, contaminated raw

materials, waste or waste receptacles,

floors, and other insanitary objects. In

the processing of cooked products, the

raw material may also serve as a

reservoir of pathogenic microorganisms.

Employees or equipment that touch the

raw material can transmit these

microorganisms to the cooked product

(Refs. 7, 63, 64, 73, 74, 84, and 85).

Finally, proper construction of the

processing plant is essential if other

sanitary measures are to be successful.

For example, incompatible operations,

such as handling of raw materials and

handling of cooked product, should be

isolated (Refs. 71, 74, 87, and 88).

(4) The maintenance of hand washing,

hand sanitizing, and toilet facilities

(§ 123.11(b)(4)). This control derives

from proposed § 123.10 (a)(8) and

(a)(16), relating to the location and

maintenance of hand washing and

sanitizing facilities, and toilet facilities.

Employee’s hands can serve as a

vector for the transmission of

pathogenic microorganisms to the food.

Hand washing and sanitizing, when

performed using suitable preparations

are effective means of preventing such

transmission. Toilet facilities eliminate

from the processing environment

pathogenic microorganisms shed in

fecal material (Refs. 63, 64, 73, 74, 84,

and 85).

(5) The 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

(§ 123.11(b)(5)). This control derives

from proposed § 123.10(a)(9), (a)(11),

and (a)(12), relating to the protection of

food from various microbiological,

chemical, and physical contaminants.

The use of toxic compounds (e.g.,

pesticides, cleaning and sanitizing

agents, and lubricants) is frequently

necessary in the processing

environment. Food and food packaging

materials should be protected or

removed from areas where pesticides

are used, and caustic cleaning

compounds should be thoroughly

removed from food contact surfaces

before processing begins (Ref. 74).

Condensate which forms on an

insanitary surface and then falls on the
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65151

product may carry with it pathogenic

microorganisms (Ref. 65, pp. 24–25).

This measure is the second about

which FDA received a comment that

challenged the value of having a

sanitation control. A comment

suggested that preventing the formation

of condensate on ceilings above

processing is, in some situations,

physically impossible. The comment

did not suggest that condensate is

irrelevant to safety.

FDA reasserts that condensate is

relevant but acknowledges that there are

instances in which it may be impractical

for it to be fully eliminated. In these

instances, after taking all reasonable

measures to minimize the development

of condensate, the processor will need

to take steps to protect the product from

the dripping condensate or to ensure

that the surface from which it is

dripping is sanitary. The development

of a written SSOP processor should

tailor its sanitation controls to its

particular situation in order to

accomplish this objective.

(6) The proper labeling, storage, and

use of toxic compounds (§ 123.11(b)(6)).

This control derives from proposed

§ 123.10(a)(10), relating to the overall

handling of toxic compounds to protect

against contamination of food. Improper

use of toxic compounds is a frequent

cause of product adulteration

throughout the food industry. Proper

labeling, storage, and use of the

compounds is necessary to minimize

the risk of occurrence of such incidents

(Ref. 74).

(7) The control of employee health

conditions that could result in the

microbiological contamination of food,

food packaging materials, and food

contact surfaces (§ 123.11(a)(7)). This

control derives from proposed

§ 123.10(a)(15), relating to the exclusion

of persons who appear to have an

illness, wound, or other affliction that

could be a source of microbial

contamination.

Employees can serve as a reservoir of

diseases, such as salmonellosis,

shigellosis, and hepatitis, that can be

transmitted to consumers by foods.

Additionally, open sores, boils, or

infected wounds present the potential

for contamination of the food with such

pathogenic microorganisms as

Staphylococcus aureus (Refs. 22, 74,

and 84).

(8) Exclusion of pests from the food

plant (§ 123.11(b)(8)). This control

derives from the proposed requirements

at § 123.10(a)(17). Pests, such as rodents,

birds, and insects carry a variety of

human disease agents, which they can

introduce to the processing environment

(Refs. 63, 64, 73, and 84).

113. FDA proposed at § 123.10(a)(14)

that, ‘‘Refrigeration units that store raw

materials, in-process, or finished fish or

fishery products that are cooked, readyto-eat, smoked, or made in whole or in

part from scombroid toxin forming

species shall be operated at a

temperature of 40 °F (4.4 °C) or below.’’

The purpose of the proposed

requirement was to ensure that

processors control the microbiological

hazards associated with refrigerated

storage for these particularly susceptible

products. A significant number of

comments argued the control of

temperature in refrigerated storage is a

processing hazard rather than a

sanitation issue, and should be covered

by a firm’s HACCP plan.

FDA agrees with these comments and

has not included a provision on

refrigeration in the sanitation section of

these regulations. A large number of

comments were received relative to the

appropriateness of a 40 °F (4.4 °C) limit.

These comments are no longer relevant

to these regulations but will be

addressed in the redrafting of the Guide.

FDA has also incorporated the

corrective action requirement relative to

sanitation conditions proposed at

§ 123.10(d) in § 123.11(b). Section

123.11(b) the processor shall, correct in

a timely manner those sanitation

conditions and practices that are not

met. The phrase ‘‘in a timely manner’’

did not appear in the language of

proposed § 123.10(d). However, it was

implicit that corrections should be made

as quickly as possible so as not to

subject subsequently processed product

to conditions that could both jeopardize

their safety and render them

adulterated. FDA has added the phrase

for clarity.

Note that the other corrective action

requirements in these regulations, i.e.,

those in § 123.7, do not apply to

sanitation controls that are exclusively

addressed in § 123.11. The controls in

§ 123.7 apply to a processor’s HACCP

system only.

7. Records

114. FDA received approximately 20

comments that addressed the issue of

sanitation records. Many others

discussed recordkeeping in general but

did not specifically mention records of

sanitation controls. These latter

comments have already been addressed

in the ‘‘Records’’ section of this

preamble.

Of those that commented specifically

on sanitation records, approximately

three-fifths, from processors and trade

associations, objected to the proposed

requirement that processors maintain

records that demonstrate compliance

with the appropriate sanitation

standards. In fact, a number of

comments listed this issue as a

significant reason for their objection to

the overall proposed approach to

sanitation control. The comments

suggested that sanitation recordkeeping

is costly and has not been demonstrated

to be effective. None of these comments

provided any data in support of their

statements. Some argued that, while

they accepted the notion of records for

CCP monitoring, they opposed records

of sanitation monitoring.

The remaining comments that

addressed the issue of sanitation

records, from consumer advocacy

groups, an individual, a Federal

government agency, a trade association,

and a seafood broker, supported the

need for such records. These comments

argued that sanitation records are

essential to ensure that processors

adhere to established sanitary standards,

and that they need not be extensive.

FDA does not find the arguments

against the requirement for sanitation

control records to be compelling. The

agency concludes that the burden will

be minimal. Checklist type or simple

notation records will suffice in most

instances. Creating them should be

incidental to monitoring. Monitoring to

ensure that sanitation is under control is

the responsibility of all processors.

Monitoring and recording of

sanitation conditions is as much a key

to the success in improving those

conditions, and, hence, to increasing

consumer confidence in the seafood

processing industry, as is the

development by a processor of an SSOP.

As in the case of HACCP records,

sanitation records require that

processors engage in systematic

monitoring of their own sanitation

practices and conditions. It enables

them to see trends. Moreover,

participation in recordkeeping helps

empower the work force and foster

responsibility. It also allows the

regulator to assess a processor’s

compliance over a period of time, not

just at the time of an inspection.

FDA believes that the records bearing

on the monitoring of relevant sanitation

conditions and practices and FDA’s

access to such records are all essential

if § 123.11 is to be an effective

regulatory strategy. Therefore, FDA has

concluded that the recordkeeping

requirement proposed at § 123.10(b) will

be retained. To reflect other

modifications in this section, § 123.11(c)

has been modified to read, ‘‘Each

processor shall maintain sanitation

control records that, at a minimum,

document the monitoring and

corrections prescribed by paragraph (b)
65152 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

of this section. These records are subject

to the requirements of § 123.9.’’

Additionally, FDA has moved the

requirement that sanitation corrections

be documented from proposed § 123.10

(d) to § 123.11 (b).

Finally, FDA notes that § 123.11 does

not contain any mention of importers.

The lack of a mention of importers in

this section reflects the position that the

agency is taking in these regulations

that, to the extent that importers are also

processors, they would be subject to the

sanitation requirements in this section.

To the extent that they serve as

importers only, the sanitation

provisions are not relevant to their

operations.

L. Imports

1. Background

The majority of seafood consumed in

the United States is imported. FDA’s

surveillance system for imports largely

consists of reviewing the customs

entries for fish and fishery products

being offered for entry into the United

States, engaging in wharf examinations

and sample collections for laboratory

analysis, and placing products with a

history of problems on automatic

detention. As with domestic

inspections, this method is basically a

‘‘snapshot’’ approach that places a

significant burden on the government to

uncover problems. It has failed to result

in full compliance or consumer

confidence in the safety of imported

seafood. Consequently, the agency

tentatively concluded that HACCP

controls should apply to imported fish

and fishery products as well as to

domestic products. Among other things,

FDA proposed that the definition of

‘‘processor’’ explicitly include those

who process seafood in foreign

countries.

In addition, FDA tentatively

concluded that the importer should

share some responsibility with the

foreign processor for safety. More often

than not, it is an U.S. importer, rather

than the foreign processor, who actually

offers imported fish and fishery

products for entry into the United

States. The preamble noted that, while

many importers are conscientious about

the safety of the products that they

import, others have little understanding

of the potential hazards associated with

their products. Thus, the agency

tentatively concluded that the existing

system of import controls had not

promoted a sense of responsibility in

the import industry.

Therefore, in addition to proposing to

require that foreign processors that

export to the United States comply with

part 123, FDA proposed that importers

of fish and fishery products take steps

to ensure that their shipments are

obtained from such processors.

Specifically, FDA proposed that

importers: (1) Have and implement a

HACCP plan that describes how the

product will be processed while under

their control; (2) maintain a copy of the

foreign processor’s HACCP plan; and (3)

take affirmative steps to ensure that the

imported fish or fishery product was

produced in conformance with the

foreign processor’s HACCP plan and

with the proposed sanitation

requirements. The agency also proposed

that importers need not take affirmative

steps if the fish or fishery product was

imported from a country with which

FDA has a MOU documenting the

equivalency of the foreign inspection

system with the U.S. system.

2. Should Imports Be Subject to These

Regulations?

115. Approximately 70 comments

addressed various aspects of the

proposed requirements for imports.

Approximately half of the comments

that addressed the import provisions

argued that it is necessary to subject

imported products to the same

regulatory requirements as domestically

processed products. These comments

were submitted by processors, trade

associations, State and foreign

government agencies, professional

associations, and individuals. Many of

these comments argued that exempting

foreign processors from the

requirements of these regulations would

put the domestic industry at an unfair

economic disadvantage. Other

comments stated that the import

requirements would increase consumer

confidence in seafood because they

would ensure that imported fishery

products have been produced under the

same HACCP requirements and held to

the same sanitation standards as

domestically produced product. A few

comments suggested that imported

products are more likely to present

safety hazards than domesticallyproduced products because of a lack of

understanding of CGMP’s on the part of

foreign processors. One comment

asserted that a number of countries,

including Canada, the EU, Iceland, and

Thailand are in varying stages of

establishing HACCP programs for their

own domestic seafood processors.

Most of the remaining comments

(approximately one-half) did not

comment on whether HACCP controls

should be required for imported fish

and fishery products but discussed

aspects of the agency’s proposed

approach. These comments will be

addressed later in this section.

FDA did not receive any comments

that persuaded it that imports should be

exempt from the requirements of these

regulations. On the contrary, the

comments reflect a nearly universal

recognition that the safety of seafood

cannot be adequately ensured if the

majority of products (that is, imports)

are not subject to the same controls as

domestic products.

Therefore, the agency has not

modified the regulations’ basic

approach for imports.

116. Only two comments objected to

the concept that imported fish or fishery

products should meet the same

requirements as those for domestic

products. One of these comments

argued that FDA should be tolerant of a

foreign processor that may not have the

knowledge or time to develop a HACCP

plan before its product is ready for

export and urged the agency to develop

a temporary waiver system to

accommodate such firms.

FDA is convinced that a 2-year

implementation period, as discussed in

the ‘‘Effective Date and Compliance’’

section of this preamble, will provide

sufficient time for processors, both

within and outside the United States, to

develop and implement HACCP plans

and otherwise come into compliance

with the provisions of these regulations.

The comment provided no basis for

treating foreign processors any

differently than domestic processors in

this regard.

117. Another comment suggested that

raw material fish and fishery products

imported for further processing in the

United States should be exempt from

the requirements of the regulations but

provided no reason to support that

position.

The exemption requested by the

comment would make it difficult, if not

impossible, to control environmental

hazards that may be associated with

these products. This preamble and the

preamble to the proposed regulations

fully discuss the conclusions of the

NAS, which identified raw material

hazards, such as microbiological

contamination in molluscan shellfish

and natural toxins in both shellfish and

finfish, as among the most pressing

problems that must be addressed to

ensure seafood safety. For the most part,

these hazards are best addressed at the

time of harvest and by primary

processors, through HACCP, at the time

of receipt. In many cases, there is little

opportunity for control beyond the latter

point. Raw material fish and fishery

products for further processing

comprise a substantial portion of fish
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65153

and fishery products imported into the

United States (Ref. 212, p. 49). Thus, to

exempt foreign processing of such

products from the requirements of these

regulations would be to greatly diminish

the scope and, therefore, the overall

effectiveness of these regulations.

118. One comment that supported the

need for equitable treatment of imported

and domestically produced products

urged the agency to provide the same

opportunities for processors abroad to

familiarize themselves with the

requirements of these regulations as it

does the domestic industry. The

comment argued that just printing the

regulations in the Federal Register

would not fulfill that responsibility. The

comment further suggested that FDA

send copies of guidance materials to all

known foreign seafood processors,

preferably in their native language.

FDA acknowledges the difficulty in

reaching foreign processors with

information about the requirements of

these regulations. However, mass

mailings to, and multiple translations

of, these regulations and the Guide for

all foreign seafood processors that

export to the United States would not be

practicable for FDA.

The agency intends to reach foreign

processors primarily by briefing foreign

embassy staffs and by communicating

with U.S. importers during public and

trade association meetings. Based on

experience in disseminating information

about U.S. requirements to the import

community, the agency expects that

these two groups will provide the

necessary information and guidance

materials (in the appropriate languages)

to the foreign processors that they

represent. This same approach was used

in disseminating information about the

proposed regulations. In fact, FDA

became aware of a Japanese translation

of the proposal shortly after it issued.

In addition, FDA traditionally has

provided training and technical

assistance for foreign processors and

government officials on a variety of food

control topics, within the constraints of

budget and manpower. These projects

have principally been conducted in

developing countries, often those in

which the agency has become aware of

a particular problem that threatens the

safety of products offered for entry into

the United States. FDA anticipates that

these kinds of projects will continue,

and that they will focus more closely on

HACCP. FDA also expects that HACCP

training, performed in accordance with

the standardized training materials

under development by the Alliance (see

the ‘‘Training’’ section of this preamble),

will provide further opportunity for

foreign processors to be exposed to the

requirements of these regulations.

3. Should Importers Be Subject to These

Regulations?

119. Approximately half of those who

commented on the import provisions

addressed whether the importer should

be required to take steps to ensure that

its shipment originates from a foreign

processor that operates under HACCP.

Approximately half of these comments

favored the concept and half opposed it,

with both groups being diverse in their

representation.

Of those who opposed it, many

argued that these requirements should

be the responsibility of the government,

and that FDA should not require that

importers enforce them. A number of

these comments further argued that

equivalent foreign government

inspection systems cannot be presumed

to be in place, and that the only way to

achieve a ‘‘level playing field’’ is for

FDA to perform inspections of foreign

processors at the same frequency, and

using the same standards, that the

agency applies to domestic processors.

One comment suggested that it may be

necessary to obtain legislative authority

to perform foreign inspections, as a

condition of importation. Another

comment suggested that FDA auditing

of foreign processor compliance would

give importers assurance that the

products that they obtain from such

sources had been produced in

accordance with appropriate U.S.

standards.

One comment, while not opposed to

mandatory importer responsibilities,

nonetheless argued that FDA should

spend as much time and effort

inspecting foreign processors as it does

on domestic processors because over 50

percent of the seafood consumed in the

United States is imported. The comment

continued that, ‘‘to do any less would be

an unfair burden to domestic processors

and would not accomplish the stated

goal to significantly improve the safety

of seafood consumed in the U.S.’’

One comment argued that there is no

real cost savings in assigning importers

the responsibility of verifying foreign

processor compliance rather than

assigning that responsibility to FDA,

because importers will merely pass

along the additional costs to the

consumer. Another comment noted that

many small importers obtain products

from over 25 countries, and that they

cannot afford to provide the

surveillance necessary to ensure

compliance.

Another comment argued that many

importers function simply as brokers,

connecting a buyer with a seller, and

that they lack the expertise, manpower,

and facilities to evaluate the adequacy

of a processor’s HACCP controls. One

comment stated, ‘‘Many of the people

involved in importing never see the

product and know nothing about fish—

these are people in a small room with

a battery of phones!’’ Another comment

argued against placing reliance for

assuring the safety of imported seafood

on persons who have a financial interest

in the product but lack the required

knowledge about seafood safety.

One comment argued that requiring

importers to exercise control over their

suppliers has no parallel in the

proposed domestic HACCP scheme. The

comment stated that domestic

processors must control the hazards that

are introduced during their processing

operations but need not be involved in

verifying the control of those hazards

associated with their supplier’s

operations. Some comments argued that

the responsibility for controlling

hazards that are reasonably likely to

occur should be assigned to the foreign

processor, while others argued that it

should be assigned to the U.S. processor

to whom the importer sells the product.

One comment asserted that importers

are not in a position to exercise control

over the processing of products in

foreign plants any more than they are in

a position to exercise control over how

the products are handled by their

customers.

Most of those comments that

supported the concept of importer

responsibility provided no reason.

However, one comment stated that

requirements on importers would

ensure that someone in the United

States would be legally responsible for

the safety and wholesomeness of each

imported product.

FDA recognizes that requiring

importers to take steps to ensure that

foreign processors from whom they

purchase seafood products are in

compliance with these regulations could

necessitate significant changes in the

operations of importers who have

limited their activities to matching

buyers with sellers based on product

specifications that may have had little to

do with safety. However, for two

reasons, FDA cannot agree that

responsibility with regard to safety is

inappropriate for importers.

First, it has always been the

importer’s responsibility to offer for

entry into this country products that are

not adulterated under U.S. law. It is a

prohibited act, under section 301(a) of

the act, to introduce into interstate

commerce an adulterated food. Thus, an

importer would be committing a

prohibited act if it failed to ensure that
65154 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

the food that it is offering for import

into the United States is not adulterated

under section 402 of the act, including

section 402(a)(4), one of the principal

provisions on which these regulations

are based.

Currently, however, the importer is

not required to operate in a proactive

manner to ensure that it is meeting this

responsibility. Rather, the importer need

only offer products for entry into

commerce and thereby place the burden

on the government to find a problem.

Many importers traditionally have

purchased ‘‘FDA rejection insurance’’ to

hedge against that possibility. The

government can shift the burden to the

importer by placing the importer’s

products on automatic detention if it

finds problems that warrant such a step,

but in most instances the burden

remains on the government.

Second, responsible importers

understand the issues related to the

safety of the seafood products that they

import and customarily require that

foreign suppliers conform to their

product specifications and applicable

U.S. regulations relating to safety. These

importers take various measures to

ensure that a foreign processor can

comply with their specifications and

safety requirements before they agree to

purchase products from the foreign

processor.

Thus, it is feasible for importers to

take steps to ensure that they are not

offering adulterated products for entry

into U.S. commerce. Requiring such

measures will not be a significant added

burden for many importers, particularly

as HACCP principles become more

widely used and understood in

international commerce. Foreign

processors that want to participate in

the export market, not only to the

United States but to the EU, Canada,

and an increasing number of other

countries, will implement HACCP and

sanitation control programs and will be

prepared to address an importer’s needs

for verification.

FDA does not agree that there is no

parallel in the domestic scheme to the

importer’s responsibility to ensure that

the goods it is offering were produced

under HACCP. Domestic processors,

like importers must work with their

suppliers (e.g., fishermen) to ensure that

all reasonably likely hazards (e.g.

natural toxins and agricultural and

industrial chemical contaminants) are

controlled. FDA is confident that

importers, like processors, will realize

that ensuring that foreign processors

institute preventive control systems is a

cost effective means of ensuring that the

products that they offer for entry into

the United States will consistently meet

FDA’s entry requirements and will be

safe for consumption. FDA also

disagrees with those comments that

suggested that a requirement that

importers take steps to ensure that the

products they offer for entry have been

produced under a HACCP plan is an

abrogation of FDA’s responsibilities. As

stated previously, the industry has a

responsibility to ensure that the food

that it introduces into interstate

commerce is not adulterated. FDA has a

responsibility to verify that industry is

meeting its obligation and to take

remedial action if industry fails to do so.

Importers, who are usually the owners

of the products that they are offering

into commerce, are a part of that

industry. FDA cannot accept that

importers have no responsibility to

ensure that their products are not

adulterated.

The agency recognizes that probably

the most effective way for a regulatory

agency to evaluate a processor’s

compliance with the HACCP and

sanitation requirements is through

onsite inspection of facilities, practices,

and records. FDA has performed a

limited number of inspections of foreign

processors and, within its budgetary

limitations, will continue to do so to

enforce these regulations. However,

such inspections are costly, and any

attempt to significantly increase their

number would require additional

resources.

FDA will continue its traditional

import surveillance role, utilizing entry

document review, wharf examinations,

sample collections, and automatic

detentions as screening tools. These

tools indirectly evaluate the adequacy of

HACCP and sanitation controls and will

continue to be useful in detecting

significant problems. While end-product

testing and evaluation are not adequate

substitutes for preventive controls in

ensuring the safety of a product, they

can provide verification where

appropriate (Ref. 34, pp. 201–202).

FDA has concluded that requiring

HACCP controls, together with import

surveillance and periodic inspections of

importers to ensure their compliance

with the requirements of § 123.12, will

better ensure the safety of imports than

the current system.

In a related matter, § 123.3(g) makes

clear that, under ordinary

circumstances, freight forwarders,

custom house brokers, carriers, or

steamship representatives will not be

required to fulfill the obligations of an

importer. It is possible, although FDA

has no way to know with any certainty,

that some of those that objected to being

required to fulfill those obligations

would, as a result of these clarifications,

find that they would not be expected to

do so.

4. Memoranda of Understanding

(MOU’s)

120. Many of the comments that

objected to the importer responsibility

provisions of the proposal on the

grounds that the government is the

appropriate entity to ensure foreign

processor compliance, stated that the

most effective means of ensuring such

compliance would be for FDA to enter

into MOU’s with the governments of

exporting nations. Approximately onethird of those that commented in any

way on the importer provisions urged

FDA make the negotiation of MOU’s a

high priority. Only one comment

objected to the development of MOU’s.

Several comments argued that FDA

should develop MOU’s with all

countries from which seafood is

imported. One of these comments

pointed out that to do otherwise would

unfairly cause the obligations of

importers to vary considerably. A few

comments argued that the existence of

an MOU should be a prerequisite for the

importation of seafood products from a

country. One of these comments stated

that mandatory MOU’s would reduce

the complexity of the present import

surveillance situation, reduce the

number of countries exporting seafood

to the United States, and encourage the

development of improved food safety

programs in exporting countries.

Another comment asserted that MOU

development is appropriate because

government-to-government

relationships and audits can be free of

influence from packers and importers,

whereas foreign suppliers may be prone

to provide false assurances about their

programs to prospective importers.

One comment urged FDA to fully

describe the process and criteria for

developing and evaluating MOU’s and

expressed concern about the process

because of the varying level of

sophistication of foreign seafood control

programs. One comment stated that the

foreign government should be

responsible for evaluating the foreign

processor’s HACCP plan, inspecting the

foreign processor, periodically

analyzing products produced by the

foreign processor, and issuing health

certificates. A few comments stated that

FDA should monitor the effectiveness of

the foreign government’s control

program in a manner that is authorized

in the MOU. These comments stated

that, under the MOU’s, the foreign

government should provide FDA with

periodic lists of processors that meet the

requirements of these regulations, or,

alternately, that all seafood processors
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65155

in the country would be required to

meet the requirements.

One comment urged FDA to publish

periodic reports on the status of MOU’s

on seafood products and to make them

available to all importers. This comment

and others argued that it should be

FDA’s responsibility to notify importers

about changes in the status of MOU’s,

rather than be the responsibility of the

importer to find out about any changes.

One of these comments noted that,

because a change in the status of an

MOU could be very detrimental to

importers, there must be sufficient lead

time to allow importers to develop

alternate verification procedures when

changes do occur.

Another comment urged FDA to

coordinate with U.S. importers and

exporters in developing a schedule for

MOU development. The same comment

urged FDA to assign more resources to

the development of MOU’s.

On the other hand, one comment

stated that the MOU development

process is overly open-ended and could

result in inconsistencies between

domestic and foreign requirements. The

comment argued that this inconsistency

could result in an economic

disadvantage for domestic processors.

FDA agrees with those comments that

urged that the agency give high priority

to the establishment of MOU’s with U.S.

seafood trading partners. In the absence

of significant numbers of agency

inspections of foreign processing

facilities, FDA acknowledges that an

MOU can be the most efficient and

effective mechanism for ensuring that

foreign processing plants are operating

in compliance with the requirements of

these regulations. FDA also agrees that

the potential for signing an MOU with

FDA is likely to serve as an incentive for

the improvement of regulatory food

control programs and processing

conditions in seafood exporting

countries, especially where the

existence of an MOU serves to excuse

the importer of products from that

country from certain verification

activities.

FDA has concluded that the

development of MOU’s or similar

agreements with foreign regulatory

agencies is an appropriate method for

ensuring that foreign processors that

export to the United States are in

compliance with the requirements of

these regulations. Moreover, as

suggested by several comments, the

agency has determined that, where an

MOU exists, there is no need for the

importer to perform any independent

verification procedures for purposes of

these regulations. In this situation, the

importer should be able to rely upon the

foreign regulatory authority to ensure

compliance by foreign processors.

FDA is therefore retaining the

provision on MOU’s from the proposal

but modifying it to provide that, where

an importer elects to obtain a fish or

fishery product from a country with

which FDA has an active MOU or other

similar agreement, the importer need

not engage in any independent

verification activities.

The agency has developed an internal

protocol for developing MOU’s and is

negotiating agreements with several

countries. FDA is committed to

negotiating as many MOU’s as possible.

Also in the Federal Register of June 15,

1995 (60 FR 31485), FDA published the

notice of availability of a new

Compliance Policy Guide on MOU’s.

However, it is not reasonable to

expect that an agreement could be

reached with all countries from which

seafood is imported into the United

States. The barriers to achieving such a

result include the inadequacy of foreign

regulatory programs and the lack of

interest on the part of some foreign

governments in entering into an

agreement. The availability of FDA

resources also can affect at least how

long it takes FDA to enter into a

particular MOU.

For these reasons, the existence of an

MOU or similar agreement as a

requirement of entry of fish or fishery

products into the United States would

result in an enormous negative

economic impact to a major segment of

the U.S. seafood industry. Moreover,

such a restriction is not warranted from

a public health perspective given the

alternative means of verifying the

existence of HACCP controls that are

provided in these regulations.

Experience obtained in part in the

international portion of the FDA/NMFS

seafood HACCP pilot project has

demonstrated that foreign seafood

regulatory programs vary considerably,

both in their capabilities and in their

structures. Likewise, foreign seafood

processing conditions are highly

variable. Thus, FDA cannot simply

follow a boiler plate format in

negotiating MOU’s. Rather, they must be

tailored to the specifics of the situation

presented by a particular country. It is

possible that some agreements can

provide simply for the submission of

lists of approved processors to FDA at

regular intervals; others may require

much more extensive FDA involvement

before and after goods flow under the

agreement. Some agreements may cover

all of a country’s seafood processors,

while others may be targeted to specific

species or product forms, depending on

factors such as the capability of the

foreign regulatory authority.

In any case, all agreements can be

expected to provide for FDA verification

of the effectiveness of the foreign

programs, including onsite visits. FDA

is principally interested in two- way

agreements, that is, agreements that

acknowledge the acceptability of the

U.S. regulatory system to the foreign

government as well as the acceptability

of the foreign regulatory system to the

U.S. government.

The agency will make every

reasonable effort to communicate with

the industry about changes in the status

of MOU’s through Federal Register

notifications and other means. FDA is

open to suggestions about the best ways

to communicate in this regard.

Nevertheless, it will ultimately be the

importer’s responsibility to keep

appraised of any changes in the status

of MOU’s.

The agency is also receptive to the

views of the seafood industry and others

about how countries should be

prioritized for the purpose of

negotiating MOU’s. Any information

that the agency receives on this topic

will be coupled with existing

information concerning the likelihood

of negotiation success and the types and

quantity of products typically offered

for entry from the country in question.

5. Importer Verification Procedures

121. The remaining comments

discussed specific aspects of the

proposed importer requirements. Some

of these comments argued that the

responsibilities that were proposed for

importers are onerous, unworkable, and

inefficient but offered nothing in

support of these assertions.

A number of comments objected to

the proposed requirement that all

importers have and implement a

HACCP plan. Several of these comments

contended that an importer’s plan can

only address the hazards that occur

during the time that products are under

the importer’s control (i.e., from the

time the importer takes possession of

the product until it is shipped to its

customer), and that requiring that the

plan cover this point is inconsistent

with the principles of HACCP. One

comment agreed that an importer

should be required to develop a plan if

it also processes the product, as in the

case of an importer who stores the

product. The comment asserted that, in

such a case, however, the importer’s

HACCP plan would be minimal. The

comment further asserted that the

foreign processor should be the party

responsible for developing a HACCP

plan that addresses the hazards
65156 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

introduced during processing in the

foreign plant. The comment

recommended that, as an alternative to

having a HACCP plan, an importer

should be able to develop SOP’s that

outline the steps that it will take to

determine whether to purchase the

product from a foreign supplier.

A number of comments supported the

proposed requirement for importer

HACCP plans but provided no reasons

for their support.

The agency agrees that it would be

inappropriate to require that importers

have and implement a HACCP plan

regardless of whether they process the

products they import. As stated

elsewhere in this preamble, HACCP is a

system that provides immediate

feedback, through the monitoring of

CCP’s, as to whether a process is under

control. Unless an importer is also a

processor, there are no CCP’s in the

classic sense for the importer to

monitor, and from which to obtain realtime feedback. Consequently, only

where importers also process in

accordance with the definition of that

term at § 123.3(k) will they be required

to have and implement a HACCP plan

that meets the requirements of § 123.6.

Those food safety hazards that can be

controlled by the foreign processor must

be addressed in the foreign processor’s

HACCP plan in accordance with § 123.6.

Consequently, FDA has revised the

regulations to limit the responsibilities

of importers. Instead of having to

maintain their own HACCP plan, under

§ 123.12(a), in the absence of an MOU

or similar agreement, importers only

need to maintain and implement written

verification procedures for ensuring that

the fish and fishery products that they

offer for import into the United States

have been processed in accordance with

the requirements of these regulations.

The only exception to this rule would

be if the importer itself engages in

processing, such as holding food, in

which case the importer would, as

stated above, also be a processor and

subject to § 123.6.

122. In determining the nature of the

verification procedures that an importer

must have and implement, FDA

considered the comments that

addressed the appropriate functions and

existing procedures of importers.

Several comments noted that importers

routinely purchase products according

to specifications and observed that these

specifications could be the basis for

reasonable control measures for

importers. The NACMCF recommended

that importers be required to maintain

product specifications that are relevant

to product safety for fish and fishery

products that they import. The

NACMCF listed water activity, pH,

histamine content, and, perhaps,

pathogen limits as examples of

specifications that importers might set

in an effort to ensure product safety.

The agency agrees with the comments

that product specifications can be useful

tools with which importers can exercise

some control over the products that they

purchase and offer for entry into the

United States. In fact, FDA stated in the

preamble to the proposed regulations

that the purpose of an importer’s plan

was, in part, to include criteria for how

the importer will decide to purchase

seafood. FDA is also encouraged by the

fact that the comments generally agreed

that having product specifications

would not constitute a new burden for

many importers.

For these reasons, the agency in

§ 123.12(a)(2)(i), is requiring that the

importer’s written verification

procedures include product

specifications that are designed to

ensure that the product is not

adulterated under section 402 of the

Federal Food, Drug, and Cosmetic Act

because it may be injurious to health or

have been processed under insanitary

conditions. These are the adulteration

sections that relate to the safety of fish.

In many cases, importers will find

existing Federal food safety standards,

including tolerances and guidelines, to

be useful specifications. In other cases,

specifications may need to be tailored to

the circumstances. For example, the

importer might need to ensure that the

temperature of a modified atmosphere

packaged product, when it comes off a

ship, is 38 °F (in such foods there is a

risk of C. botulinum type E growth and

toxin development which can occur at

temperatures as low as 38 °F), although

the CGMP’s at § 110.80(b)(3)(i) state

only that refrigerated foods should be

stored at 45 °F or below. The importer

is encouraged to seek the advice of

qualified experts, as needed, in setting

specifications. The same resources

available to help domestic processors in

setting CL’s are available to importers,

including the Guide; Sea Grant

Institution and other academics;

Federal, State, and local food safety

regulatory agencies; consultants; the

Alliance and other training courses; and

published literature.

6. Affirmative Steps: General

As a second part of the importer’s

verification procedure, FDA is

essentially retaining from the proposal,

in § 123.12(a)(2)(ii), the requirement that

the importer take affirmative steps to

ensure that the products being offered

for entry are actually being produced

under controls that meet the

requirements of these regulations. In

order for product specifications to be

meaningful, importers must take steps

to establish that their suppliers are in

fact operating in a manner that can

reasonably be expected to produce a

product that meets those specifications.

Effective verification involves

scrutinizing the standard, much like

evaluating whether the HACCP plan

continues to be appropriate, and

scrutinizing performance to determine

whether the standard is consistently

reached, much like reviewing

monitoring records (Ref. 34, p. 201).

FDA is adopting this approach in

§ 123.12(a)(2)(ii).

Among the affirmative steps that FDA

proposed that a processor take were: (1)

Obtaining the foreign processor’s

HACCP-monitoring records; (2)

obtaining a certificate from a foreign

government inspection authority

certifying that the firm is operating

under a valid HACCP plan or

certification on a lot-by-lot basis; (3)

regularly inspecting a supplier’s

facilities; (4) periodic end-product

testing by the importer or a private

laboratory hired by the importer; or (5)

other such verification measures as

appropriate. FDA listed these

affirmative steps as examples of the

types of measures that would be

acceptable to the agency. FDA does not

wish to predetermine all the possible

ways that an importer could perform

affirmative steps.

123. A number of comments objected

to each of the affirmative steps that FDA

listed in the proposed regulations, and

a few expressed support for each.

However, few of the comments provided

any reasons for their positions.

One comment suggested that the best

means by which an importer can ensure

that the conditions at a foreign

processing facility are at least equivalent

to those required of domestic processors

is for the importer to verify the

adequacy and implementation of the

foreign processor’s HACCP plan during

a visit to the facility. Another comment

stated that, ‘‘without both audits and

HACCP records, foreign plants (possibly

domestic facilities too) will not adhere

to the letter of the FDA regulation and

assure safe product in the market.’’

Conversely, a number of comments

argued that it would be unworkable for

importers to conduct inspections of

foreign processors. One of these

comments stated that to justify the

expense of such an undertaking would

necessitate that a highly trained,

competent individual perform the

function.

As stated earlier, FDA remains

convinced that importers must exercise
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65157

sufficient control over the fish and

fishery products that they offer for entry

into their country to ensure that the

products are produced pursuant to the

requirements of these regulations. The

agency recognizes that any one of the

affirmative steps may not be appropriate

or feasible for a particular importer or

foreign processor. The regulations allow

importers to select an affirmative step

that is workable for their circumstances

and to develop appropriate affirmative

steps other than those listed in the

regulations (see § 123.12(a)(2)(ii)(F)).

However, such measures must provide

at least an equivalent level of assurance

of foreign processor compliance as that

provided by the listed affirmative steps.

Additionally, FDA has modified the

importer requirements to allow for the

performance of any of the affirmative

steps by a competent third party

(§ 123.12(b)). This provision provides

even greater flexibility to importers in

meeting the requirements of these

regulations.

Thus, FDA is not persuaded that the

affirmative steps are not feasible or

appropriate and has included them in

these final regulations.

124. A comment argued that

government certificates should not be

acceptable unless they are issued by

countries with which FDA has signed

an MOU or similar agreement. The

comment asserted that, especially in

developing countries, there may be

different interpretations of the

regulations, and differences in

competency, credibility, infrastructure,

intent, and uniformity that might bring

the utility of such certificates into

question.

FDA acknowledges that it is likely to

have a higher level of confidence in

certificates received from a government

entity with which it has signed an

agreement than with one with which no

agreement exists. However, as discussed

above, it is unlikely that the agency will

be able to negotiate an MOU with every

country that exports seafood to the

United States. Thus, there may be

countries that have excellent

certification programs with which FDA,

for a variety of reasons, simply does not

have an opportunity to enter into an

agreement. Moreover, if the agency

learns, either through its own routine

surveillance activities, consumer

complaints, or other means, that there is

evidence that a country is routinely

issuing certificates inappropriately, the

agency will try to inform firms that

import fish or fishery products from that

country that it will expect them to use

other means of verification if they want

to avoid the appearance that those

products are adulterated under section

402(a)(4) of the act (see § 123.12(d)).

125. One comment urged that

certification be permitted on a

continuing basis rather than requiring

lot-by-lot certification.

FDA agrees that continuing

certification is appropriate and notes

that the language and intent of the

proposed regulations would have

allowed for it. Nonetheless, in an effort

to further clarify this situation, the

agency provided in § 123.12(a)(2)(ii)(B)

that: ‘‘Obtaining either a continuing or

lot-by-lot certificate * * *’’ will be one

way to satisfy the requirement that an

importer take affirmative steps to ensure

that the product is produced in

accordance with the requirements of

this part.

7. Foreign Processor HACCP Plans

126. Approximately 15 comments

addressed whether importers should be

required to have on file copies of the

HACCP plans of each of their foreign

processors. Approximately half of these

comments supported such a

requirement, although for the most part

they provided no reasons for their

support. The other half objected to the

requirement. One of these comments

argued that possession of a foreign

processor’s HACCP plan would be

cumbersome for the importer and would

provide no assurance that product

shipped by that processor was

processed in accordance with the plan.

One comment cautioned that it would

be unrealistic to expect that importers

could make any but a rudimentary

judgment as to the adequacy of foreign

processors’ HACCP plans. Such

judgments, these comments asserted,

should be reserved for the regulator

when the plans are assessed during

inspections of importers’ records.

One comment cited the possibility of

breaches in confidentiality because

commercially sensitive material would

be supplied to importers. A related

comment suggested that, to solve the

confidentiality problem, the foreign

processors’ HACCP plans should be

filed directly with FDA rather than with

importers.

Although the agency continues to

believe that a foreign processor’s

HACCP plan provides a useful basis for

verification, FDA is persuaded by the

comments that there are logistical and

other issues that could render the

retention of HACCP plans by importers

unmanageable in some cases. FDA has

also concluded that, in most cases,

affirmative steps such as those listed in

§ 123.12(a)(2)(ii) (e.g., onsite inspection

by the importer and certification by a

foreign government agency) will be

adequate to enable an importer to verify

that the products being imported are

safe in accordance with the

requirements of these regulations.

As described previously, the

NACMCF recommendations describe

two primary goals of verification: (1)

Ensure that the plan is adequate to

address the hazards that are likely to

affect the product; and (2) ensure that

the plan is being consistently

implemented. The affirmative steps

listed in § 123.12(a)(2)(ii) are designed

to address both of these functions. For

example, obtaining HACCP and

sanitation monitoring records from the

foreign processor (§ 123.12(a)(2)(ii)(A))

enables the importer to confirm that the

foreign processor has addressed the

relevant hazards and sanitation

concerns (i.e., those for which there are

monitoring records), and that it is

monitoring to ensure that these

concerns are under control during the

production of lots that are shipped to

the importer. Similarly, obtaining

governmental or third party certification

of foreign processor compliance with

the requirements of these regulations

(§ 123.12(a)(2)(ii)(B)) or inspecting the

foreign processor directly

(§ 123.12(a)(2)(ii)(C)) enables the

importer to confirm that the foreign

processor has an adequate HACCP plan

and SSOP, and that the relevant

sanitation and safety concerns are being

controlled for those lots that are shipped

to the importer. The affirmative step

options provided for by

§ 123.12(a)(2)(ii)(D) and (a)(2)(ii)(E) are

discussed later in this section.

Consequently, FDA has not included

a requirement that importers of fish and

fishery products have on file the HACCP

plans of each of their foreign suppliers

in these final regulations.

Nonetheless, FDA points out that

maintaining copies of these plans could

be one of several measures that an

importer could incorporate into its

affirmative steps. Therefore, these final

regulations in § 123.12(a)(2)(ii)(D)

incorporate the concept as one of the

affirmative steps that an importer may

choose to use for verification purposes.

127. One comment noted that the

plans of foreign processors would

normally be prepared in the native

language of the country of origin and

asked whether FDA would require that

these documents be translated into

English. On the other hand, another

comment recommended that HACCP

plans be maintained in both the

language of the native country and in

English.

FDA agrees with the comment that

argued that a copy of a processor’s

HACCP plan would not, by itself,
65158 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

provide adequate assurance that a given

shipment of imported product was

processed in compliance with that

HACCP plan or that the sanitation

requirements of § 123.11 were met. One

additional thing is needed to provide

such assurance: a written guarantee

from the foreign processor that the

products shipped to the importer are

processed in accordance with these

regulations. The guarantee is necessary

to demonstrate that the HACCP and

sanitation control systems are being

implemented for products shipped to

the importer. An importer should be

able to make a reasonable judgement

about the validity of the guarantee

through a rudimentary review of the

plan, as described below. Therefore,

FDA is including these requirements in

§ 123.12(a)(2)(ii)(D).

FDA is also providing in

§ 123.12(a)(2)(ii)(D) that the foreign

processors’ HACCP plans that are

maintained by importers be written in

English, so that they will be meaningful

to the importer and will allow for

regulatory review.

128. As stated above, one comment

cautioned the agency about the ability of

many importers to evaluate the

adequacy of HACCP plans that they

might retain.

FDA acknowledges that many

importers may not have the technical

expertise to evaluate the adequacy of

seafood HACCP plans. However, the

agency is convinced that, as a result of

the importers’ assessment of the food

safety hazards that are reasonably likely

to be presented by the product, the

importer should have developed some

general expectations about the content

of the HACCP plan (e.g., which hazards

should be addressed). The importer

should be able to spot any obvious

shortcomings and to discuss them with

the foreign processor. It is not enough

that importers simply file away the

documents upon receipt. Importers may

find it advantageous to make a judgment

about the likelihood that their product

specifications will be met and to insist

that they be given a guarantee that

contains assurances that the

specifications will be met.

129. Regarding the comment that

complained about the potential loss of

confidentiality of foreign processor

HACCP plans that are provided to

importers, since the agency has

eliminated the requirement that all

importers retain copies of foreign

processor plans, the significance of this

issue has been minimized. In the case

where a foreign processor does not wish

to share its plan with the importer, the

processor and the importer would need

to agree upon another means of

providing for importer verification.

130. Regarding the comment that

suggested that all foreign processors file

their plans with FDA, the resource

demands on the agency that would

come with such an undertaking would

be prohibitive. FDA cannot accept this

suggestion.

8. Other Affirmative Steps

As a related matter, FDA has

determined that, in the absence of a

requirement that importers maintain a

copy of the foreign processor’s HACCP

plan, finished product tests alone are

insufficient as an importer affirmative

step to ensure that the foreign processor

is operating in accordance with these

regulations. Finished product testing

alone has a small statistical likelihood

of detecting defects in a product,

especially when the occurrence of such

a defect is an uncommon event, as is the

case with most seafood hazards (Ref.

213). The proposed requirement for the

importer to obtain a copy of the foreign

processor’s HACCP plan, in addition to

performing finished product testing,

would have provided indirect evidence

that HACCP controls are in place and

would have lent support to a

conclusion, based upon the analytical

findings, that the relevant hazards are

under control. In the absence of such

evidence, the importer cannot

reasonably conclude that the hazards

are being controlled based solely on a

negative analytical finding. For this

reason FDA has required in

§ 123.12(a)(2)(ii)(E) that such sampling

be accompanied by a written guarantee

from the foreign processor that products

being shipped to the importer are

processed in a manner consistent with

the requirements of these regulations.

The guarantee provides the importer

with reasonable assurance that HACCP

and sanitation controls are in place and

are being implemented, in a manner

similar to the way that the foreign

processor’s HACCP plan would have

under the requirements of the proposed

regulations. Under this alternative, the

importer would not have to maintain a

copy of the HACCP plan.

For clarification and consistency

within the document, FDA has revised

the language of two of the affirmative

steps to include reference to the

sanitation provisions of the regulations.

In both the proposed regulations and

these final regulations the stated

purpose of the affirmative steps is to

enable the importer to verify that the

fish or fishery product was processed

under conditions that meet both the

HACCP and sanitation requirements of

these regulations. However, the

formulations of two of the affirmative

steps in the proposal did not make

specific reference to sanitation. To avoid

confusion over what the affirmative

steps should cover, § 123.12(a)(2)(ii)(A)

now reads ‘‘Obtaining from the foreign

processor the HACCP and sanitation

monitoring records * * *’’ and

§ 123.12(a)(2)(ii)(B) reads ‘‘* * *

certifying that the imported fish or

fishery product is or was processed in

accordance with the requirements of

this part.’’

131. Several comments asked the

agency to specify the frequency with

which the importer affirmative steps

must be taken. A few comments

suggested that the frequency should be

no greater than the frequency of

equivalent FDA verification activities.

It would not be practical for the

agency to specify frequencies for

affirmative steps that would be

appropriate in all circumstances.

Consistent with the frequency of

monitoring by processors, importers

should take affirmative steps to monitor

their suppliers with sufficient frequency

to accomplish its purpose—that is, to

provide the importer with reasonable

assurance that the foreign processor is

operating in compliance with these

regulations.

It would be inappropriate to tie

importer affirmative step frequencies to

average FDA sampling and inspection

frequencies. FDA sample collection and

inspection frequencies are determined,

in part, by the compliance history of

individual firms, agency priorities, and

overall agency resources, not simply on

a desired average minimum rate of

verification. Thus, FDA’s rate of

inspection has no bearing on how

frequently an importer should monitor a

supplier.

132. A number of comments urged

that the agency permit importers to

contract with third parties to perform

verification activities on their behalf.

Two comments opposed such a

provision but did not provide reasons

for their position.

Several comments urged that

certificates by nongovernmental third

parties be accepted as an affirmative

step. One of these comments, from a

trade association, suggested that an

equivalent arrangement has been

accepted by FDA in controlling the

importation of canned mushrooms from

the Peoples Republic of China. This

same comment argued that a system

where individual importers inspect each

of their suppliers is highly inefficient.

The comment suggested that a single,

technically competent party should

perform the inspections. The trade

association offered to serve as a
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65159

clearinghouse for the reports of such

inspections. Likewise, the association

offered to serve as a clearinghouse for

finished product sample results for

imported products, reducing the

number of samples needed when the

same product is imported by a number

of importers. The comment further

suggested that the association be

permitted to hold foreign processor

HACCP plans for its members, and

perhaps for nonmembers. The comment

argued that acceptance of this

suggestion would reduce the number of

duplicate records for the same product

stored by various importers.

The agency accepts that third party

verification can be an appropriate and

efficient control mechanism. Such a

system is consistent with the use of

third parties by processors for plan

development, record review, and CL

deviation evaluation. Therefore, FDA

has added a new provision at

§ 123.12(b), that reads, ‘‘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.’’ It is worth pointing

out that where an importer uses the

services of a third party, the importer

remains responsible for the verification

procedures that are performed. The

importers must be able to demonstrate

that appropriate verification measures

have been performed. This step may

involve providing an FDA investigator

with a copy of the foreign processor’s

HACCP plan, results of end-product

sampling, results of an onsite

inspection, the foreign processor’s

monitoring records, or the foreign

processor’s written guarantee. Third

parties must, of course, be competent to

perform the duties in question, and FDA

reserves the right to challenge such

competency. The agency has no

objection to the use of clearinghouses

for importer verification activities, as

long as the forgoing requirements are

met.

9. Importer Records

As previously mentioned, the

proposed regulations would have

required that importers develop and

implement a HACCP plan. One effect of

such a requirement would have been

that importers would have had to

maintain appropriate records. As has

been explained, FDA is adopting only

those essential components of the

proposed approach that the agency

considers to be practicable for

importers. One such component is

recordkeeping. Recordkeeping is

essential in documenting for the benefit

of importers and the agency the

affirmative steps of importers, in the

same way that it is essential in

documenting the monitoring, corrective

action, and verification activities of

processors. For this reason, the agency

has retained the recordkeeping aspect of

the proposal for importers, in a manner

that is consistent with the overall

approach for importers in these final

regulations. Section 123.12(c), which

treats importer records identically to

processor records, reads, ‘‘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 § 123.9.’’

133. FDA proposed that importers

encourage foreign processors to obtain

HACCP training. A few comments urged

the agency to make it clear that foreign

processors must comply with the same

training requirements as are applicable

to domestic processors. One comment

urged the agency to permit HACCPtraining courses for foreign processors to

be conducted in the country of origin by

‘‘an official agency.’’

FDA agrees that the need for training

is the same for foreign processors as it

is for domestic processors. The intended

benefits of the training requirements are

fully discussed in the ‘‘Training’’

section of this preamble. Nonetheless,

the agency finds that the proposed

requirement that importers encourage

foreign processors to obtain training is

unnecessary. Foreign processors that

ship seafood products to the United

States are advised of the training

requirement of these regulations in the

same way that they are advised of the

other requirements of these regulations,

through publication of the regulations.

In addition, as mentioned elsewhere in

this preamble, FDA intends to provide

the embassies of seafood exporting

countries with information concerning

these regulations in order that they may

in turn provide it to the processors in

their countries. Consequently, FDA is

not adopting this provision.

FDA has no objection to HACCP

training being performed in the country

of origin by ‘‘an official agency’’ or other

entity, as long as the course of

instruction is at least equivalent to that

provided by the standardized course

under development by the Alliance.

10. Determination of Compliance

FDA proposed to require that there be

evidence that imported fish and fishery

products were processed under

conditions that comply with the

requirements of these regulations, and

that if assurances that this was the case

did not exist, the product would appear

to be adulterated and would be denied

entry. This section of the proposed

regulations provided five types of

evidence that the agency would

consider as adequate to provide such

assurance.

134. A few comments supported these

provisions. However, a few comments

suggested that, if the importer is unable

to provide assurance that a HACCP

system is in place, the importer should

be permitted to conduct finished

product testing rather than having the

product denied entry. One comment

urged that importers be held only to a

‘‘best efforts’’ standard in determining

whether their suppliers are in

compliance with these regulations. This

comment suggested that if an importer

cannot determine that such compliance

exists after using its best efforts, the

importer’s product should not be

banned from the United States.

The purpose of these regulations is to

cause processors of fish and fishery

products, both domestic and foreign, to

develop and implement HACCP systems

of preventive controls to ensure the

safety of their products. The importer

requirements are designed to impose an

obligation on importers to ensure that,

like domestic products, the products

that they are importing are not

adulterated within the meaning of

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

requirement means that importers must

be able to satisfy themselves, and

ultimately FDA, that the fish and fishery

products that they are offering for

import were produced subject to a

HACCP system and sanitation controls

designed to prevent insanitary

processing conditions that may render

the food injurious to health. If an

importer does not have evidence that

shows that the products were produced

subject to such controls, it should not

offer the product for import into this

country. The lack of such evidence

creates the appearance of adulteration

that cannot be overcome by the

collection and analysis of a finished

product sample by an importer. Given

the problems that can arise in seafood

processing if HACCP and sanitation

controls are not in place, under sections

402(a)(4), 701(a), and 801(a) of the act,

FDA is adopting § 123.12(d), which

provides that if evidence does not exist

that an imported fish or fishery product

has been processed under conditions

that are equivalent to those required of

domestic processors, the product will

appear to be adulterated.

Section 123.12(d) derives from

proposed § 123.12 (a) and (b). FDA has

combined these provisions and, as
65160 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

suggested by a comment, has used

terminology consistent with the rest of

the regulation in § 123.12(d). While

proposed § 123.12 (a)(1) through (a)(5),

which described the types of evidence

that could be used to demonstrate

compliance with the proposed

regulations, reflected important

principles for the importation of fish,

based on the comments, FDA finds that

these provisions were causing

confusion, and that the statute can

appropriately be implemented without

including them in the final rule. For this

reason, FDA has not adopted these

provisions.

135. One comment asked what

documents, if any, would have to be

presented to FDA at the time of entry

concerning the status of the foreign

processor. Another comment suggested

that importers should note on the entry

documents that a HACCP plan is

available for the foreign processor. This

comment stated that FDA would have

an opportunity to review the plan as

part of its determination of whether to

allow entry of the product.

FDA is not requiring that evidence of

the importers’ affirmative steps be

presented along with the existing U.S.

Customs Service entry documents as a

matter of routine practice. It is possible

that, in some circumstances, such a step

will be necessary (e.g., where the agency

has reason to believe that inappropriate

conditions exist in the foreign

processing facility). However, typically,

the importer will be able to retain such

evidence in its files and to make it

available to the agency when FDA

performs an inspection at the importer’s

place of business. Such a system is

necessary because of the time that is

necessary for the agency to properly

review the importer’s documentation of

its affirmative steps and of the foreign

processors’ HACCP plans. Nonetheless,

the agency is willing to explore alternate

methods of implementing the import

requirements of these regulations, such

as that suggested by the comment. FDA

welcomes a continuing public dialog

about this matter.

136. One comment asked whether

FDA would maintain an approved list of

foreign processors.

The agency has no plans to maintain

such a list, nor is it apparent upon what

basis such a list would be prepared. A

possible exception would be as part of

an MOU arrangement, where the foreign

country would agree to provide a list of

‘‘approved’’ firms to FDA. In such a

situation, FDA would use reasonable

means to inform the import industry of

the purpose and contents of the list and

update them as rapidly as possible

when changes are made.

137. One comment expressed concern

that the same foreign processor HACCP

plan might be reviewed by different

FDA investigators in different ports of

entry, and that these investigators might

reach different conclusions as to its

adequacy. The comment urged that the

agency coordinate such reviews, as well

as reviews of importers’ affirmative

steps, in a way that would minimize

inconsistencies.

FDA acknowledges that the situation

might well arise where different

investigators review the same foreign

processor HACCP plan as a part of

different importer inspections. To

minimize inconsistencies in such

reviews, the agency intends to train its

inspectional staff in the requirements of

these regulations and the application of

HACCP principles to seafood

processing, including training on the

Guide. The agency also intends to

develop guidance relative to importer

verification activities.

M. Guidelines or Regulations?

1. Background

FDA recognizes that many processors

will need guidance in the preparation of

HACCP plans, and that HACCP plans

will vary in complexity. The agency is

committed to providing the industry

with technical assistance that includes

general guidelines for HACCP plans and

the contents of plans for specific types

of products and processes.

As part of FDA’s seafood HACCP

proposal, the agency included

guidelines, in the form of appendices,

on how processors of cooked, ready-toeat products and products involving

scombrotoxin-forming species could

meet various provisions of the proposed

regulations relating to the development

and implementation of HACCP plans.

FDA regards these products as being

high-risk relative to other seafoods.

They involve special considerations or

special hazards for which additional

guidance would likely be useful.

Cooked, ready-to-eat fishery products

present an elevated risk of a

microbiological hazard compared to

most other seafood products. They are

cooked as part of processing and might

not receive additional cooking by

consumers before consumption.

Consequently, to be safe, these products

must not contain pathogens at a level

that will cause disease and must not be

subjected to time-temperature abuse that

would allow any existing pathogens to

grow to unacceptable levels.

Scombrotoxin-forming species are fish

that can form a toxin if exposed after

death for significant periods to

temperatures that permit the growth of

certain bacteria. Scombrotoxin can

result in a mild to severe allergic

response in humans.

The guidelines for these products

contained advice about hazards that are

reasonably likely to occur and on details

for HACCP plans for the control of these

hazards. In addition to asking for

comments on the substance of the

guidelines, the agency asked for

comment on whether these guidelines

should remain as guidelines, or whether

some or all of them should be adopted

as regulations. As regulations, they

would, essentially, tell processors that

certain hazards must be controlled in

their HACCP plans, identify in advance

critical points in the processing of these

products that processors must control to

minimize these hazards, and tell

processors what they would have to do,

at a minimum, to maintain proper

control of those critical points.

In another appendix to the proposed

regulations, FDA published excerpts

from the draft Guide, mentioned earlier

in this preamble, for the stated purposes

of publicizing the existence of that draft

Guide and of providing processors with

information about the types of guidance

that the agency expected would be

available in it.

One of the excerpts that FDA

published was guidance on the

processing of smoked and smokeflavored fish. These products represent

a significant hazard relative to

contamination with C. botulinum,

especially when packaged in reduced

oxygen atmosphere packaging. FDA

requested comment on whether this

guidance should remain solely within

the Guide, whether it should be

provided an appendix to the

regulations, or whether it should be

adopted as regulations. The effect of

adopting these materials as regulations

would be the same as for the appendices

described above.

If these materials remained in the

form of guidelines, processors would be

free to adopt them or not, so long as

measures that provide an equivalent or

superior degree of safety are

implemented.

138. Approximately 55 comments

responded to FDA’s request for

comment on whether these materials

should remain as guidelines or be

adopted as regulations. The majority of

comments preferred guidelines. A few

comments suggested that FDA initially

issue guidelines, then possibly convert

them to regulations after gaining

experience with them as adjuncts to a

functioning HACCP system or after pilot

testing them. A few comments preferred

to retain some of the materials as
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65161

guidelines and convert others to

regulations.

Over one-third of those who

commented on this subject supported

guidelines in general, without

distinguishing among the three

guidelines. They argued that guidelines

are in keeping with the general

philosophy of HACCP that processors

assume responsibility for the safety of

their products. Some stated that detailed

regulations for processors to follow

would not provide an adequate

incentive to processors to develop a full

understanding of the hazards associated

with their products or processes. The

result could be the development of rote

HACCP plans that might be inadequate

for safety in specific situations.

Some comments pointed out that,

while guidelines can assist processors to

identify controls, guidelines probably

could never properly identify the CCP’s

and limits for all processors given the

uniqueness of individual processing

methods. In the case of regulations,

processors would be obliged to adhere

to the presented limits regardless of

their appropriateness to the operation.

Many of these comments preferred the

flexibility that guidelines provide in

permitting HACCP controls to evolve

with a changing knowledge base and

new technologies. Some expressed

concern that if the guidelines were

adopted as regulations, the industry

would bear an unnecessary burden of

having to petition FDA for amendments

in order to accommodate new products

or processes. Modifications to the

regulations could take considerable

time.

Several comments specifically

objected to adopting either the

guidelines for cooked, ready-to-eat

products or the guidelines for

scombroid toxin-forming species, or

both, as regulations. The reasons were

generally the same as those given by

those comments that supported the use

of guidelines generally.

One comment did express the concern

that adopting the scombroid guideline

as regulations would have the effect of

adopting a policy action level for

histamine as a defacto regulation

without a formal notice and comment

rulemaking.

Several comments requested that

guidelines only appear in the Guide,

and not in appendices to the

regulations, to alleviate confusion.

However, FDA did receive a number

of comments that urged the agency to

adopt these guidelines as regulations.

These comments cited a need for

minimum enforceable standards for

these products to ensure the protection

of the public health. The comments

argued that minimum standards would

avoid confusion about what is

enforceable, and what is not. They

pointed out that as regulations, these

provisions could be more readily

enforced.

FDA believes that all of these

comments have merit. Guidelines can

provide flexibility that regulations

sometimes lack. Moreover, because they

are advisory in nature, guidelines are

less likely to be followed by rote.

FDA thus agrees that, ideally, HACCP

should serve as a catalyst for processors

to develop a full understanding of the

relationships between their products

and processes and human food safety

and to devise controls for ensuring

safety. There may well be more than one

way to reach an appropriate safety

endpoint. Regulations might not always

take such alternatives into account.

On the other hand, in those cases

involving high-risk products where

adherence to scientifically established

minimum standards or procedures is

necessary to ensure a safe product by

design, and those minimums are not

likely to change, there is good reason to

make those minimums something more

than advisories. In those types of

situations, it makes no sense to act as if

the work that scientifically established

the minimum processing conditions had

not been done.

2. Cooked, Ready-To-Eat Products and

Scombroid Species

These, then, are the considerations

that FDA has weighed. In the case of

cooked, ready-to-eat products and

products made in whole or in part from

scombroid toxin-forming species, FDA

is persuaded that the guidelines should

remain as guidelines, at least until there

is enough experience with them to

determine whether a change to

regulations is warranted. The agency

has concluded that processors should be

given maximum flexibility, at least

initially, to identify the reasonably

likely hazards and the CCP’s and CL’s

for those hazards that are most

appropriate for their manufacturing

processes. FDA will examine over time

whether processors are achieving an

adequate degree of preventive control

for these products under the guidelines,

and whether they are doing so by

following the guidelines exactly or

partially or by relying on alternative

approaches.

FDA acknowledges that many

comments objected to the details of the

appendices. These comments will be

addressed when the first edition of the

Guide is published. FDA recognizes that

these materials will be more easily

modified and improved if they remain

as guidelines, at least for the time being.

FDA agrees that all of these guidelines

should appear solely in the Guide.

There are no appendices to these final

regulations.

3. Smoked and Smoke-Flavored Fishery

Products

The guidance for smoked and smokeflavored fish contained specific

processing parameters (i.e., time and

temperature of smoking and finished

product salt and nitrite concentrations)

to be met in the processing of such

products, and control mechanisms for

ensuring that they are met. C. botulinum

toxin production is prevented in

smoked and smoke-flavored fish by

controlling these interrelated variables,

as well as by controlling the

temperature of the product throughout

the chain of distribution.

139. Approximately 25 comments

addressed whether these materials

should be regulations or guidelines.

About half of the comments,

representing State and Federal

regulatory agencies, professional

associations, and others, urged that the

materials be codified as regulations. The

remainder, representing processors and

trade associations, requested that the

guidelines remain as guidelines.

A number of the comments that urged

that the smoked and smoke-flavored fish

guidelines be issued as regulations

asserted that regulations are more easily

enforceable, would provide clear

direction to the industry, and would

provide much needed nationwide

uniformity in the processing of smoked

fish. One comment from a State

regulatory agency observed that

processors are not adhering to existing

guidelines, such as the 1991

recommendations for these products by

AFDO, and are unlikely to change their

operations in response to another

guideline. Several comments argued

that the States need Federal regulations

to support their own efforts to regulate

the industry and to foster uniformity

among the various existing State

requirements. One of these comments

also stated that such regulations are

needed to ensure the safety of smoked

fish, because the product has a history

of involvement in botulism outbreaks, is

handled more than most other products,

increasing the risk of microbiological

contamination, and is frequently not

cooked prior to consumption. One

comment suggested that the guidelines

be tested in pilot programs before

making them mandatory, and that

research information on smoked fish be

disseminated to industry through
65162 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

technical bulletins, workshops, and

meetings.

Several of the comments that

suggested that the proposed guidelines

remain as guidelines argued that FDA

has not demonstrated that present

practices in the smoked fish industry

are causing risks that would justify

regulations, and that there have been no

recent incidents of botulism attributable

to smoked fish. Several comments stated

that most of the problems with smoked

fish in the past have resulted from abuse

of the product at retail or by the

consumer.

A few comments objected to FDA’s

contention that large portions of the

industry do not conduct final product

testing and to the inference that all

smoked fish processors do not monitor

the composition of their products. The

comments stated that responsible

companies do conduct product testing

on a regular and routine schedule, have

scheduled processes, and are aware of

what they are doing.

Other comments recommended that

FDA enforcement of the current

CGMP’s, coupled with State and local

enforcement of the Food Code for

smoked products that are produced in

restaurants, retail, and food service

establishments, would make it

unnecessary to treat smoked fish

products any differently than other

products under these HACCP

regulations. One comment suggested

that guidelines would have the same

impact as regulations because HACCP

plans would be rejected by FDA if they

do not contain the recommended

controls, and because States would

adopt the guidelines as regulations.

One comment argued that the

issuance of prescriptive regulations

would eliminate the diversity in the

types of smoked fish products available

and result in a ‘‘homogeneous’’ market.

Another comment counseled that the

issuance of a regulation would cause

Alaskan native salmon processors to

abandon their traditional trade.

The agency remains convinced that

smoked and smoke-flavored fish is a

potentially hazardous food. While cases

of botulism have not been attributed to

commercially prepared smoked or

smoke-flavored fish in over 30 years, the

outbreaks of the 1960’s clearly

demonstrate the potential for such

occurrence. Virtually all the research

that has been conducted establish that

processors need to control time,

temperature, and salinity (T-T-S)

parameters and other matters for these

products in order to provide adequate

barriers to toxin production (Ref. 214).

As the preamble to the proposed

regulations pointed out, FDA and a

number of States have longstanding

concerns that the actions of a significant

portion of the smoked fish industry do

not demonstrate a full appreciation for

the nature of the risks. FDA and New

York State surveys of the smoked fish

industry in the late 1980’s, for example,

showed that many processors did not

routinely control their T-T-S

parameters.

The comments have not persuaded

FDA that, even without regulations,

processors will employ preventive

controls to ensure the safety of these

products as a matter of design and not

of chance. Botulism derives from one of

the most dangerous toxins known to

exist. Controls to prevent the formation

of this toxin cannot be left to chance.

HACCP controls for this hazard are

highly appropriate because HACCP

requires that the processor analyze its

operation to determine how hazards

affecting its product can arise, and that

it institute specific controls to prevent

those hazards. The majority of

comments that addressed smoked and

smoke flavored fish products either

supported the concept of HACCP

controls or did not argue against them.

140. The question, therefore, is

whether, in addition to requiring

HACCP plans for these products, FDA

should mandate specific CCP’s,

minimum CL’s, monitoring frequencies,

and other matters that processors would

have to include in their HACCP plans.

If the agency were to codify draft

guidelines as regulations, the agency

would be answering that question in the

affirmative. The preamble to the

proposed regulations identified the T-TS parameters in the draft guidelines as

being scientifically established

minimums for ensuring that toxin

produced by C. botulinum will not be

produced over the shelf life of the

product under refrigerated conditions

and under conditions of moderate

temperature abuse. FDA has been urged

for years to mandate such T-T-S

parameters for these products. In 1988

and 1989, for example, AFDO passed

resolutions asking FDA to expedite the

development of regulations for the safe

processing of smoked fish. The

comments to this rulemaking that

supported regulations over guidelines

support the mandating of specific T-TS parameters.

However, a significant number of

other comments challenged whether

some of the parameters in the guidelines

were actually minimums, as FDA had

contended. They specifically objected to

the minimum water-phase salt levels in

the draft guidelines for air packaged

smoked and smoke-flavored fish.

Generally, these comments stated that

there is little safety concern with airpackaged smoked or smoke-flavored fish

(hot or cold smoked) containing as little

as 2.5 percent water phase salt (less than

the minimum stated in the guidelines),

and requested that FDA reexamine the

existing scientific data. A few comments

stated that air-packaged smoked fish has

a limited shelf life in the refrigerated

state and that NMFS research has shown

that spoilage occurs before toxin

production. One comment stated that

NMFS, New York State Department of

Agriculture and Markets, and AFDO all

consider a minimum water-phase salt

content of 2.5 percent to be acceptable

for air-packaged products.

A few comments suggested that an

alternative to specifying T-T-S

parameters would be to require that all

processors have a scheduled process for

air-packaged products. The comment

stated that this requirement has been

successful in the State of New York and

has enabled industry to produce

products with water-phase salt

concentrations that are lower than those

proposed by FDA. A few comments

suggested that the high salt levels

proposed by FDA for smoked and

smoke-flavored products would be

counterproductive to those government

programs aimed at reducing salt in the

human diet and would be unacceptable,

or only marginally acceptable, to

consumers. Other comments suggested

that the necessary minimum salt levels

for smoked and smoke-flavored fish

might be reduced by shortening the

shelf life of the product or by storing

and distributing the product frozen.

The comments have persuaded FDA

that it may be possible for processors to

use parameters other than those in

FDA’s draft guidelines and still produce

a safe product. Moreover, the NACMCF

has recently endorsed AFDO’s

recommended parameters for smoked

and smoke-flavored fish. Most notably,

these recommendations differ from

those in FDA’s draft guidelines in that

they provide for a minimum finished

product water phase salt content in airpacked product of 2.5 percent, whereas

the FDA proposal provided for a range

of minimum values of from 2.5 percent

to 3.5 percent, depending upon other

processing parameters.

The agency acknowledges, therefore,

that some recommended T-T-S

parameters differ from those in FDA’s

draft guidelines. FDA acknowledges the

possibility that other safe T-T-S

parameters exist as well. It is reasonable

to suppose that there is more to be

learned about how the development of

C. botulinum toxin is controlled in these

products, given the lack of reported

illnesses in recent years. Thus, while
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65163

FDA strongly believes that the T-T-S

parameters in its draft guidelines

provide effective controls for botulism,

the agency accepts that they are not

necessarily the only effective controls,

or that all effective controls have been

identified.

Consequently, the agency has

concluded that, at least for now, the

most appropriate place for such

guidance on T-T-S parameters and

related matters is the Guide, and that it

would not be appropriate to adopt

specific parameters for the processing of

smoked fish by regulation. However,

because of the extreme nature of the

hazard, and in response to comments,

FDA has chosen to codify a rudimentary

performance standard for the control of

botulism in these products from the

draft guidelines (item number 11). As

incorporated at subpart B, § 123.16, the

performance standard reads:

In order to meet the requirements of

subpart A of this part, processors of smoked

and smoke-flavored fishery products, except

those subject to the requirements of part 113

or 114 of this chapter, shall include in their

HACCP plans how they are controlling the

food safety hazard associated with the

formation of toxin by C. botulinum for at

least as long as the shelf life of the product

under normal and moderate abuse

conditions.

This requirement responds in part to

the comments that proposed that FDA

require that all processors scientifically

establish scheduled processes for

smoked and smoke-flavored fish, rather

that mandate specific T-T-S parameters

and other matters. It requires processors

to establish CL’s that are both

appropriate to their operation and

scientifically sound. Because botulism

is undoubtedly a hazard that must be

controlled in the production of these

products, subpart B of part 123 does not

impose a requirement that would not

exist in its absence. It has been included

for emphasis and as a reminder to

processors. The Guide will provide

processors with assistance with regard

to specific T-T-S parameters and related

matters.

141. FDA proposed that, with certain

exceptions, fish to be smoked or salted

be eviscerated and free of residual

viscera. The preamble to the proposed

regulations explained that salted or

smoked uneviscerated fish present a

potential hazard for the development of

C. botulinum toxin production. The

viscera of fish contain the majority of C.

botulinum normally present.

One comment argued that the entire

evisceration provision should be moved

to the Guide. Another comment

suggested that specific evisceration

requirements be codified but not as part

of sanitation.

These regulations require in subpart B

of part 123 that the processors of

smoked and smoke-flavored fish

describe in their HACCP plans how they

are controlling the food safety hazard

associated with the formation of toxin

by C. botulinum. Specific types of

controls will be provided in the Guide.

Because evisceration is one form of

control for this toxin, it will be covered

in the Guide as well and need not be

included in the regulations.

Consequently, FDA has not included

this proposed provision in these final

regulations.

N. Molluscan Shellfish

1. Background

In addition to the general HACCP

provisions in subpart A of part 123,

FDA proposed subpart C of part 123—

‘‘Raw Molluscan Shellfish,’’ which set

forth specific requirements for the

processing of fresh or frozen molluscan

shellfish. Proposed subpart C of part 123

described certain types of controls that

processors of these products must

include in their HACCP plans in order

to meet the requirements of subpart A

of part 123.

Specifically, FDA proposed to require

that processors of raw molluscan

shellfish identify in their HACCP plans

how they are controlling the origin of

the molluscan shellfish that they

process. FDA proposed to require that

these controls include accepting only

molluscan shellfish that originated from

growing waters that are approved by a

shellfish control authority, that are from

harvesters that are licensed or from

processors that are certified by a

shellfish control authority, and that are

properly tagged or labeled. In addition,

FDA proposed to require that processors

maintain records to document that each

lot of raw molluscan shellfish meets

these requirements. FDA also proposed

to amend § 1240.60 (21 CFR 1240.60) to

provide for a system of tagging for

shellstock and labeling for shucked

molluscan shellfish as a means of source

identification.

It is important to note that shellfish

control authorities in the United States

are generally agencies of State

governments, and that the tagging of

molluscan shellfish is an important

aspect of State shellfish control

programs. As discussed below, reference

to aspects of existing State programs in

these Federal regulations is not

intended to supplant or override the

State programs in any way. Rather, these

provisions are intended to strengthen

the Federal system in ways that will

complement, and thereby better

support, State programs.

Molluscan shellfish consumed raw or

partially cooked pose unique public

health risks. As the preamble to the

proposed regulations noted, they

probably cause the majority of all

seafood-related illnesses in the United

States. This situation is not unexpected,

given the nature of the product and the

way that it is consumed. The preamble

documented a relationship between the

microbiological quality of molluscan

shellfish growing waters and the

incidence of molluscan shellfish-borne

disease. It also noted that naturally

occurring toxins may accumulate in

molluscan shellfish because they are

filter-feeding animals.

The NSSP was established as a

cooperative program among FDA, State

regulatory agencies, and the molluscan

shellfish industry, relying on section

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

provide for the classification and patrol

of shellfish growing waters and the

inspection and certification of shellfish

processors. The preamble to the

proposal reaffirmed FDA’s support for

the NSSP but noted the difficulties that

are associated with ensuring the safety

of these uncooked products. As the

preamble stated, FDA tentatively

determined that it could strengthen and

provide additional support for the

cooperative program through these

regulations.

2. Should There Be Specific

Requirements for Raw Molluscan

Shellfish?

FDA received approximately 45

comments about the proposed

requirements for raw molluscan

shellfish. The responses were from

processors, trade associations, State and

Federal government agencies,

individuals, consumer advocacy groups,

and a foreign country. Approximately

half of these comments urged FDA to

eliminate proposed subpart C of part

123 and the proposed amendment to

§ 1240.60, while the other half

acknowledged the advisability of

including these kinds of provisions but

commented on, or questioned, various

specifics of them.

The comments that generally

supported the need for specific

requirements for raw molluscan

shellfish were from trade associations,

molluscan shellfish industry members,

consumer advocacy groups, Federal and

State government agencies, individuals,

and a professional organization. A

number of comments noted that special

requirements for molluscan shellfish are

warranted because of the association of

these products with illness. One
65164 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

comment in particular stated that, with

respect to seafood, molluscan shellfish

‘‘serve as the primary source of illness

due to ingestion.’’ One comment noted

that Federal regulations relating to

source of origin controls for raw

molluscan shellfish would enable FDA

to lend support to the States in the

administration of the NSSP. Another

comment suggested that the proposed

regulations would improve FDA’s

regulatory effectiveness with regard to

molluscan shellfish control. The

comment from the ISSC stated that ‘‘The

Conference has long recognized and

supported expansion of FDA authority

to assist States in assuring the safety of

molluscan shellfish.’’

The comments that suggested that

subpart C of part 123 and the

amendment to § 1240.60 be deleted

were from State government agencies

and seafood processors. A number of the

comments that suggested deletion of the

proposed provisions stated that the

tagging and labeling requirements of the

NSSP are designed not to serve as a

control to prevent harvesting from

closed areas but to assist States in

tracing shellfish that are implicated in

illness outbreaks back to the harvest

area. The comments went on to state

that harvesters who illegally harvest

from closed waters do not identify the

shellfish as originating from the closed

area. The comments maintained that

preventing illegal harvesting is the key

to reducing the incidence of illness, and

that the only known method to achieve

this goal is through effective law

enforcement, including the patrol of

closed waters.

A number of these comments argued

that increased FDA funding and support

for State molluscan shellfish control and

patrol efforts would do more than the

proposed rule to deter illegal harvesting,

to increase States’ compliance with the

NSSP, and reduce the number of

illnesses caused by molluscan shellfish.

The comments went on to state that the

proposed regulations unnecessarily

duplicate the requirements now in place

in the Manual of Operations for the

NSSP. They contended that formal

adoption of NSSP requirements into

Federal regulations would release State

agencies from their cooperative

relationship with FDA under the NSSP.

One comment noted that the

weaknesses in State molluscan shellfish

control programs are in areas not

addressed by the proposed regulations,

such as improperly classified growing

waters; the ability of State growing

water classification programs to respond

to breakdowns at waste water treatment

facilities or unexpected climatic events

that affect the quality of molluscan

shellfish growing waters; and improper

handling by caterers and consumers.

The comment concluded that the

proposed HACCP provisions for

molluscan shellfish will, therefore, not

reduce the incidence of illness

attributable to such products.

As previously mentioned, FDA is a

partner with State and foreign

regulatory authorities and with industry

in the NSSP. The NSSP Manual of

Operations provides the standards for

State and foreign molluscan shellfish

regulatory programs that belong to the

cooperative program, as well as for

processors. The participating States

routinely adopt those standards as law

or regulations, but the NSSP itself has

neither Federal nor State regulatory

stature.

Each participating State and foreign

nation classifies and monitors its

molluscan shellfish growing waters,

controls harvesting, inspects molluscan

shellfish processors, and issues

certificates for those that meet the

shellfish control authority’s criteria.

FDA evaluates State and foreign

molluscan shellfish control programs

and publishes monthly the ‘‘Interstate

Certified Shellfish Shippers List,’’

which lists the molluscan shellfish

processors that are certified under the

cooperative program. States that are in

the program are not willing to receive

shellfish from noncertified shippers.

FDA disagrees with the comments

that suggest that establishment of the

proposed source controls in Federal

regulations would supplant the similar

and, in some cases more stringent,

requirements of participating States and

foreign nations or the standards set forth

in the NSSP. Rather, the agency is

convinced that they will reinforce and

support these requirements and

standards.

The molluscan shellfish industry is

subject to significant regulatory

oversight in those States that participate

in the NSSP. However, the quality and

effectiveness of State laws and

enforcement activities can vary

considerably as a function of the

financial and administrative support

available to the responsible State units

(Ref. 7, p. 15). For example, FDA

documented discrepancies in State

enforcement practices during its 1994

evaluation of State programs to

determine compliance with the NSSP

standards (Ref. 215). Moreover, although

all harvesting States participate in the

NSSP, many other States do not.

Based on these factors, FDA proposed,

and is now adopting, subpart C of part

123 and amendments to § 1240.60 to

support and strengthen the shellfish

program in two ways. First, these

provisions will complement the efforts

of the States. FDA recognizes that while

States are making significant and

important efforts to ensure that all

shellfish harvested in their jurisdiction

are taken only from open waters and

then properly tagged, some shellfish

that do not meet these requirements

inevitably escape State control. The new

provisions will allow FDA to take action

against shellfish that are not harvested

from open waters or that are not

properly tagged if it encounters such

shellfish in interstate commerce and

make the gravamen of such action the

origination from unopen waters or the

lack of proper tagging itself, rather than

evidence that the shellfish are injurious

to health.

Second, the regulations require that

processors only use shellfish that

originate from growing waters that have

been approved for harvesting and that

have been properly tagged. Failure to do

so can result in Federal regulatory

action against the product or against the

processor itself. This fact should

provide a significant incentive to

processors to ensure that they are not

receiving shellfish that do not meet

these requirements.

Taken as a whole, rather than

diminishing in any way the importance

of State programs, FDA’s regulations

elevate the importance of those

programs. These regulations make

proper origin and tagging—concepts

that derive directly from the NSSP—

keys to the unimpeded movement of

shellfish in interstate, as well as

intrastate, commerce.

Moreover, these requirements extend

these control measures to imported

products, enabling FDA to more

efficiently and effectively ensure the

safety of imported raw molluscan

shellfish. At present, the agency must

resort to advising State regulatory

authorities of the prospective entry of

raw molluscan shellfish from an

uncertified source (Ref. 216, part V, p.

5). While States normally take action

against uncertified imported raw

molluscan shellfish, FDA is aware that

uncertified imports enter interstate

commerce (Ref. 107).

FDA acknowledges that uniform

Federal tagging and record-keeping

requirements will not completely

eliminate illegal harvesting. The agency

agrees with the comments that rigorous

enforcement of closed area restrictions

by State regulatory agencies will always

be needed. Unquestionably, increased

funding would help State efforts to

classify and patrol growing areas.

However, FDA does not have resources

for this purpose. Nonetheless, the

agency remains convinced that there are
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65165

significant, positive steps that can be

taken to strengthen source controls as

part of HACCP, and thereby to support

the cooperative program.

A processor’s most significant safety

control for raw molluscan shellfish is at

the point of receipt. If processors refuse

to accept molluscan shellfish for which

there is no assurance that they have

been legally harvested, the incentive for

illegal harvesting would be eliminated.

FDA participation in a number of covert

investigations into illegal molluscan

shellfish harvesting in recent years has

convinced the agency that, in many

cases, processors are aware of the illegal

harvesting activity of their suppliers

(Ref. 217). If the provisions of these

regulations can help foster a culture

change in that respect, shellfish safety

will be significantly enhanced.

Based on these considerations, the

agency proposed that, as a universal

aspect of the HACCP plans for these

products, molluscan shellfish

processors engage in certain activities to

ensure that the products that they

receive originate only from waters that

have been approved by a shellfish

control authority (e.g., checking tags on

containers of shellstock, licenses of

fishermen, and certification of

suppliers). Molluscan shellfish that are

clearly improperly tagged or from

questionable sources must be rejected

by processors as a requirement of their

HACCP plans. It is reasonable to

conclude that, as more processors adopt

HACCP and exercise greater control

over their suppliers, the amount of

illegally harvested shellfish offered for

sale will decrease, because the market

for such product will decline.

While it is true that the tagging

requirements of the NSSP were

primarily designed as a means of tracing

back molluscan shellfish involved in

incidences of illness to their harvest

area, they have also served as a key

component in efforts by FDA and State

regulators and industry to ensure that

molluscan shellfish that are placed in

commerce originate from areas that are

approved by a shellfish control

authority. It is certainly true that the

tags on containers of molluscan

shellfish that are harvested from closed

waters are often falsified to disguise

their true origin. However, such

falsification carries potential Federal

and State penalties and is a focus of

current molluscan shellfish control

programs.

Regarding the comments that pointed

to weaknesses in State programs, at

retail, in the classification of molluscan

shellfish growing waters, and elsewhere,

which are not directly addressed by

these regulations, the agency

acknowledges that HACCP plans and

specific source control requirements

cannot serve as a substitute for

improvements in the food safety system

that directly address these weaknesses.

Regulatory systems will always have

their strengths and weaknesses, and

research to better understand and

control hazards will always be needed.

Nonetheless, these comments provide

no reason for FDA to abandon its efforts

to remedy existing agency weaknesses

and, in particular, to lend support to the

States in those areas to which these

regulations do relate.

141. One comment stated that

references cited in the preamble to the

proposed regulations in support of the

tagging requirements (Refs. 102 through

109) do not provide convincing

evidence of a need for such a measure.

The comment stated that, for the most

part, the references that FDA cited

document corrective actions taken by

State regulatory agencies that would

likely be the same measures that FDA

officials would take under the proposed

regulations. In addition, the comment

stated that a failure to have properly

tagged shellfish does not always mean

that the shellfish were harvested

illegally. The comment pointed out that

the absence of a tag could mean simply

that the tag was lost.

The references in the question contain

examples of problems associated with

molluscan shellfish tagging,

recordkeeping, and harvesting. FDA

cited these references to demonstrate

that, in some cases, the deterrent effect

of existing State tagging requirements

and sanctions is inadequate to prevent

problems from arising (Refs. 102, 103,

and 109). The problems documented in

the references helped persuade FDA to

propose Federal source control

requirements to help deter the interstate

shipment of shellfish from unapproved

harvest areas. FDA did not intend to

imply that the State actions that were

documented in these references were

incorrect, or that FDA would have

responded in a different manner. FDA

continues to believe that the references

are relevant and supportive to its

intended assertion.

A few comments maintained that a

better strategy for decreasing illness

from the consumption of molluscan

shellfish would be to increase the

education efforts of FDA and of the ISSC

that are directed toward consumers and

the medical community to alert

susceptible individuals to the risks

associated with the consumption of raw

molluscan shellfish.

The agency agrees that consumer

education can play a vital role in

reducing illnesses associated with the

consumption of raw molluscan

shellfish, particularly in medically

compromised individuals. During the

period of 1984 through 1994, the agency

expended nearly $1 million to alert the

public to the risks of raw molluscan

shellfish consumption by distributing

brochures to consumer groups, groups

that represent those with special

medical conditions, and consumers;

developing a video news release; issuing

press releases; and establishing the tollfree, FDA Seafood Hotline. Included in

this expenditure is the agency’s efforts

to inform the medical community about

the illnesses associated with the

consumption of raw molluscan shellfish

by providing informative articles to

medical bulletins and journals and by

mailing brochures and news articles to

target professional groups. The agency

will continue its consumer education

efforts, but such efforts alone will be

insufficient to address the hazards

posed by the consumption of raw

molluscan shellfish harvested from

unapproved growing waters. The

existing and planned consumer

education efforts are geared toward

individuals in high-risk consumer

groups, advising them to avoid

molluscan shellfish that have not been

fully cooked. The risks posed by

viruses, toxins, and many bacteria are to

the population as a whole. There is little

advice that the agency could provide

that would enable consumers to protect

themselves from these kinds of hazards

in molluscan shellfish.

143. Several comments questioned the

validity of FDA’s statement that

molluscan shellfish consumed raw or

partially cooked pose unique public

health risks and probably cause the

majority of all seafood-related illnesses

in the United States.

The comments provided no data upon

which to conclude that either the NAS

or FDA is wrong in this regard. FDA

remains convinced that the statements

made in the preamble to the proposed

regulations are valid, and that the

references support these statements.

3. Cooked Versus Raw Molluscan

Shellfish

144. Comments from a number of

State agencies, trade associations,

seafood processors, and the ISSC

objected to the use of the terms ‘‘raw’’

and ‘‘fresh or frozen’’ in the title of part

123 subpart C and the text of the

proposed regulations on shellfish. These

comments were concerned because

these terms would have the effect of

exempting canned and any other heatprocessed molluscan shellfish from the

source control, recordkeeping, and
65166 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

tagging provisions of subpart C of part

123 and § 1240.60(b).

The comments stated that limiting

these provisions to raw products would

allow foreign firms to continue to heattreat or can molluscan shellfish that are

harvested from foreign waters that do

not meet NSSP standards and to export

them to the United States. The

comments stated that this situation was

not in the best interest of the public

health because of the potential for the

presence of heat-stable natural toxins,

such as paralytic shellfish poison or

amnesiac shellfish poison, as well as

chemical contaminants. The comments

also complained that, because State

laws and regulations require that all

molluscan shellfish harvested in the

United States come from waters

approved by a shellfish control

authority regardless of whether they are

to be consumed raw or cooked,

continuing to allow foreign processors

who export cooked shellfish to the

United States to use molluscan shellfish

from unapproved growing waters places

the domestic shellfish industry at a

competitive disadvantage. Other

comments requested that FDA clarify

whether canned shellfish were included

in subpart C of part 123 but did not

suggest that canned and other heatprocessed shellfish be included.

FDA has responded to these

comments generally in response to

comment 34, supra. The agency adds

the following points:

It is important to recognize that

foreign processors who export cooked

molluscan shellfish to the United States

now will have to have HACCP systems

through which they identify and control

hazards that are reasonably likely to

occur. These hazards include heat stable

toxins and chemical contaminants that

would cause these products to be

adulterated under U.S. law.

To further clarify that the

requirements of subpart C of part 123

apply only to the processing of

molluscan shellfish that are not heat

treated or treated in some other manner

by the processor to eliminate

microorganisms of public health

concern, FDA has modified the language

at § 123.20 to read, ‘‘This subpart

augments subpart A of this part by

setting forth specific requirements for

processing fresh or frozen molluscan

shellfish, where such processing does

not include a treatment that ensures the

destruction of vegetative cells of

microorganisms of public health

concern.’’

4. Shellfish Control Authorities

FDA proposed to require that

processors only process molluscan

shellfish that originate from waters

approved for harvesting by a shellfish

control authority. The term ‘‘shellfish

control authority’’ is defined at

§ 123.3(o) to include foreign government

health authorities that are legally

responsible for the administration of a

program that includes classification of

molluscan shellfish growing areas.

145. Two trade associations

questioned how a processor could

evaluate the competency of a foreign

shellfish control authority. They stated

that FDA should require that a foreign

country that exports shellfish to the

United States have an agreement with

the agency that establishes that a

competent shellfish control authority

exists in that country, and that the

foreign shellfish program meets NSSP

standards. One comment from a seafood

processor argued that it would be

unreasonable to require processors to

verify that molluscan shellfish from all

over the world are caught or cultivated

in waters that meet NSSP standards.

The comment stated, moreover, that a

processor could not keep abreast of

which countries have current shellfish

agreements with FDA and which

countries do not.

FDA acknowledges the merits of

requiring that a foreign country that

exports shellfish to the United States

have an agreement with the agency but

has concluded that, given the

significance of such a requirement and

the agency’s failure to raise the

possibility of imposing it in the

proposal, it is beyond the scope of this

rulemaking. Even though FDA is not

imposing such a requirement, it is the

case that the only means by which a

processor can ensure that the molluscan

shellfish of foreign origin that it receives

are in compliance with the requirements

of subpart C of part 123 of these

regulations is by determining whether

the foreign shellfish control authority is

formally recognized by FDA. It is not

likely that the processor could employ

any other process that would give it

assurance that molluscan shellfish

harvesting waters that are approved by

the shellfish control authority are

properly classified. Such a

determination is appropriately

performed through government to

government audit.

5. Shellfish From Federal Waters

146. Comments from a significant

number of trade associations and

seafood processors stated that a

requirement that shellfish originate only

in waters ‘‘approved for harvesting by a

shellfish control authority’’ would

preclude harvesting in Federal waters

unless the Federal government

introduced a formal approval process

for waters under its purview through a

Federal shellfish control authority.

Under the current system, State

agencies are responsible for approving

molluscan shellfish growing waters.

However, State jurisdiction extends

only to waters that are within three

miles of the shore. Waters beyond that

point but up to 200 miles offshore are

under the jurisdiction of the Federal

government. The comments pointed out

that the harvesting of molluscan

shellfish is permitted in all of the

oceanic waters under Federal control

unless there is a specific Federal action

to declare an area unsafe under the

provisions of the Magnuson Fishery

Conservation and Management Act. The

comments further noted that large

volumes of molluscan shellfish are

harvested in Federal waters.

How Federal waters will be classified,

and by whom, has not been fully

resolved. The comments are correct that

the proposed requirement, if

incorporated into the final rule, would

pose significant problems for molluscan

shellfish processors who receive

product harvested from Federal waters.

Therefore, FDA has modified § 123.28(b)

to allow for the receipt of molluscan

shellfish that are harvested in U.S.

Federal waters except where such

waters are specifically closed to

harvesting by an agency of the Federal

government. This provision is

consistent with the provisions of the

Magnuson Act.

It is worth noting that, by allowing

Federal waters to be open unless they

are specifically closed, this system is the

opposite of the State system, under

which waters are closed unless they are

affirmatively classified so as to be open.

This difference is reasonable from a

public health standpoint because there

is less likelihood that Federal waters

will be affected by pollution than will

near shore State waters.

Furthermore, because there is no

Federal authority to license shellfish

harvesters who fish in Federal waters,

FDA has modified § 123.28(c) to require

only that a harvester be in compliance

with such licensure requirements as

may apply to the harvesting of

molluscan shellfish, rather than

specifically requiring licensure.

6. Tagging and Recordkeeping

Requirements

147. FDA proposed recordkeeping

requirements for processors to follow

with respect to shellstock and shucked

molluscan shellfish in § 123.28 and

requirements for the information to be

included on the shellstock tag in

§ 1240.60. A few comments stated that
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65167

the proposed molluscan shellfish tag

and record requirements were too

specific, and that placing such

requirements in the form of regulations

would make it difficult to make timely

changes to these requirements as future

needs may dictate. The comments

asserted that FDA or the ISSC may wish

to modify the content or form of

molluscan shellfish tags or records to

improve product traceability. They

suggested that FDA write the tagging

and recordkeeping requirements at

§ 123.28 and § 1240.60 in general terms

and allow the specific form and

information required on the tags to be

addressed by the NSSP. The comments

went on to urge that, if the agency were

determined to include specific tagging

and recordkeeping requirements as part

of the final regulations, they should be

fully consistent with current NSSP

guidelines.

It is not the agency’s intent that the

provisions of § 123.28 and § 1240.60

would preclude the ISSC or State

agencies from adopting additional

recordkeeping or tagging requirements.

The recordkeeping and tagging

requirements in these regulations are

the minimum necessary to ensure that

shellfish can be traced through

distribution channels, back to the

harvest source. FDA explained why

each of the specific requirements is

necessary in the preamble to the

proposed regulations, and the comments

did not take issue with the agency’s

explanation with respect to any of the

particulars. Therefore, FDA disagrees

with the comments that the

recordkeeping or tagging requirements

are more restrictive than they need to

be, or that they would interfere with the

NSSP tagging program.

Moreover, as stated previously, the

agency has drafted the regulations

broadly enough so as not to conflict

with any improvements that the ISSC

may wish to make in the form that a tag

may take or in how information on tags

is to be stored. The definition of the

word ‘‘tag’’ at § 123.3(t) (added at

§ 1240.3(u) for consistency) reads, in

part, ‘‘a record of harvesting information

attached to a container of shellstock

* * *.’’ This definition is sufficiently

broad to include such systems as bar

codes, embossed plastic, or other

nontraditional methods of identification

that may be used by the industry in the

future. The agency is supportive of

efforts to improve the existing methods

of recording harvesting information.

Nonetheless, it is important for the

regulations to identify the minimum

specific information that must appear

on a tag. During past illness outbreaks,

FDA, State regulatory agencies, and

industry have had difficulty tracing the

implicated shellfish to their sources,

especially after they have been in the

possession of several different

processors (Refs. 99; 100; 102–106; 109;

218; and 219, pp. 37–39). These

difficulties in tracing the shellfish have

occurred because the shellfish were not

in compliance with the tagging and

recordkeeping provisions of the NSSP.

The requirements at § 123.28 will enable

FDA to help the States to enforce

minimum tagging and recordkeeping

requirements for imported and domestic

products. Moreover, the agency believes

that placing the tagging and

recordkeeping requirements in Federal

regulations will emphasize the

nationwide importance of this

information in protecting the public

health, as described earlier.

148. One comment noted that the

NSSP does not specify that the name of

the harvester must be on a molluscan

shellfish tag, but that the proposed

regulations would require this

information.

The NSSP specifies that the number

assigned to the harvester by the shellfish

control authority must be listed on the

tag. The agency recognizes that there

may be a variety of effective ways to

identify the harvester of the molluscan

shellfish, depending on the method of

harvest, State requirements, and local

tradition. For this reason, the agency has

modified § 1240.60(b) to read that the

tag shall disclose:

* * * by whom they were harvested (i.e., the

identification number assigned to the

harvester by the shellfish control authority

or, if such identification numbers are not

assigned, the name of the harvester or the

name or registration number of the

harvester’s vessel).

For consistency, FDA has made a

similar change in § 123.28(c)(5).

149. A significant number of

comments recommended that FDA

modify § 1240.60(b) to allow bills of

lading or other shipping documents to

accompany bulk shipments of shellstock

in lieu of tags, as long as they provide

the same information. A few comments

suggested that bills of lading or other

shipping documents be used in lieu of

tags on individual containers of

shellstock when a shipment consists of

a large volume of shellstock in sacks or

boxes. Several comments asked for

clarification of the impact of the

proposed requirements on current

repacking operations that commingle

shellstock from various harvesters into

one container.

FDA recognizes that an inconsistency

existed between proposed § 123.28 and

proposed § 1240.60 because the former

would have allowed shipping

documents to provide the required

information for bulk shipment, and the

latter would not. FDA agrees with the

comments that recommended providing

for the use of shipping documents and

has modified § 1240.60(b) to provide the

needed consistency. Under existing

industry practice the truck, cage, or

vessel hold serve the same purpose as

a container for the shellstock, making

tagging impractical. In that case, the

shipping document serves the same

function as the tag.

However, the agency does not agree

with the suggestion that containers of

shellstock in large shipments be allowed

to be covered by shipping documents in

lieu of tags. FDA cannot justify treating

shellstock in large shipments differently

than shellstock in smaller shipments,

nor could the terms ‘‘large’’ or ‘‘small’’

be readily defined. Large shipments can

be subdivided, perhaps many times, or

commingled with other lots of

molluscan shellfish. The source

information would, therefore, be

necessary on each container to ensure

proper identification. Without tags, the

identity of individual containers could

be lost. FDA is requiring that all

shellstock, even after repacking, bear a

tag that identifies the prescribed

information, including the identification

of the harvesters to ensure that all

shellstock is readily traceable

(§ 1240.60).

7. Other Considerations

150. Comments from a few trade

associations and from seafood

processors stated that FDA should

require a production code on each

container of shucked molluscan

shellfish. The comments suggested that

the code consist of an identifying mark

that allows the processor to determine

where the remainder of the lot was

shipped, and where and when the

relevant shellstock was harvested.

FDA agrees that production codes can

be useful on containers of shucked

molluscan shellfish to facilitate trace

back of questionable product. The

agency encourages the use of codes by

molluscan shellfish processors.

However, such a requirement is not

within the scope of the proposed

regulations. The agency will consider

whether such a requirement should be

pursued in a separate rulemaking.

151. Comments from several

consumer groups stated that if a

warning label is not mandated by FDA

on raw molluscan shellfish to alert atrisk consumers of the danger to health

posed by the product, FDA should

require that Gulf Coast oyster processors

adequately cook the product to
65168 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

eliminate risks from Vibrio vulnificus

during periods when shellfish cannot be

harvested free from this bacterium. They

further stated that cooking should not be

required when the shellfish are free

from this bacterium.

FDA agrees that effective controls are

needed to protect consumers from the

hazard posed by V. vulnificus in Gulf

Coast oysters during certain times of the

year. The agency is evaluating the

potential effectiveness of a variety of

control mechanisms. Mandating specific

mechanisms, however, would be

outside the scope of this rulemaking.

FDA is therefore taking these comments

under advisement.

152. A few comments urged that the

word ‘‘processor’’ be changed to

‘‘certified dealer and licensed harvester’’

throughout § 123.28 to make the

terminology consistent with the NSSP

and to clarify that these requirements

apply to everyone who buys and sells

shellfish before the shellfish reach the

retail marketplace. The comments also

recommended changing the word

‘‘shipper’’ to ‘‘processor or packer’’ in

the provision that is codified at

§ 123.28(d)(3) in these final regulations

to include the shucker, repacker,

shipper, reshipper, or depurator.

As mentioned in the ‘‘Definitions’’

section of this preamble, the agency has

concluded that the definition for

‘‘processor’’ covers all NSSP

classifications of shellfish dealers,

without specifically naming each one.

For consistency throughout the

regulations, use of the term will remain

unchanged.

FDA agrees, however, that the word

‘‘shipper,’’ as the agency used it in the

proposed regulations, could cause

confusion because that term has a

different meaning in the NSSP Manual

of Operations. Therefore, FDA has

changed the language of the final

regulations to read ‘‘packer or

repacker.’’ The certification number of

the packer or repacker is readily

available to the processor since it is

required, under the NSSP standards, on

each label of shucked product. For

consistency, FDA has modified

§ 1240.60(c) to also read ‘‘packer or

repacker’’ where it had previously read

‘‘processor.’’

153. A few comments stated that

proposed § 123.28(b), which referred to

molluscan shellfish that ‘‘originate from

growing areas that are approved for

harvesting,’’ appears to prohibit

processors from using products from

harvest waters classified under the

NSSP as ‘‘conditionally restricted.’’

Under the NSSP, shellstock taken from

such waters cannot be directly marketed

for human consumption but can be

‘‘relayed’’ to an open growing area for

harvest at a later date. In addition, the

comments pointed out that the word

‘‘approved’’ is a formal classification

designation used in the NSSP. These

comments said that harvesting is

permitted from areas with other than

‘‘approved’’ classifications but would

appear to be prohibited under the

provisions of proposed § 123.28(b). The

comments suggested use of the term

‘‘open’’ growing waters, which would

apply to several different NSSP harvest

area classifications.

FDA agrees that the word ‘‘originate’’,

as used in proposed § 123.28(b), is too

restrictive and has revised this section

to say ‘‘harvested from.’’ With regard to

the word ‘‘approved,’’ FDA concludes

that no change is warranted. The

proposal neither adopted nor referenced

the NSSP growing water classification

system. The phrase ‘‘approved for

harvesting’’ should not be construed to

be limited to those waters classified by

a State under the NSSP as ‘‘approved’’

areas. The phrase ‘‘approved for

harvesting’’ is used in the final

regulations for its common sense

meaning (i.e., those areas from which

harvesting is allowed), which FDA

believes is appropriate.

154. For clarification purposes,

definitions for the terms ‘‘certification

number’’, ‘‘shellfish control authority’’,

and ‘‘tag’’ have been added at

§ 1240.3(s), (t), and (u), respectively.

These definitions are taken directly

from § 123.3.

155. One comment urged that the

regulations be modified to specifically

state that a HACCP plan for raw

molluscan shellfish that contains the

controls specified in subpart C of part

123 is deemed to meet the requirements

of § 123.6.

The agency disagrees with this

comment. The requirements of subpart

C of part 123 are designed to control the

environmental hazards associated with

the harvest waters from which

molluscan shellfish are taken,

particularly those relating to sewagerelated pathogens, chemical

contaminants, and natural toxins. For

this reason, they must be included in

the HACCP plans of all raw molluscan

shellfish processors. However, they are

not intended to control process-related

hazards resulting from, for example,

time-temperature abuse of the product,

improper use of food additives, or metal

fragments. To control these hazards, the

processor needs to follow the general

approach set out in subpart A of part

123. The agency has developed the two

subparts to be complementary and has

strived to eliminate any redundancy in

their provisions. Thus, it is theoretically

possible that a HACCP plan that

contains the controls specified in

subpart C alone of part 123 still might

not meet all the requirements of § 123.6.

FDA has made two modifications in

§ 1240.60(b) for clarity only. Where the

proposed regulations required that the

tag identify the ‘‘* * * place where

harvested * * *,’’ FDA has added, ‘‘(by

State and site).’’ This change makes

§ 1240.60(b) consistent with

§ 123.28(c)(2). Additionally, where the

proposed regulations stated that

improperly tagged or labeled product

would be ‘‘subject to seizure and

destruction,’’ FDA has amended the

language to read, ‘‘subject to seizure or

refusal of entry, and destruction.’’ This

change is to make clear that, for

imported products, the appropriate

regulatory procedure is refusal of entry,

rather than seizure.

O. Compliance and Effective Date

1. Effective Date

FDA proposed that these final

regulations be effective and enforced 1

year after the date that they are

published in the Federal Register. The

purpose of this proposed effective date

was to provide processors with enough

time to develop and implement HACCP

plans. The agency invited comment on

whether 1 year would be adequate.

156. FDA received more than 60

comments about the proposed effective

date. Virtually all comments agreed that

the agency should provide some period

before the regulations become effective.

The comments either agreed with a 1-

year implementation period or

requested a longer period of 2 years or

more. There were also a number of

comments that responded to the

agency’s question about whether

implementation dates should be

staggered based on such factors as size

of firm and level of risk.

A minority of comments stated that 1

year for implementation is adequate.

These comments argued that after 1

year, the industry would have had 3-

years notice of the requirements. The

comments argued that 3 years was

sufficient total time to be informed

about impending regulations. Another

comment stated that one year might be

sufficient for the seafood industry, but

other food industries could need

considerably more time.

Several comments recommended that

FDA provide an implementation period

of longer than 1 year but did not

recommend a specific alternative. These

comments were concerned that HACCP

training would not be completed in time

for a 1-year implementation date; that

foreign processors would need more
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65169

time to implement HACCP; and that 1

year after Canada required HACCP for

its seafood industry, only half of its

firms had complied.

The largest number of comments on

this topic recommended that FDA make

the regulations effective 2 years after

publication. The reason most often cited

was that it will be more than 1 year

before most of the affected firms can

complete HACCP training. The next

most frequently cited reason was that

firms and trade associations needed

more time for HACCP plan

development. Several comments also

discussed the time required to modify

equipment and raise capital; to respond

to initial, voluntary reviews of HACCP

plans by regulatory agencies; and for

Federal, State, and local officials to

understand HACCP and how to enforce

it and to arrange for cooperative

enforcement. A few comments stated

that FDA needs sufficient time to

develop agreements with foreign

countries.

Several comments contended that

more than 2 years should be allowed to

implement the regulation. These

comments mentioned the cultural

change that HACCP will require and

concern about the impact that the

regulations will have on small firms as

well as on large firms with multiple

products and lines. They also

mentioned the time needed for training.

Over 20 comments recommended that

FDA stagger effective dates. A majority

of these comments stated that such a

phased-in start-up should be based on

product risk. The remainder of the

comments split in favor of either

considering both the size of a firm and

the risk from the products it makes or

just the size of a firm.

A smaller number of comments

argued against a staggered start. These

comments expressed the view that small

firms and foreign products should not

be treated differently and pointed out

that all firms will already have had 3

years of notice. Some of these comments

stated that it would be hard to justify

staggering implementation based on risk

when the illness data are so incomplete.

Others expressed the view that

administering a staggered start would

use up valuable resources and only

result in confusion; that staggering

would put some firms at a competitive

disadvantage; and that it might

encourage procrastination.

After fully considering all of these

comments, FDA agrees with the

comments that suggested that a 2-year

effective date is appropriate. Based on

FDA’s participation with the Alliance

that is developing training materials for

this program, FDA has come to realize

that 2 years must be provided to

establish training programs and to give

participants enough time to take them.

Two years is also the minimum time

necessary to train regulatory personnel.

The additional time is also necessary so

that the States will have a full

opportunity to understand and respond

to the effects of these regulations. It will

also increase the likelihood that more

agreements with other countries will

exist.

The additional year will also increase

the opportunity for processors to engage

in ‘‘voluntary’’ HACCP inspections in

advance of the effective date in order to

obtain preliminary, nonregulatory

feedback from the agency on their

progress.

The agency acknowledges that it has

urged the industry to begin preparing

for HACCP well before the issuance of

these final regulations. However, as this

preamble amply demonstrates, a

significant number of questions were

raised as a result of the proposal that

could not be answered until now.

Moreover, the entire support structure

for HACCP, including the issuance of

the first edition of the Guide and the

development of training courses, model

plans, and other forms of technical

assistance that will be useful to the

industry, and especially to small

businesses, will not be in place in time

to permit a 1-year effective date.

On the other hand, more than 2 years

does not appear at this time to be

warranted. The agency is concerned that

additional time would adversely affect

the momentum for this program without

adding significantly to the likelihood

that it will succeed.

On the other hand, FDA is sensitive

to the need to ensure that small

businesses will not incur an

unreasonable threat to their survival by

an effective date that is too short. The

agency intends to monitor the progress

of the industry after the regulations are

published and invites feedback on this

subject. If FDA determines that the

effective date is placing a significant

and unreasonable burden on the

industry, particularly on small

businesses, the agency would be willing

to consider an extension for as much as

one additional year or some form of

additional technical assistance. The

agency would consider whether the

delay is needed for training, drafting

plans, or taking other measures that

directly relate to the installation of a

HACCP system, or whether the time is

needed to comply with existing

CGMP’s, which are a prerequisite for

HACCP. FDA will likely be reluctant to

give firms an extended period of time to

achieve compliance with existing

requirements.

FDA also finds that there is not an

adequate basis at this time for staggering

the starts based on size or risk. The

arguments for and against staggering

generally parallel those for and against

exempting firms from these regulations

altogether on the basis of either size or

risk. These arguments are discussed in

the section of this preamble entitled

‘‘Should Some Types of Processors Be

Exempt?’’ In summary, a good case can

be made that implementation by small

firms should not be delayed because

such firms account for much of the

products with significant potential for

risk, such as cooked, ready-to-eat

products. Moreover, most seafood

processors are small firms. Risk-based,

as opposed to size-based, criteria for

staggering firms would inevitably be

arbitrary to some degree because data

from foodborne illness reporting

systems tend to skew the reports toward

more easily diagnosable illnesses.

The comments received on the subject

of staggering do not provide a ready way

to overcome these problems. Moreover,

the 2-year effective date (rather than 1

year as proposed), guidance, technical

assistance, and training that will be

available to all processors should make

staggering much less necessary than it

otherwise might have been.

As stated above, however, the agency

welcomes feedback on the progress that

processors are making to implement

HACCP that could have a bearing on

whether staggering or an extension of

the effective date would be appropriate,

especially for small businesses.

157. Several comments asked for a

form of staggering based on when an

inspection occurs before the effective

date. These comments stated that

processors who voluntarily submit to

inspection under the regulations before

the effective date and are advised that

their HACCP systems are not yet in

compliance with the regulations should

have at least a 6-month grace period to

correct the problems. The example

given in these comments was that of a

processor who is so advised 1 day

before the effective date and thus is

inevitably out of compliance on the

effective date.

As reflected in the comments,

inspections of HACCP systems before

the effective date will occur because a

firm desires feedback and volunteers for

it when an FDA investigator arrives for

an inspection. That feedback will

constitute informal advice only and will

provide training for the investigator as

well as for the processor. There may be

some advantage to a processor to obtain

feedback and training sooner rather than
65170 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

later, but the results will have no formal

status with the agency and would not

warrant an extension of the effective

date.

The agency has heard considerable

concern that it will automatically seek

to seize or otherwise remove from

commerce all products being produced

under a HACCP system that is

determined to be deficient in any

respect. That concern is unfounded. The

consequence of being out of compliance

with HACCP requirements, on the first

inspection after implementation or

otherwise, is addressed throughout this

section. In summary, FDA’s reaction

will depend, as it does today, on the

overall public health significance of the

deficiency.

2. Public Meetings

158. One comment suggested that

FDA conduct public meetings to explain

the requirements of these regulations to

the seafood processing industry between

the publication date and effective date

of these regulations. The comment also

encouraged a coordination of research,

training, and educational efforts

between industry and FDA in order to

facilitate the implementation of this

HACCP program.

FDA fully agrees with the comment.

It is the intent of the agency to engage

in a dialog with industry, through a

combination of public meetings and

discussions at trade association

meetings, to facilitate a thorough

understanding of the regulations. FDA’s

affiliation with the Alliance reflects the

agency’s commitment to a cooperative

relationship among industry,

government (Federal and State), and

academia in the areas of research,

training, and technical assistance.

3. Penalties for Noncompliance

159. A significant number of

comments, from processors and trade

associations, requested that FDA

address how noncompliance with the

mandatory sanitation control

procedures will be handled. Several of

these comments also requested that FDA

describe the penalties that can be

imposed upon a processor and its

officers for: Failure of a processor to

have and implement a HACCP plan;

noncompliance with sanitation control

procedures; and failure to meet minor

requirements of the regulations, such as

the lack of a signature on a document.

One comment stated that FDA’s legal

authorities and enforcement procedures

do not provide a means for the agency

to respond in a manner that is related

to the severity of deficiencies—that is, a

less severe response to a less significant

deficiency.

FDA has a longstanding practice of

tailoring its regulatory response to the

facts. A deviation from any of the

provisions of these regulations,

including those involving the control of

sanitation, carries the potential for

regulatory action pursuant to section

402(a)(4) of the act. However, FDA

intends to enforce these regulations in a

manner that focuses on those deviations

that have the greatest potential for

causing harm. It is not FDA’s intent to

pursue regulatory action against a

product or a processor exclusively for

clerical errors or minor errors of

omission. To do so would certainly not

be an efficient use of agency resources,

nor would it be in the best interests of

the consuming public.

The penalty provisions for food found

to be adulterated are described at

‘‘Prohibited Acts and Penalties,’’ in

chapter III of the act. The statutory

sanctions that FDA may seek include

seizure and condemnation of a food and

injunction and criminal penalties

against a person (i.e., a firm and its

responsible management).

FDA may also use existing

administrative procedures, such as

warning letters and conferences with a

processor, to bring instances of

noncompliance to the processor’s

attention as it frequently does under its

current inspection programs.

The agency cannot state precisely

what type of action it will take when it

detects a deficiency because FDA

evaluates each deficiency on a case-bycase basis to determine the public

health significance of the violation and

the appropriate response.

4. Preapproval of HACCP Plans

In the preamble to the proposed

regulations, FDA tentatively concluded

that HACCP plans would not have to be

submitted to the agency or otherwise

preapproved before their

implementation by processors. The

reasons for the agency’s tentative

conclusion included: (1) HACCP plans

should be judged in the context of the

processing plant, a process best

accomplished during routine FDA

inspections of processing facilities; and

(2) the agency does not have sufficient

resources to review HACCP plans from

all domestic and foreign seafood

processors in advance of either HACCP

implementation by the processor or the

conduct of HACCP-based inspections by

FDA.

160. Approximately 20 comments

addressed this issue. About two-thirds

of these comments, from consumer

advocacy groups, processors, trade

associations, and State government

agencies, contended that a processor

should be required to file a HACCP plan

and obtain approval from FDA before

implementing the plan. The remaining

comments, from processors, trade

associations, and a foreign government,

agreed with FDA’s tentative conclusion

that HACCP plans need not be

submitted to the agency or preapproved

before they are implemented.

Some of the comments favoring

preapproval argued that FDA should

have control over the design of each

plan before it is implemented to ensure

that all of the CCP’s are identified, and

that appropriate records will be kept.

Other comments contended that, in the

absence of a preapproved plan, a

processor may implement a plan that

FDA would later judge to be inadequate,

possibly raising concerns about the

product already produced under the

plan.

Several comments in opposition to

preapproval argued that it would be too

expensive and difficult for both FDA

and the processors (the latter because

implementation would be delayed while

processors waited for FDA to

preapprove the plan and every

subsequent change to the plan). One

comment expressed concern that, in

formally approving a HACCP plan,

regulatory authorities would assume

some responsibility for the HACCP

system of an individual processor.

A few comments stated that HACCP

plans will evolve as operations are

adjusted, based on the processor’s

verification activities. These comments

argued that a requirement for the

preapproval of HACCP plans would

encumber a processor’s ability to update

its HACCP plan.

The resource situation since the

proposal was issued in January, 1994,

has not changed in any way that would

make the preapproval of HACCP plans

by FDA practicable. Thus, FDA’s

analysis of the comments has focused

on whether a lack of preapproval raises

significant implementation problems

that the agency must address. The

comments have not convinced the

agency that it does. FDA finds that a

preapproval system would unduly

burden the agency’s resources, without

providing significant advantages to the

public health. The effectiveness of a

HACCP plan, including monitoring,

recordkeeping, and verification, can best

be evaluated under actual operating

conditions.

The preapproval of HACCP plans is

distinguishable from the situation for

low acid canned foods, where FDA

reviews submissions of scheduled

processes and revisions to these

processes without hinging that review

on a visual inspection of the facility. For
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65171

low-acid canned foods, the submission

relates solely to the adequacy of the

cooking process to control one hazard

(C. botulinum). This process lends itself

to a paper evaluation.

FDA agrees with the comments that

suggested that a requirement for agency

approval of a processor’s changes to an

existing HACCP plan would

unnecessarily slow the process of plan

improvement. The ability to modify the

plan quickly based on feedback from

verification activities is an important

aspect of HACCP that could be degraded

by a preapproval requirement.

With regard to the concern that the

lack of plan preapproval will expose a

processor to risk of product loss if a

HACCP plan, under which it had been

operating, is deemed by FDA to be

inadequate, the agency advises that

there are several issues that should

mitigate this concern. First, the agency

is committed to providing guidance, in

the form of the Guide, to assist

processors in the development of

HACCP plans that are likely to be

acceptable to the agency. The Guide will

be further discussed later in this section.

Second, FDA is convinced that the

training requirements of these

regulations will serve to inform the

regulated industry about the

expectations of the agency with respect

to HACCP plan content. FDA is working

closely with the Alliance to ensure that

training reflects FDA policy.

Third, FDA recognizes and accepts

that, for HACCP plans to be effective

and efficient, they must be tailored to

the operating conditions of the

individual processor. Of necessity, this

fact means that there may be multiple

ways to control an individual hazard.

Consequently, FDA investigators will be

trained to objectively evaluate the

processor’s HACCP plan from the

standpoint of whether it accomplishes

its intended function (i.e., hazard

control), rather than whether it follows

any preconceived model.

Finally, as described earlier, for the

HACCP program, FDA intends to

respond proportionally to deficiencies

that it finds during inspections. The

nature of the agency’s response will

depend on the totality of the situation

and on the public health implications of

the deficiency. When circumstances

permit, the processor will be given the

opportunity to make appropriate

corrections.

5. Filing Plans With FDA

161. A few comments stated that FDA

should require processors to file HACCP

plans with the agency, not necessarily to

obtain preapproval, but to allow FDA to

compile HACCP plans from all seafood

processors. The comments suggested

that FDA selectively audit a sample of

processor HACCP plans from the file

copies, perhaps based on product risk,

the presence or absence of certain

CCP’s, or other relevant factors. Some of

these comments recommended that FDA

request voluntary submission of plans

prior to the implementation deadline.

A file, or library, of HACCP plans of

all seafood processors would likely

present various benefits from the

standpoint of trend analysis and

program evaluation. The agency finds,

however, that the burdens would

outweigh the benefits, largely for the

same reasons that rule out the

preapproval of plans by FDA. For

example, the library would have to be

updated every time that any processor

updated its plan. Therefore, FDA is not

requiring that processors file their plans

with the agency.

6. Third Party-Approval

162. Several comments urged FDA to

include a provision requiring thirdparty approval of processors’ HACCP

plans, especially if preapproval by FDA

is not required. The comments

suggested that the lack of a requirement

for a processor to use a disciplinary

team approach to develop a HACCP

plan, as suggested by the NACMCF,

coupled with infrequent FDA

inspections, could mean that a

processor might operate for years

without an appropriate plan. The

comments noted that competent

processing authorities are available to

provide third-party plan approvals and

audits.

On the other hand, one comment

argued that a requirement for third party

HACCP plan approval is not necessary.

This comment stated that a

nonregulatory first inspection would

obviate any form of preapproval.

FDA recognizes that some processors

may benefit from obtaining third-party

assistance in developing their HACCP

plans and in evaluating their

implementation. An independent audit

is often helpful in locating problems in

a system and offers the benefit of

bringing in expertise not always

possessed by many seafood processors.

FDA is aware that some processors have

engaged in these kinds of arrangements

in the past and encourages their use.

However, the agency cannot agree that

third party assistance should serve as an

‘‘approval’’ for regulatory purposes.

First, to maximize consistency and fair

treatment, the responsibility for the

initial HACCP plan evaluation (outside

of the processor’s own verification

activities) belongs to FDA, through

routine inspections of processing plants.

Second, establishing, certifying, and

auditing a network of third parties

whose approvals FDA would

automatically accept would impose

significant burdens on the agency that

FDA could not accommodate.

As discussed above, FDA is engaging

in significant efforts to facilitate the

development of appropriate HACCP

plans. The overall high level of policy

guidance and technical assistance that

will be available to processors from FDA

and a variety of other sources should

minimize the incidence of processors

developing and implementing plans that

do not address those hazards that are

reasonably likely to occur. Therefore,

FDA is not providing for third-party

approval of HACCP plans.

7. The First Inspection

In the preamble to the proposed

regulations, FDA tentatively concluded

that, after the effective date of these

regulations, FDA’s review of processors’

HACCP plans and procedures would

occur at the time of the routine

establishment inspection. FDA

requested comment on whether the first

HACCP review should be nonregulatory,

even though the inspection of the

processor would otherwise be

regulatory.

163. Approximately 30 comments,

mostly representing processors and

trade associations, addressed this issue.

All but one of the comments asked that

the first review of a processor’s HACCP

plan and procedures be nonregulatory.

Approximately one-fourth of these

comments further asked that the second

such evaluation also be nonregulatory.

The comments stated that a

nonregulatory visit by FDA would assist

the processor in determining

deficiencies in its plan without fear of

enforcement action and would provide

FDA investigators with hands-on

experience in a HACCP-based

inspection. The comments suggested

that this arrangement would foster a

cooperative spirit between the agency

and the industry and would provide the

time necessary for the investigator to

discuss with the processor how the plan

should be tailored to address the details

of the processor’s operation.

One comment stated that the

initiation of a sweeping, new program

will generate many questions and will

necessitate innumerable judgments on

the part of both processors and

investigators. The comment suggested

that it would be preferable for these

questions and judgments to occur

during nonregulatory visits.

On the other hand, one comment

suggested that the first review of a

processor’s HACCP plan should be
65172 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

regulatory, because once the effective

date has been reached, compliance with

the regulations should be enforced.

FDA agrees with the comments that

suggested that a smooth transition to a

mandatory HACCP system of preventive

controls is more likely the result of

dialogue than regulatory action. For

HACCP to succeed, processors must be

committed to it because they perceive

benefits to themselves from its use other

than simply the avoidance of regulatory

sanctions.

FDA has concluded that a 2-year

effective date, rather than the 1-year

date that was proposed, will provide

substantial opportunity for dialogue.

Moreover, the proportional response to

problems that FDA intends to employ,

taking into account the newness of the

system, should obviate many of the

comments’ concerns about excessive

regulatory sanctions early in the

process. Consequently, FDA concludes

that an officially designated,

nonregulatory first inspection is not

necessary.

FDA has concluded that 2 years is

sufficient time for a processor to train

employees or secure properly trained

consultants, perform a hazard analysis,

develop a HACCP plan, and implement

and evaluate HACCP control procedures

that will comply with these regulations.

The additional year will enable the

agency’s field investigative force and the

industry to begin sorting out many of

the issues that are likely to develop

during implementation.

As stated earlier, the agency intends

to perform informal HACCP evaluations

of willing processors during routine

inspections conducted during the 2-year

implementation period. These

evaluations should serve to aid the

development of both the industry’s

HACCP programs and the agency’s

HACCP inspectional skills. They will

also largely take the place of the

proposed type of nonregulatory

inspections.

FDA agrees with the comment that

pointed out that the initiation of this

program will generate many questions

and issues that will have to be worked

out between processors and the agency.

Moreover, FDA accepts that, despite the

years of groundwork and the pilot

programs that have been the basis for

agency policy decisions to date, there

will be details that will have to evolve

over time as the program is

implemented. It is highly likely that this

evolution will continue well after the

effective date of these regulations. FDA

will take this factor into account in its

initial interactions with processors after

the effective date. The agency may find

it appropriate to use its regulatory

discretion when it finds a basis for

concern about a processor’s HACCP

plan or procedures that relate to a

matter about which policy is still being

formulated.

However, the agency is concerned

that there could be significant problems

if it officially designated its HACCP

review during the first inspection as

being nonregulatory. First, such a step

could create unfair situations. For

example, FDA could find itself in the

position of pursuing regulatory action

against one processor for failure to

adequately control a particular hazard

while, at the same time, treating a

similar deficiency by another processor

as ‘‘nonregulatory.’’ Second, it could

foster actions by firms to avoid

application of the regulations, such as

name changes or reorganizations to

create the argument that the ‘‘new firm’’

is entitled to a nonregulatory inspection.

Third, it is not clear how long such a

policy should last. Arguably, the

reasons in support of a nonregulatory

first inspection become much weaker in

the case of a firm that goes into business

for the first time a number of years after

the effective date of the program.

For all of the foregoing reasons, FDA

has concluded that it can accomplish

the things that led it to inquire about the

possibility of, and the comments to

support, designating the first HACCP

inspection as a nonregulatory inspection

without making such a designation and

creating the problems that such a

designation could cause.

8. Role of the FDA Investigator

164. In the preamble to the proposal,

FDA stated its tentative conclusion that

its investigators would, among other

things, evaluate the adequacy of

processors’ HACCP plans during routine

inspections. A few comments objected

to this role for the investigators. These

comments stated that investigators

should be responsible for verifying that

the processor has performed a hazard

analysis; developed a HACCP plan

where warranted; implemented the

HACCP plan; and recognized, corrected,

and recorded deviations from the

HACCP plan. The comments further

stated that investigators should not be in

a position to challenge the adequacy or

design of a HACCP plan.

The comments pointed out that

HACCP plans are tailored for each

operation, designed by either a company

team or a knowledgeable individual

thoroughly familiar with the operation.

They questioned whether an FDA

investigator would have the expertise to

determine the acceptability of the plan.

Many FDA investigators already have

considerable training in HACCP and

food science, and most have an

academic background in the sciences.

They will also receive training during

the implementation period that focuses

on compliance with these regulations.

The investigators will be exposed to the

Guide, among other sources, for

information about potential hazards to

be considered for particular products

and processes. This exposure, coupled

with investigators’ experience with the

industries with which they work, will

give them a sound basis for making

screening determinations about the

adequacy of processors’ HACCP plans.

There is little doubt that the caliber of

investigator screening decisions will

improve with experience with these

regulations and with exposure to more

and varied processor HACCP programs.

FDA is confident that its field

investigative staff will quickly adjust to

the task of fostering compliance with

these regulations, as they have to past

initiatives.

Where investigators are unsure about

the adequacy of a processor’s HACCP

plan, they will have ready access to, and

will be encouraged to consult with,

district, regional, and headquarters

experts. Investigators will also be

instructed to discuss with plant

management the reasons and scientific

support for hazard analysis and HACCP

plan decisions that are in question.

Where, because of the complexity of a

particular situation, the investigator

cannot reach a decision about the

adequacy of a particular aspect of a

processor’s HACCP plan, the

investigator will be instructed to collect

as much information, including

supporting data, as is necessary in order

to facilitate further agency review.

Therefore, FDA concludes that the

existing system adequately addresses

the concerns of the comments.

9. Disagreements and Appeals

165. A significant number of

comments, primarily from processors

and trade associations, stated that FDA

should have a mechanism to resolve

differences between an FDA investigator

and a processor regarding the adequacy

of the processor’s HACCP plan,

especially given the subjective nature of

the determination as to what the

hazards are that are reasonably likely to

occur and that therefore must be

controlled through HACCP. The

comments contended that a cooperative

discussion between FDA and the

processor’s HACCP experts would be

preferable to an enforcement

confrontation, and that this discussion

would allow a processor to explain its

decisions and procedures. Other

comments urged FDA to formalize an
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65173

appeal process in the regulations that

would establish a processor’s rights to

contest any HACCP compliance action

by FDA. Moreover, these comments

stated that FDA should not take

enforcement action based on a

disagreement in the field between an

investigator and the developers of the

plan.

As previously mentioned, agency

investigators will be instructed to

discuss their concerns about potential

inadequacies in processor HACCP plans

with the management of the firm in an

effort to learn the basis of the firm’s

decisions. If the investigator retains

concern that a plan is inadequate in

some regard even after discussing it

with the firm, the investigator will list

findings on the report that is provided

to the management of the firm at the

conclusion of the inspection

(Inspectional Observations, FDA483).

The FDA483 only represents the

opinion of the investigator and is not

necessarily the final opinion of the

agency. The investigator will document

the processor’s response to, or

explanation of, the findings listed on the

FDA483 report.

It has been longstanding FDA policy

to conduct an internal review of

investigators’ inspectional findings

before initiating regulatory action. There

is an opportunity at each stage for

discussion between the firm and the

agency. These FDA review practices

will not change under a HACCP-based

system.

Based on the foregoing, the agency

concludes that the concern expressed in

the comments about possible

precipitous compliance action as a

result of the findings of FDA

investigators is unwarranted. It is worth

repeating that the agency intends to

engage in conflict resolution through

dialogue wherever possible and

appropriate. Given these facts, FDA has

concluded that a provision for a special

appeals process for matters concerning

these regulations is not necessary.

10. Status of the ‘‘Guide’’

In the preamble to the proposed

regulations, FDA discussed the ‘‘five

preliminary steps’’ to HACCP

recommended by the NACMCF. These

steps lead a processor through a logical

process for identifying hazards that are

likely to occur in a product and for

developing a HACCP plan. In an effort

to facilitate this process, especially for

the many small businesses involved in

seafood processing, FDA is developing

the Guide, a draft of which was made

available shortly after publication of the

proposed regulations. The draft Guide

provides information on hazards and

appropriate controls by species and by

product type. The preamble said that

the information contained in the draft

Guide is the kind of information that

would likely result in a HACCP plan

that is acceptable to the agency. FDA

received considerable comment on the

contents of the draft Guide and intends

to publish a redrafted first edition

shortly after the publication of these

regulations.

166. A number of comments

expressed concern about how the Guide

would be used by FDA investigators

when evaluating a processor’s HACCP

plan. The commenters were troubled by

the prospect that FDA investigators

would not be trained to evaluate HACCP

plans that differ from the Guide, and

that, therefore, they would take

exception to a HACCP plan that deviates

from the Guide. The comments stated

that industry experience with HACCP

demonstrates the need to provide

flexibility so that HACCP plans can be

tailored to the specific operating

conditions of a processor.

Other comments stated that the Guide

did not provide express guidance on the

meaning of the key phrase ‘‘reasonably

likely to occur.’’ The comments stated

that the Guide should clarify whether it

is FDA’s intention that the hazards

identified in the Guide are the

‘‘reasonably likely’’ hazards under all

conditions for the specific species and

processing operations that are listed.

Several comments cautioned that the

Guide should not be characterized as a

‘‘safe harbor,’’ i.e., that FDA should not

promote strict adherence to the Guide

regardless of the circumstances. Such a

characterization, they argued, could

cause processors to omit the critical

hazard analysis step in HACCP plan

development and risk developing plans

that do not fit the conditions of their

processes.

The Guide is, in the agency’s opinion,

a compilation of the best available

information on the subject of hazards

and controls in seafood processing. It

contains FDA’s recommendations as to

the hazards that it believes are

‘‘reasonably likely’’ to occur in specific

species and finished product forms

under ordinary circumstances, but it

also provides information on rarer

hazards as well. FDA recognizes that the

first edition of the Guide must clearly

distinguish between the two.

The term ‘‘reasonably likely’’ is now

effectively defined in § 123.6(a). It is

worth noting that, under § 123.6(a),

whether a hazard is ‘‘reasonably likely’’

will depend, at least in part, on the

circumstances that exist at the time that

the hazard analysis is conducted. For

example, a certain toxin might be rare,

but if it starts presenting itself in fish

and becomes known, it may warrant a

new hazard analysis that may identify it

as ‘‘reasonably likely’’ for a period of

time.

FDA also recognizes that

circumstances may occur in which

hazards will exist that are not identified

in the Guide. These hazards may be the

result of a previously unidentified

phenomenon (e.g., the identification of

a natural toxin in a species previously

not associated with that toxin) or of

unique conditions in the way that the

product is handled by a particular

processor (e.g., unusual equipment or

processing methods). Thus, a definitive

determination of ‘‘reasonably likely to

occur’’ can come only as a result of a

carefully conducted hazard analysis

performed for a specific product under

specific processing conditions.

FDA recognizes that a HACCP

approach requires flexibility and will

endeavor to make the Guide consistent

with such flexibility. FDA will provide

training to its investigators so that they

will be prepared to evaluate a HACCP

plan that is not consistent with the

Guide and to evaluate the effectiveness

of controls that differ from those

suggested in the Guide. The agency

agrees that the Guide is not a ‘‘safe

harbor’’ for all situations. Processors

who utilize the Guide should compare

it to their own circumstances and make

whatever adjustments in the approach

suggested in the Guide that are

necessary.

11. Trade With the EU

167. One comment suggested that,

because of directives issued by the EU,

many processors may need early

recognition of their HACCP programs by

FDA. The comment further suggested

that early recognition could be used by

the agency as a means of training FDA

inspectional personnel.

FDA is aware of the directives of the

EU. The agency intends to consider how

it can best help processors respond to

those directives, among other factors, as

it formulates its plans for

implementation of these regulations.

12. Measuring Program Success

In the preamble to the proposed

regulations, FDA asked for comment on

what tests should be used to measure

the success of the HACCP program as a

whole, and how often those tests should

be conducted.

168. A significant number of

comments stated that indicators of the

success of the seafood HACCP program

could include: A reduction in the

number of seafood-borne illnesses;

improved consumer confidence in
65174 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

seafood consumption; and a reduction

in the number of violative products that

enter the marketplace. Several

comments stated that periodic

inspections of, and sampling at,

processors and importers by FDA, State,

and foreign officials, coupled with

illness reporting from a strengthened

CDC program, would provide adequate

verification of the effectiveness of the

program. However, two other comments

stated that the success of the seafood

HACCP program cannot be measured

solely by a decrease in illnesses,

because many food-borne illnesses are

the result of problems in the retail

sector, which is neither covered by

these regulations nor adequately

regulated by the States.

The agency agrees with those

comments that suggested that the

ultimate goal of these regulations should

be the improved safety of fish and

fishery products—a reduction in the

actual number of seafood-related

illnesses. FDA will continue to closely

monitor the CDC system, as well as

reports of illness and death attributable

to the consumption of seafood that it

receives from other sources, for trends

that may indicate an emerging problem

or the intensification or modification of

an existing problem. However, the

agency also agrees with those comments

that suggested that, because many of the

seafood-related illnesses are attributable

to recreational or subsistence fishing or

to problems in the retail and foodservice sectors (Ref. 7, pp. 2; 15; 27; and

28), improvements in process controls

that result from the implementation of

HACCP may not be fully reflected by a

reduction in the number of illnesses.

Additionally, as has been previously

discussed, the CDC system encompasses

only reported illnesses and is an

imperfect means of judging reductions

in actual numbers of illnesses. FDA is

supportive of a strengthening of the CDC

reporting system.

Based in part on the comments

received, the agency will be looking at

ways to assess a relationship between

success of the HACCP program and

levels of consumer confidence, levels of

violative product in the marketplace,

improvements in the quality and

quantity of preventive controls

throughout the industry; and the results

of FDA and cooperating State and

foreign inspections. As indicated in the

summary of the Regulatory Impact

Analysis elsewhere in this preamble,

FDA is planning to evaluate key features

of this program within the first several

years of implementation. This

evaluation will include an assessment of

its effectiveness.

169. One comment suggested that

end-product testing should be used by

FDA for program surveillance purposes,

particularly for imports. This comment

encouraged FDA to conduct statistically

reliable baseline and monitoring

surveys, modeled after those used in the

MSSP, conducted by NMFS, to: (1)

Determine how often consumer hazards

occur; (2) set specific goals, objectives,

and operational strategies for the

HACCP program; and (3) provide a

means by which the program’s success

can be measured.

FDA has historically collected and

analyzed surveillance samples during

and outside the course of its routine

inspections. The purposes for these

sample collections, in many ways, align

with those suggested by the comment.

The agency is committed to continued

surveillance sampling and intends to

use such sampling in an assessment of

the HACCP program.

170. Another comment suggested that

HACCP will only be successful in

improving confidence in seafood if the

program is accompanied by a consumer

education effort that explains the

benefits of HACCP. The comment

encouraged FDA to perform a baseline

study that assesses the level of

consumer anxiety with respect to

seafood consumption and compare it to

the results of a study that it performs

sometime in the future.

FDA agrees that another major goal of

these regulations is to increase

consumer confidence in the safety of

seafood. The agency recognizes that

publication and enforcement of

regulations aimed at improving seafood

safety alone will not achieve that goal.

Consumers must be informed of the

benefits of producing products under

HACCP preventive controls. Within its

budgetary constraints, the agency

intends to engage in a program of

consumer education for that purpose.

The prospect of baseline and followup

studies of consumer confidence (or

anxiety) will also be considered.

P. Other Issues

FDA received a number of additional

comments that did not address any

specific provision of the proposal,

although some of them were in response

to invitations in the preamble to

comment on various subjects.

1. Relationship to Other Programs

In the preamble to the proposed

regulations, FDA invited comment on

how FDA’s HACCP program for seafood

processors should mesh with existing

State HACCP programs for seafood, in

order to avoid imposing inconsistent

Federal and State HACCP requirements.

In the preamble, FDA acknowledged

that many States are under considerable

pressure to cut back on programs where

there is an overlapping Federal program.

Nonetheless, the agency urged States to

maintain, if not strengthen, their

seafood programs and to work with FDA

to develop an integrated Federal/State,

HACCP-based seafood control program.

171. Approximately 12 comments,

representing processors, trade

associations, and State government

agencies, recommended that FDA

coordinate its HACCP program with

existing State and Federal seafood

control programs. Several comments

emphasized that a coordinated effort

would ensure uniform application and

interpretation of HACCP principles,

while preventing duplication of effort

that wastes limited enforcement

resources. One comment stated that

such a coordinated effort would be

facilitated if only a single HACCP plan

were required for each processing

facility, rather than one that was

designed to meet FDA requirements and

another that would meet State

requirements. Another comment noted

that a multitude of differing HACCP

regulations would only serve to confuse

processors and dilute the effectiveness

of the Federal program. The comment

further recommended that FDA work

with AFDO to promote State laws and

regulations that are compatible with

FDA’s HACCP program.

One comment suggested the formation

of a task force representing the food

industry, FDA, USDA, and DOC to work

towards the goal of reducing regulatory

duplication.

The agency agrees that there is a need

for Federal/State partnership to

facilitate the efficient implementation of

HACCP programs. FDA believes that

coordination with the States would

permit both the agency and the States to

leverage their inspectional resources.

FDA, as well as the States, would

benefit by dividing the workload and

sharing data and other information.

Such coordination would also benefit

industry through consistent inspections

and regulatory requirements.

The agency has already begun to

coordinate its efforts with the States on

seafood. The formation of the Alliance,

to which AFDO is a member, is one

such endeavor. The Alliance is

described in detail in the ‘‘Training’’

section of this preamble.

With FDA’s support, AFDO passed a

resolution supporting the development

of FDA/State partnership agreements at

its 1994 meeting in Portland, ME (Ref.

220). The resolution specifically

recommended that HACCP be the basis

of such partnerships and noted the
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65175

shared roles of FDA and State regulators

in seafood safety, the limited resources

of both levels of government, and the

existence and the potential impact of

the Alliance.

Meanwhile, FDA is increasing its use

of partnership agreements with State

enforcement agencies. For instance, the

Northeast Region of FDA has entered

into a threeway partnership agreement

with the Northeast Food and Drug

Officials Association and individual

States to provide industry with HACCP

training at the retail level. FDA also

expects to enter into partnership

agreements with States to implement

HACCP pilot programs for foods other

than seafood. FDA’s Northeast Region

has already signed such an agreement

with the Commonwealth of

Massachusetts, and more are

anticipated.

These initiatives demonstrate the

agency’s desire to coordinate its efforts

with the States. The agency’s

cooperative efforts in the area of HACCP

reflect a trend. The agency has used

cooperative efforts in other areas, such

as pesticide sampling and workplan

sharing. FDA will continue to explore

ways to coordinate the Federal and State

role in the regulation of seafood.

172. A number of comments

recommended that States act as the

primary enforcement agencies for these

HACCP regulations, while FDA’s

responsibility would be to evaluate the

States’ compliance with HACCP

inspection protocols. Some of these

comments suggested that such a

program could be patterned after the

NSSP.

FDA is adopting these HACCP

regulations to implement and enforce

the act. While FDA plans to work

cooperatively with the States in all ways

possible, the agency cannot delegate its

authority under the act. It is possible

that in some aspects of seafood

processing, the States will serve as the

primary enforcement agencies, with

FDA serving primarily an auditing

function. However, responsibility for

enforcing the act and these regulations

must remain with FDA.

173. A number of comments, from

processors, trade associations, and one

consumer advocacy group, maintained

that FDA’s HACCP regulations should

preempt any existing State HACCP

programs. The comments contended

that Federal preemption would

ultimately reduce confusion caused by

conflicting State programs, reduce costs,

and promote uniformity. Examples of

the specific areas of conflict were not

provided by the comments.

As was previously stated, FDA

intends to work through AFDO and

through Federal/State partnerships to

seek consistency in State regulatory

approaches to HACCP for seafood

inspection and through the NSSP

process and the ISSC to attain this goal

specifically for molluscan shellfish.

Moreover, processors in each State must

comply with Federal HACCP

requirements if their product moves in

interstate commerce. For these reasons,

the agency has concluded that there is

no need for Federal preemption of State

regulatory requirements.

174. Several comments encouraged

FDA to work closely with NMFS to

coordinate FDA’s program with the

existing NMFS’ HACCP program. The

comments noted that cooperation with

NMFS would help the two agencies

avoid wasteful duplication of effort and

would reduce the burden on those firms

already operating under the NMFS

program.

FDA agrees with these comments and

notes that FDA and NMFS are

coordinating their HACCP programs to

ensure compatibility. Nonetheless, FDA

advises that the NMFS program is a

voluntary, fee-for-service program and is

likely to continue to include features

that go beyond the requirements of these

regulations, especially in the area of

preventive controls for economic fraud

and plant and food hygiene.

A 1974 MOU between FDA and

NMFS recognizes the respective roles of

the two agencies and commits the two

agencies to consistency and

cooperation. FDA will continue to work

with NMFS to maintain a coordinated

Federal effort.

2. ‘‘Whistleblower’’ Protection

175. A few comments urged that these

regulations include ‘‘whistleblower’’

protection for employees of seafood

processors. Whistleblower protection is

designed to protect workers from being

fired or otherwise discriminated against

for revealing wrongdoing by their

employers. The wrongdoing in this case,

presumably, would likely involve the

falsification of HACCP records. The

comments argued that: ‘‘Whistleblowers

are iispensable as the eyes and ears for

overextended FDA personnel making

limited spot checks. The public’s line of

defense will be no stronger than the

shield protecting industry worker’s

rights to obey and help enforce this

law.’’

One concern that FDA has heard

about the credibility of a HACCP system

is that important records can be

falsified. It is alleged that, without

whistleblower protection, it is much

less likely that the agency will know

about falsifications.

While the agency is confident, based

in part on its experience reviewing

records in the low-acid canned food

program, that it can detect falsification,

FDA also expects from experience that

it will be alerted to possible wrongdoing

from time to time by employees of

processors even in the absence of

whistleblower protection. FDA has

received, and acted upon, confidential

information from employees of

regulated firms for decades. This

assistance has proven invaluable on

many occasions. The only protection to

these employees available from FDA has

been confidentiality.

The question raised by the comments

is whether, in addition to the actions

against the product or the processor that

would be available to FDA as a result of

violations of the requirements of the act

and these regulations, there must be

specific protection for employees in

order for the program to succeed. The

agency has concluded that, like other

FDA programs, this program can be

successful in the absence of specific

whistleblower protection, and that

congressional action would be necessary

to provide protection other than

confidentiality.

FDA cannot provide whistleblower

protection in these regulations. FDA

believes—and case law bears out—that

there must be a nexus between the

conduct being required by regulations

and the focus of the underlying statute,

in this case primarily section 402(a)(4)

of the act. An analysis of the application

of section 402(a)(4) of the act to these

regulations can be found in the ‘‘Legal

Basis’’ section of this preamble.

While FDA has determined that an

assessment of processing risks and a

plan that ensures that these risks are

minimized has the requisite nexus to

section 402(a)(4) of the act, and that this

nexus justifies adopting these

regulations, the agency does not see a

sufficient nexus between whistleblower

protection and the prevention of

adulteration of food. If a firm retaliates

against an employee who brings

complaints or other information about

the firm to FDA, the implication of such

an action is that there is a condition at

the firm that may need investigation,

not that the products produced by the

firm are necessarily adulterated. It may

be the case that the products are

adulterated, but such a conclusion does

not flow as directly from section

402(a)(4) of the act as does the

conclusion that seafood products not

produced under a HACCP plan have

been produced under insanitary

conditions whereby they may have been

rendered injurious to health. For this

reason, FDA concludes that it lacks
65176 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

clearcut authority to provide

whistleblower protection in these

regulations.

3. Separation of Quality Control (QC)

and Production

176. A few comments requested that

the regulations mandate structural

independence within a processing firm

between ‘‘HACCP QC [quality control]

personnel’’ and ‘‘production’’

personnel. Otherwise, according to the

comments, ‘‘HACCP QC personnel

could still be hired and fired by a

production supervisor.’’

FDA does not believe that a change in

the regulations would be beneficial in

this regard. It is important to recognize

that, under HACCP, production

personnel are the observer/operators

who perform the initial monitoring of

CCP’s as well as the recordkeeping that

documents the results of this

monitoring. The operation of the

HACCP system must involve the whole

organization, not just QC personnel.

However, it is reasonable to expect

that, where practical, verification

activities should be performed by

individuals other than those who made

the records in the first place. For

verification, the agency encourages the

kind of organizational separation that is

being urged in the comments.

The agency recognizes, however, that

many seafood companies will not be

large enough to have distinct,

independent organizational units that

can verify each other’s work. The

seafood industry is characterized by

small businesses. FDA has concluded

that such a requirement is not practical

for this industry.

It is worth noting that the regulations

at parts 113 and 114 for low-acid

canned foods and acidified foods

contain recordkeeping requirements and

some verification requirements that are

similar to the provisions of these

regulations. In certain respects, parts

113 and 114 served as models for the

seafood HACCP program. Those

regulations have succeeded even though

they do not require a separation

between QC personnel and production

personnel. Given this history, the

agency is reluctant to mandate the

internal structure of seafood processors.

4. Education

177. FDA received a number of

comments on the subject of seafood

safety education. These comments were

in response to an invitation in the

preamble to the proposed regulations for

comments on risk reduction activities

that could be regarded as

complementary to HACCP, primarily

directed toward postprocessing

handling. In addition, FDA asked for

comment on appropriate education and

information that should be directed

toward consumers and recreational

fishermen, even though education

aimed at these groups is actually outside

the scope of this rulemaking. FDA made

this request based on a recognition that

HACCP cannot reasonably be expected

to solve every problem. The agency

recognizes that HACCP must be

integrated into a comprehensive

program for seafood safety. Education is

another important component of that

program. As one comment noted:

* * * the responsibility for seafood safety

should be met at every level of seafood

distribution, from harvesters to processors to

retailers, restaurants and, finally, the

consumers themselves. Regulations are not a

substitute for informed and responsible

behavior and it is impractical to extend the

scope of the proposed regulations to

everyone involved in handling and

consuming seafood.

The comments overwhelmingly

endorsed the value of education. They

strongly supported education for: (1)

Consumers on the handling and

purchasing of seafood, especially

through brochures at the point of

purchase and information available at

pharmacies, and on the significance of

HACCP, especially with regard to the

government’s verification role; (2)

recreational fishermen, provided by the

State during licensure (with guidance

from the Federal government) and

through articles in popular fishing and

outdoors magazines; (3) subsistence

fishermen; (4) retailers, including food

service and restaurants.

FDA greatly appreciates these

comments. The agency agrees that

education is an essential

complementary activity to HACCP as

well as to other aspects of FDA’s overall

seafood program. The comments will be

taken into account as the agency

develops its educational program.

178. FDA also invited comment on

whether the agency should consider

proposing to require handling

instructions for consumers on the

labeling of seafood. Any action that FDA

were to take along these lines would be

as part of a separate rulemaking.

The agency received about 20

comments on this issue. Approximately

half of those comments supported the

notion of mandatory safe handling

instructions. One business noted that

safe handling instructions would help to

ensure the safety of a product through

the distribution chain, while another

business said that such instructions had

a real potential to decrease seafoodrelated illness. One individual

commented that safe handling

instructions would increase consumer

confidence in these products. One

industry comment noted that a task

force composed of industry, Federal and

State agencies, and consumers should

agree on the appropriate statement.

Some comments indicated that safe

handling instructions might be

appropriate for high-risk products.

The remainder of the comments on

this issue disagreed that safe handling

instructions for seafood should be

required by FDA. Many of these

comments noted that most seafood

products include such instructions

voluntarily. One trade association

commented that such a requirement

would limit retailers’ flexibility and

creativity and impose significant new

costs on retailers and consumers. Most

of those comments noted that requiring

new information would detract from

other labeling requirements.

FDA appreciates these comments and

the different points of view that they

represent. The agency will use the

comments in its deliberations on this

issue.

179. Finally, FDA described some of

its educational efforts aimed at

medically compromised individuals

about avoiding raw molluscan shellfish

and invited comment on types of

education and information activities

that might be useful in this regard. The

agency received about a dozen

comments on this subject.

Most of these comments addressed

whether there should be mandatory

warning labeling for raw molluscan

shellfish. A majority of the comments

stated that the agency should require

warning labeling. Three comments from

consumer groups stressed the need to

protect high-risk individuals. One State

government commented that warnings

for raw molluscan shellfish should be

tied to specific locations and times of

year. One professional association

requested that the warning state that the

shellfish should only be eaten if it is

certified and tagged.

Three comments stated that warning

labels would be inappropriate. One

comment noted that shellfish are not

consumed in enough quantity to be a

problem. Another comment stated that

warning labels would unduly alarm

those not at risk and that better channels

exist for educating those at risk.

A few comments did not specifically

address warning labels but

recommended that FDA target advice

directly to compromised individuals.

Those comments suggested that FDA

direct information to the medical

community involved in the treatment of

those individuals.
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65177

Again, FDA thanks the comments for

providing views on a matter that is

outside the scope of this rulemaking.

FDA is working to provide information

to at-risk populations and its strategy on

how best to do so is evolving. The

agency will take the comments into

account as it develops policy in this

area.

In summary, the agency agrees that

education is an essential

complementary activity to HACCP as

well as to other aspects of FDA’s overall

seafood program. The comments

relating to education will be useful to

the agency as it develops its education

programs.

5. Traceback Mechanisms

180. One comment recommended that

FDA develop and incorporate methods

to trace back fish and mandate such

traceback in these regulations. The

comment described the use of bar codes

and computer-based tracking numbers

by a meat products company that enable

it to trace a specific cut of meat from a

store or restaurant to its source.

The agency acknowledges that

traceback to the water would be useful

for certain species of fish associated

with certain hazards, e.g., ciguatoxin.

On the other hand, traceback to the

water for scombrotoxin would not be

particularly useful, although traceback

through the distribution chain to find

out the source of mishandling would be

useful. The agency urges the industry to

consider this comment. FDA advises

that it is willing to explore this idea

further, although not as part of this

rulemaking.

6. Tribal Governments

181. FDA received a few comments on

the effect of these regulations on tribal

governments. The preamble to the

proposed regulations noted that

Executive Order 12875 of October 26,

1993, requires, among other things,

consultation with tribal governments

before the formal promulgation of

regulations containing unfunded

Federal mandates. While FDA does not

believe that these regulations impose an

unfunded Federal mandate, the agency

wishes to foster consultation on matters

that might significantly affect tribal

communities. Consequently, FDA

requested comment on the economic

effect of the regulations on tribal

governments.

FDA received no comments from

tribal governments. One comment, from

a tribal business, stated that the impact

of the regulations on tribal governments

will be beneficial because they will

result in safe products, positive

consumer perceptions, and positive

market impacts. The other comment that

mentioned this subject was from an

academic, who expressed the view that

the regulations will have a major impact

on tribal groups involved in fisheries

and contains unfunded Federal

mandates. The comment did not

elaborate. Neither of these comments

justifies any change in these regulations.

The agency remains interested in

fostering consultation with tribal

communities as they see fit and

encourages correspondence from tribal

governments.

7. HACCP System Improvements

182. A comment urged that there be

a process to continually amend or

update these regulations.

FDA points out that such a

mechanism exists in its regulations.

Under § 10.30 (21 CFR 10.30), interested

persons are provided with a process by

which they can petition the agency to

amend and update these regulations.

From a less mechanistic viewpoint,

the agency recognizes that these

regulations represent a pioneering

program that has not been attempted

before. While the agency believes that

sufficient groundwork has been laid to

adopt these regulations and to begin to

implement them, FDA also

acknowledges that full scale

implementation will reveal

modifications that may be necessary,

both in the short and long terms.

Consequently, the agency will be highly

receptive to feedback from all parties

who are affected by these regulations

and will remain open to changes that

are necessary in the regulations. The

‘‘Verification’’ section of this preamble

reflects the agency’s interest in

evaluating this program.

183. A number of comments asked for

improvements in the foodborne-illness

reporting system operated by CDC.

Some comments urged collaboration

between FDA and CDC. One comment

advocated the creation of an active

reporting system.

These comments are essentially

outside the scope of this rulemaking.

Nonetheless, the agency recognizes that

the strength of the foodborne-illness

reporting system bears directly on the

ability of the agency to measure the

public health impact of HACCP. Both

FDA and CDC agree that underreporting

is an undesirable feature of the current

system. FDA and CDC have been

collaborating on an active-type reporting

system. The limiting factor, however,

will always be resources. Significant

improvements in the current system

will involve considerable expense.

184. One comment provided views on

factors that would limit the

effectiveness of HACCP. The comment

cited:

[P]oor commitment by company

management and lack of allocation of

necessary resources; improper training; lack

of understanding and planning in all stages

of implementation of a plan[,] and failure to

recognize the need to understand the

corporate culture change which must

accompany an effective HACCP program.

FDA agrees with this comment but

hopes that company management will

embrace HACCP and recognize the

benefits that it offers to the firm.

III. Paperwork Reduction Act of 1995

This final rule contains collections of

information that are subject to review by

the Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995 (Pub. L. 104–13). The title,

description, and respondent description

of the information collections are shown

below along with an estimate of the

annual recordkeeping and periodic

reporting 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 the collection of information.

Title: Reporting and recordkeeping

requirements for processors and

importers of fish and fishery products

under the provisions of 21 CFR parts

123 and 1240. Procedures for the Safe

and Sanitary Processing and Importing

of Fish and Fishery Products.

Description: This regulation

implements the use of Hazard Analysis

and Critical Control Point (HACCP)

methodology to ensure that processed

and imported fish and fishery products

are safe within the meaning of sections

402(a)(1) and 402(a)(4) of the Federal

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

342(a)(1) and 342(a)(4)).

Description of Respondents:

Businesses or other for profit

organizations.

Although the January 28, 1994,

proposed rule provided a 60 day

comment period (extended to 90 days in

the April 7, 1994, Federal Register, 59

FR 16578) under the Paperwork

Reduction Act of 1980, and this final

rule incorporates the comments

received, as required by 44 U.S.C.

section 3507(d), FDA is providing

additional opportunities for public

comment under the Paperwork

Reduction Act of 1995, which applies to

this final rule and was enacted after the

expiration of the comment period.

Therefore, the agency solicits public

comment on the information collection

requirements in order to: (1) Evaluate

whether the proposed collection of

information is necessary for the proper
65178 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

performance of the functions of the

agency, including whether the

information will have practical utility;

(2) evaluate the accuracy of the agency’s

estimate of the burden of the proposed

collection of information, including the

validity of the methodology and

assumptions used; (3) enhance the

quality, utility, and clarity of the

information to be collected; and (4)

minimize the burden of the collection of

information on those who are to

respond, including through the use of

appropriate automated, electronic,

mechanical, or other technological

collection techniques or other forms of

information technology, e.g., permitting

electronic submission of responses.

Individuals and organizations may

submit comments on the information

collection requirements by February 16,

1996, and should direct comments to

FDA’s Dockets Management Branch

(address above).

Prior to the effective date of this final

rule, FDA will publish a notice in the

Federal Register when the information

collection requirements in this rule are

submitted for OMB approval, and again

when OMB makes a decision to

approve, modify or disapprove the

information collection requirements.

Sections of this final rule require that

certain businesses collect information

and keep records. Under Public Law

104–13 Federal agencies are required to

estimate the hours and costs attributable

to collections of information, as defined

in 44 U.S.C. 3502(3), that are required

by Federal regulation. Table 1 sets forth

an estimate of the hours that are

required annually for compliance with

each section in part 123 that requires

regulated entities to collect or record

information.

TABLE 1.—ESTIMATED AVERAGE ANNUAL INFORMATION COLLECTION AND RECORDKEEPING BURDEN

21 CFR

No. of respondents

No. of responses

per respondent 1

Hours per

response 2

Total

hours

123.6(a),(b),(d) ................................................................................................................................. 4,850 1 16 77,600 3

123.6(c)(5) ........................................................................................................................................ 4,850 4 0.3 5,280

123.8(a)(1),(c) .................................................................................................................................. 4,850 1 4 19,400

123.12(a)(2)(ii) .................................................................................................................................. 1,000 80 0.2 16,000

123.6(c)(7) ........................................................................................................................................ 4,850 280 0.3 470,400

123.7(d) ............................................................................................................................................ 1,940 4 0.1 1,940

123.8(d) ............................................................................................................................................ 4,850 47 0.1 22,795

123.11(c) .......................................................................................................................................... 4,850 280 0.1 135,800

123.12(c) .......................................................................................................................................... 1,000 80 0.1 8,000

123.12(a)(2) ...................................................................................................................................... 20 1 20 4,000 3

123.10 .............................................................................................................................................. 24 1 24 116,400 3

First year total burden hours .................................................................................................... ................ ................ ................ 877,615

Annual recurring total hours ..................................................................................................... ................ ................ ................ 679,615

1Based on an estimated average of 280 working days per year.

2Estimated average time per 8 hour work day unless one time response.

3 Nonrecurring burdens.

The above estimates include the information collection requirements in the following sections:

123.16 Smoked Fish—process controls (see 123.6(b))

123.28(a) Source Controls—Molluscan Shellfish (see 123.6(b))

123.28(c),(d) Records—molluscan shellfish (see 123.6(c)(7))

123.9 Records control general (see recording and records)

The time and costs of these activities

will vary considerably among

processors and importers of fish and

fishery products, depending on the type

and number of products involved, and

the nature of the equipment or

instruments required to monitor critical

control points. The burdens have been

estimated using the typical small

seafood processing firm as a model

because these firms represent a

significant proportion of the industry.

The burden estimate in Table 1

includes only those collections of

information under this rule that are not

already required under current statutes

and regulations and are being added by

this rule. For example, the current good

manufacturing practices provisions in

21 CFR part 110 already require that all

food processors ensure good sanitary

practices and conditions, monitor the

quality of incoming materials, monitor

and control food temperatures to

prevent bacterial growth, and perform

certain corrective actions and

verification procedures.

In addition, the estimate does not

include collections of information that

are a usual and customary part of

businesses’ normal activities. For

example, the tagging and labelling of

molluscan shellfish (§ 1240.60) is a

customary and usual practice among

seafood processors. Consequently, the

estimates in Table 1 accounts only for

new information collection and

recording requirements attributable to

part 123.

There are no additional capital costs

associated with this regulation that are

not also attributable to the preexisting

requirements of part 110.

FDA estimated in the proposal that

the total burden to all respondents

would be 2,826,850 hours. That

estimate, however, significantly

overestimated the burden because it

included activities performed by

domestic processors that are not related

to information collection and

recordkeeping, and, more significantly,

did not account for existing regulatory

requirements and usual and customary

business practices, as described above.

The agency has recalculated the

recordkeeping burden in a manner that

is more consistent with the intent of

Public Law 104–13. Therefore, the

burdens presented in Table 1 are those

actually associated with collecting and

recording the pertinent HACCP

information. The burdens for HACCP

plan development, plan reassessment,

and record review are also included in

the recalculated burden. In estimating

the time for the preparation of a HACCP

plan, the agency believes that a

significant portion of the training hours

can also be characterized as time spent

on preparation of the plan.

Additionally, the agency recognizes

that the regulations will place a burden

on seafood importers. For this reason,

FDA has included in the burden
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65179

estimate the time necessary for

importers to develop a written

verification plan, verify compliance of

imports, and keep records of their

verification activities.

Few comments provided information

on the number of hours that a processor

would expend on information collection

and recordkeeping, as described in the

preamble to the proposed regulation.

One comment estimated that the annual

burden would vary from 200 to over 700

hours, depending on the type of

product, and another comment

suggested that one hour per day, or 365

hours per year, would be required. One

comment stated that the agency’s

estimate of 650 hours per year was

reasonable. Another comment estimated

four to five hours per day, or 1,820

hours per year as the likely burden.

None of these comments provided

information to support how the

commenters arrived at their estimates.

It seems likely that the estimates

suggested by the comments were

calculated based on the same errors that

the agency made in the proposal, that is,

by combining the burdens associated

with HACCP data collection and

recordkeeping with other HACCP

activities unrelated to information

collection and recordkeeping, with

usual and customary information

collection and recordkeeping practices,

and with collections of information

required by the provisions of the

Federal Food, Drug, and Cosmetic Act

and implementing regulations. This

conclusion is supported by the fact that

some of the comments expressed

agreement with the agency’s

calculations. For these reasons, FDA

concludes that no changes in its

corrected calculations are necessary to

respond to the comments.

IV. Economic Impact

A. Introduction

In accordance with Executive Order

12866 and the Regulatory Flexibility

Act, FDA has examined the impacts of

the final rule. Executive Order 12866

directs agencies to assess all costs and

benefits 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). The Regulatory Flexibility Act

(Pub. L. 96–354) requires analyzing

options for regulatory relief for small

businesses.

The Unfunded Mandates Reform Act

(Pub. L. 104–4) requires (in section 202)

that agencies prepare an assessment of

anticipated costs and benefits before

proposing any rule that may result in an

annual expenditure by State, local and

tribal governments, in the aggregate, or

by the private sector, of $100,000,000

(adjusted annually for inflation). The

Unfunded Mandates Reform Act also

requires (in section 205) that the agency

identify and consider a reasonable

number of regulatory alternatives and,

from these alternatives, select the least

costly, most cost-effective, or least

burdensome alternative that achieves

the objective of the rule. Even though

FDA finds that the costs of this final

rule may be below $100 million a year,

estimating these costs is a difficult task

involving uncertainties. This analysis,

together with the preamble published in

the Federal Register and supporting

analysis and materials, constitutes a

final RIA. Therefore, FDA has treated

the final rule as an economically

significant regulatory action under

Executive Order 12866. Consequently,

the agency has completed this full RIA

which demonstrates that this rule is

consistent with the principles set forth

in the Executive Order and in these two

statutes. In addition, this document has

been reviewed by the Office of

Management and Budget as an

economically significant regulatory

action under Executive Order 12866.

FDA has concluded that the net benefits

of this rule (benefits minus costs) are

largest for the regulatory option selected

as specified by Executive Order 12866.

FDA has also concluded that, pursuant

to the Unfunded Mandates Act, the

regulatory option selected is the least

burdensome option to accomplish the

goal of controlling all physical,

chemical, and microbiological hazards

reasonably likely to be present in

seafood.

As a part of the preamble to the

proposed regulation, FDA published a

summary of the Preliminary Regulatory

Impact Analysis (PRIA) and placed on

file with FDA’s Docket Managements

Branch the complete PRIA. In addition,

FDA has placed the full final Regulatory

Impact analysis on file at Dockets

Management Branch (address above).

FDA has fully reviewed the

information on which the PRIA was

based, the comments on the PRIA, and

other available information on the costs

and benefits of HACCP for the seafood

industry. Based on this review, FDA has

arrived at two estimates of the costs in

this final rule as well as upper and

lower estimates of benefits. As can be

seen in the agency’s summary of costs

and benefits are summarized in Table 2,

FDA believes that the costs of the final

rule will range from $677 million to

$1.488 while the benefits will range

from $1.435 to $2.561 billion. In its final

analysis, the agency maintains that the

total benefits of this mandatory seafood

HACCP rule will exceed the total costs.

Regulatory Options

The agency raised and received

comment on a number of regulatory

options in the PRIA. The most

significant two options raised were

regulating only high risk products or the

most serious hazards and providing

regulatory relief for small businesses.

The first option is inconsistent with the

objective of this regulation, to control all

physical, chemical or microbiological

hazards reasonably likely to be found in

seafood products. Although FDA has

not granted relief only for small

business, the agency has extended the

compliance date for all firms from 1

year to 2 years.

TABLE 2.—SUMMARY OF TOTAL COSTS AND BENEFITS

Year

Costs from

FDA models

(millions)

Costs adjusted

from NMFS

model (millions)

Benefits lower

(millions)

Benefits upper

(millions)

1 ....................................................................................................................... $69 $162 $73 $108

2 ....................................................................................................................... 42 9173 108

3 ....................................................................................................................... 41 83 85 156

4 ....................................................................................................................... 38 80 87 158

Total1 ..................................................................................................... 677 1,482 1,435 2,561

1The total defines the total discounted costs and benefits beyond the 4th year and discounted at 6 percent.
65180 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

B. Costs

In the PRIA, FDA was reluctant to rely

only on results of the limited experience

with HACCP in the seafood industry.

FDA balanced the reports of some

seafood firms, which showed that the

costs of HACCP were low, with a study

of the costs of HACCP that had been

done under contract with NMFS by A.

T. Kearney, Inc. (Contract No.

NA88AA–H–SK006). This study

showed significantly higher costs (as

reflected in the range of cost estimates

summarized above) but had several

flaws that engender skepticism about its

results as well. For example, none of the

plants that were the subjects of the

study had actually implemented

HACCP, and the system whose costs

were studied was significantly more

demanding than the system embodied

in the 21 CFR part 123. Despite these

facts, the cost estimates in the PRIA

were based on the results of the NMFS

study because FDA considered it to

represent the best evidence available at

that time.

As explained more fully below, FDA

used modeling technique and the

experience reported about seafood firms

to produce estimates that are in general

agreement and that are approximately

one-fourth of those estimated in the

NMFS study reported in the PRIA.

In estimating the costs in this PRIA,

there are three checks that have helped

ensure the accuracy of the costs that

would be imposed by adoption of this

regulation. The first is the cost

comments, but these, the agency’s

analysis revealed, were in most cases

rather general, not well supported, and

of only marginal assistance. The second

is modeling by FDA experts based on

their experience with the use of HACCP

in the seafood industry; working with

aquatic species and the public health

problems that they present; inspecting

and studying both seafood plants and

low acid canned food plants (which

have operated under HACCP principles

for almost two decades); and

participating in the FDA–NMFS seafood

pilot. The results of this modeling are

detailed below. The third source is

information that FDA received from

firms that have actually implemented

HACCP. Even though FDA finds that the

costs of this final rule may be below

$100 million, estimating these costs is a

difficult task involving some

uncertainties. The agency recognizes

that the rule may affect in a material

way a sector of the economy. Therefore,

FDA has treated the final rule as a

significant regulatory action under

Executive Order 12866. Consequently,

the agency has completed a full

Regulatory Impact Analysis.

The agency received approximately

230 comments on issues involving the

PRIA. These comments are fully

summarized and addressed in the full

RIA which is included in the record as

Reference 229. However, because of the

problems with these comments noted

above, FDA did not generally use them

in the revised estimates reported here

and in the full RIA. The reasons for this

are more fully explained in the full RIA.

These adjusted NMFS model cost

estimates result in per plant costs for

domestic manufacturers of $23,000 in

the first year and $13,000 in subsequent

years. Total costs for compliance with

these regulations using the adjusted

NMFS data are shown in Table 3. FDA

has also concluded that the PRIA

represents a reasonable upper estimate

of the costs of HACCP. Table 3 also

summarizes the specific cost estimates

that FDA arrived at using data from the

NMFS model with cost refinements

received from commenters and FDA

seafood industry experts.

TABLE 3.—DISAGGREGATED COSTS

FROM ADJUSTED NMFS MODEL

Million

1st Year:

Domestic manufacturers and Importers ..................................... $112

Major plant repair and renovation 13

Sea Grant expertise .................... 1

Repackers and warehouses ....... 14

Harvesters for rejected raw product ............................................ 1

Shellfish vessels ......................... 3

Foreign processors ..................... 18

Total ..................................... 162

2d Year:

Domestic manufacturers ............. 65

Sea Grant expertise .................... 1

Repackers and warehouses ....... 14

Shellfish vessels ......................... 1

Foreign processors ..................... 10

Total ..................................... 91

3d Year:

Domestic manufacturers ............. 65

Sea Grant expertise .................... 1

Repackers and warehouses ....... 14

IQF Shellfish plants ..................... 3

Total ..................................... 83

4th Year:

Domestic manufacturers ............. 65

Sea Grant expertise .................... 1

Repackers and warehouses ....... 14

TABLE 3.—DISAGGREGATED COSTS

FROM ADJUSTED NMFS MODEL—

Continued

Million

Total ..................................... 80

Total discounted costs beyond the 4th year

and discounted at 6 percent, the costs are

$1,482 million.

1. Alternative Model for Estimating the

Costs

In addition to the cost estimate based

on the NMFS modeling, FDA is

presenting a second cost estimate for

these regulations. The uncertainties

associated with the choices made by

seafood processors to control hazards

justify providing a range of potential

costs based on more than one model.

In examples created by seafood

experts within FDA, the cost of

compliance with these regulations was

estimated for two small hypothetical

seafood processors that the agency

believes to be representative of a

significant portion of the seafood

industry. One of the plants is assumed

to be in substantial compliance with

existing CGMP requirements. Therefore,

the costs experienced by that plant are

attributable exclusively to the

establishment and maintenance of a

HACCP system. The other plant has

some CGMP deficiencies that the agency

believes are typical of those displayed

by seafood processors. This plant is

identical to the first plant except for the

CGMP deviations. The costs calculated

for this second plant represent the cost

associated with the establishment and

maintenance of HACCP as well as costs

associated with the correction and

monitoring of sanitation conditions.

The models concern two plants that

cut and package tuna which is received

frozen and that also distribute orange

roughy fillets. The complexity of the

processing operations, and the nature

and number of hazards, are assumed to

be roughly equivalent to that of the

other types of operations. FDA

recognizes the difficulty in validating

these assumptions. Nonetheless, the

results demonstrate that processors may

have costs that are significantly below

the averages estimated by means of the

NMFS report. As discussed later, data

received from firms that have

implemented HACCP are generally

supportive of the results of this

modeling.

a. Small plant cost example 1. This is

the example of a firm that is a processor

of frozen tuna steaks and distributor of

imported orange roughy fillets who

receives all fish frozen. This plant is
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65181

located in a major seafood processing

region, so there is no need for plant

personnel to travel to other cities to

receive training as it would be available

locally. This processor operates 280

days per year. The plant manager is paid

$15 per hour and production workers

are paid $8.50 per hour. No food safety

hazards are reasonably likely to occur in

orange roughy, so a written hazard

analysis shows hazards for tuna only.

This processor has no need to make

CGMP improvements so the plant costs

are limited to the following:

(1) Training—($760). This is

calculated as follows: $400 tuition plus

the opportunity cost of training time

($24 hours x $15 per hour). The

processor is expected to do most of the

hazard analysis during the class.

(2) HACCP Plan Refinement—($240).

This is calculated by taking 16 hours

billed at $15 per hour using the FDA

Fish and Fishery Products Hazards and

Controls Guide.

(3) Plant Sanitation Audit—($0). This

is done 3 times daily for 20 minutes

each time. However, because the firm is

modeled as being in compliance with

existing CGMP’s, it is assumed that

these audits are already being done. It

is assumed that there is a negligible cost

for recordkeeping.

i. Critical Control Points (CCP). (4)

Receiving CCP (histamine)—($3,200).

This processor gets a freezing log from

the tuna harvester and makes a visual

check of the fish to see that they are

frozen. The processor keeps a copy of

the freezing log and makes a note of the

visual check. The fish are then

transferred to a plant freezer. The

monitoring takes 15 minutes per lot for

4 lots per day. Similar monitoring is

already occurring and the marginal cost

for the recordkeeping is negligible.

The processor drills a representative

sample of each lot and performs an

organoleptic examination for

decomposition of the tuna. It is assumed

that this monitoring is not being done

previous to this regulation and takes 20

minutes per lot for 4 lots per day.

Monitoring is billed at $8.50 per hour.

Also, there is a cost for a new drill ($50)

and it is assumed that recordkeeping

costs are negligible.

(5) Cutting CCP (metal fragments)—

($0). A worker checks the saw blade at

every break to look for broken saw teeth

and keeps a log of checking on the teeth.

Monitoring takes a few minutes per

break. It is assumed that there is a

negligible marginal cost for the

monitoring and recordkeeping. Fish is

weighed, packed, labeled and returned

to the freezer.

ii. Corrective actions. (6) Problems

with incoming product—($0). It is

expected that product rejects in the first

year would be higher but they would

return to current levels in the second

year as harvesters became aware of the

processor’s new requirements. The total

cost for the industry is $1 million for the

first year and zero in the following

years. Because harvesters and not

processors bear the cost of rejected raw

product, this cost is included in Table

4 as a separate line item and not in

Table 3 which includes only costs borne

by processors.

(7) A saw tooth breaks every two

years—($20). A worker needs to

examine potentially affected product

every 2 years. This is expected to take

4 hours billed at $8.50 to check two

hours worth of cutting.

iii. Verification. (8) Record review—

($400). This involves a review of five

sanitation records, five receiving

records, and a log book for the cutting

operation. These are expected to be very

simple (e.g., check mark records).

Consequently, this review is expected to

take 30 minutes per week billed at $15

per hour.

(9) Review hazard analysis & HACCP

plan—($60). This is expected to take 4

hours per year at $15 per hour.

(10) Administrative changes—20

percent of all of the other costs in the

first year and 10 percent in the second

year.

b. Small plant cost example 2. The

categories of costs that are different from

Example 1 are explained below.

(1) Plant Sanitation Audit—($2,800).

This will need to be done 3 times daily

taking approximately 20 minutes for

each audit. It is assumed that some

minimal sanitation assessment is

already being done once per day, but an

additional 40 minutes would be

required to perform three adequate

audits. Again, it is assumed that there is

a negligible cost for recordkeeping.

(2) Extra Equipment Cleaning and

Sanitizing—($2,480). This is assumed to

take 1 hour per day billed at $8.50 per

hour. Also, additional water, and

cleaning and sanitizing materials are

assumed to cost $100.

(3) Eliminate Fly Infestation—($330).

Torn screens need to be repaired taking

2 hours billed at $8.50 per hour. Also,

screening materials assumed to cost $15

are needed. An exterminator to apply

pesticides costs $300.

Table 4 represents the models

described above in tabular form.

TABLE 4.—FDA MODELS OF SMALL PLANTS

Category

Small plant 1 (no GMP

costs)

Small plant 2 (GMP

costs)

Year 1 Year 2— Year 1 Year 2—

Training ............................................................................................................................ 760 0 760 0

HACCP plan refinement ................................................................................................... 240 0 240 0

Sanitation audit ................................................................................................................ 0 0 2,800 2,800

Receiving CCP ................................................................................................................. 3,200 3,200 3,200 3,200

Cutting CCP ..................................................................................................................... 0 0 0 0

Sawtooth monitoring ........................................................................................................ 20 20 20 20

Record review .................................................................................................................. 400 400 400 400

HACCP plan review ......................................................................................................... 60 60 60 60

Equipment cleaning .......................................................................................................... 0 0 2,500 2,500

Eliminate pests ................................................................................................................. 0 0 330 0

Administration ................................................................................................................... 940 370 2,100 900

Per plant costs .......................................................................................................... $5,600 $4,000 $12,400 $9,900

In order to estimate an average plant

cost from these FDA model plants, FDA

assumed that, based on the results of the

agency’s 1990/1991 survey of the

seafood industry, 20 percent of small

firms are similar to the model plant that

requires some GMP improvements

(Small Plant 2) and that 80 percent of

the small firms are similar to the model

plant that is in compliance with current

CGMP’s (Small Plant 1). The agency has

also assumed that the cost of
65182 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

compliance for large firms is the same

as that of small firms. There are

offsetting considerations that have led

the agency to make this assumption in

this model. For example, agency

experience suggests that it is likely that

small firms will, on average, have larger

sanitation costs and thus incur greater

expenses to rectify existing CGMP

deviations. Large firms, on the other

hand, are more likely to have a greater

number of products and processing

lines, resulting in greater costs of plan

development and monitoring. However,

the agency believes that large firms are

more likely to already have preventive

controls, formalized sanitation

programs, and record keeping systems

in place than small firms. Additionally,

large firms are more likely to take on

new monitoring regimes with their

existing quality control and production

staffs than are small firms. The agency

believes that these considerations would

counteract each other and should result

in fairly equal costs for large and small

firms.

To complete the FDA model, FDA

assumed that exporters (one- half of the

1,000 large firms) would only need to

spend $1,000 in order to comply with

this rule. Combining the two plant total

costs as reported in Table 4 and

weighting the proportion of the industry

they are assumed to represent, average

plant costs are estimated to be $6,400 in

the first year and $4,800 in subsequent

years.

The foreign processor costs associated

with this rule and passed on to U.S.

consumers are estimated to be 13

percent of the average domestic plant

costs. The total cost of this regulation

using this method of cost modeling is

$71 million in the first year and $38

million in the fourth year and beyond.

Total costs for compliance with these

regulations using the FDA model are

shown in Table 5.

TABLE 5.—DISAGGREAGATED COSTS FROM FDA MODEL

1st Year Costs:

Domestic manufacturers and importers ............................................................................................................................................. $32 million.

Major plant repair and renovation ...................................................................................................................................................... 13 million.

Sea Grant expertise ........................................................................................................................................................................... 1 million.

Repackers and warehouses ............................................................................................................................................................... 14 million.

Harvesters for rejected raw product ................................................................................................................................................... 1 million.

Shellfish vessels ................................................................................................................................................................................. 3 million.

Foreign processors ............................................................................................................................................................................. 5 million.

Total .................................................................................................................................................................................................... 69 million.

2d Year Costs

Domestic manufacturers ..................................................................................................................................................................... $ 23 million.

Sea Grant expertise ........................................................................................................................................................................... 1 million.

Repackers and warehouses ............................................................................................................................................................... 14 million.

Shellfish vessels ................................................................................................................................................................................. 1 million.

Foreign processors ............................................................................................................................................................................. 3 million.

Total ............................................................................................................................................................................................. 42 million.

3d Year Costs:

Domestic manufacturers ..................................................................................................................................................................... 23 million.

Sea a grant expertise ......................................................................................................................................................................... 1 million.

Repackers and warehouses ............................................................................................................................................................... 14 million.

IQF Shellfish plants ............................................................................................................................................................................ 3 million.

Total ............................................................................................................................................................................................. 41 million.

4th Year (and subsequent years) Costs

Domestic manufactures ...................................................................................................................................................................... 23 million.

Sea Grant expertise ........................................................................................................................................................................... 1 million.

Repackers and warehouses ............................................................................................................................................................... 14 million.

Total ............................................................................................................................................................................................. 38 million.

Total Discounted Costs:

Beyond the 4th year and discounted at 6 percent, the costs are $677 million.

There are a number of explanations

that would account for the uncertainty

between the FDA and NMFS models.

Virtually all of the difference can be

explained by the two different estimates

of what it would take to come into

compliance with 21 CFR part 110

(FDA’s CGMP regulations). In the case

of the NMFS study, the contractors

estimated the cost of coming into full

compliance with all CGMPs. Using this

methodology, they found that

approximately 80 percent of the plants

were out of compliance. On the other

hand, the FDA model uses the results of

FDA’s own survey of the industry,

which only listed plants as being out of

compliance if the CGMP violations were

related to potential contamination of the

seafood product. In this case, FDA

found that only about 20 percent of the

firms were out of compliance. In

addition, the FDA cost model assumes

the simplest, least expensive corrective

action to solve the CGMP violation. The

NMFS model did not use the same

approach in all cases.

2. Other Cost Reports

Reports received by FDA on the cost

of implementing HACCP discussed

below appear generally to support the

results of FDA modeling across the

seafood industry. While the modeling

was limited to certain types of small

operations, the firms for which FDA has

information on reported costs represent

a cross section of processing operation

types, including canned, fresh, frozen,

smoked/salted, molluscan shellfish, and

cooked, ready-to-eat products as well as

warehouses and repacking operations. It

should be noted that these costs are

reported only as an additional source of

information. They were not used to

generate FDA’s model plants.

The cost information obtained from

industry includes responses to a 1991

evaluation questionnaire from four firms

that participated in the FDA/NOAA

seafood HACCP pilot in 1990–1991. It

also includes information provided to

FDA from seven firms through the

assistance of the National Food

Processors Association. (These 7 firms

operate a total of 44 processing plants.)

It further includes information from two

seafood trade associations, the National

Fisheries Institute and the New England

Fisheries Development Association
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65183

11The costs referred to here are those estimated

for NMFS for the type of HACCP system it was

studying. For the purposes of the PRIA and RIA,

FDA made adjustments to the costs estimated for

NMFS so as to be consistent with FDA’s own

regulation. These adjusted costs from the NMFS

models are the estimates presented earlier in this

document.

(NEFDA), which provided FDA with

summary information about member

firms that had implemented HACCP

systems. The 2 seafood trade

associations provided information on 16

firms. NEFDA operated a HACCP pilot

with member firms through a Federal

grant. All of this information was

received by FDA before the publication

of the proposed regulations and was

reported in the PRIA. After the

publication of the proposal, FDA

received information from a large

processor-exporter on its HACCP startup costs. This processor reported start

up costs of $1,000 per plant. In total,

FDA has information on 86 plants (Refs.

129 and 223).

Many of these firms have

implemented HACCP as participants in

either pilot programs, the NOAA fee-forservice program, or the State of Alaska

program, and therefore their HACCP

systems have been subject to some form

of third party verification. Virtually all

of these plants have developed HACCP

plans, many of which included critical

control points for quality or economic

fraud or both in addition to safety. In

this respect, many firms implemented a

more extensive form of HACCP than is

being mandated by FDA.

More complete information on startup costs received from 22 firms who

have implemented HACCP is

summarized in Table 6. Some of these

costs are for multi-plant firms and some

for firms operating only one plant.

TABLE 6.—START-UP COSTS

No. of firms Start-up costs ($)

4 <1,000

15 1,000–5,000

1 5,000–10,000

1 10,000–15,000

1 >20,000

FDA notes that there are several

uncertainties with these data. The

agency does not have sufficient

information to extrapolate the costs

observed by these firms to the entire

industry. FDA also does not know the

extent of previous HACCP-type

activities in these firms so that they may

have different incremental costs than

the industry average. Additionally, for

subsequent year costs, some of the firms

reported costs that exceeded the start-up

costs shown in the table although some

were below, and it is not clear if costs

that might be incurred in order to

comply with CGMP’s are represented.

Nevertheless, the range of reported

costs, are consistent with the FDA

model for a processing operation that

does not incur such costs. Notably, the

estimates developed for NMFS of the

costs of operating HACCP systems for

small businesses are consistent with the

FDA model and with the reports to FDA

by trade associations discussed above.1

Thus, three independent sources of

information suggest that annual HACCP

costs, at least for small businesses, are

within a range of $3,000 to $6,000 per

plant if sanitation costs are not

included. Although the HACCP cost

estimates made for NMFS did not

include certain aspects of a HACCP

system such as HACCP plan

development, plan verification, and

taking corrective actions, the estimates

did include the costs of operating

HACCP systems for quality and

economic adulteration in addition to

safety. These costs were not included in

the NMFS cost estimates reported here.

The FDA HACCP system involves safety

only and is therefore less expensive.

It is also worth noting that three

independent sources (FDA’s own

inspection experience, NMFS

inspection experience with plants

purchasing its voluntary inspection

services, and the contractor’s report for

NMFS) confirm the existence of

sanitation deficiencies in some seafood

plants. Because FDA holds that these

conditions must be corrected under

existing requirements, the costs

associated with these corrections will be

borne by processors regardless of

whether sanitation provisions are

included in the seafood HACCP

regulations or somewhere else.

Sanitation controls for processors may

address a number of enteric pathogens

discussed elsewhere in this analysis

including Salmonella, Shigella,

hepatitis A, L. monocytogenes,

campylobacter, and C. botulinum.

Contamination may come from either

the raw product or from poor hygiene

practices such as insufficient control of

vermin (flies and rodents) or insanitary

water. In addition, poor sanitation may

cause contamination of the product with

pesticides, lubricants, cleaning

compounds, or other toxic substances

because of improper labeling, storage or

use. The system in the seafood HACCP

regulations is based on the monitoring

of sanitation conditions by processors.

FDA is not aware of any method for

processors to take control of the

sanitation conditions within their plants

other than by a method that involves

routine monitoring. Recording the

results of these observations, as required

by the regulations, need involve only

minimal additional cost.

3. Seafood Prices

A number of comments referred to the

effect that the regulation will have on

the price of seafood that consumers

experience at the retail level. In the

PRIA, it was presumed that most of the

cost of compliance of the proposed

regulations would be passed on to

consumers. In the PRIA, it was

calculated that if the domestic industry

passed on to consumers all of the costs

estimated in the PRIA, prices for

domestically produced seafood would

increase by less than 1 percent in the

first year and less than one-half of 1

percent in succeeding years. It was

noted in the PRIA that price changes of

such magnitude are unlikely to have a

significant impact on general seafood

purchases.

Some commenters claimed that all of

the cost of the regulation would be born

by processors, and that none of the

increase in cost would be passed on to

consumers. These commenters

explained that seafood is currently at a

disadvantage compared to other flesh

foods for consumers’ food dollars

because seafood has a higher price per

pound. If the relative price of seafood

were to increase further, consumers

would eat less seafood. The commenter

also explained that domestic seafood

processors are at a competitive

disadvantage compared with seafood

that can be imported at low cost (i.e.,

lower wages). If domestic processors

were to raise their prices, seafood

imports would take an even larger part

of the seafood market away from

domestically produced seafood.

Other comments said that processors

will pass on all of the cost of the

regulation, and that the regulation will

cause the consumer price of seafood to

rise. Some said that the price increase

would be large enough to cause a

decrease in seafood consumption.

Both theories have some merit,

although neither is completely correct.

The agency agrees that, all other things

remaining the same, an increase in the

price of seafood will decrease seafood

consumption and increase the

consumption of other fresh foods.

However, the decision of a consumer to

purchase a product depends on a

number of factors.

Seafood includes many invertebrate

and vertebrate species which vary in

price per pound, often by over 100

percent, for a particular species

(depending, in part, on seasonal

supply). Such diversity, compared with
65184 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

meat and poultry, makes it clear that

there is not perfect substitution among

the flesh foods. Nevertheless, data bases

on food consumption are equally clear

at showing that as people have

increased their consumption of various

seafood products, they have reduced

their consumption of meat and poultry.

There are other nonprice factors in the

consumption decision. A consumer

survey found that taste, quality, and

freshness were rated above price

(‘‘moderately important’’) in decisions

to order seafood in a restaurant or to

purchase for preparation at home. In a

survey of retailers’ experiences,

consumers ranked quality ahead of price

in making seafood selections and rated

the need for information on cooking as

a concern equal to price (Refs. 244 and

225).

Another relevant consideration is the

fact that a disproportionate percentage

of seafood is consumed in restaurants as

a luxury item where the cost of the raw

material is not as important a factor in

the purchasing decisions made by these

consumers.

All of this information is consistent

with other data in this analysis that

suggests that a 1 percent change in price

results in less than one-half of one

percent change in seafood consumption.

Another major factor that lessens any

competitive cost advantage meat and

poultry products might experience from

an increase in seafood cost is that USDA

is proposing similar HACCP regulations

for meat and poultry. USDA’s proposal,

if finalized for meat and poultry

products, suggests that all segments of

the flesh food market may face cost

increases in the near future. It is entirely

possible that the price of seafood

relative to meat and poultry will not

change. The agency agrees that some

seafood imports have a cost advantage

over domestically produced seafood,

primarily due to lower labor and capital

costs of production. However, because

the regulation applies to imports as well

as domestic products and because

importers from EU member nations will

soon be under HACCP requirements and

experiencing increased costs, it is

reasonable to assume that the price of

imported seafood relative to domestic

seafood will not change.

In the short run, the ability of

producers to pass on cost increases is

largely determined by the elasticity of

demand (the degree to which consumers

reduce their consumption of a good in

response to a given increase in price)

and the elasticity of supply (the degree

to which producers increase their

production of a good in response to a

given increase in price). The elasticity of

demand is determined in turn by,

among other things, the presence or

absence of close substitutes. Thus, for

example, if there are close substitutes

and the price of a good goes up,

consumers will not continue to

consume the higher priced good but

switch to one of the substitutes.

If manufacturers know that consumers

will not switch to a substitute when

there is a price increase, then they are

free to pass along all of the increased

costs (from complying with the

regulation) in the form of price

increases. However, where there are

close substitutes for seafood, such as

other flesh foods, consumers respond to

price increases by reducing their

consumption of the high priced good.

Rather than attempting to pass on all of

the costs of the regulation in the form

of higher prices, producers must accept

reduced profits and bear some, if not all,

of the burden of the cost increase.

In very competitive markets, such as

the market for flesh food, where meat,

fish, and poultry are considered

substitutes, producers bear the entire

burden of any increases in fixed costs.

Fixed costs are costs that do not change,

despite the size of the firm and changes

in the level of output. Examples of fixed

costs are costs of plant, equipment, and

management; much of these costs are

expected to be borne by processors.

Because large firms spread fixed costs

over larger output, they may be able to

pass on these costs when smaller firms

cannot.

In addition, also in the short run,

producers may bear some portion of the

variable costs that cannot be profitably

passed on to consumers. Variable costs

are costs that vary with changes in the

amount of output. Examples of variable

costs are costs of raw materials and

hourly labor. However, it is likely that

much of the variable costs will be

passed on to consumers.

When firms in a competitive market

cannot pass on all of a cost increase in

the short run, profits decline. Beyond

some point profits become either so low

or negative that the firm is forced to

close (discussed more fully in the

Regulatory Flexibility Analysis below).

In the long run, the exit of these

marginal firms reduces the industry

supply (of seafood) and permits the

remaining firms to raise prices to cover

the full costs of production, both

variable and fixed costs. Thus, in the

long run, seafood prices will rise by the

full cost of the regulation.

A few comments requested a better

analysis of price changes. These

commenters criticized the approach

used to estimate price increases in the

Executive Summary of the PRIA. Rather

than dividing the estimated domestic

cost of the regulation by the total

domestic production, the commenters

suggested estimating price changes for

each market segment. The advantages of

this approach are that different types of

seafood are treated separately (the

change in the price of raw tuna might

be very different from the change in the

price of ready-to-eat shrimp cocktail)

and that different sized firms are treated

separately (small firms may be forced to

raise prices more than large firms).

FDA agrees that this method of

determining price changes is more

legitimate than the method employed in

the PRIA. However, FDA did not receive

any information from commenters that

would enable the agency to calculate

prices in this manner. It is worth noting,

however, that the contractor that

performed the study upon which many

of the estimated costs in this RIA are

based did take product type into

account when estimating cost increases.

That contractor estimated a range of cost

increases from negligible to 1.3 percent,

depending on the product. Again, it is

important to note that that study

included costs for the control of types

of hazards not covered by this final

regulation.

Finally, while the methodology used

in the PRIA might not produce accurate

price changes, it suggests that overall

price increases due to this regulation

could well have a negligible effect on

demand.

C. Benefits

In the PRIA, FDA estimated that the

proposed option, which is being

adopted in this final rule, would: (1)

Reduce the amount of foodborne illness

that results from consumption of

seafood and; (2) generate significant

nutrition benefits as a result of the

increased consumption of seafood

(brought about by a decrease in

consumer anxiety) with a concomitant

decrease in the consumption of meat

and poultry; (3) reduce the amount of

rent seeking (rent seeking is a term

economists have applied to activities

which do not contribute to societal

welfare but only seek to transfer

resources from one party to another);

and (4) generate export benefits by

allowing U.S. exporters to continue to

export to countries requiring HACCP.

The last benefit, the export benefit, is

characterized as the benefit to firms

exporting to countries that require

federal oversight and certification of

HACCP programs. In addition to the

benefits cited in the PRIA, the agency is

addressing benefits derived from

reduced enforcement costs, and is

discussing other unquantified benefits

of adopting the seafood HACCP
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65185

regulations. The agency has fully

considered all of the comments on

benefits. These estimates are more fully

explained in the full RIA. What follows

is FDA’s conclusion as to how these

benefits should be valued.

1. Safety Benefits

In the tables below, FDA presents

revised estimates of the benefits of

mandatory HACCP for seafood

processors. Several changes from the

preamble to the proposal are

noteworthy. First, based on the

comment that said that FDA had

underestimated the number of cases,

FDA has reestimated the baseline

numbers of cases for certain illnesses

(Ref. 226). Next, some changes were

made to the valuations of particular

cases, as better information was

obtained concerning the probabilities of

death per type of illness. Finally, as

mentioned above, some changes have

been made to the estimates of the

percentages of the illnesses reduced.

Although Canada, for example, has

mandatory HACCP for its seafood

processors, no data exist on the efficacy

of HACCP. Therefore, for the

percentages of the illnesses reduced,

FDA used three different types of its

experts (seafood experts,

epidemiologists familiar with microbial

hazards, and microbiologists) to address

the efficacy of seafood HACCP. Each of

these experts reviewed the literature on

each type of hazard as well as the

requirements of HACCP. The ranges

reflect likely upper and lower bounds

on how effective HACCP will be at

controlling production deficiencies by

processors, including indirect controls

exerted by processors on the owners of

harvesting vessels. In addition, the

tables reflect the fact that some of the

cases of illness are not addressable by

this rule as they are caused by either

consumer or restaurant mishandling or

poor fishing practices by recreational

fishermen.

In order to calculate the number of

cases (annual cases resulting from

exposure to hazards associated with

seafood consumption) that would be

reduced by HACCP, each of the four

experts followed a series of methodical

steps. The first was to determine the

types of seafood associated with each

hazard. The second step consisted of

reviewing the various aspects of the rule

to determine the areas of seafood

harvesting and processing that the rule

could affect. The third step was to

eliminate those cases that could not be

affected by the rule.

These would be cases that seafood

processors could neither eliminate

through processing nor prevent from

being introduced, either by their own

staff or by control over raw materials.

Cases caused or controlled by factors

outside of the HACCP system include

recreational harvest (approximately 20

percent of all seafood harvested) that

does not pass through processing plants

and problems caused by restaurant,

supermarket or consumer improper

cooking or mishandling. In addition,

there will be some types of hazards that

will not, for the foreseeable future, be

controllable by means other than

avoiding contaminated waters, which

will not be 100 percent effective

(ciguatera, for example). Until rapid,

inexpensive tests are developed, HACCP

cannot be 100% effective at controlling

these hazards.

Once each expert had accounted for

those cases that could not potentially be

reached by this rule, the experts then

assessed the likely effectiveness of

control steps associated with broad

sanitation improvements and mandatory

controls on specific hazards and specific

species.

Ciguatera: Both the lower and upper

bound reductions in illness are

relatively small in the near term because

there does not yet exist a rapid,

inexpensive test for this toxin.

Processors and commercial fishermen

must rely on information about whether

geographic areas are ciguatoxic.

Moreover, many illnesses are

attributable to recreational harvest.

Hepatitis A virus: This illness derives

mostly from molluscan shellfish. For

molluscan shellfish, the controls are

harvesting from approved waters and

good sanitation in the plant. These

regulations specifically involve both

types of controls. The upper bound

number is 50 percent of the total

estimated number of illnesses largely

because of the problems that states have

in patrolling and controlling illegally

harvested molluscan shellfish.

Norwalk virus: This illness derives

from raw molluscan shellfish that are

contaminated from human pollution in

harvesting areas. Control involves

harvesting from approve waters. These

regulations include this kind of control.

The upper bound number is 50 percent

of the total estimated number of

illnesses largely because of the problems

that states have in patrolling and

controlling illegally harvested

molluscan shellfish and because of the

uncertainty of the control of sewage

from harvesting and recreational

vessels.

Vibrio vulnificus: This illness

essentially derives from eating raw

molluscan shellfish from the Gulf of

Mexico. Vibrio vulnificus is a naturally

occurring, ubiquitous, marine organism.

The lower and upper bound numbers

reflect the fact that controls are newly

emerging for this organism and still

have uncertainties associated with

them.

Table 6a sets out the new estimates of

baseline cases of foodborne disease

related to HACCP and the range of cases

averted by HACCP.

TABLE 6a.—ESTIMATE OF ANNUAL CASES AVERTED

Hazard

Estimated

number of

cases 1

Number of

cases averted (lower) 2

Number of

cases averted (upper) 1

Anasakis ................................................................................................................................................... 100 25 60

Campylobacter jejuni ............................................................................................................................... 200 100 150

Ciguatera .................................................................................................................................................. 1,600 96 200

Clostridium botulinum .............................................................................................................................. 10 3 5

Clostridium perfringens ............................................................................................................................ 200 100 150

Diphyllobothrum latum ............................................................................................................................. 1,000 250 600

Giardia ...................................................................................................................................................... 30 15 23

Hepatitis A Virus ...................................................................................................................................... 1,000 150 500

Other Marine Toxins ................................................................................................................................ 20 .................... 1

Norwalk Virus ........................................................................................................................................... 100,000 15,000 50,000

Other Vibrio’s ........................................................................................................................................... 1,000 200 500

Paralytic Shellfish Poisoning .................................................................................................................... 10 .................... 1

Salmonella non typhi ............................................................................................................................... 200 100 150

Scombrotoxin ........................................................................................................................................... 8,000 4,000 6,000
65186 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

TABLE 6a.—ESTIMATE OF ANNUAL CASES AVERTED—Continued

Hazard

Estimated

number of

cases 1

Number of

cases averted (lower) 2

Number of

cases averted (upper) 1

Shigella .................................................................................................................................................... 200 100 150

Vibrio vulnificus (3d year) ........................................................................................................................ 60 12 30

Total .............................................................................................................................................. 113,630 20,151 58,520

1These numbers were determined in consultation with representatives from the Centers for Disease Control and Prevention.

2The upper and lower bounds were determined by a panel of scientists at CFSAN (Dr. George P. Hoskin, Dr. Karl C. Klontz, Dr. Kaye I

Wachsmuth and Dr. Thomas C. Wilcox.

Table 7 reflects revised estimates of the total cost of seafood illness.

TABLE 7.—ANNUAL COST OF SEAFOOD ILLNESS

Hazard Value per

case

Total cost of

seafood illness

Anasakis .................................................................................................................................................................. $1,703 $170,332

Campylobacter jejuni ............................................................................................................................................... 9,390 1,877,924

Ciguatera ................................................................................................................................................................. 15,247 24,395,438

Clostridium botuli num ............................................................................................................................................. 223,252 2,232,524

Clostridium perfrin gens ........................................................................................................................................... 6,551 1,310,164

Diphyllobothrum latum ............................................................................................................................................. 2,753 2,752,617

Giardia ..................................................................................................................................................................... 6,104 183,112

Hepatitis A Virus ...................................................................................................................................................... 22,669 22,668,870

Other Marine Toxins ................................................................................................................................................ 269 5,380

Norwalk Virus ........................................................................................................................................................... 575 57,500,000

Other Vibrio’s ........................................................................................................................................................... 2,955 2,954,842

Paralytic shellfish poisoning .................................................................................................................................... 92,356 1,200,628

Salmonella non-typhi ............................................................................................................................................... 8,199 1,639,756

Scombrotoxin ........................................................................................................................................................... 339 2,708,755

Shigella .................................................................................................................................................................... 16,750 3,349,961

Vibrio vulnificus ........................................................................................................................................................ 2,008,917 120,535,039

Total .............................................................................................................................................................. ........................ 245,485,342

Table 8 shows the estimates of the efficacy of mandatory seafood HACCP at reducing foodborne disease in the

third year following the date of implementation (undiscounted).

TABLE 8.—ESTIMATE OF THE EFFICACY OF MANDATORY HACCP AT REDUCING FOODBORNE DISEASE IN THE THIRD YEAR

Hazards

Lower bound

estimate (3d

year)

Upper bound

estimate (3d

year)

Anasakis .................................................................................................................................................................. $42,583 $102,199

Campylobacter jejuni ............................................................................................................................................... 938,962 1,408,443

Ciguatera ................................................................................................................................................................. 1,463,726 3,049,430

Clostridium botulinum .............................................................................................................................................. 558,131 1,116,262

Clostridium perfringens ............................................................................................................................................ 655,082 982,623

Diphyllobothrum latum ............................................................................................................................................. 688,154 1,651,570

Giardia ..................................................................................................................................................................... 91,556 137,334

Hepatitis A Virus ...................................................................................................................................................... 3,400,331 11,334,435

Other Marine Toxins ................................................................................................................................................ ........................ 269

Norwalk Virus ........................................................................................................................................................... 8,625,000 28,750,000

Other Vibrio’s ........................................................................................................................................................... 590,968 1,477,421

Paralytic Shellfish Poisoning ................................................................................................................................... ........................ 46,178

Salmonella non-typhi ............................................................................................................................................... 819,878 1,229,817

Scombrotoxin ........................................................................................................................................................... 1,354,377 2,031,566

Shigella .................................................................................................................................................................... 1,674,981 2,512,471

Vibrio vulnificus (3d year) ........................................................................................................................................ 24,107,004 60,267,519

Total .............................................................................................................................................................. 45,010,733 116,097,537

Finally, in response to the comments, FDA has attempted in Table 9 to associate particular hazards with categories

of seafood (to the extent the data allow).
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65187

TABLE 9.—ASSOCIATION OF PARTICULAR HAZARDS WITH CATEGORIES OF SEAFOOD

Hazards

Estimated

number of

cases

Affected species

Anasakis ........................................................................................ 100 Raw Finfish.

Campylobacter jejuni ..................................................................... 200 Cooked Ready-to-Eat Fish, Smoked Fish, Molluscan Shellfish.

Ciguatera ....................................................................................... 1600 Tropical, reef associated species of finfish.

Clostridium botulinum .................................................................... 10 Vacuum Packaged Fish, Smoked and Salted Fish.

Clostridium perfringens ................................................................. 200 Cooked Ready-to-Eat Fish, Smoked Fish, Molluscan Shellfish.

Diphyllobothrum latum ................................................................... 1000 Raw Finfish.

Giardia ........................................................................................... 30 Cooked Ready-to-Eat Fish, Smoked Fish, Molluscan Shellfish.

Hepatitis A Virus ............................................................................ 1000 Cooked Ready-to-Eat Fish, Smoked Fish, Molluscan Shellfish.

Other Marine Toxins ...................................................................... 20 Molluscan Shellfish.

Norwalk Virus ................................................................................ 100,000 Molluscan Shellfish.

Other Vibrio’s ................................................................................. 1,000 Cooked Ready-to-Eat Fish, Smoked Fish, Molluscan Shellfish.

Salmonella non-typhi ..................................................................... 200 Cooked Ready-to-Eat Fish, Smoked Fish, Molluscan Shellfish.

Scombrotoxin ................................................................................. 8,000 Scombroid Species of Finfish.

Paralytic Shellfish Poisoning ......................................................... 10 Molluscan Shellfish.

Shigella .......................................................................................... 200 Cooked Ready-to-Eat Fish, Smoked Fish, Molluscan Shellfish.

Vibrio vulnificus ............................................................................. 60 Molluscan Shellfish.

Total .................................................................................... 113,630

2. Summary of Safety Benefits

The safety benefits are shown by year

in Table 10 (undiscounted).

TABLE 10.—SAFETY BENEFITS

Year Lower bound

benefits

Upper bound

benefits

1 .................... 32,957,233 67,897,751

2 .................... 32,957,233 67,897,751

3 .................... 45,010,733 116,097,537

4 and beyond 45,010,733 116,097,537

3. Nutrition Benefits From Mandatory

Seafood HACCP and Increased

Consumer Confidence

In the PRIA, FDA estimated what the

potential nutrition benefits might be if

reduced consumer anxiety over seafood

safety led to increased sales. FDA

hypothesized that this might lead to

consumers eating lower fat meals (on

average) as they replaced higher fat meat

and poultry with lower fat seafood.

The agency has considered this issue

in greater detail in the full RIA. FDA

acknowledged in the PRIA that the

entire estimate of nutrition benefits

resulting from increased sales of seafood

at the expense of meat and poultry sales

is speculative. Although the agency

believes that increased consumer

confidence would result from having a

state-of-the-art HACCP system in place

for the seafood industry, no data were

received to confidently predict the

ultimate increase in the quantity of

seafood sold as a result of this

regulation. Sales data of this type were

also not available before or after the

agency initiated its low acid canned

food regulations. Finally, the agency

was unable to determine if any increase

in consumer confidence would offset a

price increase resulting from HACCP

costs.

The agency was equally concerned

about possible nutrition benefits as to

whether there would be an exact

exchange in the nutrient profile between

fish as prepared and meat and poultry.

The agency finds that some fish dishes

as consumed are eaten fried or served

with heavy sauces, and that different

species of fish have different fat profiles.

Thus, for some consumers who make

substitutions of fish meals for meat and

poultry, it is not totally clear if there

will be a favorable decrease in fat

intake. Because there are too many

unknown variables surrounding these

substitutes and the lack of sales data,

the agency is unable to quantify this

benefit.

4. Rent Seeking

Rent seeking activities were

characterized in the proposal as ‘‘public

and private resources (which) have been

expended in attempts to alter the level

of regulatory effort toward seafood

safety, as well as alter which Federal

agency should oversee the industry.’’

‘‘Rent seeking’’ is a term economists

have applied to activities that do not

contribute to societal welfare but only

seek to transfer resources from one party

to another. An example often given is

lobbying to change the ownership of a

government granted special privilege so

that profits change hands. In many

cases, however, it is difficult to

distinguish between activities that

ultimately indirectly benefit society

from those that only transfer profits. The

proposal hypothesized that one benefit

of the regulation was to reduce the

social costs of rent seeking.

One commenter noted that the reason

large firms support HACCP is because

they must have HACCP to export to

Europe. The commenter noted that

mandated HACCP would ‘‘ensure that

all domestic processing firms face the

same costs, thereby reducing any

competitive disadvantage.’’

FDA does not agree that this is a

justification for HACCP. The reason for

implementing HACCP is to reduce the

incidence of foodborne disease.

However, FDA agrees that this ‘‘rentseeking’’ argument may explain some

support for HACCP by larger exporting

firms. It is important to note, however,

that there are small firms who export to

Europe as well.

5. Export Benefits

In the PRIA, FDA asserted that one

benefit (unquantified) of the rule was to

allow firms now exporting to the EU to

continue to do so because of the EU

requirement for a federally overseen

voluntary HACCP program. Several

commenters noted that some countries

that import seafood from the United

States are beginning to require HACCP.

One commenter noted that more than 30

percent of seafood produced in the

United States is exported. The same

commenter noted the disruption in

trade when French authorities did not

coordinate their seafood safety

requirements with ‘‘other officials.’’

Several commenters noted the need for

more Memoranda of Understandings

(MOU’s) between the United States and

other countries for seafood. One

suggested that such MOU’s be based

upon HACCP as defined by various

international bodies. Finally, one

commenter noted that FDA ‘‘should take

into account how the international
65188 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

community is implementing HACCP

before the agency imposes regulations

that may create unnecessary trade

barriers.’’

As discussed in the PRIA, this

program will benefit those seafood

processors who are exporting to nations

requiring HACCP. However, as also

noted in the PRIA, there is in place a

federally overseen HACCP program,

specifically, the program being offered

to processors by the National Marine

Fisheries Service (NMFS).

FDA has made an estimate of the cost

savings to exporting firms of being in

FDA’s mandatory program in lieu of the

NMFS program. The alternative to

NMFS review (if FDA were not to adopt

this regulation) would be inspection of

product that is offered for entry into the

EU on an entry-by-entry basis and the

payment of a significant fee for these

inspection services. With approximately

2 billion pounds being exported each

year, this savings of resources amounts

to, at a minimum, $20 million per year.

In addition, although the EU has

announced the requirement that HACCP

be in place by January 1, 1996, adoption

of a U.S. plan reduces some of the

uncertainty for U.S. firms and firms

exporting to the United States

concerning the ultimate form of an

internationally agreed upon HACCP

requirement.

6. Reduced Enforcement Costs

Comments qualitatively mentioned

other benefits including fewer product

recalls and other enforcement actions.

FDA agrees that there will be fewer

product recalls, seizures, injunctions

and detentions of seafood and seafood

products. As examples of what benefits

could have accrued in 1994, the agency

has calculated the value of each of these

actions and addressed them below.

a. Seizures. A seizure is a civil action

designed to remove violative goods from

consumer channels. Table 11 shows the

actions and their associated costs that

follow a determination that a violation

exists and that goods should be seized.

TABLE 11.—SEIZURE STEPS

Action Hours/Other Cost

Federal personnel collect and analyze samples, write up recommendations (program

and general counsel), review the case and make recommendations to the U.S. attorney.

120 .............................................................. $12,840

U.S. attorney files complaint and Court orders goods arrested ........................................ 16 ................................................................ 1,712

U.S. Marshal and other federal official seizes goods at location ...................................... 8 ..................................................................

Travel ..........................................................

856

200

Firm hires attorney to contest/accept action ..................................................................... 16 ................................................................ 1,712

Food is reconditioned by firm ............................................................................................ 16 firm .........................................................

16 Federal lower valued food 2 ...................

1,712

1,712

Food is denatured (converted to a non-food use) or; ....................................................... 16 firm .........................................................

8 Federal lower valued food 2 .....................

1,712

856

Food is destroyed .............................................................................................................. 8 firm ...........................................................

8 Federal lost food 1 ....................................

856

856

1The rate of $107 per hour represents the cost of a loaded (including equipment and benefits) employee plus headquarters support of approximately 70 percent. 2Total seizure costs are calculated in Table 12.

Table 12 shows the seizures in 1994. Assuming that half of all seizures are prevented each year, the benefits

are expected to be approximately $290,000 each year.

TABLE 12.—SEIZURES IN 1994

Problem No. Administrative costs 1 Action 2 Total

Decomposition (Destroy) .............................................................................................................. 5 $17,320 $46,565 $320,925

Filth (Denature) ............................................................................................................................ 3 17,320 8,709 78,087

Chemicals (Destroy) ..................................................................................................................... 2 17,320 10,108 54,856

Other (Destroyed) ........................................................................................................................ 4 17,320 14,212 126,128

Total ................................................................................................................................... 14 .................... .................... 3 579,996

1 Costs of items (1) through (4) in the preceding Table totaled are $17,320.

2The actions that are typically taken for each type of hazard are listed in the PROBLEM column. Costs include the value of destroyed food

multiplied by the number of actions or, in the case of denaturing, it is assumed that 10 percent of the value of the product is retained. No food

was reconditioned. 3This number may well underestimate the benefit. FDA recently completed a seizure proceeding (not filed in 1994) in which $5 million of product was condemned. Thus, preventing seizure can have a significantly higher value than that reflected in this table.

b. Detentions. A detention is a procedure for preventing violative products from entering the United States. Table

13 shows the actions and their associated costs that follow a determination that a sample is violative, the following

actions take place.

TABLE 13.—DETENTION STEPS

Action Hours/other Cost 2

Federal personnel send a detention notice to the importer with an opportunity to introduce testimony ......... 2 ....................................... $214

Importer hires attorney and introduces evidence. Submits response application ........................................... 16 ..................................... 1,712

Determination of action to take ......................................................................................................................... 24 ..................................... 2,568

Reshipment allowed, or .................................................................................................................................... 10 .....................................

Travel, Cost to Reship .....

1,070

200
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65189

TABLE 13.—DETENTION STEPS—Continued

Action Hours/other Cost 2

Product is denatured, or ................................................................................................................................... 8, Loss of value,2 Cost of

denaturing,2, Reselling

costs 2.

856

Goods are destroyed under Federal supervision ............................................................................................. 16, Loss of product 1.

1These costs are calculated in table 14 which gives estimates of the numbers and estimated costs for detentions in 1994.

2Seizure can have a significantly higher value than that reflected in this table.

TABLE 14.—DETENTIONS IN 1994

Reason Number of

detentions Quantity 1 Dollars 1 Detention

disposition 2

Detention

admin 3

Borates ........................................................................................... 25 21,484 1,827,173 183,017 112,350

C. botulinum ................................................................................... 1 113,790 363,434 363,434 4,494

E.coli/coliforms ............................................................................... 14 254,774 742,786 149,413 62,916

Histamines ...................................................................................... 2 98,023,014 1,361,714 273,199 8,988

Lead ............................................................................................... 2 102,188 87,440 9,044 8,988

Listeria/Other Pathogens ............................................................... 51 2,792,808 21,369,692 4,274,794 229,194

Mercury .......................................................................................... 11 7,338,900 12,720,272 1,272,327 49,434

Poisonous/Deleterious sub-nec ..................................................... 7 180,000 446,025 446,025 31,458

Salmonella/arizona ......................................................................... 129 221,543,300 76,137,973 15,228,451 579,726

Staphylocci ..................................................................................... 6 55,810 199,550 40,766 26,964

Sulfites ............................................................................................ 23 713,653 8,100,620 810,362 103,362

Unsafe food additives—NEC ......................................................... 5 67,160 540,201 540,201 22,470

Total ..................................................................................... 276 ...................... ...................... 23,591,033 1,240,344

1Quantity and dollars include the total amount of both detentions and automatic detentions and are shown to illustrate how detentions were

calculated. 2 Disposition included reshipping which was estimated to be 10 percent times the number of shipments (quantity) times the value per shipment

(dollars/quantity); reconditioning which was estimated to be 20 percent of the value of the shipment (dollars) or destruction which was estimated

to be 100 percent of the value of the shipment. 3Administrative costs are estimated to be $4,494 per detention, the sum of the first three rows of the previous table.

Assuming just half of these detentions are prevented by HACCP, benefits to the federal government and industry

would be approximately $12 million per year.

c. Automatic detentions. Automatic detentions place each lot of imported products on detention upon arrival at

the border until the importer has demonstrated that the products do not violate the Federal Food, Drug, and Cosmetic

Act. This is normally done by the importer hiring independent labs to sample each lot. Table 15 shows the number

and types of relevant automatic detentions that took place in 1994.

TABLE 15.—AUTOMATIC DETENTIONS IN 1994

Reason

Number of

automatic detentionsSample cost1 Storage cost2

Borates ............................................................................................................................................... 53 $132,500 $182,717

C. botulinum ....................................................................................................................................... 104 260,000 36,343

E.coli/coliforms ................................................................................................................................... 8 20,000 74,279

Histamines ......................................................................................................................................... 63 157,500 136,171

Lead ................................................................................................................................................... 1 2,500 8,744

Listeria/Other Pathogens ................................................................................................................... 236 590,000 2,136,969

Mercury .............................................................................................................................................. 397 992,500 1,272,027

Pesticide chlorothalanil ...................................................................................................................... 1 2,500 50

Poisonous and Deleterious sub-nec .................................................................................................. 4 10,000 44,603

Salmonella/arizona ............................................................................................................................. 759 1,897,500 7,613,797

Staphylocci ......................................................................................................................................... 0 0 19,955

Sulfites ............................................................................................................................................... 12 30,000 810,062

Underprocessed ................................................................................................................................. 3 7,500 15,454

Unsafe food additives—NEC ............................................................................................................. 3 7,500 54,020

Total ........................................................................................................................................ 1,644 4,110,000 12,405,191

1 1 Calculation of costs assumes that, for each product placed on automatic detention, 10 lots per year will be analyzed with 1 sample each at

a cost of $250 per sample. 2Assumes storage costs equals 10 percent of the stated value of the goods.

Again assuming that half of the above

automatic detentions are eliminated

each year, then the benefits will be

approximately $6 million per year.

d. Recalls. The costs of recalls to a

firm vary from inexpensive notification
65190 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

of consignees to several million dollars,

depending on the nature of the hazard,

the type of seafood, the cost and amount

of product involved, and the

distribution chain of the product. The

costs of a recall include searching for

the recalled products, removing them

from retail and wholesale outlets,

replacing the adulterated product,

effectiveness checks, and disposal or

reconditioning. In some cases recalls

cause marketing disruptions, loss of

shelf space, and subsequent losses in

sales via publicity.

FDA costs include investigative and

analytical time and expenses,

administrative costs, cost of samples,

and auditing time.

FDA assumes that the costs of recalls

borne by firms are directly related to the

distribution costs associated with the

products and to the size of the

contaminated lots. Distribution costs

account for about one-third of the final

value of seafood. FDA assumes that the

firm must bear the full amount of the

distribution costs of the recall. In

addition, the other costs listed above

raise the total cost of recalls borne by

firms to one-half the value of the

product. FDA uses one-half the value of

the product as the base for the estimate

of total recall costs. The total recall cost

of seafood processing firms in 1994 is

estimated to be $2,461,906, as shown in

table 16. FDA audit checks for seafood

took 474 hours in 1994. FDA assumes

that total FDA costs per recall were

proportional to audit hours. The cost

per hour of an audit check is $107,

giving an FDA audit cost of $50,718

(474 x 107). FDA collected 72 samples

at $250 per sample, giving sample costs

of $18,000 (72 x 250). FDA thus

estimates additional costs due to recalls

to be $68,718 ($50,718 + $18,000). The

total recall cost is estimated to be

$2,530,624 ($2,461,906 + $68,718).

Again, the estimate for the purpose of

this benefits analysis assumes that half

of all recalls will be prevented or about

$1,250,000.

TABLE 16.—RECALLS IN 1994

Fish Hazards Amount Total

Canned tuna ......................................................... Filth, decomposed, punctured cans, short

weight.

6,599 cases .................. $150,687

Crab ...................................................................... L. monocytogenes ............................................... 16,156 lbs ..................... 64,624

Escolar fish ........................................................... Decomposed, sc ombroid, illness ....................... 1,719 lbs ....................... 1,614

Herring, salted Schmaltz ...................................... L. monocytogenes ............................................... 1,200 lbs ....................... 1,740

Hilsha fish ............................................................. Salmonella ........................................................... 2,000 lbs ....................... 2,100

Lobster .................................................................. L. monocytogenes, salmonella ............................ 25,920 lbs ..................... 243,648

Mahi mahi, fresh ................................................... Decomposed ....................................................... 575 lbs .......................... 834

Nova chips ............................................................ L. monocytogenes ............................................... 54 lbs ............................ 157

Oysters, shellstock ............................................... V. vulnificus ......................................................... 9,219,430 lbs ................ 1,843,886

Oysters, shucked .................................................. V. vulnificus ......................................................... 21,944 lbs ..................... 87,776

Sardines, flat fillets ............................................... Rusty, leaky, decomposed .................................. 33,600, 13 oz cans ...... 50,400

Smoked catfish, salmon, sturgeon, tuna .............. L. monocytogenes ............................................... 1,060 lbs ....................... 2,963

Tuna steaks .......................................................... Decomposed ....................................................... 7,110 lbs ....................... 11,477

Total ........................................................... .............................................................................. ....................................... 2,461,906.00

e. Injunctions. Injunctions are the

most severe form of domestic penalties

whereby a firm is enjoined from

producing/distributing a product until a

violation is remedied. There are

approximately 5 injunctions by FDA

against seafood products each year

costing the firm an average of about

$70,000 and FDA an average of about

$30,000 each or about $500,000 per

year. These costs include court costs,

analytical testing costs, inspections

costs, and lost production costs. Again,

if this rule reduced injunctions by half,

societal savings would be $250,000.

Total enforcement benefits are the

sum of all of the reduced enforcement

costs estimated to be approximately $20

million per year.

7. Other Benefits

Commenters also mentioned benefits

including better process control

(resulting in lower production costs)

and improved employee morale.

FDA believes that there may be ‘‘reengineering’’ types of benefits

associated with these regulations. For

both seafood and other foods for which

HACCP has been implemented, FDA has

received information that firms have

found cost-saving innovations in other

areas as they implement HACCP. These

innovations are considered trade secrets

by firms and thus, their description

(actual process innovations) and

quantification is impossible as firms

have not released this data into the

public domain. This phenomenon

involves unexpected savings and

efficiencies as a result of establishing a

new system in a processing operation.

The majority of firms that have

previously instituted HACCP reported

that they believed that the advantages

they derived from HACCP were worth

the costs to them in terms of better

control over their operations, better

sanitation, and greater efficiencies, such

as reduced waste. Virtually all foresaw

long-term benefits from operating under

HACCP.

Improved employee morale depends

on how HACCP is implemented. If, for

example, employees are (1) participating

in day-to-day monitoring of critical

control points, (2) allowed through

corrective action plans to participate in

corrective actions including shutting

down a line when a critical limit has

been exceeded, and (3) are rewarded for

this decision rather than penalized or

forced to rigorously defend their

actions, then employee morale may

increase. Such an increase in morale, if

valid, may lead to greater productivity.

However, it is in the direct financial

interest of every company to maintain

employee morale such that any

additional benefit from this regulation is

likely to be small.

A final benefit will be realized for

finfish where processing plants and

vessels, in an effort to control for

histamine formation, keep fish cooled

from harvest to retail. This will

simultaneously decrease the

decomposition rate that causes seafood

to be thrown out because of organoleptic

problems. The same situation exists

relative to cooked, ready-to-eat products

and smoked fish. One retailer cited

losses of 4 percent to 8 percent of all

seafood because of decomposition. If

some of this decomposition begins prior

to arrival at the retail level and is

reduced in any degree by this
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65191

regulation, benefits could potentially be

large.

However, FDA recognizes that there is

also a short term cost (e.g., as molluscan

shellfish harvesters attempt to supply

processors with untagged shellfish or

from vessels without sanitary facilities

aboard and find the harvest rejected).

The same will also be true for finfish

which have not been properly

temperature controlled from harvest to

processor. These harvests will be

discarded although this behavior is not

expected to occur often, or more than

once in any instance.

D. Costs and Benefits of Sanitation

A portion of the costs and benefits of

this rule derive from the improvements

in the facilities and CGMP’s in seafood

plants. Although all food manufacturing

plants are required to produce food

under sanitary conditions now, FDA’s

experience, and that of others, indicate

that many seafood processors are not

producing seafood under those

conditions. The sanitation, monitoring,

and recordkeeping provisions of this

rule are expected to drive processors to

improve their sanitation conditions and

thus reduce the need for FDA to enforce

CGMP’s through regulatory actions.

These provisions will produce net

increases in societal welfare with

accompanying costs and benefits.

Current goods manufacturing

practices include such things as

cleanliness and habits of personnel, the

conditions of buildings and facilities,

equipment, production and process

controls, and conditions of warehousing

and distribution of the product. It is

difficult to differentiate between costs

and benefits that are HACCP-related and

those that are sanitation-related. For

example, processors are required under

HACCP to keep records that show that

CGMP’s such as ‘‘Measures such as

sterilizing, irradiating, pasteurizing,

freezing, refrigerating, controlling pH or

controlling aw that are taken to destroy

or prevent the growth of undesirable

microorganisms, particularly those of

public health significance, shall be

adequate under the conditions of

manufacture, handling, and distribution

to prevent food from being adulterated

within the meaning of the act’’ are being

followed (see 21 CFR 110.80(a) (2) and

(4)). However, the benefits derive from

making plant and processing changes,

uncovering problems in processing due

to recordkeeping and taking corrective

action which prevents hazardous

seafood from being sold. Thus, HACCP

and CGMP’s are inextricably

intertwined and it is difficult to

calculate the marginal benefits and

marginal costs of each.

E. Costs and Benefits Attributable to

Foreign Governments

FDA has reported the portion of the

increased costs that are expected to be

passed on to U.S. consumers by foreign

processors. The justification for this

action is that FDA has not included

safety benefits that foreign consumers

may enjoy when foreign firms that

export to the United States introduce

HACCP into their plants. FDA has also

included, as a benefit of this regulation,

reduced enforcement actions toward

products produced by foreign firms and

reduced illnesses that U.S. consumers

suffer from imported seafood.

In a benefit-cost analysis, costs and

benefits are attributable to choices made

among competing options. However, in

this rule, there are difficulties in

assigning the costs and benefits to

choices made by FDA to require HACCP

of domestic and foreign seafood

processors. This difficulty arises

because other countries either already

require HACCP or have indicated that

they will do so in the near future—for

both their domestic and imported

seafood products. No costs or benefits

should be ascribed to choices made by

the U.S. Government in this rule that

affect firms already complying with

foreign regulations, if the regulations are

the same and no changes need to be

made to be in compliance with the U.S.

regulation.

Thus, foreign firms in those countries

who export to the United States may be

required to comply first with the U.S.

plan or first with their own country’s

plan; the timing is impossible to predict.

However, FDA does have evidence from

the European Union that the seafood

produced by the following countries (at

least seafood for export) have met the

EU standard for HACCP— Albania,

Australia, Austria, Belgium, Brazil,

Canada, Chile, Columbia, Denmark,

Ecuador, England, Faro Is., Finland,

France, Germany, Greece, Holland,

Iceland, Indonesia, Ireland, Italy, Japan,

Luxembourg, Mexico, Morocco, New

Zealand, Norway, Peru, Philippines,

Sweden, Taiwan, Thailand, and Turkey.

F. Conclusion

As the above analysis demonstrates,

FDA finds that the estimated benefits

exceed the estimated costs. The

estimated costs are approximately one

third of those in the PRIA, ranging from

$677 million to $1.488 billion. These

estimated costs were based primarily on

the reports of some seafood firms and

modeling done by FDA experts based on

their experience with HACCP but also

considered the study done under

contract with NMFS. The benefits range

from $1.435 billion to $2.561 billion and

include benefits from safety, nutrition,

increased consumer confidence, rent

seeking activities, exports, and reduced

enforcement costs.

G. Final Regulatory Flexibility Analysis

The Regulatory Flexibility Act (Pub.

L. 96–354) requires analyzing options

for regulatory relief for small businesses.

In the PRIA, FDA listed for comment a

series of regulatory options on how to

grant regulatory relief for small firms. In

that document, FDA defined small firms

as having less than $1 million in annual

gross revenue (for non-shrimp

processors) and less than $2 million for

shrimp processors. In the PRIA,

regulatory options for small business

relief included:

(1) Requiring HACCP-type controls for

those critical control points in

individual plants that have a history of

failure.

(2) Exempting very small processors

from the requirements in the proposed

regulatory option.

(3) Allowing a longer implementation

period such that HACCP requirements

may be phased in over a longer period

of time.

(4) Providing generic HACCP plans

(without mandatory control points) for

certain types of operations, providing

federal verification, or less frequent

monitoring of critical control points.

FDA received a large number of

comments on these options and on the

costs that small businesses would incur

as a result of the proposed option.

The agency has fully considered all of

the comments received on its regulatory

flexibility analysis and has responded to

these comments in the full RIA. What

follows is a summary of FDA’s major

conclusions from the analysis.

FDA received comments on whether

there should be exemptions for

processors based on either the size of

the processor or the degree of risk

associated with the product or process.

For example, one commenter supported

the exemption of small firms on the

basis that small firms that represent 75

percent of the industry in terms of the

number of plants, produce less than 10

percent of the seafood consumed.

FDA has concluded that there should

be no exemptions for small firms. Small

processors often engage in relatively

high risk seafood processing, and an

exemption based on size could

inappropriately exempt high risk

operations. An exemption based on risk

might entail knowing which seafood

might be responsible for a reported and

confirmed illness. The agency finds

however that because underreporting

and skewed reporting of foodborne
65192 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

illnesses occurs it is not always directly

possible to relate the reported illnesses

to risk. This subject is also discussed at

length in the preambles to both the

proposed and final rule.

One comment recommended that no

firms be completely exempt, but that

some firms be subject to different

HACCP requirements depending on

size. The smaller the firm, the less strict

the record-keeping, testing, and

monitoring requirements. The use of a

short form for recordkeeping and

informal monitoring was supported in

some comments.

Again, this is a topic that is

extensively covered in the preamble to

the final rule. FDA notes that HACCP

depends on the degree of risk and

complexity of processing and that

HACCP requirements for each plant are

calibrated based on these factors.

Whether the plant is large or small, if

there are few hazards and simple

processes, HACCP requirements are

inherently minimal. If there are no

hazards, no HACCP plan is required.

Overall, however the agency believes

that many smaller firms are associated

with simpler processes and that the

HACCP system already accommodates

the commenter’s concern.

In the long run, as processors adopt

HACCP and attempt to pass costs on to

consumers, the retail price of seafood

will rise by less than 1 percent. In the

absence of an increase in consumer

demand that may result from this

regulation, as the price of seafood rises,

consumers will purchase less seafood.

As producers fail to sell all of the

seafood offered at the higher price,

output must fall. Moreover, output must

decrease in the highest cost sector of the

industry, generally small processors.

Although it is possible that small

processors will cut back production but

stay in business, the small profit

margins of some small seafood

producers strongly imply that the

reduction in output will come about

because small processors go out of

business. For every one percent increase

in the price of seafood, approximately

140 small processors could go out of

business. The estimated number comes

from the following calculation. FDA has

estimated that as costs are passed on,

HACCP will raise the price of seafood to

consumers. The price elasticity of

demand, which is the percentage change

in quantity purchased divided by the

percentage change in price, is estimated

to be ¥0.37 for seafood (Ref. 227). A

one percent increase in the price

consumers pay for seafood should

therefore reduce the quantity purchased

by 0.37 percent (1 percent times ¥0.37).

FDA believes that the entire reduction

in output attributable to HACCP will be

borne by small processors who go out of

business. Although close to 80 percent

of seafood processors are classified as

small, small processors account for only

10 percent of total industry output (Ref.

228). In the case of a 0.37 percent

decline in total processing output

represents a decline in the output of

small processors of 3.7 percent (0.37

percent divided by 0.10). If the decline

in the number of processors were

proportional to the decline in the output

of small processors, the reduction in the

number of processors would be 3.7

percent in the case of a 1 percent price

increase. FDA is uncertain as to what

price increase will actually occur.

The agency finds that the number of

small seafood processors that go out of

business will be determined by the cost

per unit (or per plant) of implementing

HACCP, the effect of HACCP on seafood

prices, the ability of small plants to pass

costs on to consumers, the current

practices of the plants and the

implementation time. The analysis has

assumed that the regulation will have

no positive effect on the demand for

seafood. If the regulation in fact

increases consumer confidence in

seafood sufficiently to increase the

demand for seafood, then the effect on

small business would be less.

Although the economic impact on

small firms is difficult to predict, many

small firms should be able to implement

HACCP at low cost, as they have already

fulfilled many of its basic requirements.

The closer a firm’s current practices are

to HACCP, the lower the cost of HACCP

and the more likely is firm survival.

Some small firms occupy market niches

that allow them to pass on more of their

costs than the industry average,

increasing their likelihood of survival.

The effect of HACCP on small seafood

processors depends on their costs of

compliance and on the changes in the

relative price of seafood. FDA expects

the relative price increase attributable to

HACCP to be small. For many small

firms, the flexibility built into the

regulation strongly implies that HACCP

costs will be low. In consideration of

small firms, the agency has extended the

effective date to 2 years from

publication. FDA will also be

publishing a Guide that will provide

small processors with valuable

information for developing and

implementing HACCP. Additionally, the

agency, in cooperation with Sea Grant

Universities and others through the

Seafood HACCP Alliance, will be

providing to small firms assistance on

training and other needs.

FDA recognizes that HACCP is an

innovative regulatory system that has

not been applied on a large scale to

ongoing commercial enterprises in the

United States. For this reason all of the

agency’s estimates of firm behavior,

costs and benefits necessarily involve

substantial uncertainty. As explained in

this Regulatory Impact Analysis, FDA

has used modeling techniques and

informed judgements rather than firm

empirical data to estimate many effects.

In order to determine the accuracy of

these estimates, and also to assist in

possible mid-course corrections, FDA

and HHS plan to conduct an evaluation

study during the first few years after the

effective date of these regulations. This

study could focus on each major type of

one-time or continuing compliance cost,

on different types of firms, on different

sizes of firms (with particular attention

to the smallest firms), and on both costs

required by the regulation and on costs

that firms may incur unnecessarily. It

could also address the ability of firms to

understand and implement HACCP

properly, and any other problems that

may impede rapid and inexpensive

implementation. This study could also

include an exploratory analysis of

benefits, addressing both improvements

in processing as measured by

elimination of hazards and, to the extent

permitted by existing data systems,

early trends in reported incidence of

illness caused by seafood.

V. Environmental Impact

The agency has previously considered

the environmental effects of this rule as

announced in the proposed rule (59 FR

4142, January 28, 1994). No new

information or comments have been

received that would affect the agency’s

previous determination that there is no

significant impact on the human

environment, and that an environmental

impact statement is not required.

VI. References

The following references have 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.

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List of Subjects

21 CFR Part 123

Fish, Fishery products, Imports,

Reporting and recordkeeping

requirements, Seafood.

21 CFR Part 1240

Communicable diseases, Public

health, Travel restrictions, Water

supply.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, title 21 CFR chapter

I is amended as follows:

1. New part 123 is added to read as

follows:

PART 123—FISH AND FISHERY

PRODUCTS

Subpart A—General Provisions

Sec.

123.3 Definitions.

123.5 Current good manufacturing practice.

123.6 Hazard Analysis and Hazard Analysis

Critical Control Point (HACCP) plan.

123.7 Corrective actions.

123.8 Verification.

123.9 Records.

123.10 Training.

123.11 Sanitation control procedures.

123.12 Special requirements for imported

products.

Subpart B—Smoked and Smoke-Flavored

Fishery Products

123.15 General.

123.16 Process controls.

Subpart C—Raw Molluscan Shellfish

123.20 General.

123.28 Source controls.

Authority: Secs. 201, 402, 403, 406, 409,

701, 704, 721, 801, 903 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 321, 342,

343, 346, 348, 371, 374, 379e, 381, 393); secs.

301, 307, 361 of the Public Health Service

Act (42 U.S.C. 241, 242l, 264).

Subpart A—General Provisions

§ 123.3 Definitions.

The definitions and interpretations of

terms in section 201 of the Federal

Food, Drug, and Cosmetic Act (the act)

and in part 110 of this chapter are

applicable to such terms when used in

this part, except where they are herein

redefined. The following definitions

shall also apply:

(a) Certification number means a

unique combination of letters and

numbers assigned by a shellfish control

authority to a molluscan shellfish

processor.

(b) Critical control point means a

point, step, or procedure in a food

process at which control can be applied,

and a food safety hazard can as a result

be prevented, eliminated, or reduced to

acceptable levels.

(c) 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 safety hazard.

(d) Fish means fresh or saltwater

finfish, crustaceans, other forms of

aquatic animal life (including, but not

limited to, alligator, frog, aquatic turtle,

jellyfish, sea cucumber, and sea urchin

and the roe of such animals) other than

birds or mammals, and all mollusks,

where such animal life is intended for

human consumption.

(e) Fishery product means any human

food product in which fish is a

characterizing ingredient.

(f) Food safety hazard means any

biological, chemical, or physical

property that may cause a food to be

unsafe for human consumption.

(g) Importer means either the U.S.

owner or consignee at the time of entry

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, who is responsible for

ensuring that goods being offered for

entry into the United States are in

compliance with all laws affecting the

importation. For the purposes of this

definition, ordinarily the importer is not

the custom house broker, the freight

forwarder, the carrier, or the steamship

representative.

(h) Molluscan shellfish means any

edible species of fresh or frozen oysters,

clams, mussels, or scallops, or edible

portions of such species, except when

the product consists entirely of the

shucked adductor muscle.

(i) Preventive measure means

physical, chemical, or other factors that

can be used to control an identified food

safety hazard.

(j) Process-monitoring instrument

means an instrument or device used to

indicate conditions during processing at

a critical control point.

(k)(1) Processing means, with respect

to fish or fishery products: Handling,

storing, preparing, heading,

eviscerating, shucking, freezing,

changing into different market forms,

manufacturing, preserving, packing,

labeling, dockside unloading, or

holding.

(2) The regulations in this part do not

apply to:

(i) Harvesting or transporting fish or

fishery products, without otherwise

engaging in processing.

(ii) Practices such as heading,

eviscerating, or freezing intended solely

to prepare a fish for holding on board

a harvest vessel.

(iii) The operation of a retail

establishment.

(l) Processor means any person

engaged in commercial, custom, or

institutional processing of fish or fishery

products, either in the United States or

in a foreign country. A processing

includes any person engaged in the

production of foods that are to be used

in market or consumer tests.

(m) Scombroid toxin-forming species

means tuna, bluefish, mahi mahi, and

other species, whether or not in the

family Scombridae, in which significant

levels of histamine may be produced in

the fish flesh by decarboxylation of free

histidine as a result of exposure of the

fish after capture to temperatures that

permit the growth of mesophilic

bacteria.

(n) Shall is used to state mandatory

requirements.

(o) Shellfish control authority means

a Federal, State, or foreign agency, or

sovereign tribal government, legally

responsible for the administration of a

program that includes activities such as

classification of molluscan shellfish

growing areas, enforcement of
65198 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

molluscan shellfish harvesting controls,

and certification of molluscan shellfish

processors.

(p) Shellstock means raw, in-shell

molluscan shellfish.

(q) Should is used to state

recommended or advisory procedures or

to identify recommended equipment.

(r) Shucked shellfish means

molluscan shellfish that have one or

both shells removed.

(s) Smoked or smoke-flavored fishery

products means the finished food

prepared by:

(1) Treating fish with salt (sodium

chloride), and

(2) Subjecting it to the direct action of

smoke from burning wood, sawdust, or

similar material and/or imparting to it

the flavor of smoke by a means such as

immersing it in a solution of wood

smoke.

(t) Tag means a record of harvesting

information attached to a container of

shellstock by the harvester or processor.

§ 123.5 Current good manufacturing

practice.

(a) Part 110 of this chapter applies in

determining whether the facilities,

methods, practices, and controls used to

process fish and fishery products are

safe, and whether these products have

been processed under sanitary

conditions.

(b) The purpose of this part is to set

forth requirements specific to the

processing of fish and fishery products.

§ 123.6 Hazard Analysis and Hazard

Analysis Critical Control Point (HACCP)

Plan.

(a) Hazard analysis. Every processor

shall conduct, or have conducted for it,

a hazard analysis to determine whether

there are food safety hazards that are

reasonably likely to occur for each kind

of fish and fishery product processed by

that processor and to identify the

preventive measures that the processor

can apply to control those hazards. Such

food safety hazards can be introduced

both within and outside the processing

plant environment, including food

safety hazards that can occur before,

during, and after harvest. A food safety

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 it will occur

in the particular type of fish or fishery

product being processed in the absence

of those controls.

(b) The HACCP plan. Every processor

shall have and implement a written

HACCP plan whenever a hazard

analysis reveals one or more food safety

hazards that are reasonably likely to

occur, as described in paragraph (a) of

this section. A HACCP plan shall be

specific to:

(1) Each location where fish and

fishery products are processed by that

processor; and

(2) Each kind of fish and fishery

product processed by the processor. The

plan may group kinds of fish and fishery

products together, or group kinds of

production methods together, if the food

safety hazards, critical control points,

critical limits, and procedures required

to be identified and performed in

paragraph (c) of this section are

identical for all fish and fishery

products so grouped or for all

production methods so grouped.

(c) The contents of the HACCP plan.

The HACCP plan shall, at a minimum:

(1) List the food safety hazards that

are reasonably likely to occur, as

identified in accordance with paragraph

(a) of this section, and that thus must be

controlled for each fish and fishery

product. Consideration should be given

to whether any food safety hazards are

reasonably likely to occur as a result of

the following:

(i) Natural toxins;

(ii) Microbiological contamination;

(iii) Chemical contamination;

(iv) Pesticides;

(v) Drug residues;

(vi) Decomposition in scombroid

toxin-forming species or in any other

species where a food safety hazard has

been associated with decomposition;

(vii) Parasites, where the processor

has knowledge or has reason to know

that the parasite-containing fish or

fishery product will be consumed

without a process sufficient to kill the

parasites, or where the processor

represents, labels, or intends for the

product to be so consumed;

(viii) Unapproved use of direct or

indirect food or color additives; and

(ix) Physical hazards;

(2) List the critical control points for

each of the identified food safety

hazards, including as appropriate:

(i) Critical control points designed to

control food safety hazards that could be

introduced in the processing plant

environment; and

(ii) Critical control points designed to

control food safety hazards introduced

outside the processing plant

environment, including food safety

hazards that occur before, during, and

after harvest;

(3) List the critical limits that must be

met at each of the critical control points;

(4) List the procedures, and frequency

thereof, 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 § 123.7(b), to be followed in

response to deviations from critical

limits at critical control points;

(6) List the verification procedures,

and frequency thereof, that the

processor will use in accordance with

§ 123.8(a);

(7) Provide for a recordkeeping system

that documents the monitoring of the

critical control points. The records shall

contain the actual values and

observations obtained during

monitoring.

(d) Signing and dating the HACCP

plan. (1) The HACCP plan shall be

signed and dated, either by the most

responsible individual onsite at the

processing facility or by a higher level

official of the processor. This signature

shall signify that the HACCP plan has

been accepted for implementation by

the firm.

(2) The HACCP plan shall be dated

and signed:

(i) Upon initial acceptance;

(ii) Upon any modification; and

(iii) Upon verification of the plan in

accordance with § 123.8(a)(1).

(e) Products subject to other

regulations. For fish and fishery

products that are subject to the

requirements of part 113 or 114 of this

chapter, the HACCP plan need not list

the food safety hazard associated with

the formation of Clostridium botulinum

toxin in the finished, hermetically

sealed container, nor list the controls to

prevent that food safety hazard. A

HACCP plan for such fish and fishery

products shall address any other food

safety hazards that are reasonably likely

to occur.

(f) Sanitation. Sanitation controls may

be included in the HACCP plan.

However, to the extent that they are

monitored in accordance with

§ 123.11(b) they need not be included in

the HACCP plan, and vice versa.

(g) Legal basis. Failure of a processor

to have and implement a HACCP plan

that complies with this section

whenever a HACCP plan is necessary,

otherwise operate in accordance with

the requirements of this part, shall

render the fish or fishery products of

that processor adulterated under section

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

processor’s actions are consistent with

ensuring the safety of food will be

determined through an evaluation of the

processors overall implementation of its

HACCP plan, if one is required.
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65199

§ 123.7 Corrective actions.

(a) Whenever a deviation from a

critical limit occurs, a processor shall

take corrective action either by:

(1) Following a corrective action plan

that is appropriate for the particular

deviation, or

(2) Following the procedures in

paragraph (c) of this section.

(b) Processors may develop written

corrective action plans, which become

part of their HACCP plans in accordance

with § 123.6(c)(5), by which they

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.

(c) 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 (c)(2) and (c)(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 a review. Adequate

training may or may not include

training in accordance with § 123.10;

(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;

(5) Perform or obtain timely

reassessment by an individual or

individuals who have been trained in

accordance with § 123.10, to determine

whether the HACCP plan needs to be

modified to reduce the risk of

recurrence of the deviation, and modify

the HACCP plan as necessary.

(d) All corrective actions taken in

accordance with this section shall be

fully documented in records that are

subject to verification in accordance

with § 123.8(a)(3)(ii) and the

recordkeeping requirements of § 123.9.

§ 123.8 Verification.

(a) Overall verification. Every

processor shall verify that the HACCP

plan is adequate to control food safety

hazards that are reasonably likely to

occur, and that the plan is being

effectively implemented. Verification

shall include, at a minimum:

(1) Reassessment of the HACCP plan.

A reassessment of the adequacy of the

HACCP plan whenever any changes

occur that could affect the hazard

analysis or alter the HACCP plan in any

way or at least annually. Such changes

may include changes in the following:

Raw materials or source of raw

materials, product formulation,

processing methods or systems, finished

product distribution systems, or the

intended use or consumers of the

finished product. The reassessment

shall be performed by an individual or

individuals who have been trained in

accordance with § 123.10. The HACCP

plan shall be modified immediately

whenever a reassessment reveals that

the plan is no longer adequate to fully

meet the requirements of § 123.6(c).

(2) Ongoing verification activities.

Ongoing verification activities

including:

(i) A review of any consumer

complaints that have been received by

the processor to determine whether they

relate to the performance of critical

control points or reveal the existence of

unidentified critical control points;

(ii) The calibration of processmonitoring instruments; and,

(iii) At the option of the processor, the

performing of periodic end-product or

in-process testing.

(3) Records review. A review,

including signing and dating, by an

individual who has been trained in

accordance with § 123.10, of the records

that document:

(i) 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

they document values that are within

the critical limits. This review shall

occur within 1 week of the day that the

records are made;

(ii) 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 § 123.7. This

review shall occur within 1 week of the

day that the records are made; and

(iii) The calibrating of any process

control instruments used at critical

control points and the performing 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.

(b) Corrective actions. Processors shall

immediately follow the procedures in

§ 123.7 whenever any verification

procedure, including the review of a

consumer complaint, reveals the need to

take a corrective action.

(c) Reassessment of the hazard

analysis. Whenever a processor does not

have a HACCP plan because a hazard

analysis has revealed no food safety

hazards that are reasonably likely to

occur, the processor shall reassess the

adequacy of that hazard analysis

whenever there are any changes that

could reasonably affect whether a food

safety hazard now exists. Such changes

may include, but are not limited to

changes in: Raw materials or source of

raw materials, product formulation,

processing methods or systems, finished

product distribution systems, or the

intended use or consumers of the

finished product. The reassessment

shall be performed by an individual or

individuals who have been trained in

accordance with § 123.10.

(d) Recordkeeping. The calibration of

process-monitoring instruments, and the

performing of any periodic end-product

and in-process testing, in accordance

with paragraphs (a)(2)(ii) through (iii) of

this section shall be documented in

records that are subject to the

recordkeeping requirements of § 123.9.

§ 123.9 Records.

(a) General requirements. All records

required by this part shall include:

(1) The name and location of the

processor or importer;

(2) The date and time of the activity

that the record reflects;

(3) The signature or initials of the

person performing the operation; 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.

(b) Record retention. (1) All records

required by this part shall be retained at

the processing facility or importer’s

place of business in the United States

for at least 1 year after the date they

were prepared in the case of refrigerated

products and for at least 2 years after the

date they were prepared in the case of

frozen, preserved, or shelf-stable

products.

(2) Records that relate to the general

adequacy of equipment or processes

being used by a processor, including the
65200 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

results of scientific studies and

evaluations, shall be retained at the

processing facility or the importer’s

place of business in the United States

for at least 2 years after their

applicability to the product being

produced at the facility.

(3) If the processing facility is closed

for a prolonged period between seasonal

packs, or if record storage capacity is

limited on a processing vessel or at a

remote processing site, the records may

be transferred to some other reasonably

accessible location at the end of the

seasonal pack but shall be immediately

returned for official review upon

demand.

(c) Official review. All records

required by this part and all plans and

procedures required by this part shall be

available for official review and copying

at reasonable times.

(d) Public disclosure. (1) Subject to

the limitations in paragraph (d)(2) of

this section, all plans and 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

they relate to a product or ingredient

that has been abandoned and they no

longer represent a trade secret or

confidential commercial or financial

information as defined in § 20.61 of this

chapter.

(2) However, these records and plans

may be 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 generictype HACCP plans that reflect standard

industry practices.

(e) Tags. Tags as defined in § 123.3(t)

are not subject to the requirements of

this section unless they are used to

fulfill the requirements of § 123.28(c).

(f) Records maintained on computers.

The maintenance of records on

computers is acceptable, provided that

appropriate controls are implemented to

ensure the integrity of the electronic

data and signatures.

§ 123.10 Training.

At a minimum, the following

functions shall be performed by an

individual who has successfully

completed training in the application of

HACCP principles to fish and fishery

product processing at least equivalent to

that received under standardized

curriculum recognized as adequate by

the U.S. Food and Drug Administration

or who is otherwise qualified through

job experience to perform these

functions. Job experience will qualify an

individual to perform these functions if

it has provided knowledge at least

equivalent to that provided through the

standardized curriculum.

(a) Developing a HACCP plan, which

could include adapting a model or

generic-type HACCP plan, that is

appropriate for a specific processor, in

order to meet the requirements of

§ 123.6(b);

(b) Reassessing and modifying the

HACCP plan in accordance with the

corrective action procedures specified

in § 123.7(c)(5), the HACCP plan in

accordance with the verification

activities specified in § 123.8(a)(1), and

the hazard analysis in accordance with

the verification activities specified in

§ 123.8(c); and

(c) Performing the record review

required by § 123.8(a)(3); The trained

individual need not be an employee of

the processor.

§ 123.11 Sanitation control procedures.

(a) Sanitation SOP. Each processor

should have and implement a written

sanitation standard operating procedure

(herein referred to as SSOP) or similar

document that is specific to each

location where fish and fishery products

are produced. The SSOP should specify

how the processor will meet those

sanitation conditions and practices that

are to be monitored in accordance with

paragraph (b) of this section.

(b) Sanitation monitoring. Each

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 both

appropriate to the plant and the food

being processed and relate to the

following:

(1) Safety of the water that comes into

contact with food or food contact

surfaces, or 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 cooked 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.

The processor shall correct in a timely

manner, those conditions and practices

that are not met.

(c) Sanitation control records. Each

processor shall maintain sanitation

control records that, at a minimum,

document the monitoring and

corrections prescribed by paragraph (b)

of this section. These records are subject

to the requirements of § 123.9.

(d) Relationship to HACCP plan.

Sanitation controls may be included in

the HACCP plan, required by § 123.6(b).

However, to the extent that they are

monitored in accordance with

paragraph (b) of this section they need

not be included in the HACCP plan, and

vice versa.

§ 123.12 Special requirements for

imported products.

This section sets forth specific

requirements for imported fish and

fishery products.

(a) Importer verification. Every

importer of fish or fishery products shall

either:

(1) Obtain the fish or fishery product

from a country that has an active

memorandum of understanding (MOU)

or similar agreement with the Food and

Drug Administration, that covers the

fish or fishery product and documents

the equivalency or compliance of the

inspection system of the foreign country

with the U.S. system, accurately reflects

the current situation between the

signing parties, and is functioning and

enforceable in its entirety; or

(2) Have and implement written

verification procedures for ensuring that

the fish and fishery products that they

offer for import into the United States

were processed in accordance with the

requirements of this part. The

procedures shall list at a minimum:

(i) Product specifications that are

designed to ensure that the product is

not adulterated under section 402 of the

Federal Food, Drug, and Cosmetic Act

because it may be injurious to health or

have been processed under insanitary

conditions, and,

(ii) Affirmative steps that may include

any of the following:

(A) Obtaining from the foreign

processor the HACCP and sanitation

monitoring records required by this part

that relate to the specific lot of fish or

fishery products being offered for

import;

(B) Obtaining either a continuing or

lot-by-lot certificate from an appropriate
Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations 65201

foreign government inspection authority

or competent third party certifying that

the imported fish or fishery product is

or was processed in accordance with the

requirements of this part;

(C) Regularly inspecting the foreign

processor’s facilities to ensure that the

imported fish or fishery product is being

processed in accordance with the

requirements of this part;

(D) Maintaining on file a copy, in

English, of the foreign processor’s

HACCP plan, and a written guarantee

from the foreign processor that the

imported fish or fishery product is

processed in accordance with the

requirements of the part;

(E) Periodically testing the imported

fish or fishery product, and maintaining

on file a copy, in English, of a written

guarantee from the foreign processor

that the imported fish or fishery product

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 § 123.9.

(d) Determination of compliance.

There must be evidence that all fish and

fishery products offered for entry into

the United States have been processed

under conditions that comply with this

part. If assurances do not exist that the

imported fish or fishery product 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.

Subpart B—Smoked and Smokeflavored Fishery Products

§ 123.15 General.

This subpart augments subpart A of

this part by setting forth specific

requirements for processing smoked and

smoke-flavored fishery products.

§ 123.16 Process controls.

In order to meet the requirements of

subpart A of this part, processors of

smoked and smoke-flavored fishery

products, except those subject to the

requirements of part 113 or 114 of this

chapter, shall include in their HACCP

plans how they are controlling the food

safety hazard associated with the

formation of toxin by Clostridium

botulinum for at least as long as the

shelf life of the product under normal

and moderate abuse conditions.

Subpart C—Raw Molluscan Shellfish

§ 123.20 General.

This subpart augments subpart A of

this part by setting forth specific

requirements for processing fresh or

frozen molluscan shellfish, where such

processing does not include a treatment

that ensures the destruction of

vegetative cells of microorganisms of

public health concern.

§ 123.28 Source controls.

(a) In order to meet the requirements

of subpart A of this part as they apply

to microbiological contamination,

chemical contamination, natural toxins,

and related food safety hazards,

processors shall include in their HACCP

plans how they are controlling the

origin of the molluscan shellfish they

process to ensure that the conditions of

paragraphs (b), (c), and (d) of this

section are met.

(b) Processors shall only process

molluscan shellfish harvested from

growing waters approved for harvesting

by a shellfish control authority. In the

case of molluscan shellfish harvested

from U.S. Federal waters, the

requirements of this paragraph will be

met so long as the shellfish have not

been harvested from waters that have

been closed to harvesting by an agency

of the Federal government.

(c) To meet the requirements of

paragraph (b) of this section, processors

who receive shellstock shall accept only

shellstock from a harvester that is in

compliance with such licensure

requirements as may apply to the

harvesting of molluscan shellfish or

from a processor that is certified by a

shellfish control authority, and that has

a tag affixed to each container of

shellstock. The tag shall bear, at a

minimum, the information required in

§ 1240.60(b) of this chapter. In place of

the tag, bulk shellstock shipments may

be accompanied by a bill of lading or

similar shipping document that contains

the information required in § 1240.60(b)

of this chapter. Processors shall

maintain records that document that all

shellstock have met the requirements of

this section. These records shall

document:

(1) The date of harvest;

(2) The location of harvest by State

and site;

(3) The quantity and type of shellfish;

(4) The date of receipt by the

processor; and

(5) The name of the harvester, the

name or registration number of the

harvester’s vessel, or an identification

number issued to the harvester by the

shellfish control authority.

(d) To meet the requirements of

paragraph (b) of this section, processors

who receive shucked molluscan

shellfish shall accept only containers of

shucked molluscan shellfish that bear a

label that complies with § 1240.60(c) of

this chapter. Processors shall maintain

records that document that all shucked

molluscan shellfish have met the

requirements of this section. These

records shall document:

(1) The date of receipt;

(2) The quantity and type of shellfish;

and

(3) The name and certification

number of the packer or repacker of the

product.

PART 1240—CONTROL OF

COMMUNICABLE DISEASES

2. The authority citation for 21 CFR

part 1240 continues to read as follows:

Authority: Secs. 215, 311, 361, 368 of the

Public Health Service Act (42 U.S.C. 216,

243, 264, 271).

3. Section 1240.3 is amended by

revising paragraph (r), and by adding

new paragraphs (s), (t), and (u) to read

as follows:

§ 1240.3 General definitions.

* * * * *

(r) Molluscan shellfish. Any edible

species of fresh or frozen oysters, clams,

mussels, and scallops or edible portions

thereof, except when the product

consists entirely of the shucked

adductor muscle.

(s) Certification number means a

unique combination of letters and

numbers assigned by a shellfish control

authority to a molluscan shellfish

processor.

(t) Shellfish control authority means a

Federal, State, or foreign agency, or

sovereign tribal government, legally

responsible for the administration of a

program that includes activities such as

classification of molluscan shellfish

growing areas, enforcement of

molluscan shellfish harvesting controls,

and certification of molluscan shellfish

processors.

(u) Tag means a record of harvesting

information attached to a container of

shellstock by the harvester or processor.

4. Section 1240.60 is amended by

revising the section heading, by
65202 Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / Rules and Regulations

redesignating the existing text as

paragraph (a) and adding the word

‘‘molluscan’’ before the word

‘‘shellfish’’ the two times that it appears,

and by adding new paragraphs (b), (c),

and (d) to read as follows:

§ 1240.60 Molluscan shellfish.

* * * * *

(b) All shellstock shall bear a tag that

discloses the date and place they were

harvested (by State and site), type and

quantity of shellfish, and by whom they

were harvested (i.e., the identification

number assigned to the harvester by the

shellfish control authority, where

applicable or, if such identification

numbers are not assigned, the name of

the harvester or the name or registration

number of the harvester’s vessel). In

place of the tag, bulk shellstock

shipments may be accompanied by a

bill of lading or similar shipping

document that contains the same

information.

(c) All containers of shucked

molluscan shellfish shall bear a label

that identifies the name, address, and

certification number of the packer or

repacker of the molluscan shellfish.

(d) Any molluscan shellfish without

such a tag, shipping document, or label,

or with a tag, shipping document, or

label that does not bear all the

information required by paragraphs (b)

and (c) of this section, shall be subject

to seizure or refusal of entry, and

destruction.

Dated: October 3, 1995.

David A. Kessler,

Commissioner of Food and Drugs.

Donna E. Shalala,

Secretary of Health and Human Services.

[FR Doc 95–30332 Filed 12–11–95; 10:40 am]

BILLING CODE 4160–01–P