Development of Hazard Analysis Critical Control Points for the Food Industry; Request for Comments

SUMMARY: The Food and Drug Administration (FDA) is asking for public

comment about whether and how the agency should develop regulations

that would establish requirements for a new comprehensive food safety

assurance program for both domestically produced and imported foods.

Such regulations, if promulgated, would enhance FDA's ability to ensure

the safety of the U.S. food supply. In this document, FDA is proposing

that this program be based upon the principles of Hazard Analysis

Critical Control Points (HACCP). FDA is requesting comments on a number

of specific issues, as well as on all aspects of such a food safety

program.

DATES: Written comments by December 2, 1994.

ADDRESSES: Written comments to the Dockets Management Branch (HFA-305),

Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville,

MD 20857, 301-443-1751.

FOR FURTHER INFORMATION CONTACT: John E. Kvenberg, Center for Food

Safety and Applied Nutrition (HFS-10), Food and Drug Administration,

200 C St. SW., Washington, DC 20204, 202-205-4010.

SUPPLEMENTARY INFORMATION:

I. Background

A. Status of the Food Safety Assurance Program in the United States

FDA's mandate to ensure the safety of the nation's food supply is

derived principally from the Federal Food, Drug, and Cosmetic Act (the

act) (21 U.S.C. 321 et seq). Under the act, FDA has authority to ensure

that all foods in interstate commerce, or that have been shipped in

interstate commerce, are not contaminated or otherwise adulterated, are

produced under sanitary conditions, and are not misbranded or

deceptively packaged\1\. The agency also has authority to ensure food

safety under the Public Health Service Act (the PHS act) (42 U.S.C.

264), which relates to the control of the spread of communicable

diseases from one State, territory, or possession to another, or from

outside the United States into this country.

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\1\Two other Federal agencies share with FDA the responsibility

for regulating the safety of the food supply. The U.S. Department of

Agriculture (USDA) has authority under the Meat Inspection Act (21

U.S.C. 601), the Poultry Inspection Act (21 U.S.C. 451), and the Egg

Products Inspection Act (21 U.S.C. 1031) to inspect facilities in

which meat, poultry, and eggs, respectively, are processed, and to

regulate such products. The U.S. Environmental Protection Agency has

authority, under provisions of the act, to establish legal limits

(tolerances) for residues of pesticides on foods. FDA and USDA

enforce such tolerances.

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To carry out its mandate to ensure the safety of the U.S. food

supply, FDA conducts periodic inspections of food processors, shippers,

food packers and repackers, food labelers and relabelers, and food

warehouses. Some inspections are carried out by the States, under

contract with FDA. In addition, although subject to FDA jurisdiction,

the many hundreds of thousands of retail food outlets and restaurants

in the United States are inspected by State and local health

departments with technical assistance and training from FDA. FDA's

program to ensure the safety of the U.S. food supply also includes

sample analyses of food offered for import, research into rapid

detection methodologies for potential hazards, enforcement activities,

and education and information sharing programs. The goal of all of

these regulatory and enforcement activities is to ensure that the food

supply is, and remains, safe.

Although the current food safety assurance program has generally

functioned effectively, it currently faces new stresses and challenges.

New food processing and packaging technologies, new food distribution

and consumption patterns, increasing public health concerns about low

levels of certain chemical contaminants, and new microbial pathogens

all contribute to today's food safety challenge. For example, the

composition of the food supply has changed dramatically in the 55 years

since passage of the act. More people consume commercially processed or

commercially prepared foods than ever before, and there is increased

consumer demand for ``fresh'' foods in convenient, ready-to-cook forms,

which has fostered the development of sophisticated processing and

packaging systems that can significantly extend the shelf life of a

variety of foods. However, new food safety risks can be associated with

these new food products, new packages, and new patterns of distribution

and consumption.

One of the most important challenges to FDA's current food safety

assurance program is the increasing number of new food pathogens.

Although food borne illness has always been a public health problem,

such illness appears to be on the rise, and new pathogens are appearing

(Ref. 1). In addition, because foods are more extensively processed and

handled, there is now a greater opportunity for food to be

contaminated.

Food borne illness is a major cause of morbidity in the United

States; estimates of the yearly incidence of food borne illness vary

greatly, ranging from 6.5 million (Ref. 1) to 12.6 million cases per

year (Ref. 2), and from 24 to 81 million cases per year (Ref. 3). In

the 15 years between 1973 and 1988, the number of recognized food borne

pathogens broadened considerably. During that period, bacteria not

previously recognized as important food borne pathogens emerged,

including Campylobacter jejuni, Escherichia coli, Listeria

monocytogenes, Yersinia enterocolitica, and a variety of Vibrio spp.

During that same period, experts recognized that certain food borne

illnesses may be followed by serious complications, such as arthritis,

kidney damage, heart disease, and neurological damage (Ref. 3).

Pathogens are not the only potential contaminants of food, however.

The extensive use of industrial chemicals, coupled with past failures

to deal adequately with chemical waste, have resulted in significant

chemical pollution of the environment in some regions. Many of these

chemicals have found their way into the food chain. The legal use of

pesticides in agriculture may also result in residues in food.

Naturally occurring chemicals, such as toxic elements and mycotoxins,

can also be found in food at levels of concern. The sheer number of

these potential contaminants, the concerns about their toxicity even at

very low levels, and the difficulty and expense associated with many of

the analytical methods used to quantify their levels in food, make

exhaustive endpoint monitoring of the food supply virtually impossible.

The size and diversity of the food industry adds to the stress on

the current food safety assurance program. FDA's current inventory

lists over 30,000 food manufacturers and processors, and in excess of

20,000 food warehouses. The number of foreign manufacturers and

processors shipping food products to the United States continues to

increase. In 1992, there were well over 1 million food import entries

into the United States. In addition, the diversity of food imports

continues to increase, with a rising volume of foods entering the

United States in processed forms.

Finally, the current food safety program is under stress

internally. It is unlikely that FDA will ever have sufficient resources

to inspect, sample, and analyze more than a small percentage of

imported food shipments. State and local governments, on which FDA

relies heavily for surveillance of the growing retail food sector, are

also under severe resource constraints. Indeed, some States are

considering proposals to reduce their food safety programs.

FDA's current regulatory strategy for ensuring food safety, with

its emphasis on periodic visual inspection of food facilities and end-

product testing, was designed to control the problems that were known

to exist when the act was established in 1938. The agency has struggled

to keep up with the enormous growth and changes in the food industry

and the resulting new food safety challenges. FDA's current regulatory

approach is relatively resource intensive and inefficient compared to

other ways of ensuring food safety. Inspections that FDA conducts under

the current system can determine the adequacy of conditions in a food

plant at the time of the inspection but not whether the company has in

place a food safety assurance program that is operating reliably and

consistently to produce safe food at all times. Furthermore, the

current inspectional approach is generally reactive, not preventive. It

is effective in detecting and correcting problems after they occur,

but, except in certain limited areas such as the regulation of infant

formula and low acid canned foods, it is not currently based on a

system of preventive controls.

For all of these reasons, FDA believes that it is appropriate at

this time for the agency to consider improvements to its food safety

assurance program to focus the program on prevention of food safety

risks and problems. FDA's goals in establishing additional food safety

regulations would be to: (1) Make the food supply safer through

prevention of food safety problems; (2) enable FDA and its State and

local counterparts to make more efficient use of the existing resources

devoted to ensuring food safety, and (3) enhance the ability of the

Federal Government to provide consumers with the assurance they seek

that the U.S. food supply is safe.

FDA recognizes that risks vary across the food supply and that

measures to make food safer should focus on the potential of particular

foods or possible contaminants in those foods to cause illness. The

agency also recognizes that there is no proven method or approach for

ensuring the safety of food that will eliminate risk in all

circumstances. Indeed, one purpose of this notice is to seek public

comment on the degree of potential risks posed by those microorganisms,

chemicals, and physical hazards (e.g., broken glass) that can get into

food and be passed on to the consumer, if appropriate care is not

exercised. FDA also desires comments on the consequences of these risks

if they occur. In addition, the agency seeks comment on how these risks

can best be controlled and which systems of quality control can best

protect consumers from potentially unsafe food.

Although the agency has reached no final conclusions about how its

regulatory programs should be revised to make food as safe as possible,

FDA has tentatively concluded that the improvements in the agency's

current food safety assurance program should be based on a state-of-

the-art, preventive approach known as HACCP. HACCP was developed

approximately 30 years ago by the U.S. food industry, and it is

currently used in a number of domestic food processing facilities.

HACCP is internationally regarded as the most effective system for

producing safe food. FDA is considering HACCP as the foundation for

revision of the U.S. food safety assurance program because, although

simple in its basic concepts, HACCP is a sophisticated and powerful

tool for ensuring food safety. HACCP is a science based, systematic

approach to preventing food safety problems by anticipating how such

problems are most likely to occur and by installing effective measures

to prevent them from occurring. HACCP thus requires that the processor

and the regulatory authority be aware of the state-of-the-art science

relative to food safety and processing technology. HACCP appropriately

affirms that the food industry has primary responsibility for producing

safe food, and it provides an important opportunity to link the food

industry's system for producing safe food with the Government's system

of regulatory oversight. A more in-depth discussion of the HACCP

concept follows.

B. The HACCP System

The HACCP concept (Ref. 4) is a systematic approach to the

identification, assessment of risk (likelihood of occurrence and

severity), and control of the biological, chemical, and physical

hazards associated with a particular food production process or

practice. HACCP is a preventive strategy. It is based on development by

the food producer of a plan that anticipates food safety hazards and

identifies the points in the production process where a failure would

likely result in a hazard being created or allowed to persist; these

points are referred to as critical control points (CCP's). Under HACCP,

identified CCP's are systematically monitored, and records kept of that

monitoring. Corrective actions are taken when control of a CCP is lost,

including proper disposition of the food produced during that period,

and these actions are documented.

Use of the HACCP system for the food industry will underscore the

industry's role in continuous problem prevention and problem solving,

rather than relying solely on traditional facility inspections by

regulatory agencies to detect loss of control. HACCP provides for real

time monitoring procedures to assess the effectiveness of control. Each

HACCP plan would reflect the uniqueness of a food, its method of

processing, and the facility in which it is prepared.

HACCP has been endorsed by the National Advisory Committee on

Microbiological Criteria for Foods (NACMCF) as an effective and

rational means of ensuring food safety from harvest to table. The

NACMCF was established in 1988 by USDA in conjunction with FDA to

fulfill a recommendation of the National Academy of Sciences, and

includes officials from FDA, USDA, the National Oceanic and Atmospheric

Administration, and the Department of Defense, as well as experts from

academia and the food industry. HACCP is also recognized in the

international food safety community as the state-of-the-art means to

ensure the safety and integrity of food. In particular, the Committee

on Food Hygiene of the United Nations' Codex Alimentarius Commission

(Codex) has endorsed the HACCP concept as a world wide guideline.

Indeed, the European Union (EU) and other countries around the world

have begun to require that foods produced within their borders be

processed under HACCP requirements.

The NACMCF has developed the following seven principles that

describe the HACCP concept:

1. Hazard Analysis

The first step in the establishment of a HACCP system for a food

process or practice is the identification of the hazards associated

with the product. The NACMCF defines a hazard as a biological,

chemical, or physical property that may cause a food to be unsafe for

consumption. The hazard analysis step should include an assessment of

both the likelihood that such a hazard will occur and its severity if

it does occur. This analysis should also involve the establishment of

preventive measures to control identified hazards.

2. Identification of CCP's

A CCP is a point, step, or procedure at which control can be

applied, the result being that a potential food safety hazard can be

prevented, eliminated, or reduced to acceptable levels. Points in the

manufacturing process that may be CCP's include cooking, chilling,

specific sanitation procedures, product formulation control, prevention

of cross contamination, and certain aspects of employee and

environmental hygiene.

3. Establishment of Critical Limits for Preventive Measures Associated

With Each Identified CCP

This step involves establishing a criterion that must be met for

each preventive measure associated with a CCP. Critical limits can be

thought of as boundaries of safety for each CCP and may be set for

preventive measures such as temperature, time, physical dimensions,

moisture level, water activity, pH, and available chlorine.

4. Establishment of Procedures to Monitor CCP's

Monitoring is a planned sequence of observations or measurements to

assess whether a CCP is under control and to produce an accurate record

for use in future verification procedures. Continuous monitoring is

possible with many types of physical and chemical methods. When it is

not possible to monitor a critical limit on a continuous basis,

monitoring intervals must be frequent enough to permit the manufacturer

to determine whether the step/process/procedure designed to control the

hazard is under control.

5. Establishment of Corrective Actions To Be Taken When Monitoring

Shows That a Critical Limit Has Been Exceeded

While the HACCP system is intended to prevent deviations in a

planned process from occurring, total prevention can rarely, if ever,

be achieved. Therefore, there must be a corrective action plan in place

to ensure appropriate disposition of any food produced during a

deviation, to fix or correct the cause of noncompliance to ensure that

the CCP is once again under control, and to maintain records of

corrective actions taken.

6. Establishment of Effective Recordkeeping Systems That Document the

HACCP System

This principle requires the preparation and maintenance of a

written HACCP plan that lists the hazards, CCP's, and critical limits

identified by the firm, as well as the monitoring, recordkeeping, and

other procedures that the firm intends to use to implement the plan.

This principle also requires the maintenance of records generated

during the operation of the plan.

7. Establishment of Procedures to Verify That the HACCP System is

Working

This process involves verifying that the critical limits are

adequate to control the hazards identified, ensuring that the HACCP

plan is working properly and verifying that there is documented,

periodic revalidation of the plan to confirm that the plan is still

performing its intended function under existing plant conditions at any

point in time.

C. FDA's Authority to Mandate HACCP

In the Federal Register of January 28, 1994 (59 FR 4142), FDA

proposed regulations that would require HACCP controls in the seafood

industry. The agency believes that it is now appropriate to explore the

application of HACCP to segments of the industry other than seafood. At

this time the agency would plan to proceed in a stepwise fashion with

those segments of the industry that are suitable candidates for

adoption of HACCP principles. This document is intended to explore how

the agency should pursue that broader HACCP program. FDA is doing so

because the agency believes that such a program would be an effective

and efficient way to ensure that food meets the act's safety standards

and to implement section 402(a)(4) of the act (21 U.S.C. 342(a)(4)). As

explained below, if FDA proceeds with a HACCP proposal covering

additional segments of the food industry, such proposal would be made

pursuant to the authority of sections 402 and 701(a) of the act (21

U.S.C. 371(a)).

Section 201 of the act defines the term ``food'' as ``articles used

for food or drink for man or other animals.'' Under section 402(a)(4)

of the act, a food is deemed adulterated if it has been ``prepared,

packed, or held under insanitary conditions whereby it may have become

contaminated with filth, or whereby it may have been rendered injurious

to health.'' Proof that a food is actually contaminated or otherwise

hazardous is not required to establish that a food is adulterated under

section 402(a)(4) of the act. (See United States v. H. B. Greggory Co.,

502 F.2d 700, 704 (7th Cir. 1974), cert. denied, 422 U.S. 1007 (1975).)

Instead, such adulteration requires only a showing that the conditions

under which food is prepared, packed, or held create a ``reasonable

possibility'' of contamination. (See Berger v. United States, 200 F.2d

818, 821 (8th Cir. 1952).)

In its enforcement of section 402(a)(4) of the act, FDA has

considered, among other things, prevailing industry standards and the

technical state-of-the-art in determining, on a case-by-case basis,

whether the conditions under which a company is processing or otherwise

handling food violate the standard of section 402 (a)(4). FDA's current

intention is to propose to codify, in a future rulemaking, a state-of-

the-art standard based upon HACCP principles. This standard would

establish those conditions of food manufacturing, packing, and holding

that are consistent with section 402(a)(4) of the act. Such regulations

would thus ensure the agency's efficient enforcement of section

402(a)(4) and the other food safety provisions of the act, as

authorized by section 701(a) of the act.

At this juncture, the regulations that FDA is considering for

proposal would specify the requirements that the agency believes are

the minimum necessary to ensure that food products under FDA's

jurisdiction are not adulterated under section 402(a)(4) of the act.

Under the program that FDA is considering, if a food purveyor covered

by the program does not adopt and implement a HACCP plan that complies

with the program's requirements or does not operate the plan in

accordance with the program, food prepared, packed, or held in that

facility would be adulterated under section 402(a) (4) of the act and

potentially subject to regulatory action by FDA.

D. Rationale for a HACCP Approach

FDA expects that adoption of HACCP by some or all segments of the

food industry, coupled with Government verification through inspections

of the HACCP system, will more effectively and efficiently ensure the

safety of the American food supply. The agency has tentatively chosen a

HACCP approach because HACCP addresses the root causes of food safety

problems in production, storage, transportation, etc., and is

preventive. Two principal alternatives to HACCP exist; end-product

testing and comprehensive current good manufacturing practice (CGMP)

regulations. End-product testing does not address the root causes of

food safety problems; it is not preventive by design and requires that

a large number of samples be analyzed to ensure product integrity.

Similarly, CGMP's are not a practical approach because of the breadth

and diversity of the food industry, the limited resources available

within FDA to prepare the many specific CGMP regulations that would be

needed to cover effectively such a diverse industry, and the time

required to implement such regulations. However, FDA may consider the

promulgation of CGMP's for certain food processes or types if such

regulations would be more effective than a HACCP system for such

processes. For example, some of the comments have suggested that

sanitation would be better addressed through CGMP's than through a

HACCP plan.

A HACCP system for food safety assurance has numerous distinct

advantages including the following: (1) HACCP focuses on prevention and

is designed to prevent hazards from entering food; (2) HACCP permits

more effective and efficient Government oversight; (3) HACCP places

primary responsibility for ensuring food safety appropriately on the

food manufacturer/distributor; and (4) HACCP assists food companies in

competing more effectively in the world market.

The primary purpose of any HACCP system is to prevent problems

through the systematic analysis and control of the production system by

industry. This analysis and control would be confirmed by Government

verification of the industry's monitoring. As such, a HACCP approach

provides an appropriate balance between the responsibilities of

industry and Government in ensuring food safety. A HACCP based program

will also allow FDA and its State and local government counterparts to

conduct more efficient and focused inspections of food facilities.

In addition to being preventive in nature and more efficient, a

HACCP approach offers two additional benefits over conventional

inspection techniques. First, in contrast to FDA's current regulatory

approach, a HACCP approach requires industry to analyze, in a rational,

scientific manner, its production processes in order to identify CCP's

and to establish critical limits and monitoring procedures. An

essential part of the industry's role under HACCP is to establish and

maintain records to document adherence to the critical limits relating

to the identified CCP's, which will result in continuous self

inspection.

Second, HACCP allows the regulator to monitor more effectively a

firm's compliance with food safety laws. With its current system of

inspection, FDA can determine the conditions at a food plant only

during the period of inspection. The agency must therefore make

assumptions about conditions before and after the inspection based on a

snapshot of plant conditions and practices at the time of the

inspection.

With an HACCP-based program in place, an investigator can determine

and evaluate both current and past conditions critical to ensuring the

safety of food produced by the facility. As discussed above, an

essential part of a HACCP system is maintenance of monitoring records.

By examining such records, the Government inspector can, in effect,

look back through time at the conditions of a facility. Under the

proposal that FDA currently envisions, the agency would have access to

CCP monitoring records to verify that the HACCP plan is working.

Government monitoring under a HACCP system would provide assurance that

systems of preventive controls are in place and functioning properly

and thus afford greater public assurance of food safety.

Current Federal inspection and surveillance strategies attempt to

gauge the industry's knowledge of hazards and preventive control

measures largely by inference, i.e., whether a company's products are

in fact adulterated, or whether conditions in a plant are in compliance

with CGMP's. Consequently, the current inspection system places a great

deal of responsibility on Government regulators to uncover problems and

to take regulatory action to address those problems. Under a HACCP-

based inspection system, it would be the responsibility of the company

to develop a plan for producing safe food, and the role of Government

inspectors would be to verify that the company is carrying out its

plan.

Finally, adopting a HACCP system could potentially enhance

international trade opportunities for the United States. Although

enhancing trade has no direct effect on public health, participation in

international trade in food products is critical to the U.S. economy.

The United States is by far the world's major food exporter, with

exports of raw agricultural and processed food products of over $40

billion per year. The United States also imports a substantial quantity

of food products each year from many countries around the world. HACCP

will improve FDA's ability to monitor such imports and thus ensure

confidence in their safety. Also, HACCP is becoming the world-wide

standard to ensure the safety of food and will thus serve as basis for

harmonizing U.S. food safety regulations with those of other nations.

The Uruguay Round negotiations under the General Agreement on

Tariffs and Trade (GATT) has resulted in further focus on this area.

The Agreement on the Application of Sanitary and Phytosanitary Measures

states the desire of member countries, including the United States, to

further ``* * * the use of harmonized sanitary and phytosanitary

measures between members, on the basis of international standards,

guidelines and recommendations developed by the relevant international

organizations, including the Codex Alimentarius Commission * * *''

(Ref. 5). This trend toward harmonization, coupled with the current

recommendations of the Codex Alimentarius Commission encouraging the

international use of HACCP, provide further support for FDA's serious

consideration of a HACCP program for all or part of the food industry.

E. How the Agency Intends to Proceed

FDA began its initiative to mandate HACCP with a proposal covering

the seafood industry due in large part to the fact that a substantial

amount of work on the application of HACCP to seafood processing and

importation, including the development of specific HACCP models, has

already been done by the Federal Government, some States, academia, and

by the seafood industry itself. Thus, there is a considerable body of

literature and expertise, which can facilitate the development of HACCP

systems by seafood processors and importers. Moreover, seafood industry

representatives have been urging the Federal Government to adopt a

mandatory HACCP program. The National Fisheries Institute, the largest

seafood industry trade association, has testified repeatedly at

congressional hearings in support of legislation that would mandate

such a system. The agency recommends that interested persons refer to

the seafood proposal to understand how the HACCP approach might work

with respect to one category of food product.

The body of knowledge and experience on the application of HACCP to

food production has not, as far as the agency is aware, been developed

for other commodities to the extent that it has for seafood. (One

possible exception is the low acid canned food industry, where much

work has been done in HACCP's application due to FDA's long standing

regulatory program for this industry.) Moreover, the food industry is

extremely diverse and complex. For these reasons, FDA has decided to

issue this advance notice of proposed rulemaking to request comments on

various aspects of the implementation of a mandatory HACCP program for

some or all other sectors of the food industry. Those comments may

suggest that an industry-wide HACCP requirement is appropriate or may

indicate that such a program should be phased-in as data on individual

commodities is compiled. FDA is open to any other suggestions. Specific

issues on which FDA is particularly interested in receiving comments

are set out below.

The agency believes that it could benefit from experience with the

application of HACCP to selected commodities outside the seafood area.

To gain this experience the agency has announced a voluntary pilot

HACCP program and invited interested food producers to participate.

Some of the objectives of this pilot program are to obtain data on

the hazards associated with particular types of food, and to develop

and implement HACCP plans to control those hazards in conjunction with

the participating firms. The pilot program could provide the agency and

the industry with the practical knowledge and experience that would

assist in the development and implementation of a HACCP program for

particular segments of the food industry.

FDA recognizes that an ongoing exchange of scientific, technical,

and operational information between the agency, the food industry,

trade associations, consumer groups, FDA's State and local

counterparts, and other affected parties is essential for the

successful implementation of HACCP in the food industry. Consequently,

FDA intends to maintain a dialogue with all affected parties during the

process of developing its proposed regulations. In particular, FDA will

meet with the food industry, consumer groups, and other interested

parties during the comment period on this advance notice of proposed

rulemaking.

FDA anticipates that it will receive a substantial number of

comments in response to this document. The agency will review these

comments and have further dialogue with industry and consumer

representatives, as well as other groups and organizations

knowledgeable in food safety, as part of its process for determining

the appropriate regulatory approach prior to publication of a proposed

rule.

FDA intends to work closely with USDA, as it considers development

of its own HACCP regulations for meat and poultry products, to ensure

that the two regulatory bodies have a consistent approach in applying

HACCP principles to the food industry, while recognizing that inherent

differences may exist between food commodity groups that will

necessitate different approaches.

FDA also intends to work closely with its State and local

counterparts that regulate the retail segment of the food industry. One

principal way FDA conveys its recommended food regulatory policy to the

nation's State and local food control agencies is through FDA's model

Food Code. A notice of availability of the latest revision of the Food

Code, which incorporates certain HACCP principles and terminology, was

published in the Federal Register of January 28, 1994 (59 FR 4085).

II. Request for Comments

Under the act, the food industry has the primary responsibility for

ensuring the safety of the food it produces and distributes. In its

simplest terms, the role of Government is to verify that the industry

is carrying out its responsibility and to initiate regulatory or other

appropriate action when the industry fails to do so. FDA believes that

establishing a HACCP program throughout the food industry could enable

both the industry and FDA to carry out their respective

responsibilities far more efficiently and effectively. FDA invites

comments on this point, as well as on specific issues relating to the

application of HACCP to foods other than seafood, as set out below.

A. Scope of a HACCP Regulation

NACMCF supports the adoption of HACCP throughout the food industry

((Ref. 4). Additionally, the Codex Ailmentarius Committee on Food

Hygiene considers HACCP to be the most efficient and cost effective

means to manage food safety (Ref. 4). FDA recognizes, however, that not

all foods pose the same inherent risks. The agency intends to work with

the Centers for Disease Control and Prevention and other Federal and

State agencies as well as health professionals, industry, and consumer

groups to access and evaluate data on the relative risks associated

with various foods. FDA has concluded that HACCP has great potential to

improve food safety and can be successfully used beyond seafood.

However, specific HACCP requirements established for the various

segments of the industry may be different because of differences in

risk as well as differences in processes, etc. The agency encourages

the food industry generally to begin using HACCP more widely.

FDA specifically requests comments on the scope of any mandatory

HACCP program proposed by the agency. Should FDA mandate HACCP for all

segments of the food industry? Or should HACCP be required only for

certain segments of the food industry? In deciding whether to cover all

or some segments of the food industry by a mandatory HACCP rule, what

criteria should FDA use? In particular, should any exclusions from a

HACCP requirement be determined on any basis other than the risk

presented by the particular activity? Are there categories of

activities, such as the warehousing of certain types of foodstuffs,

that deserve exclusion?

The agency also requests comment on how a mandatory HACCP rule

should apply to those in the chain of distribution of imported foods.

How should the agency ensure that imported foods are produced and

handled safely? In the seafood proposal, FDA is proposing that all

domestic and foreign processors and importers adopt HACCP controls, and

FDA is proposing to take steps to ensure that the HACCP controls are in

fact implemented by foreign processors. The seafood proposal broadly

defines ``processor'' to include packers, repackers, wholesalers, and

warehousers. Should the agency adopt the same approach with respect to

foreign processors, handlers, and importers of all other foods?

FDA also solicits comments on whether and how a mandatory HACCP

rule should apply to food retailers. The agency's seafood proposal

specifically excludes retailers from the definition of ``processor.''

Should a similar exclusion be made for retailers of all other foods as

well? The agency notes that its updated Food Code, which serves as

guidance to the States as part of an ongoing cooperative program for

regulating the retail sector, incorporates several HACCP elements. The

agency requests comment on this cooperative program for the retail

sector and on how governments at all levels can best collaborate to

ensure the safety of food from farm or fishery to the dinner table,

including food sold ready-to-eat at the retail level. Should HACCP be

required in restaurants and other retail outlets? Should HACCP

requirements be applied directly to raw material suppliers and

transportation companies? Or should such requirements be imposed

indirectly through the HACCP plans of processors and others who receive

food (e.g., by using purchase specifications)?

FDA also specifically requests comment on how small firms should be

covered by any mandatory HACCP regulations. In the seafood proposal,

FDA has made no distinctions in the application of proposed

requirements based on firm size. If small firms should be exempt, on

what basis should the exemption be made?

B. Focus of HACCP

NACMCF believes that HACCP and HACCP plans should address food

safety, including all biological, chemical, and physical hazards that

would affect a particular food. Consistent with this view, FDA has

limited the scope of the HACCP requirements in the seafood proposal to

safety concerns and has not included food quality and labeling

standards and requirements. Although the agency believes that the

primary focus of a HACCP program should be safety, FDA is aware that

food quality is also important to consumers and is an issue in

international trade.

Should FDA's HACCP program for the broader food industry be limited

to food safety and the hazards presented by a particular activity? If

so, how broadly should hazard be defined? What level of risk warrants

HACCP-type control? Should different levels of control be required in

HACCP plans for different levels of risk? Or should FDA's proposal

mandate that food quality issues be included in HACCP plans? Should

sanitation practices within the plant be required to be included in

HACCP plans?

C. Implementation of HACCP

FDA recognizes that, because of the size and diversity of the

overall food industry, any mandatory HACCP program would likely be

costly for some segments of the food industry and need to be phased in

gradually. Development of HACCP plans would require at least some

segments of the industry to adopt new ways of thinking and operating.

Review by FDA of HACCP plans and monitoring records as part of its

plant inspections would necessitate additional training of FDA, State,

and local investigators.

In view of the scope of the task, what would be a reasonable time

period for the implementation of HACCP? In the seafood proposal, FDA is

proposing a 1-year period for implementation, measured from the date of

the final regulations. This proposed lead time takes into account the

fact that a considerable amount of developmental work has already been

done on the application of HACCP to seafood processing. Are there

special considerations for other types of foods that could affect

implementation time? Are there circumstances that would require some

industry segments to need an implementation period longer than 1 year

after final rule promulgation?

If implementation of HACCP is to be phased in (i.e., certain

segments would gradually be subject to the HACCP requirements

established), how should this be accomplished? How should firms or

segments of the food industry be differentiated for purposes of such a

phased in implementation? What would be appropriate time intervals

between each implementation phase? What criteria should be used to

decide the order of implementation for the various segments of the food

industry? For example, should potential food safety risks associated

with the product be considered in determining an implementation

schedule, and if so, what factors should be used in ranking foods with

respect to potential risk? Likewise, for example, should firm size be

considered in determining the order of implementation?

The agency is interested in learning about the experiences that

food manufacturers have had with the implementation of HACCP and

therefore requests comments from firms who have had actual experience

in the application of HACCP concepts to food production, both on what

has worked and on what has not worked. In particular, FDA seeks

information on: (1) How long it took to implement a HACCP program; (2)

the start-up and maintenance costs; and (3) the impact of implementing

HACCP on the safety of the product, the efficiency of the firm's

operation, and any long-term savings (cost effectiveness). The agency

is also interested in any measures that have been, or could be, used to

measure the effectiveness of HACCP to improve product safety. The

agency is particularly interested in the experiences of small food

firms on all of the above.

D. Evaluation of the HACCP System

FDA believes that implementation of HACCP beyond the seafood

industry, whether voluntary or mandatory, will more effectively and

efficiently ensure the safety of the American food supply. The agency

recognizes, however, that there may be alternatives to the HACCP

approach and invites comment on such alternatives and their

effectiveness.

The agency also invites comment on whether there are factors that

would limit the effectiveness of the HACCP approach. What information

is needed in order to judge the effectiveness of a HACCP program?

Should HACCP programs be pilot tested before implementation? Should

there be a minimum level of certainty that a HACCP plan would be

effective in controlling hazards prior to implementation?

What should be the qualifications of individuals responsible for

developing HACCP plans? What should be the qualifications of

individuals responsible for verification of HACCP plans? Is the current

state of knowledge sufficient to make adequate hazard analyses? Is

there a need for microbiological criteria in HACCP plans? Will end-

product microbiological testing be necessary?

How should the appropriate frequency of monitoring CCP's be

determined? Should a processing plant be required to submit a report to

FDA each time a process is found to be out of control? What, if any,

circumstances should trigger mandatory reporting to FDA? Is it

necessary to require that a food processor have a reliable and well-

tested method of recall as part of its HACCP plan?

E. Roles of FDA, the States, and the Food Industry

FDA's interest in institutionalizing HACCP for the food industry is

based on the agency's recognition of the need to revise the current

regulatory approach and make it more effective and comprehensive. This

revision must coordinate and maximize the efforts of all levels of

Government and the food industry to provide effective coverage of food

from farm or fishery to table. The respective roles of industry, State

and local authorities, and FDA must be clearly articulated, and they

must be integrated and coordinated. FDA's preliminary thinking on the

nature of these respective roles follows.

If FDA decides to make HACCP mandatory for some or all segments of

the food industry, firms would be required to develop, implement, and

maintain an effective HACCP system in their facility, and to verify

that the system is adequate to ensure a safe product. The HACCP system

developed by the firm would have to include all relevant critical

limits (such as tolerances) contained in existing FDA regulations and

guidelines, as well as other CCP's judged necessary by the firm to

ensure the safety of the food. Firms would also be responsible for

taking appropriate corrective actions whenever a CCP deviation has

occurred. The system would be considered out of compliance when a

critical limit of a CCP has been exceeded and corrective actions are

not taken or are ineffective.

Regulated industry segments would also be responsible for providing

appropriate training for personnel involved in implementing HACCP in

each facility. Each facility would have to maintain an accurate, up-to-

date HACCP plan, which would be available for review by FDA

investigators during an inspection. Records pertinent to the monitoring

of the CCP's in the HACCP plan would also have to be available for

review by FDA.

FDA is seeking comment on the appropriateness of imposing these

obligations on the food industry under a mandatory HACCP system. The

agency is especially interested in receiving comments on records

access, including:

(1) What records should be considered HACCP records, and therefore

be accessible to FDA (and State and local) investigators? Under FDA's

proposed HACCP regulations for seafood, HACCP records include the HACCP

plan itself, records of the monitoring of critical control points, and

records of corrective actions. In the case of seafood, FDA tentatively

concluded that the agency should have access to all records deemed to

be HACCP records, because without such access, the regulatory

requirements would not be meaningful.

(2) How should consumer complaint files relating to CCP failures be

utilized in a HACCP system? In FDA's proposed HACCP regulations for

seafood, the agency tentatively concluded that each HACCP system should

take advantage of consumer complaints as they relate to the operation

of CCP's. The agency proposed that procedures for monitoring CCP's

include procedures for monitoring relevant consumer complaints, and

that consumer complaints that potentially relate to the performance of

critical control points be considered HACCP records. FDA invites

comment on this approach for foods generally. Should FDA have access to

consumer complaint files relating to CCP failures? What criteria should

be used to determine whether a consumer complaint is linked to a CCP

failure?

(3) How long should HACCP records be kept? The proposed HACCP

regulations for seafood mandate 1 year for fresh products and 2 years

for frozen and preserved products.

As an additional matter, FDA is aware that there is substantial

public interest in the extent to which industry-generated HACCP records

could or should be publicly available. FDA invites comment on the

general question of public disclosure of HACCP records and on the

agency's preliminary analysis of the availability of such records,

which follows.

FDA has long had explicit statutory authority to obtain access to

certain industry records during inspections involving infant formula,

drugs, and devices (21 U.S.C. 374), and has had access by virtue of

agency regulations to certain processing records during inspections of

low acid canned food processors and manufacturers of infant formula.

The agency has the right to copy and take possession of these records,

but does not routinely do so. FDA typically copies and takes possession

of records only when they may be needed for regulatory purposes. As a

preliminary matter, FDA expects to continue this practice with regard

to HACCP records.

The public availability of those HACCP documents that would become

part of FDA's official records as a result of copying during an

inspection would be governed by section 301(j) of the act and by the

Freedom of Information Act (FOIA) and regulations issued under the FOIA

by the Department of Health and Human Services (HHS) and by FDA.

Section 301(j) of the act expressly prohibits any person from

disclosing trade secret information obtained during the course of an

inspection. The agency's FOIA regulations also state that FDA will not

disclose either trade secret or confidential commercial information.

FDA's preliminary view is that HACCP plans and monitoring records fall

within these two categories of protected records. As a consequence, FDA

may have little discretion to disclose such records. Moreover, under

HHS FOIA regulations, processors may be entitled to challenge in court

a pending disclosure of records on the ground that the records to be

disclosed are confidential commercial or trade secret.

Additionally, there are significant legal and practical questions

as to whether FDA has the authority to require disclosure of industry

records that are not in FDA's possession.

The agency is also seeking comments on whether there should be a

standardized format (structure and organization) for written HACCP

plans. If so, how should this standard format be developed and who

should develop it?

As is the case today, the overall goal of FDA's inspection program

would be to ensure that foods are safely prepared, packed, and held. To

achieve this goal under a HACCP system, FDA's inspection would seek to

verify that a HACCP plan is adequate to ensure food safety and that it

is being implemented and maintained properly. The agency is seeking

comments on the appropriate frequency of agency inspections under a

mandatory HACCP program to achieve its goal of ensuring food safety.

The agency is also interested in receiving comments on the possible

role that FDA could play to assist the food industry in developing and

establishing HACCP programs. This assistance could take the form of

agency guidelines for developing HACCP plans and generic HACCP plans

developed in cooperation with the industry. FDA could also promote and

participate in educational programs to encourage the use of HACCP and

FDA could continue to represent the United States at international

meetings on HACCP. The agency could work with interested groups to

identify new food safety hazards and to develop new strategies for

their control.

The agency expects that the States would play a major role in

enhancing FDA's enforcement coverage. State authorities could

participate in HACCP inspections both as part of their own enforcement

activities and under FDA contract. State and local authorities could

also be involved in actively promoting the use of HACCP at the retail

level.

The agency is seeking comments on what its role should be relative

to the review, verification, monitoring, and certification of HACCP

plans. In the seafood proposal, FDA is not proposing to require that

HACCP plans be submitted to FDA in advance, or that preapproval by FDA

be a condition of the adoption or implementation of these plans. If FDA

proposes to make HACCP mandatory for other portions of the food

industry, should it adopt this approach? Should FDA indentify CCP's and

establish critical limits in its HACCP regulation, or should it defer

to firms to develop these themselves? What role should FDA serve in

overseeing the corrective actions taken when a deviation has occurred?

Can any HACCP oversight function, including review of plans and

monitoring, be performed by certified third parties? If so, how should

they be certified and by whom?

For implementation of HACCP for fish and fishery products, FDA is

developing guidelines for processors. These guidelines inventory and

describe the likely hazards associated with both products and

processes, and provide advice on how these hazards can be controlled.

These guidelines also include a fill-in-the-blank HACCP plan to serve

as an example of how a basic HACCP plan could be developed. Are such

guidelines necessary for other commodities and, if so, who should

develop them? What specifically should be included? What role should

the food industry play in the development of these materials? What

other forms of assistance should FDA provide? To what extent, if any,

should any of this additional guidance be made mandatory?

F. Training and Education

The agency's experience with low acid canned foods established that

appropriate training is critical to the successful implementation of

HACCP in the food industry. The industry will need training on how to

develop HACCP plans, i.e., how to identify hazards and establish

critical limits, control measures, corrective actions, and

recordkeeping procedures. Investigators employed by regulatory

agencies, including FDA, will need training to understand how to review

HACCP plans as well as industry records pertaining to implementation

and operation of such plans.

Based upon its low acid canned food experience, FDA believes that

employee training is an essential element of an effective HACCP

program. Should FDA mandate training for plant personnel responsible

for developing and maintaining the HACCP program? In the seafood

proposal, FDA is proposing to require that each processor and importer

employ at least one individual who has successfully completed a

training course on the application of HACCP to fish and fishery

products processing. Moreover, the regulations propose to require that

those at each establishment who have received training be responsible

for reviewing records of CCP monitoring, recognizing critical limit

deficiencies, and assessing the need for corrective actions relative to

the product in question and the HACCP plan itself. FDA seeks comment on

the question of training. Are there reasons why such training should

not be mandated? If such training is required, as FDA currently

believes it should be, who should conduct these training courses? Who

should be required to attend? What role, if any, should FDA have

regarding course materials and instructors? Should a third party be

certified by FDA to review and approve the training courses? Should

one, some, or all responsible plant employees be certified?

G. International Harmonization

As the international community moves toward HACCP, FDA believes an

opportunity exists to improve the safety of the U.S. food supply by

working toward harmonized approaches that would elevate FDA's

confidence that food entering the United States meets U.S. safety

standards. Such harmonization would also support U.S. exports. For

example, after January 1, 1995, unless seafood products for import into

the EU are produced under HACCP, the EU will carry out extensive end-

product testing, and the competitiveness of importers will be

significantly affected. How should FDA approach any effort to harmonize

HACCP standards with those of other countries? What role should the

Codex play?

H. Potential Costs and Benefits

The agency is also requesting relevant economic information. In

particular, FDA seeks estimates of the following costs: (1) The initial

costs of developing a HACCP plan and the frequency and costs of

altering the plan; (2) costs of monitoring and recordkeeping by type of

process, product, and packaging, and the costs of reviewing records

before shipment; (3) costs of necessary training of employees, and rate

of turnover of employees; (4) administrative costs to oversee all

phases of HACCP implementation and operation; (5) the cost of

monitoring equipment and other types of equipment needed to implement a

HACCP program; (6) the cost and frequency of corrective actions when

critical limits are exceeded; (7) the potential cost to the industry of

FDA inspections of HACCP programs; (8) cost of testing for chemical and

contaminant residues as a component of HACCP; (9) cost of process

redesign; (10) cost of new product design; and (11) the costs of any

consultants that might be required under a HACCP approach. FDA also

seeks comments about the costs of expanding HACCP to elements of the

food industry other than manufacturers and processors, such as retail

supermarkets and restaurants, food transporters, and raw material

suppliers. FDA is particularly interested in the cost experience of

small firms who have implemented HACCP, and how HACCP implementation by

these firms is different from that of large firms.

FDA is also announcing its intention to survey the food processing

industry (except for seafood) to estimate the costs of complying with

mandatory HACCP requirements and requests comments on how such a survey

should be designed and implemented.

FDA is also interested in receiving comments on benefits of

mandating HACCP for particular products, processes, and packaging.

Thus, FDA is seeking information about the existing risk levels

presented by various foods, including risk from microorganisms,

contaminants, and chemical residues from all interested parties,

including State and other Federal agencies. FDA is also interested in

receiving information concerning any quantitative reductions in risk

that have been documented by firms now using HACCP, or other evidence

that would document that illness or other food borne risks have been

reduced through use of HACCP. FDA also is interested in receiving

information that documents savings in production costs or indirect

benefits, such as increased quality, that firms using HACCP have

experienced. Because many risks are the result of consumer mishandling,

FDA requests comments on the extent of this source of illness or other

food borne risks, and how this information should be used to target

HACCP efforts. Finally, FDA requests comments on the benefits of

extending HACCP to the other areas of the food industry that are

mentioned above.

I. Potential Environmental Effects

The agency is also requesting relevant environmental information

because, under the National Environmental Policy Act, FDA must consider

the environmental impact of its actions. The agency does not currently

possess the data that would permit detailed analysis of the

environmental impact of the action under consideration by the agency,

as described in this document.

Therefore, the agency is requesting information on the potential

environmental impact including: (1) Potential for increased energy

consumption, (2) potential for increased disposal of defective foods,

(3) potential for new or increased disposal of sanitizing products, (4)

a description of measures that could be taken to avoid or mitigate

adverse environmental impacts that might result from this action, and

(5) potential for increased paper consumption.

III. 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.

1. Bennett, J. V., S. D., Holmberg, M. F., Rogers, and S. L.,

Solomon, ``Infectious and Parasitic Diseases,'' in ``Closing the

Gap: The Burden of Unnecessary Illness,''Amlet, R. W. and H. B.,

Dull, ed., Oxford University Press, pp. 102-114, New York, 1987.

2. Todd, E. C. D., ``Preliminary Estimates of the Costs of Food

borne Disease in the United States,'' Journal of Food Protection,

52:595-601.

3. Archer, D. L., and J. E., Kvenberg, ``Incidence and Cost of

Food borne Diarrheal Disease in the United States,'' Journal of Food

Protection, 48:887-894.

4. NACMCF, ``National Advisory Committee on Microbiological

Criteria for Foods, Hazard Analysis and Critical Control Point

System Adopted March 20, 1992,'' ``HACCP: Principles and

Applications,'' Van Nostrand Reinhold, 1992.

5. GATT Secretariat, ``Final Act Embodying the Results of the

Uruguay Round of Multilateral Trade Negotiations,'' December 15,

1993.

IV. Comments

Interested persons may, on or before December 2, 1994, submit to

the Dockets Management Branch (address above) written comments

regarding this document. Two copies of any comments are to be

submitted, except that individuals may submit one copy. Comments are to

be identified with the docket number found in brackets in the heading

of this document. Received comments may be seen in the office above

between 9 a.m. and 4 p.m., Monday through Friday.

This document is issued under sections 402, 404, 701, and 704 of

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342, 344, 371, and

374).

Dated: July 29, 1994

David A. Kessler,

Commissioner of Food and Drugs.

Donna E. Shalala,

Secretary of Health and Human Services.

[FR Doc. 94-18970 Filed 8-1-94; 8:45 am]

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