[Federal Register Volume 59, Number 149 (Thursday, August 4, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-18970]


[[Page Unknown]]

[Federal Register: August 4, 1994]


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Part IV





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



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21 CFR Ch. I



Food and Safety Assurance Program; Development of Hazard Analysis 
Critical Control Points; Proposed Rule
DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Ch. I

[Docket No. 93N-0325]

 

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking.

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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]
BILLING CODE 4160-01-F