[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: 94-18969]


[[Page Unknown]]

[Federal Register: August 4, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0196]

 

Hazard Analysis Critical Control Point Systems; Invitation to 
Participate in a Voluntary HACCP Pilot Program for the Food 
Manufacturing Industry

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
intends to conduct a pilot program in which volunteers from the food 
manufacturing industry will use the Hazard Analysis Critical Control 
Point (HACCP) system. This pilot program is intended to provide 
information that FDA can use in deciding whether to propose to adopt 
and, should it decide to do so, in developing and implementing a 
regulatory system in which food manufacturers are required to operate 
based on HACCP principles. FDA expects that the pilot program will 
involve a small number of firms making products presenting a range of 
risks. FDA is inviting individual firms that wish to participate in 
this program to submit letters of interest.

DATES: Letters of interest from individual firms must be submitted by 
October 3, 1994.

ADDRESSES: Submit letters of interest to the Office of Policy, 
Planning, and Strategic Initiatives (HFS-4), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 200 C St. SW., 
Washington, DC 20204.

FOR FURTHER INFORMATION CONTACT: John E. Kvenberg, Center for Food 
Safety and Applied Nutrition (HFS-4), Food and Drug Administration, 200 
C St. SW., Washington, DC 20204, 202-205-4010.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 321 et seq), FDA acts to help ensure that 
foods in interstate commerce are safe. To achieve this goal of safe 
foods, FDA engages in a range of activities, including providing 
guidance about measures that manufacturers can take to ensure the 
safety of their products. One such measure is the adoption of HACCP, a 
systematic approach to the identification and control of biological, 
chemical, and physical hazards associated with the production of a 
particular food. HACCP is recognized as being particularly effective in 
limiting the risks from the hazards presented by food processing 
because each firm tailors the HACCP approach to fit its specific 
product, processing, and distribution conditions. For example, the low-
acid canned food regulations contained in part 113 (21 CFR part 113) 
incorporate the principles of HACCP in a manner designed to prevent 
Clostridium botulinum outgrowth and toxin production in thermally 
processed, low-acid foods packaged in hermetically sealed containers.
    In the Federal Register of January 28, 1994 (59 FR 4142), FDA 
published a proposal to establish regulations to require the 
implementation of HACCP programs by the seafood industry. The agency is 
now considering action to extend HACCP beyond seafood to the other food 
products, domestic and imported, that it regulates. Elsewhere in this 
issue of the Federal Register, FDA intends to publish an advance notice 
of proposed rulemaking (ANPRM) that requests comments on the 
application of HACCP to the food industry. After the comments to the 
ANPRM are evaluated and as FDA gathers information from the pilot 
program that is the subject of this notice, the agency may begin 
rulemaking to expand HACCP to other segments of the food industry.
    To collect information on how HACCP might be implemented in the 
food industry, FDA is announcing a pilot program designed to provide 
insight into the problems, costs, and benefits of developing and 
implementing HACCP for firms that produce a variety of food products. 
This program will also provide the agency with information on the 
implications for the agency of implementing a HACCP system. The agency 
invites individual firms to submit letters of interest in participating 
in this voluntary program. FDA will select firms with a goal of 
ensuring that the participants in the program produce products that 
present a range of potential hazards, have a range of scientific 
capabilities, have processing facilities of varying sizes, and have a 
range of HACCP experience. FDA anticipates that this program will 
provide the selected firm as well as the agency with extremely useful 
practical experience.
    The potential benefits to industry from participation in the pilot 
program include: (1) An opportunity to work with FDA to determine how 
best to apply HACCP in the firm's particular plant or segment of the 
food industry, (2) the chance to engage in a scientific dialogue with 
FDA, (3) an opportunity to contribute to the development of sound 
regulatory policy relative to food safety hazards, and (4) an 
opportunity to learn how firms can reduce the likelihood of recalls or 
seizures.
    Participation in this pilot program offers several benefits to FDA 
and to the consumer: (1) Experience gained during this program may 
allow the agency to generalize what it has found and to make its 
insights available to the whole food industry, (2) the agency will gain 
experience that it can rely on in deciding whether HACCP is practicable 
for the food industry as a whole, and (3) the agency will be able to 
determine how it can better focus its monitoring of food safety to 
concentrate on areas of greatest public health need. Moreover, the 
agency intends to make a summary of the results of the pilot program 
publicly available, which should help other firms, both inside and 
outside the segments of the food industry represented in the program, 
to develop and implement their own HACCP programs, should they choose 
to do so, or should the agency require that they do so. This will also 
serve to increase public understanding of, and involvement in this new 
food safety regimen.
    FDA requests that individual firms submitting letters of interest 
provide information concerning the nature of their products, the size 
of their processing facility, the processing techniques that they use 
to manufacture their products, their scientific capability (e.g., 
research and development programs, quality control laboratories), and 
the extent to which, and how, they employ HACCP (e.g., Does the firm 
have valid HACCP plans? Is it operating under those plans? If not, does 
the firm have the capability to develop and implement HACCP plans?). 
FDA will consider these factors in reviewing the letters of interest as 
a basis for identifying a limited number of individual firms that, in 
the judgment of the agency, are best suited to participate in the 
program. After a list of potential participants has been compiled, FDA 
will review the regulatory status and inspectional history of each firm 
on the list.
    FDA will meet with the firms that have expressed an interest in 
participating in the program. At this meeting, FDA will present the 
details of the voluntary HACCP pilot program. If a firm is still 
interested in participation in the program, it will be visited by the 
team of FDA employees that will be responsible for the pilot program 
(the FDA HACCP Pilot Core Team) and by representatives of the local FDA 
district office. Representatives of a trade association may also 
participate in the visit if invited by the firm. The purpose of the 
visit will be to allow FDA to assess how well the firm fits within the 
agency's goals for the pilot program and to review the firm's HACCP 
plan, if one exists. Based on the results of these visits, the FDA 
HACCP Pilot Core Team will select the firms that will participate in 
the program. Because FDA's resources are limited, only a few firms can 
be selected.
    Each firm selected to participate in the pilot program will be 
expected to design, develop, and implement its own HACCP program 
tailored to control the hazards presented in producing its products and 
by its processing facility. FDA will assist each firm that it selects 
in developing a HACCP program that, at minimum, includes: An employee 
training program on HACCP principles; a written general sanitation 
program that the firm will use to maintain its production facility in a 
sanitary manner, in accordance with FDA's regulation, ``Current Good 
Manufacturing Practice in Manufacturing, Packing, or Holding Human 
Food'' (21 CFR part 110); and a written HACCP plan based upon the HACCP 
principles outlined by the National Advisory Committee on 
Microbiological Criteria for Food for each product covered by the 
program. FDA will expect each firm that participates in the program to 
agree to: (1) FDA review of its HACCP program before the firm 
participates in the pilot program, (2) FDA HACCP-based inspections of 
its processing facility, (3) FDA review of the firm's regularly 
scheduled internal monitoring to determine the degree of compliance 
with the HACCP plan, and (4) use of its own resources to accomplish 
assigned efforts (e.g., developing HACCP plans, training employees on 
the HACCP principles, conducting audits of HACCP programs) during the 
course of the program.
    FDA intends to implement this program on a carefully controlled 
basis. Within 6 weeks of the date that a firm is accepted and 
operational in its HACCP program, FDA will conduct an initial 
verification inspection to determine the firm's compliance with its 
HACCP program. The firm will be expected to submit monthly verification 
reports to the FDA HACCP Pilot Core Team for evaluation. FDA will 
conduct subsequent verification inspections as appropriate.
     Interested firms are invited to submit a letter of interest to 
Office of Policy, Planning, and Strategic Initiatives (HFS-4), Center 
for Food Safety and Applied Nutrition, Food and Drug Administration, 
200 C St. SW., Washington, DC 20204. Letters of interest must be 
submitted by October 3, 1994.

    Dated: July 28, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-18969 Filed 8-1-94; 8:45 am]
BILLING CODE 4160-01-F