[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
