[Federal Register: March 26, 1999 (Volume 64, Number 58)]
[Notices]
[Page 14736-14737]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26mr99-117]
 
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
Food and Drug Administration
[Docket Number 99D-0392]
 
 
Seafood HACCP Transition Guidance; Request for Comment
 
AGENCY: Food and Drug Administration, HHS.
 
ACTION: Notice.
 
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SUMMARY: The Food and Drug Administration (FDA) is issuing for comment
draft guidance setting forth circumstances under which the agency may
consider refraining from regulatory action under the seafood Hazard
Analysis Critical Control Point (HACCP) regulation and the Federal
Food, Drug, and Cosmetic Act (the act) pending completion of studies to
resolve scientific issues relating to whether the agency should revise
or amend its policies concerning particular hazard analyses or
controls.
 
DATES: Submit written comments by May 26, 1999.
 
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Comments should contain the docket number found in
brackets in the heading of this document. Received comments are
available for public examination in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday.
 
FOR FURTHER INFORMATION CONTACT: Donald W. Kraemer, Center for Food
Safety and Applied Nutrition (HFS-400), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3133.
 
SUPPLEMENTARY INFORMATION: On December 18, 1995 (60 FR 65096), FDA
published final regulations (21 CFR part 123) that require processors
of fish and fishery products to develop and implement HACCP systems for
their operations. Those regulations became effective on December 18,
1997. As a companion to the regulation, FDA also issued a guidance
document entitled the Fish and Fishery Products Hazards and Controls
Guide (the Guide). The Guide contains FDA's compilation of what the
agency believes to be the latest, science-based knowledge about when
food safety hazards are reasonably likely to occur and what controls
are appropriate for those hazards. In the period since the publication
of the final regulations, FDA has produced two editions of the Guide.
The agency intends to publish
 
[[Page 14737]]
 
new editions of the Guide as knowledge and technology advance about
fish and fishery products hazards and controls.
    Under the act and its implementing regulations, processors are
responsible for ensuring that their HACCP systems are adequate. If
processors need help in developing a HACCP system, the Guide provides
them with information that can help them put in place a HACCP system
that should generally satisfy a processor's obligations under the
seafood HACCP regulation. However, as the Guide itself makes clear, the
materials contained in the Guide consist of recommendations, and not
binding requirements. Processors may control hazards in other ways so
long as they can demonstrate that their approaches are scientifically
defensible. Processors may also rely on hazard analyses that differ
from those in the Guide so long as they can demonstrate that their own
analyses are valid for their particular circumstances.
    As a general matter, processors should establish the adequacy of a
hazard analysis or control before implementing it. FDA can envision
circumstances, however, where the industry could make a strong
threshold case for the validity of a particular hazard analysis or
system of controls even though complete confirmation of its validity
was not yet available from scientific studies.
    FDA believes that a mandatory HACCP program should serve as a
catalyst for research and science-based resolution of food safety
questions. Thus, where the consuming public would not be placed at
risk, FDA believes it is appropriate to use a mechanism that encourages
the resolution of legitimate scientific questions before they become
legal controversies.
    The purpose of this notice is to propose and obtain comment on
guidance on the submission of citizen's petitions under Sec. 10.30 (21
CFR 10.30), whereby any member of the public may request that FDA
consider exercising enforcement discretion on certain matters under the
seafood HACCP regulations pending their scientific resolution. This
proposed guidance applies to issues involving matters of scientific
fact related to whether a hazard is reasonably likely to occur or
whether a control is sufficient, the resolution of which is likely only
after the completion of a scientific study or a search of existing
scientific literature. Other issues that relate to broader policy, such
as circumstances where regulations specify hazards that are reasonably
likely to occur in certain situations or enumerate performance
standards or the actual critical limits that must be met, may also be
addressed by filing a citizen's petition, or by discussing the issue
directly with the agency in a less formal manner, but are not within
the scope of this proposed guidance.
    FDA anticipates that matters for which limited enforcement
discretion will be considered will be narrow. In determining whether to
exercise enforcement discretion, the agency may consider, among other
things, whether the position presented by the petitioner has sufficient
scientific merit and whether the petitioner's proposal is appropriate
and adequate to answer the necessary scientific questions (e.g.,
whether the study and/or literature search that will be undertaken
will, in the agency's judgment, provide the information needed to
support the requested change; whether the identification of the time
necessary to complete the study and any data analysis is reasonable;
whether the petitioner commits to keeping FDA apprised of the progress
being made on the study plan over the course of the study; and whether
the petitioner agrees to provide FDA with all data from the study in
order to advance the public state of knowledge, regardless of the
outcome of the study).
    FDA recommends that such petitions be submitted as requests to
revise or amend the Guide. If a party believes that the Guide should be
revised based on scientific data to be provided at a later date, the
party should submit a petition under Sec. 10.30 to the Dockets
Management Branch (address above). Petitions must comply with the
requirements of Sec. 10.30. In addition, interested persons are
encouraged to discuss the contents of an intended petition in advance
of submission with representatives of FDA's Office of Seafood either in
person or by telephone (202-418-3133). Such communication may minimize
misunderstandings and time-consuming written communication during the
consideration process.
    If FDA determines, after reviewing a request, that it is
appropriate for the agency to exercise enforcement discretion, the
agency will advise the requester in writing that the agency does not
anticipate enforcement action for the practice at issue and will post
the letter on its Internet website at ``http://www.fda.gov''. FDA will
also advise the requester of the time period that the agency believes
is reasonable for the study and data analysis. If, at the end of this
timeframe, the agency concludes that the data from the study are
inadequate, or if no data are submitted, FDA will proceed with its
regulatory options. The agency may also reconsider the use of
enforcement discretion before the end of the timeframe if circumstances
change or otherwise warrant reconsideration. If such reconsideration
takes place, FDA will notify the original requester and make its
reconsideration public.
    In considering the information submitted, FDA will evaluate, as
appropriate: (1) The methodology of the scientific study; (2) the
scientific merit of the conclusions; and (3) the consistency of the
recommended action with agency policy. Any changes in agency position
will be posted on FDA's Internet website at ``http://www.fda.gov'' and
then reflected in the next edition of the Guide.
    The public is reminded that it is welcome to discuss with the
agency at any time, including before finalization of this guidance,
issues relating to seafood hazards and controls and how these issues
may be resolved through research.
    The guidance provided in this notice represents the agency's
current thinking on the subject and does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public.
    FDA tentatively concludes that this guidance would not impose any
paperwork burden that has not already been approved by OMB under OMB
No. 0910-0183 ``Citizen Petition--21 CFR 10.30.'' These guidelines
simply provide information to the public to assist them in submitting
citizen petitions to obtain changes in the Guide under certain
circumstances.
 
    Dated: March 17, 1999.
 William K. Hubbard,
 Acting Deputy Commissioner for Policy.
[FR Doc. 99-7363 Filed 3-25-99; 8:45 am]
BILLING CODE 4160-01-F
 
 

Seafood HACCP Transition Guidance December 1999