[Federal Register Volume 64, Number 58 (Friday, March 26, 1999)]
[Notices]
[Pages 14736-14737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-7363]


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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draft guidance setting forth circumstances under which the agency may 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