Pamela Tom (pdtom@ucdavis.edu)
Wed, 2 Feb 2000 15:50:59 -0800 (PST)
Federal Register web listing:
http://frwebgate3.access.gpo.gov/cgi-bin/waisgate.cgi?WAISdocID=3504228289+0+0+0&WAISaction=retrieve
Seafood HACCP Transition Guidance web listing:
http://vm.cfsan.fda.gov/~dms/guidance.html#sea
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[Federal Register: February 2, 2000
(Volume 65, Number 22)] [Notices]
[Page 4984-4985]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-0392]
Seafood HACCP Transition Guidance; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Seafood HACCP Transition
Guidance.'' This guidance sets forth the policies and procedures under
which the agency may consider refraining from regulatory action under the
seafood Hazard Analysis Critical Control Point (HACCP) regulations and the
Federal Food, Drug, and Cosmetic Act (the act). This guidance provides for
the submission to FDA of citizen petitions that describe scientific
studies that petitioners are proposing to resolve issues relating to
particular hazard analyses or controls for particular food safety hazards.
DATES: This notice is effective February 2, 2000.
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:
I. Background
In the Federal Register of March 26, 1999 (64 FR 14736), FDA published
for comment a notice containing a draft guidance setting forth policies
and procedures under which the agency may take into account a planned or
ongoing scientific study when deciding whether to pursue regulatory action
under the seafood HACCP regulations and the act. Specifically, the draft
guidance indicated that FDA might consider refraining from regulatory
action against a seafood processor or processors to allow the conduct of a
scientific study to resolve a dispute between FDA and the processor(s)
over questions of fact. These questions would either relate to whether
certain food safety hazards are reasonably likely to occur in specific
situations or to the effectiveness or need for certain controls for those
hazards. FDA would only consider refraining from regulatory action if the
public would not be jeopardized by doing so.
The draft guidance requested that individuals desiring to propose a
scientific study under these circumstances submit a petition to the agency
in accordance with FDA's regulations for citizen's petitions at 21 CFR
10.30. The petition would describe the study and request that FDA consider
exercising enforcement discretion on certain matters under the seafood
HACCP regulations and the act pending their scientific resolution.
FDA further recommended that the petition be submitted as a request to
revise or amend the agency's 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.
II. The Comments
Three comments were received on the draft of the Seafood HACCP
Transition Guidance. Two of the comments were from trade associations, and
one was from a professional association. All comments supported the
general approach proposed by the agency to rely on scientific studies
under circumstances described in the draft, but asked for specific
modifications in order to expedite or otherwise improve the process.
1. One comment suggested that the petition process would be time
consuming and would inhibit the agency's ability to respond quickly to
requests for discretionary enforcement, especially considering that the
agency allows itself up to 180 days to respond on petitions.
As noted by the comment, the 180-day period is the maximum permitted
tentative response time. However, given the significance of the food
safety issues that are likely to be submitted for review under the
guidance and the desire of the agency to obtain new scientific information
on issues having bearing on scientific questions related to HACCP
implementation, FDA believes that it would be mutually advantageous for
the agency to respond to the petitioner as expeditiously as possible. For
this reason, the agency continues to encourage potential petitioners to
engage in presubmission consultations with FDA on the merits. Familiarity
with the issues presented in a petition would greatly facilitate the
agency's ability to respond quickly. The agency anticipates that review of
the scientific merits of any proposal will be a more likely cause of
delay, than the mechanics of the petition process. Consequently, FDA does
not agree that the citizen's petition process will cause the agency to
significantly delay its response.
A related comment stated that the citizen's petition is a cumbersome
mechanism, which could be overwhelming for those unaccustomed to FDA's
administrative procedures. This comment recommended that the guidance
policy clarify the applicability of certain provisions in part 10 (21 CFR
part 10), particularly as they relate to the need for environmental and
economic impact statements.
FDA does not anticipate that the contents of a citizen's petition
would be notably different than the contents of a request to the agency
under another format. The contents need only include information that
enables FDA to make an informed decision on a petitioner's request. In
that regard, the agency does not expect that either an environmental or
economic impact statement will be relevant, especially since the research
to be conducted is at the petitioner's initiative and would not ordinarily
be the subject of an extramural contract, grant, or other research
agreement with the government.
2. One comment expressed concern for the need for confidentiality to
protect proprietary information, in that the citizen petition process
could result in the disclosure of trade secrets to competitors.
FDA's regulations (21 CFR 10.30 and 21 CFR 10.20(j)) provide that
citizen petitions and supporting information are to go on public display
(i.e., be made public). Under 21 CFR 10.20(j)(2), the only exception is
for petitions that contain information the disclosure of which would be a
clearly unwarranted invasion of personal privacy. Thus, FDA is not in a
position to protect other information in a citizen petition from
disclosure. If a person believes they have a situation that CFSAN should
consider under this guidance, but would need to rely on trade secret on
confidential commercial information to make their case, they should raise
the matter with CFSAN to see if other approaches are appropriate
3. Two comments stated that FDA should consider other options to
further advance the science needed to support HACCP implementation. One of
these comments suggested that the agency should consider establishing an
external scientific review process to evaluate the scientific merit of the
research proposed in a citizen petition. The comment stated that an
outside review would provide a wider range of scientific input and
discussion than otherwise occur and may yield a stronger consensus among
FDA, industry, and academia.
FDA agrees there may be cases when the agency will need the assistance
of an expert review panel, particularly when there is a diversity of
scientific opinion within the agency. However, two advisory committees,
the National Food Advisory Committee and the National Advisory Committee
on Microbiological Criteria for Foods, already exist for this purpose. FDA
anticipates that the benefits of consulting with a panel of outside
experts will be considered on a case-by-case basis.
4. One comment requested that the HACCP transition guidance outline
the agency's expectation of the level of detail expected in studies, and
the amount of time allowed for completion of scientific studies or
literature searches, and that these factors should be influenced by the
nature of the specific issue being addressed. The comment stated that, in
many cases, the scientific detail need not be exhaustive, especially where
the issue applies to a product that has been marketed safely for some
time, or where the data supporting FDA's current policy are not
exhaustive.
FDA intends to assess the adequacy of scientific detail on a
case-by-case basis. The factors that the agency will generally take into
consideration when determining the adequacy of a scientific study may
include the severity of the hazard at issue in the petition and the extent
and credibility of existing data.
5. One comment expressed the need for caution should the agency
announce that it intends to exercise enforcement discretion, because State
agencies may have compliance actions occurring on their own. To avoid
inconsistent regulatory policies between FDA and the States, it was
suggested that FDA establish an information sharing mechanism with the
States on this subject.
FDA agrees with this concern and intends to take steps to prevent
conflict between Federal and State actions. FDA expects to advise the
public about petitions on its website. In addition, the agency intends to
take appropriate steps to ensure that states are adequately apprised.
These steps may include advising the Association of Food and Drug
Officials (AFDO), a professional association of State, Federal, and local
regulatory officials (with industry representatives participating as
associate members) on the status of petitions and posting petition
information in the State Action Information Letter (SAIL) at
http://www.fda.gov/ora/fed<INF>--</INF>state/sail.htm.
III. Availability
This Seafood HACCP Transition Guidance is now available on the home
page for FDA's Center for Food Safety and Applied Nutrition (CFSAN) at
http://vm.cfsan.fda.gov/~dms/guidance.html. It may also be obtained
through the Activities Staff, Office of Constituent Operations, CFSAN,
phone 202-205-5251.
IV. Status of This Guidance
This guidance 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.
V. Paperwork Reduction Act
FDA concludes that this guidance would not impose a paperwork burden
that has not already been estimated and approved by OMB under OMB Control
No. 0910-0183 ``Citizen Petition--21 CFR 10.30.'' This guidance provides
information to the public to assist them in submitting petitions to obtain
changes in the Guide under certain circumstances.
Dated: January 21, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-2147 Filed 2-1-00; 8:45 am]
BILLING CODE 4160-01-F
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