[Federal Register Volume 65, Number 22 (Wednesday, February 2, 2000)]
[Notices]
[Pages 4984-4985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-2147]


-----------------------------------------------------------------------

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published for comment a notice containing a draft guidance setting 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 Specifically, the draft guidance indicated that FDA might consider 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    The draft guidance requested that individuals desiring to propose a 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

[[Page 4985]]

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--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