[Federal Register Volume 62, Number 123 (Thursday, June 26, 1997)]
[Notices]
[Pages 34480-34481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16729]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Application of Good Guidance Practices to Revisions to the
Shellfish Sanitation Model Ordinance
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Shellfish Sanitation Model Ordinance, which is part of the
National Shellfish Sanitation Program (NSSP), contains procedures for
the harvesting and processing of raw molluscan shellfish that the
States belonging to the ISSC should adhere to if their shellfish are to
be acceptable to the other States in the ISSC. The Model Ordinance is a
Food and Drug Administration (FDA) guideline and, as such, is subject
to FDA's policy relating to the development, issuance, and use of
guidance documents. FDA is providing notice on how it intends to apply
its policy on guidance documents to any revisions of the Model
Ordinance that may result from the meeting of the Interstate Shellfish
Sanitation Conference (ISSC) scheduled for July 12 through 18, 1997.
ADDRESSES: Submit written requests for copies of the issues that will
be considered by the ISSC in July to Kenneth Moore, Executive Director,
Interstate Shellfish Sanitation Conference, 115 Atrium Way, suite 117,
Columbia, SC 29233.
FOR FURTHER INFORMATION CONTACT: Paul DiStefano, Center for Food Safety
and Applied Nutrition (HFS-415), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-418-3149.
SUPPLEMENTARY INFORMATION:
I. Program for Molluscan Shellfish
FDA is responsible for enforcing, among other laws, the Federal
Food, Drug, and Cosmetic Act and certain portions of the Public Health
Service Act. These laws require that all foods shipped in interstate
commerce, including molluscan shellfish, be prepared, packed, and held
under sanitary conditions that will protect their safety; that they be
honestly and informatively labeled; and that the food itself be safe,
clean, and sanitary. FDA is authorized to accept assistance from State
and local authorities in the enforcement of laws to prevent and to
suppress the spread of communicable disease (42 U.S.C. 243 and 21
U.S.C. 372).
This latter authority gave rise to the NSSP, which was initiated in
1925 and has continued to date as a voluntary FDA, State, and shellfish
industry program. The safety of raw molluscan shellfish for human
consumption begins with ensuring the quality of the water in which
these sedentary organisms are grown and from which they are harvested.
These waters are mostly State resources. Consequently, the NSSP is
based on the premise that public health controls for raw molluscan
shellfish can best be accomplished under State laws with Federal
technical support and industry participation.
The success of the NSSP is largely dependent on the States adopting
and implementing recommended requirements for the operation of
effective programs. These recommended requirements, which traditionally
have been incorporated into the NSSP ``Manual of Operations,'' relate
to the proper ways to classify and monitor shellfish growing areas, to
harvest and process shellfish, to inspect processors, and to address
other related matters.
The ISSC consists of agencies from shellfish producing and
receiving States, FDA, the National Marine Fisheries Service of the
U.S. Department of Commerce, and the shellfish industry. A primary
purpose of the ISSC has been to provide a formal structure for these
entities to provide input on the Manual of Operations.
Recently, the ISSC has chosen to reconstitute the Manual of
Operations in the form of a Shellfish Sanitation Model Ordinance in
order to facilitate uniform adoption by the member States. The use of
the Model Ordinance is expected to begin on January 1, 1998. The Model
Ordinance is an FDA guideline and as such, is subject to the policy of
FDA relating to the development, issuance, and use of guidance
documents, as expressed in the Federal Register of February 27, 1997
(62 FR 8961 at 8969 through 8971).
Since the Manual of Operations was written, FDA has published the
manual and periodic revisions to it and has issued interpretations of
its provisions. The agency expects to do the same with the Model
Ordinance. FDA performs this function in accordance with a memorandum
of understanding (MOU) entered into in 1984 between FDA and the ISSC.
The Model Ordinance is revised through a process that begins with
[[Page 34481]]
discussion and voting at a meeting of the ISSC, usually its annual
meeting. Revisions that have been agreed upon by the ISSC are forwarded
to FDA for inclusion in the Model Ordinance. The agency may reject any
revisions that conflict with Federal laws, regulations, or policies.
This year's meeting of the ISSC will take place in Sturbridge, MA,
July 12 through 18, 1997. The ISSC and its meeting are open to all
persons interested in fostering controls that will assure sources of
safe and sanitary shellfish.
II. FDA's Guidance Documents Policy
As stated previously, although it is the States that use the Model
Ordinance, this document is a Federal guideline. It is thus subject to
FDA's policy regarding the issuance of guidance documents. It is FDA
policy that the public be afforded the opportunity to comment on
guidance documents, either before implementation or upon issuance,
depending on whether the guidance document is classified as Level 1 or
Level 2 guidance (see 62 FR 8961 at 8965).
Guidance documents are typically developed within the agency and
lend themselves to a relatively simple notice and comment procedure.
However, the annual meeting of the ISSC has, in the past, provided an
essential forum for the development of revisions to the Manual of
Operations. FDA expects this to continue to be the case with the Model
Ordinance. Given the Federal-State cooperative nature of the program,
FDA strongly believes that the participatory process that occurs at
this meeting serves many of the purposes and principles set forth in
the agency's guidance documents policy. Moreover, FDA expects to
publish a notice of availability of the Model Ordinance after the work
of the July ISSC meeting is complete.
FDA is also advising the public that the issues to be discussed at
the July ISSC meeting are now available and may be obtained from the
Executive Director of the ISSC at the address provided above.
Information on how to attend the meeting may also be obtained from the
Executive Director.
Dated: June 19, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-16729 Filed 6-25-97; 8:45 am]
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