[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]
BILLING CODE 4160-01-F