Application of Good Guidance Practices to
Revisions to the Shellfish Sanitation Model Ordinance

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.

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 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. [p34481]

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]