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.

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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

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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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