[Federal Register Volume 63, Number 137 (Friday, July 17, 1998)]
[Notices]
[Pages 38659-38660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19029]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0393]
National Shellfish Sanitation Program Guide for the Control of
Molluscan Shellfish; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guide entitled ``National Shellfish Sanitation
Program (NSSP) Guide for the Control of Molluscan Shellfish.'' The
guide was developed cooperatively by FDA and the Interstate Shellfish
Sanitation Conference (ISSC) with the intent of replacing the existing
NSSP Manuals of Operation, Parts I and II. The guide contains a Model
Ordinance for ensuring that only safe and sanitary shellfish are
offered for sale in interstate commerce. Language contained in the
Model Ordinance has been codified for easy adoption into law or
regulation by State regulatory agencies. The guide also includes
documentation supportive of the codified language of the Model
Ordinance, including: The NSSP's history, public health reasons and
explanations specific to the guidelines contained in the Model
Ordinance, NSSP guidance documents, suggested NSSP forms, shellfish
policy setting documents, pertinent Federal regulations, and references
to the public health reasons and explanations. These supportive
materials aid in ensuring consistent and uniform implementation of a
national shellfish safety program.
DATES: Comments on the guide may be submitted at any time.
ADDRESSES: Submit written comments on the guide to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. Submit written requests for single
copies of the guide entitled ``National Shellfish Sanitation Program
Guide for the Control of Molluscan Shellfish'' to the contact person in
the nearest regional office listed in the SUPPLEMENTARY INFORMATION
section of this document. Send two self-addressed adhesive labels to
assist in processing your requests. An electronic version of the guide
is available on the World Wide Web at (http/www.issc.org).
FOR FURTHER INFORMATION CONTACT: Paul W. DiStefano, Office of Seafood,
Center for Food Safety and Applied Nutrition (HFS-417), Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, 202-418-3150, FAX:
202-418-3198, e-mail: pdistefa@bangate.fda.gov'', or the contact
person in the nearest regional office as listed in the SUPPLEMENTARY
INFORMATION section of this document.
SUPPLEMENTARY INFORMATION: Copies of the guide entitled ``National
Shellfish Sanitation Program Guide for the Control of Molluscan
Shellfish'' can be obtained from the nearest regional office as
follows:
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FDA Addresses Contact Person
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Stoneham District Office, State Programs Branch, One David G. Field
Montvale Ave., Stoneham, MA 02180
New York Regional Office, 850 Third Ave., Brooklyn, NY Jerry H. Mulnick
11232-1593
Baltimore District Office, Investigations Branch, 900 Al A. Ondis
Madison Ave., Baltimore, MD 21201
Atlanta Regional Office, State Cooperative Programs, 60 James A. Casey
Eighth St. NE., Atlanta, GA 30309
Charleston Resident Post, 334 Meeting St., rm. 505, Donald Hesselman
P.O. Box 21077, Charleston, SC 29413
Tallahassee Resident Post, Hobbs Federal Bldg., 227 Marc B. Glatzer
North Bronough St., suite 4150, Tallahassee, FL 32301
Baton Rouge Resident Post, 5353 Essen Lane, suite 220, John E. Veazey
Baton Rouge, LA 70809
Detroit District Resident Post, 1560 East Jefferson Nicholas L. Majerus
Ave., Detroit, MI 48207
Dallas Regional Office, 7920 Elmbrook Dr., suite 102, David A. Blevins
Dallas, TX 75247
Seattle District Office, 100 Second Ave., suite 2400, Tim E. Sample
Seattle, WA 98104
Shellfish Safety Team (HFS-628), 200 C St. SW., Stanley D. Ratcliffe
Washington, DC 20204
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FDA is the Federal agency responsible for administration of the
NSSP. The NSSP is a voluntary program in which State shellfish control
agencies, the shellfish industry, FDA, and other Federal agencies
participate. The NSSP, which has been in existence since 1925,
addresses the sanitary control of fresh and frozen molluscan shellfish
(oysters, clams, mussels, and scallops) offered for sale in interstate
commerce. To promote uniform administrative and technical controls, the
NSSP has developed and maintained recommended shellfish control
practices for adoption by member States. These control practices, which
were initially published as the NSSP Manuals of Operation, Parts I and
II, are contained in the guide ``NSSP Guide for the Control of
Molluscan Shellfish.''
In 1982, interested State officials and members of the shellfish
industry formed the ISSC to provide a structure wherein State
regulatory authorities could meet on a regular basis to discuss ways to
improve shellfish sanitation and safety. FDA and the ISSC entered into
a memorandum of understanding (MOU) that was published in the Federal
Register of March 30, 1984 (49 FR 12751), agreeing, among other things,
that FDA would provide technical assistance to the ISSC. The ISSC in
turn would help FDA develop or revise program criteria and guidelines
in the NSSP Manuals of Operation. Based on the MOU, and in cooperation
with the ISSC, FDA periodically publishes revisions of the NSSP
[[Page 38660]]
Manuals of Operation based on resolutions adopted by voting delegates
of the ISSC and with which FDA concurs.
The success of the NSSP is largely dependent on the States adopting
and implementing the recommended shellfish control practices for the
operation of effective programs. These recommended practices, which
traditionally have been incorporated into the NSSP Manuals of Operation
have been reconstituted in the form of a ``NSSP Guide for the Control
of Molluscan Shellfish.'' The purpose of the ``NSSP Guide for the
Control of Molluscan Shellfish'' handbook is twofold. First, it serves
to redraft existing guidelines contained in the NSSP Manuals of
Operation into a NSSP Model Ordinance, which contains language that can
be readily codified into law or regulation by a State. Second, it sets
forth supportive documentation pertinent to the codified language of
the Model Ordinance, including: The NSSP's history, public health
reasons and explanations specific to the guidelines contained in the
Model Ordinance, NSSP guidance documents, suggested NSSP forms,
shellfish policy-setting documents, pertinent Federal regulations, and
references to the public health reasons and explanations.
Redrafting of the NSSP Manuals of Operation was accomplished
through the efforts of the ISSC working in cooperation with FDA. This
effort began in 1989 and continued through December 1997. Wherever
possible, the concepts and language contained in the NSSP Manuals of
Operation were used in the NSSP Model Ordinance. Where language did not
exist to explain a requirement (e.g., flow charts), an explanation was
developed. In cases where the intent of the NSSP Manuals of Operation
was not clear, new definitions were developed. Apparently conflicting
requirements in the Manuals of Operation were resolved by selecting the
requirement that most clearly reflected the intent of the NSSP or by
selecting the more restrictive requirement.
In 1997, FDA was asked by the ISSC to adopt the Model Ordinance.
FDA recognized that if it were to do so, the NSSP Model Ordinance would
be a FDA guideline, and as such, it would be 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). This policy states that the public
will be afforded an opportunity to comment on guidance documents in
accordance with Level 1 Good Guidance Practices documents as set out in
the Federal Register of February 27, 1997 (62 FR 8961).
The annual meeting of the ISSC, in the past and again at the July
1997 meeting, provided an essential forum for the development of
revisions to the NSSP. The participatory process that occurs at this
meeting serves the purposes and principles set forth in the agency's
guidance documents policy. Therefore, in a notice published in the
Federal Register of June 26, 1997 (62 FR 34480), FDA announced that the
Model Ordinance was to be discussed at the July 1997 ISSC meeting, and
that this meeting would act as the forum for public comment on the
Model Ordinance as an FDA guidance document. FDA requested comment on
the procedure, but received none.
With concurrence from FDA, the NSSP Model Ordinance was adopted by
the ISSC at its July 1997 meeting in Sturbridge, MA. With this notice,
FDA is announcing the availability of the Model Ordinance as contained
within the guide ``NSSP Guide for the Control of Molluscan Shellfish.''
At the Federal level, the Model Ordinance has the status of guidance
and, as such, does not create or confer any rights for or on any person
and does not operate to bind FDA or the public. However, through their
participation in the NSSP and the ISSC, participating States have
voluntarily agreed to follow the Model Ordinance as the requirements
which are minimally necessary for membership.
The public may comment on this document at anytime. The public may
comment in one of two ways: (1) By attending the ISSC conference held
annually for the purpose of, among other things, considering changes to
the Model Ordinance; or (2) by commenting to FDA. Those comments that
the agency finds meritorious will be offered by FDA for consideration
and vote at a subsequent ISSC.
The NSSP Model Ordinance will facilitate uniform adoption of the
recommended shellfish control practices by States for regulation of
their shellfish industry. Adoption of the NSSP Model Ordinance by each
State will strengthen the credibility of the National Shellfish
Sanitation Program and the ``Interstate Certified Shellfish Shippers
List'' (ICSSL), which identifies shellfish dealers certified by their
State of residence as being in compliance with NSSP guidelines.
Assurance that all shellfish dealers are meeting the minimum criteria
will foster confidence in product safety.
Interested persons may, at any time, submit to the Dockets
Management Branch (address above) written comments on the guide. Two
copies of any comments should be submitted, except that individuals may
submit one copy. Comments are to be identified with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the office above between 9 a.m. and 4 p.m., Monday
through Friday. At the discretion of FDA, received comments will be
used to develop issues for submission to the ISSC for consideration at
its July 1999, annual meeting.
Dated: July 8, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-19029 Filed 7-16-98; 8:45 am]
BILLING CODE 4160-01-F
