[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: ``[email protected]'', 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