[Federal Register Volume 61, Number 57 (Friday, March 22, 1996)]
[Notices]
[Pages 11849-11851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-6959]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96D-0071]


1995 Revision of the National Shellfish Sanitation Program Manual 
of Operations, Part I ``Sanitation of Shellfish Growing Areas'' and 
Part II ``Sanitation of the Harvesting, Processing, and Distribution of 
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 the 1995 revision of the

[[Page 11850]]
National Shellfish Sanitation Program (NSSP) Manual of Operations, part 
I, ``Sanitation of Shellfish Growing Areas,'' and part II, ``Sanitation 
of the Harvesting, Processing, and Distribution of Shellfish.'' This 
revision was initiated in cooperation with the Interstate Shellfish 
Sanitation Conference (ISSC) to help assure that only safe and sanitary 
shellfish are offered for sale in interstate commerce.

ADDRESSES: Submit written requests for single copies of the manual 
(free of charge) from the contact person in the nearest Regional Office 
listed in the table below:

                                                                        
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             Addresses                          Contact Person          
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FDA, Stoneham District Office,       David Field                        
 State Programs Branch, One                                             
 Montvale Ave., Stoneham, MA 02180.                                     
FDA, New York Regional Office, 850   Jerry Mulnick                      
 Third Ave., Brooklyn, NY 11232-                                        
 1593                                                                   
FDA, Baltimore District Office,       Al Ondis                          
 Investigations Branch, 900 Madison                                     
 Ave., Baltimore, MD 21201                                              
FDA, Atlanta Regional Office, State  Robert Creasy                      
 Cooperative Programs, 60 Eighth                                        
 St. NE., Atlanta, GA 30309                                             
FDA, Charleston Resident Post, 334   Donald M. Hesselman                
 Meeting St., rm. 505, P.O. Box                                         
 21077, Charleston, SC 29413                                            
FDA, Tallahassee Resident Post,      Marc Glatzer                       
 Hobbs Federal Bldg., 227 North                                         
 Bronough St., suite 4150                                               
 Tallahassee, FL 32301                                                  
FDA, Baton Rouge Resident Post,      John Veazey                        
 5353 Essen Lane, suite 220, Baton                                      
 Rouge, LA 70809                                                        
FDA, Detroit District Resident       Nicholas Majerus                   
 Post, 1560 East Jefferson Ave.,                                        
 Detroit, MI 48207                                                      
FDA, Dallas Regional Office, 7920    Linda Collins                      
 Elmbrook Dr., suite 102, Dallas,                                       
 TX 75247                                                               
FDA, Seattle District Office, 100    Tim Sample                         
 Second Ave., suite 2400, Seattle,                                      
 WA 98104                                                               
FDA, Shellfish Program               Stanley Ratcliffe                  
 Implementation Branch (HFS-628),                                       
 200 C St. SW., Washington, DC                                          
 20204                                                                  
------------------------------------------------------------------------

    Requests should be identified with the docket number found in 
brackets in the heading of this document. Send two self-addressed 
adhesive labels to assist in processing your requests. The manual is 
available for public examination in the Dockets Management Branch (HFA-
305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Paul W. DiStefano, Office of Seafood, 
Center for Food Safety and Applied Nutrition (HFS-417), 200 C St. SW., 
Washington, DC 20204, 202-418-3177.

SUPPLEMENTARY INFORMATION: FDA is responsible for the Federal 
administration of the NSSP, which is a voluntary program involving 
State shellfish control agencies, the shellfish industry, FDA, and 
other Federal agencies. Five foreign countries also actively 
participate in the NSSP through international bilateral agreements.
    The NSSP is concerned with the sanitary control of fresh and frozen 
molluscan shellfish (oysters, clams, mussels, and scallops) offered for 
sale in interstate commerce. The program has been in existence since 
1925. In the interest of assuring uniform administration and technical 
controls, the NSSP has developed and maintained recommended shellfish 
control practices. These control practices have been published in the 
form of a Manual of Operations, parts I and II.
    In 1982, interested State officials and members of the shellfish 
industry formed the Interstate Shellfish Sanitation Conference (ISSC) 
to provide a formal structure wherein State regulatory authorities 
could establish regularly updated and uniform guidelines for improving 
shellfish sanitation and safety. Those persons interested in obtaining 
additional information about the ISSC should contact: Kenneth Moore, 
Interstate Shellfish Sanitation Conference, 115 Atrium Way, suite 117, 
Columbia, SC 29223.
    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 and participate in the cooperative program of 
the Conference to develop or revise program criteria and guidelines.
    Based on the MOU, FDA developed draft revisions of the NSSP Manual 
of Operations, parts I and II, in cooperation with the ISSC. FDA 
announced the availability of the 1986 revision of part I in the 
Federal Register of June 5, 1987 (52 FR 21375). An initial working 
draft of part II was made available for comment in the Federal Register 
of September 11, 1985 (50 FR 37055), with a revised second draft being 
made available for further comment in the Federal Register of July 11, 
1986 (51 FR 25261). Based on the comments received, and in 
consideration of later comments expressed by State regulatory 
officials, industry representatives, and other interested parties at 
the ISSC's 1987 and 1988 annual meetings in Austin, TX, and Denver, CO, 
respectively, FDA announced the availability of the 1988 revision of 
the manual in the Federal Register of February 17,1989 (54 FR 7281). 
Subsequent revisions were announced in the Federal Register of April 
25, 1990 (55 FR 17503), December 13, 1990 (55 FR 51341), and January 
13, 1993 (58 FR 4174).
    The 1995 manual revision contains changes and improvements to the 
NSSP that were considered and passed at the ISSC's 1994 and 1995 annual 
meetings in Tacoma, WA and Orlando, FL, respectively. Noteworthy 
changes include: (l) A detailed shellfish laboratory evaluation 
checklist for State and Federal laboratory evaluation officers to use 
for certifying that laboratories are operated in compliance with 
criteria of the National Shellfish Sanitation Program; (2) new time 
temperature controls to prevent

[[Page 11851]]
excessive post harvest increases in the levels of Vibrio vulnificus 
bacteria in shellfish harvested from the waters confirmed as an 
original source of product associated with two or more V. vulnificus 
illnesses. Matrix controls establish times for shellfish to be under 
refrigeration following harvest. The time from harvest until shellfish 
are placed under refrigeration needs to decrease as water temperatures 
rise. Matrix time/temperature controls are recommended for use with 
shellfish that are harvested from waters with a Vibrio problem and then 
sold for raw consumption; and (3) new tagging procedures to improve the 
traceability of wet-stored shellstock to its original harvest site. 
These procedures include a recommendation to use a shipping tag that 
identifies the certified wet-storage facility and the storage dates for 
shellstock that has entered interstate commerce and then been wet 
stored for 90 days or less.

    Dated: March 15, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-6959 Filed 3-21-96; 8:45 am]
BILLING CODE 4160-01-F