[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
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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