U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
FDA Prime Connection

Federal Register Announcement on Shellfish Guidance Documents
 
 
 
 
 
 
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FN93-04        FEDERAL REGISTER ANNOUNCEMENT         02/26/93
              ON SHELLFISH GUIDANCE DOCUMENTS
 
 
 
DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
Food and Drug Administration
 
[Docket No. 93D-0057]
 
"Guidance Document for Arsenic in Shellfish"; "Guidance Document
for Cadmium in Shellfish"; "Guidance Document for Chromium in
Shellfish"; and "Guidance Document for Nickel in Shellfish";
Availability
 
AGENCY: Food and Drug Administration, HHS.
 
ACTION: Notice.
 
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of four guidance documents on elemental contaminants
in shellfish entitled "Guidance Document for Arsenic in Shellfish,"
"Guidance Document for Cadmium in Shellfish," "Guidance Document
for Chromium in Shellfish," and "Guidance Document for Nickel in
Shellfish."  FDA developed these documents in response to requests
from various State public health and environmental agencies.  They
address contaminants that are of particular concern to State
authorities.  The information provided in the guidance documents
should assist State and local decisionmakers in addressing the
local or regional public health significance of contaminants in
seafood.  The information will be useful in determining the need to
issue consumption advisories or to close harvesting waters when
seafood harvested from particular waters is found to be
contaminated.  FDA is developing additional guidance documents to
address other contaminants that are of public health significance
that may be present in shellfish and finfish.
 
ADDRESSES:  Submit written requests for single copies of these four
guidance documents (free of charge) to the Food and Drug
Administration, Policy Guidance Branch (HFS-416), 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 that office in
processing your requests.  The four guidance documents are
available for public examination in the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn
Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through
Friday.
 
FOR FURTHER INFORMATION CONTACT:  Gregory M. Cramer, Center for
Food Safety and Applied Nutrition (HFS-416), Food and Drug
Administration, 200 C St. SW., Washington, DC 20204,
202-254-3888.
 
SUPPLEMENTARY INFORMATION:  The purpose of the Federal Food, Drug,
and Cosmetic Act (the act) is to ensure a safe and wholesome food
supply.  The act and other related statutes, including the Public
Health Service Act, provide the regulatory framework under which
FDA assesses the effects of environmental contaminants on the
safety of consumption of fish and shellfish.
 
     Under the act, FDA may establish a formal tolerance limiting
the level in food of an added poisonous or deleterious substance
that is required in the production of the food or that cannot
be avoided by current good manufacturing practice.  However, when
toxicological data are scanty or conflicting, when additional data
are being developed, or when other conditions are rapidly changing,
FDA may choose not to establish a tolerance.  Nevertheless, it may
still be appropriate to control exposure to a contaminant.  In such
circumstances, FDA may consider developing guidelines or regulatory
limits.  In either case, tolerances, regulatory limits, and
guidelines are typically designed for use on a national basis, when
the agency judges that a national problem exists with respect to a
particular contaminant.
 
     In the present instance, however, the substances that are the
subject of these guidance documents are primarily of local concern,
and FDA has not developed tolerances, regulatory limits, or
guidelines for them.  In the absence of a reference for assessing
the public health significance of contaminants found in local
seafood, local and State officials have repeatedly sought the
advice of FDA on these matters.
 
     These guidance documents are intended for use by public health
officials as a tool for assessing the public health significance of
contaminants found in local seafood.  Each of the documents
provides public health information about the contaminant in
question, how to sample shellfish in preparation for testing for
that contaminant, procedures for analyzing for the contaminant,
consumption and exposure assessments, and a summary of the
toxicological and adverse effects of the contaminant.  Guidance is
also provided on how tolerable levels of shellfish consumption
or contamination might be determined.
 
     FDA plans to develop additional guidance documents to address
other contaminants present in shellfish and finfish that are of
public health significance.