FDA Logo U.S. Food and Drug AdministrationCenter for Food Safety and Applied Nutrition
U.S. Department of Health and Human Services
horizontal rule

National Shellfish Sanitation Program
Guide for the Control of Molluscan Shellfish
2003

VI. NSSP Policy Setting Documents


Table of Contents

(Department of Health and Human Services FDA Policy Statement Consumption of Raw Molluscan Shellfish  |  ISSC Policy Statement Consumption of Raw Molluscan Shellfish  |  Interstate Shellfish Sanitation Conference Resolution 97 - 01 )

Logo of Department of Health and Human Services
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
Washington DC 20204


POLICY STATEMENT

CONSUMPTION OF RAW MOLLUSCAN SHELLFISH

Molluscan shellfish are animal-derived protein foods that are widely consumed and play an important role in the diets of some consumers. Most animal-derived protein foods are cooked prior to consumption. Cooking can reduce a number of potentially pathogenic organisms and the risk of illness. However, molluscan shellfish are often consumer raw or partially cooked. Therefore, some cases of illness are inevitable from consuming them in this way.

The majority of illnesses that occur from the consumption of raw molluscan shellfish are the result of pollution. They are not life threatening to the general population and commonly range from mild intestinal disorders of short duration to acute gastroenteritis. More serious illnesses can occur, but are rare.

Certain medically compromised individuals are at increased risk from common marine vibrio bacteria that are unrelated to pollution. Therefore, it may not be possible to address this risk through environmental controls. Although the reported number of illnesses and fatalities from these bacteria in the United States each year is small in comparison with other food borne illnesses, the best advice for medically compromised individuals is not to eat raw molluscan shellfish. At most risk are those affected by: AIDS; chronic alcohol abuse; liver, stomach or blood disorders; cancer; diabetes; and kidney disease. Those uncertain of their health should seek the advice of their physician.

To reduce the risk of illnesses associated with raw shellfish consumption, the Food and Drug Administration (FDA) administers the National Shellfish Sanitation Program (NSSP). The NSSP is a tripartite cooperative program of Federal and State public health officials and the shellfish industry working together to improve shellfish safety. FDA is committed to the NSSP partnership as providing the best means of making molluscan shellfish as safe as possible. States annually spend millions of dollars to monitor waters to assure that they are safe before harvesting is permitted. FDA routinely audits the States' classification of shellfish harvesting areas to verify that none pose a threat to public health. FDA has also increased its cooperative efforts with State and Federal law enforcement officers to prevent illegal harvesting from closed waters, a practice that probably leads to most shellfish illnesses. Adhering to NSSP controls will help to keep risks to a minimum.

 

ISSC POLICY STATEMENT

CONSUMPTION OF RAW MOLLUSCAN SHELLFISH

Introduction

The Interstate Shellfish Sanitation Conference (ISSC) was organized in 1982 to address the safety and sanitation of molluscan shellfish (oysters, mussels, clams, and whole and roe-on scallops. The ISSC has a formal Memorandum of Understand with the U.S. Food and Drug Administration (FDA) to promote shellfish sanitation through the National Shellfish Sanitation Program (NSSP), a tripartite cooperative program of Federal and State public health officials and the shellfish industry working together to improve shellfish safety. The ISSC recognizes the success of this Program, which is founded on the premise that through appropriate controls, molluscan shellfish can be consumed raw by most people with reasonable risk. The ISSC remains committed to that premise.

Policy Statement

Molluscan shellfish are animal-derived protein foods that are widely consumed and play an important role in the diets of some consumers. Most animal-derived protein foods are cooked prior to consumption. Cooking can reduce a number of potentially pathogenic organisms and the risk of illness. Consumption of raw shellfish, as with consumption of other types of raw animal-derived protein foods, increases the risk of illness. The majority of illnesses related to the consumption of raw molluscan shellfish are a result of pollution. These illnesses are not life threatening to the general population and commonly range from mild intestinal disorders of short duration to acute gastroenteritis. More serious illnesses can occur, but are rare.

To reduce the potential risk associated with consumption of raw molluscan shellfish, the FDA in cooperation with the States administers the National Shellfish Sanitation Program. States monitor shellfish growing waters to determine that they are safe before harvesting is permitted. The FDA routinely audits the States' classification of shellfish harvesting areas to verify that none pose a threat to public health. The FDA has also increased its cooperative efforts with State and Federal law enforcement officers to prevent illegal harvesting from closed waters and ensures that all shellfish in interstate commerce are properly labeled or has a tag identifying the harvest area and shipper. The tagging and labeling requirement of the NSSP is designed to ensure that only shellfish from approved growing waters reach interstate commerce. Adherence to NSSP controls minimizes risks. Recognizing the NSSP partnership provides the best possible means of ensuring that molluscan shellfish are safe, the FDA, the States, and the ISSC are committed to continued support of the Program.

Certain medically compromised individuals are at increased risk from common marine bacteria that are unrelated to pollution. Therefore, it may not be possible to address this risk through environmental controls. Although the reported number of illnesses and fatalities from these bacteria in the United States each year is small in comparison with other food borne illnesses, total abstinence from raw molluscan shellfish is the best advice for medically compromised individuals. Those at greatest risk include, but are not restricted to those affected by: AIDS; chronic alcohol abuse; liver, stomach or blood disorders; cancer, diabetes and kidney disease. Those uncertain of their health status should seek the advice of their physician.


INTERSTATE SHELLFISH SANITATION CONFERENCE

RESOLUTION 97 - 01

SUBJECT: Post-Harvest Treatment Processing

TEXT OF RESOLUTION:

            WHEREAS, the effect of naturally occurring Vibrio vulnificus in raw shellstock oysters has been a problem that has caused considerable concern for the Interstate Shellfish Sanitation Conference (ISSC), the FDA, State public health regulators, the molluscan shellfish industry and the general public; and

            WHEREAS, the ISSC had previously adopted a position (stated in a resolution by the 1991 conference) that "in absence of definitive information regarding Vibrio vulnificus, the only realistic approach is education of the high risk groups"; and

            WHEREAS, the ISSC also had recommended that "states and industry take immediate steps to institute harvesting, processing and handling procedures which will eliminate illnesses attributable to Vibrio vulnificus"; and

            WHEREAS, the State public health regulators and shellfish control agencies are awaiting guidance from the ISSC and FDA regarding Post-Harvest Treatment (PHT) processes; therefore

            BE IT RESOLVED, that the ISSC encourages the development and SSCA approval of PHT processes which are able to consistently and reliably reduce Vibrio vulnificus to non-detectable levels in raw molluscan shellfish.


horizontal rule
horizontal rule