U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
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HHS News - Seafood Safety Regulations Announced
 
 
HHS NEWS
 
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
P95-9                              Food and Drug
Administration
FOR IMMEDIATE RELEASE              Judith Foulke  (202) 205-
4144
Dec. 5, 1995                       Home  (703) 451-8132
 
 
 
             SEAFOOD SAFETY REGULATIONS ANNOUNCED
 
 
 
The Clinton Administration today moved to increase the safety
of the U.S. food supply by requiring that seafood processors
use preventive controls to keep unsafe products from reaching
consumers.
 
The new Food and Drug Administration regulations represent a
revolution in the way food is protected.  The regulations --
based on principles of a system called Hazard Analysis
Critical Control Point (HACCP) -- replace the approach adopted
in the early 1900s that addressed safety problems after the
fact with new procedures under which food processors will take
greater responsibility for preparing safe food, and government
and industry will work more closely together to protect public
health.
 
It is estimated that these regulations will prevent 20,000 to
60,000 seafood poisonings a year, which cost consumers up to
$116 million annually.  The regulations lead the way toward a
21st century food safety system; they will be followed next
year by subsequent years by additional FDA regulations
covering other segments of the food supply.
 
"Many Americans are making an effort to eat healthier and are
including seafood in their diet," said Health and Human
Services Secretary Donna E. Shalala.  "A system that will
ensure the safety of seafood products, regardless of what
country or environment they come from, is a high public health
priority.  These changes also represent another step in the
Clinton administration's continuing effort to protect the
public health through smart, state-of-the-art regulations."
 
The key HACCP components of the system are identification of
potential problems that could make seafood hazardous;
establishment and monitoring of targeted control points to
minimize such risks; and keeping a record of the results.
 
Under the FDA rule, seafood processors will have to identify
hazards that, without preventive controls, are reasonably
likely to affect the safety of the products.  If at least one
such hazard can be identified, the firm will be required to
adopt and implement an appropriate HACCP plan.  For example, a
highly mechanized processing line would be checked regularly
for metal fragments in the food and records kept of those
checks.  In addition to helping ensure that the food is free
of such contaminants, this process also helps manufacturers
who subsequently have problems with their food determine how
and when those problems could have occurred.
 
Seafood processors using the HACCP system will continue to be
monitored under FDA surveillance and inspection programs.
HACCP record keeping will enable FDA regulators to monitor
product safety more closely and on a more continuous basis
than through spot checks.
 
"Our safety inspections should focus on preventing problems
rather than chasing the horses after they're out of the barn,"
said FDA Commissioner David A. Kessler, M.D.  "HACCP is a
system that will make that possible.
 
While the HACCP rules do not apply to fishing vessels or
transporters, processors of imported as well as domestic
seafood must take responsibility for incoming materials.  If
the supplier does not provide satisfactory information about
the area where the fish were caught or how they were handled,
the HACCP plan will strengthen the processor's position in
refusing to accept the shipment.
 
The HACCP regulations contain special provisions to protect
the safety of certain types of products.  For instance,
processors of raw molluscan shellfish (oysters, clams and
mussels) must specify in their plans, among other things, that
they will accept only molluscan shellfish that have been
harvested from approved waters.  In the case of smoked fish,
HACCP controls call for procedures that will provide safety
from Clostridium botulinum toxin through the shelf life of the
product.
 
Retail seafood operations, while exempt from the FDA rule, are
regulated by state and/or local authorities with training and
other technical assistance from FDA.
 
The HACCP regulations for seafood processors will be published
in the Federal Register shortly.  The rule will be fully
implemented over the next two years and the agency anticipates
being able to perform HACCP inspections beginning in 1996.
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