[StBernard] Letter dated June 14, 2010 from the Acting Director for Food and Safety and Applied Nutrition for the Food and Drug Administration Michael M. Landa

[Westley Annis]

The following is a letter dated June 14, 2010 from the Acting Director for
Food and Safety and Applied Nutrition for the Food and Drug Administration
Michael M. Landa:

 

"Dear Fish and Fishery Products Industry:

 

"In light of the accident, on April 20, 2010, in which an oil platform in
the Gulf of Mexico caught fire and sank, the Food and Drug Administration
(FDA) wants to remind fish and fishery product processors of FDA's
regulations and policy concerning the food safety hazard of environmental
chemical contaminants.

 

"The accident resulted in a large, ongoing release of crude oil into the
environment. Environmental chemical contaminants, such as polycyclic
aromatic hydrocarbons (PAHs) from crude oil, in fish and shellfish pose a
potential human health hazard. These contaminants may accumulate in fish and
shellfish at levels that can cause illness. As is the case with most oil
spills off the coast of the United States, state and federal authorities
closed waters to fish and shellfish harvesting to prevent the sale or
consumption of potentially contaminated fish and fishery products.

 

"FDA's Fish and Fishery Products Regulation (Title 21 of the Code of Federal
Regulations Part 123 (21 CFR 123)) requires processors to have and implement
a written Hazard Analysis Critical Control Point (RACCP) plan when a hazard
analysis reveals that one or more food safety hazards are reasonably likely
to occur (21 CFR 123.6(b)). Furthermore, these processors are required to
reassess the adequacy of their HACCP plan or, when a processor does not have
a RACCP plan because a hazard analysis did not reveal food safety hazards
that were reasonably likely to occur, to reassess the adequacy of their
hazard analysis whenever any changes occur that could affect the hazard
analysis or alter the HACCP plan in any way (21 CFR 123.8(a)(1); 21 CFR
123.8(c)).

 

"The regulation specifically requires processors of molluscan shellfish to
include in their RACCP plans how they are controlling the origin of the
molluscan shellfish they process to ensure that they only process shellfish
harvested from growing waters approved for

harvest by a shellfish control authority or, in the case of shellfish
harvested from U.S. Federal waters, from waters that have not been closed to
harvesting by an agency of the Federal government (21 CFR 123.28). To meet
this requirement, processors who receive shell stock must only accept shell
stock from a harvester that is in compliance with the licensure requirements
that apply to the harvesting of molluscan shellfish or from a processor that
is certified by a shellfish control authority, and that has a tag affixed to
each container of shell stock. 

 

"The tag must include the date and place the shell stock were harvested (by
State and site), type and quantity of shellfish harvested, and an
identification of the harvester or the harvester's vessel. In place of the
tag, bulk shell stock shipments may be accompanied by a bill of lading or
similar shipping document that contains the same information (21 CFR
123.28(c); 21 CFR 1240.60(b)).

 

"The regulation does not include specific requirements for other fish and
fishery product processors on what to include in their HACCP plans to ensure
that they only process fish, and other types of shellfish, from waters that
have not been closed to harvesting by state and federal authorities.
However, FDA provides recommendations concerning different control
strategies that processors may use to control environmental chemical
contaminant hazards in Chapter 9 of FDA's "Fish and Fisheries Products
Hazards and Controls Guidance - Third Edition; June 2001" (the Guide). One
of these control strategies is called "Source Control."

 

"For products other than molluscan shellfish, FDA recommends among other
things that processors offish and fishery products set a critical limit in
their RACCP plan of "No fish may be harvested from an area that is closed to
commercial fishing by foreign, federal, state, or local authorities" and
establish monitoring procedures for the "Location and status (e.g. open,
closed) of the harvest area" for "Each lot received" to ensure that the
critical limit is consistently met. (See Control Strategy Example 6- Source
Controls in Step 14 (Set the critical limits (CL) & Step 15 (Establish
monitoring procedures) of Chapter 9 of the Guide).

 

"The Guide also provides recommendations on what corrective actions should
be taken if the critical limits are not met, what records to keep, and how
to verify that the RACCP plan is adequate to address the hazard and is
consistently being followed.

 

"FDA recognizes that the oil spill has had a major impact on much of the
fish and fishery products industry in the region. In the coming days, FDA
will conduct a conference call with Gulf state stakeholders to review
expectations, answer questions, and ensure that processors have plans and
tools in place to ensure the safety of the seafood they are receiving and
selling to their customers."

 

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