FDA Letter to Fish and Fishery Products Industry
June 14, 2010
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 (HACCP) 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
HACCP 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 HACCP 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 shellstock must only accept shellstock 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 shellstock. The tag must
include the date and place the shellstock 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 shellstock shipments may be
accompanied by a bill of lading or similar shipping document that contains the same information (21 CFR 123.28(c); 21
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 of fish and fishery
products set a critical limit in their HACCP 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 HACCP plan is adequate to address the hazard and is consistently
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.
Michael M. Landa
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Consumers Can Be Confident in the Safety of Gulf Seafood
The following is an Op-Ed written by officials from FDA, NOAA, and Louisiana. It published in a number of
newspapers in early March 2011.
Eric Schwaab, NOAA's Assistant Administrator for NOAA's Fisheries Service
Donald Kraemer, Deputy Director, FDA's Center for Food Safety and Applied Nutrition
Dr. Jimmy Guidry, Louisiana State Health Officer, Louisiana Department of Health and Hospitals
As is the case with so many parts of the response to the BP/Deepwater Horizon oil spill, the seafood safety program put
in place during this crisis was unprecedented. The system set up to keep tainted seafood out of circulation worked.
At the top of the list for NOAA, FDA and the Gulf states has always been ensuring public safety and the integrity of Gulf
seafood. Federal waters in the Gulf were first closed to fishing on May 2, and closures increased in federal and state
waters as the oil spread. At the height of the spill, more than a third of the federal waters in the Gulf were closed to
fishing. With the Coast Guard, we enforced the closure boundaries, and together we developed and carried out a
comprehensive plan for testing Gulf seafood.
Driven by science and with human health as the highest priority, the extensive sampling and testing plan allowed areas
to open only when every piece of seafood sampled there passed both sensory and chemical testing. We were
precautionary on purpose: when there was a potential for tainted seafood, waters were closed, and they could only be
opened when we could prove the seafood from those waters was safe to eat.
Scientists knew already, from real-world experiences (like the Exxon Valdez disaster) and laboratory research, that fish
can metabolize and excrete oil. Knowing that finfish can clear it from their bodies within days, shrimp and crabs take a
little longer, and shellfish like oysters take the longest time, we tested these various types of seafood individually to make
sure we didn't miss anything. The results of the tests, all publicly available, should help Americans buy Gulf seafood with
confidence: the seafood has consistently tested 100 to 1000 times lower than the safety thresholds established by the
FDA for the residues of oil contamination.
The large-scale use of dispersants to help oil rapidly break down in the environment was one of the many unique
aspects of this spill and response. Scientists expected seafood would metabolize and excrete dispersant and that it was
unlikely to be taken up by seafood in large quantities, but to support consumer confidence, NOAA and FDA worked to
develop a chemical test to detect traces of the dispersant in fish tissue. In October, the agencies announced the results:
every sample tested was far below the safety threshold established by FDA, and over 99 percent of the thousands of
samples tested showed no detectable residue.
We saw firsthand the devastating impact the BP/Deepwater Horizon disaster had on the lives and livelihoods of the Gulf
fishing community. We had many opportunities to work with the fishermen and seafood processors throughout the
region, and we witnessed their steadfast commitment to ensuring the safety and wholesomeness of their catch every
day. We continue to be thankful for their cooperation through the often challenging process of closing and reopening
Because of the hard work and cooperation of Gulf fishermen, seafood processors, and state, local and federal health
and fisheries officials, American consumers can feel confident in the quality and safety of Gulf seafood.
|FDA Letter to Fish and Fishery Products Industry Regarding the Gulf of Mexico Oil Spill
November 6, 2011 firstname.lastname@example.org