FSMA and Seafood – understanding its exemption


– Today I’d like to talk
about another exemption that’s written into FSMA
and that FDA, of course, has recognized as regulations,
and it relates to seafood. The FDA has regulated seafood, of course, as a regulatory agency for decades. Since about the mid-1990s, FDA had created a new regulatory regime,
it’s called Seafood HACCP. People in the industry
are extremely familiar with Seafood HACCP. Congress created an exemption into FSMA that said that those seafood products and the facilities that make them that are subject to Seafood HACCP and that also comply with the requirements are exempt from many of
the provisions of FSMA. And this, of course, was welcome news to the seafood industry. Now, what is Seafood HACCP? Very, very briefly, Seafood HACCP, HACCP stands for Hazard
Analysis Critical Control Point. It’s a seafood safety system
that’s based upon risk. It’s designed to require
that the processor, and anybody along the supply chain that deals with the product, conducts a review of
the significant hazards that could be related to
that particular seafood and then also develop control
points at critical spots in the processing or
the handling of the food to mitigate or control those hazards. It’s really a risk-based program. If you’re an importer of seafood, then you have a verification step where your requirement is to ensure that the foreign supplier has
in place a Seafood HACCP plan and also to create certain specifications related to your imported food so that you have identified any
hazards that might be related to that food as you’re bringing it in. Again it’s a pretty mature system. Interestingly enough, in
spite of the existence of Seafood HACCP, FDA still
samples quite frequently imported seafood that comes
into the United States and there are still
continually new facilities added to FDA import alerts
that process seafood and bring them to the United States. So it’s a system that’s existed and much of the FSMA program was sort of loosely based on the
Seafood HACCP program, so Congress created these exemptions. So what has FDA done and where is it going with respect of regulation
of seafood under FSMA? Well, very early on in the process, in the rule writing stage with FSMA, FDA also proposed a rule
to modify what are called good manufacturing
practices in the food area, and FDA’s finalized those regulations. That seems like it’s relatively innocuous. One of the things the FDA did was they changed a lot of the appearances of the word “should” into “must,” which is pretty significant. I mean, “should” is a recommendation. “Must” is mandatory, if you don’t comply with a “must,” you’re violating the law. So that’s a significant change. One of the areas they made this change is requiring certain training
and certain record keeping about training for people
who are irresponsible for food safety in a food facility, and that’s across the board. The reason that matters for seafood is that Seafood HACCP looks
to those same regulations requiring essentially seafood
importers to comply with them. So even though there’s a HACCP regime, the general good manufacturing practice for foods also applies. So that’s the way the
FDA has already created a change in the way seafood
processors must operate. Well, where is FDA going? One thing I think that’s most important is really at the import stage. It’s true that as long as
you comply with Seafood HACCP that you would be exempt from the Foreign Supplier Verification Program and the preventative controls requirements ordinarily applicable to food companies. Of course, that requires compliance. If you’re out of compliance, then the exemption wouldn’t apply. But part of the problem we have is that seafood is recognized as a high-risk food and yet the import
provisions in Seafood HACCP are far less rigorous than
the import controls in FSMA under the Foreign Supplier
Verification Program. And here are some examples
of that difference. For instance, under
HACCP, you are required to have in place written
verification procedures. Those procedures must include
a product specification and an affirmative step. The affirmative step relates to ensuring the foreign supplier has
a HACCP plan in place, that you’ve taken some step to affirm that they’re complying with it and some record keeping requirements with respect to the imported food. But compare that to FSVP under FSMA and you’ll find the requirements
for a hazard analysis, a risk evaluation,
verification activities, corrective actions, a reassessment
of your food safety plan, and record keeping. Significantly more rigorous
requirements under FSVP even though seafood is clearly recognized as a high-risk food. So when you do the comparison between Seafood HACCP and the
importer requirements and compare them with FSVP, you see this dichotomy of control. My opinion is FDA is not
gonna allow that to persist. What that would do is create two really dual, parallel food
import safety programs where one of your highest risk foods are controlled by a lesser, a lower, a less rigorous regime, compared to the balance of imported food that has to go through all
these additional steps. So how would FDA fix that? The likelihood is, and FDA’s
basically confirmed this, that after they’ve finished
with the FSMA regulations they would turn to Seafood HACCP. And they would begin to increase, under their ordinary jurisdiction, the importer requirements
for Seafood HACCP. So how do you prepare for this, as an importer or a processor, a packer of seafood? Well, the first thing would be ensure that you’re already taking steps to improve your sanitation requirements, your sanitation plans and your compliance with good manufacturing practices because that regulation
is already finalized and it’s gonna be implemented
in the near future. The second thing would
be to take a serious look at your implementation
program of verification as an importer, if you import. Why? Because the agency will
begin to ask questions about how do you know the foreign supplier is actually complying with Seafood HACCP? Another thing you can expect is continued inspections
and continued samplings. The FDA has been increasing
its sampling of seafood and I believe, in part,
in order to justify increasing the requirements
under Seafood HACCP, under its general food safety
authority outside of FSMA. Thank you for spending a few minutes with us here at fdaimports.com. We remain committed to
helping the industry and our clients understand and comply with these regulations as they’re
implemented by the FDA.

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