FDA is seeking views on if the EU system for raw bivalve molluscan shellfish intended for export into the US is equivalent to the one in America because it provides the same level of sanitary protection.
The comment period ends on 23 May.
The determination is based on FDA’s review of the EU’s food safety controls including provisions for ensuring safety of molluscan shellfish.
If finalized, it would permit importation of shellfish harvested from selected production areas (initially in the Netherlands and Spain) and processed by establishments listed by FDA on its Interstate Certified Shellfish Shippers List (ICSSL).
The American seafood industry contributes more than $90bn to the economy, according to the Brookings Institution, and supports about 1.5 million jobs.
Market opportunity
Scott Gottlieb, FDA commissioner, said it will offer new market access for US exporters and give consumers a wider selection of shellfish options.
“Bringing fish to Americans begins with the harvesters and fishers and involves shuckers, processors, distributors and retailers that all work with regulatory agencies to make sure standards of food safety are met whether fish is harvested at home or abroad,” he said.
“Fish products account for more than $5bn in total value of US exports, and roughly one-third of that is shellfish. With a 6% share of global trade, the US represents the sixth-largest supplier of fish and seafood products to the world market.
“The proposed shellfish equivalence determination will help to unlock economic opportunity for both US and EU exporters by creating new market access as well as making a wider selection of healthy and safe shellfish options available to consumers.”
The European Commission is finalizing its equivalence determination of the US control system for shellfish. If approved it would permit imports of shellfish harvested from approved growing areas in Massachusetts and Washington with other states possibly added over time.
US shellfish imports have not been allowed by Europe since 2010. FDA has not permitted import of live, fresh or fresh-frozen molluscan shellfish from the EU since the 1980s.
Fresh herb and avocado sampling
Meanwhile, the FDA has begun testing fresh cilantro, parsley and basil, as well as processed avocado and guacamole, for microbial contaminants. The agency plans to collect 1,600 samples for each.
As of the start of 2018, it had collected 35 domestic and 104 import samples of fresh herbs. None of the domestic ones tested positive.
Of the import samples, four were positive for Salmonella, three for Shiga toxin-producing E. coli and none for E. coli O157:H7.
In the same timeframe, FDA collected 58 domestic and 49 import samples of processed avocado/guacamole.
Of the domestic samples, three were positive for Listeria monocytogenes. Of the imported ones, one tested positive for L. monocytogenes.
FDA chose to sample fresh herbs because they are eaten without undergoing a ‘kill step,’ such as cooking, to reduce or eliminate bacteria. They are also often consumed as part of multi-ingredient foods and people may not report having eaten them when they become ill.
It will get baseline estimates of the prevalence of Salmonella and Shiga toxin-producing E. coli (STEC) in cilantro, basil and parsley. The agency also intends to test for Cyclospora cayetanensis during summer months when Cyclospora-related illnesses typically occur.
The agency chose to sample processed avocado because it has a high moisture content and a non-acidic pH level, conditions that support growth of bacteria.
It is seeking data on prevalence of Salmonella and L. monocytogenes in processed avocado and such products.