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  5. Questions and Answers Supplementing Information Contained in the Federal Register Notice and Request for Comment Relating to the Proposed Equivalence Determination Regarding the European Food Safety Control System for Raw Bivalve Molluscan Shellfish
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Questions and Answers Supplementing Information Contained in the Federal Register Notice and Request for Comment Relating to the Proposed Equivalence Determination Regarding the European Food Safety Control System for Raw Bivalve Molluscan Shellfish

The Federal Register notice 2018-04772, provides the technical basis for the FDA’s proposed determination of equivalence regarding the European Union (EU) food safety control system for raw bivalve molluscan shellfish. The European Commission (EC) also is in the process of finalizing its proposed equivalence determination of the U.S. food safety control system for shellfish after completing its own technical assessment. These equivalence determinations, when finalized, would enable both imports and exports of molluscan shellfish between the U.S. and the EU.

How to Comment

FDA invited public comment on this proposed determination that the European Union (EU) food safety control system for raw bivalve molluscan shellfish intended for export into the U.S. is equivalent to the U.S. system because it provides at least the same level of sanitary protection as the U.S. system.

The comment period opened March 9, 2018 for 75 days. The comment period closed May 23, 2018.

View submitted comments electronically in docket folder FDA-2018-N-0810 on www.regualtions.gov. For more information on how to comment, see the Federal Register notice.

U.S. exports of bivalve molluscan shellfish (specifically, oysters, clams, mussels, and roe-on and whole scallops) to the EU stopped in 2010 following a compliance audit by the EC. The U.S. ceased importing raw shellfish from EU countries in the 1980s. To allow the resumption of bilateral trade, the FDA and the EC initiated equivalence assessments in 2010 under the Veterinary Equivalency Agreement (VEA). Since 2010, the FDA and the EC have been working to complete the equivalence assessments.

The items below provide information on the implementation, operation, and maintenance of the equivalence determinations.

When can molluscan shellfish export shipments resume?

Several steps remain to resume trade. First, the administrative procedure to finalize the FDA equivalence determination must be completed, including consideration of comments received on the Federal Register notice. For the EC, the process involves 1. submitting the equivalence determination to the EU Council for consideration and 2. adding the U.S. to the list of approved countries from which shellfish can be imported. The FDA and EC will also implement operational details associated with a resumption of shellfish shipments.

How was equivalence evaluated?

The FDA and EC proposed equivalence determinations are based on a comparison of sanitary measures applied in the U.S. through the National Shellfish Sanitation Program (NSSP) with those applied in the EU through EC food safety controls for shellfish and their implementation by EU Member States. Technical experts from the FDA and EC relied on a review of legislation and regulations, technical consultations and observations from on-site evaluations, and data and risk assessments. The document reviews covered the following topics: regulatory framework; training programs; inspection programs; program assessment and audit; food-related illness and outbreaks; compliance and enforcement; industry and community relations; program resources; international communication and harmonization; and laboratory support.

FDA technical experts reviewed the EC submission and verified that EC program components provide an adequate foundation to support a shellfish safety control system. In addition, the FDA technical experts concluded that most EU food safety controls applied to raw shellfish are equivalent to provisions of the NSSP. Similarly, the EC evaluated the U.S. system through a documentary review of NSSP requirements.

The FDA and the EC technical experts agreed to focus their reviews by conducting assessments in a limited number of shellfish growing areas. The EC selected programs in the Netherlands and Spain with Class A waters and the FDA, through the Interstate Shellfish Sanitation Conference (ISSC), identified Massachusetts and Washington state with U.S. approved waters.

In addition to assessing NSSP raw shellfish controls, the EC also considered conditions to allow imports of processed U.S. shellfish that have been heat-treated to kill microbial pathogens.

The technical experts decided to make a recommendation for an equivalence determination following the completion of the technical assessment in November 2016.

Which components of the U.S. and EU shellfish control systems required additional evaluation?

  1. Procedures and enforcement criteria for assessing the safety of molluscan shellfish, including the following: procedures for assessing growing water quality and classification of waters (for the U.S.); criteria for assessing the safety of molluscan shellfish meat (for the EU); the relationship between these two approaches, including the use of various statistical analysis procedures; and procedures for conducting sanitary surveys.
  2. Procedures and enforcement mechanisms for assessing biological toxins and contaminants.
  3. Postharvest controls, policing of growing waters, product tracing/traceability, and recall.

If there is a final determination of equivalence, what products would be eligible for export?

In the United States:

  • Raw and processed molluscan shellfish harvested from U.S. approved growing areas in Massachusetts and Washington State.

In the European Union:

  • Raw molluscan shellfish harvested from Class A growing areas in Spain and the Netherlands. Note: The FDA already permits the importation of processed molluscan shellfish from all EU Member States.

What processed products are eligible for export to the EU?

The EC defines processed products as “foodstuffs resulting from the processing of unprocessed products. These products may contain ingredients that are necessary for their manufacture or to give them specific characteristics.” The EC further defines processing to mean, “any action that substantially alters the initial product, including heating, smoking, curing, maturing, drying, marinating, extraction, extrusion or a combination of these processes.”* Such products are eligible for export initially from Massachusetts and Washington State, and other U.S. states as they are approved by the FDA in accordance with the provisions of the equivalence arrangement with the EC.

* REGULATION (EC) No 852/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 on the hygiene of foodstuffs.

Would U.S. states operating under a Vibrio vulnificus (Vv) control plan be eligible to export molluscan shellfish to the EU after a final equivalence determination by the EC?

Not at this time. Molluscan shellfish harvested from growing area waters covered by an NSSP Vibrio vulnificus (Vv) risk management plan are prohibited from export to the EU.

However, the EC agreed to consider a U.S. proposal for the export of post-harvest processed molluscan shellfish from U.S. states operating under a Vv risk management plan. The proposal describing acceptable post-harvest processes will require review and assessment by the European Food Safety Authority.

Are there specific requirements for export shipments to the EU?

If the equivalence determination is finalized, eligible U.S. export shipments to the EU must be accompanied by an EU seafood export certificate.

All raw, shucked molluscan shellfish must be labeled “cook before eating.”

Will additional U.S. states be eligible for export in the future?

Yes, the FDA and EC have established a process to add new U.S. states to the list of states approved for export of molluscan shellfish to the EU.

What is the process for adding new U.S. states to the equivalence determination?

Once the equivalence determination is finalized, new U.S. states may be added to the equivalence determination through the following steps:

  • U.S. states will notify the FDA of their intent to export shellfish to the EU.
  • The FDA will confirm that the U.S. State is in conformance with NSSP requirements and that growing areas from which product is harvested for export to the EU have a U.S. Approved classification.
  • The FDA will confirm that growing area controls are in place, including assessment of the risk related to marine biotoxins and other hazards in shellfish.
  • The FDA will notify the EC of the U.S. state(s), the identification of the growing areas, and the names of the shellfish processing facilities to be recognized.
  • The EC will evaluate the application to recognize the facilities and growing areas eligible for export.
  • The addition of new states or new growing areas within a state will not require prior on-site audits before their approval; these new states or growing areas will be incorporated into the on-going periodic audits.

Are there other requirements U.S. shippers must meet that aren’t covered by the equivalence determination?

Yes, there are requirements that are not covered by the proposed equivalence determination that shippers would have to comply with.

  • Pesticide residue tolerances
  • Veterinary drug residue tolerances
  • Food and color additive maximum levels
  • Contaminant (e.g., heavy metals, dioxins) maximum permitted levels
  • Product labeling requirements

For more information:

How will the FDA and EC maintain their equivalence?

Both parties will carry out periodic audits of each other’s molluscan shellfish food control systems. The passage of substantive new legislation or regulations or substantive changes in existing legislation/regulations could trigger reassessment.