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These questions and answers provide information about the implementation, operation, and maintenance of an equivalence determination for food safety measures related to shellfish traded between the European Union (EU) and the United States. The Food and Drug Administration (FDA or we) announced in a Federal Register Notice publishing on September 24, 2020, a final determination that the adoption and implementation by Spain and the Netherlands of the EU’s system of food safety control measures, along with their application of additional measures specifically adopted for this purpose, for raw bivalve molluscan shellfish (“shellfish”) for export to the United States, as evaluated by FDA, provides at least the same level of sanitary protection as comparable food safety measures in the United States and is therefore equivalent. The European Commission (EC) has finalized its equivalence determination of the U.S. system of food safety control measures for shellfish after completing a technical assessment of two U.S. participants implementing the National Shellfish Sanitation Program (NSSP participants),Massachusetts and Washington. These equivalence determinations will enable exports of shellfish from Massachusetts and Washington to the EU and from Spain and the Netherlands to the United States. Upon request by FDA, the EC will consider whether to permit importation from additional NSSP participants and FDA will evaluate additional EU Member States for equivalence according to procedures described below.
The EC equivalence determination applies to live, chilled, frozen, and processed bivalve molluscs harvested from U.S. Approved growing areas of certain NSSP participants. The EC will add NSSP participants receiving a positive evaluation to the U.S. entry on the EU “List of third countries and territories from which imports of live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods for human consumption are permitted” (EU List).
Accordingly, the following U.S. shellfish products are initially eligible for export to the EU:
Live, chilled, frozen, and processed shellfish harvested from U.S. growing areas with Approved classification in Massachusetts and Washington.
Yes. Shellfish covered by the EC determination includes live, chilled, frozen, and processed bivalve molluscs originating from certain NSSP participants, initially Massachusetts and Washington. The EC equivalence determination applies to shellfish harvested and processed from U.S. Approved growing areas from NSSP participants on the EU List.
The Directorate General for Health And Food Safety of the European Commission (DG SANTE) has agreed to undertake a separate equivalence evaluation of the food safety control system in place for processed molluscan shellfish, which FDA applies and is seeking recognition on a national basis. FDA oversees the safety of processed shellfish in the United States through the enforcement of mandatory, national Seafood Hazard Analysis and Critical Control Point (Seafood HACCP) requirements governing the commercial sale of processed shellfish intended for human consumption. In conducting its evaluation of regulatory controls applied to U.S. processed molluscan shellfish, DG SANTE has agreed to rely also on information collected during its systems recognition reviews of FDA food safety controls, the evaluation of the U.S. system of controls applied to raw molluscan shellfish, and a long history of auditing Seafood HACCP controls applied to U.S. fish and fishery products.
Raw shellfish must be harvested from Approved growing areas and sourced from establishments eligible to export to the EU. U.S. firms seeking to ship shellfish products to the EU should apply for inclusion on the EU List of Third Country Establishments via the FDA’s Export Listing Module (ELM). The ELM is an automated system for listing firms eligible to export FDA-regulated commodities. On a regular basis, FDA will transmit requests to the EU to update this list based on information provided in the ELM. All shipments must be accompanied by an export certificate issued by the National Oceanic and Atmospheric Administration (NOAA) (Health Certificate For Imports Of Bivalve Molluscs, Echinoderms, Tunicates And Marine Gastropods Intended For Human Consumption From The United States Of America). For more information see ELM instructions.
The EC equivalence determination does not cover any applicable EU requirements that fall outside the scope of this final equivalence determination, including the following subject areas:
- Pesticide residue tolerances;
- Veterinary drug residue tolerances;
- Food and color additive maximum levels;
- Contaminant (e.g., heavy metals, dioxins) maximum permitted levels; and
- Product labeling requirements.
To verify compliance with requirements not covered by the equivalence determination, the EC will conduct periodic audits in the United States.
The EC’s equivalence determination recognizes the equivalence of the U.S. shellfish safety control measures and initially accepts exports of raw and processed bivalve molluscan shellfish harvested from Approved growing areas in Massachusetts and Washington. The EC assessed compliance of these two NSSP participants with the NSSP, which ensures the safety of molluscan shellfish by providing for the classification and control of shellfish growing waters and for the inspection and certification of shellfish processors. In consultation with the Interstate Shellfish Sanitation Conference (ISSC), NSSP participants Massachusetts and Washington were selected as examples of the U.S. system.
FDA and the EC have established a process to evaluate additional NSSP participants. By following the procedure outlined in A.7 below, additional NSSP participants will be considered and, following a positive evaluation, added to the U.S. entry on the EU List of countries approved to export shellfish to the EU.
FDA and DG SANTE established a process for adding NSSP participants to the EU List (See Administrative Arrangement Between the United States Food and Drug Administration and the Directorate-General for Health and Food Safety of the European Commission Regarding Trade in Bivalve Molluscan Shellfish) (Administrative Arrangement).
An additional NSSP participant can seek to be added to the EU List by notifying the designated FDA shellfish specialist, in writing, and providing the documents required by the EC to evaluate the NSSP participant. FDA will review the documents and inform DG SANTE that, based on the information provided, the NSSP participant seeking to be added to the EU List has applied the relevant measures.
DG SANTE will review the following information provided by each NSSP participant seeking to be added to the EU List:
- List of Approved growing areas;
- List of firms/processors harvesting product in Approved growing areas;
- Most recent FDA audit of the NSSP participant’s implementation of the NSSP and any corrective actions taken after the audit;
- Most recent sanitary survey(s) for those Approved growing areas;
- Most recent inspection reports for firms operating in those Approved growing areas and, in case of non-compliance, corrective actions taken by firms after the inspections; and
- List of laboratories performing official regulatory analyses of raw molluscan shellfish samples and the most recent NSSP evaluation report for each lab, including any resulting corrective actions; and
- Summary description of applicable U.S. mechanisms for implementing and enforcing FDA regulations, plus enforcement of additional measures, if any, applied to those growing areas/processors.
For NSSP participants seeking to ship raw or live shellfish harvested from an Approved growing area in another NSSP participant that is already on the EU List, required documentation consists of the most recent FDA Plant and Shipping Element Program Evaluation Report and the most recent inspection report for each shellfish processing firm seeking to be listed for export to the EU.
DG SANTE will promptly evaluate the NSSP participant’s request and notify FDA of the results of its evaluation. If the evaluation is positive, DG SANTE will undertake its administrative process for adding the NSSP participant to the U.S. entry on the EU list of countries approved to export shellfish to the EU. FDA will then use the ELM to generate a list of U.S. shellfish exporters that are eligible to be added to the EU List of Third Country Establishments and to obtain an export certificate from NOAA, which is required for shellfish exported to the EU.
Not initially. The EC’s equivalence determination does not include shellfish harvested from growing area waters covered by an NSSP Vibrio vulnificus (Vv) risk management plan, so these products are not permitted to be exported to the EU at this time.
Following its equivalence determination, DG SANTE agreed to consider a U.S. request to permit the importation into the EU of raw shellfish from NSSP participants implementing a Vv risk management plan and applying specific processes to control the pathogens in raw shellfish. FDA’s request must be reviewed by the European Food Safety Authority (EFSA), which must determine the effectiveness of those processes. DG SANTE has agreed to facilitate EFSA’s review.
OsHV-1 is a contagious viral disease that can affect the health of bivalve shellfish but presents no risk to human health. The disease has already been detected in U.S. waters, but to prevent additional introduction of the disease, it is recommended that importers take specific precautions bringing live oysters into the United States from countries where OsHV-1 microvariants have been detected; principally:
- do not place oysters in U.S. waters for freshening or other purposes,
- do not discharge untreated water used to clean shipping materials or hold oysters in the environment or U.S. waters, and
- do not discard oyster remnants or shells into the environment or U.S. waters.
Under the Animal Health Protection Act (AHPA) the U.S. Secretary of Agriculture has the authority to enact measures to prevent, detect, control, and eradicate animal diseases. USDA’s Animal and Plant Health Inspection Service has evaluated the potential risks that imported shellfish may introduce OsHV-1 microvariants into U.S. domestic and wild shellfish populations and has posted their review along with additional information on the APHIS Aquatic Animal Diseases web page under “Mollusk Diseases."
FDA’s equivalence determination applies to raw bivalve molluscan shellfish, which includes live, chilled, and frozen shellfish, harvested in Spain and the Netherlands from EC-identified Class A production areas to which additional food safety control measures have been applied, i.e., the Community Guide to the Principles of Good Practice for the Microbiological Classification and Monitoring of Bivalve Mollusc Production and Relaying Areas with Regard to Regulation 854/2004 (Community Guide) and the Microbiological Monitoring of Bivalve Mollusc Harvesting Areas Guide to Good Practice: Technical Application (Technical Application Guide).
Accordingly, initially the following EU shellfish products are eligible for export to the United States:
Live, chilled and frozen shellfish harvested from eligible EC-identified Class A production areas in Spain and the Netherlands.
Note: FDA does not require a determination of equivalence for imported processed shellfish. Processed shellfish products imported from another country, including from an EU Member State, must comply with U.S. requirements, including U.S. seafood HACCP regulations (21 CFR part 123 and 1240.60), in order to be eligible for export to the United States. Processed shellfish products from EU Member States must comply with U.S. requirements, including U.S. seafood HACCP regulations (21 CFR part 123 and 1240.60), in order to be eligible for export to the United States.
The FDA equivalence determination does not cover any applicable U.S. requirements that fall outside the scope of this final equivalence determination, including the following subject areas:
- Pesticide residue tolerances;
- Veterinary drug residue tolerances;
- Food and color additive maximum levels;
- Contaminant (e.g., heavy metals, dioxins) maximum permitted levels; and
- Product labeling requirements
In addition, EU shippers must comply with any other regulatory requirements governing the importation of animal products that are implemented by other U.S. agencies.
FDA will verify compliance with requirements not covered by the equivalence determination by using the same tools FDA uses to confirm compliance for imported seafood, including:
- Inspections of foreign processing facilities;
- Sampling of seafood offered for import into the U.S.;
- Domestic surveillance sampling of imported products;
- Inspections of seafood importers;
- Evaluations of seafood import filers;
- Foreign country program assessments;
- Facilities certification under the Voluntary Qualified Importer Program; and
- Relevant information from our foreign partners and FDA overseas offices.
FDA’s determination recognizes that the EU system of food safety control measures for shellfish, along with the application of additional measures described in the Community Guide and the Technical Application Guide (the Guides), as adopted and implemented in Spain and the Netherlands, provides the same level of public health protection. Our equivalence determination is limited to product harvested from EC-identified Class A production areas to which Spain and the Netherlands have applied both the EU shellfish safety control measures and additional control measures provided in the Guides. The EC selected Spain and the Netherlands initially for assessment by FDA.
FDA will use its review of the EU system of food control measures for shellfish safety, the equivalence determination regarding Spain and the Netherlands and the application of additional control measures provided in the Community Guide and the Technical Application Guide, as a basis for evaluating additional EU Member States. FDA has provided the EC with the list of documents required for FDA’s evaluation of whether an EU Member State’s adoption and implementation of the relevant measures, including the Community Guide and Technical Application Guide, is equivalent.
As described in the Administrative Arrangement, DG SANTE will review the documents and inform FDA that, based on the information provided, the EU Member State seeking to be added to the Interstate Certified Shellfish Shippers List (ICSSL) has applied relevant EU measures, including agreed additional measures.
FDA will review the following information for each EU Member State that is seeking recognition:
- List of eligible Class A production areas;
- List of firms/processors harvesting product in those Class A production areas;
- Most recent EC audit of the EU Member State’s implementation of the EU’s measures, additional measures referenced in 4.2 of the Administrative Arrangement (i.e., DG SANTE intends to confirm that EU Member States seeking to be added to the ICSSL have applied relevant EU measures, including agreed additional measures), and the correction action taken, if any, after the audit;
- Most recent sanitary survey(s) for eligible Class A production areas;
- Most recent inspection reports for firms operating in those Class A production areas and, in case of non-compliance, the corrective actions taken, if any, after the inspection;
- List of laboratories performing official regulatory analyses of raw molluscan shellfish samples, and the last ISO 17025:2017 (or equivalent) audit report for each laboratory, including any resulting corrective actions;
- Summary description of EU Member State’s mechanisms for implementing and enforcing: EU measures applied to raw bivalve molluscan shellfish; any additional national measures adopted by the EU Member State; and application of additional agreed measures referenced in point 4.2. of the Administrative Arrangement.
FDA will evaluate promptly the EU Member State’s request and notify DG SANTE of the results of its evaluation. If the evaluation is positive, FDA will undertake its administrative process for publication in the Federal Register. If FDA recognizes an EU Member State, FDA will update the ICSSL with the names of the firms/processors submitted by the EU Member State.
While FDA retains the authority to audit at any time the shellfish food safety control measures adopted and implemented by EU Member States seeking recognition or already recognized, on-site assessments are not generally required in order to determine the equivalence of an individual EU Member State.
FDA and DG SANTE will carry out periodic on-site evaluations or audits to verify that equivalence is maintained. In addition, FDA and DG SANTE will notify each other if they are planning to adopt, modify or repeal a food safety control measure applicable to raw bivalve shellfish or make substantive changes to their molluscan shellfish safety programs so that the other authority can determine whether those measures or changes are likely to affect its equivalence determination.
In both the United States and the EU, shellfish products implicated in a foodborne illness outbreak are not compliant under applicable NSSP or EU requirements, and the growing or production areas from which the shellfish was harvested are closed. After the outbreak investigation is completed and measures have been taken to mitigate future risk, competent authorities reassess the closed growing or production area for compliance with domestic requirements.
EU Member States must report outbreaks and adverse events associated with foods distributed in commerce to the EC’s Rapid Alert System for Food and Feed (RASFF). FDA receives RASFF notifications for implicated product shipped to the United States and takes appropriate steps to control the product in domestic commerce and at the port of entry. Likewise, FDA will notify DG SANTE if U.S. shellfish exported to the EU are linked to an outbreak or an adverse event.
 The National Shellfish Sanitation Program (NSSP) is the federal/state cooperative program recognized by FDA and the Interstate Shellfish Sanitation Conference (ISSC) for the sanitary control of shellfish produced and sold for human consumption. NSSP participants refers to authorities from shellfish producing and non-producing States responsible for implementing the NSSP.
 In the United States, the term “growing area” means any site which supports or could support the propagation of shellstock by natural or artificial means. National Shellfish Sanitation Program (NSSP), Guide for the Control of Molluscan Shellfish (2017 Revision) (NSSP Guide), p. 6. “Approved” means a classification used to identify a growing area where harvest for direct marketing is allowed. NSSP Guide, p. 3.
 Commission Implementing Decision (EU) 2018/1668 of November 6, 2018 amending Annex I to Decision 2006/766/EC as regards the entry for the United States of America in the list of third countries and territories from which imports of live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods for human consumption are permitted.
These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information associated with the Interstate Shellfish Dealer’s Certificate have been approved under OMB Control No. 0910-0021. The collections of information in 21 CFR part 123 have been approved under OMB Control No. 0910-0354. Other collections of information have been approved under OMB Control No. 0910-0509.
 The EC uses the term “production area” and defines it as “any sea, estuarine or lagoon area, containing either natural beds of bivalve molluscs or sites used for the cultivation of bivalve molluscs, and from which live bivalve molluscs are taken.” Commission Regulation (EC) No. 853/2004, Annex I, 2.5 (April 29, 2004). EC-identified “Class A” production area means the production area is approved for the harvesting of shellfish for direct consumption.