[Federal Register Volume 85, Number 186 (Thursday, September 24, 2020)]
[Notices]
[Pages 60172-60175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20755]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0810]


Food and Drug Administration Equivalence Determination Regarding 
Implementation by Spain and the Netherlands of the European Union 
System of Food Safety Control Measures for Raw Bivalve Molluscan 
Shellfish With Additional Controls

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing a 
final determination that the adoption and implementation by Spain and 
the Netherlands of the European Union's (EU's) system of food safety 
control measures for raw bivalve molluscan shellfish (``shellfish''), 
along with their application of additional measures specifically 
adopted for this purpose, i.e., for export to the United States, 
provides at least the same level of sanitary protection as comparable 
food safety measures in the United States and is therefore equivalent. 
This final equivalence determination will permit the importation of raw 
shellfish harvested from certain production areas in Spain and the 
Netherlands from establishments that have been listed by FDA on the 
Interstate Certified Shellfish Shippers List (ICSSL).

DATES: The determination becomes final on September 24, 2020.

FOR FURTHER INFORMATION CONTACT: Melissa Abbott, Center for Food Safety 
and Applied Nutrition (HFS-325), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-1401; or Robert Tuverson, 
Center for Food Safety and Applied Nutrition (HFS-550), Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1586.

SUPPLEMENTARY INFORMATION:

I. Background

A. Introduction

    FDA is responsible for protecting public health by ensuring, among 
other things, the safety of our nation's food supply, including 
imported foods. This includes raw bivalve molluscan shellfish (oysters, 
clams, mussels, roe-on scallops, and whole scallops, referred to as 
``shellfish'' throughout this notice) imported into the United States. 
In the Federal Register of March 9, 2018 (83 FR 10487), we published a 
notice that announced and explained the basis for our proposed 
equivalence determination that the EU system of food safety control 
measures for shellfish, along with the application of additional 
measures specifically adopted for this purpose, i.e., for export to the 
United States, as adopted and implemented in Spain and the Netherlands, 
provides at least a level of sanitary protection as comparable food 
safety measures in the United States. This notice announces that, after 
considering comments we received on the proposed equivalence 
determination, we are finalizing the equivalence determination as 
proposed, except that we are narrowing the scope of this final 
equivalence determination so that it only encompasses two EU Member 
States, Spain and the Netherlands. FDA will use this determination as a 
basis to evaluate additional EU Member States that adopt and implement 
these measures.
    In the future, we will evaluate and recognize as equivalent, as 
appropriate, other EU Member States in separate determinations. In 
addition, we further clarify and explain our basis for the final 
equivalence determination in response to the comments. We note that, in 
the March 9, 2018, notice, we used both ``production area'' and 
``growing area'' in referring to beds or sites that support or could 
support the propagation of bivalve molluscan shellfish. For purposes of 
this notice, we continue to use the same terminology.

B. Basis for Equivalence Determination

    Under section 432 of the Uruguay Round Agreements Act (URAA), 
Public Law 103-465, U.S. Agencies may not find foreign sanitary and 
phytosanitary measures (SPS measures) equivalent to comparable SPS 
measures in the United States unless the Agency determines that the 
foreign measures provide at least the same level of sanitary or 
phytosanitary protection as the

[[Page 60173]]

comparable SPS measures established under Federal law (19 U.S.C. 
2578a(a)). The URAA also provides that FDA publish a notice in the 
Federal Register and consider public comment before finalizing an 
equivalence determination when the determination is based on domestic 
SPS measures that FDA is not required to issue as a rule under the 
Federal Food, Drug, and Cosmetic Act or other statute we administer (19 
U.S.C. 2578a(c)). In accordance with these procedures specified in the 
URAA, we are finalizing this equivalence determination.
    As explained in the March 9, 2018, notice, our equivalence 
assessment focused on whether the EU's food safety control measures for 
shellfish, along with the application of additional measures 
specifically required for export to the United States, which have been 
adopted and implemented by Spain and the Netherlands, provide at least 
the same level of sanitary protection as comparable food safety 
measures in the United States applied through the National Shellfish 
Sanitation Program (NSSP) (83 FR 10487 at 10488). The NSSP is a 
Federal-State cooperative program that provides a broad framework of 
shellfish sanitation standards through its ``Guide for the Control of 
Molluscan Shellfish'' (NSSP Guide) (Ref. 1). The NSSP Guide functions 
as a model ordinance incorporated into State law by participating 
States but is not itself a Federal regulation. The NSSP Guide 
incorporates Federal regulations specific to fish and fishery products, 
which are found at part 123 (21 CFR part 123) and Sec.  1240.60 (21 CFR 
1240.60). We explained in the March 9, 2018, notice that the NSSP, 
which governs how U.S. growing areas are managed and classified for 
shellfish harvest, is implemented and enforced by U.S. States, and 
contains within it all relevant Federal requirements concerning, among 
other things, current good manufacturing practices, hazard analysis and 
Hazard Analysis Critical Control Point (HACCP) plans, recordkeeping, 
sanitation control procedures, and the restriction of interstate 
transport of shellfish in an insanitary manner (83 FR 10487 at 10488). 
Because the NSSP incorporates relevant Federal food safety measures, we 
determined that the NSSP standards are the appropriate SPS measures to 
use in determining whether the EU's food safety control measures for 
shellfish, along with the application of additional measures 
specifically adopted for export to the United States, which have been 
adopted and implemented by Spain and the Netherlands, are equivalent to 
comparable U.S. food safety control measures.
    We also explained in the March 9, 2018, notice the process by which 
we conducted our equivalence assessment (83 FR 10487 at 10489). In the 
EU, the European Commission (EC) establishes food safety measures that 
the EU Member States adopt and implement. Our proposed determination 
was predicated on an indepth evaluation of the EC and certain Member 
States' regulatory approach, including a comprehensive document review, 
technical consultations, expert analysis, and onsite evaluations in 
Spain and the Netherlands to verify their adoption and implementation 
of relevant EU measures (id.).
    In the course of our assessment, FDA's technical experts identified 
sanitary measures in the EU system that differed from those in the U.S. 
regulatory approach and determined that further evaluation was needed. 
As explained in our March 9, 2018, notice, our technical experts 
completed indepth quantitative and qualitative analyses and determined 
that in most areas, despite differing regulatory approaches of certain 
sanitary measures, such measures provided at least the same level of 
sanitary protection as comparable food safety measures in the United 
States. However, FDA's technical experts identified some gaps in the 
EU's system of control measures that provided less sanitary protection 
than is provided by U.S. measures. To address these gaps, the EC 
amended and re-issued two Guides to include additional controls that EU 
Member States must adopt and implement in Class A growing areas to 
achieve equivalence with the U.S. system of food safety measures: 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) (Ref. 2); and the ``Microbiological Monitoring of 
Bivalve Mollusc Harvesting Areas Guide to Good Practice: Technical 
Application'' (Technical Application Guide) (Ref. 3). The Community 
Guide specifically prescribes additional controls that EU Member States 
exporting shellfish to the United States will have to adopt and 
implement, while the Technical Application Guide sets specific sampling 
methodologies that must be followed as part of implementation. For 
purposes of FDA's equivalence evaluation, the EC-identified Class A 
production areas within Spain and the Netherlands where the EU food 
safety control measures and the additional controls in the Community 
Guide and the Technical Application Guide (Guides) are being applied. 
(Class ``A'' is an EU shellfish production area from which live bivalve 
molluscs may be harvested for direct human consumption.) (Ref. 5)
    We note that since the publication of our proposed equivalence 
determination the EU has implemented two new regulations for official 
food and feed controls. These new regulations reorganize and 
incorporate several existing laws into a comprehensive regulation for 
the safe handling of food and feed. However, the EU's regulatory 
amendments do not change our determination of equivalence. 
Specifically, Regulation (EU) 2017/625, applicable as of December 14, 
2019, repeals and replaces Regulations (EC) No 854/2004 and (EC) No 
882/2004, which FDA previously identified and assessed as part of our 
proposed shellfish equivalence determination (Ref. 4). Relatedly, the 
EU also adopted Regulation (EU) 2019/627, which harmonizes procedures 
to verify compliance with the rules set forth in Regulation (EU) 2017/
625 and related EU legislation for the safe handling of products of 
animal origin. Regulation (EU) 2019/627, applicable as of December 14, 
2019, repeals and replaces procedures formerly contained within 
Regulation (EC) No 854/2004 (Ref. 5). Importantly, FDA has reviewed 
Regulations (EU) 2017/625 and (EU) 2019/627 and has confirmed that 
there is no impact on FDA's technical findings that support this final 
shellfish equivalence determination because the new regulations include 
the relevant controls from Regulations (EC) No 854/2004 and (EC) No 
882/2004 that were the basis of FDA's technical evaluation for the 
proposed equivalence determination. Since the relevant controls of 
Regulation (EU) 2017/625 and (EU) 2019/627 are now being applied as of 
December 14, 2019, this final equivalence determination cites to these 
new regulations instead of Regulations (EC) No 854/2004 and (EC) No 
882/2004, among other applicable requirements that have not changed, 
when describing EU food safety control measures for shellfish.
    Based on our extensive review of relevant EU measures, the adoption 
and implementation by Spain and the Netherlands of those measures with 
additional controls contained in the Guides, and onsite evaluations in 
Spain and the Netherlands, we conclude that EU food safety control 
measures for raw bivalve shellfish, along with the Guides, when 
successfully adopted and

[[Page 60174]]

implemented, provide at least the same level of sanitary protection as 
comparable food safety measures in the United States, as contained in 
the NSSP; currently these controls have been adopted and implemented in 
certain production areas in Spain and the Netherlands. Therefore, we 
are finalizing our equivalence determination for EC-identified Class A 
production areas in Spain and the Netherlands.
    After considering comments received on the proposed equivalence 
determination, as discussed in section C, the scope of this final 
equivalence determination only encompasses two EU Member States, Spain 
and the Netherlands. We will evaluate and recognize as equivalent, as 
appropriate, other EU Member States in the future in separate 
determinations. In addition, the scope of the final equivalence 
determination applies to raw bivalve molluscan shellfish harvested from 
EC-identified Class A production areas in the EU where additional 
controls specified in the Guides have been adopted and implemented, and 
then verified by competent authorities, which currently applies only to 
raw bivalve shellfish harvested from EC-identified Class A production 
areas in Spain and the Netherlands. To ensure that equivalence is 
maintained, FDA intends to engage in technical consultations with 
relevant competent authorities, conduct surveillance of imported 
product, and perform audits of EU Member States, as appropriate.
    As a result of this determination, only raw bivalve shellfish 
harvested from EC-identified Class A production areas in Spain and the 
Netherlands are eligible to be exported to the United States at this 
time. Shippers of shellfish harvested from these areas must be listed 
on the ICSSL before they are permitted to export product to the United 
States (Refs. 6 and 7).
    Additionally, certain sanitary measures are not covered by the 
scope of our equivalence determination. For example, measures related 
to food and color additives, processing aids, flavors, pesticide and 
chemical residues, animal drug residues, physical contaminants, and 
labeling (including nutrition labeling) are not part of this 
equivalence determination pertaining to raw bivalve molluscan shellfish 
because the equivalence evaluation did not include these measures and 
because these measures are excluded from the Agreement between the 
United States of America and the European Community on Sanitary 
Measures to Protect Public and Animal Health in Trade in Live Animals 
and Animal Products (Ref. 8). For measures not covered by the scope of 
our equivalence determination, raw bivalve shellfish exported from EC-
identified Class A production areas in Spain and the Netherlands to the 
United States, must comply with applicable U.S. requirements.

C. Consideration of Comments Received

    In the March 9, 2018, notice, we gave interested parties an 
opportunity to submit comments and any supporting information by May 
23, 2018. We received approximately 25 comments. Most comments 
generally supported the proposed equivalence determination and did not 
take specific issue with the technical basis for our conclusion that 
the EU system of food safety control measures for shellfish, along with 
the application of additional measures specifically adopted for this 
purpose, i.e., for export to the United States, as adopted and 
implemented in Spain and the Netherlands, provides at least a level of 
sanitary protection as comparable food safety measures in the United 
States. Several comments questioned the procedural steps by which FDA 
reached the proposed equivalence determination, the respective roles of 
the EC and competent authorities in Spain and the Netherlands, and the 
process FDA will follow when considering additional EU Member States in 
the future. Some comments asked about whether processed shellfish are 
included in the present determination.
    Other comments pertained to the EC's equivalence determination of 
the U.S. system of food safety control measures for shellfish, the 
process the EC will follow for assessing additional U.S. States, the 
classification of growing areas eligible for export, and other matters 
associated with the export of shellfish from the United States to the 
EU. These comments are outside the scope of this equivalence 
determination.
    One comment questioned whether importing live bivalve molluscan 
shellfish from the EU would present an animal disease risk for native 
U.S. shellfish wild stocks. Animal disease risks are beyond the scope 
of this equivalence determination, which is based on an assessment of 
safety for human consumption. Importers of raw molluscan shellfish must 
also comply with any applicable U.S. requirements that fall outside the 
scope of this final equivalence determination, including any regulatory 
requirements governing the importation of animal products that are 
implemented by other U.S. Agencies.

D. Clarifications

    In response to comments to the March 9, 2018, notice regarding our 
proposed equivalence determination, we make the following 
clarifications. On the respective roles and authority of the EC and 
competent authorities in the individual EU Member States (including 
Spain and the Netherlands) in the equivalence determination process, we 
note that the EC is responsible for establishing harmonized food safety 
measures that the EU Member States adopt and implement. The EC audits 
EU Member States to ensure that they have adopted and are implementing 
harmonized measures, and competent authorities in the EU Member States 
provide oversight of food business operators to enforce compliance with 
the measures. The scope of this equivalence determination applies to EC 
measures for raw bivalve molluscan shellfish in EC-identified Class A 
production areas and implementation of additional controls in the 
Guides, as adopted and implemented by Spain and the Netherlands. We did 
not include processed shellfish in this equivalence determination 
because we currently permit the importation of processed shellfish that 
comply with U.S. seafood HACCP regulations (part 123 and Sec.  1240.60) 
from all EU Member States. This determination does not extend to the 
implementation of EU food safety control measures for shellfish by 
other EU Member States. We have revised the title of this notice and 
the scope of our final equivalence determination to clarify this point. 
In summary, we have determined that the adoption and implementation by 
Spain and the Netherlands of the EU's system of food safety control 
measures for shellfish, along with their application of additional 
control measures provided in the Guides, is equivalent to the 
comparable U.S. measures because the adoption and implementation by 
Spain and the Netherlands of the EU measures and additional controls 
achieves at least the same level of sanitary protection as comparable 
food safety measures in the United States.
    On the matter of recognizing additional EU Member States in the 
future, we stated in the March 9, 2018, notice that we would update the 
ICSSL with the names of the establishments in recognized EU Member 
States intending to export to the United States (83 FR 10487 at 10492). 
In order for FDA to recognize additional EU Member States as 
equivalent, the competent authority in the EU Member State would need 
to demonstrate that it has adopted and implemented EU shellfish safety 
control

[[Page 60175]]

measures, along with the additional control measures provided in the 
Guides. The process for seeking such recognition is identified in the 
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 (Ref. 9). In the future, FDA will publish in the Federal 
Register any proposal to recognize additional EU Member States as 
equivalent and accept comments on the proposal before finalizing the 
Agency's determination.
    Regarding the maintenance of equivalence, both FDA and the EC will 
carry out periodic onsite evaluations or audits to ensure that 
equivalence is maintained. In addition, the EC will notify FDA of any 
plan to adopt, modify or repeal a food safety control measure 
applicable to molluscan shellfish so that FDA can determine whether the 
new, modified or repealed measure affects its equivalence determination 
(Ref. 9).
    After considering the comments, we are finalizing the equivalence 
determination for Spain and the Netherlands.

II. Equivalence Determination

    We are announcing that we recognize the adoption and implementation 
by Spain and the Netherlands of the EU system of food safety control 
measures for raw bivalve molluscan shellfish, along with their 
application of additional control measures described in the Guides, as 
equivalent because the adoption and implementation of these measures by 
Spain and the Netherlands provide at least the same level of sanitary 
protection as comparable food safety measures in the United States (19 
U.S.C. 2578a(a)).
    Because FDA recognizes these control measures have been 
successfully adopted and implemented by Spain and the Netherlands, this 
final equivalence determination allows FDA, the competent authorities 
in Spain and the Netherlands, and the EC to implement procedures for 
resuming trade in accordance with the final equivalence determination. 
For the export of raw bivalve shellfish from Spain and the Netherlands 
to the United States, these procedures include the subsequent listing 
of eligible establishments in Spain and the Netherlands on the ICSSL 
once the EC has been notified of our final equivalence determination.

III. References

    The following references are on display at the Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

1. National Shellfish Sanitation Program (NSSP) Guide for the 
Control of Molluscan Shellfish. Food and Drug Administration and 
Interstate Shellfish Sanitation Conference. 2007 through 2017 
revisions (web page last updated October 2018). Accessed online at 
https://www.fda.gov/food/guidanceregulation/federalstatefoodprograms/ucm2006754.htm.
2. ``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.'' 
European Commission. June 2012, updated January 2014 and January 
2017. Accessed online at https://ec.europa.eu/food/sites/food/files/safety/docs/biosafety_fh_guidance_community_guide_bivalve_mollusc_monitoring_en.pdf.
3. ``Microbiological Monitoring of Bivalve Mollusc Harvesting Areas 
Guide to Good Practice: Technical Application (Technical Application 
Guide).'' EU Working Group on the Microbiological Monitoring of 
Bivalve Mollusc Harvesting Areas. Issue 4, August 2010, updated June 
2014 (Issue 5) and January 2017 (Issue 6). Accessed online at 
https://www.cefas.co.uk/media/jyzhl1si/good-practice-guide-issue-6.pdf.
4. Regulation (EU) 2017/625 of the European Parliament and of the 
Council of 15 March 2017 repeals Regulations (EC) No 854/2004 and 
(EC) No 882/2004. Accessed online at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0625&from=EN.
5. Commission Implementing Regulation (EU) 2019/627 of 15 March 
2019, lays down uniform practical arrangements for the performance 
of official controls on products of animal origin intended for human 
consumption in accordance with Regulation (EU) 2017/625 of the 
European Parliament and of the Council and amending Commission 
Regulation (EC) No 2074/2005 as regards official controls. Accessed 
online at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019R0627&from=EN.
6. National Shellfish Sanitation Program (NSSP) Guide for the 
Control of Molluscan Shellfish. Food and Drug Administration and 
Interstate Shellfish Sanitation Conference. 2007 through 2017 
revisions (web page last updated October 2018). See Section II, 
Chapter 1 @.02, page 13 and Section IV, Chapter III, .03, page 363. 
Accessed online at https://www.fda.gov/food/guidanceregulation/federalstatefoodprograms/ucm2006754.htm.
7. Meeting Summary and Attachment from the U.S.-EU Bivalve Molluscan 
Shellfish Equivalence Project. November 19 to 20, 2015. FDA 
Hillandale Building, Silver Spring, MD.
8. Agreement between the United States of America and the European 
Community on Sanitary Measures to Protect Public and Animal Health 
in Trade in Live Animals and Animal Products dated July 20, 1999.
9. 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.

    Dated: September 16, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-20755 Filed 9-23-20; 8:45 am]
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