[Federal Register Volume 83, Number 47 (Friday, March 9, 2018)]
[Notices]
[Pages 10487-10493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04772]



[[Page 10487]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Equivalence Determination Regarding the European Union Food 
Safety Control System for Raw Bivalve Molluscan Shellfish

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or we) is inviting 
public comment on a proposed determination that the European Union (EU) 
food safety control system for raw bivalve molluscan shellfish 
(``shellfish'') intended for export into the United States, as 
administered by the European Commission (EC), provides at least the 
same level of sanitary protection as the United States' system and is 
therefore equivalent. If finalized, this determination would permit the 
importation of shellfish harvested from certain production areas and 
processed by establishments that have been listed by FDA on the 
Interstate Certified Shellfish Shippers List (ICSSL). This notice also 
briefly describes the processes whereby other EU Member States (EUMS) 
may be approved in the future.

DATES: Comments must be received on or before May 23, 2018 to ensure 
consideration before the equivalence determination is finalized.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-0810 for ``Equivalence Determination Regarding the European 
Union Food Safety Control System for Raw Bivalve Molluscan Shellfish.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information to be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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

    FDA is responsible for protecting public health by ensuring the 
safety of our nation's food supply, including imported foods. This 
includes raw bivalve molluscan shellfish (oysters, clams, mussels, and 
roe-on and whole scallops, referred to as ``shellfish'' throughout this 
notice) imported into the United States. This notice announces and 
explains the basis for our proposed determination that the EU food 
safety control system for shellfish intended for export to the United 
States, which is currently being implemented in certain growing areas 
in the Netherlands and Spain, provides a level of sanitary protection 
equivalent to the relevant elements of the U.S. system. FDA is seeking 
comment on this proposed determination.

A. What is an equivalence determination?

    Under the 1995 World Trade Organization (WTO) Agreement on the 
Application of Sanitary and Phytosanitary Measures (SPS Agreement), WTO 
Member States are required to enter into consultation with the aim of 
achieving bilateral and multilateral agreements on recognition of the 
equivalence of specified sanitary or phytosanitary measures (SPS 
Agreement, Article 4.2) (Ref. 1). When a WTO Member State requests an 
equivalence determination from another WTO Member State, the requesting 
WTO Member State must objectively demonstrate that its measures achieve 
the other WTO Member State's

[[Page 10488]]

appropriate level of sanitary or phytosanitary protection (SPS 
Agreement, Article 4.2) (Ref. 1).
    Equivalence is evaluated by an examination of the sanitary and 
phytosanitary measures (SPS measures) in use in the country, which 
include all relevant laws, decrees, regulations, requirements and 
procedures, including end-product criteria, processes and production 
methods, testing, inspection, and certification and approval 
procedures. In addition, equivalence is evaluated by how the country 
implements those SPS measures. In this case, equivalence is evaluated 
by an examination of sanitary measures relating to shellfish safety.
    The United States implemented the SPS Agreement requirement 
relating to equivalence in section 432 of the Uruguay Round Agreements 
Act (URAA), Public Law 103-465, which amended section 492 of the Trade 
Agreements Act of 1979 (Pub. L. 96-39). Under the URAA's section 
432(a), U.S. agencies may not find foreign 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 comparable SPS measures 
established under Federal law (19 U.S.C. 2578a(a)).
    Also under the URAA, where the comparable domestic SPS measures 
corresponding to an equivalence determination are not required to be 
issued as a rule under the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) or other statute that we administer, we must publish a notice in 
the Federal Register and consider public comment before finalizing the 
equivalence determination (19 U.S.C. 2578a(c)). Once an equivalence 
determination is made final, we intend to engage in technical 
consultations and ongoing verification, including appropriate checking 
of imports, to ensure that equivalence continues to exist.

B. How are domestic and imported shellfish regulated in the United 
States?

    FDA regulates the safety of fish and fishery products, including 
shellfish, under the FD&C Act, the Public Health Service Act (PHS Act), 
and our regulations (21 CFR part 123 Fish and Fishery Products and 21 
CFR 1240.60 Molluscan Shellfish). To satisfy those regulatory 
requirements, shellfish in interstate commerce is regulated by the 
States of the United States (States or State) through the National 
Shellfish Sanitation Program (NSSP) and its Guide for the Control of 
Molluscan Shellfish (NSSP Guide) (Ref. 2), which together constitute 
the broad framework of sanitation standards adopted by each 
participating State. While the NSSP Guide functions as a model 
ordinance incorporated into State law by participating States, it is 
not itself a Federal regulation.
    The NSSP, which is authorized under section 702 of the FD&C Act (21 
U.S.C. 372) and section 311 of the PHS Act (42 U.S.C. 243), is a 
Federal-State cooperative program supported collaboratively by FDA and 
the Interstate Shellfish Sanitation Conference (ISSC). The ISSC is a 
voluntary national organization of Federal and State regulatory 
officials and the shellfish industry that is engaged in the sanitary 
control of shellfish. The ISSC provides a formal structure for State 
regulatory authorities to create legal requirements, guidelines, and 
procedures for managing the safety of shellfish intended for human 
consumption. The ISSC passed a resolution in 2011 recognizing FDA as 
the U.S. authority responsible for considering equivalence with the 
NSSP if so requested by foreign countries (Ref. 3).

C. What is the history of requests for equivalence determinations by 
the United States and the EU with respect to shellfish?

    The Veterinary Equivalency Agreement of 1998 (VEA) established a 
framework for the United States and the EU to pursue equivalence 
determinations for food of animal origin, including shellfish (Ref. 4). 
For FDA-regulated products, FDA is the competent authority for the 
United States. For the EU, the EC's Directorate-General for Health and 
Food Safety (DG SANTE, formerly known as DG SANCO), is the competent 
authority and represents EUMS with respect to equivalence 
determinations.
    In June 2008, DG SANCO formally requested that the United States 
undertake an equivalence determination under the VEA with respect to 
shellfish to allow the EU to export to the United States (Ref. 5). In 
March 2009, DG SANCO audited the U.S. food safety control system for 
shellfish, concluding that certain aspects of the U.S. control system 
were not equivalent to those in the EU (Ref. 6). As a result, in 
October 2009 the EC determined that the U.S. eligibility to ship 
shellfish to the EU would end on December 31, 2009 (this date was later 
moved to July 1, 2010). In 2010, FDA and DG SANCO agreed to engage in 
equivalence determinations and agreed on a process to evaluate one 
another's shellfish safety systems to determine whether they provide an 
equivalent level of food safety protection (Refs. 7 and 8). This 
process involved expert technical consultations, together with 
documentary and onsite evaluations and audits, conducted between 2010 
and 2016 by both the United States and the EC. This Federal Register 
notice provides the basis for FDA's proposed determination that the EU 
food safety control system for shellfish is equivalent to the NSSP. As 
a result of its own assessment of the United States' system, the EC 
also has made a determination that the United States' system is 
equivalent to its own, and as a result of that determination has stated 
its intent to accept shellfish from certain growing areas in the 
States. For information about the EC's evaluation of the U.S. food 
safety control system for shellfish, including its onsite visits to 
production and processing facilities, see Refs. 9 and 10.

II. What is FDA's proposed determination concerning the equivalence of 
the EU shellfish safety system to the system in the United States?

A. What U.S. SPS measures for shellfish did FDA compare to comparable 
EU SPS measures?

    FDA's assessment focused on whether the EU food safety control 
system for shellfish contains measures that provide the same level of 
protection as the food safety measures of the NSSP, which has 
incorporated Federal regulations specific to fish and fishery products 
(these are found at part123 and Sec.  1240.60). Thus, the NSSP, which 
is implemented and enforced by the States, 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. The NSSP provisions, similar to the incorporated 
Federal requirements, apply to both imported and domestic products 
(Ref. 2). Because of the incorporation in the NSSP of the relevant 
Federal requirements, we have determined that the NSSP standards are 
the appropriate SPS measures to use in determining whether the EC 
regulations are equivalent to U.S. shellfish safety safeguards.

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B. What was the scope and process of our assessment of the EU's food 
safety control system for shellfish?

    FDA's proposed determination of equivalence is predicated on an in-
depth evaluation of the EC's food safety controls for shellfish and 
their implementation by EUMS. FDA focused its review on Class A growing 
areas in the Netherlands and Spain, based on selections made by the EC.
    We began our consultation regarding shellfish equivalence by 
comparing sanitary measures applied by the States through the NSSP with 
those shellfish sanitary measures applied by the EUMS in accordance 
with EC legislation. This documentary review included the 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.
    For sanitary measures related to growing area controls, 
enforcement, and biotoxins, FDA technical experts determined that 
further evaluation was needed. In conducting this further review, FDA 
technical experts relied on technical consultations and observations 
from onsite evaluations, as well as appropriate data analysis and risk 
assessments. In addition to documentary review, technical 
consultations, and expert analysis, we performed onsite evaluations as 
well as appropriate data and risk assessments to verify EUMS 
implementation of the EU food safety control system for shellfish (Ref. 
11).
    The FDA expert evaluation combined both quantitative and 
qualitative considerations, such as the statistical analysis of 
shellfish meat versus water standards and the review of legal systems. 
Whether considering quantitative or qualitative factors, we relied on 
the knowledge and experience of our technical experts and their 
understanding of known or reasonably foreseeable hazards in shellfish. 
Our technical experts used their extensive scientific knowledge and 
experience with shellfish control systems to evaluate and determine 
whether different control measures were equivalent in controlling 
identified hazards.

C. What did FDA tentatively conclude based on its evaluation?

    FDA technical experts concluded, based on their extensive review of 
relevant EU measures and onsite evaluations, that the EU's food safety 
control system for shellfish provides an equivalent level of sanitary 
protection as the NSSP. Specifically, FDA technical experts concluded 
that:

     The documentary review demonstrated that most of the 
shellfish sanitary measures applied by the EUMS in accordance with EC 
legislation, including certain additional controls negotiated with FDA, 
are equivalent to the sanitary measures applied by the States through 
the NSSP (Refs. 7, 8, 11, and 12);
     EC procedures and enforcement criteria for assessing the 
safety of shellfish using shellfish meat are equivalent to the sanitary 
measures applied by the States through the NSSP, which rely on 
assessing growing water quality and classification of waters (Ref. 13); 
and
     With respect to identifying and responding to emerging 
pathogens of public health concern, including Vibrio spp., the EU food 
safety systems provide the same level of public health protection as 
U.S. systems (Ref. 14).
    In reaching these conclusions, FDA technical experts relied on 
their documentary review, technical consultations with counterparts 
with the EC, observations from onsite evaluations, as well as 
appropriate data and risk assessments, described more fully in sections 
II.E. and II.F.

D. To what growing areas and processing facilities in the EU does this 
proposed determination apply?

    This proposed determination only applies to EC Class A growing 
areas where additional controls have been implemented to satisfy 
specific U.S. food safety concerns (``Class A'' means approved for the 
harvesting of shellfish for direct consumption). For purposes of this 
notice, we use the term ``growing area,'' by which we mean any site 
which supports or could support the propagation of shellstock by 
natural or artificial means. (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'' (Regulation (EC) No 853/2004, Annex I, 2.5).) Currently, 
the only shellfish growing areas in the EU that have been determined to 
be implementing these additional controls are in the Netherlands and 
Spain. This notice describes the process whereby we may recognize 
additional EUMS growing areas and list additional EUMS processing 
facilities on the ICSSL in the future.

E. What is the basis for the FDA's tentative conclusion that procedures 
and enforcement for assessing shellfish growing area controls in the EU 
are equivalent to those in the United States?

1. Growing Area Controls
    In the United States, the microbiological quality and safety of 
shellfish is determined through extensive sanitary surveys of shellfish 
growing areas, which include microbiological testing of the water. 
Sanitary surveys are ``the written evaluation report[s] of all 
environmental factors, including actual and potential pollution 
sources, which have a bearing on the water quality in a shellfish 
growing area'' (NSSP Guide at page 9) (Ref. 2). The EC, in contrast, 
historically has determined the safety of shellfish and classified 
shellfish growing areas based on the levels of indicator bacteria found 
in shellfish meats.
    In January 2012, the EC stated that an effort was underway to 
develop a set of guidelines on how to interpret and implement EU Food 
Hygiene Regulation (EC) No. 854/2004 (basic food hygiene regulation) as 
it related to shellfish growing areas, including through the use of 
sanitary surveys. These new guidelines were contained in a document 
entitled 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). In April 2012, the EC provided the Community Guide 
to FDA for review (Refs. 5 and 15).
    The Community Guide incorporated growing area controls that 
provided for the assessment of pollution sources in sanitary surveys, 
the selection of representative monitoring points, the creation of 
sampling plans, the classification of growing areas, and ongoing 
monitoring. The EC also provided the associated Microbiological 
Monitoring of Bivalve Mollusc Harvesting Areas Guide to Good Practice: 
Technical Application (Technical Application Guide) (Ref. 16), which 
provides implementation guidance for the Community Guide. FDA technical 
experts indicated that the Community Guide and the Technical 
Application Guide (``Guides'') would be satisfactory if they included 
additional controls specific for products coming to the United States. 
To address the U.S. proposal for more detailed guidance covering 
pollution source identification and the implementation of buffer zones 
around pollution sources, FDA and the EC formed a working group. In 
September 2013, this working group

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presented annexes addressing buffer zones to be added to the Guides 
(Refs. 5, 15, and 16).
    On the basis of this consultation, and on the agreement of the EC 
to add additional provisions to the Guides, we decided that the two 
Guides provided additional controls that would, if properly 
implemented, provide the same level of public health protection as U.S. 
controls. While the EC said that these Guides would be voluntary for 
EUMS, it affirmed that it would require their application in growing 
areas that would be authorized to export shellfish to the United States 
under a finding of equivalence and that it planned ultimately to 
require the use of the Guides by EUMS, including the additional growing 
area controls (Ref. 5).
    The Community Guide specifically prescribes additional guarantees 
that shellfish exported to the United States from the EU will have to 
meet. EUMS must ensure that shellfish originate from a specifically 
listed growing area; the listed growing area will be of permanent Class 
A status; and all aspects of the guidance set out in both Guides, 
including a full sanitary survey and the buffer zone requirements, will 
have been implemented for the listed growing areas prior to export to 
the United States. The Technical Application Guide sets specific 
sampling methodologies that must be followed. FDA and the EC identified 
priority growing areas within the Netherlands and Spain that would 
implement the two Guides' provisions and form the basis for FDA's 
onsite evaluation. FDA and the EC technical experts concluded that only 
growing areas fully implementing the two Guides would be permitted to 
export shellfish to the United States as a part of the equivalence 
determination (Ref. 17).
2. Classification of Growing Areas Using Water Versus Shellfish Meat 
Testing
    In the United States, growing areas are classified as U.S. 
Approved, U.S. Conditionally Approved, U.S. Restricted, U.S. 
Conditionally Restricted, or U.S. Prohibited. Growing areas that are 
U.S. Approved include those areas where harvesting is permitted for 
direct marketing. Areas that are U.S. Conditionally Approved meet the 
criteria for the U.S. Approved classification, except under certain 
conditions (e.g., excessive rainfall) described in a management plan, 
in which case they are either closed to harvest or classified as U.S. 
Restricted. Management plans are formulated by State shellfish 
authorities and establish the criteria that must be met for growing 
areas to remain U.S. Approved (NSSP Guide, Section IV, Chapter II .05) 
(Ref. 2). Areas that are U.S. Restricted allow harvesting by special 
license only of shellstock that are subjected to a suitable and 
effective post-harvest treatment process through depuration or 
relaying. Depuration is the process of reducing pathogenic organisms 
that may be present in shellstock by using a controlled aquatic 
environment as a treatment process. Relaying means transferring 
shellstock from a growing area classified as U.S. Restricted to a 
growing area classified as U.S. Approved or U.S. Conditionally Approved 
for the purpose of reducing pathogens. Areas that are U.S. 
Conditionally Restricted are considered U.S. Restricted except under 
certain conditions described in a management plan, in which case they 
are closed to harvest. Areas that are U.S. Prohibited are closed to all 
harvest.
    In contrast to FDA's approach of classifying shellfish growing 
waters based primarily on indicator levels of microorganisms measured 
in growing waters, the EC classifies its growing areas primarily based 
on the indicator levels measured in shellfish meats. The EC separates 
shellfish growing areas into Classes A, B, and C. Class A growing areas 
are approved for the harvesting of shellfish for direct human 
consumption. Shellfish harvested from Class B and Class C growing areas 
are treated in a purification center or relayed so as to meet EU health 
standards. Shellfish from unclassified areas may not be harvested for 
human consumption (Ref. 18). Although the classification approach is 
different, both systems use complex decisional rules based on levels of 
indicator microorganisms to determine how shellfish from the growing 
area may be used.
    In September 2010, FDA provided initial results of a statistical 
analysis and model relating to the comparison of shellfish meat versus 
water testing as the means for providing assurances as to the safety of 
shellfish (Ref. 13), after which the EC provided additional 
microbiological and site information data. Following further 
statistical analysis, FDA's technical experts concluded that the EU's 
system of growing area classification provided a level of protection 
equivalent to that of the United States, as long as the shellfish was 
from EC Class A growing areas. The report of the statistical analysis, 
entitled FDA Evaluation of EU and US Microbiological Standards Used for 
Classifying Shellfish Growing Areas, concluded that, ``For comparisons 
made using E. coli [Escherichia coli] standards prescribed by the EC 
for shellfish and fecal coliform standards prescribed by the US for 
waters, no statistically significant level of disagreement can be 
established between failure and approval outcomes using EU Category A 
criteria and US Approved criteria (p >0.05). However, a statistically 
significant level of disagreement between outcomes is demonstrated for 
comparison using EU Category B criteria and US Restricted criteria (p 
<0.001)'' (Ref. 13). Based on this statistical analysis, FDA technical 
experts concluded that EC Class A growing areas were equivalent to U.S. 
Approved growing areas and that, despite different regulatory 
approaches and testing methods, restricting shellfish harvesting to EC 
Class A areas provides the same level of public health protection 
(Refs. 13 and 17).
    Following completion of the statistical analysis, the EC adopted a 
new regulation in December 2015 (Commission Regulation (EU) 2015/2285) 
(Ref. 18), establishing a new E. coli standard for molluscan shellfish 
which required further analysis to ensure the adoption of this new E. 
coli standard did not impact the conclusion that EC Class A growing 
areas are equivalent to U.S. Approved growing areas. To evaluate the 
impact of this new standard, FDA technical experts compared statistical 
assessments of the new sampling methodology and concluded that the EC's 
requirement for monitoring shellfish to maintain Class A growing area 
status remained equivalent to the U.S. standard (Ref. 19). Further, the 
EC committed to clarify requirements contained in Annex II (Additional 
Requirements for Production Areas from which Live Bivalve Molluscs are 
Harvested for Export to the USA) of the Community Guide to specify that 
``the listed production area will be of permanent Class A status with a 
minimum data set of 24 samples to establish classification.'' Based on 
this understanding, the FDA technical experts concluded that the 
revised EU E. coli standard contained in Commission Regulation (EU) 
2015/2285 (Ref. 18), in conjunction with instructions for its 
application contained in the Community Guide and the Technical 
Application Guide (Guides), provides the same level of public health 
protection between the EC Class A molluscan shellfish standard and U.S. 
Approved growing areas (Refs. 15 and 16).

[[Page 10491]]

F. What did FDA conclude regarding the EU food safety system's approach 
to marine Vibrio spp.?

    Differing approaches to control pathogenic strains of Vibrio spp. 
were identified as an area that required further analysis as to whether 
FDA's and the EU's control programs were equivalent. Specifically, 
approaches to controlling for two species of pathogenic Vibrio 
bacteria, Vibrio vulnificus (V. vulnificus) and Vibrio parahaemolyticus 
(V. parahaemolyticus), were considered. Filter feeding by shellfish can 
cause V. vulnificus and V. parahaemolyticus to concentrate in their 
tissues. Consuming raw or undercooked shellfish can lead to illness 
from these pathogens. V. vulnificus is found in estuarine environments 
throughout coastal waters of the continental United States (Ref. 20). 
Optimal temperatures for V. vulnificus growth are between 20 [deg]C to 
35 [deg]C, and therefore it appears most often in warm waters. Ninety 
percent of V. vulnificus illnesses linked to shellfish in the United 
States are associated with the consumption of raw oysters from the Gulf 
of Mexico. While illnesses associated with V. vulnificus are less 
common than other Vibrio species in shellfish, the mortality rate is 
high. V. parahaemolyticus appears in tropical and temperate coastal 
areas worldwide, including in the United States and the EU. Pathogenic 
strains of V. parahaemolyticus cause more illnesses than V. vulnificus, 
but usually result in only mild or moderately severe gastrointestinal 
symptoms (Ref. 20).
    In December 2012, the FDA and EU technical experts decided to form 
a working group to discuss differing approaches to address pathogenic 
strains of Vibrio spp. in order to determine whether their control 
programs were equivalent. Coming out of this working group, the EU's 
Centre for Environment, Fisheries & Aquaculture Science (CEFAS), as 
chair of the working group, produced a summary in April 2013 that 
discussed the occurrence of V. vulnificus and V. parahaemolyticus 
illnesses in both the United States and EU (Ref. 10). The summary 
reported that while the United States has experienced significant 
public health problems with marine Vibrios following consumption of 
products from at risk areas, currently Vibrio infection associated with 
consumption of shellfish produced in the EU was rarely documented.
    Both parties recognized that V. vulnificus poses a significant 
public health concern. As environmental conditions in the EU (e.g. 
growing water temperature) do not present the same level of risk, FDA's 
technical experts concluded that the EU is able to achieve the same or 
better public health outcomes as the U.S. system (Ref. 21).
    With regard to V. parahaemolyticus, both the United States and the 
EC recognized that the pathogen poses a growing public health concern 
and recognized the need to engage specific controls when appropriate, 
given the environmental changes that could impact growing conditions 
for this organism (Refs. 22 and 23). Given that currently Vibrio 
infection associated with consumption of shellfish produced in the EU 
was rarely documented, FDA technical experts evaluated the EU food 
safety system for identifying and responding to pathogens of growing 
public health concern and illness events, and the EU's underlying 
systems for controlling pathogens in shellfish to determine whether 
those systems offered the same level of public health protection as 
systems in use in the United States. Through this evaluation, FDA 
technical experts concluded that the EU and the United States have 
equivalent systems in place to identify and respond to emerging 
pathogens, including those involving V. parahaemolyticus (Ref. 14).
    Specifically, FDA technical experts determined that both the United 
States and EU food safety systems for shellfish are designed and 
operate to identify and control risks associated with emerging public 
health threats, including V. parahaemolyticus. While the EC does not 
currently consider V. parahaemolyticus nationally notifiable, the Rapid 
Alert System for Food and Feed (RASFF) is designed to capture adverse 
events and has included V. parahaemolyticus related notifications, 
which, to date, are from shellfish harvested outside the EU. The RASFF 
ensures that information is shared and urgent notifications are 
responded to in order to ensure food safety for consumers within and 
outside of the EU. In an event, such as a shellfish-related illness 
outbreak, the EUMS are required to report and investigate the event in 
order to take appropriate action. The evidence from RASFF alerts 
(relating to notifications of products presenting a serious health risk 
or to products tested at border entry and found to present a risk) 
indicates that Vibrio contamination of bivalve mollusc on the EU market 
is an uncommon occurrence (Ref. 14).
    In addition to the EC requiring adverse event reporting through 
RASFF, FDA technical experts concluded that the EU has significant 
controls in place to minimize exposure to hazards generally, including 
foodborne pathogens, that contribute to V. parahaemolyticus control:
     The EC mandates that EUMS have systems to ensure that 
shellfish is harvested from classified growing waters;
     It mandates additional post-harvest controls through 
mandatory HACCP systems that require business operators to identify and 
control hazards in their products before they are marketed to 
consumers; and
     Finally it mandates harvested shellfish are subject to 
tagging and labeling so that contaminated lots are identified and 
recalled rapidly (Ref. 14).
    Therefore, FDA technical experts have concluded that the EU food 
safety systems for identifying and responding to emerging pathogens and 
illness events, together with their underlying systems for controlling 
pathogens in shellfish, provide that same level of public health 
protection as the United States to identify and respond to emerging 
pathogens, including Vibrio spp.

G. What was the outcome of FDA's June 2015 onsite evaluation of the EU 
food safety control system for shellfish?

    Finally, FDA performed an onsite evaluation of the EU food safety 
control system for shellfish in June 2015 to verify EUMS implementation 
of the EU food safety system, including the additional controls 
specified in the Guides. FDA's onsite evaluation, conducted in the 
Netherlands and Spain, focused on the procedures for classifying 
shellfish growing areas; testing of shellfish growing area waters and 
shellfish meats; preventing harvest of shellfish from growing areas 
that would not meet the EC Class A or U.S. Approved criteria; assessing 
and controlling post-harvest processing, handling, labeling, and 
traceback activities; and assessing and controlling the risk from 
marine biotoxins (Ref. 11). We identified several issues regarding the 
implementation of EC controls by the competent authorities of the EUMS 
evaluated and made recommendations for corrective action. The EC and 
FDA agreed these recommended corrective actions in the Netherlands and 
Spain would be implemented before trade could commence under 
equivalence. The issues identified during our onsite evaluations, and 
our recommendations for corrective action, are summarized in our 2015 
onsite assessment report of Spain and the Netherlands (Ref. 11).

[[Page 10492]]

III. Recommended Determination of Equivalence With Conditions

    Based on the evaluation described in section II, FDA technical 
experts conclude that the EU food safety control system for shellfish 
intended for export to the United States, including implementation of 
the EC regulations, directives, and the Guides (see Refs. 12, 15, and 
16), provides at least the same level of public health protection as 
the U.S. system, as contained in the NSSP sanitation standards adopted 
and implemented as law by the States.
    While recognizing the equivalence of the food safety control 
systems for raw bivalve molluscan shellfish under the conditions 
described in this notice, and while FDA and the EC understand that 
eligibility to export under equivalence would initially apply to 
growing areas and processing facilities meeting applicable standards in 
the evaluated EUMS, FDA, and the EC also discussed and established the 
following steps for adding growing areas and processing facilities in 
the EUMS:
     EUMS seeking to export shellfish into the United States 
will notify the EC;
     The EC will confirm that the growing areas to be used for 
harvesting product intended for export to the United States have a 
Class A designation;
     The EC will confirm that the growing area controls, 
including those specified in the Guides, are in place, including 
assessment of the risk related to marine biotoxins and other hazards in 
shellfish;
     The EC will notify FDA of the EUMS notification, including 
the location of the growing areas, and the names of the shellfish 
processing facilities intending to export to the United States; and
     FDA will update the ICSSL as appropriate.
    FDA has concluded that it would evaluate exporting EUMS on a 
periodic basis as part of our routine evaluation program as is done 
under the NSSP, but would not require prior onsite evaluations before 
allowing new EUMS or growing areas to export into the United States.
    After consideration of public comment submitted in response to this 
notice, FDA will issue a final determination. FDA and the EC confirmed 
that the following subjects were excluded from the equivalence finding, 
as stated in the VEA: Food labeling requirements; food additive maximum 
levels (MLs); pesticide maximum residue limits (MRLs); drug MRLs; and 
contaminant MLs. Exported shellfish must comply with the importing 
country's requirements for these items. FDA and the EC committed to 
negotiate a bilateral equivalence arrangement that documents the 
understandings reached during the equivalence process.

IV. Additional Issues for Consideration and Comment

    FDA seeks comment on this Federal Register notice, including 
comments and any supporting data or other information, addressing 
whether this proposed equivalence determination for shellfish coming 
from the EU, subject to the limitations added by FDA, meets the 
standard that the EU measures provide at least the same level of 
sanitary protection as our domestic program's measures (19 U.S.C. 
2578a(a)).

V. References

    The following references are on display in the Dockets Management 
Staff (see ADDRESSES) 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. The WTO Agreement on the Application of Sanitary and 
Phytosanitary Measures (SPS Agreement), World Trade Organization 
(WTO), 1995. Accessed online at https://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm.
2. National Shellfish Sanitation Program (NSSP) Guide for the 
Control of Molluscan Shellfish. Food and Drug Administration and 
Interstate Shellfish Sanitation Conference. 2007 through 2015 
revisions. Accessed online at https://www.fda.gov/food/guidanceregulation/federalstatefoodprograms/ucm2006754.htm.
3. Guidance on Equivalence Criteria for Food, Interstate Shellfish 
Sanitation Conference Resolution 11-003, at p. 376 in National 
Shellfish Sanitation Program (NSSP) Guide for the Control of 
Molluscan Shellfish. Food and Drug Administration and Interstate 
Shellfish Sanitation Conference. 2011 Revision. Accessed online at 
https://www.fda.gov/food/guidanceregulation/federalstatefoodprograms/ucm2006754.htm.
4. Veterinary Equivalency Agreement of 1998. Accessed online at 
https://trade.ec.europa.eu/doclib/docs/2003/october/tradoc_111716.pdf.
5. EU-U.S. Molluscan Shellfish Project Major Event Timeline. Food 
and Drug Administration. 2016.
6. Final Report of a Mission Carried Out in the United States From 
02 March to 16 March 2009 in Order to Evaluate the Control Systems 
in Place Governing the Production of Bivalve Molluscs Intended for 
Export to the European Union. European Commission, Health & 
Consumers Directorate-General, Directorate F--Food and Veterinary 
Office. DG (SANCO)/2009-8055-MR--FINAL.
7. Meeting Summary and Attachments from the U.S.-EU Molluscan 
Shellfish Equivalence Project. January 27-28, 2010. Brussels, 
Belgium.
8. Meeting Summary and Attachments from the U.S.-EU Molluscan 
Shellfish Equivalence Project. September 21-22, 2010. College Park, 
MD.
9. Final Report of an Audit Carried Out in the United States from 17 
March 2015 to 27 March 2015 in Order to Evaluate the Control Systems 
in Place Governing the Production of Bivalve Molluscs and Fishery 
Products Derived Therefrom Intended for Export to the European 
Union. European Commission, Directorate-General for Health and Food 
Safety, Directorate F--Food and Veterinary Office. December 2015. 
Accessed online at http://ec.europa.eu/food/audits-analysis/audit_reports/details.cfm?rep_id=3585.
10. Marine vibrio's--Summary of Food Safety Concerns Regarding Trade 
of Bivalve Molluscs from USA to EU. The Center for Environment, 
Fisheries & Aquaculture Science (CEFAS). April 2013. Accessed online 
at https://eurlcefas.org/media/13641/ws12_13.pdf.
11. EU-U.S. Molluscan Shellfish Equivalence Project Report of the 
U.S. Food and Drug Administration's On-site Assessment of Spain and 
the Netherlands, 15 June-26 June, 2015. FDA. December 9, 2015.
12. Comparison Chart of FDA-NSSP-EC Provisions That Achieve the Same 
Shellfish Safety Outcomes. FDA, Center for Food Safety and Applied 
Nutrition. 2016.
13. FDA Evaluation of EU and U.S. Microbiological Standards Used for 
Classifying Shellfish Growing Areas. Food and Drug Administration. 
February 2011.
14. FDA Technical Memo to File on EU safety systems for identifying 
and responding to emerging pathogens and illness events associated 
with shellfish. Food and Drug Administration. November 8, 2017.
15. 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://eurlcefas.org/media/13972/cg_issue-3_final-170117.pdf.
16. Microbiological Monitoring of Bivalve Mollusc Harvesting Areas 
Guide to Good Practice: Technical Application. 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://eurlcefas.org/media/13973/gpg_issue-6-fianl-170117.pdf.

[[Page 10493]]

17. Meeting Summary and Attachment from the U.S.-EU Bivalve 
Molluscan Shellfish Equivalence Project. November 19-20, 2015. FDA 
Hillandale Building, Silver Spring, MD.
18. Commission Regulation (EU) 2015/2285 of 8 December 2015 Amending 
Annex II to Regulation (EC) No. 854/2004 of the European Parliament. 
Accessed online at http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32015R2285&from=EN.
19. Meeting Summary and Attachment from the U.S.-EU Bivalve 
Molluscan Shellfish Equivalence Project. September 19-20, 2016. FDA 
Center for Food Safety and Applied Nutrition, College Park, MD.
20. Bad Bug Book, Foodborne Pathogenic Microorganisms and Natural 
Toxins. Second Edition. FDA. 2012. Accessed online at https://www.fda.gov/food/foodborneillnesscontaminants/causesofillnessbadbugbook/.
21. Risk Assessment of Vibrio vulnificus in Raw Oysters, 
Interpretive Summary and Technical Report. World Health 
Organization/Food and Agriculture Organization of the United 
Nations. 2005. Accessed online at http://www.who.int/foodsafety/publications/micro/mra8.pdf.
22. Meeting Summary and Attachments from the U.S.-EU Molluscan 
Shellfish Equivalence Project. September 5-6, 2013. FDA White Oak 
Campus, Silver Spring, MD.
23. On-going Activities on Emerging Risks in the SCER Unit. 
Presentation at European Food Safety Authority (EFSA) 56th Advisory 
Forum Meeting. June 11-12, 2015. Accessed online at https://www.efsa.europa.eu/sites/default/files/assets/af150611a-p9d.pdf.


    Dated: March 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04772 Filed 3-8-18; 8:45 am]
 BILLING CODE 4164-01-P