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

Federal Register / Vol. 83, No. 47 / Friday, March 9, 2018 / Notices
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.

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:
SUMMARY:

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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://
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the docket unchanged. Because your
comment will be made public, you are
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information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.

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• 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
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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

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FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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

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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

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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).

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.

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 DirectorateGeneral 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

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

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

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
§ 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 indepth 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

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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.

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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

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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

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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).

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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 °C to
35 °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

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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 shellfishrelated 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

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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).

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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

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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/federalstate
foodprograms/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/federalstate
foodprograms/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

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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_final170117.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.

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Federal Register / Vol. 83, No. 47 / Friday, March 9, 2018 / Notices
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.

Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments’’ that appeared in
the Federal Register of February 22,
2018. The document was published
with the incorrect docket number. This
document corrects that error.
FOR FURTHER INFORMATION CONTACT: Lisa
Granger, Office of Policy and Planning,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, Rm.
3330, Silver Spring, MD 20993–0002,
301–796–9115.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Thursday, February
22, 2018 (83 FR 7727), in FR Doc. 2018–
03603, on page 7727, the following
correction is made:
1. On page 7727, in the first column,
in the header of the document, the
docket number is corrected to read
‘‘FDA–2018–N–0410.’’
Dated: March 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–04774 Filed 3–8–18; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–P–5946]

Determination That DORYX MPC
(Doxycycline Hyclate), DelayedRelease Tablets, 60 Milligrams, Were
Not Withdrawn From Sale for Reasons
of Safety or Effectiveness
AGENCY:

Food and Drug Administration,

HHS.

[FR Doc. 2018–04772 Filed 3–8–18; 8:45 am]

ACTION:

BILLING CODE 4164–01–P

Notice.

The Food and Drug
Administration (FDA or Agency) has
determined that DORYX MPC
(doxycycline hyclate), delayed-release
tablets, 60 milligrams (mg), were not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for DORYX MPC
(doxycycline hyclate), delayed-release
tablets, 60 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Aaron Young, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6217,
Silver Spring, MD 20993–0002, 301–
796–8083.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
SUMMARY:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0410]

Peripheral and Central Nervous
System Drugs Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments;
Correction
AGENCY:

Food and Drug Administration,

amozie on DSK30RV082PROD with NOTICES

HHS.
Notice; establishment of a
public docket; request for comments;
correction.

ACTION:

The Food and Drug
Administration is correcting a notice
entitled ‘‘Peripheral and Central
Nervous System Drugs Advisory

SUMMARY:

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Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (§ 314.162 (21
CFR 314.162)).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
DORYX MPC (doxycycline hyclate),
delayed-release tablets, 60 mg, are the
subject of NDA 50–795, held by Mayne
Pharma International Pty Ltd., and
initially approved on May 6, 2005.
DORYX MPC is indicated for rickettsial
infections; sexually transmitted
infections; respiratory tract infections;
specific bacterial infections; ophthalmic
infections; anthrax, including
inhalational anthrax (post-exposure);
alternative treatment for selected
infections when penicillin is
contraindicated; adjunctive therapy in
acute intestinal amebiasis and severe
acne; and prophylaxis of malaria.
Mayne Pharma International Pty Ltd.
has never marketed DORYX MPC
(doxycycline hyclate), delayed-release
tablets, 60 mg. In previous instances
(see, e.g., 72 FR 9763 (March 5, 2007)
and 61 FR 25497 (May 21, 1996)), the
Agency has determined that, for

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