Food and Drug Administration Equivalence Determination Regarding Implementation by Spain and the Netherlands of the European Union System of Food Safety Control Measures for Raw Bivalve Molluscan Shellfish With Additional Controls, 60172-60175 [2020-20755]
Download as PDF
<![CDATA[
60172
Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices
a beneficiary currently purchasing
Medicare premium Part A coverage, is
receiving retirement payments based on
State or local government employment,
how long the claimant worked for the
State or local government employer, and
whether the former employer or pension
plan is subsidizing the individual’s Part
A premium.
Form CMS–R–285 provides the
necessary information regarding the
prior state or local government
employment to process the individual’s
request for premium Part A reduction
based on their employment by a state or
local government.
The form is completed by the state or
local government employer on behalf of
the individual seeking the Medicare
premium reduction. The SSA—CMS’
agent for processing Medicare
enrollments and premium amount
determinations will use this information
to help determine whether a beneficiary
meets the requirements for reduction of
the Part A premium. The form is owned
by CMS but not completed by CMS staff.
Form Number: CMS–R–285 (OMB
control number: 0938–0769); Frequency:
Yearly; Affected Public: State, Local, or
Tribal Governments; Number of
Respondents: 500; Total Annual
Responses: 500; Total Annual Hours:
125. (For policy questions regarding this
collection contact Carla Patterson at
410–786–1000.)
4. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Certification
Statement for Electronic File
Interchange Organizations (EFIOs) that
submit National Provider Identifier
(NPI) data to the National Plan and
Provider Enumeration System (NPPES);
Use: The EFI process allows
organizations to submit NPI application
information on large numbers of
providers in a single file. Once it has
obtained and formatted the necessary
provider data, the EFIO can
electronically submit the file to NPPES
for processing. As each file can contain
up to approximately 25,000 records, or
provider applications, the EFI process
greatly reduces the paperwork and
overall administrative burden associated
with enumerating providers. It is
essential to collect this information from
the EFIO to ensure that the EFIO
understands its legal responsibilities as
an EFIO and attests that it has the
authority to act on behalf of the
providers for whom it is submitting
data. In short, the certification
statement, which must be signed by an
authorized official of the EFIO, serves as
a safeguard against EFIOs attempting to
obtain NPIs for illicit or inappropriate
VerDate Sep<11>2014
17:00 Sep 23, 2020
Jkt 250001
purposes. Form Number: CMS–10175
(OMB control number 0938–0984);
Frequency: Once, Annually; Affected
Public: Private Sector, State, Business,
and Not-for Profits; Number of
Respondents: 32; Number of Responses:
32; Total Annual Hours: 8. For
questions regarding this collection
contact DaVona Boyd at 410–786–7483.
Dated: September 21, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–21095 Filed 9–23–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0810]
Food and Drug Administration
Equivalence Determination Regarding
Implementation by Spain and the
Netherlands of the European Union
System of Food Safety Control
Measures for Raw Bivalve Molluscan
Shellfish With Additional Controls
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing a final determination that
the adoption and implementation by
Spain and the Netherlands of the
European Union’s (EU’s) system of food
safety control measures for raw bivalve
molluscan shellfish (‘‘shellfish’’), along
with their application of additional
measures specifically adopted for this
purpose, i.e., for export to the United
States, provides at least the same level
of sanitary protection as comparable
food safety measures in the United
States and is therefore equivalent. This
final equivalence determination will
permit the importation of raw shellfish
harvested from certain production areas
in Spain and the Netherlands from
establishments that have been listed by
FDA on the Interstate Certified Shellfish
Shippers List (ICSSL).
DATES: The determination becomes final
on September 24, 2020.
FOR FURTHER INFORMATION CONTACT:
Melissa Abbott, Center for Food Safety
and Applied Nutrition (HFS–325), Food
and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240–402–
1401; or Robert Tuverson, Center for
Food Safety and Applied Nutrition
(HFS–550), Food and Drug
SUMMARY:
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–1586.
SUPPLEMENTARY INFORMATION:
I. Background
A. Introduction
FDA is responsible for protecting
public health by ensuring, among other
things, the safety of our nation’s food
supply, including imported foods. This
includes raw bivalve molluscan
shellfish (oysters, clams, mussels, roeon scallops, and whole scallops,
referred to as ‘‘shellfish’’ throughout
this notice) imported into the United
States. In the Federal Register of March
9, 2018 (83 FR 10487), we published a
notice that announced and explained
the basis for our proposed equivalence
determination that the EU system of
food safety control measures for
shellfish, along with the application of
additional measures specifically
adopted for this purpose, i.e., for export
to the United States, as adopted and
implemented in Spain and the
Netherlands, provides at least a level of
sanitary protection as comparable food
safety measures in the United States.
This notice announces that, after
considering comments we received on
the proposed equivalence
determination, we are finalizing the
equivalence determination as proposed,
except that we are narrowing the scope
of this final equivalence determination
so that it only encompasses two EU
Member States, Spain and the
Netherlands. FDA will use this
determination as a basis to evaluate
additional EU Member States that adopt
and implement these measures.
In the future, we will evaluate and
recognize as equivalent, as appropriate,
other EU Member States in separate
determinations. In addition, we further
clarify and explain our basis for the
final equivalence determination in
response to the comments. We note that,
in the March 9, 2018, notice, we used
both ‘‘production area’’ and ‘‘growing
area’’ in referring to beds or sites that
support or could support the
propagation of bivalve molluscan
shellfish. For purposes of this notice, we
continue to use the same terminology.
B. Basis for Equivalence Determination
Under section 432 of the Uruguay
Round Agreements Act (URAA), Public
Law 103–465, U.S. Agencies may not
find foreign sanitary and phytosanitary
measures (SPS measures) equivalent to
comparable SPS measures in the United
States unless the Agency determines
that the foreign measures provide at
least the same level of sanitary or
phytosanitary protection as the
E:\FR\FM\24SEN1.SGM
24SEN1
Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices
comparable SPS measures established
under Federal law (19 U.S.C. 2578a(a)).
The URAA also provides that FDA
publish a notice in the Federal Register
and consider public comment before
finalizing an equivalence determination
when the determination is based on
domestic SPS measures that FDA is not
required to issue as a rule under the
Federal Food, Drug, and Cosmetic Act
or other statute we administer (19 U.S.C.
2578a(c)). In accordance with these
procedures specified in the URAA, we
are finalizing this equivalence
determination.
As explained in the March 9, 2018,
notice, our equivalence assessment
focused on whether the EU’s food safety
control measures for shellfish, along
with the application of additional
measures specifically required for
export to the United States, which have
been adopted and implemented by
Spain and the Netherlands, provide at
least the same level of sanitary
protection as comparable food safety
measures in the United States applied
through the National Shellfish
Sanitation Program (NSSP) (83 FR
10487 at 10488). The NSSP is a FederalState cooperative program that provides
a broad framework of shellfish
sanitation standards through its ‘‘Guide
for the Control of Molluscan Shellfish’’
(NSSP Guide) (Ref. 1). The NSSP Guide
functions as a model ordinance
incorporated into State law by
participating States but is not itself a
Federal regulation. The NSSP Guide
incorporates Federal regulations specific
to fish and fishery products, which are
found at part 123 (21 CFR part 123) and
§ 1240.60 (21 CFR 1240.60). We
explained in the March 9, 2018, notice
that the NSSP, which governs how U.S.
growing areas are managed and
classified for shellfish harvest, is
implemented and enforced by U.S.
States, and contains within it all
relevant Federal requirements
concerning, among other things, current
good manufacturing practices, hazard
analysis and Hazard Analysis Critical
Control Point (HACCP) plans,
recordkeeping, sanitation control
procedures, and the restriction of
interstate transport of shellfish in an
insanitary manner (83 FR 10487 at
10488). Because the NSSP incorporates
relevant Federal food safety measures,
we determined that the NSSP standards
are the appropriate SPS measures to use
in determining whether the EU’s food
safety control measures for shellfish,
along with the application of additional
measures specifically adopted for export
to the United States, which have been
adopted and implemented by Spain and
VerDate Sep<11>2014
17:00 Sep 23, 2020
Jkt 250001
the Netherlands, are equivalent to
comparable U.S. food safety control
measures.
We also explained in the March 9,
2018, notice the process by which we
conducted our equivalence assessment
(83 FR 10487 at 10489). In the EU, the
European Commission (EC) establishes
food safety measures that the EU
Member States adopt and implement.
Our proposed determination was
predicated on an indepth evaluation of
the EC and certain Member States’
regulatory approach, including a
comprehensive document review,
technical consultations, expert analysis,
and onsite evaluations in Spain and the
Netherlands to verify their adoption and
implementation of relevant EU
measures (id.).
In the course of our assessment,
FDA’s technical experts identified
sanitary measures in the EU system that
differed from those in the U.S.
regulatory approach and determined
that further evaluation was needed. As
explained in our March 9, 2018, notice,
our technical experts completed indepth
quantitative and qualitative analyses
and determined that in most areas,
despite differing regulatory approaches
of certain sanitary measures, such
measures provided at least the same
level of sanitary protection as
comparable food safety measures in the
United States. However, FDA’s
technical experts identified some gaps
in the EU’s system of control measures
that provided less sanitary protection
than is provided by U.S. measures. To
address these gaps, the EC amended and
re-issued two Guides to include
additional controls that EU Member
States must adopt and implement in
Class A growing areas to achieve
equivalence with the U.S. system of
food safety measures: The ‘‘Community
Guide to the Principles of Good Practice
for the Microbiological Classification
and Monitoring of Bivalve Mollusc
Production and Relaying Areas with
Regard to Regulation 854/2004’’
(Community Guide) (Ref. 2); and the
‘‘Microbiological Monitoring of Bivalve
Mollusc Harvesting Areas Guide to
Good Practice: Technical Application’’
(Technical Application Guide) (Ref. 3).
The Community Guide specifically
prescribes additional controls that EU
Member States exporting shellfish to the
United States will have to adopt and
implement, while the Technical
Application Guide sets specific
sampling methodologies that must be
followed as part of implementation. For
purposes of FDA’s equivalence
evaluation, the EC-identified Class A
production areas within Spain and the
Netherlands where the EU food safety
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
60173
control measures and the additional
controls in the Community Guide and
the Technical Application Guide
(Guides) are being applied. (Class ‘‘A’’ is
an EU shellfish production area from
which live bivalve molluscs may be
harvested for direct human
consumption.) (Ref. 5)
We note that since the publication of
our proposed equivalence determination
the EU has implemented two new
regulations for official food and feed
controls. These new regulations
reorganize and incorporate several
existing laws into a comprehensive
regulation for the safe handling of food
and feed. However, the EU’s regulatory
amendments do not change our
determination of equivalence.
Specifically, Regulation (EU) 2017/625,
applicable as of December 14, 2019,
repeals and replaces Regulations (EC)
No 854/2004 and (EC) No 882/2004,
which FDA previously identified and
assessed as part of our proposed
shellfish equivalence determination
(Ref. 4). Relatedly, the EU also adopted
Regulation (EU) 2019/627, which
harmonizes procedures to verify
compliance with the rules set forth in
Regulation (EU) 2017/625 and related
EU legislation for the safe handling of
products of animal origin. Regulation
(EU) 2019/627, applicable as of
December 14, 2019, repeals and replaces
procedures formerly contained within
Regulation (EC) No 854/2004 (Ref. 5).
Importantly, FDA has reviewed
Regulations (EU) 2017/625 and (EU)
2019/627 and has confirmed that there
is no impact on FDA’s technical
findings that support this final shellfish
equivalence determination because the
new regulations include the relevant
controls from Regulations (EC) No 854/
2004 and (EC) No 882/2004 that were
the basis of FDA’s technical evaluation
for the proposed equivalence
determination. Since the relevant
controls of Regulation (EU) 2017/625
and (EU) 2019/627 are now being
applied as of December 14, 2019, this
final equivalence determination cites to
these new regulations instead of
Regulations (EC) No 854/2004 and (EC)
No 882/2004, among other applicable
requirements that have not changed,
when describing EU food safety control
measures for shellfish.
Based on our extensive review of
relevant EU measures, the adoption and
implementation by Spain and the
Netherlands of those measures with
additional controls contained in the
Guides, and onsite evaluations in Spain
and the Netherlands, we conclude that
EU food safety control measures for raw
bivalve shellfish, along with the Guides,
when successfully adopted and
E:\FR\FM\24SEN1.SGM
24SEN1
60174
Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices
implemented, provide at least the same
level of sanitary protection as
comparable food safety measures in the
United States, as contained in the NSSP;
currently these controls have been
adopted and implemented in certain
production areas in Spain and the
Netherlands. Therefore, we are
finalizing our equivalence
determination for EC-identified Class A
production areas in Spain and the
Netherlands.
After considering comments received
on the proposed equivalence
determination, as discussed in section
C, the scope of this final equivalence
determination only encompasses two
EU Member States, Spain and the
Netherlands. We will evaluate and
recognize as equivalent, as appropriate,
other EU Member States in the future in
separate determinations. In addition, the
scope of the final equivalence
determination applies to raw bivalve
molluscan shellfish harvested from ECidentified Class A production areas in
the EU where additional controls
specified in the Guides have been
adopted and implemented, and then
verified by competent authorities,
which currently applies only to raw
bivalve shellfish harvested from ECidentified Class A production areas in
Spain and the Netherlands. To ensure
that equivalence is maintained, FDA
intends to engage in technical
consultations with relevant competent
authorities, conduct surveillance of
imported product, and perform audits of
EU Member States, as appropriate.
As a result of this determination, only
raw bivalve shellfish harvested from ECidentified Class A production areas in
Spain and the Netherlands are eligible
to be exported to the United States at
this time. Shippers of shellfish
harvested from these areas must be
listed on the ICSSL before they are
permitted to export product to the
United States (Refs. 6 and 7).
Additionally, certain sanitary
measures are not covered by the scope
of our equivalence determination. For
example, measures related to food and
color additives, processing aids, flavors,
pesticide and chemical residues, animal
drug residues, physical contaminants,
and labeling (including nutrition
labeling) are not part of this equivalence
determination pertaining to raw bivalve
molluscan shellfish because the
equivalence evaluation did not include
these measures and because these
measures are excluded from the
Agreement between the United States of
America and the European Community
on Sanitary Measures to Protect Public
and Animal Health in Trade in Live
Animals and Animal Products (Ref. 8).
VerDate Sep<11>2014
17:00 Sep 23, 2020
Jkt 250001
For measures not covered by the scope
of our equivalence determination, raw
bivalve shellfish exported from ECidentified Class A production areas in
Spain and the Netherlands to the United
States, must comply with applicable
U.S. requirements.
C. Consideration of Comments Received
In the March 9, 2018, notice, we gave
interested parties an opportunity to
submit comments and any supporting
information by May 23, 2018. We
received approximately 25 comments.
Most comments generally supported the
proposed equivalence determination
and did not take specific issue with the
technical basis for our conclusion that
the EU system of food safety control
measures for shellfish, along with the
application of additional measures
specifically adopted for this purpose,
i.e., for export to the United States, as
adopted and implemented in Spain and
the Netherlands, provides at least a level
of sanitary protection as comparable
food safety measures in the United
States. Several comments questioned
the procedural steps by which FDA
reached the proposed equivalence
determination, the respective roles of
the EC and competent authorities in
Spain and the Netherlands, and the
process FDA will follow when
considering additional EU Member
States in the future. Some comments
asked about whether processed shellfish
are included in the present
determination.
Other comments pertained to the EC’s
equivalence determination of the U.S.
system of food safety control measures
for shellfish, the process the EC will
follow for assessing additional U.S.
States, the classification of growing
areas eligible for export, and other
matters associated with the export of
shellfish from the United States to the
EU. These comments are outside the
scope of this equivalence determination.
One comment questioned whether
importing live bivalve molluscan
shellfish from the EU would present an
animal disease risk for native U.S.
shellfish wild stocks. Animal disease
risks are beyond the scope of this
equivalence determination, which is
based on an assessment of safety for
human consumption. Importers of raw
molluscan shellfish must also comply
with any applicable U.S. requirements
that fall outside the scope of this final
equivalence determination, including
any regulatory requirements governing
the importation of animal products that
are implemented by other U.S.
Agencies.
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
D. Clarifications
In response to comments to the March
9, 2018, notice regarding our proposed
equivalence determination, we make the
following clarifications. On the
respective roles and authority of the EC
and competent authorities in the
individual EU Member States (including
Spain and the Netherlands) in the
equivalence determination process, we
note that the EC is responsible for
establishing harmonized food safety
measures that the EU Member States
adopt and implement. The EC audits EU
Member States to ensure that they have
adopted and are implementing
harmonized measures, and competent
authorities in the EU Member States
provide oversight of food business
operators to enforce compliance with
the measures. The scope of this
equivalence determination applies to EC
measures for raw bivalve molluscan
shellfish in EC-identified Class A
production areas and implementation of
additional controls in the Guides, as
adopted and implemented by Spain and
the Netherlands. We did not include
processed shellfish in this equivalence
determination because we currently
permit the importation of processed
shellfish that comply with U.S. seafood
HACCP regulations (part 123 and
§ 1240.60) from all EU Member States.
This determination does not extend to
the implementation of EU food safety
control measures for shellfish by other
EU Member States. We have revised the
title of this notice and the scope of our
final equivalence determination to
clarify this point. In summary, we have
determined that the adoption and
implementation by Spain and the
Netherlands of the EU’s system of food
safety control measures for shellfish,
along with their application of
additional control measures provided in
the Guides, is equivalent to the
comparable U.S. measures because the
adoption and implementation by Spain
and the Netherlands of the EU measures
and additional controls achieves at least
the same level of sanitary protection as
comparable food safety measures in the
United States.
On the matter of recognizing
additional EU Member States in the
future, we stated in the March 9, 2018,
notice that we would update the ICSSL
with the names of the establishments in
recognized EU Member States intending
to export to the United States (83 FR
10487 at 10492). In order for FDA to
recognize additional EU Member States
as equivalent, the competent authority
in the EU Member State would need to
demonstrate that it has adopted and
implemented EU shellfish safety control
E:\FR\FM\24SEN1.SGM
24SEN1
Federal Register / Vol. 85, No. 186 / Thursday, September 24, 2020 / Notices
measures, along with the additional
control measures provided in the
Guides. The process for seeking such
recognition is identified in the
Administrative Arrangement between
the United States Food and Drug
Administration and the DirectorateGeneral for Health and Food Safety of
the European Commission Regarding
Trade in Bivalve Molluscan Shellfish
(Ref. 9). In the future, FDA will publish
in the Federal Register any proposal to
recognize additional EU Member States
as equivalent and accept comments on
the proposal before finalizing the
Agency’s determination.
Regarding the maintenance of
equivalence, both FDA and the EC will
carry out periodic onsite evaluations or
audits to ensure that equivalence is
maintained. In addition, the EC will
notify FDA of any plan to adopt, modify
or repeal a food safety control measure
applicable to molluscan shellfish so that
FDA can determine whether the new,
modified or repealed measure affects its
equivalence determination (Ref. 9).
After considering the comments, we
are finalizing the equivalence
determination for Spain and the
Netherlands.
II. Equivalence Determination
We are announcing that we recognize
the adoption and implementation by
Spain and the Netherlands of the EU
system of food safety control measures
for raw bivalve molluscan shellfish,
along with their application of
additional control measures described
in the Guides, as equivalent because the
adoption and implementation of these
measures by Spain and the Netherlands
provide at least the same level of
sanitary protection as comparable food
safety measures in the United States (19
U.S.C. 2578a(a)).
Because FDA recognizes these control
measures have been successfully
adopted and implemented by Spain and
the Netherlands, this final equivalence
determination allows FDA, the
competent authorities in Spain and the
Netherlands, and the EC to implement
procedures for resuming trade in
accordance with the final equivalence
determination. For the export of raw
bivalve shellfish from Spain and the
Netherlands to the United States, these
procedures include the subsequent
listing of eligible establishments in
Spain and the Netherlands on the ICSSL
once the EC has been notified of our
final equivalence determination.
III. References
The following references are on
display at the Dockets Management Staff
(HFA–305), Food and Drug
VerDate Sep<11>2014
17:00 Sep 23, 2020
Jkt 250001
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and are
available for viewing by interested
persons between 9 a.m. and 4 p.m.,
Monday through Friday; they are also
available electronically at https://
www.regulations.gov. FDA has verified
the website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
1. National Shellfish Sanitation Program
(NSSP) Guide for the Control of
Molluscan Shellfish. Food and Drug
Administration and Interstate Shellfish
Sanitation Conference. 2007 through
2017 revisions (web page last updated
October 2018). Accessed online at
https://www.fda.gov/food/
guidanceregulation/
federalstatefoodprograms/
ucm2006754.htm.
2. ‘‘Community Guide to the Principles of
Good Practice for the Microbiological
Classification and Monitoring of Bivalve
Mollusc Production and Relaying Areas
with Regard to Regulation 854/2004.’’
European Commission. June 2012,
updated January 2014 and January 2017.
Accessed online at https://ec.europa.eu/
food/sites/food/files/safety/docs/
biosafety_fh_guidance_community_
guide_bivalve_mollusc_monitoring_
en.pdf.
3. ‘‘Microbiological Monitoring of Bivalve
Mollusc Harvesting Areas Guide to Good
Practice: Technical Application
(Technical Application Guide).’’ EU
Working Group on the Microbiological
Monitoring of Bivalve Mollusc
Harvesting Areas. Issue 4, August 2010,
updated June 2014 (Issue 5) and January
2017 (Issue 6). Accessed online at
https://www.cefas.co.uk/media/jyzhl1si/
good-practice-guide-issue-6.pdf.
4. Regulation (EU) 2017/625 of the European
Parliament and of the Council of 15
March 2017 repeals Regulations (EC) No
854/2004 and (EC) No 882/2004.
Accessed online at https://eurlex.europa.eu/legal-content/EN/TXT/
PDF/?uri=CELEX:32017R0625&from=EN.
5. Commission Implementing Regulation
(EU) 2019/627 of 15 March 2019, lays
down uniform practical arrangements for
the performance of official controls on
products of animal origin intended for
human consumption in accordance with
Regulation (EU) 2017/625 of the
European Parliament and of the Council
and amending Commission Regulation
(EC) No 2074/2005 as regards official
controls. Accessed online at https://eurlex.europa.eu/legal-content/EN/TXT/
PDF/?uri=CELEX:32019R0627&from=EN.
6. National Shellfish Sanitation Program
(NSSP) Guide for the Control of
Molluscan Shellfish. Food and Drug
Administration and Interstate Shellfish
Sanitation Conference. 2007 through
2017 revisions (web page last updated
October 2018). See Section II, Chapter 1
@.02, page 13 and Section IV, Chapter III,
.03, page 363. Accessed online at https://
www.fda.gov/food/guidanceregulation/
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
60175
federalstatefoodprograms/
ucm2006754.htm.
7. Meeting Summary and Attachment from
the U.S.-EU Bivalve Molluscan Shellfish
Equivalence Project. November 19 to 20,
2015. FDA Hillandale Building, Silver
Spring, MD.
8. Agreement between the United States of
America and the European Community
on Sanitary Measures to Protect Public
and Animal Health in Trade in Live
Animals and Animal Products dated July
20, 1999.
9. Administrative Arrangement between the
United States Food and Drug
Administration and the DirectorateGeneral for Health and Food Safety of
the European Commission Regarding
Trade in Bivalve Molluscan Shellfish.
Dated: September 16, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–20755 Filed 9–23–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[CMS–3378–N]
Secretarial Review and Publication of
the 2019 Annual Report to Congress
and the Secretary Submitted by the
Consensus-Based Entity Regarding
Performance Measurement
Office of the Secretary of
Health and Human Services, HHS.
ACTION: Notice.
AGENCY:
This notice acknowledges the
Secretary of the Department of Health
and Human Services’ (the Secretary)
receipt and review of the National
Quality Forum 2019 Annual Activities
Report to Congress and the Secretary
submitted by the consensus-based entity
under a contract with the Secretary as
mandated by the Social Security Act
(the Act). The Secretary has reviewed
and is publishing the report in the
Federal Register together with the
Secretary’s comments on the report not
later than 6 months after receiving the
report in accordance with the Act. This
notice fulfills the statutory
requirements.
FOR FURTHER INFORMATION CONTACT:
Michelle Geppi, (410) 786–4844.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
The United States Department of
Health and Human Services (HHS) has
long recognized that a high functioning
health care system that provides higher
quality care requires accurate, valid, and
reliable measurement of quality and
efficiency. The Medicare Improvements
for Patients and Providers Act of 2008
E:\FR\FM\24SEN1.SGM
24SEN1
]]>Agencies
[Federal Register Volume 85, Number 186 (Thursday, September 24, 2020)]
[Notices]
[Pages 60172-60175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20755]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0810]
Food and Drug Administration Equivalence Determination Regarding
Implementation by Spain and the Netherlands of the European Union
System of Food Safety Control Measures for Raw Bivalve Molluscan
Shellfish With Additional Controls
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing a
final determination that the adoption and implementation by Spain and
the Netherlands of the European Union's (EU's) system of food safety
control measures for raw bivalve molluscan shellfish (``shellfish''),
along with their application of additional measures specifically
adopted for this purpose, i.e., for export to the United States,
provides at least the same level of sanitary protection as comparable
food safety measures in the United States and is therefore equivalent.
This final equivalence determination will permit the importation of raw
shellfish harvested from certain production areas in Spain and the
Netherlands from establishments that have been listed by FDA on the
Interstate Certified Shellfish Shippers List (ICSSL).
DATES: The determination becomes final on September 24, 2020.
FOR FURTHER INFORMATION CONTACT: Melissa Abbott, Center for Food Safety
and Applied Nutrition (HFS-325), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-1401; or Robert Tuverson,
Center for Food Safety and Applied Nutrition (HFS-550), Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1586.
SUPPLEMENTARY INFORMATION:
I. Background
A. Introduction
FDA is responsible for protecting public health by ensuring, among
other things, the safety of our nation's food supply, including
imported foods. This includes raw bivalve molluscan shellfish (oysters,
clams, mussels, roe-on scallops, and whole scallops, referred to as
``shellfish'' throughout this notice) imported into the United States.
In the Federal Register of March 9, 2018 (83 FR 10487), we published a
notice that announced and explained the basis for our proposed
equivalence determination that the EU system of food safety control
measures for shellfish, along with the application of additional
measures specifically adopted for this purpose, i.e., for export to the
United States, as adopted and implemented in Spain and the Netherlands,
provides at least a level of sanitary protection as comparable food
safety measures in the United States. This notice announces that, after
considering comments we received on the proposed equivalence
determination, we are finalizing the equivalence determination as
proposed, except that we are narrowing the scope of this final
equivalence determination so that it only encompasses two EU Member
States, Spain and the Netherlands. FDA will use this determination as a
basis to evaluate additional EU Member States that adopt and implement
these measures.
In the future, we will evaluate and recognize as equivalent, as
appropriate, other EU Member States in separate determinations. In
addition, we further clarify and explain our basis for the final
equivalence determination in response to the comments. We note that, in
the March 9, 2018, notice, we used both ``production area'' and
``growing area'' in referring to beds or sites that support or could
support the propagation of bivalve molluscan shellfish. For purposes of
this notice, we continue to use the same terminology.
B. Basis for Equivalence Determination
Under section 432 of the Uruguay Round Agreements Act (URAA),
Public Law 103-465, U.S. Agencies may not find foreign sanitary and
phytosanitary measures (SPS measures) equivalent to comparable SPS
measures in the United States unless the Agency determines that the
foreign measures provide at least the same level of sanitary or
phytosanitary protection as the
[[Page 60173]]
comparable SPS measures established under Federal law (19 U.S.C.
2578a(a)). The URAA also provides that FDA publish a notice in the
Federal Register and consider public comment before finalizing an
equivalence determination when the determination is based on domestic
SPS measures that FDA is not required to issue as a rule under the
Federal Food, Drug, and Cosmetic Act or other statute we administer (19
U.S.C. 2578a(c)). In accordance with these procedures specified in the
URAA, we are finalizing this equivalence determination.
As explained in the March 9, 2018, notice, our equivalence
assessment focused on whether the EU's food safety control measures for
shellfish, along with the application of additional measures
specifically required for export to the United States, which have been
adopted and implemented by Spain and the Netherlands, provide at least
the same level of sanitary protection as comparable food safety
measures in the United States applied through the National Shellfish
Sanitation Program (NSSP) (83 FR 10487 at 10488). The NSSP is a
Federal-State cooperative program that provides a broad framework of
shellfish sanitation standards through its ``Guide for the Control of
Molluscan Shellfish'' (NSSP Guide) (Ref. 1). The NSSP Guide functions
as a model ordinance incorporated into State law by participating
States but is not itself a Federal regulation. The NSSP Guide
incorporates Federal regulations specific to fish and fishery products,
which are found at part 123 (21 CFR part 123) and Sec. 1240.60 (21 CFR
1240.60). We explained in the March 9, 2018, notice that the NSSP,
which governs how U.S. growing areas are managed and classified for
shellfish harvest, is implemented and enforced by U.S. States, and
contains within it all relevant Federal requirements concerning, among
other things, current good manufacturing practices, hazard analysis and
Hazard Analysis Critical Control Point (HACCP) plans, recordkeeping,
sanitation control procedures, and the restriction of interstate
transport of shellfish in an insanitary manner (83 FR 10487 at 10488).
Because the NSSP incorporates relevant Federal food safety measures, we
determined that the NSSP standards are the appropriate SPS measures to
use in determining whether the EU's food safety control measures for
shellfish, along with the application of additional measures
specifically adopted for export to the United States, which have been
adopted and implemented by Spain and the Netherlands, are equivalent to
comparable U.S. food safety control measures.
We also explained in the March 9, 2018, notice the process by which
we conducted our equivalence assessment (83 FR 10487 at 10489). In the
EU, the European Commission (EC) establishes food safety measures that
the EU Member States adopt and implement. Our proposed determination
was predicated on an indepth evaluation of the EC and certain Member
States' regulatory approach, including a comprehensive document review,
technical consultations, expert analysis, and onsite evaluations in
Spain and the Netherlands to verify their adoption and implementation
of relevant EU measures (id.).
In the course of our assessment, FDA's technical experts identified
sanitary measures in the EU system that differed from those in the U.S.
regulatory approach and determined that further evaluation was needed.
As explained in our March 9, 2018, notice, our technical experts
completed indepth quantitative and qualitative analyses and determined
that in most areas, despite differing regulatory approaches of certain
sanitary measures, such measures provided at least the same level of
sanitary protection as comparable food safety measures in the United
States. However, FDA's technical experts identified some gaps in the
EU's system of control measures that provided less sanitary protection
than is provided by U.S. measures. To address these gaps, the EC
amended and re-issued two Guides to include additional controls that EU
Member States must adopt and implement in Class A growing areas to
achieve equivalence with the U.S. system of food safety measures: The
``Community Guide to the Principles of Good Practice for the
Microbiological Classification and Monitoring of Bivalve Mollusc
Production and Relaying Areas with Regard to Regulation 854/2004''
(Community Guide) (Ref. 2); and the ``Microbiological Monitoring of
Bivalve Mollusc Harvesting Areas Guide to Good Practice: Technical
Application'' (Technical Application Guide) (Ref. 3). The Community
Guide specifically prescribes additional controls that EU Member States
exporting shellfish to the United States will have to adopt and
implement, while the Technical Application Guide sets specific sampling
methodologies that must be followed as part of implementation. For
purposes of FDA's equivalence evaluation, the EC-identified Class A
production areas within Spain and the Netherlands where the EU food
safety control measures and the additional controls in the Community
Guide and the Technical Application Guide (Guides) are being applied.
(Class ``A'' is an EU shellfish production area from which live bivalve
molluscs may be harvested for direct human consumption.) (Ref. 5)
We note that since the publication of our proposed equivalence
determination the EU has implemented two new regulations for official
food and feed controls. These new regulations reorganize and
incorporate several existing laws into a comprehensive regulation for
the safe handling of food and feed. However, the EU's regulatory
amendments do not change our determination of equivalence.
Specifically, Regulation (EU) 2017/625, applicable as of December 14,
2019, repeals and replaces Regulations (EC) No 854/2004 and (EC) No
882/2004, which FDA previously identified and assessed as part of our
proposed shellfish equivalence determination (Ref. 4). Relatedly, the
EU also adopted Regulation (EU) 2019/627, which harmonizes procedures
to verify compliance with the rules set forth in Regulation (EU) 2017/
625 and related EU legislation for the safe handling of products of
animal origin. Regulation (EU) 2019/627, applicable as of December 14,
2019, repeals and replaces procedures formerly contained within
Regulation (EC) No 854/2004 (Ref. 5). Importantly, FDA has reviewed
Regulations (EU) 2017/625 and (EU) 2019/627 and has confirmed that
there is no impact on FDA's technical findings that support this final
shellfish equivalence determination because the new regulations include
the relevant controls from Regulations (EC) No 854/2004 and (EC) No
882/2004 that were the basis of FDA's technical evaluation for the
proposed equivalence determination. Since the relevant controls of
Regulation (EU) 2017/625 and (EU) 2019/627 are now being applied as of
December 14, 2019, this final equivalence determination cites to these
new regulations instead of Regulations (EC) No 854/2004 and (EC) No
882/2004, among other applicable requirements that have not changed,
when describing EU food safety control measures for shellfish.
Based on our extensive review of relevant EU measures, the adoption
and implementation by Spain and the Netherlands of those measures with
additional controls contained in the Guides, and onsite evaluations in
Spain and the Netherlands, we conclude that EU food safety control
measures for raw bivalve shellfish, along with the Guides, when
successfully adopted and
[[Page 60174]]
implemented, provide at least the same level of sanitary protection as
comparable food safety measures in the United States, as contained in
the NSSP; currently these controls have been adopted and implemented in
certain production areas in Spain and the Netherlands. Therefore, we
are finalizing our equivalence determination for EC-identified Class A
production areas in Spain and the Netherlands.
After considering comments received on the proposed equivalence
determination, as discussed in section C, the scope of this final
equivalence determination only encompasses two EU Member States, Spain
and the Netherlands. We will evaluate and recognize as equivalent, as
appropriate, other EU Member States in the future in separate
determinations. In addition, the scope of the final equivalence
determination applies to raw bivalve molluscan shellfish harvested from
EC-identified Class A production areas in the EU where additional
controls specified in the Guides have been adopted and implemented, and
then verified by competent authorities, which currently applies only to
raw bivalve shellfish harvested from EC-identified Class A production
areas in Spain and the Netherlands. To ensure that equivalence is
maintained, FDA intends to engage in technical consultations with
relevant competent authorities, conduct surveillance of imported
product, and perform audits of EU Member States, as appropriate.
As a result of this determination, only raw bivalve shellfish
harvested from EC-identified Class A production areas in Spain and the
Netherlands are eligible to be exported to the United States at this
time. Shippers of shellfish harvested from these areas must be listed
on the ICSSL before they are permitted to export product to the United
States (Refs. 6 and 7).
Additionally, certain sanitary measures are not covered by the
scope of our equivalence determination. For example, measures related
to food and color additives, processing aids, flavors, pesticide and
chemical residues, animal drug residues, physical contaminants, and
labeling (including nutrition labeling) are not part of this
equivalence determination pertaining to raw bivalve molluscan shellfish
because the equivalence evaluation did not include these measures and
because these measures are excluded from the Agreement between the
United States of America and the European Community on Sanitary
Measures to Protect Public and Animal Health in Trade in Live Animals
and Animal Products (Ref. 8). For measures not covered by the scope of
our equivalence determination, raw bivalve shellfish exported from EC-
identified Class A production areas in Spain and the Netherlands to the
United States, must comply with applicable U.S. requirements.
C. Consideration of Comments Received
In the March 9, 2018, notice, we gave interested parties an
opportunity to submit comments and any supporting information by May
23, 2018. We received approximately 25 comments. Most comments
generally supported the proposed equivalence determination and did not
take specific issue with the technical basis for our conclusion that
the EU system of food safety control measures for shellfish, along with
the application of additional measures specifically adopted for this
purpose, i.e., for export to the United States, as adopted and
implemented in Spain and the Netherlands, provides at least a level of
sanitary protection as comparable food safety measures in the United
States. Several comments questioned the procedural steps by which FDA
reached the proposed equivalence determination, the respective roles of
the EC and competent authorities in Spain and the Netherlands, and the
process FDA will follow when considering additional EU Member States in
the future. Some comments asked about whether processed shellfish are
included in the present determination.
Other comments pertained to the EC's equivalence determination of
the U.S. system of food safety control measures for shellfish, the
process the EC will follow for assessing additional U.S. States, the
classification of growing areas eligible for export, and other matters
associated with the export of shellfish from the United States to the
EU. These comments are outside the scope of this equivalence
determination.
One comment questioned whether importing live bivalve molluscan
shellfish from the EU would present an animal disease risk for native
U.S. shellfish wild stocks. Animal disease risks are beyond the scope
of this equivalence determination, which is based on an assessment of
safety for human consumption. Importers of raw molluscan shellfish must
also comply with any applicable U.S. requirements that fall outside the
scope of this final equivalence determination, including any regulatory
requirements governing the importation of animal products that are
implemented by other U.S. Agencies.
D. Clarifications
In response to comments to the March 9, 2018, notice regarding our
proposed equivalence determination, we make the following
clarifications. On the respective roles and authority of the EC and
competent authorities in the individual EU Member States (including
Spain and the Netherlands) in the equivalence determination process, we
note that the EC is responsible for establishing harmonized food safety
measures that the EU Member States adopt and implement. The EC audits
EU Member States to ensure that they have adopted and are implementing
harmonized measures, and competent authorities in the EU Member States
provide oversight of food business operators to enforce compliance with
the measures. The scope of this equivalence determination applies to EC
measures for raw bivalve molluscan shellfish in EC-identified Class A
production areas and implementation of additional controls in the
Guides, as adopted and implemented by Spain and the Netherlands. We did
not include processed shellfish in this equivalence determination
because we currently permit the importation of processed shellfish that
comply with U.S. seafood HACCP regulations (part 123 and Sec. 1240.60)
from all EU Member States. This determination does not extend to the
implementation of EU food safety control measures for shellfish by
other EU Member States. We have revised the title of this notice and
the scope of our final equivalence determination to clarify this point.
In summary, we have determined that the adoption and implementation by
Spain and the Netherlands of the EU's system of food safety control
measures for shellfish, along with their application of additional
control measures provided in the Guides, is equivalent to the
comparable U.S. measures because the adoption and implementation by
Spain and the Netherlands of the EU measures and additional controls
achieves at least the same level of sanitary protection as comparable
food safety measures in the United States.
On the matter of recognizing additional EU Member States in the
future, we stated in the March 9, 2018, notice that we would update the
ICSSL with the names of the establishments in recognized EU Member
States intending to export to the United States (83 FR 10487 at 10492).
In order for FDA to recognize additional EU Member States as
equivalent, the competent authority in the EU Member State would need
to demonstrate that it has adopted and implemented EU shellfish safety
control
[[Page 60175]]
measures, along with the additional control measures provided in the
Guides. The process for seeking such recognition is identified in the
Administrative Arrangement between the United States Food and Drug
Administration and the Directorate-General for Health and Food Safety
of the European Commission Regarding Trade in Bivalve Molluscan
Shellfish (Ref. 9). In the future, FDA will publish in the Federal
Register any proposal to recognize additional EU Member States as
equivalent and accept comments on the proposal before finalizing the
Agency's determination.
Regarding the maintenance of equivalence, both FDA and the EC will
carry out periodic onsite evaluations or audits to ensure that
equivalence is maintained. In addition, the EC will notify FDA of any
plan to adopt, modify or repeal a food safety control measure
applicable to molluscan shellfish so that FDA can determine whether the
new, modified or repealed measure affects its equivalence determination
(Ref. 9).
After considering the comments, we are finalizing the equivalence
determination for Spain and the Netherlands.
II. Equivalence Determination
We are announcing that we recognize the adoption and implementation
by Spain and the Netherlands of the EU system of food safety control
measures for raw bivalve molluscan shellfish, along with their
application of additional control measures described in the Guides, as
equivalent because the adoption and implementation of these measures by
Spain and the Netherlands provide at least the same level of sanitary
protection as comparable food safety measures in the United States (19
U.S.C. 2578a(a)).
Because FDA recognizes these control measures have been
successfully adopted and implemented by Spain and the Netherlands, this
final equivalence determination allows FDA, the competent authorities
in Spain and the Netherlands, and the EC to implement procedures for
resuming trade in accordance with the final equivalence determination.
For the export of raw bivalve shellfish from Spain and the Netherlands
to the United States, these procedures include the subsequent listing
of eligible establishments in Spain and the Netherlands on the ICSSL
once the EC has been notified of our final equivalence determination.
III. References
The following references are on display at the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.
1. National Shellfish Sanitation Program (NSSP) Guide for the
Control of Molluscan Shellfish. Food and Drug Administration and
Interstate Shellfish Sanitation Conference. 2007 through 2017
revisions (web page last updated October 2018). Accessed online at
https://www.fda.gov/food/guidanceregulation/federalstatefoodprograms/ucm2006754.htm.
2. ``Community Guide to the Principles of Good Practice for the
Microbiological Classification and Monitoring of Bivalve Mollusc
Production and Relaying Areas with Regard to Regulation 854/2004.''
European Commission. June 2012, updated January 2014 and January
2017. Accessed online at https://ec.europa.eu/food/sites/food/files/safety/docs/biosafety_fh_guidance_community_guide_bivalve_mollusc_monitoring_en.pdf.
3. ``Microbiological Monitoring of Bivalve Mollusc Harvesting Areas
Guide to Good Practice: Technical Application (Technical Application
Guide).'' EU Working Group on the Microbiological Monitoring of
Bivalve Mollusc Harvesting Areas. Issue 4, August 2010, updated June
2014 (Issue 5) and January 2017 (Issue 6). Accessed online at
https://www.cefas.co.uk/media/jyzhl1si/good-practice-guide-issue-6.pdf.
4. Regulation (EU) 2017/625 of the European Parliament and of the
Council of 15 March 2017 repeals Regulations (EC) No 854/2004 and
(EC) No 882/2004. Accessed online at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0625&from=EN.
5. Commission Implementing Regulation (EU) 2019/627 of 15 March
2019, lays down uniform practical arrangements for the performance
of official controls on products of animal origin intended for human
consumption in accordance with Regulation (EU) 2017/625 of the
European Parliament and of the Council and amending Commission
Regulation (EC) No 2074/2005 as regards official controls. Accessed
online at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019R0627&from=EN.
6. National Shellfish Sanitation Program (NSSP) Guide for the
Control of Molluscan Shellfish. Food and Drug Administration and
Interstate Shellfish Sanitation Conference. 2007 through 2017
revisions (web page last updated October 2018). See Section II,
Chapter 1 @.02, page 13 and Section IV, Chapter III, .03, page 363.
Accessed online at https://www.fda.gov/food/guidanceregulation/federalstatefoodprograms/ucm2006754.htm.
7. Meeting Summary and Attachment from the U.S.-EU Bivalve Molluscan
Shellfish Equivalence Project. November 19 to 20, 2015. FDA
Hillandale Building, Silver Spring, MD.
8. Agreement between the United States of America and the European
Community on Sanitary Measures to Protect Public and Animal Health
in Trade in Live Animals and Animal Products dated July 20, 1999.
9. Administrative Arrangement between the United States Food and
Drug Administration and the Directorate-General for Health and Food
Safety of the European Commission Regarding Trade in Bivalve
Molluscan Shellfish.
Dated: September 16, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-20755 Filed 9-23-20; 8:45 am]
BILLING CODE 4164-01-P
