[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)]
[Proposed Rules]
[Pages 23206-23208]
[FR Doc No: 2016-09005]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-5464; Directorate Identifier 2015-NM-097-AD]
RIN 2120-AA64

Airworthiness Directives; Dassault Aviation Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to supersede Airworthiness Directive (AD) 2011-10-
01, for all Dassault Aviation Model FALCON 7X airplanes. AD 2011-10-01
currently requires repetitive functional tests of the ram air turbine
(RAT) heater and repair if necessary. Since we issued AD 2011-10-01, we
received a revision of an airworthiness limitations items (ALI)
document, which introduces new and more restrictive maintenance
requirements and airworthiness limitations for airplane structures and
systems. This proposed AD would require revising the maintenance or
inspection program to incorporate new maintenance requirements and
airworthiness limitations. We are proposing this AD to prevent reduced
structural integrity and reduced control of these airplanes due to the
failure of system components.

DATES: We must receive comments on this proposed AD by June 6, 2016.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Dassault
Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000, South
Hackensack, NJ 07606; telephone:<PHONE_NUMBER>; Internet: http://www.dassaultfalcon.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
5464; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2016-5464;
Directorate Identifier 2015-NM-097-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On April 20, 2011, we issued AD 2011-10-01, Amendment 39-16682 (76
FR 25535, May 5, 2011). AD 2011-10-01 requires actions intended to
address an unsafe condition on all Dassault Aviation Model FALCON 7X
airplanes. Since we issued AD 2011-10-01, we received a revision of an
ALI document, Chapter 5-40-00, Airworthiness Limitations, DGT 107838,
Revision 4, dated February 2, 2015, of the Dassault Falcon 7X
Maintenance Manual, which introduces new and more restrictive
maintenance requirements and airworthiness limitations.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive AD 2015-0095, dated May 29, 2015 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for all Dassault Aviation
FALCON 7X airplanes. The MCAI states:

    The airworthiness limitations and maintenance requirements for
the FALCON 7X type design are included in Dassault Aviation FALCON
7X Aircraft Maintenance Manual (AMM) chapter 5-40 and are approved
by EASA. To ensure accomplishment of the maintenance tasks, and
implementation of the airworthiness limitations, as specified in
Dassault Aviation FALCON 7X AMM chapter 5-40 original issue,
including temporary revision (TR) TR-01, EASA issued AD 2008-0221
[http://ad.easa.europa.eu/ad/2008-0221].
    Since that [EASA] AD was issued, Dassault Aviation issued
revision 4 of the FALCON 7X AMM chapter 5-40, which introduces new
and more restrictive maintenance requirements and/or airworthiness
limitations.
    Dassault Aviation AMM chapter 5-40 revision 4 contains, among
others, the following changes:

--Fatigue and Damage tolerance airworthiness limitations,
--Miscellaneous Certification Maintenance Requirements and
Airworthiness Limitation Items,
--Periodic restoration of the DC generators (this action was
required by EASA AD 2009-0254) [http://ad.easa.europa.eu/ad/2009-0254],
--Functional test of the Ram Air Turbine heater (this action was
required by EASA AD 2010-0033) [http://ad.easa.europa.eu/ad/2010-0233] [which corresponds to FAA AD 2011-10-01, Amendment 39-16682
(76 FR 25535, May 5, 2011)],

--Special detailed fatigue inspection of fastener holes at front
spar/wing lower panel connections at RIB 26,
--Operational test of the IRS3 power supply weight-on- wheel logic,
--Inspection of the interface between wheel keys and brake inboard
rotor,
--Operational test of the Horizontal Stabilizer Trim Actuator (HSTA)
electrical motor reversion,
--Operational test of the HSTA trim emergency command,
--Detailed inspection of the brake heat sink.

    The maintenance tasks and airworthiness limitations, as
specified in the FALCON 7X AMM chapter 5-40, have been identified as
mandatory actions for continued airworthiness of the FALCON 7X type
design. Failure to accomplish the actions specified in AMM chapter
5-40 at revision 4 may result in an unsafe condition.
    For the reasons described above, this [EASA] AD retains the
requirements of EASA AD 2009-0254 and EASA AD 2010-0033, which are
superseded, and requires accomplishment of the maintenance tasks and
airworthiness limitations, as specified in Dassault Aviation FALCON
7X AMM chapter 5-40 at revision 4.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
5464.
    This AD requires revisions to certain operator maintenance
documents to include new actions (e.g., inspections) and/or Critical
Design Configuration Control Limitations (CDCCLs). Compliance with
these actions and/or CDCCLs is required by 14 CFR 91.403(c). For
airplanes that have been previously modified, altered, or repaired in
the areas addressed by this proposed AD, the operator may not be able
to accomplish the actions described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must request
approval for an alternative method of compliance according to paragraph
(k)(1) of this proposed AD. The request should include a description of
changes to the required inspections that will ensure the continued
operational safety of the airplane.
    Notwithstanding any other maintenance or operational requirements,
components that have been identified as airworthy or installed on the
affected airplanes before accomplishing the revision of the airplane
maintenance or inspection program specified in this proposed AD, do not
need to be reworked in accordance with the CDCCLs. However, once the
airplane maintenance or inspection program or airworthiness limitations
section (ALS) has been revised as required by this proposed AD, future
maintenance actions on these components must be done in accordance with
the CDCCLs.

Related Service Information Under 1 CFR Part 51

    Dassault Aviation issued Chapter 5-40-00, Airworthiness
Limitations, DGT 107838, Revision 4, dated February 2, 2015, of the
Dassault Falcon 7X Maintenance Manual, which introduces new and more
restrictive maintenance requirements and airworthiness limitations for
airplane structures and systems. This service information is reasonably
available because the interested parties have access to it through
their normal course of business or by the means identified in the
ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Costs of Compliance

    We estimate that this proposed AD affects 45 airplanes of U.S.
registry.
    The actions required by AD 2011-10-01, Amendment 39-16682 (76 FR
25535, May 5, 2011), and retained in this proposed AD take about 1
work-hour per product, at an average labor rate of $85 per work-hour.
Based on these figures, the estimated cost of the actions that are
required by AD 2011-10-01 is $85 per product.
    We also estimate that it would take about 1 work-hour per product
to comply with the basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Based on these figures, we estimate
the cost of this proposed AD on U.S. operators to be $3,825, or $85 per
product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2011-10-01, Amendment 39-16682 (76 FR 25535, May 5, 2011), and adding
the following new AD:

Dassault Aviation: Docket No. FAA-2016-5464; Directorate Identifier
2015-NM-097-AD.

(a) Comments Due Date

    We must receive comments by June 6, 2016.

(b) Affected ADs

    This AD replaces AD 2011-10-01, Amendment 39-16682 (76 FR 25535,
May 5, 2011). This AD affects AD 2014-16-23, Amendment 39-17947 (79
FR 52545, September 4, 2014).

(c) Applicability

    This AD applies to Dassault Aviation Model FALCON 7X airplanes,
certificated in any category, all serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Reason

    This AD was prompted by a revision of an airworthiness
limitations items (ALI) document, which introduces new and more
restrictive maintenance requirements and airworthiness limitations
for airplane structures and systems. We are issuing this AD to
prevent reduced structural integrity and reduced control of these
airplanes due to the failure of system components.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Retained Functional Test of the Ram Air Turbine (RAT) Heater With
New Terminating Action and With Specific Delegation Approval Language

    This paragraph restates the requirements of paragraph (g) of AD
2011-10-01, Amendment 39-16682 (76 FR 25535, May 5, 2011), with new
terminating action and with specific delegation approval language.
At the applicable times specified in paragraph (g)(1) or (g)(2) of
this AD, do a functional test of the RAT heater using a method
approved by either the Manager, International Branch, ANM-116,
Transport Airplane Directorate, FAA; or the European Aviation Safety
Agency (EASA); or Dassault Aviation's EASA Design Organization
Approval (DOA). Repeat the functional test of the RAT heater
thereafter at the applicable time specified in paragraph (g)(1) or
(g)(2) of this AD until the revision required by paragraph (h) of
this AD is done. If any functional test fails, before further
flight, repair using a method approved by either the Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA;
or EASA; or Dassault Aviation's EASA DOA.
    (1) For FALCON 7X airplanes on which modification M0305 has not
been done and on which Dassault Service Bulletin 7X-018, dated March
6, 2009, has not been done: Within 650 flight hours after the
effective date of this AD, do a functional test of the RAT heater
and repeat the functional test of the RAT heater thereafter at
intervals not to exceed 650 flight hours.
    (2) For FALCON 7X airplanes on which modification M0305 has been
done or on which Dassault Service Bulletin 7X-018, dated March 6,
2009, has been done: Within 1,900 flight hours after June 9, 2011
(the effective date of AD 2011-10-01, Amendment 39-16682 (76 FR
25535, May 5, 2011)) or after modification M0305 or Dassault Service
Bulletin 7X-018, dated March 6, 2009, has been done, whichever
occurs later, do a functional test of the RAT heater. Repeat the
functional test of the RAT heater thereafter at intervals not to
exceed 1,900 flight hours.

    Note 1 to paragraph (g) of this AD: Additional guidance for
doing the functional test of the RAT heater required by paragraph
(g) of this AD can be found in Task 24-50-25-720-801, Functional
Test of the RAT Heater, dated January 16, 2009, of the Dassault
FALCON 7X Aircraft Maintenance Manual (AMM).

(h) New Requirement of This AD: Revise the Maintenance or Inspection
Program

    Within 30 days after the effective date of this AD, revise the
maintenance or inspection program, as applicable, by incorporating
the information specified in Chapter 5-40-00, Airworthiness
Limitations, DGT 107838, Revision 4, dated February 2, 2015, of the
Dassault Falcon 7X Maintenance Manual (MM). The initial compliance
times for the tasks specified in Chapter 5-40-00, Airworthiness
Limitations, DGT 107838, Revision 4, dated February 2, 2015, of the
Dassault Falcon 7X MM are at the applicable compliance times
specified in Chapter 5-40-00, Airworthiness Limitations, DGT 107838,
Revision 4, dated February 2, 2015, of the Dassault Falcon 7X MM, or
within 30 days after the effective date of this AD, whichever occurs
later.

(i) Terminating Actions

    (1) Accomplishment of the revision required by paragraph (h) of
this AD terminates the requirements of paragraph (g) of this AD.
    (2) Accomplishment of the revision required by paragraph (h) of
this AD terminates the requirements of paragraph (q) of AD 2014-16-
23, Amendment 39-17947 (79 FR 52545, September 4, 2014).

(j) No Alternative Actions, Intervals, and/or Critical Design
Configuration Control Limitations (CDCCLs)

    After the maintenance or inspection program, as applicable, has
been revised as required by paragraph (h) of this AD, no alternative
actions (e.g., inspections), intervals, and/or CDCCLs may be used
unless the actions, intervals, and/or CDCCLs are approved as an
alternative method of compliance (AMOC) in accordance with the
procedures specified in paragraph (k)(1) of this AD.

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Tom
Rodriguez, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information
may be emailed to<EMAIL_ADDRESS>    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or EASA; or
Dassault Aviation's EASA DOA. If approved by the DOA, the approval
must include the DOA-authorized signature.

(l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2015-0095, dated May 29, 2015, for related
information. You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-
2016-5464.
    (2) For service information identified in this AD, contact
Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000,
South Hackensack, NJ 07606; telephone:<PHONE_NUMBER>; Internet:
http://www.dassaultfalcon.com. You may view this service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on April 13, 2016.
Victor Wicklund,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-09005 Filed 4-19-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 75, Number 248 (Tuesday, December 28, 2010)]
[Rules and Regulations]
[Page 81437]
[FR Doc No: 2010-32567]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-0842; Airspace Docket No. 10-ASW-11]

Amendment of Class E Airspace; Taos, NM

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace for Taos, NM.
Decommissioning of the Ski non-directional beacon (NDB) at Taos
Regional Airport, Taos, NM, has made this action necessary to enhance
the safety and management of Instrument Flight Rule (IFR) operations at
the airport.

DATES: Effective date 0901 UTC, March 10, 2011. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

History

    On October 28, 2010, the FAA published in the Federal Register a
notice of proposed rulemaking to amend Class E airspace for Taos, NM,
reconfiguring controlled airspace at Taos Regional Airport (75 FR
66345) Docket No. FAA-2010-0842. Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal to the FAA. No comments were received. Class E airspace
designations are published in paragraph 6005 of FAA Order 7400.9U dated
August 18, 2010, and effective September 15, 2010, which is
incorporated by reference in 14 CFR Part 71.1. The Class E airspace
designations listed in this document will be published subsequently in
the Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by amending Class E airspace for the Taos, NM area.
Decommissioning of the Ski NDB and cancellation of the NDB approach at
Taos Regional Airport has made this action necessary for the safety and
management of IFR operations at the airport.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, section 106, describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
subtitle VII, part A, subpart I, section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends controlled airspace at Taos Regional Airport, Taos, NM.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air)

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E. O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9U, Airspace Designations and
Reporting Points, dated August 18, 2010, and effective September 15,
2010 is amended as follows:

* * * * *

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface.

* * * * *

ASW NM E5 Taos, NM [Amended]

Taos Regional Airport, NM
    (Lat. 36[deg]27'29'' N., long. 105[deg]40'21'' W.)
Taos VORTAC
    (Lat. 36[deg]36'32'' N., long. 105[deg]54'23'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Taos Regional Airport and within 1.5
miles each side of the 129[deg] radial from the Taos VORTAC
extending from the 6.5-mile radius to 9.4 miles northwest of the
airport; and that airspace extending upward from 1,200 feet above
the surface beginning at lat. 36[deg]07'00'' N., long.
105[deg]47'42'' W., thence via the 21.3-mile arc of Taos Regional
Airport clockwise to lat. 36[deg]48'00'' N., long. 105[deg]47'35''
W., thence to lat. 36[deg]30'00'' N., long. 105[deg]30'02'' W.,
thence to the point of beginning.

    Issued in Fort Worth, Texas on December 15, 2010.
Walter L. Tweedy,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2010-32567 Filed 12-27-10; 8:45 am]
BILLING CODE 4910-13-P


State of Utah
DEPARTMENT OF ENVIRONMENTAL QUALITY
DIVISION OF AIR QUALITY

                                                             Michael O. Leavitt
                                                                       Governor
                                                       Dianne R. Nielson, Ph.D.
                                                             Executive Director
                                                              Richard W. Sprott
                                                                       Director
150 North 1950 West
P.O. Box 144820
Salt Lake City, Utah 84114-4820
(801) 536-4099 Fax
(801) 536-4414 T.D.D.
Web: www.deq.state.ut.us

                                                                    DAQE-281-02

April 12, 2002

Russell L. Christensen
Chief Engineer - Environment
Geneva Steel
P.O. Box 2500
Provo, Utah  84603

Dear Mr. Christensen:

Re:	Approval for Banked Emission Credits and Cancellation of Various Approval Orders
	Project Code:  N0796-030

Your letter received March 21, 2002, states that Geneva Steel, located at Vineyard, Utah, is shutting down several emissions units.  Geneva Steel has requested that the emissions from Approval Orders (AO) DAQE-023-96, DAQE-287-96 and DAQE-0577-93 be banked.  As requested by Geneva Steel, AOs DAQE-023-96, DAQE-287-96 and DAQE-0577-93 are now VOID.  The annual emissions from these three AOs were used to determine the emissions to be banked under R307-403-8, of the Utah Air Conservation Rules.  Under authority of the cited rule, Geneva Steel is credited in the state emission registry (maintained by the Division of Air Quality) with banked emissions credits amounting to: 183.9 tons/yr of PM10, 434.2 ton/yr of SO2 and 705.2 tons/yr of NOx.

Any future intent of Geneva Steel to use these banked credits or transfer (sell) them to another source must be documented and provided in writing to the Executive Secretary of the Utah Air Quality Board.  Please be aware that some portion of these credits may be subject to reductions that may be needed as a contingency measure for the PM10 SIP, other possible future SIP changes or Conformity Plan requirements.  Also, be reminded that normally the banked emissions can only be used in the area where the ambient environmental impact will be experienced (as shown by computer dispersion modeling).

If you have questions concerning this order, please contact John D. Jenks of our staff at<PHONE_NUMBER>.

Sincerely,

Richard W. Sprott, Executive Secretary
Utah Air Quality Board

RWS:JJ:re

cc:	Utah County Health Department
     	Teri Bateman, DAQ


[Federal Register Volume 83, Number 47 (Friday, March 9, 2018)]
[Notices]
[Pages 10487-10493]
[FR Doc No: 2018-04772]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

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

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
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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,<PHONE_NUMBER> or Robert Tuverson,
Center for Food Safety and Applied Nutrition (HFS-550), Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.

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

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

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

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

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

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

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

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

    FDA's assessment focused on whether the EU food safety control
system for shellfish contains measures that provide the same level of
protection as the food safety measures of the NSSP, which has
incorporated Federal regulations specific to fish and fishery products
(these are found at part123 and Sec.  1240.60). Thus, the NSSP, which
is implemented and enforced by the States, contains within it all
relevant Federal requirements concerning, among other things, current
good manufacturing practices, hazard analysis and Hazard Analysis
Critical Control Point (HACCP) plans, recordkeeping, sanitation control
procedures, and the restriction of interstate transport of shellfish in
an insanitary manner. The NSSP provisions, similar to the incorporated
Federal requirements, apply to both imported and domestic products
(Ref. 2). Because of the incorporation in the NSSP of the relevant
Federal requirements, we have determined that the NSSP standards are
the appropriate SPS measures to use in determining whether the EC
regulations are equivalent to U.S. shellfish safety safeguards.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

III. Recommended Determination of Equivalence With Conditions

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

IV. Additional Issues for Consideration and Comment

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

V. References

    The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

1. The WTO Agreement on the Application of Sanitary and
Phytosanitary Measures (SPS Agreement), World Trade Organization
(WTO), 1995. Accessed online at https://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm.
2. National Shellfish Sanitation Program (NSSP) Guide for the
Control of Molluscan Shellfish. Food and Drug Administration and
Interstate Shellfish Sanitation Conference. 2007 through 2015
revisions. Accessed online at https://www.fda.gov/food/guidanceregulation/federalstatefoodprograms/ucm2006754.htm.
3. Guidance on Equivalence Criteria for Food, Interstate Shellfish
Sanitation Conference Resolution 11-003, at p. 376 in National
Shellfish Sanitation Program (NSSP) Guide for the Control of
Molluscan Shellfish. Food and Drug Administration and Interstate
Shellfish Sanitation Conference. 2011 Revision. Accessed online at
https://www.fda.gov/food/guidanceregulation/federalstatefoodprograms/ucm2006754.htm.
4. Veterinary Equivalency Agreement of 1998. Accessed online at
https://trade.ec.europa.eu/doclib/docs/2003/october/tradoc_111716.pdf.
5. EU-U.S. Molluscan Shellfish Project Major Event Timeline. Food
and Drug Administration. 2016.
6. Final Report of a Mission Carried Out in the United States From
02 March to 16 March 2009 in Order to Evaluate the Control Systems
in Place Governing the Production of Bivalve Molluscs Intended for
Export to the European Union. European Commission, Health &
Consumers Directorate-General, Directorate F--Food and Veterinary
Office. DG (SANCO)/2009-8055-MR--FINAL.
7. Meeting Summary and Attachments from the U.S.-EU Molluscan
Shellfish Equivalence Project. January 27-28, 2010. Brussels,
Belgium.
8. Meeting Summary and Attachments from the U.S.-EU Molluscan
Shellfish Equivalence Project. September 21-22, 2010. College Park,
MD.
9. Final Report of an Audit Carried Out in the United States from 17
March 2015 to 27 March 2015 in Order to Evaluate the Control Systems
in Place Governing the Production of Bivalve Molluscs and Fishery
Products Derived Therefrom Intended for Export to the European
Union. European Commission, Directorate-General for Health and Food
Safety, Directorate F--Food and Veterinary Office. December 2015.
Accessed online at http://ec.europa.eu/food/audits-analysis/audit_reports/details.cfm?rep_id=3585.
10. Marine vibrio's--Summary of Food Safety Concerns Regarding Trade
of Bivalve Molluscs from USA to EU. The Center for Environment,
Fisheries & Aquaculture Science (CEFAS). April 2013. Accessed online
at https://eurlcefas.org/media/13641/ws12_13.pdf.
11. EU-U.S. Molluscan Shellfish Equivalence Project Report of the
U.S. Food and Drug Administration's On-site Assessment of Spain and
the Netherlands, 15 June-26 June, 2015. FDA. December 9, 2015.
12. Comparison Chart of FDA-NSSP-EC Provisions That Achieve the Same
Shellfish Safety Outcomes. FDA, Center for Food Safety and Applied
Nutrition. 2016.
13. FDA Evaluation of EU and U.S. Microbiological Standards Used for
Classifying Shellfish Growing Areas. Food and Drug Administration.
February 2011.
14. FDA Technical Memo to File on EU safety systems for identifying
and responding to emerging pathogens and illness events associated
with shellfish. Food and Drug Administration. November 8, 2017.
15. Community Guide to the Principles of Good Practice for the
Microbiological Classification and Monitoring of Bivalve Mollusc
Production and Relaying Areas with Regard to Regulation 854/2004.
European Commission. June 2012, updated January 2014 and January
2017. Accessed online at https://eurlcefas.org/media/13972/cg_issue-3_final-170117.pdf.
16. Microbiological Monitoring of Bivalve Mollusc Harvesting Areas
Guide to Good Practice: Technical Application. EU Working Group on
the Microbiological Monitoring of Bivalve Mollusc Harvesting Areas.
Issue 4, August 2010, updated June 2014 (Issue 5) and January 2017
(Issue 6). Accessed online at https://eurlcefas.org/media/13973/gpg_issue-6-fianl-170117.pdf.

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

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