[Federal Register Volume 79, Number 67 (Tuesday, April 8, 2014)]
[Proposed Rules]
[Pages 19301-19302]
[FR Doc No: 2014-07632]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2014-F-0364]

Eastman Chemical Company; Filing of Food Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that we have filed a petition, submitted by Eastman Chemical Company,
proposing that the food additive regulations be amended to remove the
upper bound of the melting point range in the regulation for the
antioxidant TBHQ (tertiary butylhydroquinone) and add a purity
acceptance criterion.

DATES: The food additive petition was filed on March 11, 2014.

ADDRESSES: See FOR FURTHER INFORMATION CONTACT for address.

FOR FURTHER INFORMATION CONTACT: Ellen Anderson, Center for Food Safety
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic
Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), we are giving notice
that we have filed a food additive petition (FAP 4A4803), submitted by
Eastman Chemical Company, c/o Keller and Heckman LLP, 1001 G St. NW.,
suite 500 West, Washington, DC 20001. The petition proposes to amend
the food additive regulations in Sec.  172.185 (21 CFR 172.185) TBHQ to
remove the upper bound of the melting point range specified in Sec.
172.185(a) and to add an acceptance criterion for purity as measured by
the percentage of TBHQ (not less than 99%) when tested by the titration
assay specified in the most current edition of the Food Chemicals
Codex.
    We have determined under 21 CFR 25.30(i) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

    Dated: April 1, 2014.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and
Applied Nutrition.
[FR Doc. 2014-07632 Filed 4-7-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 87, Number 125 (Thursday, June 30, 2022)]
[Notices]
[Pages 39100-39101]
[FR Doc No: 2022-13958]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-P-0069]

Determination That MICRONOR (Norethindrone Tablets, 0.35
Milligram) Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that MICRONOR (norethindrone tablets, 0.35 milligram (mg))
was not withdrawn from sale for reasons of safety or effectiveness.
This

determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for norethindrone tablets, 0.35 mg, if all other
legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-
796-3601, [email protected].

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved, and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all approved drugs. FDA publishes this list as part of the ``Approved
Drug Products With Therapeutic Equivalence Evaluations,'' which is
known generally as the ``Orange Book.'' Under FDA regulations, drugs
are removed from the list if the Agency withdraws or suspends approval
of the drug's NDA or ANDA for reasons of safety or effectiveness or if
FDA determines that the listed drug was withdrawn from sale for reasons
of safety or effectiveness (21 CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to FDA's approval of an ANDA that refers to the
listed drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an
ANDA that does not refer to a listed drug.
    MICRONOR (norethindrone tablets, 0.35 mg) is the subject of NDA
016954, held by Janssen Pharmaceuticals Inc. (Janssen), and initially
approved on January 2, 1973. MICRONOR is indicated for the prevention
of pregnancy.
    In a document dated June 6, 2018, Janssen notified FDA that the
decision to withdraw MICRONOR (norethindrone tablets, 0.35 mg) from
sale was based on business reasons and not for reasons of safety or
efficacy. FDA moved the drug product to the ``Discontinued Drug Product
List'' section of the Orange Book.
    Aurobindo Pharma USA, Inc., submitted a citizen petition dated
January 11, 2022 (Docket No. FDA-2022-P-0069), under 21 CFR 10.30,
requesting that the Agency determine whether MICRONOR (norethindrone
tablets, 0.35 mg) was withdrawn from sale for reasons of safety or
effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that MICRONOR (norethindrone tablets, 0.35 mg) was
not withdrawn for reasons of safety or effectiveness. The petitioner
has identified no data or other information suggesting that MICRONOR
(norethindrone tablets, 0.35 mg) was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of MICRONOR (norethindrone tablets, 0.35 mg)
from sale. We have also independently evaluated relevant literature and
data for possible postmarketing adverse events. We have reviewed the
available evidence and determined that this drug product was not
withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list MICRONOR
(norethindrone tablets, 0.35 mg) in the ``Discontinued Drug Product
List'' section of the Orange Book. The ``Discontinued Drug Product
List'' delineates, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to MICRONOR (norethindrone tablets,
0.35 mg) may be approved by the Agency as long as they meet all other
legal and regulatory requirements for the approval of ANDAs. If FDA
determines that labeling for this drug product should be revised to
meet current standards, the Agency will advise ANDA applicants to
submit such labeling.

    Dated: June 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13958 Filed 6-29-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 29, 2009 (Volume 74, Number 144)]
[Rules and Regulations]
[Page 37521-37523]
[DOCID:fr29jy09-5]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-1005; Directorate Identifier 2008-NM-119-AD;
Amendment 39-15981; AD 2009-15-18]
RIN 2120-AA64

Airworthiness Directives; Empresa Brasileira de Aeronautica S.A.
(EMBRAER) Model EMB-120, -120ER, -120FC, -120QC, and -120RT Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    It was found one occurrence of a fuel booster pump circuit
br[e]aker opening during an engine maintenance servicing. An
inspection inside the fuel tank revealed the fuel booster pump[']s
electrical harness chafing against its body, causing the loss of the
electrical wiring protection and resulting in a short circuit.
Further in-tank inspections have showed other fuel booster pump
electrical harnesses chafing either with the pump body and/or with
adjacent fuel lines, causing damage to the harness protective layers
and resulting * * * [in a] possible ignition source inside the fuel
tank.
* * * * *
We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective September 2, 2009.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of September 2,
2009.

ADDRESSES: You may examine the AD docket on the Internet at http://
www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-1405; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on October 7, 2008 (73
FR 58507). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    It was found one occurrence of a fuel booster pump circuit
br[e]aker opening during an engine maintenance servicing. An
inspection inside the fuel tank revealed the fuel booster pump[']s
electrical harness chafing against its body, causing the loss of the
electrical wiring protection and resulting in a short circuit.
Further in-tank inspections have showed other fuel booster pump
electrical harnesses chafing either with the pump body and/or with
adjacent fuel lines, causing damage to the harness protective layers
and resulting * * * [in a] possible ignition source inside the fuel
tank.
* * * * *
The corrective actions include revising the Limitations section of the
airplane flight manual to include a minimum fuel quantity, adding a
minimum fuel quantity limitation for operation of the fuel booster
pump, inspecting the fuel booster pump electrical harness of the left-
and right-hand fuel tanks for damage, replacing any fuel booster pump
assembly having a damaged electrical harness, installing clamps on the
tank structure, and installing tie down straps for the fuel booster
pump electrical harness. You may obtain further information by
examining the MCAI in the AD docket.

Changes to the NPRM

    We have clarified the references to the fuel booster pump by adding
``assembly'' where applicable in the paragraph immediately above this
paragraph, and in paragraphs (e) and (f)(3)(i) of the AD.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comment received.

Request To Remove Fuel Restriction for Certain Airplanes

    The manufacturer, Embraer, agrees with the main concern for issuing
the AD, and understands that the addressed unsafe condition does exist.
However, Embraer requests that operators who have inspected for and
replaced damaged wires inside the fuel tanks be excluded from the
minimum requirement of 300 kg of fuel in each tank. Embraer requests
that the AD allow operators that have already inspected their
airplanes, and are flying under a safe condition, to fly without the
restriction of 300 kg of fuel in each tank for at least 2,000 flight
hours or 12 months.
    Embraer recommends adding the following paragraph to the ``Actions
and Compliance'' section of the proposed AD: ``Aircraft that have been
inspected in accordance with paragraph (f)(3)(i) of this AD, prior to
the effective date of this AD, are exempt from the limitations imposed
by paragraphs (f)(1) and (f)(2) for a period of 12 calendar months or
2,000 flight hours from the time of inspection, whichever occurs
first.'' Embraer bases this request on

inspections of 28 airplanes where damage was found only on the first
layer of protection of the pumps' wiring, and on service experience
showing that very few fuel pumps with chafed wiring have been found on
airplanes with more than 20,000 flight hours and 18 years of operation.
    We disagree with Embraer's request to remove the fuel quantity
restriction. Paragraph (f)(4) of this AD specifies that the limitations
imposed by paragraphs (f)(1) and (f)(2) of this AD are no longer
required only after complying with both the inspection specified in
paragraph (f)(3)(i) of this AD and the installation specified in
paragraph (f)(3)(ii) of this AD (both actions must be done in
accordance with Embraer Service Bulletin 120-28-0016, dated January 9,
2008).
    We contacted Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o Civil
(ANAC), the aviation authority for Brazil, which issued the Brazilian
Airworthiness Directive 2008-05-01, effective June 13, 2008, referenced
in the NPRM. We agree with ANAC that the unsafe condition can continue
to exist until Embraer Service Bulletin 120-28-0016, dated January 9,
2008, has been accomplished, including installing the clamps in
accordance with paragraph (f)(3)(ii) of this AD. Therefore, even if the
inspection has been accomplished in accordance with paragraph (f)(3)(i)
of this AD, the limitations must remain in effect until the
installation required by paragraph (f)(3)(ii) of this AD is also done.
However, under the provisions of paragraph (g)(1) of this AD, we will
consider requests for approval of an alternative method of compliance
if sufficient data are submitted to substantiate that the method would
provide an acceptable level of safety. We have not changed the AD in
this regard.

Conclusion

    We reviewed the available data, including the comment received, and
determined that air safety and the public interest require adopting the
AD as proposed.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow our FAA policies. Any such differences
are highlighted in a NOTE within the AD.

Costs of Compliance

    We estimate that this AD will affect 110 products of U.S. registry.
We also estimate that it will take about 8 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $80 per work-hour. Required parts will cost about $269 per product.
Where the service information lists required parts costs that are
covered under warranty, we have assumed that there will be no charge
for these parts. As we do not control warranty coverage for affected
parties, some parties may incur costs higher than estimated here. Based
on these figures, we estimate the cost of this AD to the U.S. operators
to be $99,990, or $909 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 AD will not have federalism implications
under Executive Order 13132. This AD will 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 AD:
    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); and
    3. 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM, 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.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 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 adding the following new AD:

2009-15-18 Empresa Brasileira de Aeronautica S.A. (EMBRAER):
Amendment 39-15981. Docket No. FAA-2008-1005; Directorate Identifier
2008-NM-119-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective
September 2, 2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to EMBRAER Model EMB-120, -120ER, -120FC, -
120QC, and -120RT airplanes, certificated in any category, serial
numbers 120001 to 120359.

Subject

    (d) Air Transport Association (ATA) of America Code 28: Fuel.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    It was found one occurrence of a fuel booster pump circuit
br[e]aker opening during an engine maintenance servicing. An
inspection inside the fuel tank revealed the fuel booster pump[']s
electrical harness chafing against its body, causing the loss of the
electrical wiring protection and resulting in a short circuit.
Further in-tank inspections have showed other fuel booster pump
electrical harnesses chafing either with the pump body and/or with
adjacent fuel lines, causing damage to the harness protective layers
and resulting * * * [in a] possible ignition source inside the fuel
tank.
* * * * *
The corrective actions include revising the Limitations section of
the airplane flight manual (AFM) to include a minimum fuel quantity,
adding a minimum fuel quantity limitation for operation of the fuel
booster pump, inspecting the fuel booster pump electrical harness of
the left- and right-hand fuel tanks for damage, replacing any fuel
booster pump assembly having a damaged electrical harness,
installing clamps on the tank structure, and installing tie down
straps for the fuel booster pump electrical harness.

Actions and Compliance

    (f) Unless already done, do the following actions.
    (1) Within 30 days after the effective date of this AD, insert
in the Limitations section of the AFM a copy of this AD or the
following statement:

    The minimum fuel quantity inside each tank must be 300 kg (662
pounds) or 370 liters (97.75 gallons).

    (2) As of the effective date of this AD, any fuel tank defueling
or other maintenance action which demands use of the fuel booster
pumps is limited to a minimum fuel quantity of no less than 300
kilograms (662 pounds) or 370 liters (97.75 gallons) inside the
respective tank.
    (3) Within 4,000 flight hours, or 24 months, or at the next
scheduled or unscheduled fuel tank opening after the effective date
of this AD, whichever occurs first, do the following actions:
    (i) Inspect the fuel booster pump electrical harness of the
left- and right-hand fuel tanks for damage on its external
protection, in accordance with paragraph 3.F. (Part I) of the
Accomplishment Instructions of Embraer Service Bulletin 120-28-0016,
dated January 9, 2008. If any damaged fuel booster pump electrical
harness is found, before further flight, replace the affected fuel
booster pump assembly with another fuel booster pump assembly
bearing the same part number, in accordance with the Accomplishment
Instructions of Embraer Service Bulletin 120-28-0016, dated January
9, 2008.
    (ii) Install clamps and tie down straps on the tank structure
and attach each fuel booster pump electrical harness to the left-
and right-hand fuel tanks to avoid eventual chafing against the pump
body, adjacent fuel lines, structure or any other part, and to
prevent damage to the harness protective layers, in accordance with
paragraph 3.G. (Part II) of the Accomplishment Instructions of
Embraer Service Bulletin 120-28-0016, dated January 9, 2008.
    (4) After complying with the actions in paragraphs (f)(3)(i) and
(f)(3)(ii) of this AD, the limitations imposed by paragraphs (f)(1)
and (f)(2) of this AD are no longer required, and the AFM revision
required by paragraph (f)(1) of this AD may be removed from the AFM.

FAA AD Differences

    Note: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) 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. Send information to ATTN:
Sanjay Ralhan, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI Brazilian Airworthiness Directive 2008-05-01,
effective June 13, 2008; and Embraer Service Bulletin 120-28-0016,
dated January 9, 2008; for related information.

Material Incorporated by Reference

    (i) You must use Embraer Service Bulletin 120-28-0016, dated
January 9, 2008, to do the actions required by this AD, unless the
AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Empresa Brasileira de Aeronautica S.A. (EMBRAER), Technical
Publications Section (PC 060), Av. Brigadeiro Faria Lima, 2170--
Putim--12227-901 S[atilde]o Jose dos Campos--SP--BRASIL; telephone:
+55 12 3927-5852 or +55 12 3309-0732; fax: +55 12 3927-7546; e-mail:
<EMAIL_ADDRESS>Internet: http://www.flyembraer.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER> or<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

    Issued in Renton, Washington, on July 13, 2009.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-17534 Filed 7-28-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 165 (Wednesday, August 26, 2015)]
[Rules and Regulations]
[Pages 51732-51739]
[FR Doc No: 2015-21078]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0470; FRL-9929-61]

Difenoconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
difenoconazole in or on artichoke, globe; ginseng; fruit, stone, group
12-12; and nut, tree, group 14-12. This regulation additionally removes
existing tolerances in or on fruit, stone, group 12; nut, tree, group
14; and pistachio. Interregional Research Project Number 4 (IR-4)
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective August 26, 2015. Objections and
requests for hearings must be received on or before October 26, 2015,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0470, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2014-0470 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
October 26, 2015. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2014-0470, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of September 5, 2014 (79 FR 53009) (FRL-
9914-98), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3),announcing the filing of a pesticide petition (PP
4E8274) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ
08540. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of the fungicide difenoconazole,
1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-
ylmethyl]-1H-1,2,4-triazole, in or on ginseng at 0.50 parts per million
(ppm); artichoke, globe at 1.5 ppm; fruit, stone, group 12-12 at 2.5
ppm; and nut, tree, group 14-12 at 0.03 ppm. That document referenced a
summary of the petition prepared on behalf of IR-4 by Syngenta Crop
Protection, LLC, the registrant, which is available in the docket,
http://www.regulations.gov. Comments were received on the notice of
filing. EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has
revised the proposed tolerance in or on ginseng. The reason for this
change is explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in

support of this action. EPA has sufficient data to assess the hazards
of and to make a determination on aggregate exposure for difenoconazole
including exposure resulting from the tolerances established by this
action. EPA's assessment of exposures and risks associated with
difenoconazole follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Subchronic and chronic studies with difenoconazole in mice and rats
showed decreased body weights, decreased body weight gains and effects
on the liver (e.g. hepatocellular hypertrophy, liver necrosis, fatty
changes in the liver). No systemic toxicity was observed at the limit
dose in the most recently submitted rat dermal toxicity study.
    The available toxicity studies indicated no increased
susceptibility of rats or rabbits from in utero or postnatal exposure
to difenoconazole. In prenatal developmental toxicity studies in rats
and rabbits and in the 2-generation reproduction study in rats, fetal
and offspring toxicity, when observed, occurred at equivalent or higher
doses than in the maternal and parental animals.
    In a rat developmental toxicity study, developmental effects were
observed at doses higher than those which caused maternal toxicity.
Developmental effects in the rat included increased incidence of
ossification of the thoracic vertebrae and thyroid, decreased number of
sternal centers of ossification, increased number of ribs and thoracic
vertebrae, and decreased number of lumbar vertebrae. In the rabbit
study, developmental effects (increases in post-implantation loss and
resorptions and decreases in fetal body weight) were also seen at
maternally toxic doses (decreased body weight gain and food
consumption). In the 2-generation reproduction study in rats, toxicity
to the fetuses and offspring, when observed, occurred at equivalent or
higher doses than in the maternal and parental animals.
    In an acute neurotoxicity study in rats, reduced fore-limb grip
strength was observed on day one in males at the lowest-observed-
adverse-effect-level (LOAEL), and clinical signs of neurotoxicity were
observed in females only at the highest dose tested. In a subchronic
neurotoxicity study in rats, decreased hind limb strength was observed
in males only at the mid- and high-doses. The effects observed in acute
and subchronic neurotoxicity studies were considered transient.
Although there is some evidence that difenoconazole affects antibody
levels at doses that cause systemic toxicity, there are no indications
in the available studies that organs associated with immune function,
such as the thymus and spleen, are affected by difenoconazole.
    EPA is using the nonlinear reference dose (RfD) approach to assess
cancer risk. Difenoconazole is not mutagenic, and no evidence of
carcinogenicity was seen in rats.
    Evidence for carcinogenicity was seen in mice (liver tumors), but
statistically significant carcinoma tumors were only induced at
excessively-high doses. Adenomas (benign tumors) and liver necrosis
only were seen at 300 ppm (46 and 58 milligram/kilogram/day (mg/kg/day)
in males and females, respectively). Based on excessive toxicity
observed at the two highest doses in the mouse carcinogenicity study,
the presence of only benign tumors and necrosis at the mid-dose, the
absence of tumors at the study's lower doses, and the absence of
genotoxic effects, EPA has concluded that the chronic point of
departure (POD) from the chronic mouse study will be protective of any
cancer effects. The POD from this study is the no-observed-adverse-
effect-level (NOAEL) of 30 ppm (4.7 and 5.6 mg/kg/day in males and
females, respectively), which was chosen based upon only those
biological endpoints which were relevant to tumor development (i.e.,
hepatocellular hypertrophy, liver necrosis, fatty changes in the liver
and bile stasis). EPA has concluded that a nonlinear RfD approach is
appropriate for assessing cancer risk to difenoconazole and a separate
quantitative cancer exposure assessment is unnecessary since the
chronic dietary risk estimate will be protective of potential cancer
risk.
    Specific information on the studies received and the nature of the
adverse effects caused by difenoconazole as well as the NOAEL and the
LOAEL from the toxicity studies can be found at http://www.regulations.gov in document, ``Difenoconazole: Human Health Risk
Assessment for Proposed New Foliar Uses on Globe Artichoke, Ginseng and
Greenhouse Grown Cucumbers and Conversion of the Established Foliar
Uses/Tolerances for Stone Fruit Group 12 and Tree Nut Crop Group 14 to
Stone Fruit Group 12-12 and Tree Nut Group 14-12.'' at pp. 36-43 in
docket ID number EPA-HQ-OPP-2014-0470.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological POD and levels of concern to use in evaluating
the risk posed by human exposure to the pesticide. For hazards that
have a threshold below which there is no appreciable risk, the
toxicological POD is used as the basis for derivation of reference
values for risk assessment. PODs are developed based on a careful
analysis of the doses in each toxicological study to determine the dose
at which the NOAEL and the LOAEL are identified. Uncertainty/safety
factors are used in conjunction with the POD to calculate a safe
exposure level--generally referred to as a population-adjusted dose
(PAD) or an RfD--and a safe margin of exposure (MOE). For non-threshold
risks, the Agency assumes that any amount of exposure will lead to some
degree of risk. Thus, the Agency estimates risk in terms of the
probability of an occurrence of the adverse effect expected in a
lifetime. For more information on the general principles EPA uses in
risk characterization and a complete description of the risk assessment
process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for difenoconazole used
for human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of April 2, 2015 (80 FR 17697) (FRL-
9923-82).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to difenoconazole, EPA considered exposure under the
petitioned-for tolerances as well as all existing difenoconazole
tolerances in 40 CFR 180.475. EPA assessed dietary exposures from
difenoconazole in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for difenoconazole. In estimating
acute dietary exposure, EPA used food consumption information from the
United States Department of Agriculture (USDA) National Health and
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).
As to residue levels in food, EPA assumed

tolerance level residues and 100 percent crop treated (PCT)
information.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA. As to residue levels in food, EPA used USDA Pesticide Data
Program (PDP) monitoring data, average field trial residues for some
commodities, tolerance level residues for the remaining commodities,
average PCT for some commodities, and 100 PCT for the remaining
commodities.
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or nonlinear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or nonlinear approach is used and a cancer RfD is
calculated based on an earlier noncancer key event. If carcinogenic
mode of action data are not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized.
    Based on the data summarized in Unit III.A., EPA has concluded that
a nonlinear RfD approach is appropriate for assessing cancer risk to
difenoconazole. Therefore, a separate quantitative cancer exposure
assessment is unnecessary since the chronic dietary risk estimate will
be protective of potential cancer risk.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must require pursuant to FFDCA section
408(f)(1) that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such data call-ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.

In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    For the chronic dietary exposure analysis, the Agency estimated the
PCT for existing uses as follows:
    Almond, 5%; cabbage, 2.5%; cucumber, 5%; garlic, 5%; grape, 5%;
grapefruit, 2.5%; onion, 5%; orange, 2.5%; peach, 1%; pecan, 2.5%;
pepper, 2.5%; pistachio, 2.5%; pumpkin, 2.5%; squash, 5%; strawberry,
2.5%; sugar beet, 15%; tangerine, 2.5%; tomato, 25%; walnut, 2.5%;
watermelon, 5%; and wheat, 10%.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which difenoconazole may be applied in a particular area.
    2. Dietary exposure from drinking water. The drinking water
assessment was performed using a total toxic residue method, which
considers both parent difenoconazole and its major metabolite, CGA
205375, in surface and groundwater. Therefore, the Agency used
screening level water exposure models in the dietary exposure analysis
and risk assessment for difenoconazole and its major metabolite in
drinking water. These simulation models take into account data on the
physical, chemical, and fate/transport characteristics of
difenoconazole and CGA 205375. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on Surface Water Concentration Calculator (SWCC), Screening
Concentration in Ground Water (SCI-GROW), and Pesticide Root Zone Model
Ground Water (PRZM GW) models, the combined estimated drinking water
concentrations (EDWCs) of difenoconazole and CGA 205375 are estimated
to be 20.0 parts per billion (ppb) for surface water and 1.77 ppb for
ground water. For chronic exposure assessments, EDWCs are estimated to
be 13.6 ppb for surface water; EDWCs were not detected for ground water
for chronic assessments.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 20.0 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 13.6 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control,

indoor pest control, termiticides, and flea and tick control on pets).
    Difenoconazole is currently registered for the following uses that
could result in residential exposures: Treatment of ornamental plants
in commercial and residential landscapes and interior plantscapes. EPA
assessed residential exposure using the following assumptions: For
residential handlers, adult short-term dermal and inhalation exposure
is expected from mixing, loading, and applying difenoconazole on
ornamentals (gardens and trees). For residential post-application
exposures, short-term dermal exposure is expected for both adults and
children from post-application activities in treated residential
landscapes.
    The scenarios used in the aggregate assessment were those that
resulted in the highest exposures. The highest exposures consist of the
short-term dermal exposure to adults from post-application activities
in treated gardens and short-term dermal exposure to children 6 to 11
years old from post-application activities in treated gardens. Further
information regarding EPA standard assumptions and generic inputs for
residential exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Difenoconazole is a member of the triazole-containing class of
pesticides. Although conazoles act similarly in plants (fungi) by
inhibiting ergosterol biosynthesis, there is not necessarily a
relationship between their pesticidal activity and their mechanism of
toxicity in mammals. Structural similarities do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same, sequence of
major biochemical events (EPA, 2002). This document may be found at
EPA's Web site at http://www.epa.gov/oppfead1/trac/science/cumulativeguidance.pdf.
    In conazoles, however, a variable pattern of toxicological
responses is found; some are hepatotoxic and hepatocarcinogenic in
mice. Some induce thyroid tumors in rats. Some induce developmental,
reproductive, and neurological effects in rodents. Furthermore, the
conazoles produce a diverse range of biochemical events including
altered cholesterol levels, stress responses, and altered DNA
methylation. It is not clearly understood whether these biochemical
events are directly connected to their toxicological outcomes. Thus,
there is currently no evidence to indicate that conazoles share common
mechanisms of toxicity and EPA is not following a cumulative risk
approach based on a common mechanism of toxicity for the conazoles. For
information regarding EPA's procedures for cumulating effects from
substances found to have a common mechanism of toxicity, see EPA's Web
site at http://www.epa.gov/pesticides/cumulative.
    Difenoconazole is a triazole-derived pesticide. This class of
compounds can form the common metabolite 1,2,4-triazole and two
triazole conjugates (triazolylalanine and triazolylacetic acid). To
support existing tolerances and to establish new tolerances for
triazole-derivative pesticides, including difenoconazole, EPA conducted
a human health risk assessment for exposure to 1,2,4-triazole,
triazolylalanine, and triazolylacetic acid resulting from the use of
all current and pending uses of any triazole-derived fungicide. The
risk assessment is a highly conservative, screening-level evaluation in
terms of hazards associated with common metabolites (e.g., use of a
maximum combination of uncertainty factors) and potential dietary and
non-dietary exposures (i.e., high end estimates of both dietary and
non-dietary exposures). In addition, the Agency retained the additional
10X Food Quality Protection Act Safety Factor (FQPA SF) for the
protection of infants and children. The assessment includes evaluations
of risks for various subgroups, including those comprised of infants
and children.
    The Agency's complete risk assessment may be found in the
propiconazole reregistration docket at http://www.regulations.gov,
docket ID Number EPA-HQ-OPP-2005-0497. The Agency's latest complete
risk assessment for the triazole-containing metabolites was finalized
on April 9, 2015 and is entitled, ``Common Triazole Metabolites:
Updated Dietary (Food + Water) Exposure and Risk Assessment to Address
The New Section 3 Registrations For Use of Propiconazole on Tea, Dill,
Mustard Greens, Radish, and Watercress; Use of Difenoconazole on Globe
Artichoke, Ginseng and Greenhouse Grown Cucumbers and Conversion of the
Established Foliar Uses/Tolerances for Stone Fruit and Tree Nut Crop
Groups to Fruit, Stone, Group 12-12 and the Nut, Tree, Group 14-12.;
and Use of Flutriafol on Hops.'' The assessment may be found in the
propiconazole reregistration docket at http://www.regulations.gov,
docket ID number EPA-HQ-OPP-2014-0470.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA SF. In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicology database for difenoconazole includes rat and rabbit prenatal
developmental toxicity studies and a 2-generation reproduction toxicity
study in rats. The available Agency guideline studies indicated no
increased qualitative or quantitative susceptibility of rats or rabbits
to in utero and/or postnatal exposure to difenoconazole. In the
prenatal developmental toxicity studies in rats and rabbits and the 2-
generation reproduction study in rats, toxicity to the fetuses/
offspring, when observed, occurred at equivalent or higher doses than
in the maternal/parental animals. In a rat developmental toxicity study
developmental effects were observed at doses higher than those which
caused maternal toxicity. In the rabbit study, developmental effects
(increases in post-implantation loss and resorptions and decreases in
fetal body weight) were also seen at maternally toxic doses (decreased
body weight gain and food consumption). In the 2-generation
reproduction study in rats, toxicity to the fetuses/offspring, when
observed, occurred at equivalent or higher doses than in the maternal/
parental animals.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
    i. The toxicity database for difenoconazole is complete.
    ii. There are no clear signs of neurotoxicity following acute,
subchronic, or chronic exposure in multiple species in the
difenoconazole

study database. The effects observed in acute and subchronic
neurotoxicity studies are transient, and the dose-response is well
characterized with identified NOAELs. Based on the toxicity profile,
and lack of concern for neurotoxicity, there is no need for a
developmental neurotoxicity study or additional uncertainty factors
(UFs) to account for neurotoxicity.
    iii. There is no evidence that difenoconazole results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary risk assessment utilized tolerance level
residues and 100 PCT for the acute assessment; the chronic assessment
was refined by using USDA PDP monitoring data, average field trial
residues for some commodities, tolerance level residues for remaining
commodities, and average PCT for some commodities. These assumptions
will not underestimate dietary exposure to difenoconazole. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to difenoconazole in drinking water.
EPA used similarly conservative assumptions to assess postapplication
exposure of children. These assessments will not underestimate the
exposure and risks posed by difenoconazole.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to difenoconazole will occupy 49% of the aPAD for all infants less than
1 year old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
difenoconazole from food and water will utilize 89% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
difenoconazole is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Difenoconazole is currently registered for uses that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to difenoconazole.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 170 for adults
and 190 for children. Because EPA's level of concern for difenoconazole
is a MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term adverse effect was identified; however,
difenoconazole is not registered for any use patterns that would result
in intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
difenoconazole.
    5. Aggregate cancer risk for U.S. population. Based on the data
summarized in Unit III.A., the chronic dietary risk assessment is
protective of any potential cancer effects. Based on the results of
that assessment, EPA concludes that difenoconazole is not expected to
pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to difenoconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, gas chromatography with nitrogen
phosphorus detection (GC/NPD) method AG-575B, is available for the
determination of residues of difenoconazole per se in or on plant
commodities. Liquid chromatography with tandem mass spectrometry (LC/
MS/MS) method REM 147.07b is available for the determination of
residues of difenoconazole and CGA-205375 in livestock commodities.
Adequate confirmatory methods are also available.
    The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL in or on artichoke, globe.
Codex has established the following MRLs for difenoconazole: Ginseng at
0.08 ppm; dried and red ginseng at 0.2 ppm; ginseng extracts at 0.6
ppm; cherry and plum, including prune at 0.2 ppm; nectarine and peach
at 0.5 ppm; and tree nut at 0.03 ppm. The MRL for tree nut at 0.03 ppm
is the same as the tolerance being established for difenoconazole in
the United States for nut, tree, group 14-12 at 0.03 ppm. Based on the
data reviewed in conjunction with this action, harmonization with Codex
MRLs is not possible for ginseng and stone fruit

commodities (including cherry, nectarine, peach, plum, and prune). The
data supporting the EPA petition support the establishment of tolerance
levels that are higher than the established Codex MRLs. The U.S.
tolerances are being recommended by EPA are as follows: Ginseng at 1.0
ppm; and fruit, stone, group 12-12 at 2.5 ppm.

C. Response to Comments

    Several comments were received in response to the notice of filing.
All but one were concerned with potential environmental impacts, and
were not specifically related to the difenoconazole action. EPA notes
that these comments address potential environmental concerns; however,
the safety standard for approving tolerances under section 408 of the
FFDCA focuses on potential harms to human health and does not permit
consideration of effects on the environment.
    One additional comment was received that did not specifically
address the difenoconazole action, but that raised concerns about the
toxicity of pesticides and requested that no tolerance be established.
The Agency understands the commenter's concerns and recognizes that
some individuals believe that pesticides should be banned on
agricultural crops. However, the existing legal framework provided by
Section 408 of the FFDCA states that tolerances may be set when persons
seeking such tolerances or exemptions have demonstrated that the
pesticide meets the safety standard imposed by that statute. This
citizen's comment appears to be directed at the underlying statute and
not EPA's implementation of it; the citizen has made no contention that
EPA has acted in violation of the statutory framework. EPA has found
that there is a reasonable certainty of no harm to humans after
considering the toxicological studies and the exposure levels of humans
to difenoconazole.

D. Revisions to Petitioned-for Tolerances

    Based on the data supporting the petition, EPA determined that the
proposed tolerance in or on ginseng at 0.50 ppm should be established
at 1.0 ppm. Residues of difenoconazole appeared to increase
significantly with a pre-harvest interval (PHI) longer than the
proposed 0-day PHI. Average per-trial residues increased by a factor of
as much as 2.3x between the 0- and 21-day PHIs and based on this
finding, EPA determined that average per-trial residues of
difenoconazole for trials reflecting a 0-day PHI should be adjusted by
a factor of 2.3x to account for the maximum demonstrated increase in
difenoconazole residues resulting from PHIs longer than the proposed 0-
day PHI. Therefore, the adjusted residues were used in the Organization
for Economic Cooperation and Development (OECD) tolerance calculation
procedures, resulting in the recommend tolerance in or on ginseng at
1.0 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of
difenoconazole, 1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-
dioxolan-2-ylmethyl]-1H-1,2,4-triazole, in or on artichoke, globe at
1.5 ppm; ginseng at 1.0 ppm; fruit, stone, group 12-12 at 2.5 ppm; and
nut, tree, group 14-12 at 0.03 ppm. Additionally, this regulation
removes the established tolerances for residues of difenoconazole in or
on fruits, stone group 12 at 2.5 ppm; nut, tree, group 14 at 0.03 ppm;
and pistachio at 0.03 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: August 13, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.475:

0
a. Remove the entries ``Fruits, stone, group 12''; ``Nut, tree, group
14''; and ``Pistachio'' from the table in paragraph (a)(1).
0
b. Add alphabetically the following commodities to the table in
paragraph (a)(1).
    The amendments read as follows:

Sec.  180.475  Difenoconazole; tolerances for residues.

    (a)(1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Artichoke, globe..........................................          1.5

                                * * * * *
Fruit, stone, group 12-12.................................          2.5
Ginseng...................................................          1.0

                                * * * * *
Nut, tree, group 14-12....................................          0.03

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-21078 Filed 8-25-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 53 (Friday, March 18, 2011)]
[Notices]
[Pages 14966-14967]
[FR Doc No: 2011-6431]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Supplemental Notice of Technical Conference

------------------------------------------------------------------------
                                                   Docket Nos.
------------------------------------------------------------------------
Priority Rights to New Participant-     AD11-11-000.
 Funded Transmission.
Alta Wind I, LLC......................  EL10-62-000.
    Alta Wind II, LLC.................
    Alta Wind III, LLC................
    Alta Wind IV, LLC.................
    Alta Wind V, LLC..................
    Alta Wind VI, LLC.................
    Alta Wind VII, LLC................
    Alta Wind VIII, LLC...............
    Alta Windpower Development, LLC...
    TGP Development Company, LLC......
Puget Sound Energy, Inc...............  EL10-72-001.
Terra-Gen Dixie Valley, LLC, TGP Dixie  EL10-29-002.
 Development Company, LLC, and New
 York Canyon, LLC.
Green Borders Geothermal, LLC v. Terra- EL10-36-002.
 Gen Dixie Valley, LLC.
Terra-Gen Dixie Valley, LLC...........  ER11-2127-001.
Northern Pass Transmission, LLC.......  ER11-2377-000.
Cedar Creek Wind Energy, LLC..........  RC11-1-000.
Milford Wind Corridor Phase I, LLC....  RC11-2-000.
SunZia Transmission, LLC..............  EL11-24-000.
Hudson Transmission Partners, LLC.....  ER11-3017-000.

Peetz Logan Interconnect, LLC.........  ER11-2970-000.
------------------------------------------------------------------------

    On February 22, 2011, the Federal Energy Regulatory Commission
(Commission) announced that a Technical Conference on Priority Rights
to New Participant-Funded Transmission will be held on Tuesday, March
15, 2011, from 9:30 a.m. to 3:15 p.m. (EDT). The staff-led conference
will be held in the Commission Meeting Room at the Commission's
headquarters at 888 First Street, NE., Washington, DC 20426. The
conference will be open for the public to attend and advance
registration is not required. Members of the Commission may attend the
conference. On March 7, 2011, the Commission issued a supplemental
notice with an agenda for the conference.
    Discussions at the conference may address matters at issue in the
above-referenced individual proceedings that are either pending or
within their rehearing period. The March 7 Notice omitted two
proceedings before the Commission that are either pending or within
their rehearing period. This supplemental notice reflects the addition
of the following proceedings:
    Hudson Transmission Partners, LLC, Docket No. ER11-3017-000; and
Peetz Logan Interconnect, LLC, Docket No. ER11-2970-000.
    A free webcast of the technical conference will be available.
Anyone with internet access who desires to listen to this event can do
so by navigating to the Calendar of Events on the Commission's Web site
and locating this event in the Calendar. The event will contain a link
to its webcast. The Capitol Connection provides technical support for
webcasts and will offer the option of listening to the conference via
phone-bridge for a fee. If you have any questions about the webcast,
visit http://www.CapitolConnection.org or call<PHONE_NUMBER>.
    This conference will also be transcribed. Transcripts will be
available immediately, for a fee, from Ace Reporting Company (202-347-
3700 or<PHONE_NUMBER>).
    FERC conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations please
send an e-mail to<EMAIL_ADDRESS>or call toll free (866) 208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a fax to<PHONE_NUMBER>
with the requested accommodations.
    For further information please contact Becky Robinson at (202) 502-
8868 or<EMAIL_ADDRESS>or Pierson Stoecklein at (202) 502-
6372 or<EMAIL_ADDRESS>
    Dated: March 9, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-6431 Filed 3-17-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 139 (Friday, July 21, 2017)]
[Proposed Rules]
[Pages 33851-33852]
[FR Doc No: 2017-15267]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2016-0656; FRL-9965-13-Region 4]

Air Plan Approval; Florida: Unnecessary Rule Removal

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a revision to the Florida State Implementation Plan submitted
by the Florida Department of Environmental Protection on February 20,
2013. The revision removes unnecessary and superseded rules from the
Florida State Implementation Plan. Specifically, this revision removes
non-regulatory introductory language, as well as a regulation that has
been superseded by more stringent federal regulations. This action is
being taken pursuant to the Clean Air Act.

DATES: Written comments must be received on or before August 21, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2016-0656 at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the Web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on

making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Sean Lakeman, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. Mr. Lakeman can be reached via telephone at<PHONE_NUMBER>
or via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules Section of this Federal
Register, EPA is approving the State's implementation plan revision as
a direct final rule without prior proposal because the Agency views
this as a noncontroversial submittal and anticipates no adverse
comments. A detailed rationale for the approval is set forth in the
direct final rule. If no adverse comments are received in response to
this rule, no further activity is contemplated. If EPA receives adverse
comments, the direct final rule will be withdrawn and all public
comments received will be addressed in a subsequent final rule based on
this proposed rule. EPA will not institute a second comment period on
this document. Any parties interested in commenting on this document
should do so at this time.

    Dated: July 7, 2017.
V. Anne Heard,
Acting Regional Administrator, Region 4.
[FR Doc. 2017-15267 Filed 7-20-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 121 (Thursday, June 23, 2016)]
[Rules and Regulations]
[Pages 40783-40785]
[FR Doc No: 2016-14902]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 748

[Docket No. 160303186-6186-01]
RIN 0694-AG91

Amendments to Existing Validated End-User Authorization in the
People's Republic of China: Advanced Micro Devices, Inc.

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: In this rule, the Bureau of Industry and Security (BIS) amends
the Export Administration Regulations (EAR) to revise the existing
Validated End-User (VEU) list for the People's Republic of China by
updating the list of eligible items and destinations (facilities) for
VEU Advanced Micro Devices, Inc. (AMD). Specifically, BIS amends
Supplement No. 7 to part 748 of the EAR to remove an existing
``eligible destination'' (facility); add a building to an existing
address at one of AMD's already approved facilities to which eligible
items may be exported, reexported or transferred (in-country); and
reflect the recent removal of an existing ``eligible item'' from the
Commerce Control List (CCL).

DATES: This rule is effective June 23, 2016.

FOR FURTHER INFORMATION CONTACT: Chair, End-User Review Committee,
Office of the Assistant Secretary, Export Administration, Bureau of
Industry and Security, U.S. Department of Commerce, Phone: 202-482-
5991; Email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

Authorization Validated End-User

    Validated End-Users (VEUs) are designated entities located in
eligible destinations to which eligible items may be exported,
reexported, or transferred (in-country) under a general authorization
instead of a license. The names of the VEUs, as well as the dates they
were so designated, and their respective eligible destinations
(facilities) and items are identified in Supplement No. 7 to part 748
of the EAR. Under the terms described in that supplement, VEUs may
obtain eligible items without an export license from BIS, in conformity
with section 748.15 of the EAR. Eligible items vary between VEUs and
may include commodities, software, and technology, except those
controlled for missile technology or crime control reasons on the
Commerce Control List (CCL) (part 774 of the EAR).
    VEUs are reviewed and approved by the U.S. Government in accordance
with the provisions of section 748.15 and Supplement Nos. 8 and 9 to
part 748 of the EAR. The End-User Review Committee (ERC), composed of
representatives from the Departments of State, Defense, Energy,
Commerce, and other agencies as appropriate, is responsible for
administering the VEU program. BIS amended the EAR in a final rule
published on June 19, 2007 (72 FR 33646), to create Authorization VEU.

Amendments to Existing VEU Authorization for Advanced Micro Devices,
Inc. (AMD) in the People's Republic of China

Revision to the List of ``Eligible Destinations'' and ``Eligible
Items'' for AMD

    In this final rule, BIS amends Supplement No. 7 to part 748 to
revise AMD's VEU authorization. Specifically, in this rule BIS removes
one of AMD's existing eligible destinations (facilities). Also, in this
rule, BIS adds a building to an existing address at one of AMD's
facilities already approved under Authorization VEU, to which the
company's eligible items may be exported, reexported or transferred
(in-country) in the People's Republic of China (PRC) under the
authorization. Finally, in this rule, BIS removes Export Control
Classification Number (ECCN) 4D002 from the list of AMD's eligible
items to reflect the removal of that item from the CCL by 80 FR 29432
(May 21, 2015). The amendments to the eligible destinations
(facilities) are in response to a request from AMD, while the amendment
to the eligible items list reflects the recent removal of that ECCN
from the CCL. All amendments were approved by the ERC. The revisions
are as follows:

Removal of AMD's Eligible Destination (Facility)

    AMD Technologies (China) Co., Ltd., No. 88, Su Tong Road, Suzhou,
China 215021.

Revision and Update of Address for One of AMD's Eligible Destinations
(Facilities)

Current Address: Advanced Micro Devices (Shanghai) Co., Ltd., Buildings
46, 47, 48 & 49, River Front Harbor, Zhangjiang Hi-Tech Park, 1387
Zhangdong Rd., Pudong, Shanghai, China 201203
New Address: Advanced Micro Devices (Shanghai) Co., Ltd., Buildings 33
(Unit 1), 46, 47, 48 & 49, River Front Harbor, Zhangjiang Hi-Tech Park,
No. 1387 Zhang Dong Road, Pudong District, Shanghai, China 201203

Removal of AMD's Eligible Item: ECCN 4D002

    With this revision, AMD's ``Eligible Items'' are as follows: 3D002,
3D003, 3E001 (limited to ``technology'' for items classified under
3C002 and 3C004 and ``technology'' for use during the International
Technology Roadmap for Semiconductors (ITRS) process for items
classified under ECCNs 3B001 and 3B002), 3E002 (limited to
``technology'' for use during the ITRS process for items classified
under ECCNs 3B001 and 3B002), 3E003.e (limited to the ``development''
and ``production'' of integrated circuits for commercial applications),
4D001 and 4E001 (limited to the ``development'' of products under ECCN
4A003.

Export Administration Act

    Although the Export Administration Act expired on August 20, 2001,
the President, through Executive Order 13222 of August 17, 2001, 3 CFR,
2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March
8, 2013, 78 FR 16129 (March 13, 2013) and as extended by the Notice of
August 7, 2015, 80 FR 48233 (August 11, 2015), has continued the Export
Administration Regulations in effect under the International Emergency
Economic Powers Act. BIS continues to carry out the provisions of the
Export Administration Act, as appropriate and to the extent permitted
by law, pursuant to Executive Order 13222 as amended by Executive Order
13637.

Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, reducing costs, harmonizing rules, and promoting flexibility.
This rule has been determined to be not significant for purposes of
Executive Order 12866.
    2. This rule involves collections previously approved by the Office
of Management and Budget (OMB) under Control Number 0694-0088, ``Multi-
Purpose Application,'' which carries a burden hour estimate of 43.8
minutes to prepare and submit form BIS-748; and for recordkeeping,
reporting and review requirements in connection with Authorization VEU,
which carries an estimated burden of 30 minutes per submission. This
rule is expected to result in a decrease in license applications
submitted to BIS. Total burden hours associated with the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA) and OMB Control
Number 0694-0088 are not expected to increase significantly as a result
of this rule. Notwithstanding any other provisions of law, no person is
required to respond to, nor be subject to a penalty for failure to
comply with a collection of information subject to the requirements of
the PRA, unless that collection of information displays a currently
valid OMB Control Number.
    3. This rule does not contain policies with Federalism implications
as that term is defined under Executive Order 13132.
    4. Pursuant to the Administrative Procedure Act (APA), 5 U.S.C.
553(b)(B), BIS finds good cause to waive requirements that this rule be
subject to notice and the opportunity for public comment because they
are unnecessary. In determining whether to grant VEU designations, a
committee of U.S. Government agencies evaluates information about and
commitments made by candidate companies, the nature and terms of which
are set forth in 15 CFR part 748, Supplement No. 8. The criteria for
evaluation by the committee are set forth in 15 CFR 748.15(a)(2). The
information, commitments, and criteria for this extensive review were
all established through the notice of proposed rulemaking and public
comment process (71 FR 38313 (July 6, 2006) (proposed rule), and 72 FR
33646 (June 19, 2007) (final rule)). Given the similarities between the
authorizations provided under the VEU program and export licenses (as
discussed further below), the publication of this information does not
establish new policy. In publishing this final rule, BIS amends the
authorization for an existing eligible VEU to remove an eligible
destination (facility), revise an existing eligible destination
(facility) to add a building, and remove an eligible item no longer
listed on the CCL. These changes have been made within the established
regulatory framework of the VEU program. Further, this rule does not
abridge the rights of the public or eliminate the public's option to
export under any of the forms of authorization set forth in the EAR.
    Publication of this rule in other than final form is unnecessary
because the authorizations granted in the rule are consistent with the
authorizations granted to exporters for individual licenses (and
amendments or revisions thereof), which do not undergo public review.
In addition, as with license applications, VEU authorization
applications contain confidential business information, which is
necessary for the extensive review conducted by the U.S. Government in
assessing such applications. This information is extensively reviewed
according to the criteria for VEU authorizations, as set out in 15 CFR
748.15(a)(2). Additionally, just as license applications are reviewed
through an interagency review process, the authorizations granted under
the VEU program involve interagency deliberation and result from review
of public and non-public sources, including licensing data, and the
measurement of such information against the VEU authorization criteria.
Given the nature of the review, and in light of the parallels between
the VEU application review process and the review of license
applications, public comment on this authorization and subsequent
amendments prior to publication is unnecessary. Moreover, because, as
noted above, the criteria and process for authorizing and administering
VEUs were developed with public comments, allowing additional public
comment on this amendment to individual VEU authorizations, which was
determined according to those criteria, is unnecessary.
    Section 553(d) of the APA generally provides that rules may not
take effect earlier than thirty (30) days after they are published in
the Federal Register. However, BIS finds good cause to waive the 30-day
delay in effectiveness for this rule pursuant to 5 U.S.C. 553(d)(3)
because the delay would be contrary to the public interest. BIS is
simply amending the authorization of an existing VEU by removing an
existing eligible destination (facility), revising the address of
another eligible destination (facility) to add a building, and removing
an eligible item no longer listed on the CCL. BIS amends the EAR in
this rule consistent with established objectives and parameters
administered

and enforced by the responsible designated departmental representatives
to the End-User Review Committee. Delaying this action's effectiveness
would likely cause confusion regarding which items are authorized by
the U.S. Government and in turn stifle the purpose of the VEU Program.
Accordingly, it is contrary to the public interest to delay this rule's
effectiveness.
    No other law requires that a notice of proposed rulemaking and an
opportunity for public comment be given for this final rule. Because a
notice of proposed rulemaking and an opportunity for public comment are
not required under the APA or by any other law, the analytical
requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.)
are not applicable. As a result, no final regulatory flexibility
analysis is required and none has been prepared.

List of Subjects in 15 CFR Part 748

    Administrative practice and procedure, Exports, Reporting and
recordkeeping requirements.

    Accordingly, part 748 of the EAR (15 CFR parts 730-774) is amended
as follows:

PART 748--[AMENDED]

0
1. The authority citation for part 748 continues to read as follows:

    Authority:  50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O.
13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR
44025, 3 CFR, 2001 Comp., p. 783; Notice of August 7, 2015, 80 FR
48233 (August 11, 2015).

0
2. Amend Supplement No. 7 to part 748 by revising the entry for
``Advanced Micro Devices China, Inc.'' in ``China (People's Republic
of)'' to read as follows:

  Supplement No. 7 to Part 748--Authorization Validated End-User (Veu): List of Validated End-Users, Respective
                  Items Eligible for Export, Re-export and Transfer, and Eligible Destinations
----------------------------------------------------------------------------------------------------------------
                                    Validated  end-     Eligible items         Eligible        Federal Register
             Country                     user              (by ECCN)          destination          citation
----------------------------------------------------------------------------------------------------------------
 Nothing in this Supplement shall be deemed to supersede other provisions in the EAR, including but not limited
                                              to Sec.   748.15(c).
----------------------------------------------------------------------------------------------------------------
China (People's Republic of)....  Advanced Micro      3D002, 3D003,       Advanced Micro      75 FR 25763, 5/10/
                                   Devices China,      3E001 (limited to   Devices             10.
                                   Inc.                ``technology''      (Shanghai) Co.,    76 FR 2802, 1/18/
                                                       for items           Ltd., Buildings     11.
                                                       classified under    33 (Unit 1), 46,   78 FR 3319, 1/16/
                                                       3C002 and 3C004     47, 48 & 49,        13.
                                                       and                 River Front        81 FR [INSERT PAGE
                                                       ``technology''      Harbor,             NUMBER],
                                                       for use during      Zhangjiang Hi-     6/23/16.
                                                       the International   Tech Park, No.
                                                       Technology          1387 Zhang Dong
                                                       Roadmap for         Road, Pudong
                                                       Semiconductors      District,
                                                       (ITRS) process      Shanghai, China
                                                       for items           201203.
                                                       classified under   AMD Technology
                                                       ECCNs 3B001 and     Development
                                                       3B002), 3E002       (Beijing) Co.,
                                                       (limited to         Ltd., North and
                                                       ``technology''      South Buildings,
                                                       for use during      RaycomInfotech,
                                                       the ITRS process    Park Tower C, No.
                                                       for items           2 Science
                                                       classified under    Institute South
                                                       ECCNs 3B001 and     Rd., Zhong Guan
                                                       3B002), 3E003.e     Cun, Haidian
                                                       (limited to the     District,
                                                       ``development''     Beijing, China
                                                       and                 100190.
                                                       ``production'' of
                                                       integrated
                                                       circuits for
                                                       commercial
                                                       applications),
                                                       4D001 and 4E001
                                                       (limited to the
                                                       ``development''
                                                       of products under
                                                       ECCN 4A003).
----------------------------------------------------------------------------------------------------------------
 Nothing in this Supplement shall be deemed to supersede other provisions in the EAR, including but not limited
                                              to Sec.   748.15(c).
----------------------------------------------------------------------------------------------------------------
                                                                          AMD Products
                                                                           (China) Co. Ltd.,
                                                                           North and South
                                                                           Buildings,
                                                                           RaycomInfotech
                                                                           Park Tower C, No.
                                                                           2 Science
                                                                           Institute South
                                                                           Rd., Zhong Guan
                                                                           Cun, Haidian
                                                                           District,
                                                                           Beijing, China
                                                                           100190.
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

    Dated: June 17, 2016.
Matthew S. Borman,
Deputy Assistant Secretary for Export Administration.
[FR Doc. 2016-14902 Filed 6-22-16; 8:45 am]
 BILLING CODE 3510-33-P