[Federal Register Volume 78, Number 83 (Tuesday, April 30, 2013)]
[Notices]
[Pages 25266-25267]
[FR Doc No: 2013-10157]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9807-9; Docket ID No. EPA-HQ-ORD-2013-0189]

An Assessment of Potential Mining Impacts on Salmon Ecosystems of
Bristol Bay, Alaska

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing a
public comment period for the revised draft document titled, ``An
Assessment of Potential Mining Impacts on Salmon Ecosystems of Bristol
Bay, Alaska'' (EPA-910-R-12-004Ba-c). The document was revised by the
EPA after reviewing comments received from the public between May 18
and July 23, 2012 and input from the peer review panel held in August
2012. The EPA conducted this assessment to determine the significance
of Bristol Bay's ecological resources and the potential impacts of
large-scale mining on these resources.

DATES: The public comment period will begin with the publication of
this notice and will end Friday, May 31, 2013. Technical comments
should be in writing and must be received by EPA by May 31, 2013.

ADDRESSES: The revised draft ``An Assessment of Potential Mining
Impacts on Salmon Ecosystems of Bristol Bay, Alaska'' is available
primarily via the Internet on the EPA Region 10 Bristol Bay Web site at
www.epa.gov/bristolbay as well as on the National Center for
Environmental Assessment's Web site under the Recent Additions and the
Data and Publications menus at www.epa.gov/ncea. A limited number of CD
copies are available from the Information Management Team, NCEA;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>. If you are requesting
a CD copy, please provide your name, your mailing address, and the
document title, ``An Assessment of Potential Mining Impacts on Salmon
Ecosystems of Bristol Bay, Alaska.''
    Comments on the report may be submitted electronically via
www.regulations.gov, by email, by mail, by facsimile, or by hand
delivery/courier. Please follow the detailed instructions provided in
the SUPPLEMENTARY INFORMATION section of this notice.

FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the Office of Environmental Information Docket;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or email<EMAIL_ADDRESS>    For technical information concerning the report, contact Judy
Smith; telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Information About the Project/Document

    The U.S. Environmental Protection Agency (EPA) conducted this
assessment to provide a characterization of the biological and mineral
resources of the Bristol Bay watershed, increase understanding of the
potential impacts of large-scale mining on the region's fish resources,
and inform future governmental decisions.
    A previous draft was released for public comment on May 18, 2012
(77 FR 31353, May 25, 2012). Peer review panel members were announced
June 5, 2012 (77 FR 33213, June 5, 2012), and the external peer review
meeting was announced July 6, 2012 (77 FR 40037, July 6, 2012). The
external peer review meeting was held in Anchorage, AK, August 7-9,
2012. This revised draft was completed by the agency to address public
and peer review comments provided on the May 2012 draft.
    EPA is releasing this revised draft assessment for the purposes of
public comment. This draft assessment is not final as described in
EPA's information quality guidelines, and it does not represent and
should not be construed to represent Agency policy or views.
    EPA is seeking comments from the public on all aspects of the
report, including the scientific and technical information presented in
the report, the realistic mining scenario used, the data and
information used to inform assumptions about mining activities and the
evaluations of risk to the fishery, and the potential mitigation
measures considered (and effectiveness of those measures). EPA is also
specifically seeking any additional data or scientific or technical
information about Bristol Bay resources or large-scale mining that
should be considered in our evaluation. EPA will consider any public
comments submitted in accordance with this notice when revising the
document.

II. How To Submit Technical Comments to the Docket at
www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2013-
0189, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>Include the docket number in
the subject line of the message.
     Fax:<PHONE_NUMBER>.
     Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 28221T), Docket ID No. EPA-HQ-ORD-2013-0189, U.S.
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460. The phone number is<PHONE_NUMBER>. If you provide
comments by mail, please submit one unbound original with pages
numbered consecutively, and three copies of the comments. For
attachments, provide an index, number pages consecutively with the
comments, and submit an unbound original and three copies.
     Hand Delivery: The OEI Docket is located in the EPA
Headquarters Docket Center, Room 3334, EPA West Building, 1301
Constitution Ave. NW., Washington, DC. The EPA Docket Center 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 202-566-
1744. Deliveries are only accepted during the docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information. If you provide comments by hand delivery, please
submit one unbound original with pages numbered consecutively, and
three copies of the comments. For attachments, provide an index, number
pages consecutively with the comments, and submit an unbound original
and three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2013-0189. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to include all comments it receives in the public docket
without change and to make the comments available on-line at
www.regulations.gov, including any personal information provided,
unless a comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comments due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comments.
Electronic files should avoid the use of special characters and any
form of encryption and be free of any defects or viruses. For
additional information about EPA's public docket, visit the EPA Docket
Center homepage at www.epa.gov/epahome/dockets.htm.
    Docket: Documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
at www.regulations.gov or in hard copy at the OEI Docket in the EPA
Headquarters Docket Center.

    Dated: April 10, 2013.
James K. Gallahan,
Acting Deputy Director, National Center for Environmental Assessment.
[FR Doc. 2013-10157 Filed 4-29-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 169 (Wednesday, August 31, 2016)]
[Notices]
[Pages 60037-60038]
[FR Doc No: 2016-20884]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78677; File No. SR-NYSEArca-2013-107]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting an
Extension to Limited Exemption From Rule 612(c) of Regulation NMS in
Connection With the Exchange's Retail Liquidity Program Until December
31, 2016

August 25, 2016.
    On December 23, 2013, the Securities and Exchange Commission
(``Commission'') issued an order pursuant to its authority under Rule
612(c) of Regulation NMS (``Sub-Penny Rule'') \1\ that granted NYSE
Arca, Inc. (``Exchange'') a limited exemption from the Sub-Penny Rule
in connection with the operation of the Exchange's Retail Liquidity
Program (``Program'').\2\ The limited exemption was granted
concurrently with the Commission's approval of the Exchange's proposal
to adopt the Program for a one-year pilot term.\3\ The exemption was
granted coterminous with the effectiveness of the pilot Program; both
the pilot Program and exemption are scheduled to expire on August 31,
2016.\4\
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    \1\ 17 CFR 242.612(c).
    \2\ See Securities Exchange Act Release No. 71176 (December 23,
2013), 78 FR 79524 (December 30, 2013) (SR-NYSEArca-2013-107)
(``Order'').
    \3\ See id.
    \4\ The pilot term of the Program was originally scheduled to
end on April 14, 2015, but the Exchange initially extended the term
through September 30, 2015, see Securities Exchange Act Release No.
74572 (March 24, 2015), 80 FR 16705 (March 30, 2015) (NYSEArca-2015-
22), and then subsequently extended the term again through August
31, 2016, see Securities Exchange Act Release Nos. 75994 (September
28, 2015), 80 FR 59834 (October 2, 2015) (SR-NYSEArca-2015-84),
77236 (Feb. 25, 2016), 81 FR 10943 (March 2, 2016) (SR-NYSEArca-
2016-30), and 77425 (March 23, 2016), 81 FR 17523 (March 29, 2016)
(SR-NYSEArca-2016-47). Each time the pilot term of the Program was
extended, the Commission granted the Exchange's request to also
extend the Sub-Penny exemption through September 30, 2015, see
Securities Exchange Act Release No. 74609 (March 30, 2015), 80 FR
18272 (April 3, 2015), March 31, 2016, see Securities Exchange Act
Release No. 34-76021 (September 29, 2015), 80 FR 60207 (October 5,
2015), and August 31, 2016, see Securities Exchange Act Release No.
34-77437 (March 24, 2016), 81 FR 17752 (March 30, 2016).
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    The Exchange now seeks to extend the exemption until December 31,
2016.\5\ The Exchange's request was made in conjunction with an
immediately effective filing that extends the operation of the Program
through the same date.\6\ In its request to extend the exemption, the
Exchange notes that the participation in the Program has increased more
recently. Accordingly, the Exchange has asked for additional time to
allow itself and the Commission to analyze more robust data concerning
the Program, which the Exchange committed to provide to the
Commission.\7\ For this reason and the reasons stated in the Order
originally granting the limited exemption, the Commission finds that
extending the exemption, pursuant to its authority under Rule 612(c) of
Regulation NMS, is appropriate in the public interest and consistent
with the protection of investors.
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    \5\ See Letter from Martha Redding, Assistant Secretary, NYSE,
to Brent J. Fields, Secretary, Securities and Exchange Commission,
dated August 8, 2016.
    \6\ See Securities Exchange Act Release No. 78601 (August 17,
2016), 81 FR 57632 (August 23, 2016) (SR-NYSEArca-2016-113).
    \7\ See Order, supra note 2, 78 FR at 79529.
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    THEREFORE, IT IS HEREBY ORDERED that, pursuant to Rule 612(c) of
Regulation NMS, the Exchange is granted a limited exemption from Rule
612 of Regulation NMS that allows it to accept and rank orders priced
equal to or greater than $1.00 per share in increments of $0.001, in
connection with the operation of its Retail Liquidity Program, until
August 31, 2016.
    The limited and temporary exemption extended by this Order is
subject to modification or revocation if at any time the Commission
determines that such action is necessary or appropriate in furtherance
of the purposes of the Securities Exchange Act of 1934. Responsibility
for compliance with any applicable provisions of the Federal securities
laws must rest with the persons relying on the exemption that is the
subject of this Order.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
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    \8\ 17 CFR 200.30-3(a)(83).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-20884 Filed 8-30-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 69 (Friday, April 10, 2015)]
[Proposed Rules]
[Pages 19251-19252]
[FR Doc No: 2015-07991]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 121

[Docket No. FAA-2015-0881]

Interpretation of the Flight Time Limitations

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of Proposed Interpretation

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SUMMARY: This action proposes to interpret our regulations to not apply
to flight segments that are flown by a flightcrew consisting of only
two pilots and no other flight crewmembers.

DATES: Comments must be received on or before May 11, 2015.

ADDRESSES: You may send comments identified by docket number FAA-2015-
0881 using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send Comments to Docket Operations, M-30; US
Department of Transportation, 1200 New Jersey Avenue SE., West Building
Ground Floor, Room W12-140, West Building Ground Floor, Washington, DC
20590-0001.
     Hand Delivery: Take comments to Docket Operations in Room
W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue
SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
     Fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Alex Zektser, Attorney, Regulations
Division, Office of Chief Counsel, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
8018; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites interested persons to submit written comments,
data, or views concerning this proposal. The most helpful comments
reference a specific portion of the proposal, explain the reason for
any recommended change, and include supporting data. To ensure the
docket does not contain duplicate comments, please send only one copy
of written comments, or if you are filing comments electronically,
please submit your comments only one time.
    The FAA will file in the docket all comments received, as well as a
report summarizing each substantive public contact with FAA personnel
concerning this proposal. Before acting on this proposal, the FAA will
consider all comments received on or before the closing date for
comments and any late-filed comments if it is possible to do so without
incurring expense or delay. The FAA may change this proposal in light
of comments received.

Availability of This Proposed Interpretation

    You can get an electronic copy using the Internet by--
    (1) Searching the Federal eRulemaking Portal (http://www.regulations.gov);
    (2) Visiting the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies/; or
    (3) Accessing the Government Publishing Office's Web page at http://www.gpoaccess.gov/fr/index.html.
    You can also get a copy by sending a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue SW., Washington, DC 20591, or by calling<PHONE_NUMBER>. Make
sure to identify the docket number or notice number of this proposal.

Background

    The FAA has been asked to provide two legal interpretations
regarding the application of 14 CFR 121.521. Specifically, both
interpretation requests present scenarios involving supplemental all-
cargo part 121 operations that contain at least one international
segment and make an election, under 14 CFR 121.513, to operate under
the flight time limitations of Sec.  121.515 and Sec. Sec.  121.521
through 121.525.
    Both scenarios involve, in part, at least one segment in which the
aircraft would be flown by a flightcrew consisting solely of two pilots
and no other flight crewmembers. Both

interpretation requests then ask the FAA to determine which specific
flight, duty, and rest regulations would apply to these scenarios.
Accordingly, the FAA must determine whether 14 CFR 121.521 applies to a
flightcrew consisting solely of two pilots. For the reasons discussed
below, the FAA proposes to find that Sec.  121.521 does not apply to
any flight segment that is flown by a flightcrew consisting only of two
pilots and no other flight crewmembers.

Discussion of the Proposal

    Normally, air carriers conducting all-cargo supplemental operations
under part 121 must operate pursuant to the flight, duty, and rest
provisions of Sec. Sec.  121.503 through 121.509. However, supplemental
air carriers conducting overseas and international all-cargo operations
may elect, pursuant to Sec.  121.513, to comply with the flight time
limitations of Sec.  121.515 and Sec. Sec.  121.521 through 121.525
(commonly referred to as the ``international rules'').\1\
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    \1\ 14 CFR 121.513.
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    Section 121.521 governs the smallest-size flightcrew that can
operate under these international rules. The regulatory text of Sec.
121.521 unambiguously states that this section applies only to a ``crew
of two pilots and at least one additional flight crewmember.'' \2\
Thus, the plain text of Sec.  121.521 states that there must be at
least three flight crewmembers in order for Sec.  121.521 to apply: (1)
two pilots; and (2) at least one additional flight crewmember. The FAA
reaffirmed this plain-text reading of Sec.  121.521 in a 2012
interpretation in which it found that a flightcrew consisting of three
pilots would be subject to the provisions of Sec.  121.521.\3\
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    \2\ 14 CFR 121.521(a) (emphasis added).
    \3\ Letter to Timothy Slater from Rebecca MacPherson, Assistant
Chief Counsel for Regulations (Sept. 7, 2012) (answer to Question
1).
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    Because Sec.  121.521 governs the smallest-size flightcrew that can
operate under the international part 121 flight, duty, and rest rules
for supplemental all-cargo operations and because Sec.  121.521 only
applies to a flightcrew that has at least three flight crewmembers, the
FAA proposes to find that Sec.  121.521 does not apply to a flightcrew
of only two pilots and no other flight crewmembers. Under the proposed
interpretation and consistent with the FAA's precedent, a flightcrew of
only two pilots in a supplemental part 121 all-cargo operation would be
subject to the provisions of Sec.  121.503 and Sec.  121.505, which,
among other things, apply to a flightcrew consisting solely of two
pilots.

    Issued in Washington, DC on April 1, 2015.
Mark W. Bury,
Assistant Chief Counsel for Regulations, AGC-200.
[FR Doc. 2015-07991 Filed 4-9-15; 8:45 am]
 BILLING CODE 4910-13-P?>


EPA REGISTRATION DIVISION - COMPANY NOTICE OF FILING OF PESTICIDE PETITION
EPA Registration Division contact: Sidney Jackson<PHONE_NUMBER>
Interregional Research Project Number 4 (IR-4)
Pesticide Petition Number: 2E8117
	EPA has received a pesticide petition (PP# 3E8175) from IR-4, which Syngenta Crop Protection LLC supports, requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance for the combined residues of the insecticide avermectin B1 (a mixture of avermectins containing greater than or equal to 80% avermectin B1a (5-O- demethyl avermectin A1) and less than or equal to 20% avermectin B1b (5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl) avermectin A1)) and its delta-8,9-isomer in or on caneberry subgroup 13-07A to 0.20 ppm.  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.
A. Residue Chemistry
	1. Plant metabolism. The metabolism of abamectin in plants is adequately understood and the residues of concern include the parent insecticide abamectin (also referred to as avermectin B1 which is a mixture of a minimum of 80% avermectin B1a and a maximum of 20% avermectin B1b) and the delta 8,9-isomer of the B1a and of the B1b components of the parent insecticide.
	2. Analytical method. The analytical methods involve homogenization, filtration, partition, and cleanup with analysis by high performance liquid chromotography (HPLC)-fluorescence detection. The methods are sufficiently sensitive to detect residues at or above the tolerances proposed. All methods have undergone independent laboratory validation.
	3. Magnitude of residues, Caneberry
      Magnitude of residue data have been collected from seven field trials located in NAFTA Regions.  At each trial, three foliar applications of the test substance were made 6-8 days apart to the treated plots.  The application rates ranged from 0.0173 to 0.0206 pound of active ingredient per acre (lb ai/A) per application for a total rate range of 0.0547 to 0.0605 lb ai/A per season.  All applications were made using appropriate spray equipment, and the spray volume was sufficient to provide adequate dispersal of the test substance.
	Sampling started in the untreated control plot and ended in the treated plot.  At all the field trials, samples were harvested 7 days after the last application.  Additionally, at the OR03 trial, duplicate samples were collected 0, 3, 7 and 9 days after the last application.
	The total residues of abamectin ranged from 0.0062 to 0.1215 ppm in samples taken at 7 days PHI.  The residues declined over time.  Data from this study may be used to support a tolerance proposal for abamectin on caneberry subgroup 13-07A.

B. Toxicological Profile
	1. Acute toxicity.  The database includes the following studies with Syngenta's technical abamectin products:

Abamectin Technical:
i. A rat acute oral study with a lethal dose (LD)50 of 13.6 milligram per kilogram (mg/kg).
ii. A rat acute oral study with a LD50 of 214-232 mg/kg.
iii. A rabbit acute dermal study with a LD50 of 2000 mg/kg.
iv. A rat acute inhalation study with a lethal concentration (LC)50 of 0.21 mg/liter (L) (nose only).
v. A primary eye irritation study in rabbits which showed no irritation.
vi. A primary skin irritation study in rabbits which showed slight irritation.
vii. A dermal sensitization study (Buehler) in guinea pigs which was negative.

Abamectin Technical II

i. A rat acute oral study with a LD50 of 372.5  mg/kg
ii. A rat acute dermal study with a LD50 of >200 mg/kg but <2000 mg/kg
ii. A rat acute inhalation study with a LC50 of >0.0518 mg/L (nose only)
v. A primary eye irritation study in rabbits which showed no irritation.
vi. A primary skin irritation study in rabbits which showed slight irritation.
vii. A dermal sensitization study (Buehler) in guinea pigs with Abamectin Technical supports the registration of this technical.

	2. Genotoxicty. The Ames assays conducted with and without metabolic activation were both negative. The V - 79 mammalian cell mutagenesis assays conducted with and without metabolic activation did not produce mutations. In an alkaline elution/rat hepatocyte assay, abamectin was found to induce single strand DNA breaks without significant toxicity in rat hepatocytes treated in vitro at doses greater than 0.2 millimole per liter (mM). This in vitro dose of 0.2 mM is biologically unobtainable in vivo, due to the toxicity of the compound. However, at these potentially lethal doses, in vivo treatment did not induce DNA single strand breaks in hepatocytes. In the mouse bone marrow assay, abamectin was not found to induce chromosomal damage. There are also, many studies and a great deal of clinical and follow-up experience with regard to ivermectin, a closely similar human and animal drug.
	3. Reproductive and developmental toxicity. In a 2-generation study in rats, the no observed adverse effect level (NOAEL) was established at 0.12 mg/kg/day in pups based upon retinal folds, decreased body weight (bwt), and mortality. The NOAELs for systemic and reproductive toxicity were 0.4 mg/kg/day. In the 1-generation reproduction study in rats with the delta 8,9-isomer, the NOAEL was 0.4 mg/kg/day and the lowest observed adverse effect level (LOAEL) was greater than 0.4 mg/kg/day highest dose tested (HDT). In an oral developmental toxicity study in rabbits the maternal NOAEL was 1.0 mg/kg/day based upon decreased body weights and tremors. The fetal NOAEL was 1.0 mg/kg/day based upon clubbed feet. In an oral developmental toxicity study in rats the maternal and fetal NOAEL was 1.6 mg/kg/day, the HDT. In an oral developmental toxicity study the maternal NOAEL in CF-1 mice that expressed P-glycoprotein was greater than 1.5 mg/kg/day, the highest and only dose tested. No cleft palates were observed in fetuses that expressed normal levels of P-glycoprotein, but fetuses with low or no levels of P-glycoprotein had increased incidence of cleft palates. In a developmental neurotoxicity study in rats the maternal NOAEL was 0.4 mg/kg/day, the HDT, and the offspring NOAEL was 0.12 mg/kg/day with an offspring LOAEL of 0.2 mg/kg/day based on slight pup body weight loss. In a second developmental neurotoxicity study in rats the maternal NOAEL was 0.4 mg/kg/day, the HDT, and the offspring NOAEL was 0.2 mg/kg/day with an offspring LOAEL of 0.4 mg/kg/day based on decreased body weight in both sexes. There was no evidence of neurotoxicity in the offspring.
	4. Subchronic toxicity. Subchronic toxicity studies included the following:
i. A rat 14 - week oral toxicity study with a NOAEL of 0.4 mg/kg/day, the HDT.
ii. A dog 12 - week feeding study with a NOAEL of 0.5 mg/kg/day based upon mydriasis.
iii. A dog 18 - week oral study with a NOAEL of 0.25 mg/kg/day based upon mortality.
	5. Chronic toxicity. A rat 53 - week carcinogenicity feeding study was negative for carcinogenicity, with a NOAEL of 1.5 mg/kg/day based upon tremors. A CD - 1 mouse 94 - week carcinogenicity feeding study was negative for carcinogenicity, with a NOAEL of 4 mg/kg/day based upon decreased body weights. A dog 53 - week chronic feeding study resulted in a NOAEL of 0.25 mg/kg/day based upon mydriasis.
	6. Animal metabolism. Rats were given oral doses of 0.14 or 1.4 mg/kg bwt/day of abamectin or 1.4 mg/kg bwt/day of the delta 8,9 isomer. Over 7 - days, the percentages excreted in urine were 0.3 - 1% of the administered dose of abamectin and 0.4% of the dose of the isomer. The animals eliminated 69 - 82% of the dose of abamectin and 94% of the dose of isomer in feces. In rats, goats, and cattle, unchanged parent compound accounted for up to 50% of the total radioactive residues in tissues. The 24-hydroxymethyl derivative of abamectin was found in rats, goats, and cattle treated with the compound and in rats treated with the delta 8,9 isomer, and the 3''-O-demethyl derivative was found in rats and cattle administered abamectin and in rats administered the isomer.
	7. Metabolite toxicology. There are no metabolites of concern based on a differential metabolism between plants and animals. The potential hazard of the 24-hydroxymethyl or the 3''-O-demethyl animal metabolites was evaluated in toxicology studies with abamectin photolytic break-down product, the delta 8,9-isomer.
	8. Endocrine disruption. There is no evidence that abamectin is an endocrine disrupter. Evaluation of the rat multigenerational study demonstrated no effect on the time to mating or on the mating and fertility indices, suggesting no effects on the estrous cycle, on mating behavior, or on male or female fertility at doses up to 0.4 mg/kg/day, the HDT. Furthermore, the range finding study demonstrated no adverse effect on female fertility at doses up to 1.5 mg/kg/day, the HDT. Similarly, chronic and subchronic toxicity studies in mice, rats, and dogs did not demonstrate any evidence of toxicity to the male or female reproductive tract, or to the thyroid or pituitary (based upon organ weights and gross and histopathologic examination). In the developmental studies, the pattern of toxicity observed does not seem suggestive of any endocrine effect. Finally, experience with ivermectin in breeding animals, including sperm evaluations in multiple species, shows no adverse effects suggestive of endocrine disruption.
The EPA notified registrants of the EPA's  first group of specified active ingredients and manufacturers of the EPA's first group of specified  inert ingredients that the Agency was initiating the Endocrine Disruptor Screening Program for these compounds. In 2010, the EPA issued Data-Call Ins for the endocrine assays required for specified active ingredients including abamectin.  The Abamectin EDSP Consortium is generating the required assays.
C.  Aggregate Exposure
1. Dietary Exposure.  Tier III/IV acute, short-term, and chronic aggregate exposure evaluations were made for abamectin using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCIDTM , version 3.14), which incorporates food consumption data from the National Health and Nutrition Examination Survey/"What We Eat in America" (NHANES/WWEIA) dietary survey conducted in 2003-2008.  These assessments included all current foliar, food handling establishment (FHE), and residential uses for abamectin, pending uses on cotton and strawberries, including a request for updated crop group tolerances, and a proposed new IR-4 use on caneberry subgroup 13-07A.  For these exposure assessments, residue data were taken from field trial residue studies in which abamectin was applied at the maximum intended use rate and samples were harvested at the minimum pre-harvest interval (PHI) to obtain maximum residue values.  Drinking water estimates were incorporated directly into the dietary exposure assessment using the higher of the estimated drinking water concentrations (EDWCs) for surface and ground water.  Percent crop treated values were estimated based upon economic, pest, and competitive pressures.  Residue values for milk and livestock commodities were obtained from the EPA's July 18, 2011 abamectin dietary risk assessment (D380796).
i.  Food   Acute Exposure.  The abamectin acute dietary (food only) risk assessment was performed for all population subgroups with an acute reference dose of 0.005 mg/kg-bw/day based on a 12-week dose-range finding study in dogs with a No Observed Adverse Effect Level (NOAEL) of 0.5 mg/kg-bw/day and an uncertainty factor of 100X.  The 100-fold safety factor includes intra- and interspecies variations and no additional FQPA safety factors were included in these acute assessments.  For the purpose of the aggregate risk assessment, exposure values were expressed in terms of margin of exposure (MOE), which was calculated by dividing the NOAEL by the exposure for each population subgroup.  In addition, exposure was also expressed as a percent of the acute reference dose (%aRfD).  Acute (food only) exposure to the U.S. population resulted in a MOE of 719 (13.9% of the acute RfD of 0.005 mg/kg-bw/day).  The most sensitive sub-population was children (1-2 years old) with a MOE of 376 (26.6% of the aRfD).  Since the Benchmark MOE for this assessment was 100 and since the EPA generally has no concern for exposures above the benchmark or below 100% of the reference dose, Syngenta believes that there is a reasonable certainty that no harm will result from acute food exposure to residues arising from all current, pending, and proposed uses for abamectin.
Chronic Exposure.  The abamectin chronic dietary (food only) risk assessment was performed for all population subgroups with a chronic reference dose of 0.0004 mg/kg-bw/day based on combined data from three reproduction studies and two developmental neurotoxicity studies with a No Observed Adverse Effect Level (NOAEL) of 0.12 mg/kg-bw/day and an uncertainty factor of 300X.  The 300-fold safety factor includes intra- and interspecies variations (100X) and the additional FQPA safety factors of 3X for the steepness of the dose-response curve and the severity of effects.  For the purpose of the aggregate risk assessment, exposure values were expressed in terms of margin of exposure (MOE), which was calculated by dividing the NOAEL by the exposure for each population subgroup.  In addition, exposure was also expressed as a percent of the chronic reference dose (%RfD).  Chronic (food only) exposure to the U.S. population resulted in a MOE of 2,936 (10.2% of the chronic RfD of 0.0004 mg/kg-bw/day).  The most sensitive sub-population was children (1-2 years old) with a MOE of 669 (44.8% of the chronic RfD).  Since the Benchmark MOE for this assessment was 300 and since the EPA generally has no concern for exposures above the benchmark or below 100% of the reference dose, Syngenta believes that there is a reasonable certainty that no harm will result from chronic food exposure to residues arising from all current, pending, and proposed uses for abamectin.

Cancer.  Abamectin is considered "not likely to be a human carcinogen".  Therefore, no cancer risk assessment was performed for abamectin.
ii.  Drinking Water:  The Estimated Drinking Water Concentrations (EDWCs) of abamectin were determined using Tier 1SCI-GROW which estimates pesticide concentration in ground water and Tier 2 PRZM/EXAMS which estimates pesticide concentration in surface water.  EDWCs of abamectin from the currently registered and pending uses as well as a proposed use on caneberries were determined using EPA's model inputs.  Based on the SCI-GROW modeling, the highest ground water EDWC for abamectin is 0.00188 ppb (acute and chronic) based on the currently registered/pending use on strawberries.  Based on the PRZM/EXAMS modeling, the currently registered use on dry beans provided the highest surface water EDWCs of 2.35 ppb for acute and 1.39 ppb for chronic.  Since the surface water EDWCs exceed the ground water EDWC, the surface water values were used for risk assessment purposes and will be considered protective for any ground water exposure concerns.
Acute Exposure from Drinking Water.  The acute surface water EDWC of 2.35 ppb was incorporated directly into the DEEM software as "water, direct and indirect, all sources" to model the acute drinking water exposures by taking the difference between the aggregate (food + drinking water) exposures and the food (alone) exposures for each population subgroup at the 99.9%-ile of exposures.  Acute drinking water exposure to the U.S. population resulted in a MOE of 4,808 (2.1% of the acute RfD of 0.005 mg/kg-bw/day).  The most exposed sub-population was all infants (<1 year old) with a MOE of 3,106 (3.2% of the aRfD of 0.005 mg/kg/day).  Since the Benchmark MOE for this assessment was 100 and since the EPA generally has no concern for exposures above the benchmark or below 100% of the reference dose, Syngenta believes that there is a reasonable certainty that no harm will result from acute drinking water exposure to residues arising from all current, pending, and proposed uses for abamectin.
Chronic Exposure from Drinking Water.  The chronic surface water EDWC of 1.39 ppb was input directly into the DEEM software as "water, direct and indirect, all sources" to model the chronic drinking water exposures.  Chronic drinking water exposure to the U.S. population resulted in a MOE of 4,123 (7.3% of the chronic RfD of 0.0004 mg/kg-bw/day).  Chronic drinking water exposure to the most exposed sub-population (infants, <1 year old) resulted in a MOE of 1,599 (18.8% of the chronic RfD of 0.0004 mg/kg-bw/day).  Since the Benchmark MOE for this assessment was 300 and since the EPA generally has no concern for exposures above the benchmark or below 100% of the reference dose, Syngenta believes that there is a reasonable certainty that no harm will result from chronic drinking water exposure to residues arising from all current, pending, and proposed uses for abamectin.
2.  Non-Dietary Exposure:  Residential exposure risk assessments were performed for use of abamectin formulated as Varsity(R) Fire Ant Bait and Optigard(R) Fire Ant Bait for residential turf.  Residential adult handler/applicator assessments were performed for activities including push spreader, belly grinder, spoon, cup, hand dispersal, and shaker can.  Residential post-application exposure scenarios assessed included adult and child high contact dermal, adult and youth mower, adult and youth golfer, and child hand-to-mouth, object-to-mouth, soil ingestion, and ingestion of granules.  The most-exposed adult (19+ years) handler/applicator scenario was for belly-grinder applications, with a short-term MOE of 899,348 (Benchmark = 300).  The most-exposed youth (11-16 years) post-application scenario was for the youth golfer, with a short-term MOE of 15,753,170 (Benchmark = 300).  The most-exposed youth (6-11 years) post-application scenario was for the youth golfer, with a short-term MOE of 13,418,308 (Benchmark = 300).  The most-exposed children's (1-6 years) post-application scenario was via hand-to-mouth and dermal exposures resulting from play activities on treated turf, with a combined short-term MOE of 343,564 (Benchmark = 300).  Incidental oral ingestion of granules by children had a short-term MOE of 48,017 (Benchmark = 300; granule ingestion is not aggregated with other exposure scenarios).
D.  Cumulative Effects
Cumulative Exposure to Substances with a Common Mechanism of Toxicity.  Section 408(b)(2)(D)(v) 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".  If, in the future, EPA obtains new data suggesting that abamectin shares a common mechanism of toxicity with other chemical substances, the Agency will revisit the need for a cumulative risk assessment.  For the purposes of this filing, Syngenta has not assumed that abamectin has a common mechanism of toxicity with other substances.
E.  Safety Determination
1.  U.S. Population.  The acute dietary exposure analysis (food plus drinking water) showed that exposure from all current, pending, and proposed abamectin crop uses result in a MOE of 625 (16.0% of the aRfD, Benchmark MOE = 100) for the general U.S. population.  The short-term exposure analysis (food plus drinking water plus residential) showed that exposure from all current, pending, and proposed abamectin uses result in a MOE of 1,711 (Benchmark MOE = 300) for the general U.S. population.  The chronic dietary exposure analysis (food plus drinking water) showed that exposure from all current, pending, and proposed abamectin crop uses result in a MOE of 1,715 (17.5% of the chronic RfD, Benchmark MOE = 300) for the general U.S. population.  Based on the completeness and reliability of the toxicity data supporting these uses, Syngenta believes that there is a reasonable certainty that no harm will result to the general U.S. population from aggregate exposure to residues arising from all current, pending, and proposed abamectin uses, including anticipated dietary exposure from food, water, and all other types of non-occupational residential exposures.
2. Infants and children.  The acute dietary exposure analysis (food plus drinking water) showed that exposure from all current, pending, and proposed abamectin uses results in a MOE of 342 (29.2% of the aRfD) for children 1-2 years old (the most sensitive population subgroup).  For the short-term aggregate assessments, children 1-2 years old had an aggregate MOE of 542 (Benchmark MOE = 300) for all current, pending, and proposed abamectin uses.  The chronic dietary exposure analysis (food plus drinking water) showed that exposure from all current, pending, and proposed abamectin uses result in a MOE of 542 (55.3% of the cRfD) for children 1-2 years old (the most sensitive population subgroup).  Based on the completeness and reliability of the toxicity data supporting these uses, Syngenta believes that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to residues arising from all current, pending, and proposed abamectin uses, including anticipated dietary exposure from food, water, and all other types of non-occupational residential exposures.
F.  International Tolerances
Codex has established Maximum Residue Levels (MRLs) for abamectin on a number of commodities including almonds, apples, citrus, cotton, cucumbers, hops, lettuce, meat, milk, and related commodities (beef and goat), melons, pears, peppers, potatoes, squash, strawberries, tomatoes, and walnuts.  In addition, country or region-specific international MRLs for abamectin have been established or proposed in a number of countries including:  Argentina, Australia, Brazil, Canada, Chile, China, France, Germany, Greece, Hungary, Italy, Japan, Korea, Mexico, Russia, South Africa, Spain, Switzerland, Taiwan, Turkey, United Kingdom, and the United States.


[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Notices]
[Pages 37611-37612]
[FR Doc No: 2016-13797]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-2341]

Determination of Regulatory Review Period for Purposes of Patent
Extension; TANZEUM

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for TANZEUM and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human biological product.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by August
9, 2016. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by December 7, 2016.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-E-2341
    For Determination of Regulatory Review Period for Purposes of
Patent Extension; TANZEUM. Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave. Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human biological product and
continues until FDA grants permission to market the biological product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the

length of a regulatory review period for a human drug product will
include all of the testing phase and approval phase as specified in 35
U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human biological product TANZEUM
(albiglutide). TANZEUM is indicated as an adjunct to diet and exercise
to improve glycemic control in adults with type 2 diabetes mellitus.
Subsequent to this approval, the U.S. Patent and Trademark Office
(USPTO) received a patent term restoration application for TANZEUM
(U.S. Patent No. 7,141,547) from Human Genome Sciences, Inc., and the
USPTO requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated May 11,
2015, FDA advised the USPTO that this human biological product had
undergone a regulatory review period and that the approval of TANZEUM
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
TANZEUM is 3,014 days. Of this time, 2,557 days occurred during the
testing phase of the regulatory review period, while 457 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: January 15, 2006. FDA has verified the applicant's claim
that the date the investigational new drug application (IND) became
effective was on January 15, 2006.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): January 14, 2013. The applicant claims
January 11, 2013, as the date the biologics license application (BLA)
for TANZEUM (BLA 125431) was initially submitted. However, FDA records
indicate that BLA 125431 was received by FDA on January 14, 2013.
    3. The date the application was approved: April 15, 2014. FDA has
verified the applicant's claim that BLA 125431 was approved on April
15, 2014.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,577 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must be timely (see DATES) and contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Submit petitions electronically to http://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: June 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13797 Filed 6-9-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 153 (Wednesday, August 8, 2012)]
[Rules and Regulations]
[Pages 47302-47303]
[FR Doc No: 2012-19324]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 271

[EPA-R08-RCRA-2010-0933; FRL-9712-3]

South Dakota: Final Authorization of State Hazardous Waste
Management Program Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The EPA is granting final authorization of the changes to the
hazardous waste program revisions submitted by South Dakota. The Agency
published a Proposed Rule on December 27, 2010, and provided for public
comment. No comments were received on the Resource Conservation and
Recovery Act (RCRA) program issues. There was one comment from the
South Dakota State Deputy Attorney General regarding Indian country
language. No further opportunity for comment will be provided.

DATES: This final rule is effective on August 8, 2012.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R08-RCRA-2010-0933. All documents in the docket are
listed on the Federal eRulemaking Portal: http://www.regulations.gov.
Publicly available docket materials are available either electronically
through www.regulations.gov or in hard copy at: EPA Region 8, from 8
a.m. to 3 p.m., 1595 Wynkoop Street, Denver, Colorado 80202, contact:
Moye Lin, phone number<PHONE_NUMBER>, email address<EMAIL_ADDRESS>
or SDDENR, from 9 a.m. to 5 p.m., Joe Foss Building, 523 E. Capitol,
Pierre, South Dakota 57501, contact: Carrie Jacobson, phone number
(605) 773-3153.

FOR FURTHER INFORMATION CONTACT: Moye Lin,<PHONE_NUMBER>,
<EMAIL_ADDRESS>or Carrie Jacobson, phone number<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Authorization of Revisions to South Dakota's Hazardous Waste Program

    On April 1, 2010, South Dakota submitted a final complete program
revision application seeking authorization of their changes in
accordance with 40 CFR 271.21. We now make a Final decision that South
Dakota's hazardous waste program revisions satisfy all of the
requirements necessary to qualify for Final authorization. For a list
of rules that become effective with this Final Rule please see the
Proposed Rule published in the December 27, 2010 Federal Register at 75
FR 81187.
    Response to Comments: The EPA proposed to authorize South Dakota's
State Hazardous waste management Program revisions published in the
December 27, 2010 Federal Register at 75 FR 81187. The EPA received
only one comment from the state of South Dakota objecting to the EPA's
definition of Indian country, where the state is not authorized to
administer its program. Specifically, the state disagreed that all
``trust land'' in South Dakota is Indian country. With this Final Rule
the EPA is clarifying that Indian country lands within the exterior
boundary of the Yankton Reservation are excluded from the state's
authorized program. Further explanation of this interpretation of
Indian country can be found at 67 FR 45684 through 45686 (July 10,
2002).

II. Statutory and Executive Order Reviews

    The Office of Management and Budget has exempted this action from
the requirements of Executive Order 12866 (58 FR 51735, October 4,
1993), and therefore this action is not subject to review by OMB. This
action authorizes State requirements for the purpose of RCRA 3006 and
imposes no additional requirements beyond those imposed by State law.
Accordingly, I certify that this action will not have a significant
economic impact on a substantial number of small entities under the
Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this action
authorizes preexisting requirements under State law and does not impose
any additional enforceable duty beyond that required by State law, it
does not contain any unfunded mandate or significantly or uniquely
affect small governments, as described in the Unfunded Mandates Reform
Act of 1995 (Pub. L. 104-4). For the same reason, this action also does
not significantly or uniquely affect the communities of Tribal
governments, as specified by Executive Order 13175 (65 FR 67249,
November 9, 2000). This action will not have substantial direct effects
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, as specified in Executive Order 13132
(64 FR 43255, August 10, 1999), because it merely authorizes State
requirements as part of the State RCRA hazardous waste program without
altering the relationship or the distribution of power and
responsibilities established by RCRA. This action also is not subject
to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is
not economically significant and it does not make decisions based on
environmental health or safety risks. This rule is not subject to
Executive Order 13211, ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355
(May 22, 2001)) because it is not a significant regulatory action under
Executive Order 12866.
    Under RCRA 3006(b), EPA grants a State's application for
authorization as long as the State meets the criteria required by RCRA.
It would thus be inconsistent with applicable law for EPA, when it
reviews a State authorization application, to require the use of any
particular voluntary consensus standard in place of another standard
that otherwise satisfies the requirements of RCRA. Thus, the
requirements of section 12(d) of the

National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) do not apply. As required by section 3 of Executive Order 12988
(61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the
necessary steps to eliminate drafting errors and ambiguity, minimize
potential litigation, and provide a clear legal standard for affected
conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March
15, 1988) by examining the takings implications of the rule in
accordance with the ``Attorney General's Supplemental Guidelines for
the Evaluation of Risk and Avoidance of Unanticipated Takings'' issued
under the Executive Order. This rule does not impose an information
collection burden under the provisions of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this document 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 in the Federal Register. A major rule cannot take effect
until 60 days after it is published in the Federal Register. This
action is not a ``major rule'' as defined by 5 U.S.C. 804(2). This
action will be effective August 8, 2012.

List of Subjects in 40 CFR Part 271

    Environmental protection, Administrative practice and procedure,
Hazardous waste, Indian lands, Intergovernmental relations, Reporting
and recordkeeping requirements.

    Dated: July 2, 2012.
James B. Martin,
Regional Administrator, Region 8.
[FR Doc. 2012-19324 Filed 8-7-12; 8:45 am]
BILLING CODE 6560-50-P