[Federal Register Volume 80, Number 23 (Wednesday, February 4, 2015)]
[Notices]
[Pages 6158-6159]
[FR Doc No: 2015-02166]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Opportunity for Public Comment on Surplus Property
Release at Georgetown County Airport, Georgetown, South Carolina

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: Under the provisions of Title 49, U.S.C. Section 47151(d),
notice is being given that the Federal Aviation Administration (FAA) is
considering a request from Georgetown County to waive the requirement
that eleven parcels (approximately 18.32 acres) of surplus property,
located at the Georgetown County Airport be used for aeronautical
purposes.

DATES: Comments must be received on or before March 6, 2015.

ADDRESSES: Documents are available for review by prior appointment at
the following location: Atlanta Airports District Office, Attn: Rob
Rau, Community Planner, 1701 Columbia Ave., Suite 2-260, College Park,
Georgia 30337-2747, Telephone:<PHONE_NUMBER>.
    Comments on this notice may be mailed or delivered in triplicate to
the FAA at the following address: Atlanta Airports District Office,
Attn: Rob Rau, South Carolina Planner, 1701 Columbia Ave., Suite 2-260,
College Park, Georgia 30337-2747.
    In addition, one copy of any comments submitted to the FAA must

be mailed or delivered to Mr. Ray C. Funnye, Director, Departmnet of
Public Services, Georgetown County at the following address: 108
Screven Street, Georgetown, South Carolina 29440.

FOR FURTHER INFORMATION CONTACT: Rob Rau, Community Planner, Atlanta
Airports District Office, 1701 Columbia Ave., Suite 2-260, College
Park, Georgia 30337-2747,<PHONE_NUMBER>. The application may be
reviewed in person at this same location.

SUPPLEMENTARY INFORMATION: The FAA is reviewing a request by Georgetown
County to release eleven parcels (approximately 18.32 acres) of public
property at the Georgetown County Airport. On June 4, 1947, the United
States government through the War Assets Administration executed a
Lease Termination Agreement which returned approximately 675 acres of
land to Georgetown County with conditions. This property is to be used
for public airport purposes on reasonable terms and without unjust
discrimination and without grant of an exclusive right. These parcels
are currently being used for places of worship, residential homes,
educational and military facilities and industrial purposes.
    Any person may inspect the request in person at the FAA office
listed above under FOR FURTHER INFORMATION CONTACT.
    In addition, any person may, upon request, inspect the request,
notice and other documents germane to the request in person at the
Georgetown County Airport.

    Issued in Atlanta, Georgia, on January 29, 2015.
Larry F. Clark,
Manager, Atlanta Airports District Office, Southern Region.
[FR Doc. 2015-02166 Filed 2-3-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 168 (Wednesday, August 29, 2012)]
[Rules and Regulations]
[Pages 52240-52246]
[FR Doc No: 2012-21361]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0521; FRL-9360-5]

Pendimethalin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
pendimethalin in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project No. 4
(IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective August 29, 2012. Objections and
requests for hearings must be received on or before October 29, 2012,
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-2011-0521, 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), EPA West 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 (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(703) 308-9367; 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://ecfr.gpoaccess.gov/cgi/t/text/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-2011-0521 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 29, 2012. 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 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-2011-0521, 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 Confidential Business
Information (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.htm.

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 July 20, 2011 (76 FR 43231) (FRL-8880-
1), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 1E7878)
by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 08540. The
petition requested that 40 CFR 180.361 be amended by establishing
tolerances for residues of the herbicide pendimethalin, N-(1-
ethylpropyl)-3,4-dimethyl-2,6dinitrobenzenamine, and its 3, 5-
dinitrobenzyl alcohol metabolite (CL 202347), in or on lettuce, leaf at
3.0 parts per million (ppm); Brassica, leafy greens, subgroup 5B at 0.2
ppm; turnip greens at 0.2 ppm; melons subgroup 9A at 0.1 ppm;
vegetable, soybean, succulent at 0.1 ppm; and small fruit vine climbing
subgroup 13-07E, except grape at 0.1 ppm. That notice referenced a
summary of the petition prepared by BASF, the registrant, which is
available in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
modified the level for which the tolerance is being established for
leaf lettuce. The reason for this change is explained in Unit IV.C.

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 pendimethalin including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with pendimethalin
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.
    Pendimethalin has low acute oral, dermal, and inhalation toxicity,
and is not a dermal sensitizer. The thyroid is a target organ for
pendimethalin. Thyroid toxicity in chronic and subchronic rat and mouse
studies was manifested as alterations in thyroid hormones, increased
thyroid weight, and microscopic thyroid lesions. Due to these effects,
the Agency required that a developmental thyroid assay be conducted to
evaluate the impact of pendimethalin on thyroid hormones, structure,
and/or thyroid hormone homeostasis during development. A developmental
thyroid study was submitted and demonstrated that there is no potential
thyroid toxicity following pre- and/or post-natal exposure to
pendimethalin. The available prenatal and postnatal developmental
toxicity data provided no indication of qualitative or quantitative
susceptibility to the young. The overall weight of evidence suggests
that this chemical does not directly target the immune system. There is
no evidence of neurotoxicity for pendimethalin exposure.
    The points of departure (PODs) used for the chronic and short-term
risk assessments were based on a 92-day thyroid function study in rats,
a 56-day thyroid study in rats, and a 14-day intra

thyroid metabolism study in rats. Due to several important quantitative
dynamic differences between rats and humans with respect to thyroid
function, the interspecies uncertainty factor ((UF); used to account
for animal to human differences in toxicokinetics and toxicodynamics)
was reduced to 3X for the chronic and short-term risk assessments. A
10X interspecies UF was used in the acute risk assessment because the
POD was based on an acute neurotoxicity study, not a thyroid study. The
use of an oral POD, assuming 100 percent inhalation absorption is
considered protective for assessing short-term inhalation exposure
since pendimethalin has a low vapor pressure (1.24 x 10-8
Millimeter (mm) mercury (Hg) at 20[deg]C) and is not likely to
volatilize substantially. It also has a relatively low solubility in
water (0.275 ppm at 25 [deg]C). Further, the EPA has determined a
subchronic inhalation study is not needed at this time.
    Pendimethalin is considered a possible human carcinogen based on a
statistically significant increased trend and pair-wise comparison
between the high dose group and controls for thyroid folliculate cell
adenomas in male and female rats. A threshold approach is being used to
evaluate cancer risk because mode of action studies are available
demonstrating that the thyroid tumors are due to a thyroid-pituitary
imbalance (a threshold effect), and also because pendimethalin was
shown to be non-mutagenic in mammalian somatic cells and germ cells.
    Specific information on the studies received and the nature of the
adverse effects caused by pendimethalin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov, on pp. 51-54 in the document titled ``Revised
Pendimethalin: Human Health Risk Assessment for Proposed Use on Leaf
lettuce; Leafy brassica greens; Melons; Edamame; Kiwi and other small
fruit vines'' in docket ID number EPA-HQ-OPP-2011-0521.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (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 no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). 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 a reference dose (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 pendimethalin used for
human risk assessment is shown in the Table of this unit.

  Table--Summary of Toxicological Doses and Endpoints for Pendimethalin for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  NOAEL = 100 mg/kg/    Acute RfD = 1 mg/kg/ Acute neurotoxicity study
 including infants and children).   day                   day                 LOAEL = 300 mg/kg, based on
                                   UFA = 10X...........  aPAD = 1 mg/kg/day.   reduced motor activity for males
                                   UFH = 10X...........                        and females on Day 0
                                   FQPA SF = 1X........
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 10 mg/kg/day   Chronic RfD = 0.3    92-Day thyroid function study in
                                   UFA = 3X............   mg/kg/day            rats; 56-day thyroid study in
                                   UFH = 10X...........  cPAD = 0.3 mg/kg/     rats; 14-day intra thyroid
                                   FQPA SF = 1X........   day.                 metabolism study in rats
                                                                              LOAEL = 31 mg/kg/day based on
                                                                               hormonal and histopathological
                                                                               changes in the thyroid
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to   NOAEL= 10 mg/kg/day   LOC for MOE = 30     92-Day thyroid function study in
 30 days).                         UFA = 3X............                        rats; 56-day thyroid study in
                                   UFH = 10X...........                        rats; 14-day intra thyroid
                                   FQPA SF = 1X........                        metabolism study in rats
                                                                              LOAEL = 31 mg/kg/day based on
                                                                               hormonal and histopathological
                                                                               changes in the thyroid
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days).  Oral study NOAEL =    LOC for MOE = 30     92-Day thyroid function study in
                                    10 mg/kg/day                               rats; 56-day thyroid study in
                                    (dermal absorption                         rats; 14-day intra thyroid
                                    rate = 3%                                  metabolism study in rats
                                   UFA = 3X............                       LOAEL = 31 mg/kg/day based on
                                   UFH = 10X...........                        hormonal and histopathological
                                   FQPA SF = 1X........                        changes in the thyroid
----------------------------------------------------------------------------------------------------------------

Inhalation short-term (1 to 30     Oral study NOAEL= 10  LOC for MOE = 30     92-Day thyroid function study in
 days).                             mg/kg/day                                  rats; 56-day thyroid study in
                                    (inhalation                                rats; 14-day intra thyroid
                                    absorption rate =                          metabolism study in rats
                                    100%)                                     LOAEL = 31 mg/kg/day based on
                                   UFA = 3X............                        hormonal and histopathological
                                   UFH = 10X...........                        changes in the thyroid
                                   FQPA SF = 1X........
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Pendimethalin has been classified as a possible human carcinogen based on a
                                    statistically significant increased trend and pair-wise comparison between
                                    the high dose group and controls for thyroid follicular cell adenomas in
                                    male and female rats. A non-quantitative approach (i.e., non-linear, RfD
                                    approach) was used since mode of action studies are available
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to pendimethalin, EPA considered exposure under the
petitioned-for tolerances as well as all existing pendimethalin
tolerances in 40 CFR 180.361. EPA assessed dietary exposures from
pendimethalin 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 pendimethalin. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, EPA assumed 100 percent crop treated (PCT) and
tolerance-level residues for all current and proposed crops.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed 100 PCT and
tolerance-level residues for all current and proposed crops.
    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 pendimethalin. Cancer risk was assessed
using the same exposure estimates as discussed in Unit III.C.1.ii.,
chronic exposure.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for
pendimethalin. Tolerance level residues and 100 PCT were assumed for
all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for pendimethalin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of pendimethalin. 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 the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models the estimated drinking water concentrations (EDWCs) of
pendimethalin for acute exposures are estimated to be 80.5 parts per
billion (ppb) for surface water and 0.036 ppb for ground water; and for
chronic exposures are estimated to be 6.2 ppb for surface water and
0.036 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 80.5 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 6.2 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).
    Pendimethalin is currently registered for the following uses that
could result in residential exposures: Turf and ornamentals. EPA
assessed residential exposure using the following assumptions: For
handlers, it is assumed that most residential use will result in short-
term (1 to 30 days) dermal and inhalation exposures. Residential
handlers are assumed to be wearing short-sleeved shirts, short pants,
shoes and socks during application of pendimethalin.
    Residential post-application exposure is assumed to be short-term
(1-30 days) in duration, resulting from the following: physical
activities on turf: adults (dermal) and children 1-2 years old (dermal
and incidental oral); mowing: adults (dermal) and children 11 < 16
years old (dermal); and golfing: adults (dermal), children 11 < 16
years

old (dermal), and children 6 < 11 years old (dermal).
    EPA did not combine exposure resulting from adult handler and post-
application exposure resulting from treated lawns and/or golfing
because of the conservative assumptions and inputs within each
estimated exposure scenario. The Agency believes that combining
exposures resulting from handler and post-application activities would
result in an overestimate of adult exposure. EPA selected the most
conservative adult residential scenario (adults 50+ years old; dermal
post-application exposure) as the contributing source of residential
exposure to be combined with the dietary exposure for the aggregate
assessment.
    The children's oral exposure is based on post-application hand-to-
mouth exposures. To include exposure from object-to-mouth and soil
ingestion in addition to hand-to-mouth could result in a very
conservative estimation of exposure, as it would overestimate the
potential for oral exposure. However, there is potential for co-
occurrence of the dermal and oral exposure based on the use pattern and
combining them is appropriate because risk estimated from the dermal
and oral routes of exposure are based on the same toxicological study.
As a result, the children's aggregate assessment combines post-
application dermal and oral exposure along with dietary exposure from
food and water.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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.''
    EPA has not found pendimethalin to share a common mechanism of
toxicity with any other substances, and pendimethalin does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
pendimethalin does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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. There was no indication of
pre- and/or post-natal qualitative or quantitative increased
susceptibility in the developmental studies in rats and rabbits or the
2-generation reproduction studies in rats. In addition, a developmental
thyroid toxicity study demonstrated that there is no potential thyroid
toxicity following pre- and/or post-natal exposure to pendimethalin.
    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 pendimethalin is complete.
    ii. There is no indication that pendimethalin is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that pendimethalin 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. In addition, a developmental thyroid toxicity study demonstrated
that there is no potential thyroid toxicity following pre- and/or post-
natal exposure to pendimethalin.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to pendimethalin in drinking water. EPA used
similarly conservative assumptions to assess postapplication exposure
of children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
pendimethalin.

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
aPAD and 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 pendimethalin will occupy 2.0% 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
pendimethalin from food and water will utilize 1.6% of the cPAD for
children 1-2 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
pendimethalin 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).
    Pendimethalin 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 pendimethalin.
    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 125 for adults
and 93 for children 1-2 years old, the two population subgroups
receiving the greatest combined dietary and non-dietary exposure.
Because EPA's level of concern for pendimethalin is a MOE of 30 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,
pendimethalin 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
pendimethalin.
    5. Aggregate cancer risk for U.S. population. Pendimethalin is
considered a ``possible human carcinogen'' based on a statistically
significant increased trend and pair-wise comparison between the high
dose group and controls for thyroid follicular cell adenomas in male
and female rats. A non-quantitative approach (i.e., non-linear, RfD
approach) was used since mode of action studies are available to
demonstrate that the thyroid tumors are due to a thyroid-pituitary
imbalance, and also since pendimethalin was shown to be non-mutagenic
in mammalian somatic cells and germ cells. The chronic dietary risk
assessment is considered to be protective of any cancer effects.
    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 pendimethalin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    PAM Volume II lists four Gas Chromatography/Electron Capture
Detector (GC/ECD), methods for the determination of pendimethalin and
its 3,5-dinitrobenzyl alcohol metabolite in plant commodities. Methods
I and III determine residues of the parent, whereas Methods II and IV
determine residues of the 3,5-dinitrobenzyl alcohol metabolite.

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 MRLs for pendimethalin on any of
these new uses.

C. Revisions to Petitioned-For Tolerances

    The proposed tolerance of 3.0 ppm on leaf lettuce is being
increased to 4.0 ppm. This is because the Agency used the Organization
of Economic Cooperation and Development (OECD) tolerance calculation
procedures in determining appropriate tolerance levels, whereas the
petitioner used the North American Free Trade Agreement (NAFTA)
tolerance calculation procedures.

V. Conclusion

    Therefore, tolerances are established for residues of
pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6dinitrobenzenamine,
and its 3, 5-dinitrobenzyl alcohol metabolite (CL 202347), in or on
lettuce, leaf at 4.0 ppm; Brassica, leafy greens, subgroup 5B at 0.20
ppm; turnip greens at 0.20 ppm; melon subgroup 9A at 0.10 ppm;
vegetable, soybean (edamame) at 0.10 ppm; and fruit, small vine
climbing subgroup 13-07E, except grape at 0.10 ppm.

VI. Statutory and Executive Order Reviews

    This final rule 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 final rule has
been exempted from review under Executive Order 12866, this final rule
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 final rule 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 final rule 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (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 of 1995 (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 17, 2012.
Lois Rossi,
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. Section 180.361 is amended by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:

Sec.  180.361  Pendimethalin; tolerances for residues.

    (a) * * *

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

                                * * * * *
Brassica, leafy greens, subgroup 5B.....................            0.20

                                * * * * *
Fruit, small vine climbing, except grape, subgroup 13-              0.10
 07E....................................................

                                * * * * *
Lettuce, leaf...........................................            4.0
Melon subgroup 9A.......................................            0.10

                                * * * * *
Turnip greens...........................................            0.20

                                * * * * *
Vegetable, soybean, succulent...........................            0.10

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

* * * * *
[FR Doc. 2012-21361 Filed 8-28-12; 8:45 am]
BILLING CODE 6560-50-P


February 23, 2010

The Honorable Harry Reid The Honorable Mitch McConnell

Majority Leader Minority Leader

United States Senate United States Senate

Washington, DC 20510 Washington, DC 20510

Dear Senator Reid and Senator McConnell:

As environmental agency commissioners in States that have adopted the
California Clean Cars standards, we are writing to express our concern
with the Resolution of Disapproval recently introduced by Senator
Murkowski of Alaska that would invalidate the U.S. Environmental
Protection Agency (USEPA) finding of endangerment for greenhouse gases
(GHGs).

Many of our States have previously expressed opposition to this
Resolution because it would represent a denial of the overwhelming
scientific evidence of real and urgent threats to human health and
welfare posed by climate change, and would strip the nation of a proven,
effective tool to begin to address this threat.

Today we are writing to elevate a specific issue of national importance
that may be jeopardized by the Resolution.  We believe the Murkowski
Resolution would prevent the federal program for passenger vehicle GHG
standards from being finalized. As you know, under this program, USEPA
proposed federal GHG standards for vehicles that will be roughly
equivalent to both the federal corporate average fuel economy (CAFE)
standards and the GHG standards pioneered by California and adopted by
13 other states and the District of Columbia. The existence of
comparable federal GHG standards, in turn, would allow our States to
accept compliance with the federal program as demonstrating compliance
with the California program. This nationally harmonized state-federal
program has been widely praised by the automobile industry,
environmental organizations, labor unions, States, the Obama
Administration, and many members of Congress.

Without comparable federal vehicle GHG standards, our States will not be
able to offer this alternative compliance option to automakers. Although
the Resolution does not affect our States' independent authority under
the Clean Air Act to separately adopt and enforce the existing
California GHG standards, we believe that the entire nation would
benefit from the cleaner vehicles, greater energy security, and consumer
savings that a long overdue federal program will provide. Moreover, we
understand that vehicle manufacturers appreciate the flexibility of
alternative compliance options and a harmonized national program. We
would regret to lose these benefits to consumers, industry, and the
Nation.

For these reasons, we urge you to oppose the Resolution of Disapproval
and to preserve the hardwon benefits of a harmonized state-federal
vehicle standards program.  Thank you for your consideration,

______________________________ ____________________________________

Mary D. Nichols, Chair Amey Marrella, Commissioner

California Air Resources Board Connecticut Department of Environmental
Protection

_________________________________ ____________________________________

David Littell, Commissioner Laurie Burt, Commissioner

Maine Department of Environmental Protection Massachusetts Department of
Environmental Protection

_________________________________ ____________________________________

Ron Curry, Secretary Pete Grannis, Commissioner

New Mexico State Environment Department New York Department of
Environmental Conservation

__________________________________ ____________________________________

Dick Pedersen, Director W. Michael Sullivan, Director

Oregon Department of Environmental Quality Rhode Island Department of
Environmental Management

_________________________________

Ted Sturdevant, Director

Washington Department


[Federal Register Volume 78, Number 154 (Friday, August 9, 2013)]
[Notices]
[Page 48668]
[FR Doc No: 2013-19289]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[ Docket No. EL13-81-000]

PSEG Long Island LLC, Long Island Electric Utility Servco LLC,
Long Island Power Authority, Long Island Lighting Company; Notice of
Petition for Declaratory Order

    Take notice that on August 1, 2013, pursuant to Rule 207 of the
Federal Energy Regulatory Commission's (Commission) Rules of Practice
and Procedure, 18 CFR 385.207, PSEG Long Island LLC (PSEG LI), Long
Island Electric Utility Servco LLC (Servco), the Long Island Power
Authority (Authority), and Long Island Lighting Company (LIPA); (the
Authority and LIPA together, LIPA), (collectively, Petitioners) filed a
petition for declaratory order requesting the Commission to issue a
declaratory order disclaiming jurisdiction and determining that neither
PSEG LI nor Servco will be a public utility, as defined in section
201(e) of the Federal Power Act, 16 U.S.C. 824(e). Petitioners'
concerns are more fully described in the aforementioned petition.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on September 2, 2013.

    Dated: August 5, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-19289 Filed 8-8-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: April 13, 2006 (Volume 71, Number 71)]
[Notices]
[Page 19222-19224]
[DOCID:fr13ap06-127]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53608; File No. SR-ISE-2006-17]

Self-Regulatory Organizations; International Securities Exchange,
Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to Fees on the Russell 1000 Index

April 6, 2006.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on April 3, 2006, the International Securities Exchange, Inc.
(``ISE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items

have been prepared by the ISE. The ISE has designated this proposal as
one establishing or changing a due, fee, or other charge imposed by the
ISE under section 19(b)(3)(A)(ii) of the Act,\3\ and Rule 19b-4(f)(2)
thereunder,\4\ which renders the proposal effective upon filing with
the Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE is proposing to amend its Schedule of Fees to waive the
surcharge for transactions in options on the Russell 1000 Index until
September 29, 2006. The text of the proposed rule change is available
on the ISE's Web site (http://www.iseoptions.com/legal/proposed_rule_changes.asp
), at the principal office of the ISE, and at the

Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the ISE included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The ISE has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of this proposed rule change is to waive the surcharge
for transactions in options on the Russell 1000 Index (``RUI'') until
September 29, 2006. Options on RUI were previously approved for trading
by the Commission.\5\ Pursuant to a license agreement entered into by
the Exchange with the Frank Russell Company (``Russell''), the Exchange
currently charges a ten (10) cent surcharge per contract for trading
options on RUI.\6\ However, in order to promote trading in options on
RUI, the Exchange is proposing to waive all surcharges on RUI for the
2nd and 3rd quarters of 2006 (the ``promotional period'').
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 51619 (April 27,
2005), 70 FR 22947 (May 3, 2005) (Order approving the trading of
options on various Russell Indexes, including RUI).
    \6\ See Securities Exchange Act Release No. 51858 (June 16,
2005), 70 FR 36218 (June 22, 2005) (Notice of filing and immediate
effectiveness of fees on various Russell Indexes, including RUI).
---------------------------------------------------------------------------

    Due to competitive pressures, the Exchange does not charge Public
Customer Orders \7\ this surcharge fee. The surcharge fee is charged
only to Exchange members with respect to non-Public Customer Orders
(e.g., Market Maker and Firm Proprietary orders). Accordingly, during
the promotional period, the Exchange proposes to waive the surcharge
fee on all non-Public Customer Orders and, for a pilot period that is
set to expire on July 31, 2006, on all Linkage Orders.\8\ The
Exchange's normal transaction fees, i.e., an execution fee and a
comparison fee, in options on RUI shall continue to apply during the
promotional period.\9\
---------------------------------------------------------------------------

    \7\ Public Customer Order is defined in ISE Rule 100(a)(33) as
an order for the account of a Public Customer. Public Customer is
defined in ISE Rule 100(a)(32) as a person that is not a broker or
dealer in securities.
    \8\ See ISE Rules 1900(10) and 1901.
    \9\ The Exchange represents that these fees are charged only to
Exchange members.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with section 6(b)(4) of the Act,\10\ which requires that an exchange
have an equitable allocation of reasonable dues, fees, and other
charges among its members and other persons using its facilities.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange believes that the proposed rule change does not impose
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to section
19(b)(3)(A) of the Act \11\ and Rule 19b-4(f)(2) \12\ thereunder
because it changes a fee imposed by the Exchange. At any time within 60
days of the filing of such proposed rule change, the Commission may
summarily abrogate such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File No. SR-ISE-2006-17 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.
    All submissions should refer to File Number SR-ISE-2006-17. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the ISE.
    All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File

Number SR-ISE-2006-17 and should be submitted on or before May 4, 2006.
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\13\
J. Lynn Taylor,
Assistant Secretary.
 [FR Doc. E6-5480 Filed 4-12-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 77, Number 93 (Monday, May 14, 2012)]
[Notices]
[Pages 28376-28378]
[FR Doc No: 2012-11630]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2012-0333 FRL-9671-6]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Information Collection Request for the Greenhouse Gas
Reporting Program; EPA ICR No. 2300.10

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) to the Office of Management and Budget (OMB). This ICR is
scheduled to expire on November 30, 2012. Before submitting the ICR to
OMB for review and approval, the EPA is soliciting comments on specific
aspects of the proposed information collection as described below.

DATES: Comments must be submitted on or before July 13, 2012.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2012-0333, by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Air and Radiation Docket and Information Center,
Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460.
     Hand Delivery: EPA Docket Center, Public Reading Room, EPA
Headquarters West Building, Room 3334, 1301 Constitution Ave. NW.,
Washington, DC 20240. Such deliveries are only accepted during the
Docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2012-0333. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at http://www.regulations.gov, including any personal
information provided, unless the 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 http://www.regulations.gov or email. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means the 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 the EPA
without going through http://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, the 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 the EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, the
EPA may not be able to consider your comment. Electronic files should
avoid the use of special characters, 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 http://www.epa.gov/epahome/dockets.htm.

FOR FURTHER INFORMATION CONTACT: Carole Cook, Climate Change Division,
Office of Atmospheric Programs (MC-6207J), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

How can I access the docket and/or submit comments?

    The EPA has established a public docket for this ICR under Docket
ID No. EPA-HQ-OAR-2012-0333, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the EPA Air and
Radiation Docket in the EPA Docket Center (EPA/DC), EPA West, Room
3334, 1301 Constitution Ave. NW., Washington, DC. The EPA/DC 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 Reading
Room is<PHONE_NUMBER>, and the telephone number for the EPA Air and
Radiation Docket is<PHONE_NUMBER>.
    Use http://www.regulations.gov to obtain a copy of the draft
collection of information, submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the public docket that are available electronically. Once
in the system, select ``search,'' then key in the docket ID number
identified in this document.

What information is EPA particularly interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, the EPA specifically
solicits comments and information to enable it to:
    (i) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility;
    (ii) Evaluate the accuracy of the Agency's estimate of the burden
of the proposed collection of information, including the validity of
the methodology and assumptions used;
    (iii) Enhance the quality, utility, and clarity of the information
to be collected; and
    (iv) Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, the EPA is requesting comments
from very small businesses (those that employ less than 25) on examples
of specific additional efforts that the EPA could make to reduce the
paperwork burden for very small businesses affected by this collection.

What should I consider when I prepare my comments for the EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Offer alternative ways to improve the collection activity.
    6. Make sure to submit your comments by the deadline identified
under DATES.
    7. To ensure proper receipt by the EPA, be sure to identify the
docket ID number assigned to this action in the subject line on the
first page of your response. You may also provide the name, date, and
Federal Register citation.

What information collection activity or ICR does this apply to?

    [Docket ID No. EPA-HQ-OAR-2012-0333.]
    Affected entities: Entities potentially affected by this action are
suppliers of certain products that will emit GHG when released,
combusted, or oxidized, motor vehicle and engine manufacturers,
including aircraft engine manufacturers; facilities in certain
industrial categories that emit greenhouse gases; and facilities that
emit 25,000 metric tons or more of carbon dioxide equivalent
(CO2e) per year.
    Title: Information Collection Request for the Greenhouse Gas
Reporting Program.
    ICR numbers: EPA ICR No. 2300.10, OMB Control No. 2060-0629.
    ICR status: This ICR is currently scheduled to expire on November
30, 2012. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for the
EPA's regulations in title 40 of the CFR, after appearing in the
Federal Register when approved, are listed in 40 CFR part 9, are
displayed either by publication in the Federal Register or by other
appropriate means, such as on the related collection instrument or
form, if applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: In response to the FY2008 Consolidated Appropriations Act
(H.R. 2764; Pub. L. 110-161) and under authority of the Clean Air Act,
the EPA finalized the Mandatory Reporting of Greenhouse Gases Rule (GHG
Reporting Rule) (74 FR 56260; October 30, 2009). The GHG Reporting
Rule, which became effective on December 29, 2009, establishes
reporting requirements for some direct GHG emitters as well as
suppliers of certain products that will emit GHG when released,
combusted, or oxidized, industrial gas suppliers, and manufacturers of
heavy-duty and off-road vehicles and engines. It does not require
control of greenhouse gases. Instead, it requires that sources emitting
above certain threshold levels of (CO2e) monitor and report
emissions.
    Subsequent rules provide corrections and clarification on existing
requirements; include requirements for additional facilities and
suppliers; require reporters to provide information about parent
companies, NAICS code(s), and whether emissions are from cogeneration;
and finalize confidentiality determinations. Specifically, in 2010 and
2011, the EPA promulgated requirements for subparts T, FF, II, and TT
(75 FR 39736; July 12, 2010); information about parent companies, NAICS
code(s), and cogeneration (75 FR 57669; September 22, 2010); subpart W
(75 FR 74458; November 30, 2010); subparts I, L, DD, QQ, and SS (75 FR
74774; December 1, 2010); subparts RR and UU (75 FR 75060; December 1,
2010); and confidentiality determinations (76 FR 30782; May 26, 2011).
Collectively, the GHG Reporting Rule and its associated rulemakings are
referred to as the Greenhouse Gas Reporting Program (GHGRP).
    The purpose for this ICR is to renew and revise the GHG Reporting
Rule ICR to update and consolidate the burdens and costs imposed by all
of the current ICRs under the GHGRP.

    Data submitted under the GHGRP that is classified as CBI is
protected under the provisions of 40 CFR part 2, subpart B. The EPA is
determining through a series of rulemaking actions the data elements
that will be eligible for treatment as CBI. However, according to CAA
section 114(c), ``emissions data'' cannot be classified as CBI. The EPA
has proposed that inputs to emissions equations meet the definition of
``emissions data'' and cannot be afforded the protections of CBI. The
EPA has deferred the reporting deadline for data elements that are used
as inputs to emissions equations to provide the EPA time needed to
fully evaluate and resolve issues regarding the reporting and potential
release of these data (76 FR 53057, August 25, 2011).
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 1.96
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    The ICR provides a detailed explanation of the EPA's estimate,
which is only briefly summarized here:
    1. Estimated total number of potential respondents: 11,290.
    2. Frequency of response: Annual, quarterly.
    3. Estimated total average number of responses for each respondent:
43.
    4. Estimated total annual burden hours: 1,000,914 hours. This
includes estimated total respondent hours of 942,344 hours and
estimated total EPA hours of 58,570 hours.
    5. Estimated total annual costs: $98,082,191. This includes an
estimated cost of $28,086,090 for capital investment as well as
maintenance and operational costs, an estimated respondent burden cost
of $56,141,455, and an estimated EPA cost of $13,854,646.

Are there changes in the estimates from the last approval?

    There is a decrease of 764,890 hours in the total estimated
respondent burden compared with the combined burden in the currently
approved ICRs for the GHGRP identified in the ICRs currently approved
by OMB (2060-0629, -0646, -0647, -0649, -0650, -0651, and -0680). This
decrease reflects the completion of one-time activities that occurred
in the first year of data collection as well as adjustments in the
number of respondents based on facilities that reported information to
the EPA. This change is the result of an adjustment.

What is the next step in the process for this ICR?

    The EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. At that time, the EPA
will issue another Federal Register notice pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB. If you have any
questions about this ICR or the approval process, please contact the
technical person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: April 27, 2012.
Sarah Dunham,
Director, Office of Atmospheric Programs.
 [FR Doc. 2012-11630 Filed 5-11-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 188 (Wednesday, September 28, 2016)]
[Notices]
[Pages 66662-66664]
[FR Doc No: 2016-23330]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-E-0400]

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

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 IONSYS 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 drug 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
November 28, 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 March 27,
2017. 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-2007-E-0400, ``Determination of Regulatory Review Period for
Purposes of Patent Extension; IONSYS.'' 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 drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug 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 drug product IONSYS
(fentanyl hydrochloride). IONSYS is indicated for the short-term
management of acute postoperative pain in adult patients requiring
opioid analgesia during hospitalization. Subsequent to this approval,
the USPTO received a patent term restoration application for IONSYS
(U.S. Patent No. 5,697,896) from Alza Corp., and the USPTO requested
FDA's assistance in determining this patent's eligibility for patent
term restoration and the product's regulatory review period. In a
letter dated August 12, 2016, FDA advised the USPTO that this human
drug product had undergone a regulatory review period and that the
approval of IONSYS represented the first permitted commercial marketing
or use of the product.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
IONSYS is 4,835 days. Of this time, 3,862 days occurred during the
testing phase of the regulatory review period, while 973 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: February 26, 1993. The applicant claims February 27, 1993,
as the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date
was February 26, 1993, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: September
23, 2003. FDA has verified the applicant's claim that the new drug
application (NDA) for IONSYS (NDA 21-338) was initially submitted on
September 23, 2003.
    3. The date the application was approved: May 22, 2006. FDA has
verified the applicant's claim that NDA 21-338 was approved on May 22,
2006.
    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 5 years 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: September 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23330 Filed 9-27-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 198 (Friday, October 11, 2019)]
[Notices]
[Page 54897]
[FR Doc No: 2019-22297]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC20-7-000.
    Applicants: Dougherty County Solar LLC.
    Description: Application for Authorization Under Section 203 of the
Federal Power Act, et al. of Dougherty County Solar LLC.
    Filed Date: 10/4/19.
    Accession Number: 20191004-5174.
    Comments Due: 5 p.m. ET 10/25/19.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER20-43-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original ISA, SA No. 5479,
Queue No. AC1-145 to be effective 9/5/2019.
    Filed Date: 10/7/19.
    Accession Number: 20191007-5081.
    Comments Due: 5 p.m. ET 10/28/19.

    Docket Numbers: ER20-44-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original ISA, SA No. 5481,
Queue No. AC1-065/AC2-110/AD2-039 to be effective 9/5/2019.
    Filed Date: 10/7/19.
    Accession Number: 20191007-5107.
    Comments Due: 5 p.m. ET 10/28/19.

    Take notice that the Commission received the following qualifying
facility filings:

    Docket Numbers: QF20-10-000.
    Applicants: Eco Green Generation LLC.
    Description: Form 556 of Eco Green Generation LLC [Clean Power #1].
    Filed Date: 10/2/19.
    Accession Number: 20191002-5225.
    Comments Due: None-Applicable.

    Docket Numbers: QF20-12-000.
    Applicants: Eco Green Generation LLC.
    Description: Form 556 of Eco Green Generation LLC [Clean Power #2].
    Filed Date: 10/3/19.
    Accession Number: 20191003-5209.
    Comments Due: None-Applicable.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 7, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-22297 Filed 10-10-19; 8:45 am]
 BILLING CODE 6717-01-P