[Federal Register Volume 79, Number 6 (Thursday, January 9, 2014)]
[Rules and Regulations]
[Pages 1599-1606]
[FR Doc No: 2014-00163]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0909; FRL-9904-70]

Tolfenpyrad; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
tolfenpyrad in or on multiple commodities which are identified and
discussed later in this document. Nichino America, Inc. requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective January 9, 2014. Objections and
requests for hearings must be received on or before March 10, 2014, 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-2012-0909, 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: Lois Rossi, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(703) 305-0001; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP
test guidelines referenced in this document electronically, please go
to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

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-2012-0909 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
March 10, 2014. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0909, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any

information you consider to be CBI or other information whose
disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.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 May 02, 2012 (77 FR 25954) (FRL-9346-1),
EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 0F7791)
by Nichino America, Inc., 4550 New Linden Hill Rd., Suite 501,
Wilmington, DE 19808. The petition requested that 40 CFR 180 be amended
by establishing tolerances for residues of the insecticide tolfenpyrad
(4-chloro-3-ethyl-1-methyl-N-[4-(p-tolyloxy) benzyl] pyrazole-5-
carboxamide, in or on head lettuce at 5 ppm; leaf lettuce at 30 ppm;
leaf petioles, subgroup 4B at 12.5 ppm; spinach at 24 ppm; Brassica,
head and stem, subgroup 5A at 3.6 ppm; Brassica, leafy, subgroup 5B at
44 ppm; vegetable, fruiting group 8 at 0.6 ppm; potatoes at 0.04 ppm;
nut, tree group 14 (including pistachio) at 0.04 ppm; almond, hulls at
5.0 ppm; fruit, pome, group 11 at 0.6 ppm; apple, wet pomace at 5.0
ppm; vegetable, cucurbit, group 9 at 0.8 ppm; fruit, stone, group 12 at
3.0 ppm; pomegranates at 3.0 ppm; persimmons at 3.0 ppm; citrus, group
10 at 1.0 ppm; citrus, pulp, dried at 2.0 ppm; citrus, oil at 16.0 ppm;
grapes at 2.0 ppm; raisins at 5 ppm; cotton, undelinted seed at 0.6
ppm; cotton, gin byproducts at 9.0 ppm; tea at 20 ppm; milk at 0.03
ppm; cattle, fat, at 0.01 ppm; goat, fat at 0.01 ppm; horse, fat at
0.01 ppm; sheep, fat at 0.01 ppm; cattle, kidney at 0.3 ppm; goat,
kidney at 0.3 ppm; horse, kidney at 0.3 ppm; sheep, kidney at 0.3 ppm;
cattle, liver at 0.7 ppm; goat, liver at 0.7 ppm; horse, liver at 0.7
ppm; sheep, liver at 0.7 ppm; cattle, meat at 0.02 ppm; goat, meat at
0.02 ppm; horse, meat at 0.02 ppm, and sheep, meat at 0.02 ppm. That
document referenced a summary of the petition prepared by Nichino
America, Inc., 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
revised nearly all of the proposed tolerances. The reasons for these
changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for tolfenpyrad including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with tolfenpyrad 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. Tolfenpyrad is a broad-spectrum pyrazole insecticide that is
proposed for use to control thrips, aphids and scales through the egg,
larval, nymph, and adult stages. The toxicity database for tolfenpyrad
is complete. Tolfenpyrad is acutely toxic by oral route, but has low
acute inhalation and dermal toxicity. It is also not irritating to the
eye and skin and is not a skin sensitizer.
    Toxicological testing indicates that tolfenpyrad is not neurotoxic
or immunotoxic and it is classified as ``not likely to be carcinogenic
to humans.'' However, the most consistent finding across species and
studies was effects on body weight and body weight gain. Decreases in
body weight and/or body weight gain were observed in adults of all
species (rat, mice, rabbit, and dog) in the majority of the subchronic
oral and dermal toxicity studies, and all chronic toxicity studies.
    The rat is the species most sensitive to body weight changes, with
effects observed at much lower doses than in other species. In rats,
significant decreases in body weight and body weight gain were observed
in subchronic oral and acute and subchronic neurotoxicity studies.
Decreases in body weight and body weight gain were also seen in chronic
rat studies but at lower doses than observed in the other rat studies.
Although seen at lower doses, the body weight decrements noted in the
chronic study were not as pronounced as seen after subchronic exposure
or in the neurotoxicity studies. Decreases in body weight and body
weight gain were also observed in reproduction, developmental toxicity,
and developmental immunotoxicity studies at doses comparable to the
chronic study. Body weight changes observed in other species were
similar in magnitude to those in rats, but were observed at higher
doses. Significant decreases in body weight and body weight gain were
seen in both mice and dogs after subchronic exposure; these effects
were also noted in rabbits in a developmental toxicity study. Chronic
exposure resulted in body weight and body weight gain decreases in mice
and dogs at lower doses. The severity of body weight changes increased
with dose in mice while body weight effects in dogs were seen only at
the highest dose tested.
    The body weight changes observed in the database were most often
seen in the presence of decreased food consumption and in some studies,
additional toxicity including liver/kidney effects and clinical signs.
Increased liver and kidney weights, liver and kidney hypertrophy,
hyaline droplets in the kidney, and color change in the kidney were
seen after subchronic exposure in rats. Chronic exposure resulted in
similar effects along with color changes in the liver and liver
histopathology at slightly lower doses than in the subchronic studies.
Other effects noted in rats were effects on the

harderian gland and lymph nodes. In dogs, both liver and kidney
histopathology, along with testicular atrophy and clinical signs
(emaciation, decreased movement, and staggering gait) were seen in
short-term studies. Long-term exposure resulted in histopathology in
the liver only, along with increased liver enzymes. No treatment-
related effects were noted in the liver or kidney in mice. However,
rough coats, hunched posture, ataxia, and hypoactivity were seen in
subchronic studies. Missing ears and ear lesions (scabs, sores,
ulceration, and inflammation) were seen in a chronic toxicity study.
The ear lesions observed were likely self inflicted since the mice in
the study were individually caged. No explanation was given to why the
lesions occurred and the toxicological significance of this finding is
unclear.
    Moribundity and/or mortality were noted in at least one study in
all species at >= 3 milligrams/kilogram/day (mg/kg/day). Moribundity
and mortality were noted in two dams in a rat reproduction study, and
mortality was noted in one dam in a rabbit developmental toxicity
study. Mortality was also observed in two animals in an inhalation
toxicity study (range-finding only). In mice and dogs, mortality was
observed in both subchronic and chronic toxicity studies. In all cases,
effects were observed in the presence of body weight changes and the
points of departure (POD) are protective of the observed mortality.
    There is no evidence of increased quantitative or qualitative
susceptibility in the guideline rat and rabbit developmental studies,
or the rat reproduction study. Although several adverse effects were
noted in young animals in these studies, the effects were observed in
the presence of significant maternal toxicity (significant body weight
changes and/or moribundity/mortality). In a non-guideline rat
developmental immunotoxicity (DIT) study, a potential increase in
qualitative susceptibility was seen. In the study, decreased survival,
body weight, body weight gain, increased blackish abdominal cavity, and
dark green abnormal intestinal contents were observed in offspring
animals at 3 mg/kg/day. At the same dose, decreased body weight (up to
10%), body weight gain (up to 36%) and food consumption were seen in
maternal animals. There was no evidence of immunotoxicity observed in
the study.
    No evidence of neurotoxicity was observed in acute and subchronic
neurotoxicity studies for tolfenpyrad. Although hunched posture,
ataxia, and hypoactivity were seen in mice in a 28-day toxicity study,
these effects were not seen in a 90-day study or after chronic
exposure. In dogs, decreased spontaneous movement, and staggering gait
were observed after 13 weeks. In rats, decreased motor activity and
prone position (lying face down) prior to death were noted in a
reproduction study. Overall, the effects noted in the database were
agonal effects mainly seen at high doses, not associated with
neuropathology, and not noted in long-term studies. The effects
observed are consistent with the mode of action for tolfenpyrad
(mitochondrial inhibitor) and are not considered evidence of
neurotoxicity.
    No evidence of carcinogenicity was observed in cancer studies with
mice and rats. Therefore, in accordance with EPA's Final Guidelines for
Carcinogen Risk Assessment (March 2005), tolfenpyrad is classified as
``not likely to be carcinogenic to humans.'' Specific information on
the studies received and the nature of the adverse effects caused by
tolfenpyrad 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 in document
``Tolfenpyrad. Human Health Risk Assessment'' in docket ID number EPA-
HQ-OPP-2012-0909.

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 tolfenpyrad used for human risk assessment is shown in
Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Tolfenpyrad For Use In Dietary Human Health Risk
                                                   Assessments
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                                                                 RfD, PAD, level
                                   Point of       Uncertainty/   of  concern for      Study and toxicological
      Exposure/scenario           departure       FQPA safety          risk                   effects
                                                    factors         assessment
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Acute Dietary (General         NOAEL = 10 mg/   UFA = 10 x.....  Acute RfD = 0.1  LOAEL = 20 mg/kg/day from an
 Population, including          kg/day.         UFH = 10 x.....   mg/kg/day.       acute neurotoxicity study in
 Infants and Children).                         FQPA...........  aPAD = 0.1 mg/    rats, based on decreased body
                                                SF = 1x........   kg/day.          weight, body weight gain and
                                                                                food consumption
Chronic Dietary (All           NOAEL = 0.6 mg/  UFA = 10 x.....  Chronic RfD =    LOAEL = 1.5 mg/kg/day from a
 Populations).                  kg/day.         UFH = 10 x.....   0.006 mg/kg/     combined chronic/
                                                FQPA SF = 1x...   day.             carcinogenicity in rats,
                                                                 cPAD = 0.006 mg/  based on decreased body
                                                                  kg/day.          weight, body weight gain, and
                                                                                food consumption of females,
                                                                                gross changes in the
                                                                                Harderian glands of males,
                                                                                and histopathological changes
                                                                                in the liver, kidney, and
                                                                                mesenteric lymph nodes of
                                                                                females and the kidney of
                                                                                males

Cancer.......................   Classification: ``Not likely to be Carcinogenic to Humans'' based on the absence
                                 of significant tumor increases in two adequate rodent carcinogenicity studies.
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor.
  PAD = population-adjusted dose (a = acute, c = chronic). RfD = reference dose.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to tolfenpyrad, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from tolfenpyrad 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 tolfenpyrad. In estimating acute dietary exposure, EPA used food
consumption information from the U.S. Department of Agriculture (USDA)
2003-2008 National Health and Nutrition Examination Survey, What We Eat
in America (NHANES/WWEIA). As to residue levels in food, EPA assumed
100 percent crop treated (PCT) and tolerance-level residues.
    ii. Chronic exposure. The chronic assessment is significantly
refined. Inputs to the chronic assessment include average residue
levels from crop field trials; use of projected PCT estimates for foods
that were shown to have a high contribution to the overall dietary
exposure (as discussed in Unit III.C.1.iv.) and assumptions of 100 PCT
for the rest of the commodities; liberal translation of juice
processing factors; and reduction of residues from removal of head
lettuce and cabbage wrapper leaves.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that there was no evidence of carcinogenicity in cancer
studies with mice and rats. Therefore, a cancer exposure assessment was
not conducted.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must require pursuant to FFDCA section
408(f)(1) that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such Data Call-Ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.

In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency estimated the PCT for new uses as follows: 40% for
oranges; 65% for table grapes; and 50% for spinach.
    EPA estimates PCT for new uses for tolfenpyrad based on the PCT of
the dominant pesticide (i.e., the one with the greatest PCT) on that
site over the three most recent years of available data. Comparisons
are only made among pesticides of the same pesticide types (i.e., the
dominant insecticide on the use site is selected for comparison with a
new insecticide). The PCTs included in the analysis may be for the same
pesticide or for different pesticides since the same or different
pesticides may dominate for each year. Typically, EPA uses USDA/NASS as
the source for raw PCT data because it is publicly available and does
not have to be calculated from available data sources. When a specific
use site is not surveyed by USDA/NASS, EPA uses proprietary data and
calculates the estimated PCT.
    The estimated PCT for new uses, based on the average PCT of the
market leader, is appropriate for use in the chronic dietary risk
assessment. This method of estimating a PCT for a new use of a
registered pesticide or a new pesticide produces a high-end estimate
that is unlikely, in most cases, to be exceeded during the initial 5
years of actual use. The predominant factors that bear on whether the
estimated PCT for new uses could be exceeded are (1) the extent of pest
pressure on the crops in question; (2) the pest spectrum of the new
pesticide in comparison with the market leaders as well as whether the
market leaders are well-established for this use; and (3) resistance
concerns with the market leaders.

    All information currently available has been considered for
tolfenpyrad, and it is the opinion of the Agency that it is unlikely
that actual PCT for tolfenpyrad will exceed the estimated PCT for new
uses during the next 5 years.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which novaluron may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for tolfenpyrad in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of tolfenpyrad. 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
tolfenpyrad for acute exposures are 26.9 parts per billion (ppb) in
surface water and 11 ppb for ground water; for chronic exposures, 12.2
ppb in surface water and 11 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the acute dietary risk
assessment, the water concentration of value 26.9 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 12.2 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).
    Tolfenpyrad is not registered for any specific use patterns that
would result in residential exposure.
    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 tolfenpyrad to share a common mechanism of
toxicity with any other substances, and tolfenpyrad does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
tolfenpyrad 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 Safety
Factor (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. Although there seems to be
increased qualitative susceptibility in the young in the developmental
immunotoxicity study (DIT) in rats, there is low concern and there are
no residual uncertainties regarding increased quantitative or
qualitative prenatal and/or postnatal susceptibility for tolfenpyrad.
When the DIT study is considered along with the reproduction study, the
offspring toxicity in the DIT study was observed at the same dose as
comparable maternal toxicity (moribundity/mortality) in the
reproduction study. Therefore, EPA does not consider the isolated
incident in the DIT a true indicator of qualitative susceptibility.
Additionally, the effects observed in the DIT study are well-
characterized, a clear NOAEL was identified, and the endpoints chosen
for risk assessment are protective of potential offspring effects.
    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 tolfenpyrad is complete.
    ii. There is no indication that tolfenpyrad is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. Although there is some evidence that tolfenpyrad may result in
increased susceptibility, the concern for developmental or reproductive
effects is low for the reasons contained in Unit III.D.2., and thus, a
10X FQPA safety factor is not necessary to protect infants and
children.
    iv. There are no residual uncertainties with regard to the exposure
assessment. The acute dietary exposure assessment is based on high-end
health protective residue levels (that account for parent and
metabolites of concern), processing factors, and PCT assumptions
(100%). The chronic dietary assessment incorporates significant
refinement in that average residue values were used and projected PCT
estimates were used for a few crops, the estimates are below the level
of concern for all population subgroups because conservative
assumptions, including the highly unlikely scenario that 100% of the
planted acreage would be treated. Furthermore, conservative, upper-
bound assumptions were used to determine exposure through drinking
water, such that these exposures have not been underestimated. There
are no residential exposure scenarios at this time.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure

estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear
cancer risks, EPA calculates the lifetime probability of acquiring
cancer given the estimated aggregate exposure. Short-, intermediate-,
and chronic-term risks are evaluated by comparing the estimated
aggregate food, water, and residential exposure to the appropriate PODs
to ensure that an adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. For the acute assessment, the dietary risk for the U.S.
population is estimated to be 62% of the aPAD. Children 3-5 years old
are the highest-exposed population subgroup, with an estimated exposure
at the 95th percentile of 0.076 mg/kg/day, which corresponds to 76% of
the aPAD. Typically EPA has concerns when estimated exposures exceed
100% of the acute or chronic population-adjusted dose (aPAD or cPAD).
Acute dietary risk estimates are below EPA's level of concern for all
population subgroups.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
tolfenpyrad from food and water will utilize 69% 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
topramezone is not expected.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Short- and
intermediate-term adverse effects were identified; however, tolfenpyrad
is not registered for any use patterns that would result in short- or
intermediate-term residential exposure. Because there is no short- or
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 short- and
intermediate-term risk), no further assessment of short- or
intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating short- and intermediate-term
risk for tolfenpyrad.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, tolfenpyrad is not expected to pose a cancer risk to humans.
    5. 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 tolfenpyrad residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies are available in Pesticide
Analytical Manual II (PAM II) for citrus and processed fractions
(Method I), ginned cottonseed (Method IA), and bovine tissues and milk
(Method II). Additionally, Method M-073 and M-936-95-2 have been
validated by the Agency and submitted for inclusion in PAM II as
enforcement methods. These five methods are adequate for enforcement of
the tolerances on plants and livestock. Method M-073 and M-936-95-2 may
be requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established MRLs for tolfenpyrad.

C. Revisions to Petitioned-For Tolerances

    Nearly all of the commodity definitions for the petitioned-for
tolerances are inconsistent with the current Agency definitions and
must be revised. For head lettuce, spinach, and celery subgroup 4B leaf
petioles, EPA has concluded that a group tolerance of 30 ppm for
vegetable, leafy, except Brassica, group 4 is appropriate. For all
remaining crops (except prune, grape, milk, and cattle, goat, horse,
and sheep fat), EPA revised the tolerance values based on residue data
and the use of the Organization for Economic Cooperation and
Development (OECD) tolerance calculation procedures.
    The submitted data for processed commodities are adequate and
sufficient for the assessing and establishing tolerances associated
with the proposed registration. EPA cannot determine the cause of the
differences in the proposed tolerances for citrus dried pulp and oil,
and raisin.
    EPA is establishing tolerances for meat and meat byproducts that
differ from the requested livestock tolerances due to differences
between the dietary burden calculation generated by the petitioner and
that generated by the Agency.
    Finally, as EPA explained in its latest crop group rulemaking (77
FR 50617, August 22, 2012) (FRL-9354-3), EPA will attempt to conform
petitions seeking tolerances for crop groups to the newer established
crop groups, rather than establish new tolerances under the pre-
existing crop groups, as part of its effort to eventually convert
tolerances for any pre-existing crop group to tolerances with coverage
under the revised crop group. Therefore, although the petitioner
requested tolerances for crop groups 8 (fruiting vegetables), 10
(citrus fruit), 11 (pome fruit), 12 (stone fruit), and 14 (tree nuts),
EPA evaluated and is establishing tolerances for crop groups 8-10
(fruiting vegetables), 10-10 (citrus fruit), 11-10 (pome fruit), 12-12
(stone fruit), and 14-12 (tree nuts).

V. Conclusion

    Therefore, tolerances are established for residues of tolfenpyrad,
(4-chloro-3-ethyl-1-methyl-N-[4-(p-tolyloxy) benzyl] pyrazole-5-
carboxamide in or on almond, hulls at 6.0 ppm; citrus, dried pulp at
8.0 ppm; citrus, oil at 70 ppm; cotton, undelinted seed at 0.70 ppm;
cotton, gin byproducts at 15 ppm; fruit, citrus, group 10-10 at 1.5
ppm; fruit, stone, group 12-12 at 2.0 ppm; grape at 2.0 ppm; grape,
raisin at 6.0 ppm; nut, tree, group 14-12 at 0.05 ppm; persimmon at 2.0
ppm; plum, prune at 3.0 ppm; pomegranate at 2.0 ppm; potato at 0.01
ppm; tea at 30 ppm; vegetable, leafy, except Brassica, group 4 at 30
ppm; milk at 0.03. ppm; cattle, fat at 0.01 ppm; cattle, meat at 0.01
ppm; cattle, meat byproducts at 0.35 ppm; goat, fat at 0.01 ppm; goat,
meat at 0.01 ppm; goat, meat byproducts at 0.35 ppm; horse, fat at 0.01
ppm; horse,

meat at 0.01 ppm; horse, meat by products at 0.35 ppm; sheep, fat at
0.01 ppm; sheep, meat at 0.01 ppm; and sheep, meat byproducts at 0.35
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: December 23, 2013.
Steven Bradbury,
Director, 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. Add Sec.  180.675 to subpart C to read as follows:

Sec.  180.675  Tolfenpyrad; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the
insecticide tolfenpyrad, including its metabolites and degradates, in
or on the commodities in the table below. Compliance with the tolerance
levels specified below is to be determined by measuring only
tolfenpyrad, 4-chloro-3-ethyl-1-methyl-N-[4-(p-
tolyloxy)benzyl]pyrazole-5-carboxamide.

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Almond hulls..............................                           6.0
Citrus, dried pulp........................                           8.0
Citrus, oil...............................                          70.0
Cotton, gin byproducts....................                          15.0
Cotton, undelinted seed...................                          0.70
Fruit, stone, group 12-12.................                           2.0
Fruits, citrus, group 10-10...............                           1.5
Grape.....................................                           2.0
Grape, raisin.............................                           6.0
Nuts, tree, group 14-12...................                          0.05
Persimmon.................................                           2.0
Plum, prune...............................                           3.0
Pomegranate...............................                           2.0
Potato....................................                          0.01
Tea.......................................                          30.0
Vegetable, leafy, except Brassica, group 4                          30.0
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the insecticide
tolfenpyrad, including its metabolites and degradates, in or on the
commodities in the following table. Compliance with the tolerance
levels specified below is to be determined by measuring only the sum of
tolfenpyrad, 4-chloro-3-ethyl-1-methyl-N-[4-(p-
tolyloxy)benzyl]pyrazole-5-carboxamide, and its metabolite 4-[4-[(4-
chloro-3-ethyl-1-methylpyrazol-5-yl)carbonylamino-methyl]phenoxy]-
benzoic acid, calculated as the

stoichiometric equivalent of tolfenpyrad.

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Cattle, fat...............................                          0.01
Cattle, meat..............................                          0.01
Cattle, meat byproducts...................                          0.35
Goat, fat.................................                          0.01
Goat, meat................................                          0.01
Goat, meat byproducts.....................                          0.35
Horse, fat................................                          0.01
Horse, meat...............................                          0.01
Horse, meat byproducts....................                          0.35
Milk......................................                          0.03
Sheep, fat................................                          0.01
Sheep, meat...............................                          0.01
Sheep, meat byproducts....................                          0.35
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved].
    (c) Tolerances with regional registration. [Reserved].
    (d) Indirect or inadvertent residues. [Reserved].

[FR Doc. 2014-00163 Filed 1-8-14; 8:45 am]
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[Federal Register: August 12, 2008 (Volume 73, Number 156)]
[Notices]
[Page 46914]
[DOCID:fr12au08-69]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1772-DR]

Minnesota; Amendment No. 4 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Minnesota (FEMA-1772-DR), dated June 25, 2008, and
related determinations.

DATES: Effective Date: August 5, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Minnesota is hereby amended to include the following
area among those areas determined to have been adversely affected by
the catastrophe declared a major disaster by the President in his
declaration of June 25, 2008.

    Cook County for Public Assistance.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

R. David Paulison,
Administrator, Federal Emergency Management Agency.
 [FR Doc. E8-18523 Filed 8-11-08; 8:45 am]

BILLING CODE 9110-10-P


[Federal Register Volume 86, Number 38 (Monday, March 1, 2021)]
[Proposed Rules]
[Pages 11915-11916]
[FR Doc No: 2021-04106]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2020-0320; FRL-10020-55-Region 3]

Air Plan Approval; Pennsylvania; 1997 8-Hour Ozone National
Ambient Air Quality Standard Second Maintenance Plan for the
Youngstown-Warren-Sharon Area; Reopening of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; reopening of public comment period.

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SUMMARY: The Environmental Protection Agency (EPA) is reopening the
comment period for a proposed rulemaking published in the Federal
Register on October 30, 2020. EPA is reopening the comment period based
on a request for a 15-day extension.

DATES: The comment period will reopen until March 16, 2021 to allow
additional time for stakeholders to review and comment on the proposal.
The comment period for the proposed rulemaking published October 30,
2020 (85 FR 68826), which ended on November 30, 2020, is being
reopened. EPA must receive comments on or before March 16, 2021.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-
OAR-2020-0320 at https://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov, follow
the online instructions for submitting

comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. For either manner of submission, EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be confidential business information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Keila M. Pag[aacute]n-Incle, Planning
& Implementation Branch (3AD30), Air & Radiation Division, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103. The telephone number is (215) 814-
2926. Ms. Pag[aacute]n-Incle can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA proposed to approve a state
implementation plan (SIP) revision submitted on March 10, 2020 by the
Pennsylvania Department of Environmental Protection (PADEP). The SIP
submittal (also referred to as ``1997 8-hour Ozone National Ambient Air
Quality Standard Second Maintenance Plan for the Youngstown-Warren-
Sharon Area'') addresses Clean Air Act (CAA) requirements for the 1997
8-hour ozone national ambient air quality standard (NAAQS) in the
Youngstown-Warren-Sharon Area. EPA's October 30, 2020 notice proposed
to approve the second maintenance plan for the Pennsylvania portion of
the Youngstown-Warren-Sharon Area as a revision to the Pennsylvania
SIP.
    EPA is reopening the comment period based on an anonymous request
to reopen the comment period. The commenter states they were unable to
obtain information about EPA's proposed rulemaking via email or phone
from the EPA contact listed in the October 30, 2020 notice. After
reviewing this request, EPA has determined that the listed EPA contact
was not available via email or phone during approximately half of the
30-day comment period. Therefore, EPA has decided to reopen the comment
period for an additional 15 days to March 16, 2021. All comments
received on or before March 16, 2021 will be entered into the public
record and considered by EPA before taking final action on the proposed
rulemaking. Comments submitted between the close of the original
comment period and the re-opening of this comment period will be
accepted and considered.

    Dated: February 18, 2021.
Diana Esher,
Acting Regional Administrator, Region III.
[FR Doc. 2021-04106 Filed 2-26-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: February 9, 2010 (Volume 75, Number 26)]
[Notices]
[Page 6377]
[DOCID:fr09fe10-56]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2985-006]

Onyx Specialty Papers, Inc.; Notice of Availability of Draft
Environmental Assessment

February 2, 2010.
    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's regulations, 18 CFR Part
380 (Order No. 486,52 FR 47897), the Office of Energy Projects has
reviewed the application for a subsequent license for the 100-kilowatt
Willow Mill Hydroelectric Project, located on the Housatonic River, in
the Town of Lee, Berkshire County, Massachusetts, and has prepared an
Draft Environmental Assessment (DEA). In the DEA, Commission staff
analyze the potential environmental effects of relicensing the project
and conclude that issuing a subsequent license for the project, with
appropriate environmental measures, would not constitute a major
federal action significantly affecting the quality of the human
environment.
    A copy of the DEA is on file with the Commission and is available
for public inspection. The DEA may also be viewed on the Commission's
Web site at http://www.ferc.gov using the ``eLibrary'' link. Enter the
docket number excluding the last three digits in the docket number
field to access documents. For assistance, contact FERC Online Support
at<EMAIL_ADDRESS>or toll-free at 1-866-208-3676, or for
TTY,<PHONE_NUMBER>.
    You may also register online at http://www.ferc.gov/docs-filing/
esubscription.asp to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    Comments on the DEA should be filed within 30 days from the
issuance date of this notice, and should be addressed to the Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE., Room 1-A,
Washington, DC 20426. Please affix ``Willow Mill Project No. 2985-006''
to all comments. Comments may be filed electronically via Internet in
lieu of paper. The Commission strongly encourages electronic filings.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site under the ``eFiling'' link. For further information, contact
Kristen Murphy at<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-2728 Filed 2-8-10; 8:45 am]
BILLING CODE 6717-01-P


obligated by the operating administration that is administering the
TIGER Discretionary Grant.
    State and Local Planning: Project activities that are focused on
refining scope and completing Federal environmental reviews are
eligible capital expenses under the TIGER Discretionary Grants
Program and are an essential part of project development. A project
that receives TIGER Discretionary Grant funds may be required to be
approved by the Metropolitan Planning Organization or State in the
Long Range Plans and Transportation Improvement Program (TIP)/
Statewide Transportation Improvement Program (STIP). Applicants
should take steps to ensure that the project will be included in the
relevant plan if the project is required to be included in such
planning documents before an operating administration may obligate
funds to the project.
    If the project is not included in the relevant planning
documents at the time the TIGER application is submitted, applicants
should submit a certification from the appropriate planning agency
that actions are underway at the time of application to include the
project in the relevant planning document. If the obligation of
TIGER Discretionary Grant funds for construction or other activities
is contingent on the project being included in the relevant planning
documents, applicants should demonstrate they can reasonably expect
to have the project included in such planning documents by March 30,
2013. DOT is using the March 30 milestone since applicants should
demonstrate in their project schedule that all additional, necessary
pre-construction steps if a project element is for pre-construction
activities, or requirements before the total award is obligated will
be complete on or before June 30, 2013, and planning must be
complete before other pre-construction or other activities can be
completed.. The applicant should provide a schedule demonstrating
when the project will be added to the relevant planning documents.
    Environmental Approvals: Projects should have received all
environmental approvals, including satisfaction of all Federal,
State and local requirements and completion of the National
Environmental Policy Act (``NEPA'') process at the time the
application is submitted or should demonstrate, through their
project schedule and narrative, that receipt of NEPA approval, and
all additional, necessary pre-construction steps if a project
element is for pre-construction activities, or other approvals can
occur by June 30, 2013.
    If the obligation of TIGER Discretionary Grant funds for
construction or other activities is contingent on completion of
other approvals that can only take place after the environmental
approvals process, the applicant should demonstrate, through their
project schedule and narrative, that they can reasonably expect to
obtain all environmental approvals by March 30, 2013, or other date
sufficiently in advance of June 30, 2013. Like planning, the
environmental approvals must be obtained prior to completing other
pre-construction steps if a project element is for pre-construction
activities, or other activities.
    To demonstrate that this suggested milestone is achievable,
applicants should provide information about the anticipated class of
action, the budget for completing NEPA, including hiring a
consultant if necessary, and a schedule that demonstrates when NEPA
will be complete. The schedule should show how the suggested
milestones described in this section will be complied with, and
include any anticipated coordination with Federal and State
regulatory agencies for permits and approvals. The budget should
demonstrate how costs to complete NEPA factor into the overall cost
to complete the project. The budget and schedule for completing NEPA
should be reasonable and be comparable to a budget and schedule of a
typical project of the same type. The applicant should provide
evidence of support based on input during the NEPA process from
State and local elected officials as well as the public.
Additionally, the applicant should provide environmental studies or
other documents (preferably by way of a Web site link) that describe
in detail known potential project impacts and possible mitigation
for these impacts. The applicant should supply sufficient
documentation for DOT to adequately review the project's NEPA
status.
    Right-of-Way and Design: If the obligation of TIGER
Discretionary Grant funds for construction or other activities by an
operating administration may be contingent on completion of right-
of-way acquisition and final design approval, and/or additional
approvals contingent on completion of right-of-way acquisition and
design, applicants should demonstrate, through their project
schedule, that they reasonably expect to have right-of-way and
design completed, and completion of any other needed pre-
construction steps if a project element is for pre-construction
activities, or other approvals by June 30, 2013. Applicants should
submit a reasonable schedule of when right-of-way (if applicable),
design, and any other required approvals are expected to be
obtained. Applicants may expect that DOT may obligate TIGER funds
for right-of-way and design completion only after planning and
environmental approvals are obtained.
    Completion of Obligation: Applicants should plan to have all
necessary pre-construction or other approvals and activities
completed by June 30, 2013. In some instances, DOT may not obligate
for construction or other activities until all planning and
environmental approvals are obtained and right-of-way and final
design are complete. If a project is selected for a TIGER
Discretionary Grant and the TIGER Discretionary Grant funding will
be used to complete all of these activities, DOT may obligate the
funding in phases, in accordance with the laws, regulations, and
policies of the operating administration that is administering the
grant.

    Issued on: January 25, 2012.
Ray LaHood,
Secretary.
[FR Doc. 2012-1996 Filed 1-30-12; 8:45 am]
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[Federal Register Volume 76, Number 153 (Tuesday, August 9, 2011)]
[Notices]
[Pages 48835-48836]
[FR Doc No: 2011-20160]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Project No. 13466-001]

City of Gresham; Notice of Application Accepted for Filing and
Soliciting Comments, Motions to Intervene, Protests, Recommendations,
and Terms and Conditions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Conduit Exemption.
    b. Project No.: 13466-001.
    c. Date filed: May 5, 2011, and supplemented on June 28, 2011, and
July 26, 2011.
    d. Applicant: City of Gresham.
    e. Name of Project: City of Gresham Wastewater Treatment Plant
Outfall Hydroelectric Project.
    f. Location: The proposed City of Gresham Wastewater Treatment
Plant Outfall Hydroelectric Project would be located at the outfall of
the City of Gresham's Wastewater Treatment Plant, a wastewater
treatment facility effluent outfall distribution system located in
Multnomah County, Oregon. The land on which all the project structures
are located is owned by the applicant.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791a--825r.
    h. Applicant Contact: Mr. Michael Nacrelli, P.E., City of Gresham,
Oregon, Department of Environmental Services, 1333 NW Eastern Parkway,
Gresham, Oregon 97030; telephone<PHONE_NUMBER>.
    i. FERC Contact: Kim Carter, telephone<PHONE_NUMBER>, and e-mail
address<EMAIL_ADDRESS>    j. Status of Environmental Analysis: This application is ready for
environmental analysis at this time, and the Commission is requesting
comments, reply comments, recommendations, terms and conditions, and
prescriptions.
    k. Deadline for filing responsive documents: In light of the
resource agencies' comments filed with the application, the 60-day
timeframe specified in 18 CFR 4.43(b) for filing all comments, motions
to intervene, protests, recommendations, terms and conditions, and
prescriptions is shortened to 30 days from the issuance date of this
notice. All reply comments filed in response to comments submitted by
any resource agency, Indian tribe, or person, must be filed with the
Commission within 45 days from the issuance date of this notice.
    Comments, protests, and interventions may be filed electronically
via the Internet in lieu of paper; see 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's web site under the ``e-Filing''
link. The Commission strongly encourages electronic filings.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    l. Description of Project: The proposed City of Gresham Wastewater
Treatment Plant Outfall Hydroelectric Project would consist of: (1) A
new intake and a new outlet pipeline (each approximately 20-feet long)
that taps onto two sections of the City of Gresham's Wastewater
Treatment Plant's existing 3,500-foot-long, 48-inch-diameter outfall
pipe; (2) a new 16-foot-wide, 12-foot-long concrete powerhouse; (3) a
new single turbine/generator unit with an installed capacity of 50 kW;
(4) a new 10-foot-wide, 10-foot-long concrete building to house
additional controls and equipment; and (5) appurtenant facilities. The
project would have an estimated annual generation of 413,000 kilowatt-
hours. The applicant plans to sell the generated energy to Portland
General Electric under a power sales agreement.
    m. This filing is available for review and reproduction at the
Commission in the Public Reference Room, Room 2A, 888 First Street,
NE., Washington, DC 20426. The filing may also be viewed on the web at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number, here P-13466, in the docket number field to access the
document. For assistance, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy is
also available for review and reproduction at the address in item h
above.
    n. Development Application--Any qualified applicant desiring to
file a competing application must submit to the Commission, on or
before the specified deadline date for the particular application, a
competing development application, or a notice of intent to file such
an application. Submission of a timely notice of intent allows an
interested person to file the competing development application no
later than 120 days after the specified deadline date for the
particular application. Applications for preliminary permits will not
be accepted in response to this notice.
    o. Notice of Intent--A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit a competing development application. A notice of intent must be
served on the applicant(s) named in this public notice.
    p. Protests or Motions to Intervene--Anyone may submit a protest or
a motion to intervene in accordance with the requirements of Rules of
Practice and Procedure, 18 CFR 385.210, 385.211, and 385.214. In
determining the appropriate action to take, the Commission will
consider all protests filed, but only those who file a motion to
intervene in accordance with the Commission's Rules may become a party
to the proceeding. Any protests or motions to intervene must be
received on or before the specified deadline date for the particular
application.
    q. All filings must (1) bear in all capital letters the title
``PROTEST'', ``MOTION TO INTERVENE'', ``NOTICE OF INTENT TO FILE
COMPETING APPLICATION'', ``COMPETING APPLICATION'', ``COMMENTS'',
``REPLY COMMENTS,'' ``RECOMMENDATIONS,'' ``TERMS AND CONDITIONS,'' or
``PRESCRIPTIONS;'' (2) set forth in the heading the name of the
applicant and the project number of the application to

which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, recommendations, terms and conditions or prescriptions must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). Agencies may obtain copies of the
application directly from the applicant. Any of these documents must be
filed by providing the original and eight copies to: The Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. An additional copy must be sent to Director,
Division of Hydropower Administration and Compliance, Office of Energy
Projects, Federal Energy Regulatory Commission, at the above address. A
copy of any protest or motion to intervene must be served upon each
representative of the applicant specified in the particular
application. A copy of all other filings in reference to this
application must be accompanied by proof of service on all persons
listed in the service list prepared by the Commission in this
proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
    r. Waiver of Pre-filing Consultation: The applicant requested
agencies to support the waiver of the Commission's consultation
requirements under 18 CFR 4.38(c). In May 2010, the U.S. Environmental
Protection Agency, Bureau of Reclamation, Oregon Department of
Environmental Quality, Department of Public Works--City of Fairview,
U.S. Fish and Wildlife Service, Naval Seafloor Cable Protection Office,
U.S. Coast Guard and the Yakama Indian Nation had no concerns or issues
and waived the requirement for a second and third stage consultation.
Several state and federal resource agencies commented on the
application but no other comments regarding the request for waiver were
received. Therefore, we intend to accept the consultation that has
occurred on this project during the pre-filing period and we intend to
waive pre-filing consultation under section 4.38(c), which requires,
among other things, conducting studies requested by resource agencies,
and distributing and consulting on a draft exemption application.

    Dated: August 3, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-20160 Filed 8-8-11; 8:45 am]
BILLING CODE 6717-01-P