[Federal Register Volume 80, Number 145 (Wednesday, July 29, 2015)]
[Rules and Regulations]
[Pages 45073-45078]
[FR Doc No: 2015-18544]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0638; FRL-9930-73]

Fluxapyroxad; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
fluxapyroxad in or on cotton, gin byproducts and cotton, undelinted
seed. BASF Corporation requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 29, 2015. Objections and
requests for hearings must be received on or before September 28, 2015,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0638, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. 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-2012-0638 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
September 28, 2015. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0638, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of December 17, 2014 (79 FR 75107) (FRL-
9918-90),

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 4F8270)
by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 27709.
The petition requested that 40 CFR 180.666 be amended by establishing
tolerances for residues of the fungicide fluxapyroxad (BAS 700 F), 3-
(difluoromethyl)-1-methyl-N-(3',4',5'-trifluoro[1,1'-biphenyl]-2-yl)-
1H-pyrazole-4-carboxamide, its metabolites, and degradates, in or on
cotton, gin byproducts at 20 parts per million (ppm); cotton undelinted
seed at 0.30 ppm. That document referenced a summary of the petition
prepared by BASF Corporation, the registrant, which is available in the
docket, http://www.regulations.gov. There were no comments received in
response to the notice of filing

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 fluxapyroxad including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with fluxapyroxad 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.
    Fluxapyroxad is of low acute toxicity by the oral, dermal and
inhalation routes, is not irritating to the eyes and skin, and is not a
dermal sensitizer. The primary target organ for fluxapyroxad exposure
via the oral route is the liver with secondary toxicity in the thyroid
for rats only. Liver toxicity was observed in rats, mice, and dogs,
with rats as the most sensitive species for all durations of exposure.
In rats, adaptive effects of hepatocellular hypertrophy and increased
liver weights and changes in liver enzyme activities were first
observed. As the dose or duration of exposure to fluxapyroxad
increased, clinical chemistry changes related to liver function also
occurred, followed by hepatocellular necrosis, neoplastic changes in
the liver, and tumors. Thyroid effects were observed only in rats.
These effects were secondary to changes in liver enzyme regulation,
which increased metabolism of thyroid hormone, resulting in changes in
thyroid hormones, thyroid follicular hypertrophy and hyperplasia, and
thyroid tumor formation. Tumors were not observed in species other than
rats or in organs other than the liver and thyroid.
    Fluxapyroxad is classified as ``Not likely to be Carcinogenic to
Humans'' based on convincing evidence that carcinogenic effects are not
likely below a defined dose range. There is no mutagenicity concern
from in vivo or in vitro assays. The hypothesized mode of action (i.e.,
a non-genotoxic) for treatment related tumors (i.e., the liver and
thyroid) was supported by a full panel of in vitro and in vivo studies
that showed no evidence of genotoxicity, together with mechanistic
studies in the liver and thyroid of rats that satisfied stringent
criteria for establishing tumorgenic modes of action. The studies
clearly identified the sequence of key events, dose-response
concordance and temporal relationship to the tumor types. The Agency
has determined that the chronic population adjusted dose (PAD) will
adequately account for all chronic effects, including carcinogenicity
that could result from exposure to fluxapyroxad because the points of
departure (POD) for the chronic population adjusted dose (cPAD) is
based on the most sensitive endpoint, liver effects. Effects in the
liver preceded liver tumors and the effects observed in the thyroid (in
rats only) were believed to be secondary to the liver effects.
    No evidence of neurotoxicity was observed in response to repeated
administration of fluxapyroxad. An acute neurotoxicity study showed
decreased rearing and motor activity. This occurred on the day of
dosing only and in the absence of histopathological effects or
alterations in brain weights. This indicated that any neurotoxic
effects of fluxapyroxad are likely to be transient and reversible due
to alterations in neuropharmacology and not from neuronal damage. There
were no neurotoxic effects observed in the subchronic dietary toxicity
study. No evidence of reproductive toxicity was observed. Developmental
effects observed in both rats and mice (thyroid follicular hypertrophy
and hyperplasia in rats and decreased defecation, food consumption,
body weight/body weight gain, and increased litter loss in rabbits)
occurred at the same doses as those that caused adverse effects in
maternal animals, indicating no quantitative susceptibility. Since the
maternal toxicities of thyroid hormone perturbation in rats and
systemic toxicity in rabbits likely contributed to the observed
developmental effects there is low concern for qualitative
susceptibility. An immunotoxicity study in mice showed no evidence of
immunotoxic effects from fluxapyroxad.
    Subchronic oral toxicity studies in rats, developmental toxicity
studies in rabbits, and in vitro and in vivo genotoxicity studies were
performed for fluxapyroxad metabolites F700F001, M700F002, and
M700F048. Like fluxapyroxad, no genotoxic effects were observed for any
of these metabolites. All three metabolites displayed lower subchronic
toxicity via the oral route than fluxapyroxad, with evidence of non-
specific toxicity (decreased body weight) observed only for M700F0048
at the limit dose. Only M700F0048 exhibited developmental toxicity at
doses similar to those that caused developmental effects in rabbits
with fluxapyroxad treatment. However, these effects (abortions and
resorptions) were of a different nature than for fluxapyroxad (paw
hyperflexion) and are considered secondary to maternal toxicity. The
Agency considers these studies sufficient for hazard identification and
characterization and concludes that these metabolites do not have
hazards that exceed those of fluxapyroxad in nature, severity, or
potency.
    Specific information on the studies received and the nature of the
adverse effects caused by fluxapyroxad 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, ``Human Health Risk Assessment for Use of Fluxapyroxad on
Numerous Crops'' at pp. 52 in docket ID number EPA-HQ-OPP-2012-0638.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological POD and levels of concern to use in evaluating
the risk posed by human exposure to the pesticide. For hazards that
have a threshold below which there is no appreciable risk, the
toxicological POD is used as the basis for derivation of reference
values for risk assessment. PODs are developed based on a careful
analysis of the doses in each toxicological study to determine the dose
at which the NOAEL and the LOAEL are identified. Uncertainty/safety
factors are used in conjunction with the POD to calculate a safe
exposure level--generally referred to as a 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 chemical name used for
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Fluxapyroxad for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (General population  NOAEL = 125 mg/kg/    Acute RfD = 1.25 mg/ Acute neurotoxicity study in rats
 including infants and children,    day.                  kg/day.             LOAEL = 500 mg/kg/day based on
 and females 13-49 years of age).  UFA = 10x...........  aPAD = 1.25 mg/kg/    decreased motor activity and
                                   UFH = 10x...........   day.                 decreased rearing.
                                   FQPA SF = 1x........
Chronic dietary (All populations)  NOAEL = 2.1 mg/kg/    Chronic RfD = 0.021  Chronic toxicity/carcinogenicity
                                    day.                  mg/kg/day.           study in rats
                                   UFA = 10x...........  cPAD = 0.021 mg/kg/  LOAEL = 11 mg/kg/day based on non-
                                   UFH = 10x...........   day.                 neoplastic changes in the liver
                                   FQPA SF = 1x........                        (foci, masses).
Incidental oral short-term (1 to   NOAEL = 9 mg/kg/day.  LOC for MOE = 100..  28-day oral toxicity study in rats
 30 days).                         UFA = 10x...........                       LOAEL = 176 mg/kg/day based on
                                   UFH = 10x...........                        changes in thyroid hormones and
                                   FQPA SF = 1x........                        thyroid follicular hypertrophy/
                                                                               hyperplasia.
Inhalation short-term (1 to 30     NOAEL= 9 mg/kg/day..  LOC for MOE = 100..  28-day oral toxicity study in rats
 days).                            UFA = 10x...........                       LOAEL = 176 mg/kg/day based on
                                   UFH = 10x...........                        changes in thyroid hormones and
                                   FQPA SF = 1x........                        thyroid follicular hypertrophy/
                                                                               hyperplasia.
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Cancer (Oral, dermal, inhalation)  Classification: Not likely to be carcinogenic to humans at doses sufficient
                                    to induce liver and/or thyroid tumors. Quantification of risk using a non-
                                    linear approach (i.e., RfD) will adequately account for all chronic
                                    toxicity, including carcinogenicity.
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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). UFDB = to account for the absence of data or other
  data deficiency. UFH = potential variation in sensitivity among members of the human population
  (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term
  risk assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluxapyroxad, EPA considered exposure under the petitioned-
for tolerances as well as all existing fluxapyroxad tolerances in 40
CFR 180.666. EPA assessed dietary exposures from fluxapyroxad 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 fluxapyroxad. In estimating acute dietary exposure, EPA used food
consumption information from the United States 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 used tolerance-level residues adjusted upward to account for
metabolites of concern not included in the tolerance expression, 100
percent crop treated (PCT) assumptions, and dietary exposure evaluation
model (DEEM) default and empirical processing factors.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
NHANES/WWEIA. As to residue levels in food, a moderately refined
chronic dietary exposure analysis was performed. An assumption of 100
PCT and DEEM default and empirical processing factors were used for the
chronic dietary analysis. Combined average field-trial residues for
parent and highest field-trial residues for metabolites of concern were
used for all plant commodities. For livestock commodities tolerance-
level residues adjusted upward to account for

metabolites of concern not included in the tolerance expression were
used.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to fluxapyroxad. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.
    iv. Anticipated residue and percent crop treated (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.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fluxapyroxad in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fluxapyroxad. 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 Tier 1 Rice Model and the Pesticide Root Zone Model
Ground Water (PRZM GW), the estimated drinking water concentrations
(EDWCs) of fluxapyroxad for acute exposures are estimated to be 127
parts per billion (ppb) for surface water and 203 ppb for ground water.
The EDWCs for chronic exposures for non-cancer assessments are
estimated to be 127 ppb for surface water and 184 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 203 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 184 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). Fluxapyroxad is
currently registered for the following uses that could result in
residential exposures: Residential turf. EPA assessed residential
exposure using the following assumptions: Residential handler exposures
are expected to be short-term (1 to 30 days) via either the dermal or
inhalation routes of exposures. Intermediate-term exposures are not
likely because of the intermittent nature of applications by
homeowners. Since no dermal hazard was identified for fluxapyroxad,
MOEs were calculated for the inhalation route of exposure only.
    Both adults and children may be exposed to fluxapyroxad residues
from contact with treated lawns. Adult post-application exposures were
not quantitatively assessed since no dermal hazard was identified for
fluxapyroxad and inhalation exposures are typically negligible in
outdoor settings. The exposure assessment for children included
incidental oral exposure resulting from transfer of residues from the
hands or objects to the mouth, and from incidental ingestion of soil.
Post-application hand-to-mouth and object-to-mouth exposures are
expected to be short-term (1 to 30 days) in duration due to the
intermittent nature of applications in residential environments.
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 fluxapyroxad to share a common mechanism of
toxicity with any other substances, and fluxapyroxad does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
fluxapyroxad 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 Food Quality
Protection Act Safety Factor (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. No evidence of quantitative
susceptibility was observed in a reproductive and developmental
toxicity study in rats or in developmental toxicity studies in rats and
rabbits. Developmental toxicity data in rats showed decreased body
weight and body weight gain in the offspring at the same dose levels
that caused thyroid follicular hypertrophy/hyperplasia in parental
animals. Effects in rabbits were limited to paw hyperflexion, a
malformation that is not considered to result from a single exposure
and that usually reverses as the animal matures. Developmental effects
observed in both rats and rabbits occurred at the same doses as those
that caused adverse effects in maternal animals, indicating no
quantitative susceptibility. The Agency has low concern for
developmental toxicity because the observed effects were of low
severity, were likely secondary to maternal toxicity, and demonstrated
clear NOAELs. Further, the NOAELs for these effects were at dose levels
higher than the points of departure selected for risk assessment for
repeat-exposure scenarios. Therefore, based on the available data and
the selection of risk assessment endpoints that are protective of
developmental effects, there are no residual uncertainties with regard
to pre- and/or postnatal toxicity.
    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 fluxapyroxad is complete. Although no
subchronic inhalation data is available,

EPA has waived that data requirement based on, among other things, its
conclusion that even if an additional 10X safety factor was applied,
inhalation exposure would not raise a risk of concern.
    ii. There is no indication that fluxapyroxad is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity. Neither the acute nor
the subchronic neurotoxicity studies indicated specific neurotoxicity
responses to fluxapyroxad. Because fluxapyroxad can disrupt thyroid
hormone levels, the Agency considered the potential for fluxapyroxad to
cause developmental neurotoxicity as a result of thyroid hormone
disruption, which is more sensitive endpoint than the endpoints used in
a developmental neurotoxicity study. Based on its evaluation of thyroid
hormone data submitted for fluxapyroxad and the ontogeny of thyroid
hormone metabolism, the Agency has determined that adverse thyroid
hormone disruptions in the young are unlikely to occur at dose levels
as low as the points of departure chosen for risk assessment. The
Agency has low concern for neurotoxic effects of fluxapyroxad at any
life stage.
    iii. Based on the developmental and reproductive toxicity studies
discussed in Unit III.D.2., there are no residual uncertainties with
regard to prenatal and/or postnatal toxicity.
    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 or field trial residue data.
The dietary risk assessment is based on reliable data, is conservative
and will not underestimate dietary exposure to fluxapyroxad. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to fluxapyroxad 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 fluxapyroxad.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to fluxapyroxad will occupy 12% of the aPAD for children 3-5 years 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
fluxapyroxad from food and water will utilize 64% of the cPAD for
infants (< 1 year old). Based on the explanation in Unit III.C.3.,
regarding residential use patterns, chronic residential exposure to
residues of fluxapyroxad 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). Fluxapyroxad
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 fluxapyroxad. 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 320 for adults and 560 for
children. Because EPA's level of concern for fluxapyroxad is a MOE of
100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term adverse effect was identified; however,
fluxapyroxad 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
fluxapyroxad.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit
III.A., EPA has classified fluxapyroxad as ``Not likely to be
Carcinogenic to Humans'' based on convincing evidence that carcinogenic
effects are not likely below a defined dose range. The Agency has
determined that the quantification of risk using the cPAD for
fluxapyroxad will adequately account for all chronic toxicity,
including carcinogenicity that could result from exposure to
fluxapyroxad. As noted above, chronic exposure to fluxapyroxad from
food and water will utilize 64% of the cPAD for infants (< 1year old)
the population group receiving the greatest exposure.
    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 fluxapyroxad residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    A Liquid Chromatography-Mass Spectrometer/Mass Spectrometer (LC/MS/
MS) method is available as an enforcement method. This method uses
reversed-phase High Pressure Liquid Chromatography (HPLC) with gradient
elution, and includes 2 ion transitions to be monitored for the parent
fluxapyroxad.
    The method 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.
    There is a Codex MRL for cotton, undelinted seed at 0.01 ppm.
However, this MRL is based on seed treatment of cotton, and not foliar
applications (which is the proposed use for the U.S. registration and
which results in higher residues). Therefore, there is no ground for
harmonization of U.S. tolerance and Codex MRL.

V. Conclusion

    Therefore, tolerances are established for residues of fluxapyroxad
[3-(difluoromethyl)-1-methyl-N-(3',4',5'-trifluoro[1,1'-biphenyl]-2-
yl)-1H-pyrazole-4-carboxamide], including its metabolites and
degradates, in or on cotton, gin byproducts at 20 ppm and cotton
undelinted seed at 0.30 ppm.

VI. Statutory and Executive Order Reviews

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

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: July 22, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.666, revise the entries for ``Cotton, gin byproducts''
and ``Cotton, undelinted seed'' in the table in paragraph (a) to read
as follows:

Sec.  180.666  Fluxapyroxad; tolerances for residues.

    (a) * * *

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

                              * * * * * * *
Cotton, gin byproducts..................................           20
Cotton, undelinted seed.................................            0.30

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

* * * * *
[FR Doc. 2015-18544 Filed 7-28-15; 8:45 am]
 BILLING CODE 6560-50-P


32482 Federal Register / Vol. 68, No. 104 / Friday, May 30, 2003 / Notices 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure ( 18 CFR 385.211 and 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 motion to intervene. All such motions or protests should be filed on or before the comment date, and, to the extent applicable, must be served on the applicant and on any other person designated on the official service list. This filing is available for review at the Commission or may be viewed on the Commission's Web site at http:// www. ferc. gov , using the `` FERRIS'' link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC Online Support at FERCOnlineSupport@ ferc. gov or tollfree at ( 866) 208   3676, or for TTY, contact ( 202) 502   8659. 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.

Magalie R. Salas, Secretary. [ FR Doc. 03   13515 Filed 5   29   03; 8: 45 am]

BILLING CODE 6717   01   P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Intent To File an Application for a New License May 22, 2003. a. Type of Filing: Notice of Intent to File An Application for a New License. b. Project No.: 906. c. Date Filed: May 19, 2003. d. Submitted By: Virginia Electric and Power Company, d. b. a. Virginia Dominion Power   current licensee. e. Name of Project: Cushaw Hydroelectric Project. f. Location: On the James River in Amherst County, Virginia. The project occupies federal land within the Jefferson National Forest. g. Filed Pursuant to: Section 15 of the Federal Power Act. h. Licensee Contact: James Thornton, Dominion Virginia Power, ( Manager for Licensee), Innsbrook Technical Center, 1 NE., 5000 Dominion Boulevard, Glen Allen, VA 23060, ( 804) 273   3257. i. FERC Contact: Janet Hutzel, janet. hutzel@ ferc. com, ( 202) 502   8675. j. Effective date of current license: September 1, 1980. k. Expiration date of current license: June 15, 2008. l. Description of the Project: The project consists of the following existing facilities: ( 1) A 1,550 foot long, 27 foothigh concrete dam; ( 2) a 138 acre reservoir; ( 3) a powerhouse containing five turbine generating units with a total installed capacity of 7,500 kW; and ( 4) other appurtenances. m. Each application for a new license and any competing license applications must be filed with the Commission at least 24 months prior to the expiration of the existing license. All applications for license for this project must be filed by June 15, 2006. n. A copy of this filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at http:// www. ferc. gov using the `` FERRIS'' link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC Online Support at FERCOnlineSupport@ ferc. gov or tollfree at 1   866   208   3676, or TTY ( 202) 502   8659. A copy is also available for inspection and reproduction at the address in item h above. o. Register online at http:// www. ferc. gov/ esubscribenow. htm to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support as shown in the paragraph above.

Magalie R. Salas, Secretary. [ FR Doc. 03   13484 Filed 5   29   03; 8: 45 am]

BILLING CODE 6717   01   P ENVIRONMENTAL PROTECTION AGENCY [ OPPT   2003   0011; FRL   7305   4]

Endocrine Disruptor Screening Program; Endocrine Disruptor Methods Validation Subcommittee under the National Advisory Council for Environmental Policy and Technology; Request for Nominations for Membership AGENCY: Environmental Protection Agency ( EPA). ACTIONS: Notice.

SUMMARY: As mandated by the Federal Food, Drug, and Cosmetic Act ( FFDCA), amended by the Food Quality Protection Act ( FQPA) of 1996, EPA implemented an Endocrine Disruptor Screening Program ( EDSP). As part of the EDSP, the Endocrine Disruptor Methods Validation Subcommittee ( EDMVS) was established in 2001, is a Subcommittee under the National Advisory Council for Environmental Policy and Technology ( NACEPT). The members of the EDMVS may serve up to three 2   year terms. This notice is a request for nominations for new members of the EDMVS from interested organizations. NACEPT is a chartered federal advisory committee subject to the provisions of the Federal Advisory Committee Act ( FACA). Through NACEPT, the EDMVS provides technical advice and recommendations to EPA regarding validation of the Tier I screening and Tier II testing methods for the EDSP. Background information regarding the Agency's EDSP and the EDMVS are discussed in Unit III. of the SUPPLEMENTARY INFORMATION. This information is being provided to allow interested persons and organizations to review the scope of activities when nominating qualified individuals for membership on the EDMVS. DATES: Nominations, identified by docket ID Number OPPT   2003   0011 must be received on or before June 30, 2003. ADDRESSES: Nominations for membership may be submitted electronically, by fax, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit II. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: For general information contact: Barbara Cunningham, Director, Environmental Assistance Division ( 7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20406   0001; telephone number: ( 202) 554   1404; e mail address: TSCAHotline epa. gov. For technical information contact: Jane Smith, Designated Federal Official ( DFO) for the EDMVS, Exposure Assessment Coordination and Policy Division ( 7203M), Office of Science Coordination and Policy, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 202) 564   8476; fax ( 202) 564   8483; e mail address: smith. jane scott@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Notice Apply to Me?

This action is directed to the public in general. You may be interested in nominating members to the VerDate Jan< 31> 2003 19: 12 May 29, 2003 Jkt 200001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 30MYN1. SGM 30MYN1 OPPT 2003 0011 0001 RECEIVED OPPT NCIC 2003 MAY30 7: 12AM 32483 Federal Register / Vol. 68, No. 104 / Friday, May 30, 2003 / Notices subcommittee set forth in this notice if you are a member of an environmental/ public interest organization, a public health organization, an animal welfare organization, academia, or Federal agencies, state, local, or tribal governments. You also may be interested in activities of EPA's EDSP if you produce, manufacture, use, consume, work with, or import pesticides or other chemicals. To determine whether you or your business may have an interest in this notice you should carefully examine section 408( p) of the FFDCA, as amended by the FQPA of 1996 ( Public Law 104   170), 21 U. S. C. 346a( p) and amendments to the Safe Drinking Water Act ( SDWA) ( Public Law 104   182), 42 U. S. C. 300j   17. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action, consult the technical persons listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this Document or Other Related Documents? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPPT   2003   0011. This official public docket consists of this Notice, public comments regarding this Notice, and other related information. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at EPA's Docket Center, Rm. B102  Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. EPA's Docket Center is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. EPA's Docket Center Reading Room telephone number is ( 202) 566   1744 and the telephone number for the OPPT Docket, which is located in EPA Docket Center, is ( 202) 566   0282. 2. Electronic access. An electronic version of the public docket is available through EPA's electronic docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket to submit nominations and comments or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the edocket system, select `` search,'' then key in the appropriate docket ID number ( OPPT   2003   0011). Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/, or you may obtain electronic copies of this document, and certain other related documents through the EDSP Web site for the EDMVS at http:// www. epa. gov/ scipoly/ oscpendo/ edmvs. htm. 3. In person. The Agency has established an administrative record for the EDMVS under docket ID number OPPT   2003   0011. The public version of the administrative record, which includes printed, paper versions of any electronic comments that may be submitted during an applicable comment period, is available for inspection in the EPA Docket Center. See I. B. 1. for docket center information.

II. How Can I Nominate Potential Members to the Endocrine Disruptor Methods Validation Subcommittee? You may nominate technically qualified persons for membership to the EDMVS electronically, by fax or in person/ courier service. A technically qualified nominee could come from industry, an environmental/ public interest organization, a public health organization, an animal welfare organization, academia or Federal agencies, State, local or tribal governments or any other group knowledgeable in endocrine disruption, method validation or related topics. Nominations for membership may be submitted by individuals or on behalf of organizations, and must include a curriculum vitae of the nominee detailing his or her specific area of relevant scientific expertise. ( Please exclude the following information from the curriculum vitae: The nominee's social security number, birth date and place, home address, and telephone number.) Technically qualified persons may also nominate themselves. Current members whose terms are about to expire may be renominated or selfnominate as their time and interests allow. Current members being renominated will be evaluated in the same manner as newly nominated candidates. Members of the EDMVS are selected by EPA taking into consideration their relevant scientific expertise and diversity of perspectives on mammalian, ecological, and in vitro endocrine disruptor screening and testing methods and procedures, toxicity test methods standardization and validation, and chemical and pesticide regulatory processes. Members will be appointed for 2 years. In appointing members, EPA will seek to achieve balanced representation from among the following sectors: the agrichemical and commodity chemical industries; environmental/ public interest organizations; public health organizations; animal welfare organizations; Federal agencies; State, local and tribal governments; academia; consumers, and the public. Nominations must be received by EPA on or before June 30, 2003. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPPT   2003   0011 in the subject line on the first page of your submission. Do not include the nominee's private information, such as, social security number, birth date and place, home address, and telephone number. You may submit your nomination electronically, by fax, in person, or by courier. We normally would accept requests by mail, but in this time of delays in delivery of Federal government mail due to health and security concerns, we cannot assure your request would arrive in a timely manner. 1. Electronically. You may submit your nomination electronically. Do not submit any information electronically that you consider to be CBI or information protected under the Privacy Act. Use WordPerfect 6.1/ 8.0 or ASCII file format and avoid the use of special characters and any form of encryption. i. EPA docket. You may use EPA's electronic public docket to submit a nomination. Go to EPA Dockets at, http:// www. epa. gov/ edocket, and follow the online instructions for submitting materials. Once in the system, select `` search,'' and then key in docket ID number OPPT   2003   0011. Please see Unit I. B. 1. ii. E mail. Nominations may be sent by e mail to the technical contact listed under FOR FURTHER INFORMATION CONTACT, or directly to the docket at oppt. ncic@ epa. gov, Attention: Docket ID number OPPT   2003   0011. iii. Disk or CD ROM. You may submit nominations on a disk or CD ROM by courier or package service, such as Federal Express, to: the OPPT Document Control Office ( DCO) in EPA East Building Room 6428, 1201 Constitution Ave., NW., Washington, DC, Attention: Docket ID number OPPT   2003   0011. The DCO is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is ( 202) 564   8930. These electronic VerDate Jan< 31> 2003 19: 12 May 29, 2003 Jkt 200001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 30MYN1. SGM 30MYN1 32484 Federal Register / Vol. 68, No. 104 / Friday, May 30, 2003 / Notices submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. Do not submit any disk or CD ROM through the mail. Due to security measures, disks and CD ROMs risk being destroyed when handled as Federal government mail. 2. By fax. Send your nomination( s) to the technical contact identified under FOR FURTHER INFORMATION CONTACT. 3. In person or by courier. Deliver your nomination to: OPPT Document Control Office ( DCO). See Unit II. 1. iii. for Document Control Office information.

III. Background A. Action EPA's ongoing implementation of EDSP is science driven, and supported by the recommendations and comments of knowledgeable scientists and stakeholders. Information on the EDMVS meetings to date, a list of the current members of the EDMVS, and other EPA EDSP related information are available at http:// www. epa. gov/ scipoly/ oscpendo/ edmvs. htm. The EDMVS held it's initial meeting in October 2001. All 26 members started their membership with that meeting and 25 of the original members remain with the subcommittee. In October 2003, 25 of the current members will have served their initial 2   year term and may reapply to the subcommittee or not, as time and responsibilities may dictate. The purpose of this Federal Register notice is to solicit nominations for scientists who would be interested in serving on this cutting edge subcommittee. You may nominate others and you may self nominate. Qualifications for subcommittee membership are discussed in Unit II. of the SUPPLEMENTARY INFORMATION. EPA hopes to announce its selection of members for the subcommittee's third and fourth years by September 2003.

B. The Purpose of the Endocrine Disruptor Methods Validation Subcommittee 1. Purpose and authority. The EDMVS was established in accordance with the FACA ( 5 U. S. C. app. 2 section 9( c)). The EDMVS is a subcommittee of EPA's NACEPT. The purpose of the EDMVS is to assist NACEPT in providing advice and counsel to EPA on scientific issues associated with the conduct of studies necessary for validation of Tier I and Tier II assays for EPA's EDSP. The EDMVS explores issues regarding: The development and choice of initial protocols; prevalidation study designs; validation study designs; the integration of prevalidation, and validation study results into EDSP Tier I and Tier II methods documents suitable for external peer review. All EDMVS recommendations are forwarded to the Agency through NACEPT. Taking into consideration this advice and recommendations, EPA will manage and conduct prevalidation and validation laboratory studies. 2. Objective and scope of the activity. The EDMVS and NACEPT provide a forum for diverse groups of individuals representing a broad range of interests to consult with and make recommendations to the Agency on matters relating to the development, optimization, and validation of endocrine disruptor screening and testing methods. The subcommittee will analyze issues, review data and protocols, compile information, make recommendations to the Agency through NACEPT, and undertake other activities necessary to meet its responsibilities. The complete Mission Statement is available at: http:// www. epa. gov/ scipoly/ oscpendo/ edmvs. htm, press enter and page down to `` EDMVS Subcommittee Mission Statement.'' 3. Meetings. The EDMVS may hold up to six meetings a year. These meetings generally are held in Washington, DC and usually last for 2   3 days. Meeting materials to be discussed are distributed to members prior to the meetings. A regular employee of EPA acts as the DFO and will be present or represented at all meetings. All EDMVS meetings are called, announced, and held in accordance with FACA and NACEPT rules, which require open meetings and an opportunity for interested persons to file comments before or after meetings, or to make statements during the public meetings to the extent time permits. The date, time, location, and any public participation instructions for each meeting are announced in the Federal Register at least 15 days before the meeting date. Each meeting is conducted in accordance with an agenda. Meeting information and the agenda are posted on the Agency's web site as soon as available. To date, the EDMVS has held six, meetings starting with a 2   day meeting October 30   31, 2001. Other face to face meetings were held; December 10   12, 2001; March 25   27, 2002; and July 23   24, 2002. There have been two 2   hour teleconferences, each on a single topic. There are face to face meetings planned for June 5   6, 2003 and August 19   21, 2003. C. Establishment of the Endocrine Disruptor Screening Program The complexity of the scientific and regulatory issues surrounding the endocrine disruptor issue led EPA to seek broad expert advice and counsel beyond the Agency. EPA held a public meeting in May of 1996 requesting advice on how to develop a scientifically defensible, pragmatic approach to endocrine disruptor screening and testing. The stakeholder feedback indicated that a broad based multi sector stakeholder committee should be established under the FACA. Following a second public meeting and analysis of stakeholder interests ( Keystone Center Convening Report), the Agency chartered the Endocrine Disruptor Screening and Testing Advisory Committee ( EDSTAC). EDSTAC was charged with providing advice and recommendations to the Agency regarding a strategy for testing chemical substances to determine whether they may have an effect in humans similar to an effect produced by naturally occurring hormones. EDSTAC consisted of 39 representatives from industry, environmental and public health advocacy groups, state government, other Federal agencies, and academic scientists. Over a 2   year period, EDSTAC held eight meetings. In its final report ( available at http:// www. epa. gov/ scipoly/ oscpendo/ history/ exesum14. pdf), EDSTAC provided 71 consensus recommendations regarding an endocrine disruptor screening program. EPA's EDSP was set forth in a notice published in the Federal Register of August 11, 1998 ( 63 FR 42852) ( FRL   6021   3), and described in more detail in a proposed statement of policy published in the Federal Register of December 28, 1998 ( FR 67 79611) ( FRL   7286   6). The EDSP proposed statement of policy, was subsequently reviewed by a joint panel of the FIFRA Scientific Advisory Panel ( SAP) and the EPA Science Advisory Board ( SAB) in May 1999. The SAP/ SAB issued a final report that concluded that a tiered approach relying on a combination of in vivo and in vitro screens for Tier I and a set of in vivo Tier II tests was scientifically reasonable.

D. Implementation of EPA's Endocrine Disruptor Screening Program EPA's ongoing implementation of EDSP is science driven, and supported by the recommendations and comments of EDSTAC, the SAP/ SAB Joint Panel, and the EDMVS. The Agency's Implementation is currently proceeding on three fronts: Priority setting for VerDate Jan< 31> 2003 19: 12 May 29, 2003 Jkt 200001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 30MYN1. SGM 30MYN1 32485 Federal Register / Vol. 68, No. 104 / Friday, May 30, 2003 / Notices chemicals to be screened and tested: Prevalidation and validation studies on Tier I and Tier II assays; and developing policy and procedures to require endocrine disruptor testing. 1. Priority setting. Priority setting is a separate activity from the EDMVS. For the latest information on priority setting of chemicals for testing see Federal Register of December 30, 2002, ( 67 FR 79611) ( FRL   7286   6) and docket ID number OPPT   2002   0066. 2. Validation process. As a charter member of the Interagency Coordinating Committee on the Validation of Alternative Methods ( ICCVAM), EPA is following the interagency validation framework outlined in the ICCVAM report `` Validation and Regulatory Acceptance of Toxicological Test Methods'' for validating the EDSP screening and testing methods. The National Institute of Environmental Health Sciences ( NIEHS) established ICCVAM as a standing committee of Federal agencies to coordinate and facilitate interagency validation, acceptance, and harmonization of toxicological test methods with an emphasis on reducing animal use, refining procedures involving animals to make them less stressful and replacing animals where scientifically appropriate. The ICCVAM validation process was designed as a flexible, adaptable framework applicable to conventional and alternative methods, and to meet the needs of diverse test sponsors, Federal agencies and regulatory processes. EPA's EDSP is managing the validation process with substantial involvement of ICCVAM personnel. Although there is widespread interest in EPA's EDSP, the screening and testing methods are being developed and validated with the specific goal of developing test guidelines for EPA regulatory use. The test guidelines will ultimately be used by chemical manufacturers, pesticide registrants, and other entities to develop data for submission to EPA in support of the Agency's statutorily mandated chemical risk management programs. In addition to EPA's domestic EDSP validation program, certain screening assays and tests for international use are also being developed by the Organization for Economic Cooperation and Development ( OECD) Test Guidelines Program. EPA is an active member of the OECD Test Guidelines Program activities, as well as the latter's Endocrine Disruptor Testing and Assessment Workgroup. EPA will rely upon the OECD mechanism for validating those EDSP screens and tests of international interest. The OECD, EPA, and ICCVAM have also mutually agreed to this administrative arrangement to ensure that all appropriate validation and peer review steps are achieved in both domestic and international efforts. 3. Status of validation of the assays. The table below shows the validation process steps that have been initiated on each of the assays.

Screens/ Assays Literature Review Initial Protocol Demonstration Prevalidation Studies Validation Studies Amphibian metamorphosis X X X AR binding X X X Aromatase X X X ER binding X X X X Fish reproductive X X X Hershberger X X X Pubertal female X X X Pubertal male X X X Steroidogenesis X X X Uterotrophic ( Tier ?) X X X X Amphibian 2   generation development and reproduction test X X Avian 2   generation test X X X Fish life cycle test X Mammalian 2   generation test X X Mysid life cycle test X X X 4. Policy and procedures workgroup. The Agency has established a workgroup composed of scientists, economists, lawyers, and policy specialists from different EPA offices that is in the process of developing policy and procedures related to requiring endocrine disruptor testing. List of Subjects Environmental protection, Endocrine disruption, Endocrine disruptor screening program. Dated: May 21, 2003.

Stephen Johnson,

Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances. [ FR Doc. 03   13432 Filed 5   29   03; 8: 45 am]

BILLING CODE 6560   50   S VerDate Jan< 31> 2003 19: 12 May 29, 2003 Jkt 200001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 30MYN1. SGM 30MYN1


[Federal Register Volume 86, Number 210 (Wednesday, November 3, 2021)]
[Notices]
[Pages 60629-60630]
[FR Doc No: 2021-23957]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 10855-345]

Upper Peninsula Power Company; Notice of Application for
Amendment of License, Soliciting Comments, Motions To Intervene, and
Protests

    Take notice that the following hydroelectric application has been
filed with the Federal Energy Regulatory Commission and is available
for public inspection:
    a. Type of Proceeding: Request for temporary variances of Article
402.
    b. Project No.: 10855-345.
    c. Date Filed: October 14, 2021.
    d. Licensee: Upper Peninsula Power Company.
    e. Name of Project: Dead River Hydroelectric Project.
    f. Location: The project is located on the Dead River, in Marquette
County, Michigan.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Licensee Contact: Mr. Virgil Schlorke, Upper Peninsula Power
Company, 800 Greenwood Street, Ishpeming, MI 49849,<PHONE_NUMBER>.
    i. FERC Contact: Brian Bartos,<PHONE_NUMBER>,
[email protected].
    j. Deadline for filing comments, motions to intervene, and
protests, is November 29, 2021.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at [email protected],<PHONE_NUMBER> (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, MD 20852. The first page of any filing should
include docket number P-10855-033. Comments emailed to Commission staff
are not considered part of the Commission record.
    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 whose name appears on 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.
    k. Description of Request: The applicant requests a temporary
variance from the surface elevation requirements under Article 402 at
the Silver Lake Storage Basin (SLSB) and Dead River Storage Basin
(DRSB) due to ongoing drought conditions at the project. The applicant
is currently in dry year consultation with the Michigan Department of
Natural Resources, Michigan Department of Environment, Great Lakes, and
Energy, and U.S. Fish and Wildlife Service. Due to the potential long-
term nature of the variance, the applicant requests a temporary
variance from the license requirements until impoundment elevations
return to normal levels.
    Additionally, the applicant proposes to modify the start-of-month
target reservoir surface elevation requirements at the SLSB and DRSB
for the year 2022. Specifically, the applicant proposes to increase the
SLSB start-of-month target elevations in February and March from

1,477.5 to 1,479.0 feet National Geodetic Vertical Datum (NGVD); April
from 1,477.5 to 1,485.0 feet NGVD; May from 1,479.0 to 1,485.0 feet
NGVD; June from 1,481.0 to 1,485.0 feet NGVD; July from 1,481.5 to
1,485.0 feet NGVD; August from 1,480.0 to 1,482.5 feet NGVD; September
and October from 1,479.5 to 1480.0 feet NGVD. The licensee would
continue to maintain the target elevations for the remaining months as
required by Article 402. The applicant proposes to increase the DRSB
start-of-month target elevation for May from 1,340.0 to 1,341.0 feet
NGVD. The applicant states that the temporary variance will allow the
applicant to continue to determine if there are operational
modifications that can be employed to improve water quality in the Dead
River, as well as to proactively allow for increased storage in the
impoundments in the event that the watershed receives significant
precipitation and/or snowmelt in the spring.
    l. Locations of the Application: This filing may be viewed on the
Commission's website 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 the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
[email protected], for TTY, call<PHONE_NUMBER>. Agencies may
obtain copies of the application directly from the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments 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 comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (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 commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor 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
385.2010.

    Dated: October 28, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-23957 Filed 11-2-21; 8:45 am]
BILLING CODE 6717-01-P