[Federal Register Volume 77, Number 87 (Friday, May 4, 2012)]
[Rules and Regulations]
[Pages 26450-26456]
[FR Doc No: 2012-10689]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0179; FRL-9345-6]

Metconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for residues of
Metconazole, including its metabolites and degradates in or on
sugarcane, cane. BASF Corporation requested the tolerance under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 4, 2012. Objections and
requests for hearings must be received on or before July 3, 2012, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2011-0179. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Tamue L. Gibson, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; 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.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2011-0179 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
July 3, 2012. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing

request, identified by docket ID number EPA-HQ-OPP-2011-0179, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of April 20, 2011 (76 FR 22067) (FRL-8869-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
0F7807) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research
Triangle Park, NC 27709-3528. The petition requested that 40 CFR part
180 be amended by establishing tolerances for residues of the fungicide
metconazole, 5-[(4-chlorophenyl)methyl]-2,2-dimethyl-1-(1H-1,2,4-
triazol-1-ylmethyl)cyclopentanol, measured as the sum of cis- and
trans-isomers, in or on sugarcane, cane at 0.06 parts per million
(ppm); and sugarcane, molasses at 0.08 ppm. That notice 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.
    Based upon review of the data supporting the petition, tolerances
for sugarcane, molasses are not being established. The reason for this
change is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue * *
*''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 metconazole including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with metconazole
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.
    Acute oral and dermal toxicities to metconazole are moderate, while
acute inhalation toxicity is low. Metconazole is a moderate eye
irritant and a mild skin irritant. It is not a skin sensitizer.
    Metconazole was shown to affect the liver, kidney, spleen, and
certain blood parameters in all the species tested. Dose levels at
which these effects occur are similar across species with the rat and
dog being slightly more sensitive than the mouse. Like other triazoles,
a primary target organ in mammalian toxicity studies is the liver.
Liver toxicity was seen in the mouse, rat and dog following oral
exposure to metconazole via subchronic or chronic exposure durations.
While liver effects have been reported consistently across multiple
durations and species, these effects were considered slight and minimal
in some studies and appeared to be ``adaptive'' responses. However,
based on the weight of evidence from the consistency of these reported
effects and evidence that these effects increase in severity with
duration, and leading to liver tumors in the chronic mouse study, they
were considered ``adverse'' and formed the basis of the study lowest
observed adverse effect levels (LOAELs). Metconazole is considered
nongenotoxic and the liver tumors appear to have been formed via a
mitogenic mode of action and therefore, metconazole is classified as
``not likely to be carcinogenic to humans'' at levels that do not cause
mitogenesis. There is evidence of liver effects (microsomal induction,
liver weight increases, hypertrophy) at 47.6 milligrams/kilograms/day
(mg/kg/day), but no effects at 4.5 mg/kg/day in the mode of action
studies in the mouse. There is no concern for mutagenicity. The chronic
Reference Dose of 0.04 mg/kg/day based on the 2-year chronic rat study
with a no observed adverse effect level (NOAEL) of 4.3 mg/kg/day would
be protective of early liver disturbances seen in the mouse studies.
Therefore, the Agency has determined that the quantification of risk
using a non-linear approach (i.e., Reference dose (RfD)) will
adequately account for all chronic toxicity, including carcinogenicity,
that could result from exposure to metconazole.
    Other major critical effects observed in oral studies were
decreased body weight, decreased body weight gains, and blood effects
(reductions in erythrocyte and/or platelet parameters) in the mouse,
rat, dog and/or rabbit. Splenic effects including increased spleen
weight and hyperplasia were observed in the mouse, rat and dog at dose
levels where liver effects were also observed. In dogs, lenticular
degeneration (cataracts) was observed at the highest dose tested (HDT)
(114 mg/kg/day). Furthermore, at high dietary levels, there is evidence
that metconazole is a gastrointestinal irritant in the dog.
    There was no evidence of immunotoxicity at dose levels that
produced systemic toxicity. No immunotoxic effects are evident for
metconazole at dose levels as high as 52 mg/kg/day in rats, which is 12
times higher than the chronic dietary point of departure (4.3 mg/kg/
day).
    Metconazole did not demonstrate neurotoxicity in the standard
battery of tests submitted. Information available from the submitted
studies including acute, subchronic and chronic studies in several
species, developmental toxicity studies in the rat and rabbit and a 2-
generation reproduction study in the rat do not indicate any neurotoxic
signs. No effects were noted on brain weights and no clinical signs
possibly related to neurotoxicity were noted up to and including the
high doses in all studies.

    Specific information on the studies received and the nature of the
adverse effects caused by metconazole as well as the NOAEL and the
LOAEL from the toxicity studies can be found at http://www.regulations.gov in document ``Metconazole: Human Health Risk
Assessment for Proposed Uses on Sugarcane,'' at page 36 in docket ID
number EPA-HQ-OPP-2011-0179.

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 metconazole used for human risk assessment is shown in
the following Table.

   Table--Summary of Toxicological Doses and Endpoints for Metconazole for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and  uncertainty/    RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50       NOAEL = 12 mg/kg/day  Acute RfD = 0.12 mg/ Developmental toxicity in rats.
 years of age).                    UFA = 10x...........   kg/day.             LOAEL = 30 mg/kg/day based on
                                   UFH = 10x...........  aPAD = 0.12 mg/kg/    increases in skeletal variations.
                                   FQPA SF = 1x........   day.                 At 75 mg/kg/day increased
                                                                               incidence of post-implantation
                                                                               loss, hydrocephaly and visceral
                                                                               anomaliea (cranial hemorrhage,
                                                                               dilated renal pelvis, dilated
                                                                               ureters, and displaced testis)
                                                                               were reported.
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  An appropriate dose/endpoint attributable to a single dose was not observed
 including infants and children).   in the available oral toxicity studies reviewed.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 4.3 mg/kg/day  Chronic RfD = 0.04   Chronic oral toxicity study in
                                   UFA = 10x...........   mg/kg/day.           rats.
                                   UFH = 10x...........  cPAD = 0.04 mg/kg/   LOAEL = 13.1 mg/kg/day based on
                                   FQPA SF = 1x........   day.                 increased liver (M) weights and
                                                                               associated hepatocellular lipid
                                                                               vacuolation (M) and centrilobular
                                                                               hypertrophy(M). Similar effects
                                                                               were observed in females at 54 mg/
                                                                               kg/day, plus increased spleen
                                                                               weight.
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to   NOAEL= 9.1 mg/kg/day  LOC for MOE = 100..  28-Day oral toxicity study in
 30 days).                         UFA = 10x...........                        rats.
                                   UFH = 10x...........                       LOAEL = 90.5 mg/kg/day based on
                                   FQPA SF = 1x........                        decreased body weight (M),
                                                                               increased liver and kidney weight
                                                                               and hepatocellular hypertrophy
                                                                               and vacuolation (M/F).
----------------------------------------------------------------------------------------------------------------
Incidental oral intermediate-term  NOAEL= 6.4 mg/kg/day  LOC for MOE = 100..  90-Day oral toxicity study in
 (1 to 6 months).                  UFA= 10x............                        rats.
                                   UFH= 10x............                       LOAEL = 19.2 mg/kg/day based on
                                   FQPA SF = 1x........                        increased spleen wt (F) and
                                                                               hepatic vacuolation (M).
----------------------------------------------------------------------------------------------------------------
Dermal short-term and              Quantification of dermal risk is not needed due to lack of systemic or dermal
 intermediate-term.                 toxicity at the Limit Dose in a 21-day dermal toxicity study in the rat, the
                                    lack of target organ toxicity or neurotoxicity, and the lack of
                                    developmental or reproductive toxicity in the absence of parental effects
                                    which were looked for in the dermal toxicity.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     Inhalation (or oral)  LOC for MOE = 100..  28-Day oral toxicity study in
 days).                             study NOAEL= 9.1 mg/                       rats.
                                    kg/day (inhalation                        LOAEL = 90.5 mg/kg/day based on
                                    absorption rate =                          decreased body weight (M),
                                    100%).                                     increased liver and kidney weight
                                   UFA = 10x...........                        and hepatocellular hypertrophy
                                   UFH = 10x...........                        and vacuolation (M/F).
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------

Inhalation (1 to 6 months).......  Inhalation (or oral)  LOC for MOE = 100..  90-Day oral toxicity study in
                                    study NOAEL = 6.4                          rats.
                                    mg/kg/day                                 LOAEL = 19.2 mg/kg/day based on
                                    (inhalation                                increased spleen wt (F) and
                                    absorption rate =                          hepatic vacuolation (M).
                                    100%).
                                   UFA = 10x...........
                                   UFH = 10x...........
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: ``Not likely to be Carcinogenic to Humans'' based on evidence
                                    that a non-genotoxic mode of action for mouse liver tumors was established
                                    and that carcinogenic effects were not likely below a defined dose that does
                                    not cause mitogenesis.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of
  concern. M = male animals. F= female animals. Mg/kg/day = milligrams per kilogram per day. LOAEL= lowest
  observed adverse effect level. NOAEL = no observed adverse effect level.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to metconazole, EPA considered exposure under the petitioned-
for tolerances as well as all existing metconazole tolerances in 40 CFR
180.617. EPA assessed dietary exposures from metconazole 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 metconazole. In estimating acute dietary exposure, EPA used food
consumption information from the U. S. Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, EPA made the
following assumptions for the acute exposure assessment: Tolerance-
level residues and 100 percent crop treated (PCT). EPA used Dietary
Exposure Evaluation Model (DEEM\TM\) version 7.81 default processing
factors.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA made the following
assumptions for the chronic exposure assessment: Tolerance-level
residues and 100 PCT. EPA used DEEM\TM\ version 7.81 default processing
factors.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
determined that the quantification of risk using a non-linear approach
will adequately account for all chronic toxicity, including
carcinogenicity, that could result from exposure to metconazole.
Therefore, the chonic RfD is expected to be protective of chronic
toxicity including carcinogenicity. For the purpose of assessing cancer
risk under this approach EPA relied upon the exposure estimate
discussed in Unit III.C.1.ii.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for metconazole. Tolerance level residues and/or 100 PCT were assumed
for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for metconazole in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of metconazole. 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
metconazole for acute exposures are estimated to be 45.48 parts per
billion (ppb) for surface water and 0.38 ppb for ground water.
    Chronic exposures for non-cancer assessments are estimated to be
38.16 ppb for surface water and 0.38 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 45.48 ppb was used to
assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration of
value 38.16 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).
    Metconazole is currently registered for the following uses that
could result in residential exposures: Turf and ornamentals. EPA
assessed residential exposure using the following assumptions: Adults,
adolescents and children may be exposed to metconazole from its
currently registered turf and ornamental uses. Adults and adolescents
may experience short- and intermediate-term dermal exposure from
golfing and other activities on treated turf, as well as from tending
treated ornamentals. Children may experience short- and intermediate-
term dermal and incidental oral exposure from activities on treated
turf. However, because dermal toxicity endpoints for the appropriate
durations of exposure were not identified, and because inhalation
exposure is considered to be insignificant for postapplication
exposures, only children's incidental oral postapplication exposures
have been assessed. Postapplication risks to children following the
application of metconazole to home lawns were calculated for short- and
intermediate-term incidental oral exposures. 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.''
    Metconazole is a member of the triazole-containing class of
pesticides. Although conazoles act similarly in plants (fungi) by
inhibiting ergosterol biosynthesis, there is not necessarily a
relationship between their pesticidal activity and their mechanism of
toxicity in mammals. Structural similarities do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same, sequence of
major biochemical events (EPA, 2002). In conazoles, however, a variable
pattern of toxicological responses is found; some are hepatotoxic and
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some
induce developmental, reproductive, and neurological effects in
rodents. Furthermore, the conazoles produce a diverse range of
biochemical events including altered cholesterol levels, stress
responses, and altered DNA methylation. It is not clearly understood
whether these biochemical events are directly connected to their
toxicological outcomes. Thus, there is currently no evidence to
indicate that conazoles share common mechanisms of toxicity and EPA is
not following a cumulative risk approach based on a common mechanism of
toxicity for the conazoles. For information regarding EPA's procedures
for cumulating effects from substances found to have a common mechanism
of toxicity, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
    Triazole-derived pesticides can form the metabolite 1,2,4-triazole
(T) and two triazole conjugates triazolylalanine (TA) and
triazolylacetic acid (TAA). To support existing tolerances and to
establish new tolerances for triazole-derivative pesticides, EPA
conducted an initial human-health risk assessment for exposure to T,
TA, and TAA resulting from the use of all current and pending uses of
any triazole-derived fungicide as of September 1, 2005. The risk
assessment was a highly conservative, screening-level evaluation in
terms of hazards associated with common metabolites (e.g., use of a
maximum combination of uncertainty factors) and potential dietary and
non-dietary exposures (i.e., high-end estimates of both dietary and
non-dietary exposures). In addition, the Agency retained the additional
10X Food Quality Protection Act (FQPA) safety factor (SF) for the
protection of infants and children. The assessment included evaluations
of risks for various subgroups, including those comprised of infants
and children. The Agency's complete risk assessment can be found in the
propiconazole reregistration docket at http://www.regulations.gov,
Docket Identification (ID) Number EPA-HQ-OPP-2005-0497 and an update to
the aggregate human health risk assessment for free triazoles and its
conjugates may be found in Docket Identification (ID) Number EPA-HQ-
OPP-2011-0179 entitled ``Common Triazole Metabolites: Updated Aggregate
Human Health Risk Assessment to Address Tolerance Petitions for
Metconazole.''

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA SF. In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. Developmental studies in
rats and rabbits show some evidence of developmental effects, but only
at dose levels that are maternally toxic. There was no quantitative
susceptibility to the fetuses of rats or rabbits following in utero
exposure to metconazole. In the developmental toxicity study in rats,
skeletal variations (predominantly lumbar ribs) occurred in the
presence of maternal toxicity (decreased body weight gains). In the
prenatal developmental toxicity study in rabbits, developmental effects
(increased post-implantation loss and reduced fetal body weights) were
observed at the same dose that caused maternal toxicity (decreased body
weight gains, reduced food consumption and alterations in hematology
parameters). In the 2-generation reproduction study in rats, offspring
toxicity (reduced fetal body weights F2 offspring and decreased
viability in F1 and F2 offspring) was observed only at the HDT, a dose
which also resulted in parental toxicity as evidenced by reduced
parental body weight and body weight gains, increased incidence of
fatty hepatocyte changes in male parental animals and increased
incidence of spleen congestion in F1 parental females. In the rat
study, there is a concern for qualitative susceptibility (skeletal
variation in the presence of minimal maternal toxicity) due to the
presence of more severe effects at higher dose levels such as post-
implantation loss, hydrocephaly and visceral anomalies. However, there
is a clear NOAEL for these effects and the point of departure for this
endpoint is based on skeletal variations. Therefore, it is concluded
that there is no residual uncertainty for prenatal 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:
     The toxicity database is complete except for an acute
neurotoxicity study.
     There is no concern for neurotoxicity with metconazole.
However, in accordance with the revised 40 CFR part 158 data
requirements, a neurotoxicity battery is required for risk assessment.
The existing metconazole database does not include an acute
neurotoxicity study, and thus remains a data deficiency. An acceptable
subchronic neurotoxicity study showed no neurotoxic effects at levels
that produced systemic toxicity in the study, as well as in other
subchronic and chronic studies. Therefore, concern for potential
neurotoxicity is low and the 10X FQPA factor is not retained.
     There is no evidence of susceptibility following in utero
exposure in the rabbit developmental study. In the rat developmental
study there is qualitative evidence of susceptibility, however the
concern is low since the developmental effects occur in the presence of
maternal toxicity, the NOAELs are well defined, and the dose/endpoint
is used for acute dietary risk assessment for the sensitive population.
There is no evidence of increased susceptibility in the offspring based
on the result of the 2-generation reproduction study. Dietary exposure
assessments were conducted using tolerance level residues and assumed
100 PCT. Therefore, the acute and chronic dietary (food only) exposure
is considered an upper bound conservative estimate. The contribution
from drinking water is minimal. The Agency concludes that the acute and

chronic exposure estimates in this analysis are unlikely to
underestimate actual exposure. The drinking water component of the
dietary assessment utilizes water concentration values generated by
model and associated modeling parameters which are designed to provide
conservative, health protective, high-end estimates of water
concentrations which will not likely be exceeded. While there is
potential for postapplication residential exposure, the Agency used the
current conservative approaches for residential assessment. Exposures
are unlikely to be under estimated because the assessment was a
screening level assessment.

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 metconazole will occupy 3.8% of the aPAD for females 13-49 years
old, the only population subgroup of concern.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
metconazole from food and water will utilize 12.6% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
metconazole is not expected.
    3. Short-term risk. Short-term risk takes into account short-term
residential exposure plus chronic exposure to food and drinking water
(considered to be a background exposure level). Metconazole 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 metconazole.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and non-occupational/residential post application exposures result in
aggregate MOEs of 420 for children 1-2 years old and 1,700 for adults.
Because EPA's level of concern for metconazole is a MOE of 100 or
below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term risk takes into
account intermediate-term residential exposure plus chronic exposure to
food and drinking water (considered to be a background exposure level).
Metconazole is currently registered for uses that could result in
intermediate-term residential exposure, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate-term residential exposures to metconazole.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and non-occupational residential
exposures result in aggregate MOEs of 460 for children 1-2 years old
and 1,700 for adults. Because EPA's level of concern for metconazole is
a MOE of 100 or below, these MOEs are not of concern.
    5. Aggregate cancer risk for U.S. population. As explained in Unit
III.A., the Agency has determined that the quantification of risk using
a non-linear (i.e., RfD) approach will adequately account for all
chronic toxicity, including carcinogenicity, that could result from
exposure to metconazole. Therefore, based on the results of the chronic
risk assessment discussed in Unit III.E.2., metconazole is not expected
to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to metconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid
chromatography/tandem mass spectrometry (HPLC/MS/MS) method BASF D0604)
is available to enforce the tolerance expression. 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 U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established a MRL for metconazole on sugarcane.

C. Revisions to Petitioned-For Tolerances

    Based on the results of the sugarcane crop field data and the
tolerance calculation procedures, EPA has determined that separate
tolerances for sugarcane, molasses are unnecessary. The highest
metconazole residue from the sugarcane field trials is 0.036 ppm. This
residue multiplied by the processing factor for molasses (0.036 x 1.2)
yields 0.043 ppm. As this is less than the tolerance for sugarcane,
cane at 0.06 ppm, the sugarcane, cane tolerance will cover molasses.

V. Conclusion

    Therefore, tolerances are established for residues of metconazole,
5-[(4-chlorophenyl)methyl]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-
ylmethyl)cyclopentanol, including its metabolites and degradates in or
on sugarcane, cane at 0.06 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Pub. L. 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this final rule in the Federal
Register. This final rule 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: April 24, 2012.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.617 is amended by alphabetically adding the following
commodity to the table in paragraph (a) to read as follows:

Sec.  180.617  Metconazole; tolerances for residues.

    (a) * * *

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

                                * * * * *
Sugarcane, cane.............................................        0.06

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

* * * * *
[FR Doc. 2012-10689 Filed 5-3-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 91 (Wednesday, May 11, 2011)]
[Rules and Regulations]
[Page 27250]
[FR Doc No: 2011-11545]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2011-0330]

Drawbridge Operation Regulations; Hackensack River, Jersey City,
NJ

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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

SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Lower Hack Bridge across the Hackensack River, mile 3.4, at Jersey
City, New Jersey. The deviation is necessary to repair structural steel
members on the lift span. This deviation allows the bridge to remain in
the closed position to facilitate the above repairs.

DATES: This deviation is effective from 10 p.m. on May 26, 2011 through
5 a.m. on May 27, 2011.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2011-0330 and are available online
at http://www.regulations.gov, inserting USCG-2011-0330 in the
``Keyword'' and then clicking ``Search.'' They are also available for
inspection or copying at the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Mr. Joe Arca, Project Officer, First Coast Guard
District<EMAIL_ADDRESS>telephone<PHONE_NUMBER>. If you have
questions on viewing the docket, call Renee V. Wright, Program Manager,
Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Lower Hack Bridge, across the Hackensack
River at mile 3.4, has a vertical clearance in the closed position of
40 feet at mean high water and 45 feet at mean low water. The existing
drawbridge operation regulations are listed at 33 CFR 117.723(b).
    The waterway accommodates both commercial and recreational vessels
of various sizes. Recreational navigation passes under the bridge
without requiring any drawbridge openings.
    The owner of the bridge, New Jersey Transit, requested a temporary
deviation to facilitate necessary structural steel repairs at the
bridge.
    Under this temporary deviation the Lower Hack Bridge, across the
Hackensack River at mile 3.4, may remain in the closed position from 10
p.m. on May 26, 2011 through 5 a.m. on May 27, 2011. Vessels that can
pass under the bridge without a bridge opening may do so at all times.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: May 2, 2011.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. 2011-11545 Filed 5-10-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 84, Number 42 (Monday, March 4, 2019)]
[Rules and Regulations]
[Page 7274]
[FR Doc No: C1-2019-02687]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2018-0256; Airspace Docket No. 18-AEA-11]
RIN 2120-AA66

Amendment of Class D Airspace and Class E Airspace; Schenectady,
NY, Ithaca, NY, and Albany, NY

Correction

    In rule document 2019-02687, appearing on pages 4991 through 4993,
in the issue of Wednesday, February 20, 2019, make the following
correction:

Sec.  71.1   [Corrected]

0
On page 4992, in the second column, under the heading ``AEA NY E2
Ithaca, NY [Amended]'', in the third line, the entry that reads ``(Lat.
42[deg]29'29'' N, long. 76[deg]27'3'' W)'' should read ``(Lat.
42[deg]29'29'' N, long. 76[deg]27'31'' W)''.

[FR Doc. C1-2019-02687 Filed 3-1-19; 8:45 am]
 BILLING CODE 1301-00-D


[Federal Register Volume 80, Number 101 (Wednesday, May 27, 2015)]
[Notices]
[Page 30227]
[FR Doc No: 2015-12715]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Membership of Performance Review Board for Senior
Executives

    The Federal Energy Regulatory Commission hereby provides notice of
the membership of its Performance Review Board (PRB) for the
Commission's Senior Executive Service (SES) members. The function of
this board is to make recommendations relating to the performance of
senior executives in the Commission. This action is undertaken in
accordance with Title 5, U.S.C., Section 4314(c)(4).
    The Commission's PRB will remove the following members:

Michael C. McLaughlin
Jeff C. Wright

    The Commission's PRB will add the following members:

Larry R. Parkinson
Ann F. Miles
J. Arnold Quinn

    Dated: May 14, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-12715 Filed 5-26-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)]
[Notices]
[Page 5764]
[FR Doc No: 2016-01884]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0253]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Postmarketing Adverse Drug
Experience Reporting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Postmarketing Adverse Drug
Experience Reporting'' has been approved by the Office of Management
and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On July 1, 2015, the Agency submitted a
proposed collection of information entitled ``Postmarketing Adverse
Drug Experience Reporting'' to OMB for review and clearance under 44
U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0230.
The approval expires on December 31, 2018. A copy of the supporting
statement for this information collection is available on the Internet
at http://www.reginfo.gov/public/do/PRAMain.

    Dated: January 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01884 Filed 2-2-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 117 (Tuesday, June 20, 2023)]
[Notices]
[Pages 39841-39842]
[FR Doc No: 2023-13079]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 6115-016]

Pyrites Hydro, LLC; Notice of Application Ready for Environmental
Analysis and Soliciting Comments, Recommendations, Terms and
Conditions, and Prescriptions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New Major License.
    b. Project No.: 6115-016.
    c. Date filed: August 31, 2021.
    d. Applicant: Pyrites Hydro, LLC (Pyrites Hydro).
    e. Name of Project: Pyrites Hydroelectric Project (Pyrites Project
or project).
    f. Location: On the Grass River near the Town of Canton, St.
Lawrence County, New York.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791 (a)-825(r).
    h. Applicant Contact: Curtis Mooney, Manager, Regulatory Affairs,
Patriot Hydro, LLC, 59 Ayers Island Road, Bristol, New Hampshire 03222;
(603) 744-0846 or [email protected].
    i. FERC Contact: Josh Dub at<PHONE_NUMBER>, or email at
[email protected].
    j. Deadline for filing comments, recommendations, terms and
conditions, and prescriptions: 60 days from the issuance date of this
notice; reply comments are due 105 days from the issuance date of this
notice.
    The Commission strongly encourages electronic filing. Please file
comments, recommendations, terms and conditions, and prescriptions
using the Commission's eFiling system at https://ferconline.ferc.gov/FERCOnline.asp. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
https://ferconline.ferc.gov/QuickComment.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]">FERCOnline[email protected],<PHONE_NUMBER> (toll free), or (202) 502-
8659 (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,
Maryland 20852. All filings must clearly identify the project name and
docket number on the first page: Pyrites Hydroelectric Project P-6115-
016.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person 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. This application has been accepted and is now ready for
environmental analysis.
    The Council on Environmental Quality (CEQ) issued a final rule on
April 20, 2022, revising the regulations under 40 CFR parts 1502, 1507,
and 1508 that Federal agencies use to implement the National
Environmental Policy Act (NEPA) (see National Environmental Policy Act
Implementing Regulations Revisions, 87 FR 23,453-70). The final rule
became effective on May 20, 2022. Commission staff intends to conduct
its NEPA review in accordance with CEQ's new regulations.
    l. The Pyrites Project consists of: (1) a 170-foot-long and 12-
foot-high concrete Ambursen overflow spillway with 1.5-foot-high
flashboards, a 115-foot-long concrete auxiliary spillway, and a 208-
foot-long non-overflow dam, which includes a 50-foot-wide intake
structure; (2) a 6-foot-diameter, 700-foot-long steel penstock running
from the intake structure to an upper powerhouse and a 10-foot-
diameter, 2,160-foot-long penstock running from the intake structure to
a lower powerhouse; (3) a 21-foot by 31-foot upper powerhouse located
700 feet downstream of the intake structure containing one 1.2-megawatt
(MW) turbine/generator unit operating under a rated head of 76 feet and
a 50-foot by 53-foot lower powerhouse located 1,200 feet downstream of
the tailrace containing two 3.5-MW turbine/generator units operating
under a rated head of 111 feet; (4) a 50-foot by 97-foot, 115/4.16/2.3-
kilovolt (kV) switchyard and substation for use by both powerhouses;
(5) a 470-foot-long 2.3-kV transmission line connecting the upper
powerhouse to the switchyard; (6) a 1,150-foot-long 4.16-kV
transmission line connecting the lower powerhouse to the switchyard;
and (7) appurtenant facilities.
    The Pyrites Project is operated in a run-of-river mode with an
average annual generation of 27,865 megawatt-hours.
    Pyrites Hydro proposes to continue to operate the project in a run-
of-river mode and maintain a continuous minimum flow to the bypassed
reach of 45 cubic feet per second or inflow to the impoundment,
whichever is less.
    m. A copy of the application can 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. For assistance, contact FERC Online
Support. At this time, the Commission has suspended access to the
Commission's Public Reference Room. For assistance, contact FERC at
[email protected]">FERCOnline[email protected] or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    All filings must (1) bear in all capital letters the title
``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
submitting the filing; 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. Each filing must be accompanied by proof of service on all
persons listed on the service list prepared by the Commission in this
proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
    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, contact FERC
Online Support.
    n. The applicant must file no later than 60 days following the date
of issuance of this notice: (1) a copy of the water quality
certification; (2) a copy of the request for certification, including
proof of the date on which the certifying agency received the request;
or (3) evidence of waiver of water quality certification. Please note
that the certification request must comply with 40 CFR 121.5(b),
including documentation that a pre-filing meeting request was submitted
to the certifying authority at least 30 days prior to submitting the
certification request. Please also note that the certification request
must be sent to the certifying authority and to the Commission
concurrently.
    o. Procedural schedule: The application will be processed according
to the following schedule. Revisions to the schedule will be made as
appropriate.

------------------------------------------------------------------------
                 Milestone                           Target date
------------------------------------------------------------------------
Filing of Comments, Recommendations, Terms  August 2023.
 and Conditions, and Prescriptions.
Filing of Reply Comments..................  September 2023
------------------------------------------------------------------------

    p. The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: June 13, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-13079 Filed 6-16-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 153 (Thursday, August 8, 2019)]
[Rules and Regulations]
[Pages 38867-38869]
[FR Doc No: 2019-16959]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2019-0300]
RIN 1625-AA08

Special Local Regulations; Festival of Sail Duluth 2019, Lake
Superior, Duluth, MN

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary special local
regulation for a designated area of the Duluth Harbor entrance to
Superior Bay on Lake Superior during the Festival of Sail 2019 event in
Duluth, MN. This action is necessary to provide for the safety of life
on these navigable waters around the port of Duluth, MN. This
rulemaking prohibits persons and vessels from being in the designated
region unless authorized by the Captain of the Port Duluth or a
designated representative.

DATES: This rule is effective from 7 a.m. on August 11, 2019, through 5
p.m. on August 13, 2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2019-0300 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
rulemaking, call or email Lieutenant Abbie Lyons, Waterways Management,
MSU Duluth, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    On December 11, 2018 Draw Events LLC notified the Coast Guard that
it will be conducting a Festival of Sail event in Duluth, MN from
August 11 through August 13, 2019. The Coast Guard published a Notice
of Proposed Rulemaking (NPRM) in the Federal Register on May 8, 2019. A
public comment period was held from May 8, 2019 to July 7, 2019 with no
comments received. A Supplemental Notice of Proposed Rulemaking (SNPRM)
was submitted to the Federal Register with a comment period held from
July 3, 2019 to July 17, 2019, extending the Special Local Regulation
through the duration of the event. During the comment period we
received no comments.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable because action is needed during the
Festival of Sail to respond to the potential safety hazards associated
with increased vessel traffic within Superior Harbor.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The Captain of the Port Duluth (COTP) has determined that
potential hazards associated with increased traffic during the Festival
of Sail starting at 7 a.m. on August 11, 2019 will be a safety concern
for anyone the designated area. The likely combination of recreational
vessels, paddling craft, and Tall Ships present an unacceptable risk of
collisions which could result in serious injuries or fatalities. This
rule is needed to protect personnel, vessels, and the marine
environment in the navigable waters within the special local regulation
during the event.

IV. Discussion of Comments, Changes, and the Rule

    No comments were received on the SNPRM published July 3, 2019.
There are no changes in the regulatory text of this rule from the
proposed rule in the SNPRM.
    This rule establishes a Special Local Regulation from 7 a.m. on
August 11, 2019 through 5 p.m. on August 13, 2019. The duration of the
zone is intended to protect the safety of vessels and these navigable
waters before, during, and immediately after the scheduled Festival of
Sail. Only the designated Tall Ships associated with the event are
permitted within the zone while it is being enforced. No other vessels
or persons will be permitted to enter the zone without obtaining
permission from the COTP or a designated representative during the
enforcement period. The COTP or a designated representative may be
contacted via VHF Channel 16 or by telephone at<PHONE_NUMBER>. The
regulatory text appears at the end of this document.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive Orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive Orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the availability
of the Superior Harbor entrance as an alternate entry into Superior
Bay, the short time frame of the special local regulation, and the
estimated number of spectator vessels around the Duluth Harbor entrance
for the event. We anticipate that it will have minimal impact on the
economy, will not interfere with other agencies, will not adversely
alter the budget of any grant or loan recipients,

and will not raise any novel legal or policy issues. The Coast Guard
will issue a Broadcast Notice to Mariners via VHF-FM marine Channel 16
about the zone, and the rule would allow vessels to seek permission to
enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received no comments from the Small Business
Administration on this rulemaking. The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have a significant economic
impact on a substantial number of small entities.
    While some owners or operators of vessels intending to transit the
restricted area may be small entities, for the reasons stated in
section V.A above, this rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of federal
employees who enforce, or otherwise determine compliance with, federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a state, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have
determined that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves a special local regulation lasting 3
days that would prohibit entry within a designated area around the
Duluth Harbor entrance. Normally such actions are categorically
excluded from further review under paragraph L[61] in Table 3-1 of U.S.
Coast Guard Environmental Planning Implementing Procedures.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 100

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority: 46 U.S.C. 70041; 33 CFR 1.05-1.

0
2. Add Sec.  100.T09-0300 to read as follows:

Sec.  100.T09-0300  Special Local Regulations; Festival of Sail Duluth
2019, Lake Superior, Duluth, MN.

    (a) Regulated area. This area includes all waters of Lake Superior
and Duluth Harbor bounded by Rice's Point to the west and Duluth to the
north, within the following boundaries: Beginning at position
46[deg]46'48.36'' N, 092[deg]05'16.44'' W, across Duluth Harbor to
46[deg]47'02.76'' N, 092[deg]05'17.88'' W, turning north toward the
Duluth Lift Bridge to 46[deg]47'19.32'' N, 092[deg]04'04.80'' W, to
46[deg]46'50.88'' N, 092[deg]05'17.88'' W, out the Duluth Harbor
Entrance at 46[deg]46'45.12'' N, 092[deg]05'35.16'' W, then northwest
to 46[deg]46'45.12'' N, 092[deg]05'39.84'' W back to the north Duluth
Entrance Light at 46[deg]47'01.32'' N, 092[deg]05'51.00'' W, through
the canal at 46[deg]47'00.60'' N, 092[deg]05'52.08'' W, then along
Minnesota Point at 46[deg]46'51.60'' N, 092[deg]05'46.32'' W, entering
Minnesota Slip at 46[deg]46'39.00'' N, 092[deg]06'03.96'' W,
encompassing the slip from 46[deg]46'32.16'' N, 092[deg]05'38.76'' W to
46[deg]46'41.52'' N, 092[deg]05'36.24'' W and back out the slip at
46[deg]46'42.60'' N, 092[deg]05'34.44'' W and back to the starting

position of 46[deg]46'48.36'' N, 092[deg]05'16.44'' W.
    (b) Special local regulations. (1) In accordance with the general
regulations in Sec.  100.35 of this part, entry into, transiting, or
anchoring within the regulated areas is prohibited unless authorized by
the Captain of the Port (COTP) Duluth or on-scene representatives.
    (2) Vessels and persons receiving COTP Duluth or on-scene
representative authorization to enter the area of this special local
regulation must do so in accordance with the following restrictions:
    (i) Vessels and persons must transit at a speed not exceed six (6)
knots or at no wake speed, whichever is less. Vessels proceeding under
sail will not be allowed in this Area unless also propelled by
machinery, due to limited maneuvering ability around numerous other
spectator craft viewing the Festival of Sail.
    (ii) Vessels and persons will not be permitted to impede the parade
of sail from 7 a.m. to 1 p.m. on August 11, 2019 once it has commenced,
as the tall ships are extremely limited in their ability to maneuver.
    (3) The Coast Guard will provide notice of the regulated area prior
to the event through Local Notice to Mariners and Broadcast Notice to
Mariners. Notice of the requirements of this rule will also be provided
as a courtesy by on-scene representatives, as available. Notice of
actual enforcement will be provided by on-scene representatives.
    (4) The ``on-scene representative'' of the COTP Duluth is any Coast
Guard commissioned, warrant, or petty officer and any Federal, State,
or local officer designated by the COTP to act on her behalf.
    (5) Vessel operators desiring to enter or operate within the
regulated area shall contact the COTP Duluth by telephone at (218) 428-
9357, or on-scene representative via VHF radio on Channel 16, to obtain
permission to do so. Vessel operators given permission to enter,
operate, transit through, anchor in, or remain within the regulated
areas must comply with all instructions given by COTP Duluth or on-
scene representatives.
    (c) Effective date. These regulations are effective from 7 a.m. on
August 11, 2019, through 5 p.m. on August 13, 2019. These regulations
will be enforced from 7 a.m. on August 11, 2019 through 5 p.m. on
August 13, 2019, during the Parade of Sail, and during various periods
of time by the on-scene representative throughout the event.

    Dated: August 2, 2019.
F.M. Smith,
Commander, U.S. Coast Guard, Captain of the Port Duluth.
[FR Doc. 2019-16959 Filed 8-7-19; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 245 (Friday, December 21, 2018)]
[Notices]
[Pages 65647-65648]
[FR Doc No: 2018-27640]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP18-186-000]

Notice of Schedule for Environmental Review of the
Transcontinental Gas Pipe Line Company, LLC, Southeastern Trail Project

    On April 11, 2018, Transcontinental Gas Pipe Line Company, LLC
(Transco) filed an application in Docket No. CP18-186-000 requesting a
Certificate of Public Convenience and Necessity pursuant to Section
7(c) of the Natural Gas Act to construct and operate certain natural
gas pipeline facilities. The proposed project is known as the
Southeastern Trail Project (Project), and would provide 296.4 million
standard cubic feet of natural gas per day (MMcf/d) of additional firm
transportation capacity from the Pleasant Valley Interconnect facility
in Fairfax County, Virginia to the existing Station 65 pooling point in
St. Helena Parish, Louisiana.
    With this notice, this Commission is alerting agencies that issue
federal authorizations of the requirement to complete all necessary
reviews and to reach a final decision on a request for a federal
authorization within 90 days of the date of the Commission staff's
Environmental Assessment (EA) for the Project. This instant notice
identifies the FERC staff's planned schedule for the completion of the
EA for the Project.

Schedule for Environmental Review

Issuance of EA--February 8, 2019
90-day Federal Authorization Decision Deadline--May 9, 2019

    If a schedule change becomes necessary, additional notice will be
provided so that the relevant agencies are kept informed of the
Project's progress.

Project Description

    The Project would involve construction and operation of
approximately 7.7 miles of new natural gas pipeline loop located along
Transco's existing mainline (referred to as the Manassas Loop) in
Fauquier and Prince William Counties, Virginia. The Project also
includes approximately 60,720 horsepower of additional compression at
three existing facilities in Virginia (Compressor Station 185,
Compressor Station 175, and Compressor Station 165); reversal and/or
deodorization modifications at eight existing mainline facilities in
South Carolina, Georgia, and Louisiana; and modifications at 13
existing mainline valve sites in South Carolina and Georgia. In
addition, Transco proposes to retire and abandon 10 compressor units
and related buildings and ancillary equipment at existing Compressor
Station 165 in Pittsylvania County, Virginia.

Background

    On June 1, 2018, the Commission issued a Notice of Intent to
Prepare an Environmental Assessment for the Proposed Southeastern Trail
Project, Request for Comments on Environmental Issues, and Notice of
Public Scoping Sessions (NOI). The NOI was sent to affected landowners;
federal, state, and local government agencies; elected officials;
environmental and public interest groups; Native American tribes; other
interested parties; and local libraries and newspapers. In response to
the NOI, the Commission received comments from the Virginia Department
of Conservation and Recreation, the Teamsters National Pipeline Labor
Management Cooperation Trust, and four landowners. The primary issues
raised by the commentors are noise, safety, land use, and sensitive
habitats and species. All substantive comments will be addressed in the
EA.

Additional Information

    In order to receive notification of the issuance of the EA and to
keep track of all formal issuances and submittals in specific dockets,
the Commission offers

a free service called eSubscription. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.
    Additional information about the Project is available from the
Commission's Office of External Affairs at (866) 208-FERC or on the
FERC website (www.ferc.gov). Using the ``eLibrary'' link, select
``General Search'' from the eLibrary menu, enter the selected date
range and ``Docket Number'' excluding the last three digits (i.e.,
CP18-186), and follow the instructions. For assistance with access to
eLibrary, the helpline can be reached at<PHONE_NUMBER>, TTY (202) 502-
8659, or at<EMAIL_ADDRESS>The eLibrary link on the FERC
website also provides access to the texts of formal documents issued by
the Commission, such as orders, notices, and rule makings.

    Dated: December 14, 2018.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2018-27640 Filed 12-20-18; 8:45 am]
BILLING CODE 6717-01-P


By US mail: By express or courier service: Document Processing Desk ( DCI/ AD) Document Processing Desk ( DCI/ AD) Rebecca M. Miller Rebecca M. Miller US EPA ( 7510C) Office of Pesticide Programs ( 7510C) 1200 Pennsylvania Ave., NW Room 266A, Crystal Mall 2 Washington, DC 20460 1801 S. Bell Street Arlington, VA 22202 For end use products containing the active ingredient BIT, the registrant needs to submit the following items for each product.

Within 90 days from the receipt of the product specific data call in ( PDCI):

1. completed response forms to the PDCI ( i. e., PDCI response form and requirements status and registrant's response form); and 2. submit any time extension or waiver requests with a full written justification.

Within eight months from the receipt of the PDCI:

1. two copies of the confidential statement of formula ( EPA Form 8570 4);

2. a completed original application for reregistration ( EPA Form 8570 1). Indicate on the form that it is an " application for reregistration";

3. five copies of the draft label incorporating all label amendments outlined in Table 23 of this document;

4. a completed form certifying compliance with data compensation requirements ( EPA Form 8570 34); and 5. if applicable, a completed form certifying compliance with cost share offer requirements ( EPA Form 8570 32); and 6. the product specific data responding to the PDCI.

Please contact Marshall Swindell at ( 703) 308 8045 with questions regarding product reregistration and/ or the PDCI. All materials submitted in response to the PDCI should be addressed as follows:

By US mail: By express or courier service: Document Processing Desk ( PDCI/ PRB) Document Processing Desk ( PDCI/ PRB) Marshall Swindell Marshall Swindell US EPA ( 7508C) Office of Pesticide Programs ( 7508C) 1200 Pennsylvania Ave., NW Room 266A, Crystal Mall 2 Washington, DC 20460 1801 South Bell Street Arlington, VA 22202 43 A. Manufacturing Use Products 1. Additional Generic Data Requirements The generic database supporting the reregistration of BIT has been reviewed and determined to be substantially complete. However, the following additional data requirements have been identified by the Agency as confirmatory data requirements. A generic data call will be issued at a later date.

An acute inhalation study is required for the technical grade active ingredient based on new waiver criteria and advances in inhalation technology which nullified the previous waiver.

The chemical structure of BIT is not believed to be so closely related to CMIT/ MIT that an argument can be made to bridge carcinogenicity data for CMIT/ MIT to BIT. Therefore, EPA requires that the registrant submit carcinogenicity data for BIT to support the metal working fluid use. Conversely, the registrant may claim that a carcinogenicity study would not be required for the metalworking fluid use if the use is for " enclosed metalworking systems". Under this scenario, it has been determined that certain toxicology data requirements including carcinogenicity testing would be held in reserve pending review of worker exposure in such enclosed systems.

The Agency has established an interim two tiered system for toxicology testing requirements. Tier I toxicology data requirements would apply to all indirect food additives that result in residue concentrations ranging from 0 200ppb which applied to BIT. The requirements would consist of an acute toxicity testing battery, subchronic toxicity study in the rodent, a developmental toxicity study in the rat, and a mutagenicity testing battery. Each of these data requirements has been fulfilled for BIT. The Agency also conducts a literature search and can also conduct a Structural Activity Review ( SAR) if appropriate. The Agency also will hold in reserve a two generation reproduction toxicity study in the rat and a subchronic toxicity studies in a non rodent which would become data requirements if the Agency's evaluation of the Tier 1 data warranted. A 2 generation reproduction study is being held in reserve for BIT. A subchronic toxicity study in a non rodent species is available for BIT.

Tier II studies would be triggered by the presence of significant ( i. e. > 200ppb) residues in food or evidence of significant toxicity from the Tier I data set, which may include developmental / reproductive, or other systemic toxicity such as presence of neoplastic growth or significant target organ toxicity. In such cases, chronic toxicity and carcinogenicity testing would be required.

The risk assessment noted deficiencies in the surrogate dermal and inhalation exposure data available from the Chemical Manufacturers Association ( CMA) data base. Therefore, the Agency is requiring confirmatory data to support the uses assessed with the CMA exposure data within this risk assessment. The risk assessment also noted that many of the use parameters ( e. g., amount handled and duration of use) were based on professional judgments. Therefore, descriptions of human activities associated with the uses assessed are required as confirmatory.

To support the oil recovery uses of BIT, the following ecological effects data are needed:   850.1075 ( Old 72 1) Freshwater fish acute toxicity test with a warmwater species, preferably Bluegill sunfish, using TGAI   850.1075 ( old 72 3) Marine/ estuarine fish acute toxicity test, preferably with Sheepshead minnow, using TGAI Table 21. Confirmatory Data Requirements for Reregistration Guideline Study Name New OPPTS Guideline No. Old Guideline No.

Acute Inhalation Toxicity, using TGAI 870.1300 81 3 Estuarine/ Marine Fish Acute Toxicity, preferably with Sheepshead minnow, using TGAI 850.1075 72 3 Freshwater Fish Acute Toxicity with a warmwater species, preferably Bluegill sunfish, using TGAI 850.1075 72 1 Indoor Inhalation Exposure and Applicator Exposure Monitoring Data Reporting 875.1400 and 875.1600 234 and 236 Indoor Dermal Exposure and Applicator Exposure Monitoring Data Reporting 875.1200 and 875.1600 233 and 236 Descriptions of Human Activity 875.2800 133 1 Carcinogenicity 870.4200 83 2 Studies Held in Reserve 2 Generation Reproduction 870.3800 83 4 2. Labeling for Technical and Manufacturing Use Products To ensure compliance with FIFRA, technical and manufacturing use product ( MP) labeling should be revised to comply with all current EPA regulations, PR Notices and applicable policies.

B. End Use Products 1. Additional Product Specific Data Requirements Section 4( g)( 2)( B) of FIFRA calls for the Agency to obtain any needed product specific data regarding the pesticide after a determination of eligibility has been made. The Registrant must review previous data submissions to ensure that they meet current EPA acceptance criteria and if not, commit to conduct new studies. If a registrant believes that previously submitted data meet current testing standards, then the study MRID numbers should be cited according to the instructions in the Requirement Status and Registrants Response Form provided for each product.

A product specific data call in will be issued at a later date. 45 2. Labeling for End Use Products No specific labeling changes are necessary to implement measures outlined in Section IV above. However, to ensure compliance with FIFRA end use product ( MP) labeling should be revised to comply with all current EPA regulations, PR Notices and applicable policies.


[Federal Register Volume 82, Number 34 (Wednesday, February 22, 2017)]
[Notices]
[Pages 11391-11392]
[FR Doc No: 2017-03392]

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

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension:
    Rule 17a-22; SEC File No. 270-202, OMB Control No. 3235-0196.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information provided for in Rule 17a-22 (17 CFR 240.17a-22) under the
Securities Exchange Act of 1934 (``Exchange Act'') (15 U.S.C. 78a et
seq.). The Commission plans to submit this existing collection of
information to the Office of Management and Budget (``OMB'') for
extension and approval.
    Rule 17a-22 requires all registered clearing agencies to file with
the Commission three copies of all materials they issue or make
generally available to their participants or other entities with whom
they have a significant relationship. The filings with the Commission
must be made within ten days after the materials are issued or made
generally available. When the Commission is not the clearing agency's
appropriate regulatory agency, the clearing agency must file one copy
of the material with its appropriate regulatory agency.
    The Commission is responsible for overseeing clearing agencies and
uses the information filed pursuant to Rule 17a-22 to determine whether
a clearing agency is implementing procedural or policy changes. The
information filed aides the Commission in determining whether such
changes are consistent with the purposes of Section 17A of the Exchange
Act. Also, the Commission uses the information to determine whether a
clearing agency has changed its rules without reporting the actual or
prospective change to the Commission as required under Section 19(b) of
the Exchange Act.
    The respondents to Rule 17a-22 are registered clearing agencies.
The frequency of filings made by clearing agencies pursuant to Rule
17a-22 varies but on average there are approximately 200 filings per
year per active clearing agency. There are seven active registered
clearing agencies. The Commission staff estimates that each response
requires approximately .25 hours (fifteen minutes), which represents
the time it takes for a staff person at the clearing agency to properly
identify a document subject to the rule, print and makes copies, and
mail that document to the Commission. Thus, the total annual burden for
all active clearing agencies is 350 hours (7 clearing agencies
multiplied by 200 filings per clearing agency multiplied by .25 hours)
and a total of 50 hours (1400 responses multiplied by .25 hours,
divided by 7 active clearing agencies) per year are expended by each
respondent to comply with the rule.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: Pamela Dyson, Director/
Chief Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549, or send an email
to<EMAIL_ADDRESS>

    Dated: February 15, 2017.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-03392 Filed 2-21-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: October 13, 2009 (Volume 74, Number 196)]
[Notices]
[Page 52484]
[DOCID:fr13oc09-63]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER09-1748-000]

Inupiat Energy Marketing; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

October 2, 2009.
    This is a supplemental notice in the above-referenced proceeding of
Inupiat Energy Marketing's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is October 20, 2009.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-24529 Filed 10-9-09; 8:45 am]

BILLING CODE 6717-01-P