[Federal Register Volume 76, Number 235 (Wednesday, December 7, 2011)]
[Rules and Regulations]
[Pages 76309-76314]
[FR Doc No: 2011-31397]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0845; FRL-8885-8]

Isoxaflutole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
isoxaflutole in or on Soybean, seed and Grain, aspirated fractions.
Bayer CropScience requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 7, 2011. Objections and
requests for hearings must be received on or before February 6, 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-2010-0845. 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: Kathryn V. Montague, 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. To access the
harmonized test guidelines referenced in this document electronically,
please go to http://www.epa.gov/ocspp and select ``Test Methods and
Guidelines.''

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those

objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2010-0845 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
February 6, 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-2010-0845, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line 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 December 15, 2010 (75 FR 78240) (FRL-
8853-1), 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
0F7750) by Bayer CropScience, 2 T.W. Alexander Dr., Research Triangle
Park, NC 27709. The petition requested that 40 CFR 180.537 be amended
by establishing tolerances for combined residues of the herbicide
isoxaflutole, 5-cyclopropyl-4-(2-methylsulfonyl-4-
trifluoromethylbenzoyl) isoxazole and its metabolite 1-(2-
methylsulfonyl-4-trifluoromethylphenyl)-2-cyano-3-cyclopropyl propane-
1,3-dione, (RPA 202248), calculated as the parent compound, in or on
soybean at 0.05 parts per million (ppm), and soybean, aspirated grain
fractions at 0.25 ppm. That notice referenced a summary of the petition
prepared by Bayer CropScience, 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 and the
preferred crop terminology, EPA has made two changes to the requested
tolerances. First, EPA has changed the commodity descriptions for the
tolerances to soybean, seed and grain, aspirated fractions. Second, EPA
is raising the grain, aspirated fractions tolerance from 0.25 ppm to
0.30 ppm.

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 isoxaflutole including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with isoxaflutole
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.
    Isoxaflutole exhibited low acute toxicity via oral, dermal, and
inhalation routes of exposure and it is not a dermal sensitizer. In
long-term studies via the oral route, isoxaflutole caused ocular
toxicity in rats, hepatotoxicity (including liver tumor formation) and
thyroid tumors in rats and mice, and hematotoxicity (toxicity to blood)
in dogs and mice at high doses. The liver and ocular toxicities
observed in rats were consistent with the mode of action of
isoxaflutole in mammals (i.e., inhibition of the hepatic enzyme 4-
hydroxyphenylpyruvate dioxygenase (HPPD)) that leads to a buildup of
tyrosine in the blood and the eye.
    Developmental toxicity was observed in rats and rabbits primarily
as growth retardations, including delays in skeletal ossification,
effects that have been observed with other HPPD inhibitors (e.g.,
pyrasulfotole). There was no evidence of reproductive toxicity in the
2-generation reproductive toxicity study in rats; however, both adults
and offspring exhibited ocular and liver toxicities as seen in long-
term studies.
    In the acute and subchronic neurotoxicity studies in rats, mild
changes in functional-observation battery (FOB) parameters (grip
strength and/or landing foot splay) were observed in adult animals.
However, similar effects were not observed either in pregnant animals
or in offspring in a developmental neurotoxicity (DNT) study in rats.
In both maternal animals and offspring, changes in body weight and/or
food consumption were the primary effects seen in the DNT study and at
the same dose tested. Decreased brain weights were observed in
offspring on post-natal day (PND) 11 at the high dose only, but not at
a later time point, an indicator of a developmental delay and/or a
secondary effect of the decreased body weight. Although morphometric
analyses were not performed in the study, there were no effects on pup
swimming ability, learning, memory, motor activity, or auditory startle
response at any dose, nor was there any evidence of neuropathology in
the study at any dose. As a result, the missing morphometric
measurements, while required, are unlikely to affect the tentative
lowest-observed adverse-effect level (LOAEL) of the study (highest dose
tested).
    Isoxaflutole was negative in a variety of genotoxicity screening
assays. In carcinogenicity studies, isoxaflutole

induced liver and thyroid tumors in rats and liver tumors in mice.
Isoxaflutole was classified as ``likely to be a human carcinogen.'' The
method of quantification was linear cancer slope factor
(Q1*).
    Specific information on the studies received and the nature of the
adverse effects caused by isoxaflutole as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Isoxaflutole. Section 3 Registration
for Use on Soybeans. Human-Health Risk Assessment,'' p. 13 in docket ID
number EPA-HQ-OPP-2010-0845.

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 isoxaflutole used for
human risk assessment is shown in the Table of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Isoxaflutole for Use in Human Health Risk Assessment
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                                       Point of departure and
          Exposure/scenario              uncertainty/safety      RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
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Acute dietary (Females 13-49 years    LOAEL = 5 milligrams/     Acute RfD = aPAD = 0.02  Prenatal developmental
 of age).                              kilograms/day (mg/kg/     mg/kg/day.               toxicity (rabbit)
                                       day)                                               LOAEL = 5 mg/kg/day
                                      UFA = 10x                                           based on mg/kg/day
                                      UFH = 10x                                           based on increased
                                      FQPA SF = 3 (includes                               incidence of fetuses
                                       UFL)                                               with 27th pre-sacral
                                                                                vertebrae.
Acute dietary (General population     NOAEL = 125 mg/kg         Acute RfD = aPAD = 1.25  Acute neurotoxicity
 including infants and children).     UFA = 10x                  mg/kg.                   (rat) LOAEL = 500 mg/
                                      UFH = 10x                                           kg based on
                                      FQPA SF = 1x                                        significant decreases
                                                                                in hind limb grip
                                                                                strength and landing
                                                                                foot splay on day 15.
Chronic dietary (All populations)...  NOAEL= 2 mg/kg/day        Chronic RfD = cPAD =     Combined chronic
                                      UFA = 10x                  0.02 mg/kg/day.          toxicity/
                                      UFH = 10x                                           carcinogenicity (rat)
                                      FQPA SF = 1x                                        LOAEL = 20 mg/kg/day
                                                                                based on liver,
                                                                                thyroid, ocular, and
                                                                                nervous system
                                                                                toxicity (M) and liver
                                                                                toxicity (F).
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Cancer (Oral, dermal, inhalation)...  Classification: ``Likely to be Carcinogenic to Humans''. Q1* (mg/kg/day)-1
                                         of 1.14 x 10-2 from the male CD-1 mouse liver for the linear low-dose
                                          extrapolation based on statistically significant increases in liver
                                                         tumors in both sexes of mice and rats.
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UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
  study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. 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.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to isoxaflutole, EPA considered exposure under the petitioned-
for tolerances as well as all existing isoxaflutole tolerances in 40
CFR 180.537. EPA assessed dietary exposures from isoxaflutole 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 isoxaflutole. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, EPA assumed that 100% of the crop was treated and that
for all commodities residues were at tolerance levels.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed that 100% of
the crop was treated and that for all commodities residues were at
tolerance levels.
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
If quantitative cancer risk assessment is appropriate, cancer risk may
be quantified using a linear or nonlinear approach. If sufficient
information on the carcinogenic mode of action is available, a
threshold or non-linear approach is used and a cancer RfD is calculated
based on an earlier non-cancer key event. If carcinogenic mode of
action data are not available, or if the mode of action data

determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized. Based on the data summarized in Unit
III.A., EPA has concluded that isoxaflutole should be classified as
``Likely to be Carcinogenic to Humans'' and a linear approach has been
used to quantify cancer risk.
    In conducting the cancer dietary exposure assessment EPA used the
same food consumption data from the USDA and assumptions for residue
levels in food as the Chronic Exposure in Unit III. C. 1. ii., of this
unit.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for isoxaflutole in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of isoxaflutole. 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 First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of isoxaflutole and
metabolite RPA 202248 are estimated to be 8.68 parts per billion (ppb)
for surface water and 0.255 ppb for ground water for acute exposures,
1.26 ppb for surface water and 0.255 ppb for ground water for chronic
exposures for non-cancer assessments, and 0.53 ppb for surface water
and 0.255 ppb for ground water for cancer assessments.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 8.68 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 1.26 ppb was used to
assess the contribution to drinking water. For cancer dietary risk
assessment, the water concentration of value 0.53 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). Isoxaflutole is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Pyrasulfotole, mesotrione, isoxaflutole, and topramezone belong to
a class of herbicides that inhibit the liver enzyme HPPD, which is
involved in the catabolism (metabolic breakdown) of tyrosine (an amino
acid derived from proteins in the diet). Inhibition of HPPD can result
in elevated tyrosine levels in the blood, a condition called
tyrosinemia. HPPD inhibiting herbicides have been found to cause a
number of toxicities in laboratory animal studies including ocular,
developmental, liver and kidney effects. Of these toxicities, the
ocular effect (corneal opacity) is highly correlated with the elevated
blood tyrosine levels. In fact, rats dosed with tyrosine alone show
ocular opacities similar to those seen with HPPD inhibitors. Although
the other toxicities may be associated with chemically induced
tyrosinemia, other mechanisms may also be involved.
    There are marked differences among species in the ocular toxicity
associated with inhibition of HPPD. Ocular effects following treatment
with HPPD inhibitor herbicides are seen in the rat but not in the
mouse. Monkeys also seem to be recalcitrant to the ocular toxicity
induced by HPPD inhibition. The explanation of this species-specific
response in ocular opacity is related to the species differences in the
clearance of tyrosine. A metabolic pathway exists to remove tyrosine
from the blood that involves a liver enzyme called tyrosine
aminotransferase (TAT). In contrast to rats where ocular toxicity is
observed following exposure to HPPD-inhibiting herbicides, mice and
humans are unlikely to achieve the levels of plasma tyrosine necessary
to produce ocular opacities because the activity of TAT in these
species is much greater compared to rats. Thus, humans and mice have a
highly effective metabolic process for handling excess tyrosine.
    HPPD inhibitors (e.g., nitisinone) are used as an effective
therapeutic agent to treat patients suffering from rare genetic
diseases of tyrosine catabolism. Treatment starts in childhood but is
often sustained throughout patient's lifetime. The human experience
indicates that a therapeutic dose (1 mg/kg/day dose) of nitisinone has
an excellent safety record in infants, children, and adults and that
serious adverse health outcomes have not been observed in a population
followed for approximately a decade. Rarely, ocular effects are seen in
patients with high plasma tyrosine levels; however, these effects are
transient and can be readily reversed upon adherence to a restricted
protein diet. This indicates that an HPPD inhibitor in and of itself
cannot easily overwhelm the tyrosine-clearance mechanism in humans.
    Therefore, due to an efficient metabolic process to handle excess
tyrosine, exposure to environmental residues of HPPD inhibiting
herbicides is unlikely to result in high blood levels of tyrosine and
ocular toxicity in humans; and EPA has concluded that a cumulative risk
assessment with other HPPD inhibitors is unnecessary.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. Developmental toxicity was
observed in rats and rabbits as growth retardations including delays in
skeletal ossification; effects that have been observed with other HPPD
inhibitors (e.g., pyrasulfotole). There was evidence of increased
susceptibility in the rabbit study in the form of increased incidence
of fetuses with 27th pre-sacral vertebrae at a dose much lower than
those causing maternal deficits in body weight and food consumption.
Neither the rat developmental study nor the rat 2-generation
reproductive toxicity studies revealed any evidence of increased
susceptibility. However, both adults and offspring in the 2-generation
reproductive toxicity study exhibited ocular and liver toxicities seen
in long-term studies.
    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 for all exposure scenarios, except acute
dietary for females 13-49 years of age for which an FQPA SF is retained
but reduced to 3X.

That decision is based on the following findings:
    i. The toxicity database for isoxaflutole is complete.
    ii. There are not residual concerns regarding neurotoxicity,
including developmental neurotoxicity, based on the results of acute,
subchronic, and developmental neurotoxicity studies.
    iii. There is no evidence that isoxaflutole results in increased
susceptibility following in utero exposure in a rat developmental study
or in young rats in the 2-generation reproduction study. However, there
was evidence of increased susceptibility following in utero exposure in
a rabbit developmental study and a NOAEL for developmental effects was
not identified in that study. To address the concern for increased in
utero susceptibility and the lack of a NOAEL in the rabbit study, this
study was selected for the acute dietary endpoint for females of 13-49
years of age and a 3X FQPA SF was retained for that population
subgroup. Use of a 3X FQPA SF applied to the LOAEL yielded a point of
departure that is comparable to the point of departure for the chronic
dietary exposure scenario and the offspring effects in the rat 2-
generation reproductive toxicity study. Therefore, all dietary exposure
scenarios are considered protective of developmental effects.
    iv. There are no residual uncertainties identified in the exposure
databases. EPA made the very conservative, health-protective assumption
that all commodities for which tolerances exist or are proposed contain
residues at the tolerance level. Additionally, EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to isoxaflutole in drinking water. These assessments
will not underestimate the exposure and risks posed by isoxaflutole.

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 isoxaflutole will occupy 2.4% of the aPAD for females 13 to 49 years
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
isoxaflutole from food and water will utilize 1% of the cPAD for all
infants (<1 year old) the population group receiving the greatest
exposure. There are no residential uses for isoxaflutole.
    3. Short-term risk. A short-term adverse effect was identified;
however, isoxaflutole is not registered for any use patterns that would
result in short-term residential exposure. Short-term risk is assessed
based on short-term residential exposure plus chronic dietary exposure.
Because there is no short-term residential exposure and chronic dietary
exposure has already been assessed under the appropriately protective
cPAD (which is at least as protective as the POD used to assess short-
term risk), no further assessment of short-term risk is necessary, and
EPA relies on the chronic dietary risk assessment for evaluating short-
term risk for isoxaflutole.
    4. Intermediate-term risk. An intermediate-term adverse effect was
identified; however, isoxaflutole is not registered for any use
patterns that would result in intermediate-term residential exposure.
Intermediate-term risk is assessed based on intermediate-term
residential exposure plus chronic dietary exposure. Because there is no
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess intermediate-term
risk), no further assessment of intermediate-term risk is necessary,
and EPA relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for isoxaflutole.
    5. Aggregate cancer risk for U.S. population. The aggregate cancer
risk assessment for the general population takes into account exposure
estimates from dietary consumption of isoxaflutole from food and
drinking water sources. Average food plus water source dietary exposure
was used. Estimated cancer risk for the U.S. population includes
infants and children. The aggregate cancer risk estimate for
isoxaflutole is 8 x 10-7. This risk estimate is based, in
part, on the conservative assumption that 100% of all crops for which
isoxaflutole is registered or proposed for registration are treated.
Additional refinement using percent crop treated estimates would result
in a lower estimate of cancer risk.
    EPA generally considers cancer risks in the range of one in one
million (1 x 10-6) or less to be negligible. Accordingly,
EPA has concluded the cancer risk for all existing isoxaflutole uses
and the uses associated with the tolerances established in this action
is negligible.
    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 isoxaflutole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography with tandem
mass spectrometry (LC/MS/MS) method (IS-004-P10-02)) 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 isoxaflutole.

V. Conclusion

    Therefore, tolerances are established for residues of isoxaflutole,
(5-cyclopropyl-4-isoxazolyl) [2-(methylsulfonyl)-4-
(trifluoromethyl)phenyl] methanone and its metabolite 1-(2-
methylsulfonyl-4-trifluoromethylphenyl)-2-cyano-3-cyclopropyl propane-
1,3-dione, in or on

soybean, seed and grain, aspirated fractions at 0.05 ppm and 0.30 ppm,
respectively.

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: November 21, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.537 is amended in paragraph (a) by revising the
introductory text and alphabetically adding the following commodities
to the table to read as follows:

Sec.  180.537  Isoxaflutole; tolerances for residues.

    (a) General. Tolerances are established for residues of the
herbicide, isoxaflutole, including its metabolites and degradates, in
or on the commodities in the table below. Compliance with the tolerance
levels specified below is to be determined by measuring only the sum of
isoxaflutole ((5-cyclopropyl-4-isoxazolyl) [2-(methylsulfonyl)-4-
(trifluoromethyl)phenyl] methanone) and its metabolite 1-(2-
methylsulfonyl-4-trifluoromethylphenyl)-2-cyano-3-cyclopropyl propan-
1,3-dione (RPA 202248), calculated as the stoichiometric equivalent of
isoxaflutole, in or on the commodity:

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

                                * * * * *
Grain, aspirated fractions..................................        0.30
Soybean, seed...............................................        0.05
------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-31397 Filed 12-6-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: December 14, 2009 (Volume 74, Number 238)]
[Notices]
[Page 66151-66153]
[DOCID:fr14de09-84]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2009-0038]

Federal Advisory Council on Occupational Safety and Health
(FACOSH)

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for nominations to serve on FACOSH; renewal of FACOSH
charter.

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

SUMMARY: The Occupational Safety and Health Administration invites
interested parties to submit nominations for membership on FACOSH,
whose charter the Secretary of Labor renewed on November 6, 2009.

DATES: Nominations for FACOSH must be submitted (postmarked, sent,
transmitted, received) by February 12, 2010.

ADDRESSES: You may submit nominations for FACOSH, identified by Docket
No. OSHA-2009-0038, by any one of the following methods:
    Electronically: Nominations, including attachments, may be
submitted electronically at http://www.regulations.gov, the Federal
eRulemaking Portal. Follow the online instructions for submitting
nominations;
    Facsimile: If the nomination, including attachments, does not
exceed 10 pages, you may fax it to the OSHA Docket Office at (202) 693-
1648;
    Mail, express delivery, hand delivery, messenger or courier
service: Submit three copies of nominations to the OSHA Docket Office,
Docket No. OSHA-2009-0038, Room N-2625, U.S. Department of Labor, 200
Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693-
2350 (TTY number<PHONE_NUMBER>). Deliveries (hand, express mail,
messenger and courier service) are accepted during the Department of
Labor's and OSHA

Docket Office's normal business hours, 8:15 a.m.-4:45 p.m., e.t.
    Instructions: All nominations for FACOSH must include the agency
name and docket number for this Federal Register notice (Docket No.
OSHA-2009-0038). Because of security-related procedures, submitting
nominations by regular mail may result in a significant delay in their
receipt. Please contact the OSHA Docket Office, at the address above,
for information about security procedures for submitting nominations by
hand delivery, express delivery, and messenger or courier service. For
additional information on submitting nominations, see the ``Public
Participation'' heading in the SUPPLEMENTARY INFORMATION section.
    All submissions in response to this Federal Register notice,
including personal information provided, will be posted without change
at http://www.regulations.gov. Therefore, OSHA cautions interested
parties about submitting personal information such as social security
numbers and birth dates.
    Docket: To read or download submissions in response to this Federal
Register notice, go to Docket No. OSHA-2009-0038 at http://
www.regulations.gov. All documents in the docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
documents (e.g., copyrighted material) are not publicly available to
read or download through the Web page. All submissions, including
copyrighted material, are available for inspection and copying at the
OSHA Docket Office at the address above.

FOR FURTHER INFORMATION CONTACT: For press inquiries: Ms. Jennifer
Ashley, OSHA, Office of Communications, U.S. Department of Labor, Room
N-3647, 200 Constitution Avenue, NW., Washington, DC 20210; telephone
(202) 693-1999.
    For general information: Mr. Francis Yebesi, OSHA, Office of
Federal Agency Programs, U.S. Department of Labor, Room N-3622, 200
Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693-
2122; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Request for Nominations To Serve on FACOSH

    The Assistant Secretary of Labor for Occupational Safety and Health
(Assistant Secretary) invites interested parties to submit nominations
for membership on FACOSH.
    FACOSH is authorized to advise the Secretary of Labor (Secretary)
on all matters relating to the occupational safety and health of
federal employees (Occupational Safety and Health Act of 1970 (29
U.S.C. 668), 5 U.S.C. 7902, Executive Orders 12196 and 13511). This
includes providing advice on how to reduce and keep to a minimum the
number of injuries and illnesses in the federal workforce and how to
encourage the establishment and maintenance of effective occupational
safety and health programs in each Federal agency.
    FACOSH is comprised of 16 members, who the Secretary appoints for
terms not to exceed three years. The Assistant Secretary, who chairs
FACOSH, is seeking nominations both for vacancies that occurred during
calendar year (CY) 2009 and that will occur in CY 2010. To provide
continuity, the terms of FACOSH members are staggered so that the terms
of five to six members expire each year. The Secretary will make five
two-year appointments to fill the CY 2009 vacancies, and five three-
year appointments to fill the CY 2010 vacancies.
    The composition of FACOSH membership and the number of new members
to be appointed are:

     Eight members are management representatives from Federal
agencies. Five appointments will be made, including two appointments
for three-year terms and three appointments for two-year terms; and
     Eight members are representatives of labor organizations
representing federal employees. Five appointments will be made,
including three appointments for three-year terms and two appointments
for two-year terms.
    FACOSH members serve at the pleasure of the Secretary unless the
member is no longer qualified to serve, resigns, or is removed by the
Secretary. The Secretary may appoint FACOSH members to successive
terms. FACOSH usually meets between two to six times annually.
    Interested parties may nominate one or more qualified persons for
membership. Others are invited and encouraged to submit endorsements in
support of a nominee. Nominations must include the following
information:
     Nominee's resume or curriculum vitae, including contact
information, current position, and membership on FACOSH and other
relevant organizations;
     Category of membership for which the nominee is qualified
to serve;
     A summary of the nominee's background, experience and
qualifications for membership;
     Articles or other documents the nominee has authored that
indicate their knowledge, experience, and expertise in occupational
safety and health, particularly as it pertains to the federal
workforce;
     A statement attesting that that the individual is aware of
the nomination and has no apparent conflicts of interest that would
preclude membership on FACOSH; and
     A written commitment that the nominee will attend and
participate in FACOSH meetings regularly throughout the term.
    The Secretary will appoint FACOSH members based upon criteria
including, but not limited to, the nominee's level of responsibility
for occupational safety and health matters involving the federal
workforce, experience and competence in occupational safety and health,
and willingness and ability to regularly and fully participate in
FACOSH meetings. Federal agency management nominees who serve as their
agency's Designated Agency Safety and Health Official and labor
nominees who are responsible for federal employee occupational safety
and health matters within their respective organizations are preferred
as management and labor members, respectively.
    The information received through the nomination process, along with
other relevant sources of information, will assist the Secretary in
making appointments to FACOSH. In selecting FACOSH members, the
Secretary will consider individuals nominated in response to this
Federal Register notice, as well as other qualified individuals. OSHA
will publish a list of the new FACOSH members in the Federal Register.

Public Participation--Submission of Nominations and Access to Docket

    Interested parties may submit nominations and supplemental
materials by any one of the methods listed in the ADDRESSES section.
All comments, attachments and other materials must identify the agency
name and the OSHA docket number for this Federal Register notice
(Docket No. OSHA 2009-0038). You may supplement electronic nominations
by uploading document files electronically. If, instead, you wish to
submit hard copies of any additional material in reference to an
electronic submission, you must submit three copies to the OSHA Docket
Office following the instructions in the ADDRESSES section. The
additional material must clearly identify your electronic submission by
name, date, and docket number so OSHA can attach it to your nomination.
    Because of security-related procedures, the use of regular mail may
result in a significant delay in the

receipt of nominations. For information about security procedures
concerning the delivery of materials by hand, express delivery,
messenger or courier service, please contact the OSHA Docket Office
(see ADDRESSES section).
    Submissions in response to this Federal Register notice are posted
without change at http://www.regulations.gov. Therefore, OSHA cautions
interested parties about submitting personal information such as social
security numbers and birth dates. Although all submissions are listed
in the http://www.regulations.gov index, some documents (e.g.,
copyrighted material) are not publicly available to read or download
through the Web page. All submissions, including copyrighted material,
are available for inspection and copying at the OSHA Docket Office.
    Information on using the http://www.regulations.gov Web page to
make submissions and to access the docket and exhibits is available at
the Web page's Help link. Contact the OSHA Docket Office for
information about materials not available through the Web page and for
assistance in locating submissions and other documents in the docket.
    Electronic copies of this Federal Register notice are available at
http://www.regulations.gov. This notice, as well as news releases and
other relevant information, is available at OSHA's Web page at http://
www.osha.gov.

Charter Renewal

    Section 7902 of Title 5 of the U.S. Code provides that the
President may establish, by executive order, a safety council (FACOSH)
composed of representatives of Federal agencies and labor organizations
representing Federal employees to serve as an advisory body to the
Secretary on issues involving the occupational safety and health of the
federal workforce. On September 29, 2009, President Barack Obama signed
Executive Order 13511 authorizing the continuance of FACOSH for two
another years, until September 30, 2011 (5 U.S.C. 7902).
    The Federal Advisory Committee Act (FACA) requires that, upon the
continuance or renewal of an advisory committee, a new charter be filed
(5 U.S.C. App. Sec.  14). Pursuant to FACA and its implementing
regulations (41 CFR Part 102-3), on November 6, 2009, the Secretary
renewed the FACOSH charter, which expired on September 30, 2009. The
new FACOSH charter will expire on September 30, 2011, unless the
Secretary terminates it prior to that date.
    Authority and Signature: Jordan Barab, Acting Assistant Secretary
of Labor for Occupational Safety and Health, directed the preparation
of this notice under the authority granted by section 19 of the
Occupational Safety and Health Act of 1970 (29 U.S.C. 668), 5 U.S.C.
7902, the Federal Advisory Committee Act (5 U.S.C. App), Executive
Order 13511, 29 CFR Part 1960 (Basic Program Elements of for Federal
Employee Occupational Safety and Health Programs), 41 CFR Part 102-3,
and Secretary of Labor's Order 5-2007 (72 FR 31160).

    Signed at Washington, DC, this 8th day of December 2009.
Jordan Barab,
Acting Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. E9-29675 Filed 12-11-09; 8:45 am]

BILLING CODE 4510-26-P


[Federal Register: March 19, 2007 (Volume 72, Number 52)]
[Notices]
[Page 12849-12850]
[DOCID:fr19mr07-106]

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SECURITIES AND EXCHANGE COMMISSION

Submissions for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549.

Extension: Form 10-QSB, OMB Control No. 3235-0416, SEC File No. 270-
369.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) the Securities and Exchange Commission
(``Commission'') has submitted to the Office of Management and Budget
this request for extension of the previously approved collection of
information discussed below.
    Form 10-QSB (17 CFR 249.308b) is a quarterly report form that is
available to ``small business issuers'' as defined by regulations under
the Securities Exchange Act of 1934 (``Exchange Act'') (15 U.S.C. 78a
et seq.), and is used by such issuers to satisfy their quarterly
reporting obligations pursuant to Section 13 and Section 15(d) of the
Exchange Act (15 U.S.C. 78m and 78o(d)). Form 10-QSB provides a
comprehensive overview of the small business issuer's business,
although its requirements call for slightly less detailed information
than required by Form 10-Q (17 CFR 249.308a). The information provided
is mandatory and all information is made available to the public upon
request. Form 10-QSB takes approximately 182 hours per response to
prepare and is filed by 4,066 respondents three times a year for a
total of 12,198 responses. We estimate that 75% of the 182 hours per
response (136.5 hours) is prepared by the company for a total annual
reporting burden of 1,665,027 hours (136.5 hours per response x 12,198
responses).
    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 control number.
    Written comments regarding the above information should be directed
to the following persons: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503 or send an e-mail to
<EMAIL_ADDRESS>and (ii) R. Corey Booth, Director/Chief

Information Officer, Securities and Exchange Commission, c/o Shirley
Martinson, 6432 General Green Way, Alexandria, VA 22312; or send an e-
mail to<EMAIL_ADDRESS>Comments must be submitted to OMB within
30 days of this notice.

    Dated: March 7, 2007.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-4896 Filed 3-16-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: April 6, 2009 (Volume 74, Number 64)]
[Proposed Rules]
[Page 15407-15409]
[DOCID:fr06ap09-18]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2009-0124]
RIN 1625-AA00

Safety Zone; Mission Bay Yacht Club Fourth of July Fireworks;
Mission Bay, San Diego, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes establishing a temporary safety zone
on the navigable waters of Mission Bay in support of the Mission Bay
Yacht Club Fourth of July Fireworks. This temporary safety zone is
necessary to provide for the safety of crew, spectators, and other
users and vessels of the waterway. Persons and vessels are prohibited
from entering into, transiting through, or anchoring within this
temporary safety zone unless authorized by the Captain of the Port or
his designated representative.

DATES: Comments and related material must either be submitted to our
online docket via http://www.regulations.gov on or before May 6, 2009
or reach the Docket Management Facility by that date.

ADDRESSES: You may submit comments identified by docket number USCG-
2009-0124 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (4) Hand Delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these methods. For
instructions on submitting comments, see the ``Public Participation and
Request for Comments'' portion of the SUPPLEMENTARY INFORMATION section
below.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call Petty Officer Kristen Beer, USCG, Waterways Management, U.S.
Coast Guard Sector San Diego at<PHONE_NUMBER>. If you have questions
on viewing or submitting material to the docket, call Renee V. Wright,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change, to http://www.regulations.gov and will include any
personal information you have provided.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2009-0124), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online, or by fax, mail or hand delivery, but please use only one of
these means. We recommend that you include your name and a mailing
address, an e-mail address, or a phone number in the body of your
document so that we can contact you if we have questions regarding your
submission.
    To submit your comment online, go to http://www.regulations.gov,
select the Advanced Docket Search option on the right side of the
screen, insert ``USCG-2009-0124'' in the Docket ID box, press Enter,
and then click on the balloon shape in the Actions column. If you
submit your comments by mail or hand delivery, submit them in an
unbound format, no larger than 8[frac12] by 11 inches, suitable for
copying and electronic filing. If you submit them by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change the rule
based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
select the Advanced Docket Search option on the

right side of the screen, insert USCG-2009-0124 in the Docket ID box,
press Enter, and then click on the item in the Docket ID column. You
may also visit either the Docket Management Facility in Room W12-140 on
the ground floor of the Department of Transportation West Building,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays; or the U.S. Coast
Guard Sector San Diego, 2710 N. Harbor Dr., San Diego, CA 92101 between
8 a.m. and 3 p.m., Monday through Friday, except Federal holidays. We
have an agreement with the Department of Transportation to use the
Docket Management Facility.

Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008 issue of the
Federal Register (73 FR 3316).

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one to the Docket Management Facility at the address under
ADDRESSES explaining why one would be beneficial. If we determine that
one would aid this rulemaking, we will hold one at a time and place
announced by a later notice in the Federal Register.

Background and Purpose

    The Mission Bay Yacht Club is sponsoring the Mission Bay Yacht Club
Fourth of July Fireworks, which will include a fireworks presentation
originating from a barge located at approximately 32[deg]47.01' N,
117[deg]14.75' W. The safety zone will encompass all navigable waters
within 800 feet of the fireworks barge. This temporary safety zone is
necessary to provide for the safety of the crew, spectators, and other
users and vessels of the waterway.

Discussion of Proposed Rule

    The Coast Guard proposes establishing a safety zone that will be
enforced from 8:45 p.m. to 9:30 p.m. on July 4, 2009. This safety zone
is necessary to provide for the safety of the crew, spectators, and
other users and vessels of the waterway. Persons and vessels will be
prohibited from entering into, transiting through, or anchoring within
this safety zone unless authorized by the Captain of the Port or his
designated representative. The limits of the safety zone are all
navigable waters within 800 feet of the fireworks barge located at
approximately 32[deg]47.01' N, 117[deg]14.75' W.

Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
and does not require an assessment of potential costs and benefits
under section 6(a)(3) of that Order. The Office of Management and
Budget has not reviewed it under that Order. This determination is
based on the size and location of the safety zone. Commercial vessels
will not be hindered by the safety zone. Recreational vessels will not
be allowed to transit through the established safety zone during the
specified times unless authorized to do so by the Captain of the Port
or his designated representative.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed rule would have a significant economic
impact on a substantial number of small entities. 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 certifies under 5 U.S.C. 605(b) that this proposed
rule would not have a significant economic impact on a substantial
number of small entities.
    This proposed rule would affect the following entities, some of
which might be small entities: The owners or operators of vessels
intending to transit or anchor in a portion of Mission Bay from 8:45
p.m. to 9:30 p.m. on July 4, 2009.
    This safety zone would not have a significant economic impact on a
substantial number of small entities for the following reasons. This
rule would be in effect for only 45 minutes late in the evening when
vessel traffic is low. Vessel traffic could pass safely around the
safety zone. Before the effective period, the Coast Guard will publish
a local notice to mariners (LNM) and will issue broadcast notice to
mariners (BNM) alerts via marine channel 16 VHF before the temporary
safety zone is enforced.
    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.

Assistance for Small Entities

    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 proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. 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 Petty Officer Kristen Beer,
USCG, Waterways Management, U.S. Coast Guard Sector San Diego at (619)
278-7262. The Coast Guard will not retaliate against small entities
that question or complain about this proposed rule or any policy or
action of the Coast Guard.

Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this proposed rule
under that Order and have determined that it does not have implications
for federalism.

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 or more in any
one year. Though this proposed rule would not result in such an
expenditure, we do discuss the effects of this rule elsewhere in this
preamble.

Taking of Private Property

    This proposed rule would not effect a taking of private property or
otherwise

have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would 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.

Energy Effects

    We have analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies. This proposed rule does not use technical standards.
Therefore, we did not consider the use of voluntary consensus
standards.

Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 0023.1 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is one of a
category of actions which do not individually or cumulatively have a
significant effect on the human environment. An environmental analysis
checklist supporting this preliminary determination is available in the
docket where indicated under ADDRESSES. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

    1. The authority citation for part 165 continues to read as
follows:

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

    2. Add a new temporary zone Sec.  165.T11-161 to read as follows:

Sec.  165.T11-161  Safety Zone; Mission Bay Yacht Club Fourth of July
Fireworks; Mission Bay, San Diego, CA.

    (a) Location. The limits of the safety zone are all the navigable
waters within 800 feet of the fireworks barge located at approximately
32[deg]47.01' N, 117[deg]14.75' W.
    (b) Enforcement Period. This section will be enforced from 8:45
p.m. to 9:30 p.m. on July 4, 2009. If the event concludes prior to the
scheduled termination time, the Captain of the Port will cease
enforcement of this safety zone and will announce that fact via
Broadcast Notice to Mariners.
    (c) Definitions. The following definition applies to this section:
Designated representative, means any commissioned, warrant, and petty
officers of the Coast Guard on board Coast Guard, Coast Guard
Auxiliary, and local, State, and Federal law enforcement vessels who
have been authorized to act on the behalf of the Captain of the Port.
    (d) Regulations. (1) Entry into, transit through or anchoring
within this safety zone is prohibited unless authorized by the Captain
of the Port of San Diego or his designated on-scene representative.
    (2) Mariners requesting permission to transit through the safety
zone may request authorization to do so from the Patrol Commander
(PATCOM). The PATCOM may be contacted on VHF-FM Channel 16.
    (3) All persons and vessels shall comply with the instructions of
the Coast Guard Captain of the Port or the designated representative.
    (4) Upon being hailed by U.S. Coast Guard patrol personnel by
siren, radio, flashing light, or other means, the operator of a vessel
shall proceed as directed.
    (5) The Coast Guard may be assisted by other Federal, State, or
local agencies.

    Dated: March 16, 2009.
T.H. Farris,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. E9-7660 Filed 4-3-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)]
[Notices]
[Page 49364]
[FR Doc No: 2017-23110]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL18-19-000]

Notice of Institution of Section 206 Proceeding and Refund
Effective Date; Southwest Power Pool, Inc.

    On October 19, 2017, the Commission issued an order in Docket No.
EL18-19-000, Southwest Power Pool, Inc., 161 FERC 61,062 (2017)
(October 2017 Order), pursuant to section 206 of the Federal Power Act
(FPA), 16 U.S.C. 824e (2012), instituting an investigation to examine
the Southwest Power Pool, Inc. (SPP) Membership Agreement and any other
Commission-jurisdictional SPP documents that must be revised to fully
implement the refund commitment concerns identified in the Commission's
July 21, 2016 order in Docket No. EL16-91-000 in Southwest Power Pool,
Inc., 156 FERC 61,059 (2016). The October 2017 Order also consolidated
Docket Nos. EL16-91-000 and EL18-19-000.
    The refund effective date in Docket No. EL18-19-000, established
pursuant to section 206(b) of the FPA, will be the date of publication
of this notice in the Federal Register.
    Any interested person desiring to be heard in Docket No. EL18-19-
000 must file a notice of intervention or motion to intervene, as
appropriate, with the Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426, in accordance with Rule 214 of the
Commission's Rules of Practice and Procedure, 18 CFR 385.214, within 21
days of the date of issuance of the order.

    Dated: October 19, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-23110 Filed 10-24-17; 8:45 am]
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[Federal Register Volume 84, Number 125 (Friday, June 28, 2019)]
[Notices]
[Pages 31065-31066]
[FR Doc No: 2019-13786]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OLEM-2019-0158, FRL-9995-81-OMS]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Renewal for EPA's WasteWise
Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), EPA's WasteWise Program (EPA ICR
Number 1698.10, OMB Control Number 2050-0139) to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act. This is a proposed extension of the ICR,
which is currently approved through June 30, 2019. Public comments were
previously requested via the Federal Register on April 3, 2019 during a
60-day comment period. This notice allows for an additional 30 days for
public comments. A fuller description of the ICR is given below,
including its estimated burden and cost to the public. 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.

DATES: Additional comments may be submitted on or before July 29, 2019.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OLEM-
2019-0158, to (1) EPA, either online using www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
RCRA Docket (2822T), U.S. Environmental Protection Agency, 1200
Pennsylvania Avenue NW, Washington, DC 20460; and (2) OMB via email to
<EMAIL_ADDRESS>Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Kent Foerster, Office of Resource
Conservation and Recovery (mail code 5306P), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: This is a renewal ICR for reporting and recordkeeping
requirements under EPA's WasteWise program. WasteWise is a voluntary
program designed to promote partnerships with organizations in order to
bolster recycling and cut the volume of multiple materials (e.g.,
paper, aluminum cans; plastic and glass bottles; food wastes, etc.) in
municipal solid waste streams. Under this program, participants agree
to set waste reduction goals, develop and document specified actions to
reduce waste and track their progress along the way. Under WasteWise,
EPA has issued specific material or sector-based challenges. Currently
these challenges focus on food recovery and electronics, as well as
state related waste and material management efforts. A separate Federal
Green Challenge targets the Federal sector but is not part of this ICR.
Participants use a web-based online database system containing
integrated platforms with automated forms to register for
participation; set goals; and report their waste reduction achievements
on an annual basis.
    Form Numbers: None.
    Respondents/affected entities: Business and other for-profit and
not-for-profit organizations, as well as Federal/State/Local and Tribal
governments.
    Respondent's obligation to respond: Voluntary.
    Estimated number of respondents: 2,224.
    Frequency of response: Annual.
    Total estimated burden: 155,529 hours per year.
    Total estimated cost: $5,686,774 (per year), includes $164,000
annualized capital or operation & maintenance costs.
    Changes in the estimates: There is an increase of 129,685 hours in
the total estimated respondent burden compared with the ICR currently
approved by OMB. This increase is due to increase in

participation rates since the last renewal.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2019-13786 Filed 6-27-19; 8:45 am]
BILLING CODE 6560-50-P