[Federal Register Volume 77, Number 35 (Wednesday, February 22, 2012)]
[Rules and Regulations]
[Pages 10381-10387]
[FR Doc No: 2012-3795]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

 [EPA-HQ-OPP-2008-0168; FRL-9333-4]

Metaflumizone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
metaflumizone in or on citrus fruit, tree nuts, almond hulls; and
grape. BASF Corporation requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 22, 2012. Objections and
requests for hearings must be received on or before April 23, 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-2008-0168. 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: Julie Chao, 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-2008-0168 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
April 23, 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-2008-0168, 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 August 10, 2011 (76 FR 49396) (FRL-8882-
8), 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
7F7260) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC
27709. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of the insecticide metaflumizone,
in or on: Fruit, citrus, group 10 at 0.04 ppm; nut, tree, group 14 at
0.04 ppm; almond, hulls at 0.04 ppm; and grape at 0.04 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.

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 metaflumizone including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with metaflumizone
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.
    Hematotoxicity (toxicity of the blood) was the primary toxic effect
of concern following subchronic or chronic oral exposures to
metaflumizone. Splenic extramedullary hematopoiesis, increased
hemosiderin, and anemia were the most common hematotoxic effects
reported after repeated oral dosing with metaflumizone. The postulated
pesticidal mode of action of metaflumizone involves inhibition of
sodium channels in target insect species; however, in mammals (rats),
there were only clinical signs of neurotoxicity (i.e., piloerection and
body temperature variations) with no neuropathology in the presence of
systemic toxicity (e.g., recumbency and poor general state) following
acute or repeated exposures. Similarly, several immune system organs
seem to be affected following metaflumizone administration via the
oral, dermal, and inhalation routes (e.g., the presence of macrophages
in the thymus, lymphocyte necrosis in the mesenteric lymph nodes,

and diffuse atrophy of the mandibular); however, there was no evidence
of any functional deficits at the highest dose tested (HDT) in a
recently submitted and reviewed guideline immunotoxicity study.
Therefore, the clinical neurotoxicity signs and the effects on the
immune system organs following metaflumizone administration are likely
to be secondary to the hematotoxic effects. Metaflumizone induced an
increased incidence of a missing subclavian artery at a relatively high
dose that also caused severe maternal toxicity (e.g., late term
abortions) in the developmental toxicity study in rabbits. There was no
evidence (quantitative or qualitative) of increased susceptibility
following in utero exposures to rats or rabbit and following pre- and
post natal exposures. There was no evidence that metaflumizone is
genotoxic and carcinogenicity studies with mice and rabbits were
negative.
    Specific information on the studies received and the nature of the
adverse effects caused by metaflumizone 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 the document entitled ``Metaflumizone. Revised
Human-Health Risk Assessment Associated with a Section 3 Registration
for a Fire Ant Bait for Application to Citrus, Tree Nuts, and Grape,
and a new Section 3 Registration for a Fly Bait for Application around
Industrial, Commercial, Agricultural, and Recreational Facilities/
Structures and Premises'' in docket ID number EPA-HQ-OPP-2008-0168.

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 metaflumizone used for
human risk assessment is provided in this unit:
    i. Acute dietary endpoint (general population including infants and
children). An acute dietary endpoint was not established for this
population group since an endpoint of concern (effect) attributable to
a single dose was not identified in the database. Studies considered
for this endpoint included the acute neurotoxicity study in which no
toxicity was observed at any dose including the HDT, which is the limit
dose (1,000 milligrams/kilograms/day (mg/kg/day)).
    ii. Acute dietary endpoint (females 13-49 years old). This endpoint
was established based on a developmental effect observed in the rabbit
developmental toxicity study that can be potentially due to a single
dose of metaflumizone. This effect consisted of an increased incidence
of an absent subclavian artery in the offspring at the LOAEL of 300 mg/
kg body/weight/day (bw/day) metaflumizone (NOAEL = 100 mg/kg bw/day).
The rat developmental toxicity study was also considered for this
endpoint; however, no developmental effects were observed in this study
at the HDT of 120 mg/kg bw/day metaflumizone. A combined uncertainty
factor of 300 was applied to account for interspecies (10X) and
intraspecies (10X) extrapolation and a Food Quality Protection Act
(FQPA) safety factor of 3X. Thus, the acute population adjusted dose
(aPAD) for females 13-49 years old is estimated to be 0.33 mg/kg bw/
day.
    iii. Chronic dietary endpoint. This endpoint was established based
on the systemic toxicity observed in the chronic toxicity study with
dogs. At the LOAEL of 30 mg/kg bw/day (NOAEL = 12 mg/kg bw/day), the
effects consisted of reduced general health condition, slight to severe
ataxia, recumbency, and severe salivation, slight decreases in mean
corpuscular hemoglobin concentration and total hemoglobin, leading to
increased plasma bilirubin, increased urinary urobilinogen, and
increased hemosiderin in the liver. A combined uncertainty factor of
300 was applied to account for interspecies (10X) and intraspecies
(10X) extrapolation and an FQPA safety factor of 3X. Thus, the chronic
population adjusted dose (cPAD) is estimated to be 0.040 mg/kg bw/day.
    iv. Incidental oral (short- and intermediate-term). This endpoint
was selected on the basis of the maternal effects observed in the rat
2-generation reproductive toxicity study at the LOAEL of 50 mg/kg bw/
day metaflumizone (NOAEL = 20 mg/kg bw/day). Maternal toxicity
consisted of poor general health and body weight deficits which were
also associated with improper nursing behavior. Similar effects were
also noted in a developmental neurotoxicity study (gavage, range
finding) also considered for this endpoint. In this study, poor
maternal health was also observed at the LOAEL of 120 mg/kg bw/day
metaflumizone (NOAEL = 80 mg/kg bw/day). Both studies considered for
this endpoint achieved a clear NOAEL for the offspring effects, but the
NOAEL of 20 mg/kg bw/day for the 2-generation reproductive toxicity
study is considered more protective. The Agency's level of concern for
this scenario is 300 based on a 10X intraspecies factor, a 10X
interspecies factor, and an FQPA safety factor of 3X.
    v. Dermal (short- and intermediate-term). This endpoint was based
on a rat 90-day dermal toxicity study in which deficits in body weight,
body-weight gain and food consumption (in males and females);
anogenital smearing; increased macrophages in the thymus; lymphocyte
necrosis in the mesenteric lymph nodes; diffuse atrophy of the
mandibular lymph node; and increased hemosiderin in the liver (females
only) were observed at the LOAEL of 300 mg/kg bw/day (NOAEL = 100 mg/kg
bw/day). The Agency's level of concern for this scenario is 100 based
on a 10X interspecies factor, and a 10X intraspecies factor.
    vi. Inhalation (short- and intermediate-term). There is a 28-day
inhalation study for this exposure scenario. There was no NOAEL
identified for female rats. At the LOAEL of 0.10 mg/Liter (L)
metaflumizone (NOAEL = 0.03 mg/L), histopathology of the nasal tissues,
lungs, thymus, prostate, and adrenal cortex was observed in males. The
LOAEL identified in females resulted in lymphocyte necrosis in the
mesenteric lymph node. The Agency's level of concern for this scenario
is 1,000 based on a 10X interspecies factor, a 10X intraspecies factor,
and an FQPA safety factor of 10X. Route-specific toxicity studies were
selected for assessment of

short-intermediate-term dermal, inhalation, and oral exposures. Short-
intermediate-term dermal and inhalation exposures can be aggregated
based on the immunotoxic effects seen at the LOAEL in the selected
studies. Short/intermediate-term oral, dermal, and inhalation exposures
can be aggregated based on the decreased body weight or decreased body-
weight gain effects seen at the LOAEL in the selected oral and dermal
studies and at doses above the LOAEL in the selected inhalation study.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to metaflumizone, EPA considered exposure under the
petitioned-for tolerances. EPA assessed dietary exposures from
metaflumizone 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 metaflumizone. 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 tolerance-level residues. It was further assumed that 100% of
crops with the requested uses of metaflumizone were treated.
    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 tolerance-
level residues. It was further assumed that 100% of crops with the
requested uses of metaflumizone were treated.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that metaflumizone does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue or PCT information in the dietary
assessment for metaflumizone. 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 metaflumizone in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of metaflumizone. 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
metaflumizone for acute exposures are estimated to be 1.14 parts per
billion (ppb) for surface water and 0.00214 ppb for ground water. The
EDWCs of metaflumizone for chronic exposures for non-cancer chronic
assessments are estimated to be 0.597 ppb for surface water and 0.00214
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 1.14 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 0.597 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). Metaflumizone is
currently registered for the following uses that could result in
residential exposures: Pet spot-on products to control fleas on dogs
and cats; fire ant bait products for application to lawns, landscapes,
golf courses, and other non-cropland area. In addition, a pending fly
bait product is proposed for use in areas where people may be present;
therefore, a residential exposure assessment was performed for this
use.
    EPA assessed residential exposure using the following assumptions:
For the pet spot-on products, residential handler exposure is not
expected, because the product is applied directly from a tube to the
pet. Pet spot-on applications are expected to result in short- and
intermediate-term post-application dermal exposure to all populations,
and incident oral exposure (i.e., hand-to-mouth) for children 3 to <6
years of age. For the fire ant bait, applications to home lawns are
expected to result in short-term, residential handler exposure to
adults. Fire ant bait applications to lawns, landscapes, golf-courses,
and other non-cropland areas are expected to result in short-term,
post-application dermal exposure to adults, adolescents, and children 3
to <6 years old, and incident oral exposure for children 3 to <6 years
old. For the pending fly bait product, residential handler exposure is
not expected, because the product is applied by commercial handlers.
The pending fly bait product is expected to result in short-term, post-
application dermal exposure to adults and children 3 to <6 years old,
and incident oral exposure to children 3 to <6 years old.
    For residential handlers, dermal and inhalation exposures are
combined since the endpoints are similar for these routes. For children
(3 to <6 year olds), post-application hand-to-mouth and dermal
exposures are combined. Since the levels of concern (LOCs) for the
dermal, inhalation and incidental oral routes are not the same (dermal
LOC = 100, inhalation LOC = 1,000, and incidental oral LOC = 300),
these routes were combined using the aggregate risk index approach.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found metaflumizone to share a common mechanism of
toxicity with any other substances, and metaflumizone does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
metaflumizone does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for

prenatal and postnatal toxicity and the completeness of the database on
toxicity and exposure unless EPA determines based on reliable data that
a different margin of safety will be safe for infants and children.
This additional margin of safety is commonly referred to as the FQPA
safety factor. In applying this provision, EPA either retains the
default value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence for
increased qualitative or quantitative sensitivity/susceptibility
resulting from prenatal and/or postnatal exposures. In the rat prenatal
development toxicity study, there was no offspring toxicity reported at
any dose tested whereas in the rabbit study a maltransformation based
on an absent subclavian artery was noted to occur only in the presence
of severe maternal toxicity. Similarly, offspring mortality in the 2-
generation reproductive toxicity occurred only in the presence of a
poor maternal health state. Thus, there is no evidence for increased
susceptibility.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA safety factor were reduced from 10X to 3X for all oral exposure
scenarios; retained at 10X for inhalation exposure scenarios; and
reduced to 1X for dermal exposures. That decision is based on the
following findings:
    i. The toxicity database for metaflumizone is complete.
    ii. There is no indication that metaflumizone directly affects the
nervous system. Clinical signs consisting of piloerection and body
temperature variations were observed only in the absence of
neuropathology and in the presence of a poor general state. There is no
need for a developmental neurotoxicity study or additional uncertainty
factors to account for neurotoxicity.
    iii. There is no evidence that metaflumizone results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary analyses assumed tolerance-level residues, 100
PCT, and modeled drinking water estimates. Therefore, HED concludes
that while the submission of data/information by the petitioner
addressing the residue chemistry deficiencies may conceivably result in
adjustment of the maximum theoretical residue estimate, actual
metaflumizone dietary exposure estimates will not be greater than those
generated in the current risk assessment. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to metaflumizone in drinking water. EPA used
similarly conservative assumptions to assess postapplication exposure
of children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
metaflumizone.
    v. Dietary exposures (which are more relevant for human exposures)
exhibited an approximately 2-fold greater absorption into the systemic
circulation and, thus, can potentially lead to toxicity at 2-fold lower
levels of exposure. Applying a FQPA safety factor of 3X for all oral
exposure scenarios is adequate to protect against any greater toxicity
that might occur in dietary exposures (absorption was noted to be 2-
fold greater in dietary versus oral gavage studies).
    vi. The FQPA safety factor of 10X is being retained for inhalation
exposure scenarios for the use of a LOAEL instead of a NOAEL (no NOAEL
achieved) for histopathological lesions consisting of lymphocyte
necrosis in the mesenteric lymph node. The FQPA safety factor of 10X is
adequate due to the severity of lymphocyte necrosis being minimal to
slight and not exhibiting a strong dose dependence.
    vii. The FQPA safety factor for dermal exposure scenarios is being
reduced from 10X to 1X since there is a route-specific study with a
clear NOAEL.

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 metaflumizone will occupy <1% of the aPAD for females 13-49 years
old. An acute dietary exposure estimate was generated for females 13-49
years old, but not for the remaining population subgroups since an
endpoint attributed to a single dose was not identified for those
populations.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
metaflumizone from food and water will utilize <1% 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
metaflumizone is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Metaflumizone
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 metaflumizone. Since the level of
concern (LOC) is different for dermal and oral exposures (100 and 300,
respectively), the aggregate risk index method was used to determine
aggregate risk (aggregate risk indices > 1 are not a risk of concern).
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate risk indices of 3 for the
general population, and 2 for children 1-2 years old. Since the LOCs
for the dermal, inhalation and incidental oral routes are not the same
(dermal LOC = 100, inhalation LOC = 1,000, and incidental oral LOC =
300), these routes were combined using the aggregate risk index
approach. Because EPA's LOC for metaflumizone is an aggregate risk
index less than 1, the aggregate risks are not of concern. These
aggregate risk indices utilize residential exposure estimates from the
pet spot-on products, which represent the worst-case exposure scenario.
However, it should be noted that all registered pet spot-on products
containing metaflumizone are pending voluntary cancellation; therefore,
these aggregate risk indices can be considered conservative.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Metaflumizone is currently registered for uses that could
result in intermediate-term residential exposure;

however, since the PODs for the short- and intermediate-term durations
are the same for metaflumizone, the short-term aggregate assessment is
protective of longer-term exposures.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, metaflumizone 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 metaflumizone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatograph/mass
spectrometer/mass spectrometer (LC/MS/MS) Method 531/0) 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 metaflumizone.

V. Conclusion

    Therefore, tolerances are established for residues of
metaflumizone, (E and Z isomers; 2-[2-(4-cyanophenyl)-1-[3-
(trifluoromethyl) phenyl]ethylidene]-N-[4-(trifluoromethoxy)phenyl]
hydrazinecarboxamide) and its metabolite 4-{2-oxo-2-[3-
(trifluoromethyl) phenyl]ethyl{time} -benzonitrile, in or on: Fruit,
citrus, group 10 at 0.04 ppm; nut, tree, group 14 at 0.04 ppm; almond,
hulls at 0.04 ppm; and grape at 0.04 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: February 3, 2012.
Steven Bradbury,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.657 is added to subpart C to read as follows:

Sec.  180.657  Metaflumizone; tolerances for residues.

    (a) General. Tolerances are established for residues of the
insecticide metaflumizone, including its metabolites and degradates, in
or on the commodities listed in the following table. Compliance with
the tolerance levels specified in the following table is to be
determined by measuring only the sum of metaflumizone (E and Z isomers;
2-[2-(4-cyanophenyl)-1-[3-(trifluoromethyl) phenyl]ethylidene]-N-[4-
(trifluoromethoxy)phenyl]

hydrazinecarboxamide) and its metabolite 4-{2-oxo-2-[3-
(trifluoromethyl) phenyl]ethyl{time} -benzonitrile, calculated as the
stoichiometric equivalent of metaflumizone, in or on the following
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls................................................       0.04
Fruit, citrus, group 10......................................       0.04
Grape........................................................       0.04
Nut, tree, group 14..........................................       0.04
------------------------------------------------------------------------

     (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 2012-3795 Filed 2-21-12; 8:45 am]
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[Federal Register Volume 82, Number 43 (Tuesday, March 7, 2017)]
[Notices]
[Page 12814]
[FR Doc No: 2017-04374]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP17-62-000]

Gulf South Pipeline Company, LP; Notice of Application

    Take notice that on February 22, 2017, Gulf South Pipeline Company,
LP (Gulf South), 9 Greenway Plaza, Suite 2800, Houston, Texas 77046,
filed an application pursuant to section 7(c) of the Natural Gas Act
(NGA) requesting authorization to amend its certificate of public
convenience and necessity issued by the Commission, in Docket No. CP15-
517-000 for the Coastal Bend Header Project.
    Specifically, Gulf South requests to amend its certificate to (i)
install a gas-fired Solar Titan 130 turbine compressor unit in place of
the currently certificated gas-fired Solar Mars 100 turbine compressor
unit at the Magasco Compressor Station, located in Sabine County,
Texas, increasing the horsepower from 15,748 hp to 20,482 hp and (ii)
modify the emergency generator from an 800 brake-horsepower (bhp) unit
to a 691 bhp unit. This amendment will not require any additional
workspace or land disturbance beyond what has been approved by the
Commission. The estimated cost of the amendment is approximately $3
million, all as more fully set forth in the application which is on
file with the Commission and open to public inspection. The filing is
available for review at the Commission in the Public Reference Room or
may be viewed on the Commission's Web site web 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 at<EMAIL_ADDRESS>or call toll-
free,<PHONE_NUMBER> or TYY,<PHONE_NUMBER>.
    Any questions regarding this application may be directed to Kathy
D. Fort, Manager, Certificates & Tariffs, Gulf South Pipeline Company,
LP, 9 Greenway Plaza, Suite 2800, Houston, Texas 77046, by telephone at
(713) 479-8252, or by email to<EMAIL_ADDRESS>    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the EA for this proposal. The filing of the EA in the Commission's
public record for this proceeding or the issuance of a Notice of
Schedule for Environmental Review will serve to notify federal and
state agencies of the timing for the completion of all necessary
reviews, and the subsequent need to complete all federal authorizations
within 90 days of the date of issuance of the Commission staff's EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit seven copies of filings made in the proceeding with the
Commission and must mail a copy to the applicant and to every other
party. Only parties to the proceeding can ask for court review of
Commission orders in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 7 copies of the protest or intervention to the
Federal Energy regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    Comment Date: 5:00 p.m. Eastern Time on March 22, 2017.

    Dated: March 1, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-04374 Filed 3-6-17; 8:45 am]
 BILLING CODE 6717-01-P