[Federal Register Volume 78, Number 191 (Wednesday, October 2, 2013)]
[Rules and Regulations]
[Pages 60709-60715]
[FR Doc No: 2013-24127]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0912; FRL-9399-6]

Methoxyfenozide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
methoxyfenozide in or on multiple commodities which are identified and
discussed later in this document. Additionally, this regulation removes
several established time-limited and permanent tolerances, as they will
be superseded by tolerances established by this document. Interregional
Research Project Number 4 (IR-4) requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 2, 2013. Objections and
requests for hearings must be received on or before December 2, 2013,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0912, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of EPA's
tolerance

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2012-0912 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
December 2, 2013. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0912, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of January 16, 2013 (78 FR 3377) (FRL-9375-
4), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
2E8118) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ
08540. The petition requested that 40 CFR 180.544 be amended by
establishing tolerances for residues of the insecticide methoxyfenozide
(3-methoxy-2-methylbenzoic acid 2-(3,5-dimethylbenzoyl)-2-(1,1-
dimethylethyl) hydrazide) in or on atemoya at 0.6 parts per million
(ppm); berry, low growing, except cranberry, subgroup 13-07G at 1.5
ppm; biriba at 0.6 ppm; caneberry subgroup 13-07A at 6 ppm; cherimoya
at 0.6 ppm; custard apple at 0.6 ppm; date at 7 ppm; fruit, pome, group
11-10 at 1.5 ppm; fruit, small, vine climbing, except fuzzy kiwifruit,
subgroup 13-07F at 1 ppm; grain, aspirated grain fractions at 80 ppm;
herb subgroup 19A, except chive at 400 ppm; ilama at 0.6 ppm; pea and
bean, dried shelled, except soybean, subgroup 6C, except pea,
blackeyed, seed and pea, southern, seed at 0.5 ppm; sorghum, grain,
forage at 9 ppm; sorghum, grain, grain at 4 ppm; sorghum, grain, stover
at 15 ppm; sorghum, sweet, forage at 9 ppm; sorghum, sweet, grain at 4
ppm; sorghum, sweet, stalk at 9 ppm; sorghum, sweet, stover at 15 ppm;
soursop at 0.6 ppm; sugar apple at 0.6 ppm; and vegetable, fruiting,
group 8-10 at 2 ppm.
    Additionally, the petition requested that EPA establish tolerances
under paragraph (d)(2) for indirect or inadvertent residues of
methoxyfenozide in or on rapeseed subgroup 20A at 1.0 ppm and sunflower
subgroup 20B at 1.0 ppm, and to amend the tolerance for herb and spice,
group 19, except coriander, leaves at 4.5 ppm to spice subgroup 19B at
4.5 ppm. Upon approval of the proposed tolerances listed under ``New
Tolerances,'' the petition finally requested that EPA remove the
following commodities from paragraph (a)(1): Bean, dry seed at 0.24
ppm; coriander, leaves at 30 ppm; grape at 1.0 ppm; fruit, pome, group
11 at 1.5 ppm; okra at 2.0 ppm; pea, dry seed at 2.5 ppm; strawberry at
1.5 ppm; and vegetable, fruiting, group 8 at 2.0 ppm. That document
referenced a summary of the petition prepared on behalf of IR-4 by Dow
AgroSciences, LLC, the registrant, which is available in the docket,
http://www.regulations.gov. There were no comments received in response
to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
revised the proposed tolerance levels for several commodities. The
Agency has also removed the time-limited tolerances for several
commodities and the established tolerance in or on grain, aspirated
grain fractions. The reasons for these changes are explained in Unit
IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
. .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for methoxyfenozide including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with methoxyfenozide
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.
    The main target organs identified from the toxicity studies on
methoxyfenozide were the liver, thyroid, and red blood cells, though
many of the available short-term or subchronic toxicity studies showed

little or no toxicity. Effects of methoxyfenozide on the blood in
mammals (methemoglobinemia, decreased red blood cell parameters, Heinz
body formation) are consistent with those of other hydrazine compounds.
Hematologic parameters in the rat and dog were affected by exposure to
methoxyfenozide. Mild anemia (decreases in red blood cell count,
hematocrit and hemoglobin) was observed in both species following
chronic dietary exposure, along with methemoglobinemia and red blood
cell structural abnormalities. Increased platelets were also observed.
An increase in the cellularity of rib and sternum bone marrow, along
with macrophage pigmentation in the liver and spleen, were reported in
the dog. No significant hematological changes were seen in the dog or
rat subchronic studies, or the rat 2 week range-finding studies;
however, hematological effects were observed in the dog 2 week range-
finding study, along with increased spleen weight. No hematological
effects were reported in the mouse.
    Increased liver weight and periportal hypertrophy were observed in
the rat and dog. These findings were observed in the rat following 2-
week, subchronic or chronic dietary exposure and in the dietary
reproductive toxicity study, and in the dog following chronic exposure.
In the rat 2-week toxicity study, increased adrenal gland weight and
minimal hypertrophy of the zone fasciculata, and increased thyroid
follicular cell hypertrophy/hyperplasia were also observed. Thyroid
hypertrophy and altered colloid and increased adrenal weights were
observed in the rat chronic oral study, and the incidence and severity
of chronic progressive glomerulonephropathy was increased. Thyroid
weights were increased in the dog following chronic exposure.
    Acute and subchronic oral neurotoxicity studies in the rat did not
show evidence of potential neurotoxicity. In the acute study, decreased
hindlimb grip strength on day 0 was reported in males. This finding was
only observed at the limit dose in males and was not observed in the
subchronic neurotoxicity study and was therefore not considered
evidence of neurotoxicity. No clinical signs of toxicity or
neurohistopathology were observed in other guideline studies.
    No maternal or developmental effects were observed in either the
rat or rabbit developmental toxicity studies. In the rat 2-generation
reproductive toxicity study, no offspring or reproductive toxicity was
observed, and parental effects were limited to increased liver weight
and microscopic periportal hypertrophy. In an immunotoxicity study in
the rat, no immunotoxicity was observed.
    There was no evidence of carcinogenicity in the rat combined
chronic toxicity and carcinogenicity study or the mouse carcinogenicity
study. No mutagenic or clastogenic potential was observed in the
battery of genotoxicity studies on methoxyfenozide. Based on these
findings, methoxyfenozide has been classified as ``not likely to be
carcinogenic to humans.''
    Specific information on the studies received and the nature of the
adverse effects caused by methoxyfenozide 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: ``Methoxyfenozide. Human Health Risk
Assessment to Support Proposed New Uses on Herbs, Caneberries, Dates
and Sorghum; to Establish Rotational Crop Tolerances in the Rapeseed
and Sunflower Oilseed Subgroups; as well as to Extend and Update Crop
Group Tolerances on Multiple Commodities'' at pp. 35-41 in docket ID
number EPA-HQ-OPP-2012-0192.

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 methoxyfenozide used
for human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of July 11, 2012 (77 FR 40806) (FRL-
9354-1).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to methoxyfenozide, EPA considered exposure under the
petitioned-for tolerances as well as all existing methoxyfenozide
tolerances in 40 CFR 180.544. EPA assessed dietary exposures from
methoxyfenozide 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. No such effects were
identified in the toxicological studies for methoxyfenozide; therefore,
a quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used Dietary Exposure Evaluation Model software with the
Food Commodity Intake Database (DEEM-FCID) Version 3.16, which uses
food consumption data from the U.S. Department of Agriculture's
(USDA's) National Health and Nutrition Examination Survey, ``What We
Eat in America'' (NHANES/WWEIA) from 2003 through 2008. As to residue
levels in food, EPA utilized tolerance-level residues, DEEM (Version
7.81) default processing factors as necessary, an empirical processing
factor for orange juice, and 100 percent crop treated (PCT) for all
commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that methoxyfenozide 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 PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for methoxyfenozide. 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 methoxyfenozide in drinking water. These simulation
models take into account data on the physical, chemical,

and fate/transport characteristics of methoxyfenozide. 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 Pesticide Root Zone Model Ground Water (PRZM
GW), the estimated drinking water concentrations (EDWCs) of
methoxyfenozide for chronic exposures for non-cancer assessments are
estimated to be 51.6 parts per billion (ppb) for surface water and 251
ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 251 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). Methoxyfenozide is
currently registered for the following uses that could result in
residential exposures: Ornamental uses, including on residential
property. EPA assessed residential exposure using the following
assumptions: Adult handlers were assessed for short-term inhalation
exposures from mixing, loading, and applying methoxyfenozide using a
manually pressurized hand wand, backpack sprayer, or hose-end sprayer.
Since the short- and intermediate-term toxicological endpoints are the
same, only short-term exposures have been assessed and are assumed to
be protective of intermediate-term exposures. A postapplication
exposure assessment was not conducted for adults because the handler
assessment is expected to be protective of postapplication exposure via
the inhalation route. Although there is also potential for dermal
exposure, there is no expectation of dermal risk to any population,
including infants and children, based on the lack of dermal toxicity
for methoxyfenozide. Furthermore, the potential for postapplication
oral exposures to children is not expected since the extent to which
young children engage in activities associated with areas where
residential ornamentals are grown or use these areas for prolonged
periods of play is low. 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 methoxyfenozide to share a common mechanism of
toxicity with any other substances, and methoxyfenozide does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
methoxyfenozide does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different additional
safety factor when reliable data available to EPA support the choice of
a different factor.
    2. Prenatal and postnatal sensitivity. Based on the results in the
developmental toxicity studies in rats and rabbits and in the 2-
generation reproduction study in rats, no increased sensitivity of
fetuses or pups, as compared to adults, was demonstrated for
methoxyfenozide. There are no concerns or residual uncertainties for
pre- or postnatal toxicity following exposure to methoxyfenozide.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for methoxyfenozide is complete.
    ii. There is no indication that methoxyfenozide is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional uncertainty factors (UFs) to account for neurotoxicity.
    iii. There is no evidence that methoxyfenozide 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 chronic dietary food exposure assessment was performed
based on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to methoxyfenozide in drinking water. Based on the
discussion in Unit III.C.3., residential exposures to children or
toddlers are not expected. These assessments will not underestimate the
exposure and risks posed by methoxyfenozide.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
methoxyfenozide is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
methoxyfenozide from food and water will utilize 84% 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
methoxyfenozide 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).
Methoxyfenozide 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 methoxyfenozide.
    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 an aggregate MOE of 530 for adult
handlers. Because EPA's level of concern for methoxyfenozide is a MOE
of 100 or below, this MOE is not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Methoxyfenozide is currently registered for uses that could
result in intermediate-term residential exposure. However, based on the
information in Unit III.C.3., an intermediate-term aggregate exposure
assessment was not performed and is not necessary.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, methoxyfenozide 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 methoxyfenozide residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, using high performance liquid
chromatography (HPLC), with either mass spectrometric detection (LC/MS)
or ultraviolet detection (HPLC/UV), 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 United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has established MRLs for methoxyfenozide in or on
commodities associated with this action. Codex has established MRLs in
or on grapes at 1 milligram/kilogram (mg/kg); pepper and tomato at 2
mg/kg; pome fruits at 2 mg/kg; and strawberries at 2 mg/kg. The U.S.
tolerances for small vine climbing fruit, except fuzzy kiwifruit
subgroup 13-07F at 1.0 ppm (represented by grape); and vegetable,
fruiting, group 8-10 (represented by commodities including pepper and
tomato) at 2.0 ppm are harmonized with the Codex MRLs for grape and for
pepper and tomato, respectively.
    Additionally, the EPA is establishing a tolerance in or on fruit,
pome, group 11-10 at 2.0 ppm, which is increased from the current
tolerance of 1.5 ppm for fruit, pome, group 11, in order to harmonize
with the Codex MRL in or on fruit, pome at 2 mg/kg. The Agency is also
establishing a tolerance in or on berry, low growing, subgroup 13-07G,
except cranberry (represented by strawberry) at 2.0 ppm, in order to
harmonize with the Codex MRL in or on strawberry at 2 mg/kg. The 13-07G
tolerance is being increased from the current tolerance of 1.5 ppm in
or on strawberry.
    The recommended tolerance of 0.50 ppm in or on pea and bean, dried
shelled, except soybeans subgroup 6C, was proposed at the Agency's
request to better harmonize with the existing Codex MRL of 0.5 mg/kg in
or on dried beans. This tolerance will supersede the current tolerances
in or on dried beans at 0.24 ppm, and in or on dried peas at 2.5 ppm.
The Codex has not established MRLs for other commodities associated
with this action.

C. Revisions to Petitioned-For Tolerances

    Based on the data supporting the petition, EPA has revised the
proposed tolerances for several commodities, as follows: Date from 7.0
ppm to 8.0 ppm; grain, aspirated grain fractions from 80 ppm to 120
ppm; sorghum, grain, forage from 9.0 ppm to 15 ppm; sorghum, grain,
grain from 4.0 ppm to 6.0 ppm; sorghum, grain, stover from 15 ppm to 20
ppm; sorghum, sweet, forage from 9.0 ppm to 15 ppm; sorghum, sweet,
grain from 4.0 ppm to 6.0 ppm; sorghum sweet, stalk from 9.0 ppm to 15
ppm; and sorghum, sweet, stover from 15 ppm to 20 ppm. The Agency
revised these tolerance levels based on analysis of the residue field
trial data using the Organization for Economic Cooperation and
Development (OECD) tolerance calculation procedures. As previously
discussed, EPA has also revised the following proposed tolerances in
order to harmonize with established Codex MRLs: Berry, low growing,
subgroup 13-07G, except cranberry from 1.5 ppm to 2.0 ppm, and fruit,
pome, group 11-10 from 1.5 ppm to 2.0 ppm.
    EPA is establishing a tolerance in or on herb subgroup 19A, except
chive at 400 ppm. The petition to the Agency requested concurrently to
amend the established tolerance for indirect or inadvertent residues in
or on herb and spice, group 19, except coriander, leaves at 4.5 ppm to
spice subgroup 19B at 4.5 ppm, because a permanent tolerance in or on
subgroup 19A was proposed to be established and an inadvertent
tolerance is no longer needed when a commodity has a tolerance allowing
for direct treatment. However, because the permanent tolerance being
established in or on herb subgroup 19A does not include a tolerance for
chive and chive is not included in subgroup 19B, the Agency determined
that it is also necessary to maintain a tolerance for the indirect or
inadvertent residues of methoxyfenozide in or on chive, as the
commodity was previously covered by the group 19 indirect or
inadvertent residue tolerance. Therefore, EPA is also establishing an
individual tolerance for the indirect or inadvertent residues of
methoxyfenozide in or on chive at 4.5 ppm.
    Additionally, EPA determined that the time-limited tolerances in or
on sorghum, forage at 30.0 ppm; sorghum, grain at 0.05 ppm; and
sorghum, stover at 60.0 ppm should be removed because the tolerances
expired on December 31, 2012, and because they will be superseded by
permanent tolerances for these commodities. Finally, the Agency has
determined that the established

tolerance in or on grain, aspirated fractions at 2.0 ppm should be
removed, as it will be superseded by the grain, aspirated grain
fractions tolerance at 120 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of
methoxyfenozide (3-methoxy-2-methylbenzoic acid 2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide) in or on atemoya at
0.60 ppm; berry, low growing, subgroup 13-07G, except cranberry at 2.0
ppm; biriba at 0.60 ppm; caneberry subgroup 13-07A at 6.0 ppm;
cherimoya at 0.60 ppm; custard apple at 0.60 ppm; date at 8.0 ppm;
fruit, pome, group 11-10 at 2.0 ppm; fruit, small, vine climbing,
except fuzzy kiwifruit, subgroup 13-07F at 1.0 ppm; grain, aspirated
grain fractions at 120 ppm; herb subgroup 19A, except chive at 400 ppm;
ilama at 0.60 ppm; pea and bean, dried shelled, except soybean,
subgroup 6C, except pea, blackeyed, seed and pea, southern, seed at
0.50 ppm; sorghum, grain, forage at 15 ppm; sorghum, grain, grain at
6.0 ppm; sorghum, grain, stover at 20 ppm; sorghum, sweet, forage at 15
ppm; sorghum, sweet, grain at 6.0 ppm; sorghum, sweet, stalk at 15 ppm;
sorghum, sweet, stover at 20 ppm; soursop at 0.60 ppm; sugar apple at
0.60 ppm; and vegetable, fruiting, group 8-10 at 2.0 ppm. This
regulation additionally establishes tolerances for indirect or
inadvertent residues in or on rapeseed subgroup 20A at 1.0 ppm and
sunflower subgroup 20B at 1.0 ppm. The regulation also amends the
tolerance for indirect or inadvertent residues in or on herb and spice,
group 19, except coriander, leaves at 4.5 ppm to spice subgroup 19B at
4.5 ppm and chive at 4.5 ppm.
    This regulation additionally removes the established tolerances in
or on bean, dry, seed at 0.24 ppm; coriander, leaves at 30 ppm; fruit,
pome, group 11 at 1.5 ppm; grain, aspirated fractions at 2.0 ppm; grape
at 1.0 ppm; okra at 2.0 ppm; pea, dry, seed at 2.5 ppm; strawberry at
1.5 ppm; and vegetable, fruiting, group 8 at 2.0 ppm. Finally, this
regulation removes the time-limited tolerances in or on sorghum, forage
at 30.0 ppm; sorghum, grain at 0.05 ppm; and sorghum, stover at 60.0
ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: September 26, 2013.
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. In Sec.  180.544:
0
a. Remove bean, dry, seed; coriander, leaves; fruit, pome, group 11;
grain, aspirated fractions; grape; okra; pea, dry seed; strawberry; and
vegetable, fruiting, group 8 from the table in paragraph (a)(1).
0
b. Remove and reserve paragraph (b).
0
c. Remove herb and spice, group 19, except coriander, leaves from the
table in paragraph (d)(2).
0
d. Add the following commodities in alphabetical order to the tables in
paragraphs (a)(1) and (d)(2) as shown.

Sec.  180.544  Methoxyfenozide; tolerances for residues.

    (a) * * *
    (1) * * *

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

                                * * * * *
Atemoya......................................................       0.60

                                * * * * *
Berry, low growing, subgroup 13-07G, except cranberry........       2.0
Biriba.......................................................       0.60

                                * * * * *
Caneberry subgroup 13-07A....................................       6.0

                                * * * * *
Cherimoya....................................................       0.60

                                * * * * *
Custard apple................................................       0.60
Date.........................................................       8.0

                                * * * * *
Fruit, pome, group 11-10.....................................       2.0
Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup       1.0
 13-07F......................................................

                                * * * * *
Grain, aspirated grain fractions.............................     120

                                * * * * *
Herb subgroup 19A, except chive..............................     400

                                * * * * *
Ilama........................................................       0.60

                                * * * * *
Pea and bean, dried shelled, except soybean, subgroup 6C,           0.50
 except pea, blackeyed, seed and pea, southern, seed.........

                                * * * * *
Sorghum, grain, forage.......................................      15
Sorghum, grain, grain........................................       6.0
Sorghum, grain, stover.......................................      20
Sorghum, sweet, forage.......................................      15
Sorghum, sweet, grain........................................       6.0
Sorghum, sweet, stalk........................................      15
Sorghum, sweet, stover.......................................      20
Soursop......................................................       0.60

                                * * * * *
Sugar apple..................................................       0.60

                                * * * * *
Vegetable, fruiting, group 8-10..............................       2.0

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

* * * * *
    (b) Section 18 emergency exemptions. [Reserved]
* * * * *
    (d) * * *
    (2) * * *

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

                                * * * * *
Chive........................................................       4.5

                                * * * * *
Rapeseed subgroup 20A........................................       1.0
Spice subgroup 19B...........................................       4.5
Sunflower subgroup 20B.......................................       1.0
------------------------------------------------------------------------

[FR Doc. 2013-24127 Filed 10-1-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)]
[Proposed Rules]
[Pages 59548-59549]
[FR Doc No: 2016-20704]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0923; Directorate Identifier 2014-NM-176-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Proposed rule; withdrawal.

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

SUMMARY: The FAA withdraws a notice of proposed rulemaking (NPRM) that
proposed a new airworthiness directive (AD), which would have applied
to certain The Boeing Company Model 737-700, -800, and -900ER series
airplanes. The NPRM would have required repetitive inspections to
detect cracking in the crown skin panel assembly. The NPRM would also
have provided optional terminating action for the repetitive
inspections. Since the NPRM was issued, all affected airplanes
worldwide have had applicable terminating actions accomplished, and one
airplane was mistakenly included in the applicability. Accordingly, the
NPRM is withdrawn.

DATES: As of August 30, 2016, the proposed rule, which was published in
the Federal Register on December 15, 2014 (79 FR 74032), is withdrawn.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0923; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD action, the NPRM (79 FR 74032, December 15, 2014), the
regulatory evaluation, any comments received, and other information.
The address for the Docket Office (telephone:<PHONE_NUMBER>) is the
Docket Management Facility, U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Gaetano Settineri, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office
(ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-
6577; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We proposed to amend part 39 of the Federal Aviation Regulations
(14 CFR part 39) with a NPRM for a new AD for certain The Boeing
Company Model 737-700, -800, and -900ER series airplanes. The NPRM
published in the Federal Register on December 15, 2014 (79 FR 74032)
(``the NPRM''). The NPRM would have required repetitive inspections to
detect cracking in the crown skin panel assembly. The NPRM would also
have provided optional terminating action for the repetitive
inspections. The NPRM was prompted by reports of troughs in the skin
along the chem-mill pocket edges of certain fuselage crown skin panel
assemblies. The proposed actions were intended to detect and correct
cracking from troughs in the chem-mill pocket edges, which could lead
to rapid decompression of the airplane.

Actions Since NPRM Was Issued

    Since we issued the NPRM, we have determined that all affected
airplanes worldwide have had applicable terminating actions
accomplished, and one airplane had been included mistakenly in the
applicability. The unsafe condition identified in the NPRM was created
due to a production escapement and was limited to 11 airplanes.
However, the affected airplanes have all been inspected for the unsafe
condition and in instances where the unsafe condition was present, the
discrepant parts were replaced with conforming parts. With the
discrepant parts replaced, the unsafe condition no longer exists.

Comments

    We gave the public the opportunity to participate in considering
the NPRM. Two commenters, Boeing and Aviation Partners Boeing,
requested certain changes to the NPRM that are considered moot by this
withdrawal.

FAA's Conclusions

    Upon further consideration, we have determined that the unsafe
condition described in the NPRM no longer exists. Accordingly, the NPRM
is withdrawn.
    Withdrawal of the NPRM does not preclude the FAA from issuing
another related action or commit the FAA to any course of action in the
future.

Regulatory Impact

    Since this action only withdraws an NPRM, it is neither a proposed
nor a final rule and therefore is not covered under Executive Order
12866, the Regulatory Flexibility Act, or DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979).

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Withdrawal

    Accordingly, we withdraw the NPRM, Docket No. FAA-2014-0923,
Directorate Identifier 2014-NM-176-AD, which was published in the
Federal Register on December 15, 2014 (79 FR 74032).

    Issued in Renton, Washington, on August 18, 2016.
Dorr M. Anderson,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-20704 Filed 8-29-16; 8:45 am]
 BILLING CODE 4910-13-P


Comment Info: =================

General Comment:I am responding to the deeming regulations and respectfully ask that the alloted comment period be extended to allow for the public to fully review and understand the proposed regulations. With how long it took the FDA to finally propose these regulations it is only fair that the public be allowed more time to comment. This is a huge step being taken by  the FDA, and I feel it's important that they take the time to listen to the American people and implement the proper regulations based on facts and science, not big tobacco and big pharmaceutical companies that stand to lose money. I urge you to do what is right for the people of this great country and not what is in the best interest of big corporations!