[Federal Register Volume 78, Number 27 (Friday, February 8, 2013)]
[Rules and Regulations]
[Pages 9322-9327]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02924]
[[Page 9322]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-0916; FRL-9376-9]
Hexythiazox; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
hexythiazox in or on alfalfa and timothy. Gowan Company requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective February 8, 2013. Objections and
requests for hearings must be received on or before April 9, 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-2010-0916, 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: Olga Odiott, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 308-9369; email address: odiott.olga@epa.gov.
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. If OCSPP test
guidelines are cited, insert the following: 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-2010-0916 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 9, 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-2010-0916, 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 Confidential Business
Information (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.htm.
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 March 14, 2012 (77 FR 15012) (FRL-9335-
9), 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
1F7934) by Gowan Company, 370 South Main Street, Yuma, AZ 85364. The
petition requested that 40 CFR 180.448 be amended by establishing
tolerances for residues of the insecticide hexythiazox (trans-5-(4-
chlorophenyl)-N-cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide)
and its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-
thiazolidine moiety, in or on wheat, forage at 3.0 parts per million
(ppm); wheat, hay at 30 ppm; wheat, grain at 0.02 ppm; wheat, straw at
7.0 ppm; alfalfa, forage at 7.0 ppm; alfalfa, hay at 14 ppm; timothy,
forage at 35 ppm; and timothy, hay at 17 ppm. That document referenced
a summary of the petition prepared by Gowan Company, 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 on EPA's review of the data supporting the petition, Gowan
Company revised their petition (PP 1F7934) as follows:
i. By increasing the proposed tolerances for alfalfa, forage;
alfalfa, hay; timothy forage; and timothy, hay;
ii. By deleting the proposed tolerances for wheat commodities;
iii. By adding a request for an increase in the established
tolerances for cattle, fat; goat, fat; horse fat; sheep fat; and milk;
iv. By adding a request for an increase in the established
tolerances for cattle meat byproducts; goat, meat byproducts; horse,
meat byproducts; and sheep, meat byproducts; and;
v. By proposing tolerances for poultry, fat; and poultry, meat
byproducts; and egg.
The reasons for these changes are explained in Unit IV.D.
[[Page 9323]]
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 hexythiazox including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with hexythiazox 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 toxicity database for hexythiazox is complete.
Hexythiazox has low acute toxicity by the oral, dermal and inhalation
routes of exposure. It produces mild eye irritation, is not a dermal
irritant, and is negative for dermal sensitization. Hexythiazox is
associated with toxicity of the liver and adrenals following subchronic
and chronic exposure to dogs, rats and mice, with the dog being the
most sensitive species. The prenatal developmental studies in rabbits
and rats and the two-generation reproduction study in rats showed no
indication of increased susceptibility to in utero and/or postnatal
exposure to hexythiazox. Reproductive toxicity was not observed. There
is no concern for immunotoxicity or neurotoxicity following exposure to
hexythiazox. The toxicology database for hexythiazox does not show any
evidence of treatment-related effects on the immune system. Hexythiazox
is classified as ``likely to be carcinogenic to humans''; however, the
evidence as a whole is not strong enough to warrant a quantitative
estimation of human risk. Since the effects seen in the study that
serves as the basis for the chronic RfD occurred at doses substantially
below the lowest dose that induced tumors, the chronic RfD is
considered protective of all chronic effects including potential
carcinogenicity.
Specific information on the studies received and the nature of the
adverse effects caused by hexythiazox 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 ``Hexythiazox. Human Health Risk
Assessment to Support New Uses on Alfalfa and Timothy'' in docket ID
number EPA-HQ-OPP-2010-0916.
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 hexythiazox used for
human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Hexythiazox for Use in Human Health Risk Assessment
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Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Acute dietary (All populations).. No risk is expected from this exposure scenario as no hazard was identified
in any toxicity study for this duration of exposure.
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Chronic dietary (All populations) NOAEL = 2.5 mg/kg/ Chronic RfD = 0.025 One-Year Toxicity Feeding Study--
day. mg/kg/day. Dog.
UFA = 10x........... cPAD = 0.025....... LOAEL = 12.5 mg/kg/day based on
UFH = 10x........... increased absolute and relative
FQPA SF = 1x........ adrenal weights and associated
adrenal histopathology.
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Incidental oral short-term (1 to NOAEL = 30 mg/kg/day LOC for MOE = 100.. 2-Generation Reproduction Study--
30 days) and intermediate-term UFA = 10x........... Rat.
(1 to 6 months). UFH = 10x........... LOAEL = 180 mg/kg/day based on
FQPA SF = 1x........ decreased pup body weight during
lactation and delayed hair growth
and/or eye opening, and decreased
parental body-weight gain and
increased absolute and relative
liver, kidney, and adrenal
weights.
[[Page 9324]]
13-Week Oral Toxicity Study--Rat.
NOAEL = 5.5 mg/kg/day.
LOAEL = 38 mg/kg/day, based on
increased absolute and relative
liver weights in both sexes,
increased relative ovarian and
kidney weights, and fatty
degeneration of the adrenal zona
fasciculata.
@ 397.5/257.6 mg/kg/day, decreased
body-weight gain in females,
slight swelling of hepatocytes in
central zone (both sexes),
increased incidence of
glomerulonephrosis in males,
increased adrenal weights.
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Cancer (oral, dermal, inhalation) Classification: ``Likely to be Carcinogenic to Humans''. Insufficient
evidence to warrant a quantitative estimation of human risk using a cancer
slope factor based on the common liver tumors (benign and malignant)
observed only in high dose female mice, and benign mammary gland tumors of
no biological significance, observed only in high dose male rats in the
absence of mutagenic concerns. The chronic RfD is protective of all chronic
effects including potential carcinogenicity of hexythiazox.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to hexythiazox, EPA considered exposure under the petitioned-
for tolerances as well as all existing hexythiazox tolerances in 40 CFR
180.448. EPA assessed dietary exposures from hexythiazox 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 hexythiazox; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
National Health and Nutrition Examination Survey, What We Eat in
America (NHANES/WWEIA). As to residue levels in food, EPA used
tolerance level residues, assumed 100 percent crop treated (PCT), and
incorporated DEEM default processing factors when processing data were
not available.
iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or nonlinear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or nonlinear approach is used and a cancer RfD is
calculated based on an earlier noncancer key event. If carcinogenic
mode of action data are not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized. Based on the data summarized in Unit
III.A. of the Federal Register of March 17, 2010 (75 FR 12691) (FRL-
8813-7), EPA has concluded that a nonlinear RfD approach is appropriate
for assessing cancer risk to hexythiazox. Cancer risk was assessed
using the same exposure estimates as discussed in Unit III.C.1.ii.,
chronic exposure.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for hexythiazox. 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 hexythiazox in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of hexythiazox. 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), the estimated drinking water concentrations (EDWC)
of hexythiazox for chronic exposures for non-cancer and cancer
assessments are estimated to be 4.3 ppb for surface water. Since
surface water residues values greatly exceed groundwater EDWCs, surface
water residues were used in the dietary risk assessment. Modeled
estimates of drinking water concentrations were directly entered into
the dietary exposure model.
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). Hexythiazox is
currently registered for the following uses that could result in
residential exposures: Ornamental plantings, turf, and fruit and nut
trees in residential settings. EPA assessed residential exposure using
the following assumptions: Residential handler exposures are expected
to be short-term (1 to 30 days) via either the dermal or inhalation
routes of exposures. Since a quantitative dermal risk assessment is not
needed for hexythiazox; MOEs were calculated for the inhalation route
of exposure only. Both adults and children may be exposed to
hexythiazox residues from contact with treated lawns or treated
residential plants. Post application exposures are expected to be
short-term (1 to 30 days) and intermediate-term (1 to 6 months) in
duration. Adult postapplication exposures were not assessed since no
quantitative dermal risk assessment is needed for hexythiazox and
inhalation exposures are typically negligible in outdoor settings. The
exposure assessment for children included incidental oral exposure
resulting from
[[Page 9325]]
transfer of residues from the hands or objects to the mouth, and from
incidental ingestion of soil.
Details of the residential exposure and risk assessment can be
found at http://www.regulations.gov in document ``Hexythiazox. Human
Health Risk Assessment to Support New Uses on Alfalfa and Timothy'' in
docket ID number EPA-HQ-OPP-2010-0916. 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 hexythiazox to share a common mechanism of
toxicity with any other substances, and hexythiazox does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
hexythiazox 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 (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. The prenatal and postnatal
toxicology data base indicates no increased susceptibility of rats or
rabbits to in utero and/or postnatal exposure to hexythiazox.
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 hexythiazox is complete.
ii. There is no indication that hexythiazox is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no evidence that hexythiazox 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 food exposure assessments were performed based
on 100 PCT and tolerance-level residues. The dietary risk assessment is
highly conservative and not expected to underestimate risk. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to hexythiazox 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 hexythiazox.
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,
hexythiazox 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
hexythiazox from food and water will utilize 63% of the cPAD for
children 1-2 years of age, 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
hexythiazox 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).
Hexythiazox 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 hexythiazox.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 12,000 for adults
and 1,600 for children. Because EPA's level of concern for hexythiazox
is a MOE of 100 or below, these MOEs are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Hexythiazox is currently registered for uses that could result in
intermediate-term residential exposure, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate-term residential exposures to hexythiazox.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in
aggregate MOEs of 12,000 for adults and 1,900 for children. Because
EPA's level of concern for hexythiazox is a MOE of 100 or below, these
MOEs are not of concern.
5. Aggregate cancer risk for U.S. population. As discussed in Unit
III. C.1.iii., EPA concluded that regulation based on the chronic
reference dose will be protective for both chronic and carcinogenic
risks. As noted in this unit there is no chronic risks of concern.
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 hexythiazox residues.
[[Page 9326]]
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (high performance liquid
chromatography method with UV 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: (410) 305-2905; email address:
residuemethods@epa.gov.
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.
No Canadian or Mexican MRLs have been established for residues of
hexythiazox in plants or livestock. There are no codex MRLs established
for alfalfa or timothy; however, there are Code MRLs for livestock at
0.05 ppm in/on the following: edible offal (mammalian); mammalian fats
(except milk fats); milks; milk fats; poultry, edible offal; poultry
meat (fat). The U.S. and Codes residue definitions in both plants and
livestock are harmonized. There is no issue of international
harmonization with respect to the recommended alfalfa, timothy, and egg
tolerances since there are no established international tolerances for
these commodities. The tolerance for livestock meat byproducts is not
harmonized with Codex as the potential hexythiazox residue level in
meat byproducts may exceed the current Codex MRL.
C. Revisions to Petitioned-for Tolerances
Based on EPA's review of the data supporting the petition, Gowan
Company revised their petition (PP 1F7934) as follows:
i. By increasing the proposed tolerances for alfalfa, forage to 15
ppm; alfalfa, hay to 30 ppm; timothy forage to 40 ppm; and timothy, hay
to 40 ppm;
ii. By deleting the proposed tolerances for wheat, forage; wheat,
hay; wheat, grain; and wheat, straw;
iii. By adding a request for an increase in the established
tolerances for cattle, fat; goat, fat; horse fat; sheep fat; and milk
to 0.05 ppm;
iv. By adding a request for an increase in the established
tolerances for cattle meat byproducts; goat, meat byproducts; horse,
meat byproducts; and sheep, meat byproducts to 0.20 ppm; and
v. By proposing tolerances for poultry, fat; and poultry, meat
byproducts at 0.05 ppm; and egg at 0.01 ppm.
The Agency concluded that based on the residue data, these changes
are required to support the new uses. The increase in the alfalfa and
timothy tolerances were recommended by the Agency as a result of
analyzing the submitted field trial data for these commodities using
the OEDC MRL (Maximum Residue Limit) calculator. The increase in the
livestock tolerances in fat and meat byproducts of ruminants are
required due to the increased livestock dietary burden expected with
the new uses on alfalfa and timothy. The increase in the ruminant fat
and milk tolerances are recommended in order to account for the
increased dietary burden to livestock and to be harmonized with Codex.
Additionally, because of the potential increase of hexythiazox in the
poultry diet, largely due to alfalfa use, and based on updated maximum
reasonably balanced diet (MRBD) calculations for poultry, tolerances
for eggs, poultry fat, and meat byproducts are required.
V. Conclusion
Therefore, tolerances are established for residues of hexythiazox
and its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-
thiazolidine moiety, as requested in the revised petition.
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.
[[Page 9327]]
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: February 4, 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. Section 180.448 is amended as follows:
0
i. In paragraph (a), in the table, revise the entries for ``cattle,
fat;'' ``cattle, meat byproducts;'' ``goat, fat;'' ``goat, meat
byproducts;'' ``horse, fat;'' ``horse, meat byproducts;'' ``sheep,
fat;'' ``sheep, meat byproducts;'' and ``milk.''
0
ii. In paragraph (a), in the table, add entries for ``poultry, fat;''
``poultry, meat byproducts;'' and ``egg.''
0
iii. In paragraph (c), in the table, add entries for ``alfalfa, forage
(EPA Regions 9-11 only;'' ``alfalfa, hay (EPA Regions 9-11 only;''
``timothy, forage (EPA Regions 9-11 only;'' and ``timothy, hay (EPA
Regions 9-11 only.''
The additions and revisions read as follows:
Sec. 180.448 Hexythiazox; tolerance for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Cattle, fat................................................. 0.05
Cattle, meat byproducts..................................... 0.20
* * * * *
Egg......................................................... 0.01
* * * * *
Goat, fat................................................... 0.05
Goat, meat byproducts....................................... 0.20
* * * * *
Horse, fat.................................................. 0.05
Horse, meat byproducts...................................... 0.20
* * * * *
Milk........................................................ 0.05
* * * * *
Poultry, fat................................................ 0.05
Poultry, meat byproducts.................................... 0.05
* * * * *
Sheep, fat.................................................. 0.05
Sheep, meat byproducts...................................... 0.20
------------------------------------------------------------------------
* * * * *
(c) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Alfalfa, forage (EPA Regions 9-11 only)..................... 15
Alfalfa, hay (EPA Regions 9-11 only)........................ 30
* * * * *
Timothy, forage (EPA Regions 9-11 only)..................... 40
Timothy, hay (EPA Regions 9-11 only)........................ 40
------------------------------------------------------------------------
* * * * *
[FR Doc. 2013-02924 Filed 2-7-13; 8:45 am]
BILLING CODE 6560-50-P