[Federal Register Volume 76, Number 240 (Wednesday, December 14, 2011)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-32086]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Hexythiazox; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes new tolerances and revises
existing tolerances for residues of hexythiazox in or on multiple
commodities which are identified and discussed later in this document.
Gowan Company and the Interregional Research Project Number 4 (IR-4)
requested the tolerances under the Federal Food, Drug, and Cosmetic Act
DATES: This regulation is effective December 14, 2011. Objections and
requests for hearings must be received on or before February 13, 2012,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0916. 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)
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: firstname.lastname@example.org.
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.
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
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-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
February 13, 2012. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0916, 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 (703) 305-5805.
II. Summary of Petitioned-for Tolerance
In the Federal Registers of December 15, 2010 (75 FR 78240) (FRL-
8853-1) and February 4, 2011 (76 FR 6465) (FRL-8858-7), EPA issued
notices pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3),
announcing the filing of pesticide petitions (PP 0F7773) by Gowan
Company, 370 South Main St., Yuma, AZ 85364; and (PP 0E7787) by the
Interregional Research Project Number 4 (IR-4), 500 College Road East,
Suite 201 W, Princeton, NJ 08540. The petitions requested that 40 CFR
180.448 be amended by establishing tolerances for residues of the
methyl-2-oxothiazolidine-3-carboxamide), including its metabolites
containing the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety,
in or on aspirated grain fractions (PP 0F7773) at 0.5 parts per million
(ppm) and greenhouse tomatoes (PP 0E7787) at 0.5 ppm; by increasing the
existing tolerance for corn, field, stover from 2.5 ppm to 6 ppm, and
by removing the designation of ``Tolerances with regional
registrations'' from the tolerances for corn, field, forage; corn,
field, grain; and corn, field, stover (PP 0F7773). That notice
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, Gowan Company revised their petition (PP
0F7773) as follows:
i. By increasing the proposed tolerance for corn, field, stover to
ii. By adding a request for an increase in the established
tolerances for cattle, meat byproducts; goat, meat byproducts; hog,
meat byproducts; horse, meat byproducts; and sheep, meat byproducts to
0.05 ppm; and
iii. By adding a request for a decrease in the established
tolerance for corn, field, forage to 3.0 ppm.
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 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 hexythiazox including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with hexythiazox
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
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. The
target organs of hexythiazox are the liver and adrenal glands.
Developmental toxicity was not observed in rabbits at the limit dose.
Developmental effects observed in the rat occurred only at a dose level
where maternal toxicity was observed. Hexythiazox is not a reproductive
toxicant. The toxicology database for hexythiazox provides no
indication of increased susceptibility in rats or rabbits from in utero
and postnatal exposure to hexythiazox. The database does not show any
evidence of treatment-related effects on the nervous system or the
immune system. Hexythiazox is classified as ``likely to be carcinogenic
to humans''. EPA has determined that a non-quantitative risk assessment
approach (i.e., nonlinear, reference dose (RfD) approach) was
appropriate and protective of all chronic effects including potential
carcinogenicity of hexythiazox.
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 Amended Use on Field Corn and New Use on
Greenhouse Tomatoes'' 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
Point of departure and
Exposure/scenario uncertainty/safety RfD, PAD, LOC for risk Study and toxicological
factors assessment effects
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.
Chronic dietary (All populations).. NOAEL= 2.5 mg/kg/day.. Chronic RfD = 0.025 mg/ One-Year Toxicity Feeding
UFA = 10x cPAD = 0.025 mg/kg/day LOAEL = 12.5 mg/kg/day
UFH = 10x............. based on increased
FQPA SF = 1x.......... absolute and relative
adrenal weights and
Incidental oral short-term (1 to 30 NOAEL= 30 mg/kg/day... LOC for MOE = 100..... 2-Generation Reproduction
days ) and intermediate-term (1 to UFA = 10x............. Study--Rat.
6 months). UFH = 10x............. LOAEL = 180 mg/kg/day based
FQPA SF = 1x.......... on 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
13-Week Oral Toxicity
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
males, increased adrenal
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.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population
adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of
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
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 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 used tolerance level residues, assumed 100 percent
crop treated (PCT), and incorporated DEEM default processing factors.
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 non-linear 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
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 concentration (EDWC)
of hexythiazox for chronic exposures for non-cancer and cancer
assessments is estimated to be 4.5 parts per billion 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 not currently registered for any specific use
patterns that would result in residential exposure. However, the
following uses that could result in residential exposures are pending
registration and are included in this risk assessment: Turf, ornamental
landscape plantings, ornamental plants, trees and vines in nurseries,
residential fruit trees, nut trees, caneberries, and orchids.
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 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 Amended Use on Field Corn and New Use
on Greenhouse Tomatoes,'' 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
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
i. The toxicity database for hexythiazox is complete with the
exception of certain new generic testing requirements under revised 40
CFR part 158, including acute and subchronic neurotoxicity studies and
an immunotoxicity study. However, the toxicology database does not show
any evidence of treatment-related effects on the nervous system or the
immune system. The overall weight of evidence suggests that this
chemical does not directly target either system. Although acute and
subchronic neurotoxicity studies and an immunotoxicity study are
required as a part of new data requirements in 40 CFR part 158 for
conventional pesticide registrations, the Agency does not believe that
conducting these studies will result in a lower POD than any currently
used for risk assessment, and therefore, a database uncertainty factor
(UFDB) is not needed to account for the lack of these
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
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
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 population adjusted dose (aPAD) and chronic population adjusted
dose (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 51% of the cPAD for
children 1 to 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).
There are potential short-term exposures from the pending
residential uses for hexythiazox. 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 14,000 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.
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
There are potential intermediate-term exposures from the pending
residential uses for hexythiazox. 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 14,000 for adults and 2,100 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 are 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.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (high performance liquid
chromatography method with ultra violet 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:
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.
Codex MRLs are established for residues of hexythiazox on ``edible
offal (mammalian)'' and ``poultry, edible offal'' at 0.05 ppm. A Codex
MRL is established for tomatoes at 0.1 ppm. No other Codex, Canadian or
Mexican MRLs are established for the commodities that are the subject
of these petitions. Codex and U.S.
tolerance expressions are harmonized at this time. Since the maximum
residue seen in the U.S. green house tomato data is 0.34 ppm,
harmonizing with the Codex MRL of 0.1 ppm at this time is not possible
as over tolerance residues in the U.S. could result if the Codex MRL
C. Revisions to Petitioned-For Tolerances
Based on EPA's review, Gowan Company revised their petition (PP
0F7773) by increasing the proposed tolerance for corn, field, stover to
7.0 ppm; by requesting an increase in the established tolerances for
cattle, meat byproducts; goat, meat byproducts; hog, meat byproducts;
horse, meat byproducts; and sheep, meat byproducts to 0.5 ppm; and by
requesting a decrease in the established tolerance for corn, field,
forage to 3.0 ppm. The Agency concluded that based on the residue data,
these changes are required to support the amended and new uses. The
decrease in the field corn forage tolerance and the increase in the
stover tolerance were recommended by the Agency as a result of
analyzing the submitted field trial data for these commodities using
the OECD MRL (Maximum Residue Limit) calculator. The increase in the
meat byproduct tolerances is driven by the anticipated increase in
residues in field corn animal feed items as a result of the revised use
pattern for hexythiazox on field corn and was set numerically to be
harmonized with the current Codex MRL for meat byproducts.
EPA is also removing expired Section 18 tolerances for corn, field,
forage; corn, field, grain; and corn, field, stover.
Therefore, tolerances are established for residues of hexythiazox,
including its metabolites containing the (4-chlorophenyl)-4-methyl-2-
oxo-3-thiazolidine moiety, as requested in the revised petitions.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to petitions 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 tolerances 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
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
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: November 23, 2011.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Amend Sec. 180.448 as follows:
i. In the table to paragraph (a), revise the entries for ``cattle, meat
byproducts;'' ``goat, meat by products;'' ``hog, meat byproducts;''
``horse, meat byproducts;'' and ``sheep, meat byproducts.''
ii. In the table to paragraph (a), add entries for ``corn, field,
forage;'' ``corn, field, grain;'' ``corn, field, stover;'' ``grain,
aspirated fractions;'' and ``tomato.''
iii. In the table to paragraph (b), remove the entries for ``corn,
field, forage;'' ``corn, field, grain;'' and ``corn, field, stover.''
The added and revised text reads as follows:
Sec. 180.448 Hexythiazox; tolerances for residues.
(a) * * *
* * * * *
Cattle, meat byproducts................................... 0.05
* * * * *
Corn, field, forage....................................... 3.0
Corn, field, grain........................................ 0.02
Corn, field, stover....................................... 7.0
* * * * *
Goat, meat byproducts..................................... 0.05
Grain, aspirated fractions................................ 0.50
* * * * *
Hog, meat byproducts...................................... 0.05
* * * * *
Horse, meat byproducts.................................... 0.05
* * * * *
Sheep, meat byproducts.................................... 0.05
* * * * *
* * * * *
[FR Doc. 2011-32086 Filed 12-13-11; 8:45 am]
BILLING CODE 6560-50-P