
[Federal Register Volume 74, Number 120 (Wednesday, June 24, 2009)]
[Rules and Regulations]
[Pages 29958-29963]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-14869]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0386; FRL-8421-2]


Triallate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
triallate and its metabolite TCPSA in or on bermudagrass, hay under 40 
CFR 180.314(a). Gowan Company requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective June 24, 2009. Objections and 
requests for hearings must be received on or before August 24, 2009, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2008-0386. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Vickie Walters, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5704; e-mail address: walters.vickie@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

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producer, food manufacturer, or pesticide manufacturer. Potentially 
affected entities may include, but are not limited to those engaged in 
the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of EPA's tolerance regulations 
at 40 CFR part 180 through the Government Printing Office's e-CFR cite 
at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2008-0386 in the subject line on the first 
page of your submission. All requests must be in writing, and must be 
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 
on or before August 24, 2009.
    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 that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2008-0386 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. Petition for Tolerance

    In the Federal Register of June 13, 2008 (73 FR 33817) (FRL-8367-
3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
8F7334) by the Gowan Company, 370 South Main St., Yuma, AZ 85364. The 
petition requested that 40 CFR 180.314 be amended by establishing 
tolerances for residues of the herbicide triallate, (S-2,3,4-
trichloroallyl diisopropylthiocarbamate), in or on Bermudagrass hay at 
0.2 parts per million (ppm). That notice referenced a summary of the 
petition prepared by Gowan Company, the registrant, which is available 
to the public in the docket, http://www.regulations.gov. There were no 
comments received in response to the notice of filing.
    The Gowan Company has requested an amendment to a Section 3 
registration under the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) to register a new use on Bermuda grass for grass grown for 
seed or hay. The petitioner has requested a tolerance for Bermuda 
grass, hay to support registration of the new use. This petition was 
filed in conjunction with Gowan's requested amendment to its FIFRA 
registration.
    Based upon review of the data supporting the petition, EPA has 
determined that the correct commodity name and numerical value for the 
tolerance proposed in this petition is Bermudagrass, hay at 0.3 ppm. 
EPA has also assigned the proposed tolerance in this petition to 
paragraph 40 CFR 180.314(a), is correcting the tolerance expression to 
read: ``Tolerances are established for residues of the herbicide (S-
2,3,4-trichloroallyl diisopropylthiocarbamate) and its metabolite 
2,3,3-trichloroprop-2-enesulfonic acid (TCPSA) in or on the following 
food commodity Bermudagrass, hay at 0.3 ppm.'' The reasons for these 
changes are explained in Unit IV.D.

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 the petitioned-for 
tolerances for residues of triallate and its metabolite TCPSA in/on 
bermudagrass, hay at 0.3 ppm. EPA's assessment of exposures and risks 
associated with establishing tolerances 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.
    Triallate has a low order of acute toxicity via oral, dermal, and 
inhalation routes. Triallate is neurotoxic in rats

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based on the acute neurotoxicity study, the subchronic neurotoxicity 
study, the rat multi-generation reproduction study, and the 
developmental neurotoxicity study. In subchronic studies in rats, the 
major target organ appears to be the kidney. Following chronic 
exposure, systemic toxicity in dogs is limited to an increase in liver 
weight in both sexes, increases in serum alkaline phosphatase in both 
sexes, and increases in hemosiderm in the spleen. Toxicity in mice 
included increased absolute liver weight, increased incidence of 
altered foci of the liver and hematopoiesis in the spleen. In rats, 
systemic toxicity was manifested as decreased survival in both sexes, 
decreased body weight and increased adrenal weight in males. In high 
dose males from the chronic toxicity/carcinogenicity study, the only 
treatment-related finding at interim sacrifice was linear papillary 
mineralization. The only treatment-related effect noted in male Syrian 
hamsters was decreased serum triglycerides.
    There was no increased susceptibility to the offspring of rats 
following in utero exposure in the prenatal developmental toxicity 
study in rats, the 2-generation reproduction study in rats, or the 
developmental neurotoxicity study in rats. However, there is evidence 
of increased susceptibility in the prenatal developmental toxicity 
study in rabbits. Triallate has been classified as a possible human 
carcinogen based on hepatocelluar carcinomas in male mice, with a 
positive trend and borderline significance in female mice and increased 
incidence of renal tubular cell adenomas in rats. A linear low-dose 
approach is used to quantify cancer risk to humans. The existing 
toxicological data for triallate do not show any significant effects on 
immunological organs or functions.
    The Agency has determined that only triallate and its metabolite 
TCPSA should be regulated and assessed for dietary exposure in plant 
commodities. The Agency decided to regulate on the TCPSA metabolite 
because it is present at more than 10% of the total radioactive residue 
(TRR) in the plant metabolism studies, and in the absence of 
toxicological data for this metabolite, the same toxicity as the parent 
compound, triallate is assumed.
    Specific information on the studies received and the nature of the 
adverse effects caused by triallate and its metabolite TCPSA 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 Triallate: Risk Assessment for 
Proposed New Use of Triallate as Pre-Emergence Herbicide for Bermuda 
grass, Case # 824883, pages 32-42 in docket ID number EPA-HQ-OPP-2008-
0386 identified as document EPA-HQ-OPP-2008-0386-0003.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the Level of Concern (LOC).
    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 
greater than that 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 triallate and TCPSA 
used for human risk assessment can be found at http://www.regulations.gov in document Triallate: Risk Assessment for Proposed 
New Use of Triallate as Pre-Emergence Herbicide for Bermuda grass, Case 
# 824883, pages 32-42 in docket ID number EPA-HQ-OPP-2008-0386 
identified as document EPA-HQ-OPP-2008-0386-0003.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to triallate and its metabolite TCPSA, EPA considered exposure 
under the petitioned-for tolerances as well as all existing triallate 
tolerances in 40 CFR 180.314. EPA assessed dietary exposures from 
triallate and TCPSA 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.
    In estimating acute dietary exposure, EPA used food consumption 
information from the United States Department of Agriculture (USDA) 
insert 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake 
by Individuals (CSFII). As to residue levels in food, EPA used field 
trial data, empirical processing factors and 100 percent crop treated 
(PCT) for all commodities. Anticipated residues (AR) were used. All 
commodities with the exception of succulent peas were blended 
commodities; therefore, average field trial values were used for these 
commodities. The acute AR for succulent peas is the highest field trial 
residue. PCT data were not used.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA insert 
1994-1996 and 1998 CSFII. As to residue levels in food, EPA used field 
trial data, empirical processing factors and 100 PCT for all 
commodities. AR were used. All commodities with the exception of 
succulent peas were blended commodities; therefore, average field trial 
values were used for these commodities. The chronic AR for succulent 
peas is the average field trial residue. PCT data were not used.
    iii. Cancer. To assess cancer risk, EPA used the same assessment as 
for chronic exposure.
    iv. Anticipated residue information. Section 08(b)(2)(E) of FFDCA 
authorizes EPA to use available data and information on the anticipated 
residue levels of pesticide residues in food and the actual levels of 
pesticide residues that have been measured in food. If EPA relies on 
such information, EPA must require pursuant to FFDCA section 408(f)(1) 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the

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levels anticipated. For the present action, EPA will issue such data 
call-ins as are required by FFDCA section 408(b)(2)(E) and authorized 
under FFDCA section 408(f)(1). Data will be required to be submitted no 
later than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for triallate and TCPSA in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of triallate and TCSPA. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model /Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
triallate and TCPSA for acute exposures are estimated to be 9.45 parts 
per billion (ppb) for surface water and 0.21 ppb for ground water.
    The estimated EDWCs of triallate and TCPSA for chronic exposures 
for non-cancer assessments are estimated to be 1.26 ppb for surface 
water and 0.21 ppb for ground water.
     The estimated EDWCs of triallate and TCPSA for chronic exposures 
for cancer assessments are estimated to be 1.26 ppb for surface water 
and 0.21 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
     For acute dietary risk assessment, the water concentration value 
of 9.45 ppb was used to assess the contribution to drinking water.
     For chronic dietary risk assessment, the water concentration of 
value 1.26 ppb was used to assess the contribution to drinking water.
    For cancer dietary risk assessment, the water concentration of 
value 1.26 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).
    Triallate and its metabolite TCPSA are not registered for any 
specific use patterns that would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA found in 2001 that although studies suggest that the 
thiocarbamate pesticides (including triallate) share a common metabolic 
profile and a common toxic effect (neuropathology of the sciatic 
nerve), insufficient information exists to establish a common mechanism 
of toxicity for this effect. For the purposes of this tolerance action, 
therefore, EPA has assumed that triallate does not have a common 
mechanism of toxicity with other substances. For more information 
regarding the common mechanism determination for triallate and the 
other thiocarbamate pesticides see http://www.epa.gov/oppsrrd/cumulative/thiocarbamate.pdf.

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. A Degree of Concern analysis 
was performed for triallate and TCPSA because the rabbit developmental 
study provided evidence of increased susceptibility in the fetus. The 
purpose of the Degree of Concern analysis was:
     i. To determine the level of concern for the effects observed when 
considered in the context of all available toxicity data; and
     ii. Identify any residual uncertainties after establishing 
toxicity endpoints and traditional uncertainty factors to be used in 
the risk assessment.
    In the case of triallate and TCPSA, there was no increased 
susceptibility to the offspring of rats following in utero exposure in 
the prenatal developmental toxicity study in rats, in the 2-generation 
reproduction study in rats, or in the developmental neurotoxicity study 
in rats. However there was evidence of increased susceptibility in the 
prenatal developmental toxicity study in rabbits. Fetal effects include 
decreased body weight and increased skeletal variations at 15 mg/kg/
day. However, the rabbit developmental study identified a NOAEL of 5 
mg/kg/day for fetal effects, and this NOAEL was selected as the point 
of departure for the acute dietary risk assessment. The point of 
departure for chronic dietary exposure (2.5 mg/kg/day) is lower than 
the NOAEL for fetal effects (observed at 15 mg/kg/day) and is 
protective of this endpoint, thus there are no residual concerns.
    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 triallate and its metabolite is 
adequate for addressing the sensitivity of infant and children to 
triallate exposure. The toxicity database for triallate is complete 
with the exception of an immunotoxicity study. The existing subchronic 
and chronic studies did not indicate that the immune system will be 
affected by triallate based on hematology, lymphoid organ weights, and 
histopathology measurements. The effects seen in the chronic study in 
dogs and the chronic toxicity study in mice in the spleen are related 
to hematology, but not related to immunotoxicity--they're just 
manifested in the spleen as well as in other organs. They do not 
increase concern for immunotoxicity in any way. Thus, the residual 
concerns for immunotoxicity are low.
    ii. No quantitative or qualitative increased susceptibility was 
demonstrated in the fetuses in the prenatal developmental study in rats 
following in utero exposure, in the offspring in the developmental 
neurotoxicity study in rats, as well as in the offspring in the 2-
generational reproduction study in rats following in utero and/or 
postnatal exposure to triallate.
    iii. Although there was some increased susceptibility in the rabbit 
developmental toxicity study (where the developmental NOAEL of 5 mg/kg/
day was lower than the maternal NOAEL of 15 mg/kg/day), the dose 
response for this effect has been adequately characterized (see 
discussion in Unit III.D.2) and the fetal NOAEL was selected as a point 
of departure for the acute dietary risk assessment. The point

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of departure for the chronic dietary assessment (2.5 mg/kg/day) is 
lower than the NOAEL for fetal effects (observed at 15 mg/kg/day). 
Thus, these assessments are protective of potential adverse effects.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT, and reliable data from field trial studies and food 
processing studies. EPA made conservative (protective) assumptions in 
the ground and surface water modeling used to assess exposure to 
triallate and TCPSA in drinking water. There are no residential uses 
for triallate, therefore no residential exposure is expected from the 
use of triallate. These assessments will not underestimate the exposure 
and risks posed by triallate and its metabolite TCPSA.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. Using the exposure assumptions discussed in this unit 
for acute exposure, the acute dietary exposure from food and water to 
triallate and TCPSA will occupy <1% of the aPAD for (all infants <1 
year old), the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
triallate and TCPSA from food and water will utilize <1% of the cPAD 
for (all infants <1 year old) the population group receiving the 
greatest exposure. There are no residential uses for triallate and 
TCPSA.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus average exposure to food 
and water (considered to be a background exposure level).
    Triallate and its metabolite TCPSA are not registered for any use 
patterns that would result in residential exposure. Therefore, the 
short-term aggregate risk is the sum of the risk from exposure to 
triallate and TCPSA through food and water and will not be greater than 
the chronic aggregate risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus average 
exposure to food and water (considered to be a background exposure 
level).
    Triallate and its metabolite TCPSA are not registered for any use 
patterns that would result in intermediate-term residential exposure. 
Therefore, the intermediate-term aggregate risk is the sum of the risk 
from exposure to triallate and TCPSA through food and water, which has 
already been addressed, and will not be greater than the chronic 
aggregate risk.
    5. Aggregate cancer risk for U.S. population. Using the exposure 
assumptions described in this unit for cancer exposure, EPA has 
determined that the estimated dietary exposure for the general U.S. 
population corresponded to a cancer risk of 3 X 10-\7\ for 
food and drinking water, which is less than the range of 1 in 1 million 
(1 X 10-\6\), the EPA level 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 residues of triallate and its metabolite TCPSA.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Two analytical methods are available for enforcement of tolerances. 
They include the current PAM VOL. II method (gas chromatography with 
electron capture detection (GC/ECD) designated as method A and another 
GC/ECD method (designated as Method RES-099-96, Version 2) which may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.

B. International Residue Limits

    There are no Canadian, Mexican or Codex MRLs established for 
triallate and its metabolite TCPSA for Bermudagrass, hay, the tolerance 
established by this rule. Therefore, there are no issues regarding 
compatibility with respect to the tolerance established for 
bermudagrass, hay in this rule.

C. Revisions to Petitioned-For Tolerances

    Based on residue trial data submitted to the Agency, EPA determined 
that the proposed tolerance of 0.2 ppm for Bermudagrass, hay was to 
low. The residue trail data support the establishment of a tolerance of 
0.3 ppm on Bermudagrass, hay expressed in the terms of triallate and 
its metabolite TCPSA.

V. Conclusion

    Therefore, tolerances are established for residues of triallate, S-
2,3,4-trichloroallyl diisopropylthiocarbamate and its metabolite 2,3,3-
trichloroprop-2-enesulfonic acid (TCPSA), in or on the following food 
commodity: Bermudagrass, hay at 0.3 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power

[[Page 29963]]

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) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: June 12, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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. Paragraph (a) of Sec. 180.314 is revised to read as follows:


Sec. 180.314  Triallate; tolerances for residues.

    (a) General. Tolerances are established for residues of triallate, 
S-2,3,4-trichloroallyl diisopropylthiocarbamate and its metabolite 
2,3,3-trichloroprop-2-enesulfonic acid (TCPSA) in or on the following 
food commodity:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Bermudagrass, hay....................................                0.3
------------------------------------------------------------------------

* * * * *
[FR Doc. E9-14869 Filed 6-23-09; 8:45 am]
BILLING CODE 6560-50-S


