Document ID: EPA-HQ-OPP-2009-0005-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Tribenuron Methyl
Posted Date: 2009-12-18T05:00Z

[Federal Register: December 18, 2009 (Volume 74, Number 242)]
[Rules and Regulations]               
[Page 67124-67129]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18de09-15]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0005; FRL-8797-9]

 
Tribenuron methyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
tribenuron methyl and its metabolites and degradates in or on grain, 
aspirated fractions; soybean, forage; soybean, hay; and soybean, hulls; 
and revises existing tolerances for residues for tribenuron methyl and 
its metabolites and degradates in or on corn, field, forage; corn, 
field, grain; corn, field, stover; and soybean, seed. E.I. du Pont de 
Nemours and Company requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 18, 2009. Objections and 
requests for hearings must be received on or before February 16, 2010, 
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-2009-0005. 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: Susan Stanton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5218; e-mail address: stanton.susan@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. 
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. To access the OPPTS Harmonized Test 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/oppts and select ``Test Methods & Guidelines'' on 
the left side navigation menu.

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-2009-0005 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 February 16, 2010.
    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-2009-0005, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.

[[Page 67125]]

     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 April 8, 2009 (74 FR 15971) (FRL-8407-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
8F7432 and PP 8F7441) by E.I. du Pont de Nemours and Company, Laurel 
Run Plaza, P.O. Box 80038, Wilmington, DE 19880-0038. The petitions 
requested that 40 CFR 180.451 be amended by establishing tolerances for 
residues of the herbicide tribenuron methyl, methyl-2-[[[[N-(4-methoxy-
6-methyl-1,3,5-triazin-2-yl) methylamino] carbonyl] amino] sulfonyl] 
benzoate, (in PP 8F7441) in or on corn, field, grain at 0.01 parts per 
million (ppm); corn, field, forage at 0.2 ppm; corn, field, stover at 
1.1 ppm; and corn, aspirated grain fractions at 3.55 ppm; and (in PP 
8F7432) in or on soybean, seed at 0.01 ppm; soybean, forage at 0.06 
ppm; soybean, hulls at 0.04 ppm; soybean, aspirated grain fractions at 
3.46 ppm; and soybean, hay at 0.25 ppm. That notice referenced a 
summary of the petitions prepared by E.I. du Pont de Nemours and 
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.
    Based upon review of the data supporting the petitions, EPA has 
increased the proposed tolerances on soybean hay and forage, decreased 
the proposed tolerance on field corn forage, and determined that a 
tolerance should be established for ``grain, aspirated fractions'', in 
lieu of the proposed tolerances on ``soybean, aspirated grain 
fractions'' and ``corn, field, aspirated grain fractions.'' EPA has 
also revised the tribenuron methyl tolerance expression for all 
existing and new tolerances. 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 the petitioned-for 
tolerances for residues of tribenuron methyl and its metabolites and 
degradates on corn, field, forage at 0.15 ppm; corn, field, grain at 
0.01 ppm; corn, field, stover at 1.1 ppm; grain, aspirated fractions at 
1.5 ppm; soybean, forage at 0.07 ppm; soybean, hay at 0.35 ppm; 
soybean, hulls at 0.04 ppm and soybean, seed at 0.01 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.
    Tribenuron methyl has low to moderate acute toxicity via the oral, 
inhalation, and dermal routes of exposure. It is not a dermal irritant, 
but was found to be mildly irritating to the eye and is a skin 
sensitizer.
    Repeated dose oral toxicity studies in rats and dogs resulted 
primarily in decreased body weights and body weight gains accompanied 
by decreased food consumption. There is no evidence that tribenuron 
methyl targets specific organs following repeated oral exposure. There 
is no evidence that tribenuron methyl is neurotoxic. Although increased 
spleen weights were observed in the 90-day oral toxicity study in rats 
and decreased spleen weights were observed in the reproduction study 
(both potential indications of immunotoxicity), these effects occurred 
in the absence of other potential indicators of immunotoxicity.
    EPA has classified tribenuron methyl as a Group C (possible human) 
carcinogen, based on statistically significant increases in mammary 
gland adenocarcinomas in female rats at the highest dose tested (HDT) 
(76 milligram/kilogram/day (mg/kg/day)). There was no evidence of 
carcinogenicity observed in the mouse carcinogenicity study. 
Quantitative cancer risk assessment is not recommended for tribenuron 
methyl because the tumors observed in rats occurred at a dose resulting 
in excessive toxicity (i.e., greater than the maximum tolerated dose), 
there was no evidence of genotoxicity, and structurally similar 
compounds are not known to be carcinogenic in rats and mice. The no 
observed adverse effect level (NOAEL) (0.8 mg/kg/day) selected for 
chronic risk assessment is considered to be protective of any potential 
cancer risk.
    Developmental and reproductive toxicity studies indicated no 
increased susceptibility of offspring to tribenuron methyl. At the 
lowest observed adverse effect level (LOAEL) of 125 mg/kg/day in the 
developmental study in rats, decreased fetal weights were observed in 
the presence of decreased maternal body weights. At the HDT (500 mg/kg/
day), increased resorptions, fetal deaths, and incomplete ossifications 
were observed, but these effects may be secondary to maternal toxicity. 
In the developmental rabbit study, maternal toxicity consisted of 
decreased food consumption and abortions at the HDT. At this same dose 
there was a 10% decrease in fetal body weights (not statistically 
significant). Since the number of dead fetuses and resorptions per 
litter were not correlated with the dosing level, the increased 
incidence of abortions in the high dose group is likely due to maternal 
toxicity. In a two-generation reproduction study, reproductive effects 
of tribenuron methyl were limited to decreased body weight gain during 
lactation. There was no evidence of increased susceptibility, as 
parental, offspring and reproduction

[[Page 67126]]

NOAELs and LOAELs were established at similar levels.
    Specific information on the studies received and the nature of the 
adverse effects caused by tribenuron methyl as well as the NOAEL and 
the LOAEL from the toxicity studies can be found at http://
www.regulations.gov in the document ``Tribenuron methyl. Human Health 
Risk Assessment for the Proposed Use of Tribenuron methyl on Corn and 
Soybean,'' page 33 in docket ID number EPA-HQ-OPP-2009-0005.

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-term, 
intermediate-term, 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 tribenuron methyl used 
for human risk assessment can be found at http://www.regulations.gov in 
the document ``Tribenuron methyl. Human Health Risk Assessment for the 
Proposed Use of Tribenuron methyl on Corn and Soybean,'' page 20 in 
docket ID number EPA-HQ-OPP-2009-0005.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to tribenuron methyl, EPA considered exposure under the 
petitioned-for tolerances as well as all existing tribenuron methyl 
tolerances in 40 CFR 180.451. EPA assessed dietary exposures from 
tribenuron methyl 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 tribenuron methyl; 
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 U.S Department 
of Agriculture (USDA) 1994-1996 and 1998 Continuing Surveys of Food 
Intakes by Individuals (CSFII). As to residue levels in food, EPA 
assumed that residues are present in all commodities at the tolerance 
level and that 100% of commodities are treated with tribenuron methyl. 
DEEMTM 7.81 default concentration factors were used to 
estimate residues of tribenuron methyl in processed commodities.
    iii. Cancer. EPA classified tribenuron methyl as a Group C, 
possible human, carcinogen and determined that the chronic dietary risk 
assessment based on the cPAD would be protective of any potential 
cancer effects. Therefore, a separate exposure assessment to evaluate 
cancer risk is unnecessary. The weight of the evidence supporting this 
determination is discussed in Unit III.A.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue or PCT information in the dietary 
assessment for tribenuron methyl. Tolerance level residues and 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 tribenuron methyl in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of tribenuron methyl. 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 First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
Estimated Drinking Water Concentrations (EDWCs) of tribenuron methyl 
for acute exposures are estimated to be 4.1 parts per billion (ppb) for 
surface water and 6.8 ppb for ground water. For chronic exposures for 
non-cancer assessments EDWCs are estimated to be 2.7 ppb for surface 
water and 6.8 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the only dietary exposure scenario for which a 
toxicological endpoint of concern was identified, the water 
concentration value of 6.8 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). Tribenuron methyl is 
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 has not found tribenuron methyl to share a common mechanism of 
toxicity with any other substances, and tribenuron methyl does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
tribenuron methyl 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 website 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

[[Page 67127]]

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 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 
toxicity database for tribenuron methyl includes guideline rat and 
rabbit developmental toxicity studies and a two-generation reproduction 
toxicity study in rats. As discussed in Unit III.A., there is no 
quantitative or qualitative evidence of increased susceptibility of 
fetuses or offspring in any of these studies.
    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 tribenuron methyl is adequate to 
assess prenatal and postnatal toxicity. In accordance with Part 158 
Toxicology Data requirements, an immunotoxicity study (OPPTS Test 
Guideline 870.7800) and acute and subchronic neurotoxicity studies 
(OPPTS Test Guideline 870.6200) are required for tribenuron methyl. In 
the absence of specific immunotoxicity and neurotoxicity studies, EPA 
has evaluated the available tribenuron methyl toxicity data to 
determine whether an additional database uncertainty factor is needed 
to account for the lack of these studies.
    a. Immunotoxicity: Increased spleen weights were observed in the 
90-day oral toxicity study in rats at 118/135 (Male/Female) mg/kg/day, 
and decreased absolute spleen weights were observed in the offspring in 
the reproduction study at 250 mg/kg/day. These effects occurred in the 
absence of other potential indicators of immunotoxicity, including 
histopathology and alterations in hematology, and there were no 
accompanying effects on thymus weights. Finally, the dose selected for 
chronic risk assessment (cPAD of 0.008 mg/kg/day from the chronic dog 
toxicity study) is protective of any potential immunotoxicity (i.e., 
decreased spleen weights) from exposure to tribenuron methyl. 
Therefore, an additional UF is not needed to account for the lack of an 
immunotoxicity study.
    b. Neurotoxicity: No evidence of neurotoxicity or neuropathology 
was observed in any of the toxicology studies for tribenuron methyl. 
Therefore, EPA has concluded that there is no need for a developmental 
neurotoxicity study or additional UFs to account for the lack of 
specific acute/subchronic neurotoxicity studies.
    ii. There is no evidence that tribenuron methyl results in 
increased susceptibility in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iii. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed 
assuming 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground water and surface water modeling 
used to assess exposure to tribenuron methyl in drinking water. 
Residential exposure to tribenuron methyl is not expected. These 
assessments will not underestimate the exposure and risks posed by 
tribenuron methyl.

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-term, intermediate-term, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
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.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute 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, 
tribenuron methyl 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 
tribenuron methyl from food and water will utilize less than 4% of the 
cPAD for the general U.S. population and less than 8% of the cPAD for 
infants less than 1 year old, the population group receiving the 
greatest exposure. There are no residential uses for tribenuron methyl.
    3. Short-term/intermediate-term risk. Short-term/intermediate term 
aggregate exposure takes into account short-term/intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Tribenuron methyl is 
not registered for any use patterns that would result in residential 
exposure. Therefore, the short-term/intermediate-term aggregate risk is 
the sum of the risk from exposure to tribenuron methyl through food and 
water and will not be greater than the chronic aggregate risk.
    4. Aggregate cancer risk for U.S. population. As explained in Unit 
III.A. risk assessments based on the endpoint selected for chronic risk 
assessment are considered to be protective of any potential 
carcinogenic risk from exposure to tribenuron methyl. Based on the 
results of the chronic risk assessment discussed above in Unit III.E.2. 
EPA concludes that tribenuron methyl is not expected to pose a cancer 
risk.
    5. 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 tribenuron methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography with tandem 
mass-spectrometric detection (LC/MS/MS) method, DuPont Method 13412 
(Revision 1)) 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; e-mail address: 
residuemethods@epa.gov.

B. International Residue Limits

    There are no CODEX, Canadian or Mexican maximum residue limits 
(MRLs) established on the commodities associated with these petitions.

C. Revisions to Petitioned-For Tolerances

    EPA has increased the proposed tolerance on soybean, hay from 0.25 
ppm to 0.35 ppm; increased the tolerance on soybean, forage from 0.06 
ppm to 0.07 ppm; and decreased the proposed tolerance on corn, field, 
forage from 0.2 ppm to 0.15 ppm. EPA revised these tolerance levels 
based on analyses of the residue field trial data using the

[[Page 67128]]

Agency's Tolerance Spreadsheet in accordance with the Agency's Guidance 
for Setting Pesticide Tolerances Based on Field Trial Data. EPA also 
determined that a single tolerance at 1.5 ppm should be established for 
``grain, aspirated fractions'', in lieu of the separately proposed 
tolerances of 3.46 ppm on ``soybean, aspirated grain fractions'' and 
3.55 ppm on ``corn, field, aspirated grain fractions.'' The tolerance 
on grain, aspirated fractions (AGF) will cover residues on aspirated 
fractions of both corn and soybean. The tolerance level of 1.5 ppm was 
determined based on data for soybean indicating a concentration factor 
of 150x for AGF and the highest average field trial (HAFT) residue for 
of 0.01 ppm. Residues in corn AGF are expected to be lower, based on a 
concentration factor of only 13x and a HAFT of 0.01 ppm.
    Finally, EPA has revised the tribenuron methyl tolerance expression 
for all existing and new commodities to clarify the chemical moieties 
that are covered by the tolerances and specify how compliance with the 
tolerances is to be measured. The revised tolerance expression makes 
clear that the tolerances cover ``residues of tribenuron methyl and its 
metabolites and degradates,'' but that compliance with the tolerance 
levels will be determined by measuring only ``tribenuron methyl, 
methyl-2-[[[[N-(4-methoxy-6-methyl-1,3,5-triazin-2-yl) methylamino] 
carbonyl] amino] sulfonyl] benzoate, in or on the commodities.
    EPA has determined that it is reasonable to make this change final 
without prior proposal and opportunity for comment, because public 
comment is not necessary, in that the change has no substantive effect 
on the tolerance, but rather is merely intended to clarify the existing 
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of tribenuron 
methyl and its metabolites and degradates in or on corn, field, forage 
at 0.15 ppm; corn, field, grain at 0.01 ppm; corn, field, stover at 1.1 
ppm; grain, aspirated fractions at 1.5 ppm; soybean, forage at 0.07 
ppm; soybean, hay at 0.35 ppm; soybean, hulls at 0.04 ppm and soybean, 
seed at 0.01 ppm. Compliance with these tolerances will be determined 
by measuring only tribenuron methyl, methyl-2-[[[[N-(4-methoxy-6-
methyl-1,3,5-triazin-2-yl) methylamino] carbonyl] amino] sulfonyl] 
benzoate, in or on the commodities.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (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: December 8, 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. Section 180.451 is amended by revising the introductory text in 
paragraph (a); revising the existing tolerances in paragraph (a) for 
corn, field, forage; corn, field, grain; corn, field, stover; and 
soybean, seed; and alphabetically adding the commodities grain, 
aspirated fractions; soybean, forage; soybean, hay; and soybean, hulls 
to the table in paragraph (a) to read as follows:

Sec.  180.451   Tribenuron methyl; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide tribenuron methyl and its metabolites and degradates in or on 
the commodities in the following table. Compliance with the tolerance 
levels specified below is to be determined by measuring only tribenuron 
methyl,

[[Page 67129]]

methyl-2-[[[[N-(4-methoxy-6-methyl-1,3,5-triazin-2-yl) methylamino] 
carbonyl] amino] sulfonyl] benzoate, in or on the following 
commodities:

----------------------------------------------------------------------------------------------------------------
                            Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
                                                    * * * * *
 Corn, field, forage                                                                                        0.15
----------------------------------------------------------------------------------------------------------------
 Corn, field, grain                                                                                         0.01
----------------------------------------------------------------------------------------------------------------
Corn, field, stover                                                                                          1.1
----------------------------------------------------------------------------------------------------------------
                                                    * * * * *
Grain, aspirated fractions                                                                                   1.5
----------------------------------------------------------------------------------------------------------------
                                                    * * * * *
Soybean, forage                                                                                             0.07
----------------------------------------------------------------------------------------------------------------
Soybean, hay                                                                                                0.35
----------------------------------------------------------------------------------------------------------------
Soybean, hulls                                                                                              0.04
----------------------------------------------------------------------------------------------------------------
Soybean, seed                                                                                               0.01
                                                    * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. E9-30035 Filed 12-17-09; 8:45 am]

BILLING CODE 6560-50-S