[Federal Register Volume 74, Number 242 (Friday, December 18, 2009)]
[Rules and Regulations]
[Pages 67114-67118]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-30194]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0276; FRL-8800-8]


Prosulfuron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
prosulfuron and its metabolites and degradates in or on cereal grain 
commodities. Syngenta Crop Protection, Inc. 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-2008-0276. 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: [email protected].

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 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 cite at http://www.gpoaccess.gov/ecfr. To 
access the OPPTS harmonized test guidelines referenced in this document 
electronically, please go to 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-2008-0276 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-2008-0276, 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. Petition for Tolerance

    In the Federal Register of August 13, 2008 (73 FR 47186) (FRL-8375-
8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a

[[Page 67115]]

pesticide petition (PP 5F4469) by Syngenta Crop Protection, Inc., PO 
Box 18300, Greensboro, NC 27419. The petition requested that 40 CFR 
180.481 be amended by establishing tolerances for residues of the 
herbicide prosulfuron, 1-(4-methoxy-6-methyl-triazin-2-yl)-3-[2-(3,3,3-
trifluoropropyl)-phenylsulfonyl]-urea, in or on field and popcorn 
grain, fodder, and forage at 0.01 parts per million (ppm); cereal 
grains group (except rice and wild rice), fodder at 0.01 ppm; forage at 
0.10 ppm; grain at 0.01 ppm; hay at 0.20 ppm; straw at 0.02 ppm; 
cattle, goat, hog, horse, sheep fat, kidney, liver, meat, and meat 
byproducts at 0.05 ppm; and milk at 0.01 ppm. That notice referenced a 
summary of the petition prepared by Syngenta Crop Protection, 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 petition, EPA has 
determined that corn and livestock commodity tolerances proposed in the 
petition are not required. EPA has also revised the cereal grain 
commodity terms and the tolerance expression for prosulfuron. 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 prosulfuron and its metabolites and 
degradates on grain, cereal, forage, fodder, and straw, group 16, 
except rice, fodder at 0.01 ppm; grain, cereal, forage, fodder, and 
straw, group 16, except rice, forage at 0.10 ppm; grain, cereal, 
forage, fodder, and straw, group 16, except rice, hay at 0.20 ppm; 
grain, cereal, forage, fodder, and straw, group 16, except rice, straw 
at 0.02 ppm; and grain, cereal, group 15, except rice 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.
    Toxicology studies indicate that prosulfuron has minimal toxicity 
under acute exposure conditions and that it is not a skin or eye 
irritant or dermal sensitizer. In chronic and subchronic studies with 
prosulfuron, some treatment-related effects were observed, most 
commonly effects on body weight. Evidence of neurotoxicity was also 
observed in gavage studies. Effects consistent with neurotoxicity 
(primarily gait and sensorimotor effects) were observed in rabbits in 
the developmental toxicity range-finding study and in rats in the acute 
neurotoxicity screening study. However, neurotoxic effects were not 
observed following oral exposure to prosulfuron, and there was no 
evidence from the developmental and reproductive studies of increased 
susceptibility to these effects in rat or rabbit fetuses or offspring.
    Previously, EPA classified prosulfuron as a Group D Chemical (``Not 
Classifiable as to Human Carcinogenicity''), a classification 
consistent with the cancer guidelines in effect at the time (1995). 
This classification was based on the lack of evidence of 
carcinogenicity in male or female mice at the limit dose and equivocal 
evidence of carcinogenicity in female rats. In female rats, there was 
suggestive evidence of a possible treatment-related increase in the 
incidence of adenocarcinomas of the mammary glands at the mid dose but 
not at the high dose. This lack of dose-response (i.e. the relatively 
limited response in the high dose group and a more pronounced response 
in the middle-dose group) along with the lack of evidence of 
carcinogenicity in mice and the lack of evidence for in vivo or in 
vitro mutagenicity lowered the concern for the carcinogenic potential 
of prosulfuron. EPA has reviewed this evidence under the current 2005 
guidelines for Carcinogen Risk Assessment and concluded that 
Prosulfuron should be classified as ``Not Likely to Be Carcinogenic to 
Humans.''
    Specific information on the studies received and the nature of the 
adverse effects caused by prosulfuron 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 the document titled ``Prosulfuron. Revised Human 
Health Risk Assessment for the Proposed Establishment of Permanent 
Tolerances for Uses in/on Cereal Grains (Crop Group 15), Except Rice'', 
page 33 in docket ID number EPA-HQ-OPP-2008-0276.

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).

[[Page 67116]]

    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 prosulfuron used for 
human risk assessment can be found at http://www.regulations.gov in the 
document titled ``Prosulfuron. Revised Human Health Risk Assessment for 
the Proposed Establishment of Permanent Tolerances for Uses in/on 
Cereal Grains (Crop Group 15), Except Rice'', page 17 in docket ID 
number EPA-HQ-OPP-2008-0276.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to prosulfuron, EPA considered exposure under the petitioned-
for tolerances. There are no other tolerances currently in effect for 
prosulfuron. Temporary tolerances on cereal grains and livestock 
commodities expired on December 31, 1999. EPA is establishing permanent 
tolerances on cereal grain commodities in this action but has 
determined that livestock tolerances are unnecessary, since there is no 
expectation of finite residues in livestock commodities from 
prosulfuron's use on cereal grains. EPA assessed dietary exposures from 
prosulfuron 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 U. S. Department of Agriculture (USDA) 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII). As to residue levels in food, EPA assumed that residues are 
present in cereal grains at the tolerance level and that 100% of cereal 
grains are treated with prosulfuron.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA assumed that residues 
are present in cereal grains at the tolerance level and that 100% of 
cereal grains are treated with prosulfuron.
    iii. Cancer. Based on the results of carcinogenicity studies in 
rats and mice, EPA does not expect prosulfuron to pose a cancer risk. 
Therefore, an exposure assessment to evaluate cancer risk is 
unnecessary for this chemical.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue or PCT information in the dietary 
assessment for prosulfuron. Tolerance level residues and 100% CT 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 prosulfuron in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of prosulfuron. 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 
prosulfuron for acute exposures are estimated to be 1.872 parts per 
billion (ppb) for surface water and 0.655 ppb for ground water. The 
EDWCs for chronic exposures for non-cancer assessments are estimated to 
be 0.583 ppb for surface water and 0.655 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 1.872 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 0.655 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). Prosulfuron 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 prosulfuron to share a common mechanism of 
toxicity with any other substances, and prosulfuron does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
prosulfuron 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 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 prosulfuron includes a developmental toxicity 
study in the rat, two developmental toxicity studies and a range-
finding developmental study in the rabbit, and a 2-generation 
reproduction toxicity study in the rat. There was no evidence of 
increased susceptibility of fetuses or offspring in any of these 
studies.
    There were no maternal or fetal effects observed at any dose in the 
first of two rabbit developmental toxicity studies. In the second 
rabbit study and in the rat developmental toxicity study, a dose-
related increase in small fetuses and skeletal effects was observed, 
but only in the presence of maternal toxicity (decreased body weight 
gain in the rat study; and increases in abortions, decreases in food 
consumption and decreased mean body weight gain in the rabbit study).
    In the developmental range-finding study in rabbits, maternal 
effects consistent with neurotoxicity (hypoactivity, muscle weakness 
and

[[Page 67117]]

incoordination of limbs/ataxia) were observed at all doses tested. 
Sciatic nerve degeneration and white matter degeneration of the spinal 
cord were also observed at higher dose levels. There was no evidence of 
neurotoxicity to fetuses or offspring observed in any of the 
developmental or reproduction toxicity 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 prosulfuron is adequate to assess 
prenatal and postnatal toxicity. In accordance with part 158 Toxicology 
Data requirements, an immunotoxicity study (870.7800) is required for 
prosulfuron. In the absence of specific immunotoxicity studies, EPA has 
examined the available prosulfuron toxicity data for evidence of 
immunotoxic effects. No evidence of immunotoxicity was found. Due to 
the lack of evidence of immunotoxicity for prosulfuron in available 
studies, EPA does not believe that conducting immunotoxicity testing 
will result in a NOAEL less than the chronic NOAEL of 5.3 milligrams/
kilograms (mg/kg) bodyweight/day (bw/day) already established for 
prosulfuron, and an additional database uncertainty factor is not 
needed to account for the lack of this study.
    ii. Although there was evidence of neurotoxicity following gavage 
exposure to prosulfuron in the rat (ataxia, decreased motor activity, 
decreased body temperature, impaired gait and righting reflex) and in 
the pregnant rabbit (ataxia, hypoactivity, neuropathology), there is 
low concern for these effects. The findings were observed only at high 
doses (at or above 250 mg/kg/day) following gavage dosing and were not 
observed following dietary exposure to levels up to 628 mg/kg/day. For 
example, the acute neurotoxicity study in rats involved gavage dosing 
and showed neurotoxic effects at 250 mg/kg/day but the subchronic 
neurotoxicity study in rats which did not involve gavage dosing did not 
show neurotoxic effects at the highest dose tested (628/313 male/female 
(M/F) mg/kg/day). The neurotoxicity findings in the pregnant rabbit 
were observed at a dose causing death, abortions and systemic toxicity, 
and the neuropathology did not show a dose-response. Furthermore, there 
was no evidence for neurotoxicity in offspring in the developmental 
studies or in the rat reproduction study, and increased prenatal and/or 
postnatal susceptibility was not observed. Based on these 
considerations, EPA has concluded that a developmental neurotoxicity 
(DNT) study is not required for prosulfuron and an additional 
uncertainty factor is not needed to account for potential 
neurotoxicity.
    iii. There is no evidence that prosulfuron results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground water and surface water modeling 
used to assess exposure to prosulfuron in drinking water. Prosulfuron 
is not registered for residential uses. These assessments will not 
underestimate the exposure and risks posed by prosulfuron.

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 MOE 
called for by the product of all applicable UFs is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to prosulfuron will occupy less than 1% of the aPAD for the general 
population and all population subgroups, including infants and 
children's subgroups.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
prosulfuron from food and water will utilize less than 1% of the aPAD 
for the general population and all population subgroups, including 
infants and children's subgroups. There are no residential uses for 
prosulfuron.
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure take into account short-term or 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Prosulfuron 
is not registered for any use patterns that would result in residential 
exposure. Therefore, the short-term or intermediate-term aggregate risk 
is the sum of the risk from exposure to prosulfuron through food and 
water and will not be greater than the chronic aggregate risk.
    4. Aggregate cancer risk for U.S. population. Based on a lack of 
evidence for carcinogenicity in mice and rats following long-term 
dietary administration, prosulfuron 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 prosulfuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-performance liquid 
chromatography (HPLC)) 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: 
[email protected].

B. International Residue Limits

    No CODEX maximum residue limits have been established for 
prosulfuron.

C. Revisions to Petitioned-For Tolerances

    EPA has determined that the corn and livestock commodity tolerances 
proposed in the petition are not required. Field corn and popcorn are 
members of the Crop Group 15 (cereal grains); therefore, residues on 
corn commodities will be covered by the cereal grains (group 15) 
tolerances. Tolerances are not required for livestock commodities 
because there is no expectation of finite residues in livestock 
commodities from the use of prosulfuron on cereal grains. EPA has also 
revised the cereal grain commodity terms to agree with the Agency's 
Food and Feed Commodity Vocabulary.
    Finally, EPA has revised the prosulfuron tolerance expression 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

[[Page 67118]]

tolerances cover residues of prosulfuron and its metabolites and 
degradates, but that compliance with the tolerance levels will be 
determined by measuring only prosulfuron, 1-(4-methoxy-6-methyl-
triazin-2-yl)-3-[2-(3,3,3-trifluoropropyl)-phenylsulfonyl]-urea, 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 prosulfuron 
and its metabolites and degradates in or on grain, cereal, forage, 
fodder, and straw, group 16, except rice, fodder at 0.01 ppm; grain, 
cereal, forage, fodder, and straw, group 16, except rice, forage at 
0.10 ppm; grain, cereal, forage, fodder, and straw, group 16, except 
rice, hay at 0.20 ppm; grain, cereal, forage, fodder, and straw, group 
16, except rice, straw at 0.02 ppm; and grain, cereal, group 15, except 
rice at 0.01 ppm. Compliance with these tolerances will be determined 
by measuring only prosulfuron, 1-(4-methoxy-6-methyl-triazin-2-yl)-3-
[2-(3,3,3-trifluoropropyl)-phenylsulfonyl]-urea, 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 180.481 is revised to read as follows:


Sec.  180.481  Prosulfuron; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide prosulfuron and its metabolites and degradates in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified in the table below is to be determined by measuring only 
prosulfuron, 1-(4-methoxy-6-methyl-triazin-2-yl)-3-[2-(3,3,3-
trifluoropropyl)-phenylsulfonyl]-urea, in or on the commodity.

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Grain, cereal, forage, fodder, and straw, group 16,                 0.01
 except rice, fodder.................................
Grain, cereal, forage, fodder, and straw, group 16,                 0.10
 except rice, forage.................................
Grain, cereal, forage, fodder, and straw, group 16,                 0.20
 except rice, hay....................................
Grain, cereal, forage, fodder, and straw, group 16,                 0.02
 except rice, straw..................................
Grain, cereal, group 15, except rice.................               0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registration. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. E9-30194 Filed 12-17-09; 8:45 am]
BILLING CODE 6560-50-S