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

[Federal Register: December 18, 2009 (Volume 74, Number 242)]
[Rules and Regulations]               
[Page 67132-67137]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18de09-17]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0004; FRL-8796-9]

 
Rimsulfuron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends tolerances for residues of rimsulfuron 
in or on corn, field, forage and corn, field, stover and establishes 
tolerances in or on grain, aspirated fractions; soybean, forage; 
soybean, hay; soybean, hulls; 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

[[Page 67133]]

identification (ID) number EPA-HQ-OPP-2009-0004. 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: Mindy Ondish, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 605-0723; e-mail address: ondish.mindy@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'' in 
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-2009-0004 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-2009-0004, 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 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 
8F7431 and PP 8F7440) by E.I du Pont de Nemours and Company, Laurel Run 
Plaza, P.O. Box 80038, Wilmington, DE 19880-0038. The petition 
requested that 40 CFR 180.478 be amended by establishing tolerances for 
residues of the herbicide rimsulfuron, N-((4,6-dimethoxypyrimidin-2-
yl)aminocarbonyl)-3-(ethylsulfonyl)-2-pyridinesulfonamide, in or on 
corn, aspirated grain fractions at 1.02 parts per million (ppm); corn, 
field, forage at 0.4 ppm; corn, field grain at 0.01 ppm; and corn, 
field, stover at 2.5 ppm (PP 8F7440); and soybean, aspirated grain 
fractions at 4.51 ppm; soybean, forage at 0.25 ppm; soybean, hay at 1.2 
ppm; soybean, hulls at 0.035 ppm; and soybean, seed at 0.01 ppm (PP 
8F7431). That notice referenced a summary of the petition 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 petition, EPA has 
removed the proposed tolerances for corn, aspirated grain fractions at 
1.02 ppm and soybean, aspirated grain fractions at 4.51 ppm and has 
replaced them with a tolerance on grain, aspirated fractions at 4.5 
ppm. The tolerance level for soybean, hulls was rounded up from 0.035 
ppm to 0.04 ppm. The existing tolerance level for corn, field, grain 
was maintained at 0.1 ppm to remain harmonized with Mexico's maximum 
residue limit (MRL). Finally, EPA has revised the tolerance expression 
for all existing and new rimsulfuron tolerances. 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

[[Page 67134]]

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 rimsulfuron and its metabolites and 
degradates in or on corn, field, forage at 0.4 ppm; corn, field, stover 
at 2.5 ppm; grain, aspirated fractions at 4.5 ppm; soybean, forage at 
0.25 ppm; soybean, hay at 1.2 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.
    Rimsulfuron has low acute toxicity by oral, dermal, and inhalation 
routes of exposure. It is a moderate eye irritant and is not a dermal 
sensitizer. In subchronic and chronic toxicity studies in rats, toxic 
effects included decreased body weight, decreased body weight gain, 
increased relative liver and absolute kidney weights, and diuresis. At 
the higher dosage, decreased liver enzymes and bilirubin, fatty change, 
and hepatocellular hypertrophy were observed. In the chronic rat study, 
decreased body weight gain and increased liver weights were observed. 
At the higher dosage, increased mortality was observed in males. In the 
subchronic study in mice, increased red blood cell (RBC) and 
hemoglobin, and decreased body weight gain and food efficiency were 
observed. In the chronic study in mice, decreased body weight, 
increased incidences of dilation and cysts in the glandular stomach, 
and degeneration of the testicular artery and tunica albuginea were 
observed. In the subchronic study in dogs, diuresis was indicated by 
urinary volume, platelet concentration and kidney weights accompanied 
by decreased urinary osmolality. In the chronic study in dogs, 
increased absolute liver and kidney weights, increased seminiferous 
tubule degeneration, and increased number of spermatid giant cells 
present in epididymides in males were observed. At the higher dosage, 
decreased mean body weight, decreased body weight gain, as well as 
increases in serum cholesterol levels, alkaline phosphatase activity, 
absolute liver, and relative liver and kidney weights were observed.
    In the developmental toxicity study in rats, no toxicity was seen 
at the highest dose tested. In the developmental toxicity study in 
rabbits, and in the 2-generation reproduction toxicity study in rats, 
developmental/offspring toxicity was seen in the presence of maternal/
systemic toxicity and at similar dose levels. There is no quantitative 
or qualitative evidence of increased susceptibility following pre- and/
or postnatal exposures, and there are no concerns or residual 
uncertainties.
    There was no evidence of potential immunotoxicity or neurotoxicity 
in the submitted studies.
    Rimsulfuron was classified by EPA as a ``not likely'' human 
carcinogen based on the lack of evidence of carcinogenicity in studies 
conducted in rats and mice.
    Specific information on the studies received and the nature of the 
adverse effects caused by rimsulfuron 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 ``Rimsulfuron Human Health Risk 
Assessment for Proposed Section 3 Uses on Genetically Modified Field 
Corn and Soybean'' , page 28 in docket ID number EPA-HQ-OPP-2009-0004.

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 rimsulfuron used for 
human risk assessment can be found at http://www.regulations.gov in 
document ``Rimsulfuron Human Health Risk Assessment for Proposed 
Section 3 Uses on Genetically Modified Field Corn and Soybean'' , page 
18 in docket ID number EPA-HQ-OPP-2009-0004.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to rimsulfuron, EPA considered exposure under the petitioned-
for tolerances as well as all existing rimsulfuron tolerances in 40 CFR 
180.478. EPA assessed dietary exposures from rimsulfuron 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 
rimsulfuron;

[[Page 67135]]

therefore, a quantitative acute dietary exposure assessment is 
unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA assumed tolerance-
level residues and 100 percent crop treated (PCT) for all existing and 
new uses of rimsulfuron.
    iii. Cancer. Based on the lack of evidence of carcinogenicity 
observed in the 2-year rat and 18-month mouse carcinogenicity studies, 
EPA classified rimsulfuron as a ``not likely'' human carcinogen. 
Therefore, an exposure assessment for evaluating cancer risk is not 
needed for this chemical.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
rimsulfuron. 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 rimsulfuron in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of rimsulfuron. 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 rimsulfuron for 
acute exposures are estimated to be 5.596 parts per billion (ppb) for 
surface water and 0.016 ppb for ground water; and for chronic exposures 
are estimated to be 0.120 ppb for surface water and 0.016 ppb for 
ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 0.120 ppb was used to 
assess the contribution to drinking water. The surface water value was 
used in the chronic dietary assessment since it was higher than the 
groundwater value and, therefore, more protective. The acute surface 
water value is not relevant to this dietary assessment, as a toxic 
effect attributable to a single dose has not been identified for 
rimsulfuron. The cancer dietary risk assessment is also not relevant 
due to the lack of evidence of carcinogenicity in the conducted rat and 
mice toxicity studies.
    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).
    Rimsulfuron 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 rimsulfuron to share a common mechanism of 
toxicity with any other substances, and rimsulfuron does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
rimsulfuron 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. In the developmental 
toxicity in rats, no developmental toxicity was seen at the highest 
dose tested. In the developmental toxicity study in rabbits, and in the 
2-generation study in rats, developmental/offspring toxicity was seen 
in the presence of maternal/systemic toxicity. In the rabbit study, 
fetal effects (production of only two viable fetuses) occurred at a 
higher dose (1,500 mg/kg/day) than the dose (500 mg/kg/day) resulting 
in maternal toxicity (death and reduced weight gain). In the 
reproduction study offspring effects (decreased mean body weight in F1 
males, decreased body weight gain in F1 females, and decreased daily 
food consumption in F1 males) also occurred at a higher dose (1,316 mg/
kg/day) than the dose (M: 830 mg/kg/day; F: 1,021 mg/kg/day) resulting 
in parental/systemic toxicity (decreased body weight gain in males and 
females). Consequently, there is no quantitative or qualitative 
evidence of increased susceptibility following pre- and/or postnatal 
exposure to rimsulfuron.
    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 rimsulfuron is adequate to assess 
potential for pre- and/or postnatal toxicity. In accordance with part 
158 Toxicology Data requirements, an immunotoxicity study (870.7800), 
and acute and subchronic neurotoxicity studies (870.6200) are required 
for rimsulfuron. Despite the absence of specific immunotoxicity and 
neurotoxicity studies, EPA has evaluated the available toxicity data 
and has determined that there is no evidence that rimsulfuron either 
causes neurotoxic effects or directly targets the immune system, and, 
therefore, an additional UF is not needed to account for the lack of 
these studies.
    ii. There is no indication that rimsulfuron is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that rimsulfuron 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 chronic dietary food exposure assessments were performed 
based on 100% PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to rimsulfuron in drinking water. Residential 
exposure is not expected for rimsulfuron. These assessments will not 
underestimate the exposure and risks posed by rimsulfuron.

[[Page 67136]]

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. No adverse effect resulting from a single-oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
rimsulfuron 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 
rimsulfuron from food and water will utilize <1% of the cPAD for the 
general population and all population subgroups, including children 1-2 
years old, the population group receiving the greatest exposure. There 
are no residential uses for rimsulfuron.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Rimsulfuron is 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 rimsulfuron 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 chronic 
exposure to food and water (considered to be a background exposure 
level).
    Rimsulfuron is 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 rimsulfuron 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. Based on a lack of 
evidence for carcinogenicity in mice and rats following long-term 
dietary administration, rimsulfuron is not expected to pose a cancer 
risk.
    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 rimsulfuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid 
chromatography with ultraviolet (HPLC/UV) detection method AMR-1241-88) 
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 currently no established or proposed Codex maximum 
residue limits (MRLs) for residues of rimsulfuron. There are Canadian 
MRLs for rimsulfuron residues on tomatoes and blueberries, and Mexican 
tolerances for residues on potatoes, tomatoes, and corn. The Mexican 
tolerance for corn (0.1 mg/kg) is identical to the existing U.S. 
tolerance for corn grain and harmonization will be maintained.

C. Revisions to Petitioned-For Tolerances

    The proposed tolerances on corn, aspirated grain fractions at 1.02 
ppm and soybean, aspirated grain fractions at 4.51 ppm have been 
revised to grain, aspirated fractions at 4.5 ppm. Rimsulfuron residues 
were shown to concentrate in aspirated grain fractions (AGF) in both 
corn grain and soybean seed. As the residues in soybean AGF are higher 
than in corn AGF, the tolerance was established at 4.5 ppm based on the 
soybean residue data. The proposed tolerance for soybean, hulls at 
0.035 ppm was rounded up to 0.04 ppm. The tolerance level for corn, 
field, grain was maintained at 0.1 ppm, rather than the proposed 0.01 
ppm, to remain harmonized with the MRL in Mexico.
    EPA has also revised the tolerance expression for all existing and 
new rimsulfuron tolerances. The revised tolerance expression makes 
clear that the tolerances cover ``residues of rimsulfuron, including 
its metabolites and degradates'' and that compliance with the tolerance 
levels will be determined by measuring only rimsulfuron, N-((4,6-
dimethoxypyrimidin-2-yl)aminocarbonyl)-3-(ethylsulfonyl)-2-
pyridinesulfonamide. EPA has determined that it is reasonable to make 
this change in the tolerance expression 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 rimsulfuron, 
including its metabolites and degradates, in or on corn, field, forage 
at 0.4 ppm; corn, field, stover at 2.5 ppm; grain, aspirated fractions 
at 4.5 ppm; soybean, forage at 0.25 ppm; soybean, hay at 1.2 ppm; 
soybean, hulls at 0.04 ppm; and soybean, seed at 0.01 ppm. Compliance 
with these tolerance levels will be determined by measuring only 
rimsulfuron, N-((4,6-dimethoxypyrimidin-2-yl)aminocarbonyl)-3-
(ethylsulfonyl)-2-pyridinesulfonamide, 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

[[Page 67137]]

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 180.478 is amended in paragraph (a) by revising the 
introductory text, by revising the entries for Corn, field, forage and 
Corn, field, stover, and by alphabetically adding entries for Grain, 
aspirated fractions; Soybean, forage; Soybean, hay; Soybean, hulls; and 
Soybean, seed to the table to read as follows:

Sec.  180.478  Rimsulfuron; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide rimsulfuron, including its metabolites and degradates, in or 
on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only 
rimsulfuron, N-((4,6-dimethoxypyrimidin-2-yl)aminocarbonyl)-3-
(ethylsulfonyl)-2-pyridinesulfonamide), in or on the commodities.

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Corn, field, forage                         0.4
------------------------------------------------------------------------
                                * * * * *
Corn, field, stover                         2.5
------------------------------------------------------------------------
                                * * * * *
Grain, aspirated fractions                  4.5
------------------------------------------------------------------------
                                * * * * *
Soybean, forage                             0.25
------------------------------------------------------------------------
Soybean, hay                                1.2
------------------------------------------------------------------------
Soybean, hulls                              0.04
------------------------------------------------------------------------
Soybean, seed                               0.01
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E9-30045 Filed 12-17-09; 8:45 am]

BILLING CODE 6560-50-S