Document ID: EPA-HQ-OPP-2009-0057-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Nicosulfuron
Posted Date: 2010-04-07T04:00Z

[Federal Register: April 7, 2010 (Volume 75, Number 66)]
[Rules and Regulations]               
[Page 17573-17579]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07ap10-8]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0057; FRL-8818-4]

 
Nicosulfuron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
nicosulfuron in or on cattle, fat; cattle, meat; cattle, meat 
byproducts; goat, fat; goat, meat; goat, meat byproducts; grass, 
forage; grass, hay; horse, fat; horse, meat; horse, meat byproducts; 
milk; sheep, fat; sheep, meat; and sheep, meat byproducts. E. I. du 
Pont de Nemours and Company requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation also 
removes the existing tolerance for residues of nicosulfuron on corn, 
forage.

DATES: This regulation is effective April 7, 2010. Objections and 
requests for hearings must be received on or before June 7, 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-2009-0057. 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-

[[Page 17574]]

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 Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr. You may 
also access the OPPTS harmonized test guidelines referenced in this 
document electronically at http://www.epa.gov/oppts and select ``Test 
Methods and Guideline.''

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-2009-0057 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 June 7, 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-2009-0057, 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 a pesticide petition (PP 
8F7501) by E. I. du Pont de Nemours and Company, P.O. Box 80038, 
Wilmington, DE 19880-0038. The petition requested that 40 CFR 180.454 
be amended by establishing tolerances for residues of the herbicide 
nicosulfuron, 3-Pyridinecarboxamide, 2-[[[[(4,6-dimethoxy-2-
pyrimidinyl)amino] carbonyl]amino]sulfonyl]-N,N- dimethyl-, in or on 
grass, forage at 9.0 parts per million (ppm); grass, hay at 25.0 ppm; 
fat (of cattle, goat, hog, horse, and sheep) at 0.05 ppm; meat (of 
cattle, goat, hog, horse, and sheep) at 0.05 ppm; meat byproducts (of 
cattle, goat, hog, horse, and sheep) at 0.05 ppm; milk at 0.05 ppm; and 
milk, fat at 0.02 ppm. 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 is not 
establishing the proposed tolerances for hog, fat; hog, meat; hog, meat 
byproducts; and milk, fat. The proposed tolerance levels for cattle, 
fat; cattle, meat; goat, fat; goat, meat; horse, fat; horse, meat; 
milk; sheep, fat; and sheep, meat are being established at 0.01 ppm, 
not 0.05 ppm. The reasons for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue.''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for the petitioned-for 
tolerances for residues of nicosulfuron and its metabolites and 
degradates in or on cattle, fat at 0.01 ppm; cattle, meat at 0.01 ppm; 
cattle, meat byproducts at 0.05 ppm; goat, fat at 0.01 ppm; goat, meat 
at 0.01 ppm; goat, meat byproducts at 0.05 ppm; grass, forage at 9.0 
ppm; grass, hay at 25.0 ppm; horse, fat at 0.01 ppm; horse, meat at 
0.01 ppm; horse, meat byproducts at 0.05 ppm; milk at 0.01 ppm; sheep, 
fat at 0.01 ppm; sheep, meat at 0.01 ppm; and sheep, meat

[[Page 17575]]

byproducts at 0.05 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. Specific information on the studies received and the nature 
of the adverse effects caused by nicosulfuron 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 ``Nicosulfuron Human Health Risk 
Assessment for the Proposed Use on Grasses,'' p. 30 in docket ID number 
EPA-HQ-OPP-2009-0057.
    Nicosulfuron has low acute toxicity by oral, dermal, and inhalation 
routes of exposure. It is a moderate eye irritant and is not a dermal 
sensitizer. No adverse effects were observed following subchronic or 
chronic dietary administrations of doses exceeding the limit dose in 
rats and mice. Chronic dietary administration to dogs produced mild 
effects (decreased body weight gains in males, increased relative liver 
and kidney weights) at the limit dose. No findings were reported in 
dogs following subchronic dosing at comparable dietary levels.
    There was no evidence of potential immunotoxicity or neurotoxicity 
in the submitted studies.
    Nicosulfuron 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 and in the in vitro and in vivo genotoxicity 
studies.

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 nicosulfuron used for 
human risk assessment can be found at http://www.regulations.gov in 
document ``Nicosulfuron Human Health Risk Assessment for the Proposed 
Use on Grasses,'' p. 15 in docket ID number EPA-HQ-OPP-2009-0057.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to nicosulfuron, EPA considered exposure under the petitioned-
for tolerances as well as all existing nicosulfuron tolerances in 40 
CFR 180.454. EPA assessed dietary exposures from nicosulfuron 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 
nicosulfuron; 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 
(corn) and new uses (meat and milk commodities) of nicosulfuron.
    iii. Cancer. Based on the lack of evidence of carcinogenicity 
observed in the 2-year rat and 18-month mouse carcinogenicity studies 
and a lack of evidence of mutagenicity in the in vitro and in vivo 
genotoxicity studies, EPA does not expect nicosulfuron to pose a cancer 
risk to humans. 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 and/or PCT information in the dietary assessment 
for nicosulfuron. Tolerance level residues and/or 100 PCT were assumed 
for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for nicosulfuron in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of nicosulfuron. 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 nicosulfuron for 
chronic exposures for non-cancer assessments are estimated to be 0.685 
ppb for surface water and 0.056 ppb for ground water. EDWCs of 
nicosulfuron for acute exposures and chronic exposures for cancer 
assessments are not relevant to this dietary exposure assessment as 
explained in unit III.C.1.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 0.685 ppb was used to 
assess the contribution to drinking water. The surface water value was 
used in the chronic, non-cancer dietary risk assessment since it was 
higher than the ground water value and, therefore, more protective.
    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).

[[Page 17576]]

    Nicosulfuron 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 nicosulfuron to share a common mechanism of 
toxicity with any other substances, and nicosulfuron does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
nicosulfuron 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 (6,000 mg/kg/day). In the developmental study in rabbits, 
developmental toxicity (decreased fetal body weight, post-implantation 
loss) occurred at the same dose (500 mg/kg/day) as the dose (500 mg/kg/
day) resulting in maternal toxicity (abortions, clinical signs, 
decreased body weight gain, post-implantation loss). In the 2-
generation reproductive toxicity study in rats, F2a offspring effects 
(decreased litter size at birth, decreased pup weights at postpartum 
day 14 through 21) also occurred at the same dose (1265 mg/kg/day) as 
the dose (1265 mg/kg/day) resulting in parental toxicity (decreased 
body weight gain in F1 females during the last week of gestation). 
Consequently, there is no quantitative or qualitative evidence of 
increased susceptibility following pre- and/or postnatal exposure to 
nicosulfuron.
    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 nicosulfuron is adequate to assess 
potential pre- and/or postnatal toxicity. In accordance with 40 CFR 
part 158 Toxicology Data Requirements, an immunotoxicity study 
(870.7800), and acute and subchronic neurotoxicity studies (870.6200) 
are required for nicosulfuron. 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 nicosulfuron either causes neurotoxic effects or targets the 
immune system, and, therefore, EPA does not expect that these studies 
will result in a lower NOAEL than the NOAEL currently used in assessing 
nicosulfuron risk.
    ii. There is no indication that nicosulfuron 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 nicosulfuron 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 significant residual uncertainties identified in 
the exposure databases for nicosulfuron. Additional storage stability 
studies are required for residues of nicosulfuron in grass forage and 
hay, and in livestock tissues. However, as explained in this Unit, EPA 
does not expect these studies to have a measurable impact on exposure 
estimates for nicosulfuron.
    a. Data must be submitted on the stability of nicosulfuron and its 
metabolite in grass forage and hay stored frozen for intervals of up to 
9.6 and 12.4 months, respectively. Interim data are available showing 
that residues of nicosulfuron in grass hay and forage are stable when 
stored frozen up to 3 months. Additionally, storage stability data are 
available for corn, a related crop, which indicate that nicosulfuron 
residues are stable when stored frozen up to 12 months. Based on these 
data, EPA expects nicosulfuron to be stable in grass forage and hay 
stored frozen for the required 9.6 and 12.4 month intervals but is 
requiring submission of the final study reports as confirmation.
    b. Data must also be submitted on the stability of nicosulfuron and 
its metabolite in livestock tissues stored frozen up to 9.4 months. 
Despite the absence of data, EPA has assumed that nicosulfuron is 
stable in frozen livestock tissues, based on data for similar 
sulfonylurea (SU) pesticides, such as prosulfuron, where studies have 
shown residues to be stable for up to 25 months. In addition, EPA notes 
that dietary exposure to nicosulfuron is low (< 1% of the cPAD for all 
population subgroups), and that the contribution of residues in 
livestock to overall dietary exposure to nicosulfuron is minor, 
accounting for only 2.5% of total exposure for children 1-2 years old, 
the population subgroup with the highest estimated dietary exposure to 
nicosulfuron. Therefore, any adjustments in livestock residue estimates 
that might be necessary following submission of the required storage 
stability data would have little impact on overall dietary exposure 
estimates.
    The 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 nicosulfuron in drinking water. There are no residential 
uses for nicosulfuron; therefore, residential exposure is not expected. 
These assessments will not underestimate the exposure and risks posed 
by nicosulfuron.

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

[[Page 17577]]

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, nicosulfuron 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 
nicosulfuron 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 nicosulfuron.
    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).
    Nicosulfuron 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 nicosulfuron 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).
    Nicosulfuron 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 nicosulfuron 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 and lack of evidence for mutagenicity in a 
battery of genotoxicity studies, nicosulfuron 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 nicosulfuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid 
chromatography with tandem mass spectrometric (HPLC/MS/MS) detection 
method) 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 Codex or Mexican maximum residue 
limits (MRLs) for residues of nicosulfuron. Canadian MRLs are 
established on blueberries and corn, and are expressed in terms of 
nicosulfuron. There are no Canadian MRLs established on the grass and 
livestock commodities associated with this petition.

C. Revisions to Petitioned-For Tolerances

    EPA is not establishing the proposed tolerances for hog, fat; hog, 
meat; and hog, meat byproducts because there are no swine feed items 
associated with the proposed use on grasses, and the dietary burden to 
swine resulting from registered use on corn is low enough that there is 
no reasonable expectation of finite residues in hog commodities. The 
proposed tolerance for milk fat is not being established because 
residues did not concentrate in cream and thus the tolerance for milk 
will be sufficient to cover residues in milk fat from legal uses of 
nicosulfuron. The proposed tolerances for cattle, fat; cattle, meat; 
goat, fat; goat, meat; horse, fat; horse, meat; milk; sheep, fat; and 
sheep, meat were lowered from 0.05 ppm to the level of quantitation 
(LOQ) at 0.01 ppm, since the maximum adjusted residue for meat and fat 
was at 0.008 ppm.
    EPA has also revised the tolerance expression for all existing and 
new nicosulfuron tolerances. The revised tolerance expression makes 
clear that the tolerances cover ``residues of nicosulfuron, including 
its metabolites and degradates'' and that compliance with the tolerance 
levels will be determined by measuring only nicosulfuron, 3-
Pyridinecarboxamide, 2-[[[[(4,6-dimethoxy-2-pyrimidinyl)amino] 
carbonyl]amino]sulfonyl]-N,N-dimethyl-. 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.
    Finally, EPA is removing the redundant and obsolete tolerance for 
residues of nicosulfuron on ``corn, forage'' at 0.1 ppm. ``Corn, 
forage'' is an obsolete commodity term that has been replaced by the 
terms ``corn, field, forage'' and ``corn, sweet, forage.'' Since there 
are existing tolerances for residues of nicosulfuron on ``corn, field, 
forage'' and ``corn, sweet, forage'' at 0.1 ppm, the tolerance on 
``corn, forage'' at the same level is unnecessary. EPA is making this 
change final without prior proposal and opportunity for comment because 
it merely corrects a redundancy in the nicosulfuron tolerances and has 
no substantive effect on them.

V. Conclusion

    Therefore, tolerances are established for residues of nicosulfuron, 
including its metabolites and degradates, in or on cattle, fat at 0.01 
ppm; cattle, meat at 0.01 ppm; cattle, meat byproducts at 0.05 ppm; 
goat, fat at 0.01 ppm; goat, meat at 0.01 ppm; goat, meat byproducts at 
0.05 ppm; grass, forage at 9.0 ppm; grass, hay at 25.0 ppm; horse, fat 
at 0.01 ppm; horse, meat at 0.01 ppm; horse, meat byproducts at 0.05 
ppm; milk at 0.01 ppm; sheep, fat at 0.01 ppm; sheep, meat at 0.01 ppm; 
and sheep, meat byproducts at 0.05 ppm.

VI. Statutory and Executive Order Reviews

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

[[Page 17578]]

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: March 26, 2010.
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 180.454 is revised to read as follows:

Sec.  180.454  Nicosulfuron; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide nicosulfuron, including its metabolites and degradates, in or 
on the commodities in the following table [below]. Compliance with the 
tolerance levels specified in the following table [below] is to be 
determined by measuring only nicosulfuron, 3-Pyridinecarboxamide, 2-
[[[[(4,6-dimethoxy-2-pyrimidinyl)amino] carbonyl]amino]sulfonyl]-N,N- 
dimethyl-.

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Cattle, fat                                                         0.01
------------------------------------------------------------------------
Cattle, meat                                                        0.01
------------------------------------------------------------------------
Cattle, meat byproducts                                             0.05
------------------------------------------------------------------------
Corn, field, forage                                                  0.1
------------------------------------------------------------------------
Corn, field, grain                                                   0.1
------------------------------------------------------------------------
Corn, field, stover                                                  0.1
------------------------------------------------------------------------
Corn, pop, grain                                                     0.1
------------------------------------------------------------------------
Corn, pop, stover                                                    0.1
------------------------------------------------------------------------
Corn, sweet, forage                                                  0.1
------------------------------------------------------------------------
Corn, sweet, kernel plus cob with husks                              0.1
 removed
------------------------------------------------------------------------
Corn, sweet, stover                                                  0.1
------------------------------------------------------------------------
Goat, fat                                                           0.01
------------------------------------------------------------------------
Goat, meat                                                          0.01
------------------------------------------------------------------------
Goat, meat byproducts                                               0.05
------------------------------------------------------------------------
Grass, forage                                                        9.0
------------------------------------------------------------------------
Grass, hay                                                          25.0
------------------------------------------------------------------------
Horse, fat                                                          0.01
------------------------------------------------------------------------
Horse, meat                                                         0.01
------------------------------------------------------------------------
Horse, meat byproducts                                              0.05
------------------------------------------------------------------------
Milk                                                                0.01
------------------------------------------------------------------------
Sheep, fat                                                          0.01
------------------------------------------------------------------------
Sheep, meat                                                         0.01
------------------------------------------------------------------------
Sheep, meat byproducts                                              0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table [below] are established for residues 
of the herbicide nicosulfuron, 3-Pyridinecarboxamide, 2-[[[[(4,6-
dimethoxy-2-pyrimidinyl)amino] carbonyl]amino]sulfonyl]-N,N-dimethyl-, 
in or on the specified agricultural commodities, resulting from use of 
the pesticide pursuant to FFIFRA section 18 emergency exemptions. The 
tolerances expire and are revoked on the date specified in the table.

[[Page 17579]]

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    Revokation
                                                  million        Date
------------------------------------------------------------------------
Bermuda grass, forage                                    10     12/31/11
------------------------------------------------------------------------
Bermuda grass, hay                                       25     12/31/11
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2010-7745 Filed 4-6-10; 8:45 am]
BILLING CODE 6560-50-S