[Federal Register Volume 72, Number 39 (Wednesday, February 28, 2007)]
[Rules and Regulations]
[Pages 8923-8927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-3205]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0205; FRL-8113-8]


Halosulfuron-methyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
halosulfuron-methyl in or on the commodities alfalfa, forage at 1.0 
parts per million (ppm) and alfalfa, hay at 2.0 ppm. Gowan Company 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), as amended by the Food Quality Protection Act of 1996 
(FQPA). The Agency is also correcting the tolerance expression for 40 
CFR 180.479(a)(1) with this regulation. The tolerance expression is 
being corrected because the metabolites were inadvertently deleted from 
the most recent edition of 40 CFR 180.479.

DATES: This regulation is effective February 28, 2007. Objections and 
requests for hearings must be received on or before April 30, 2007, 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-2006-0205. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Vickie Walters, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5704; e-mail address: [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:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
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 an electronic copy of this Federal 
Register document through the electronic docket 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 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, as amended by FQPA, any person may 
file an objection to any aspect of this regulation and may also request 
a hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. 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-2006-0205 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 on or before April 30, 2007.
    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 your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0205, by one of the following methods:

[[Page 8924]]

     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'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 telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of December 20, 2006 (71 FR 76321) (FRL-
8104-4), 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 
2F2469) by Gowan Company, P. O. Box 5569, Yuma, AZ 85366. The petition 
requested that 40 CFR 180.479(a)(2) be amended by establishing a 
tolerance for residues of the herbicide halosulfuron methyl, methyl 5-
[(4, 6-dimethoxy-2-pyrimidinyl)amino] carbonylaminosulfonyl-3-chloro-1-
methyl-1H-pyrazole-4-carboxylate in or on the raw agricultural 
commodities alfalfa, forage at 1.0 ppm and alfalfa, hay at 2.0 ppm. The 
Agency also proposed that the tolerance expression for 40 CFR 
180.479(a)(1) be corrected to read ``Tolerances are established for 
residues of the herbicide halosulfuron-methyl, methyl 5-[(4,6-
dimethoxy-2-pyrimidiny)amino] carbonylaminosulfonyl-3-chloro-1-methyl-
1H-pyrazole-4-caboxylate, and its metabolites determined as 3-chloro-1-
methyl-5-sulfamoylpyrazole-4-carboxylic acid, expressed as 
halosulfuron-methyl equivalents in or on the raw agricultural 
commodities listed in the table in this unit.'' That notice referenced 
a summary of the petition prepared by Gowan Company, the registrant 
that has been included in the public docket. There were no comments 
received in response to the notice of filing.
    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....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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, consistent with section 
408(b)(2) of FFDCA, for a tolerance for residues of halosulfuron-methyl 
the commodities alfalfa, forage at 1.0 ppm and alfalfa, hay at 2.0 ppm. 
EPA's assessment of exposures and risks associated with establishing 
the tolerance 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 toxic effects caused by halosulfuron-methyl 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 0002 (pages 16-20) in docket ID number 
EPA-HQ-OPP-2006-0205.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which the NOAEL from the toxicology study 
identified as appropriate for use in risk assessment is used to 
estimate the toxicological level of concern (LOC). However, the LOAEL 
is sometimes used for risk assessment if no NOAEL was achieved in the 
toxicology study selected. An uncertainty factor (UF) is applied to 
reflect 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.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases. More information 
can be found on the general principles EPA uses in risk 
characterization at http://www.epa.gov/pesticides/health/human.htm.
    A summary of the toxicological endpoints for halosulfuron-methyl 
used for human risk assessment can be found at http://www.regulations.gov. in document 0002 (pages 34-35) in docket ID number 
EPA-HQ-OPP-2006-0205.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.479) for the residues of halosulfuron-methyl, 
in or on a variety of raw agricultural commodities. Tolerances have 
been established for halosulfuron-methyl and its metabolites determined 
as 3-chlore-1-methyl-5-sulfamoylpyrazole-4-carboxylic acid, expressed 
as halosulfuron-methyl equivalents in or on meat by products of cattle, 
goat, hog, horse, and sheep. Risk assessments were conducted by EPA to 
assess dietary exposures from halosulfuron-methyl in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    In conducting the acute dietary exposure assessment EPA used the 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCID\TM\), which incorporates food consumption 
data as reported by respondents in the U.S. Department of Agriculture 
(USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake 
by

[[Page 8925]]

Individuals (CSFII), and accumulated exposure to the chemical for each 
commodity. The following assumptions were made for the chronic exposure 
assessments: Tolerance level residues and 100 percent crop treated 
(PCT) for all existing and proposed uses. Percent crop treated or 
anticipated residues were not used.
    The acute dietary exposure estimates are provided for females 13-50 
years old only. The existing data showed no indication that 
halosulfuron-methyl could cause adverse effects in the general 
population based upon a single dose. Thus there is no concern for acute 
dietary exposure to the general population.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the DEEM-FCID\TM\, which incorporates food 
consumption data as reported by respondents in the USDA 1994-1996 and 
1998 Nationwide CSFII, and accumulated exposure to the chemical for 
each commodity. The following assumptions were made for the chronic 
exposure assessments: A chronic dietary analysis for halosulfuron-
methyl was conducted using tolerance level residues and 100 PCT for all 
existing and proposed uses. Percent crop treated or anticipated 
residues were not used.
    iii. Cancer. Halosulfuron-methyl is classified as a ``not likely'' 
human carcinogen based on a lack of evidence of carcinogenicity in male 
and female mice and rats following long-term dietary administration. 
Therefore, halosulfuron-methyl is not expected to pose a cancer risk 
for humans.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for halosulfuron-methyl in 
drinking water. Because the Agency does not have comprehensive 
monitoring data, drinking water concentration estimates are made by 
reliance on simulation or modeling taking into account data on the 
physical characteristics of halosulfuron-methyl. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at http://www.epa.gov/oppefed1/models/water/index.
    Based on the FQPA Index Reservoir Screening Tool (FIRST) and 
screening concentration in ground water (SCI-GROW) models, the 
estimated environmental concentrations (EECs) of halosulfuron-methyl 
for acute exposures are estimated to be 105 parts per billion (ppb) for 
surface water and 0.065 ppb for ground water. The EECs for chronic 
exposures are estimated to be 105 ppb for surface water and 0.065 ppb 
for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model (DEEM-FCID). For acute and 
chronic dietary risk assessment, the annual average concentration of 
105 ppb was used to access 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).
    Halosulfuron-methyl is currently registered for use on the 
following residential non-dietary sites: Application to commercial and 
residential turf and on other non-crop sites including airports, 
cemeteries, fallow areas, golf courses, landscaped areas, public 
recreation areas, residential property, roadsides, school grounds, sod 
or turf seed farms, sports fields, and landscaped areas with 
established woody ornamentals. Application may be by commercial 
applicator or homeowner. Residential handlers may receive short-term 
dermal and inhalation exposure to halosulfuron-methyl when mixing, 
loading, and applying the formulations. Adults and children may be 
exposed to halosulfuron-methyl residues through dermal contact with 
turf during postapplicaton activities. A residential exposure and risk 
assessment was previously conducted for these exposure scenarios. 
Combined margins of exposure (MOEs) for adults' and children's dermal 
exposure and toddlers' incidental exposure from all residential 
activities are greater than the Agency's LOC of 100, and therefore are 
not of concern. These risk assessments are fully discussed in Unit 
III.E.3. of a final rule published in the Federal Register of September 
20, 2002 (67 FR 59182) (FRL-7200-8).
    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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to halosulfuron-methyl and 
any other substances and halosulfuron-methyl does not appear to produce 
a toxic metabolite produced by other substances. For the purposes of 
this tolerance action, therefore, EPA has not assumed that 
halosulfuron-methyl has 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 the policy statements 
released by EPA's Office of Pesticide Programs concerning common 
mechanism determinations and procedures for cumulating effects from 
substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1.In general. Section 408 of FFDCA provides that EPA shall apply an 
additional tenfold 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. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor (SF) value based on the use of traditional UFs and/or special 
FQPA SFs, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility of young rats in the reproduction study with 
halosulfuron-methyl. Although there is qualitative evidence of 
increased susceptibility in the prenatal developmental studies in rats 
and rabbits, the Agency did not identify any residual uncertainties 
after establishing toxicity endpoints and traditional UFs to be used in 
the risk assessment of halosulfuron-methyl.
    3. Conclusion. EPA determined that the 10X SF to protect infants 
and children should be removed. The FQPA factor is reduced to 1X based 
on the following findings.
    i. The toxicity database for halosulfuron-methyl is complete. 
Although EPA previously required

[[Page 8926]]

submission of a developmental neurotoxicity, that requirement has been 
waived based on a review of the entire database including recently 
submitted acute and subchronic neurotoxicity studies. This review 
showed that there was no evidence of clinical signs of neurotoxicity, 
brain weights changes, or neuropathology in the subchronic (including 
the neurotoxicity study) or chronic studies in rats, mice, or dogs. The 
acute neurotoxicity study showed some minor, transient functional 
observational battery (FOB) effects on day 0 (none statistically 
significant) at the limit dose with no effects persisting past day 0. 
There were not effects on brain weights or neuropathology. The observed 
FOB effects are not considered attributable to a direct neurotoxic 
response as they are minor, transient and occurred at the limit dose.
    ii. There is no evidence of increased susceptibility of young rats 
in the reproduction study with halosulfuron-methyl. Although there is 
qualitative evidence of increased susceptibility in the prenatal 
developmental studies in rats and rabbits, the Agency did not identify 
any residual uncertainties after establishing toxicity endpoints and 
traditional UFs to be used in the risk assessment of halosulfuron-
methyl. The degree of concern for pre and/or postnatal toxicity is low.
    iii. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance level residues. Conservative ground water and 
surface water modeling estimates were used in the risk assessments. 
Agency Residential standard operational proceedures (SOPs) are used to 
assess post-application exposure to children as well as incidental oral 
exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by halosulfuron-methyl.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. The acute aggregate risk assessment is provided for 
females 13-50 years old only. The existing data showed no indication 
that halosulfuron-methyl could cause adverse effects in the general 
population based upon a single dose. Thus there is no concern for acute 
dietary exposure to the general population. Using the exposure 
assumptions discussed in this Unit III.C. for acute exposure, the acute 
dietary exposure from food and water to halosulfuron-methy will occupy 
1.0% of the acute Population Adjusted Dose (aPAD) for females 13 years 
and older. EPA does not expect the acute aggregate exposure to exceed 
100% of the aPAD.
    2. Chronic risk. Using the exposure assumptions described in Unit 
III.C. for chronic exposure, EPA has concluded that exposure to 
halosulfuron-methyl from food and water will utilize 3.0% of the 
chronic Population Adjusted Dose (cPAD) for the U.S. population, 8.0 of 
the cPAD for all infants (<1 year old), and 4.0% of the cPAD for 
children 1-2 years old and children 3-5 years old. Based the use 
pattern, chronic residential exposure to residues of halosulfuron-
methyl is not expected. EPA does not expect the aggregate exposure to 
exceed 100% of the cPAD.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Halosulfuron-methyl is currently registered for use that could 
result in short-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic food and water and short-
term exposures for halosulfuron-methyl.
    A short-term risk assessment is required for adults because there 
is a residential handler exposure scenario. In addition, a short-term 
risk assessment is required for infants and children because there is a 
residential post-application exposure scenario for infants and 
children.
    Using the exposure assumptions described in Unit III.C. for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs ranging from 2,400 to 4,400. The 
MOE for the U.S. population is 4,300. The most highly exposed subgroup 
was all infants (less than 1 year old with an MOE of 2,400. These 
aggregate MOEs do not exceed the Agency's LOC for aggregate exposure to 
food and residential uses. EPA does not expect short-term aggregate 
exposure to exceed the Agency's LOC.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Halosulfuron-methyl is currently registered for use(s) that could 
result in intermediate-term residential exposure and the Agency has 
determined that it is appropriate to aggregate chronic food and water 
and intermediate-term exposures for halosulfuron methyl.
    An intermediate-term risk assessment is required for adults because 
there is a residential handler exposure scenario. In addition, an 
intermediate-term risk assessment is required for infants and children 
because there is a residential post-application exposure scenario for 
infants and children.
    As an additional protective measure, residential handler exposures 
were included in the intermediate-term aggregate risk assessment, 
although residential exposure over the intermediate-term (more than 30 
days) is unlikely.
    Using the exposure assumptions described is Unit III.E. for 
intermediate-term exposures; EPA has concluded that food and 
residential exposures aggregated result in aggregate MOEs ranged from 
480 to 560. The MOEs for the U.S. population is 480. The most highly 
exposed children's subgroup was all infants (less than 1 year old) with 
a MOE of 560. These aggregate MOEs do not exceed the Agency's LOC for 
aggregate exposure to food and residential uses. EPA does not expect 
intermediate-term aggregate exposure to exceed the Agency's LOC.
    5. Aggregate cancer risk for U.S. population. Halosulfuron-methyl 
is classified as ``not likely to be carcinogenic to humans'' based on 
the lack of evidence for carcinogenicity in mice and rats following 
long-term dietary administration. Therefore halosulfuron-methyl is not 
expected to pose a cancer risk for humans.
    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 and to infants and children from aggregate 
exposure to halosulfuron-methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with a 
nitrogen specific detector) 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

    There are currently no established Codex, Canadian, or Mexican 
maximum residue levels (MRLs) for halosulfuron-methyl in or on alfalfa, 
forage or alfalfa, hay. International harmonization is therefore not an 
issue.

V. Conclusion

    Therefore, the tolerance is established for residues of 
halosulfuron methyl, methyl 5-[(4, 6-dimethoxy-2-pyrimidinyl)amino]

[[Page 8927]]

carbonylaminosulfonyl-3-chloro-1-methyl-1H-pyrazole-4-carboxylate in or 
on the raw agricultural commodities alfalfa, forage at 1.0 ppm and 
alfalfa, hay at 2.0 ppm (40 CFR 180.479(a)(2)). The Agency is also 
correcting the tolerance expression for 40 CFR 180.479(a)(1) to read 
``Tolerances are established for residues of the herbicide 
halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidiny)amino] 
carbonylaminosulfonyl-3-chloro-1-methyl-1H-pyrazole-4-caboxylate, and 
its metabolites determined as 3-chloro-1-methyl-5-sulfamoylpyrazole-4-
carboxylic acid, expressed as halosulfuron-methyl equivalent, in or on 
the raw agricultural commodities listed in the table in this unit.''

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). 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., or 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). 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); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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). 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. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled 
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by State and local officials in the development of 
regulatory policies that have federalism implications.'' ``Policies 
that have federalism implications'' is defined in the Executive order 
to include regulations that have ``substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government.'' This final rule directly regulates 
growers, food processors, food handlers, and food retailers, not 
States. This action does not alter the relationships or distribution of 
power and responsibilities established by Congress in the preemption 
provisions of section 408(n)(4) of FFDCA. For these same reasons, the 
Agency has determined that this rule does not have any ``tribal 
implications'' as described in Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000). Executive Order 13175, requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by tribal officials in the development of regulatory policies that have 
tribal implications.'' ``Policies that have tribal implications'' is 
defined in the Executive order to include regulations that have 
``substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal Government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes.'' This rule will not have substantial 
direct effects on tribal governments, on the relationship between the 
Federal Government and Indian tribes, or on the distribution of power 
and responsibilities between the Federal Government and Indian tribes, 
as specified in Executive Order 13175. Thus, Executive Order 13175 does 
not apply to this rule.

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: February 14, 2007.
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 180.479 is amended by revising the introductory text of 
paragraph (a)(1) and alphabetically adding commodities to the table in 
paragraph (a)(2) to read as follows:


Sec. 180.479  Halosulfuron-methyl; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
herbicide halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-
pyrimidiny)amino] carbonylaminosulfonyl-3-chloro-1-methyl-1H-pyrazole-
4-caboxylate, and its metabolites determined as 3-chloro-1-methyl-5-
sulfamoylpyrazole-4-carboxylic acid, expressed as halosulfuron-methyl 
equivalent in or on the raw agricultural commodities listed in the 
table in this unit.
* * * * *
    (2) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Alfalfa, forage......................................                1.0
Alfalfa, hay.........................................                2.0
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-3205 Filed 2-27-07; 8:45 am]
BILLING CODE 6560-50-S