Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Rules and Regulations 8923 

Commodity Parts per million 

*****

Radish, tops ..................................................................................................................................................... 4.5 

*****

Turnip, greens .................................................................................................................................................. 5.0 

*****

Vegetable, root and tuber, group 1 ................................................................................................................. 4.0 

[FR Doc. E7–3010 Filed 2–27–07; 8:45 am] 

BILLING CODE 6560–50–S 

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. 

SUMMARY: This regulation establishes 

tolerances for residues of halosulfuronmethyl 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: 

walters.vickie@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: 

• 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: 


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8924 Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Rules and Regulations 

• 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-chloro1-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 noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (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 nonthreshold 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-chlore1-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-FCIDTM), 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 


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Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Rules and Regulations 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-FCIDTM, 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 (SCIGROW) 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 (DEEMFCID). 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 nonoccupational, 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 halosulfuronmethyl. 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 


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8926 Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Rules and Regulations 

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 halosulfuronmethyl. 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 postapplication 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 halosulfuronmethyl 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 postapplication 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 intermediateterm 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; email address: residuemethods@epa.gov. 

B. International Residue Limits 

There are currently no established 

Codex, Canadian, or Mexican maximum 

residue levels (MRLs) for halosulfuronmethyl 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] 


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Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Rules and Regulations 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 halosulfuronmethyl, methyl 5-[(4,6-dimethoxy-2- 

pyrimidiny)amino] 

carbonylaminosulfonyl-3-chloro-1- 

methyl-1H-pyrazole-4-caboxylate, and 

its metabolites determined as 3-chloro1-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. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 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: 

§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-chloro1-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 


erjones on PRODPC74 with RULES