48396 Federal Register / Vol. 74, No. 183 / Wednesday, September 23, 2009 / Rules and Regulations 

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: September 9, 2009. 

Steven Bradbury, 

Acting Director, Office of Pesticides Program. 

■ 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 180.648 is added to subpart 

C to read as follows: 

§180.648 Meptyldinocap; tolerances for 

residues. 

(a) General. Tolerances are 

established for the combined residues of 

the fungicide meptyldinocap, 2-(1- 

methylheptyl)-4,6-dinitrophenyl (2E)-2- 

butenoate and 2,4-DNOP, 2,4-dinitro-6- 

(1-methylheptyl)phenol expressed as 

meptyldinocap in or on the following 

commodities: 

Commodity Parts Per Million 

Grape 0.20 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. E9–22523 Filed 9–22–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0003; FRL–8436–7] 

Halosulfuron-methyl; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of halosulfuronmethyl and its metabolites and 

degradates, in or on soybean, seed. 

Canyon Group, LLC requested this 

tolerance under the Federal Food, Drug, 

and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 23, 2009. Objections and 

requests for hearings must be received 

on or before November 23, 2009, 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–2009–0003. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; e-mail address: 

stanton.susan@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

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Federal Register / Vol. 74, No. 183 / Wednesday, September 23, 2009 / Rules and Regulations 48397 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office′s e-CFR 

cite at http://www.gpoaccess.gov/ecfr. 

To access the OPPTS Harmonized 

Guidelines referenced in this document, 

go directly to the guidelines at http:// 

www.epa.gov/opptsfrs/home/ 

guidelin.htm. 

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–2009–0003 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 November 23, 2009. 

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–2009–0003, 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 8F7424) by 

Canyon Group, LLC, c/o Gowan 

Company, 370 South Main St., Yuma, 

AZ 85364. The petition requested that 

40 CFR 180.479 be amended by 

establishing a tolerance for residues of 

the herbicide halosulfuron-methyl, 

methyl 3-chloro-5-(4,6- 

dimethoxypyrimidin-2- 

ylcarbamoylsulfamoyl)-1- 

methylpyrazole-4-carboxylic acid, in or 

on soybean at 0.05 parts per million 

(ppm). That notice referenced a 

summary of the petition prepared by 

Canyon Group, LLC, 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. 

EPA has revised the proposed 

commodity term from ‘‘soybean’’ to 

‘‘soybean, seed’’ to agree with the 

Agency′s Food and Feed Commodity 

Vocabulary. EPA has also revised the 

tolerance expressions for the existing 

plant and livestock commodity 

tolerances and the new tolerance on 

soybean, seed. 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 

tolerance for residues of halosulfuronmethyl and its metabolites and 

degradates on soybean, seed 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. 

Halosulfuron-methyl has low acute 

toxicity via the oral, dermal, and 

inhalation routes of exposure. It is nonirritating to the skin and eyes and is not 

a dermal sensitizer. With repeated 

dosing, the available data show that the 

dog is the most sensitive mammalian 

species. In the dog, decreased body 

weight was seen in the chronic oral 

toxicity study and decreased body 

weight gain was observed in females in 

the subchronic oral toxicity study. In 

the rat and mouse, there was a nonspecific decrease in body weight gain at 

high dose levels in short-term and longterm oral and dermal studies. 

Halosulfuron-methyl is classified as 

‘‘not likely to be carcinogenic to 

humans’’ based on a lack of evidence for 

carcinogenicity in mice and rats 

following long-term dietary 

administration. Halosulfuron-methyl is 

negative for mutagenicity in a battery of 

mutagenicity studies. There is no 

evidence of immunotoxicity or 

neurotoxicity in the available studies for 

halosulfuron-methyl. 

There was no quantitative evidence 

for increased susceptibility of fetuses or 

offspring following prenatal and/or 

postnatal exposure to halosulfuronmethyl in the developmental and 

reproductive toxicity studies. However, 

there was qualitative evidence for 

increased susceptibility. In the rat 

developmental toxicity study, increased 

fetal and litter incidences of soft tissue 

(dilation of the lateral ventricles) and 

skeletal variations, and decreased mean 

fetal body weight and mean litter size 

were seen at a dose resulting in less 

severe maternal effects (increased 

incidence of clinical observations, 

reduced body weight gains, reduced 

food consumption and food efficiency). 

In the rabbit study, increases in 

resorptions and post-implantation losses 

and a decrease in mean litter size were 

seen in the presence of decreases in 

body weight and food consumption in 

maternal animals. Thus, in both species, 

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the developmental effect was 

considered to be qualitatively more 

severe than maternal effects. In the 

reproduction study in rats, parental 

effects (decreased body weights, body 

weight gains, and reduced food 

consumption during the premating 

period in both sexes) were comparable 

in severity to offspring effects 

(decreased body weight in the F1 pups 

and marginal decreased body weight in 

F2 pups). 

Specific information on the studies 

received and the nature of the adverse 

effects caused by halosulfuron-methyl 

as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL) 

from the toxicity studies can be found 

at http://www.regulations.gov in the 

document, Halosulfuron-methyl: 

Human Health Risk Assessment for 

Proposed Uses on Soybean, page 36 in 

docket ID number EPA–HQ–OPP–2009– 

0003. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-term, intermediate-term, 

and chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the level of concern (LOC). 

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 halosulfuron-methyl used 

for human risk assessment can be found 

at http://www.regulations.gov in the 

document, Halosulfuron-methyl: 

Human Health Risk Assessment for 

Proposed Uses on Soybean, page 13 in 

docket ID number EPA–HQ–OPP–2009– 

0003. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to halosulfuron-methyl, EPA 

considered exposure under the 

petitioned-for tolerance as well as all 

existing halosulfuron-methyl tolerances 

in 40 CFR 180.479. EPA assessed 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. Such effects (decreased mean 

litter size, increased number of 

resorptions and increased 

postimplantation loss, assumed to occur 

after a single exposure) were identified 

for the population subgroup females 13 

to 49 years old. No such effects were 

identified for the general population, 

including infants and children. 

In estimating acute dietary exposure 

of females 13 to 49 years old, EPA used 

food consumption information from the 

U.S. Department of Agriculture (USDA) 

1994–1996 Nationwide Continuing 

Surveys of Food Intakes by Individuals 

(CSFII). As to residue levels in food, 

EPA assumed tolerance-level residues 

and 100 percent crop treated (PCT) for 

all existing and new uses of 

halosulfuron-methyl. 

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 PCT for all existing and new uses 

of halosulfuron-methyl. 

iii. Cancer. Based on the results of 

carcinogenicity studies in rats and mice, 

EPA classified halosulfuron-methyl as 

‘‘not likely to be carcinogenic to 

humans.’’ Therefore, an exposure 

assessment to evaluate cancer risk is 

unnecessary for this chemical. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue or PCT information 

in the dietary assessment for 

halosulfuron-methyl. Tolerance level 

residues and 100 PCT were assumed for 

all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for halosulfuron-methyl in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

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.htm. 

Based on the First Index Reservoir 

Screening Tool (FIRST) and Screening 

Concentration in Ground Water (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

halosulfuron-methyl for acute exposures 

are estimated to be 8.3 parts per billion 

(ppb) for surface water and 0.065 ppb 

for ground water. The EDWCs for 

chronic exposures for non-cancer 

assessments are estimated to be 1.7 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. For 

acute and chronic dietary risk 

assessment, the water concentration 

value of 59.2 ppb was used to assess the 

contribution from drinking water. This 

value is substantially higher than the 

modeled EDWCs for acute and chronic 

exposures (8.3 ppb and 1.7 ppb, 

respectively) and was derived from 

preliminary modeling using a different 

model (a Tier one rice model). This 

model overestimates levels that would 

occur in drinking water, because it does 

not consider the degradation of the 

pesticide or the dilution of the pesticide 

as it is transported away from the rice 

field into the drinking water source. The 

Agency has concluded that the EDWCs 

derived using the FIRST model and 

based on the crop scenarios corn and 

sugarcane provide a more reasonable 

high end estimate of expected levels in 

surface water used for drinking water. 

However, since acute and chronic 

exposure estimates using the higher 

value are below EPA’s LOC, EPA did 

not revise the dietary exposure 

assessment to incorporate the lower 

EDWCs. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

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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 the following uses that 

could result in residential exposures: 

Residential turfgrass and ornamentals. 

EPA assessed residential exposure using 

the following assumptions: Residential 

handlers may receive short-term dermal 

and inhalation exposure to 

halosulfuron-methyl when mixing, 

loading and applying halosulfuronmethyl products. Adults and children 

may be exposed to halosulfuron-methyl 

residues through dermal contact with 

turf during post-application activities. 

In addition, toddlers may receive shortterm and intermediate-term oral 

exposure from incidental ingestion 

during post-application activities. EPA 

assessed short-term dermal and 

inhalation exposure of residential 

handlers and the following postapplication exposure scenarios: 

i. Adult and toddler post-application 

dermal exposure 

ii. Toddlers′ incidental ingestion of 

pesticide residues on lawns from handto-mouth transfer. 

iii. Toddlers′ object-to-mouth transfer 

from mouthing of pesticide-treated 

turfgrass. 

iv. Toddlers′ incidental ingestion of 

soil from pesticide-treated residential 

areas. 

v. 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 halosulfuronmethyl to share a common mechanism 

of toxicity with 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 assumed that 

halosulfuron-methyl does not have a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA SF. In applying this provision, 

EPA either retains the default value of 

10X, or uses a different additional safety 

factor when reliable data available to 

EPA support the choice of a different 

factor. 

2. Prenatal and postnatal sensitivity. 

The prenatal and postnatal toxicity 

database for halosulfuron-methyl 

includes rat and rabbit developmental 

toxicity studies and a 2-generation 

reproduction toxicity study in rats. As 

discussed in Unit III.A., there was 

qualitative evidence of increased 

susceptibility of fetuses in the rat and 

rabbit developmental studies. Fetal 

effects (increased incidences of soft 

tissue and skeletal variations, decreased 

mean fetal body weight and mean litter 

size in the rat study; increases in 

resorptions and post-implantation losses 

and a decrease in mean litter size in the 

rabbit study) occurred at doses resulting 

in less severe maternal toxicity 

(increased incidence of clinical 

observations, reduced body weight 

gains, reduced food consumption and 

food efficiency in the rat study; 

decreases in body weight and food 

consumption in the rabbit study). The 

degree of concern for these effects is 

low, and there are no residual 

uncertainties for prenatal toxicity in rats 

and rabbits for the following reasons. In 

both studies, there are clear NOAELs/ 

LOAELs for developmental and 

maternal toxicities; developmental 

effects were seen in the presence of 

maternal toxicity; and effects were seen 

only at the high dose. Additionally, in 

rats, developmental effects were seen at 

a dose which is approaching the limitdose. 

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 

halosulfuron-methyl is adequate to 

assess prenatal and postnatal toxicity. In 

accordance with 40 CFR part 158 

Toxicology Data requirements, an 

immunotoxicity study (870.7800) is 

required for halosulfuron-methyl. In the 

absence of specific immunotoxicity 

studies, EPA has evaluated the available 

halosulfuron-methyl toxicity data to 

determine whether an additional 

uncertainty factor is needed to account 

for potential immunotoxicity. The 

toxicology database for halosulfuronmethyl does not show any evidence of 

biologically relevant effects on the 

immune system following exposure to 

this chemical. The overall weight-ofevidence suggests that this chemical 

does not directly target the immune 

system. Based on these considerations, 

EPA does not believe that conducting 

immunotoxicity testing will result in a 

point of departure lower than those 

already selected for halosulfuron-methyl 

risk assessment, and an additional 

database uncertainty factor is not 

needed to account for the lack of this 

study. 

ii. There is no indication that 

halosulfuron-methyl is a neurotoxic 

chemical and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. Although there is evidence of 

increased qualitative susceptibility in in 

utero rats and rabbits in the prenatal 

developmental studies, the degree of 

concern for developmental effects is 

low, and EPA did not identify any 

residual uncertainties after establishing 

toxicity endpoints and traditional UFs 

to be used in the risk assessment of 

halosulfuron-methyl. 

iv. 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. EPA made 

conservative (protective) assumptions in 

the ground water and surface water 

modeling used to assess exposure to 

halosulfuron-methyl in drinking water. 

EPA used similarly conservative 

assumptions to assess post-application 

exposure of 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 

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 

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additional cancer cases given the 

estimated aggregate exposure. Shortterm, intermediate-term, and chronicterm risks are evaluated by comparing 

the estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

halosulfuron-methyl will occupy <1% 

of the aPAD for females 13 to 49 years 

old, the only population group for 

which acute exposure is of toxicological 

concern. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to halosulfuronmethyl from food and water will utilize 

1.6% of the cPAD for the general U.S. 

population and 4.6% of the cPAD for 

infants less than 1 year old, the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of halosulfuron-methyl is not 

expected. 

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). Halosulfuron-methyl is 

currently registered for uses that could 

result in short-term residential exposure 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

halosulfuron-methyl. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs ranging from 2,800 (infants less 

than 1 year old) to 4,800 (females, 13 to 

49 years old). The aggregate MOEs for 

adults include short-term dermal and 

inhalation exposures for residential 

handlers and post-application dermal 

exposures from activities on turfgrass 

previously treated with halosulfuronmethyl. The aggregate MOEs for 

children’s subgroups include short-term 

post-application dermal and incidental 

oral exposures from activities on 

halosulfuron-methyl-treated turfgrass. 

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). 

Halosulfuron-methyl is currently 

registered for uses that could result in 

intermediate-term residential exposure 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure to halosulfuron-methyl 

through food and water with 

intermediate-term exposures for 

halosulfuron-methyl. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures result 

in aggregate MOEs ranging from 500 

(U.S. population, females 13 to 49 years 

old, and adults 50 years and older) to 

700 (infants less than 1 year old). The 

aggregate MOEs for adults include 

intermediate-term dermal and 

inhalation exposures for residential 

handlers and post-application dermal 

exposures from activities on turfgrass 

previously treated with halosulfuronmethyl. The inclusion of intermediateterm residential handler exposures in 

the aggregate MOE is conservative 

(protective), since intermediate-term 

exposure of handlers is unlikely. The 

aggregate MOEs for children′s 

subgroups, including infants, include 

intermediate-term post-application 

dermal and incidental oral exposures 

from activities on halosulfuron-methyltreated turfgrass. 

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, halosulfuron-methyl 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 

halosulfuron-methyl residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography, Monsanto 

Analytical Method RES-109–97–4) is 

available to enforce the tolerance. 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 

residues limits (MRLs) for halosulfuronmethyl. 

C. Revisions to Petitioned-For Tolerance 

EPA has revised the proposed 

commodity term from ‘‘soybean’’ to 

‘‘soybean, seed’’ to agree with the 

Agency′s Food and Feed Commodity 

Vocabulary. EPA is also revising the 

tolerance expression for soybean, seed 

and the existing plant and livestock 

commodities to clarify the chemical 

moieties that are covered by the 

tolerances and specify how compliance 

with the tolerances is to be measured. 

The revised tolerance expression for 

plants makes clear that the tolerances 

cover ‘‘residues of halosulfuron-methyl 

and its metabolites and degradates’’ and 

that compliance with the tolerance 

levels will be determined by measuring 

only halosulfuron-methyl. The revised 

tolerance expression for livestock 

commodities makes clear that the 

tolerances cover residues of 

halosulfuron-methyl and its metabolites 

and degradates and that compliance 

with the tolerance levels will be 

determined by measuring only those 

halosulfuron-methyl residues 

convertible to 3-chloro-1-methyl-5- 

sulfamoylpyrazole-4-carboxylic acid, 

expressed as the stoichiometric 

equivalent of halosulfuron-methyl. EPA 

is also revising the chemical name for 

halosulfuron-methyl to conform to the 

nomenclature recommendations of the 

Chemical Abstracts Service (CAS): 

methyl 3-chloro-5-[[[[(4,6-dimethoxy-2- 

pyrimidinyl)amino] carbonyl] amino] 

sulfonyl]-1-methyl-1H-pyrazole-4- 

carboxylate. 

EPA has determined that it is 

reasonable to make these changes in the 

tolerance expression final without prior 

proposal and opportunity for comment, 

because public comment is not 

necessary, in that the changes have no 

substantive effect on the tolerance, but 

rather are merely intended to clarify the 

existing tolerance expression. 

V. Conclusion 

Therefore, a tolerance is established 

for residues of halosulfuron-methyl and 

its metabolites and degradates on 

soybean, seed at 0.05 ppm. Compliance 

with the tolerance level will be 

determined by measuring only 

halosulfuron-methyl, methyl 3-chloro-5- 

[[[[(4,6-dimethoxy-2-pyrimidinyl)amino] 

carbonyl] amino] sulfonyl]-1-methyl-1Hpyrazole-4-carboxylate, in or on the 

commodity. 

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 

mstockstill on DSKH9S0YB1PROD with RULES

Federal Register / Vol. 74, No. 183 / Wednesday, September 23, 2009 / Rules and Regulations 48401 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 15, 2009. 

Rachel C. Holloman, 

Acting 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 

paragraphs (a)(1) and (a)(2) and 

alphabetically adding an entry for 

‘‘soybean, seed’’ to the table in 

paragraph (a)(2) to read as follows: 

§ 180.479 Halosulfuron-methyl; tolerances 

for residues. 

(a)* * * (1) Tolerances are established 

for residues of the herbicide 

halosulfuron-methyl, methyl 3-chloro-5- 

[[[[(4,6-dimethoxy-2- 

pyrimidinyl)amino]carbonyl] amino] 

sulfonyl]-1-methyl-1H-pyrazole-4- 

carboxylate, and its metabolites and 

degradates in or on the commodities in 

the table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only those 

halosulfuron-methyl residues 

convertible to 3-chloro-1-methyl-5- 

sulfamoylpyrazole-4-carboxylic acid, 

expressed as the stoichiometric 

equivalent of halosulfuron-methyl, in or 

on the commodity. 

* * * * * 

(2) Tolerances are established for 

residues of the herbicide halosulfuronmethyl and its metabolites and 

degradates in or on the commodities in 

the table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only 

halosulfuron-methyl, methyl 3-chloro-5- 

[[[[(4,6-dimethoxy-2-pyrimidinyl)amino] 

carbonyl] amino] sulfonyl]-1-methyl-1Hpyrazole-4-carboxylate, in or on the 

commodity. 

Commodity Parts per million 

*****

Soybean, seed ......................................................................................................... 0.05 

*****

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48402 Federal Register / Vol. 74, No. 183 / Wednesday, September 23, 2009 / Rules and Regulations 

* * * * * 

[FR Doc. E9–22915 Filed 9–22–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0810; FRL–8434–2] 

Spinosad; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of spinosad in or 

on date and pomegranate, and 

additionally increases established 

tolerances in or on almond hulls; tree 

nut, group 14; and pistachio. 

Interregional Research Project Number 4 

(IR-4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

September 23, 2009. Objections and 

requests for hearings must be received 

on or before November 23, 2009, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION ). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0810. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; e-mail address: 

nollen.laura@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

cite at http://www.gpoaccess.gov/ecfr. 

To access the OPPTS Harmonized 

Guidelines referenced in this document, 

go directly to the guidelines at http:// 

www.epa.gov/opptsfrs/home/ 

guidelin.htm. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2008–0810 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 November 23, 2009. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2008–0810, 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 December 3, 

2008 (73 FR 73648) (FRL–8391–3), 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 8E7445) by IR-4, 

500 College Rd. East, Suite 201 W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.495 be 

amended by establishing tolerances for 

residues of the insecticide, spinosad, a 

fermentation product of 

Saccharopolyspora spinosa, consisting 

of two related active ingredients: 

Spinosyn A (Factor A; CAS#131929-60- 

7) or 2-[(6-deoxy-2,3,4-tri-O-methyl-a-Lmanno-pyranosyl)oxy]-13-[[5- 

(dimethylamino)-tetrahydro-6-methyl2H-pyran-2-yl]oxy]-9-ethyl2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16btetradecahydro-14-methyl-1H-asIndaceno[3,2-d]oxacyclododecin-7,15- 

dione; and Spinosyn D (Factor D; 

CAS#131929-63-0) or 2-[(6-deoxy-2,3,4- 

tri-O-methyl-a-L-manno-pyranosyl)oxy]- 

13-[[5-(dimethyl-amino)-tetrahydro-6- 

methyl-2H-pyran-2-yl]oxy]-9-ethylmstockstill on DSKH9S0YB1PROD with RULES