Federal Register / Vol. 77, No. 232 / Monday, December 3, 2012 / Rules and Regulations 71555 

continue to attain the 1997 8-hour ozone 

NAAQS. 

VI. Statutory and Executive Order 

Reviews 

These actions make determinations of 

attainment based on air quality, result in 

the suspension of certain federal 

requirements, grant attainment date 

extensions, and/or would not impose 

additional requirements beyond those 

imposed by state law. For that reason, 

these actions: 

• Are not ‘‘significant regulatory 

actions’’ subject to review by the Office 

of Management and Budget under 

Executive Order 12866 (58 FR 51735, 

October 4, 1993); 

• Do not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• Are certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• Do not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Do not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Are not economically significant 

regulatory actions based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Are not significant regulatory 

actions subject to Executive Order 

13211 (66 FR 28355, May 22, 2001); 

• Are not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the CAA; and 

• Do not provide EPA with the 

discretionary authority to address 

disproportionate human health or 

environmental effects with practical, 

appropriate, and legally permissible 

methods under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, these actions do not have 

Tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because the SIP 

obligations discussed herein do not 

apply to Indian Tribes and thus will not 

impose substantial direct costs on Tribal 

governments or preempt Tribal law. 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this action 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 the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by February 1, 2013. Filing a 

petition for reconsideration by the 

Administrator of this final rule does not 

affect the finality of this action for the 

purposes of judicial review nor does it 

extend the time within which a petition 

for judicial review may be filed, and 

shall not postpone the effectiveness of 

such rule or action. This action may not 

be challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Nitrogen dioxide, Ozone, Reporting and 

recordkeeping requirements, Volatile 

organic compounds. 

Dated: November 19, 2012. 

Jared Blumenfeld, 

Regional Administrator, Region IX. 

Part 52, Chapter I, Title 40 of the Code 

of Federal Regulations is amended as 

follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart F—California 

■ 2. Section 52.282 is amended by 

adding paragraph (e) to read as follows: 

§ 52.282 Control Strategy and regulations: 

Ozone. 

* * * * * 

(e) Determinations of Attainment: 

Effective January 2, 2013. 

(1) Approval of applications for 

extensions of applicable attainment 

dates. Under section 181(a)(5) of the 

Clean Air Act, EPA is approving the 

applications submitted by the California 

Air Resources Board dated March 23, 

2010 and May 24, 2010 for extensions 

of the applicable attainment date for the 

Mariposa and Tuolumne Counties and 

Nevada County 8-hour ozone 

nonattainment areas, respectively, from 

June 15, 2010 to June 15, 2011. 

(2) Determinations of attainment by 

the applicable attainment dates. EPA 

has determined that the Amador and 

Calaveras Counties, Chico, Kern County, 

Mariposa and Tuolumne Counties, 

Nevada County, and Sutter County 8- 

hour ozone nonattainment areas in 

California attained the 1997 8-hour 

ozone national ambient air quality 

standard (NAAQS) by their applicable 

attainment dates. The applicable 

attainment dates are as follows: Amador 

and Calaveras Counties (June 15, 2010), 

Chico (June 15, 2007), Kern County 

(June 15, 2010), Mariposa and 

Tuolumne Counties (June 15, 2011), 

Nevada County (June 15, 2011), and 

Sutter County (June 15, 2007). 

(3) Determinations of attainment. EPA 

is determining that the Amador and 

Calaveras Counties, Chico, Kern County, 

Mariposa and Tuolumne Counties, 

Nevada County, Sutter County and 

Ventura County 8-hour ozone 

nonattainment areas have attained the 

1997 8-hour ozone standard, based upon 

complete quality-assured data for 2009– 

2011. Under the provisions of EPA’s 

ozone implementation rule (see 40 CFR 

51.918), these determinations suspend 

the attainment demonstrations and 

associated reasonably available control 

measures, reasonable further progress 

plans, contingency measures, and other 

planning SIPs related to attainment for 

as long as the areas continue to attain 

the 1997 8-hour ozone standard. If EPA 

determines, after notice-and-comment 

rulemaking, that any of these areas no 

longer meets the 1997 ozone NAAQS, 

the corresponding determination of 

attainment for that area shall be 

withdrawn. 

* * * * * 

[FR Doc. 2012–29013 Filed 11–30–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0781; FRL–9370–6] 

Halosulfuron-Methyl; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 


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SUMMARY: This regulation establishes 

tolerances for residues of halosulfuronmethyl in or on multiple commodities 

which are identified and discussed later 

in this document. Canyon Group L.L.C., 

c/o Gowan Company requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 3, 2012. Objections and 

requests for hearings must be received 

on or before February 1, 2013, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2011–0781, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Maggie Rudick, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–0257; email address: 

rudick.maggie@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. To access the 

OCSPP test guidelines referenced in this 

document electronically, please go to 

http://www.epa.gov/ocspp and select 

‘‘Test Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 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–2011–0781 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before February 1, 2013. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

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 (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2011–0781, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.htm. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

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

dockets. 

II. Summary of Petitioned-for Tolerance 

In the Federal Register of December 8, 

2011 (75 FR 76676) (FRL–9328–8), EPA 

issued a document pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 1F7916) by Canyon Group 

L.L.C., c/o Gowan Company, 370 South 

Main St., Yuma, AZ 85364. The petition 

requested that 40 CFR 180.479 be 

amended by establishing tolerances for 

residues of the herbicide halosulfuronmethyl, methyl 5-[(4,6-dimethoxy-2-

pyrimidinyl)amino]carbonylamino

sulfonyl]-3-chloro-1-methyl-1Hpyrazole-4-carboxylate, in or on millet, 

proso, forage at 7.0 parts per million 

(ppm); millet, proso, hay at 0.02 ppm; 

millet, proso, grain at 0.01 ppm; millet, 

proso, straw at 0.01 ppm; grass, forage, 

fodder, and hay, group 17, forage at 17 

ppm; and grass, forage, fodder, and hay, 

group 17, hay at 0.90 ppm. That 

document referenced a summary of the 

petition prepared by Canyon Group, 

L.L.C., the registrant, which is available 

in the docket, http:// 

www.regulations.gov. Comments were 

received on the notice of filing. EPA’s 

response to these comments is 

discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has revised 

the proposed tolerance levels, 

determined that established tolerances 

for certain livestock commodities 

should be increased and multiple new 

livestock commodity tolerances should 

be established. The reasons for these 

changes are explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

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 


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Federal Register / Vol. 77, No. 232 / Monday, December 3, 2012 / Rules and Regulations 71557 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue * * *.’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), 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 halosulfuronmethyl including exposure resulting 

from the tolerances established by this 

action. EPA’s assessment of exposures 

and risks associated with halosulfuronmethyl 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 a low acute 

toxicity via the oral, dermal, and 

inhalation routes of exposure. 

Halosulfuron-methyl is a non-irritant for 

skin and eyes and is not a dermal 

sensitizer. 

With repeated dosing, halosulfuronmethyl produces non-specific effects, 

which are frequently characterized by 

reduced body weight/body weight gain 

in the test animals. 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 decrease in body weight 

gains at high dose levels in short- and 

long-term oral and dermal studies. 

In the prenatal developmental toxicity 

study in rats, increases in resorptions, 

soft tissue (dilation of the lateral 

ventricles) and skeletal variations, and 

decreases in body weights were seen in 

the fetuses compared to clinical signs 

and decreases in body weights and food 

consumption in the maternal animals at 

similar dose level. 

In the rabbit developmental toxicity 

study, increases in resorptions and postimplantation losses and decrease in 

mean litter size was seen in the 

presence of decreases in body weight 

and food consumption in maternal 

animals were observed. However, a 

clear no-observed-adverse-effect-level 

(NOAEL) for these effects was 

established in both rat and rabbit 

developmental toxicity studies. 

Halosulfuron-methyl did not produce 

reproductive effects. No neurotoxic 

effects were observed in the acute or 

subchronic neurotoxicity studies. 

Halosulfuron-methyl is classified as 

‘‘not likely to be carcinogenic to 

humans’’ because in both rat and mouse 

carcinogenicity studies halosulfuronmethyl does not cause; compoundrelated increases in tumor incidence. It 

is negative for mutagenicity in a battery 

of genotoxicity studies. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by halosulfuron-methyl as well as the 

NOAEL and the lowest-observedadverse-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 New Uses 

on Proso Millet and Crop Group 17 

(Grass, Forage, Fodder, and Hay)’’ at p. 

19 in docket ID number EPA–HQ–OPP– 

2011–0781. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern (LOC) to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which the NOAEL and the 

lowest dose at which adverse effects of 

concern are identified (the LOAEL). 

Uncertainty/safety factors are used in 

conjunction with the POD to calculate a 

safe exposure level—generally referred 

to as a population adjusted dose (PAD) 

or a reference dose (RfD)—and a safe 

margin of exposure (MOE). For nonthreshold 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 

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 is shown in the 

following Table. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR HALOSULFURON-METHYL FOR USE IN HUMAN HEALTH

RISK ASSESSMENT

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (Females 13–50 

years of age).

NOAEL = 50 mg/kg/ 

day.

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

Acute RfD = 0.5 mg/ 

kg/day.

aPAD = 0.5 mg/kg/ 

day 

Developmental Toxicity—Rabbit. 

LOAEL = 150 mg/kg/day based on decreased mean litter size, 

increased number of resorptions (total and per dam) and increased post-implantation loss (developmental toxicity). 

Acute dietary (General population including infants and 

children).

N/A ........................... N/A ........................... No adverse effect attributable to a single dose was identified; 

therefore, no dose/endpoint was selected for this exposure 

scenario. 

Chronic dietary (All populations) NOAEL = 10 mg/kg/ 

day.

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

Chronic RfD = 0.1 

mg/kg/day.

cPAD = 0.1 mg/kg/ 

day.

Chronic Toxicity—Dog. 

LOAEL = 40 mg/kg/day based on decreased body weight gains 

in females. 


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TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR HALOSULFURON-METHYL FOR USE IN HUMAN HEALTH

RISK ASSESSMENT—Continued 

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Incidental oral short-term (1 to 

30 days).

NOAEL = 50 mg/kg/ 

day.

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

LOC for MOE = 100 Developmental Toxicity—Rabbit. 

LOAEL = 150 mg/kg/day based on decreased body weight 

gain, food consumption, and food efficiency (maternal toxicity). 

Incidental oral intermediateterm (1 to 6 months).NOAEL = 10 mg/kg/ 

day.

UFA= 10X 

UFH= 10X 

FQPA SF = 1X 

LOC for MOE = 100 13 Week Subchronic Toxicity—Dog. 

LOAEL = 40 mg/kg/day based on decreased body weight gains 

and food efficiency along with hematological and clinical 

chemistry changes. 

Dermal short-term (1 to 30 

days).

NOAEL = 100 mg/ 

kg/day.

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

LOC for MOE = 100 21 Day Dermal Toxicity Study—Rats. 

LOAEL = 1,000 mg/kg/day based on decreased body weight 

gains in males. 

Dermal intermediate-term (1 to 

6 months).

NOAEL = 10 mg/kg/ 

day.

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

LOC for MOE = 100 13 Week Subchronic Toxicity—Dog. 

LOAEL = 40 mg/kg/day based on decreased body weight gains 

and food efficiency along with hematological and clinical 

chemistry changes. 

Inhalation short-term (1 to 30 

days).

NOAEL = 50 mg/kg/ 

day.

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

LOC for MOE = 100 Developmental Toxicity—Rabbit. 

LOAEL = 150 mg/kg/day based on decreased body weight 

gain, food consumption, and food efficiency (maternal toxicity). 

Inhalation (1 to 6 months) ......... NOAEL = 10 mg/kg/ 

day.

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

LOC for MOE = 100 13 Week Subchronic Toxicity—Dog. 

LOAEL = 40 mg/kg/day based on decreased body weight gains 

and food efficiency along with hematological and clinical 

chemistry changes. 

Cancer (Oral, dermal, inhalation).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. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). 

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 tolerances 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 were identified 

for halosulfuron-methyl. In estimating 

acute dietary exposure, EPA used food 

consumption information from the U.S. 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA conducted an unrefined 

assessment that assumed 100 percent 

crop treated (PCT), dietary exposure 

evaluation model (DEEMTM) 7.81 default 

concentration factors, and tolerancelevel residues for all existing and 

proposed uses. There was no indication 

of an adverse effect attributable to a 

single dose for the general U.S. 

population. Therefore, an acute dietary 

assessment was not conducted for the 

general U.S. population. 

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 conducted a chronic 

dietary assessment that utilized the 

same food residue assumptions as in the 

acute dietary exposure assessment 

discussed in Unit III.C.1.i. 

iii. Cancer. In both rat and mouse 

carcinogenicity studies, halosulfuronmethyl does not produce compound 

related increases in tumor incidence; 

EPA has concluded that halosulfuronmethyl does not pose a cancer risk to 

humans. Therefore, a dietary exposure 

assessment for the purpose of assessing 

cancer risk is unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for halosulfuron-methyl. Tolerance level 

residues and/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for 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 


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Federal Register / Vol. 77, No. 232 / Monday, December 3, 2012 / Rules and Regulations 71559 

http://www.epa.gov/oppefed1/models/ 

water/index.htm. 

Based on the Tier 1 Rice Model and 

Screening Concentration in Ground 

Water (SCI–GROW) models, the 

estimated drinking water concentrations 

(EDWCs) of halosulfuron-methyl for 

acute and chronic exposures are 

estimated to be 59.2 parts per billion 

(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 

both acute and chronic dietary risk 

assessments, the water concentration 

value of 59.2 ppb was used to assess 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 the following uses that 

could result in residential exposures: 

Residential turf. EPA assessed 

residential exposure using the default 

assumptions of the 2012 Residential 

Standard Operating Procedures (SOPs). 

Residential handler short-term (1–30 

days) dermal and inhalation exposures, 

and residential post-application shortterm dermal and incidental oral (handto-mouth, object-to-mouth, and soil 

ingestion) exposures are expected from 

activities associated with the existing 

uses. Intermediate-term exposures are 

not likely because of the intermittent 

nature of applications by homeowners. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

trac/science/trac6a05.pdf. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ EPA has not 

found halosulfuron-methyl to share a 

common mechanism of toxicity with 

any other substances, and halosulfuronmethyl 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 Web site 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 Safety Factor (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 pre-natal 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 e.g., 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 e.g., 

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 complete except 

for an immunotoxicity study. In 

accordance with 40 CFR part 158, 

Toxicology Data Requirements, an 

immunotoxicity study 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 of 

evidence 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 

POD 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 and surface water modeling 

used to assess exposure to halosulfuronmethyl 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 dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 


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71560 Federal Register / Vol. 77, No. 232 / Monday, December 3, 2012 / Rules and Regulations 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

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 13–49 years old, 

the population group receiving the 

greatest exposure. 

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 

6% of the cPAD for all infants, 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 of 1,800 for adults and 840 for 

children. For adults, potential pathways 

of exposure include oral (background) 

and dermal (post-application primary) 

routes, while for children, potential 

pathways of exposure include oral 

(background) and incidental oral and 

dermal (primary) routes. Because EPA’s 

level of concern for halosulfuron-methyl 

is a MOE of 100 or below, these MOEs 

are not of concern. 

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). An 

intermediate-term adverse effect was 

identified; however, halosulfuronmethyl is not registered for any use 

patterns that would result in 

intermediate-term residential exposure. 

Intermediate-term risk is assessed based 

on intermediate-term residential 

exposure plus chronic dietary exposure. 

Because there is no intermediate-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess intermediateterm risk), no further assessment of 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating intermediateterm risk for halosulfuron-methyl. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

halosulfuron-methyl is not expected to 

pose a cancer risk to 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, or to infants and children 

from aggregate exposure to 

halosulfuron-methyl residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodologies 

are available to enforce the tolerance 

expression: A gas chromatography with 

nitrogen phosphorus detection; GC/NPD 

method for crop commodities and a gas 

chromotagraphy with electron capture 

detection (GC/ECD) method for 

livestock commodities. The methods 

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 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. There are no 

Maximum Residue Limits (MRLs) 

established by Codex, Canada, or 

Mexico for any crop or livestock 

commodities for halosulfuron-methyl. 

C. Response to Comments 

An anonymous citizen objected to the 

presence of any pesticide residues on 

food. The Agency understands the 

commenter’s concerns and recognizes 

that some individuals believe that 

pesticides should be banned 

completely. However, the existing legal 

framework provided by section 408 of 

the FFDCA contemplates that tolerances 

greater than zero may be set when 

persons seeking such tolerances or 

exemptions have demonstrated that the 

pesticide meets the safety standard 

imposed by that statute. This citizen’s 

comment appears to be directed at the 

underlying statute and not EPA’s 

implementation of it; the citizen has 

made no contention that EPA has acted 

in violation of the statutory framework. 

D. Revisions to Petitioned-for 

Tolerances 

EPA has revised the requested 

tolerances by increasing the tolerance 

values for millet, proso, forage and 

grass, forage, fodder, and hay, group 17, 

forage and reducing the tolerance values 

for millet, proso, hay and grass, forage, 

fodder, and hay, group 17, hay. 

Differences in proposed and 

recommended tolerances may be 

attributed to the petitioner having used 

the North American Free Trade 

Agreement (NAFTA) tolerance 

calculation procedures for determining 

the tolerance and EPA’s use of the 

Organization for Economic Cooperation 

and Development (OECD) tolerance 

calculation procedures. Recently, EPA 

has adopted use of the OECD tolerance 

calculation procedures to increase 

international harmonization of tolerance 

levels. For grass hay, the petitioner used 

values below the level of quantitation 

(LOQ) in the tolerance calculation 

whereas EPA used LOQ values. In 

addition, already established tolerances 

for cattle, goat, horse, and sheep meat 

byproducts are being increased and 

multiple new livestock commodity 

tolerances are being established. 

Livestock tolerances are derived from 

reevaluation of the dairy/beef cattle diet 

with new feed items (millet and grass). 

V. Conclusion 

Therefore, tolerances are established 

for residues of halosulfuron-methyl, 

including its metabolites and 

degradates, as set forth in the regulatory 

text. 


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Federal Register / Vol. 77, No. 232 / Monday, December 3, 2012 / Rules and Regulations 71561 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.). 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action 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: November 21, 2012. 

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. In § 180.479 revise the table in 

paragraph (a)(1) and add alphabetically 

the following new entries to the table in 

paragraph (a)(2). 

The revised and added text read as 

follows: 

§ 180.479 Halosulfuron-methyl; tolerances 

for residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

Cattle, fat ................................ 0 .05 

Cattle, meat ............................ 0 .05 

Cattle, meat byproducts ......... 1 .0 

Goat, fat .................................. 0 .05 

Goat, meat .............................. 0 .05 

Goat, meat byproducts ........... 1 .0 

Hog, meat byproducts ............ 0 .1 

Horse, fat ................................ 0 .05 

Horse, meat ............................ 0 .05 

Horse, meat byproducts ......... 1 .0 

Milk ......................................... 0 .05 

Sheep, fat ............................... 0 .05 

Sheep, meat ........................... 0 .05 

Sheep, meat byproducts ........ 1 .0 

(2) * * * 

Commodity Parts per 

million 

*****

Grass, forage, fodder, and 

hay, group 17, forage ......... 20 

Grass, forage, fodder, and 

hay, group 17, hay .............. 0 .5 

*****

Millet, proso, forage ................ 10 

Millet, proso, grain .................. 0 .01 

Millet, proso, hay .................... 0 .01 

Millet, proso, straw ................. 0 .01 

*****

* * * * * 

[FR Doc. 2012–29105 Filed 11–30–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 716 

[EPA–HQ–OPPT–2011–0363; FRL–9355–9] 

RIN 2070–AJ89 

Health and Safety Data Reporting; 

Addition of Certain Chemicals 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This final rule requires 

manufacturers (including importers) of 

cadmium or cadmium compounds, 

including as part of an article, that have 

been, or are reasonably likely to be, 

incorporated into consumer products to 

report certain unpublished health and 

safety studies to EPA. The Interagency 

Testing Committee (ITC), established 

under section 4(e) of the Toxic 

Substances Control Act (TSCA) to 

recommend chemicals and chemical 

mixtures to EPA for priority testing 

consideration, amends the TSCA section 

4(e) Priority Testing List through 

periodic reports submitted to EPA. The 

ITC added cadmium and cadmium 

compounds to the Priority Testing List 

through its 69th ITC Report. 

DATES: This final rule is effective 

January 2, 2013. For purposes of judicial 

review, this final rule shall be 

promulgated at 1 p.m. eastern daylight/ 

standard time on December 17, 2012. 

(See 40 CFR 23.5.) 

A request to withdraw a chemical 

from this final rule pursuant to 

§ 716.105(c) must be received on or 


emcdonald on DSK67QTVN1PROD with RULES