Federal Register / Vol. 78, No. 167 / Wednesday, August 28, 2013 / Rules and Regulations 53047 

Commodity Parts per million 

Vegetable, cucurbit, group 

9 ...................................... 0 .5 

Vegetable, foliage of legume, except soybean, 

subgroup 7A .................... 25 .0 

Vegetable, fruiting, group 

8–10 ................................ 1 .4 

Vegetable, leafy, except 

brassica, group 4 ............ 29 .0 

Commodity Parts per million 

Vegetable, leaves of root 

and tuber, group 2, except sugar beet ............... 16 .0 

Vegetable, legume, edible 

podded, subgroup 6A ..... 0 .5 

Vegetable, root, except 

sugar beet, subgroup 1B 0 .4 

Vegetable, tuberous and 

corm, subgroup 1C ......... 0 .04 

Commodity Parts per million 

Vegetables, foliage of legume, group 7 ................... 25 

Wheat, grain ....................... 0 .02 

Wheat, hay ......................... 6 .0 

Wheat, straw ....................... 8 .5 

* * * * * 

(b) Section 18 emergency exemptions. 

* * * 

Commodity Parts per 

million 

Expiration/revocation date 

Endive, belgium ....................................................................................................................................................... 11.0 12/31/13 

* * * * * 

[FR Doc. 2013–20921 Filed 8–27–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0586; FRL–9393–8] 

Halosulfuron-methyl; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of halosulfuronmethyl in or on artichoke and caneberry 

subgroup 13–07A. The Interregional 

Research Project Number 4 (IR–4) 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

August 28, 2013. Objections and 

requests for hearings must be received 

on or before October 28, 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–2012–0586, 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: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotice@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://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 

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–2012–0586 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 October 28, 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– 

2012–0586, 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 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.html. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

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

dockets. 


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II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of September 

28, 2012 (77 FR 59578) (FRL–9364–6), 

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 2E8050) by IR–4, 

IR–4 Project Headquarters, 500 College 

Rd. East, Suite 201 W., Princeton, NJ 

08540. The petition requested that 40 

CFR 180.479 be amended by 

establishing tolerances for residues of 

the herbicide halosulfuron-methyl, 

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

pyrimidinyl)amino] 

carbonylaminosulfonyl]-3-chloro-1- 

methyl-1H-pyrazole-4-carboxylate, 

including its metabolites and 

degradates, in or on artichoke and 

caneberry subgroup 13–07A at 0.05 

parts per million (ppm). That document 

referenced a summary of the petition 

prepared by Gowan Company, the 

registrant, which is available in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

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 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 their 

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. With repeated 

dosing, halosulfuron-methyl produces 

non-specific effects, which are 

frequently characterized by reduced 

body weight/body weight gain in the 

test animals. 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 

a similar dose level. In the rabbit 

developmental toxicity study, increases 

in resorptions and post-implantation 

losses and decrease in mean litter size 

were 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.’’ It is negative for mutagenicity 

in a battery of genotoxicity studies. 

Although there is no immunotoxicity 

study for halosulfuron-methyl, the 

available data indicate that 

halosulfuron-methyl is unlikely to be an 

immuno toxicant. EPA is currently 

reviewing a waiver request for these 

data. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by halosulfuron-methyl 

as well as the NOAEL and Lowest 

Observed-Adversed-Effective-Level 

(LOAEL) from the toxicity studies can 

be found at http://www.regulations.gov 

in document: ‘‘Halosulfuron-Methyl: 

Human Health Risk Assessment for 

Proposed New Uses on Artichoke and 

Caneberry (Crop subgroup 13–07A),’’ 

dated March 25, 2013, pp. 30–34, docket 

ID number EPA–HQ–OPP–2012–0586– 

0004. 

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 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 no adverse effects are 

observed (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 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 

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 discussed 

in Unit III. of the final rule published in 

the Federal Register of December 3, 

2012 (77 FR 71555) (FRL–9370–6). 

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. There was no indication of an 

adverse effect attributable to a single 

dose for the general U.S. population 

including infants and children. 

Therefore, an acute dietary assessment 

was not conducted for the U.S. general 

population. However, such effects were 

identified for females 13–49 years old 


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for halosulfuron-methyl. In estimating 

acute dietary exposure, EPA used the 

Dietary Exposure Evaluation Model— 

Food Consumption Intake Database 

(DEEM–FCID, ver. 3.16), which 

incorporates consumption information 

from the United States Department of 

Agriculture (USDA) National Health and 

Nutrition Examination Survey, What We 

Eat in America (NHANES/WWEIA); 

2003–2008). As to residue levels in 

food, EPA conducted an unrefined 

assessment that assumed 100 percent 

crop treated (PCT), dietary exposure 

evaluation model (DEEM) 7.81 default 

processing factors, and tolerance-level 

residues for all existing and proposed 

uses. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the DEEM–FCID, ver. 3.16 

which incorporates consumption 

information from the USDA NHANES/ 

WWEIA; 2003–2008. As to residue 

levels in food, EPA conducted an 

unrefined assessment that assumed 100 

PCT, DEEM 7.81 default processing 

factors, and tolerance-level residues for 

all existing and proposed uses. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that halosulfuron methyl 

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 or PCT information 

in the dietary assessment for 

halosulfuron-methyl. Tolerance level 

residues and100 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 Tier 1 Rice Model v.1.0 

and Screening Concentration in Ground 

Water (SCI–GROW) models, 

respectively, the estimated drinking 

water concentrations (EDWCs) of 

halosulfuron-methyl for acute exposures 

are estimated to be 59.2 parts per billion 

(ppb) for surface water and 0.065 ppb 

for ground water. 

For chronic exposures for non-cancer 

assessments EDWC’s are estimated to be 

59.2 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 the 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 use. EPA assessed 

residential exposure using the following 

assumptions: Residential handler shortterm (1–30 days) dermal and inhalation 

exposures, and residential postapplication short-term dermal and 

incidental oral (hand-to-mouth, objectto-mouth, and soil ingestion) exposures 

are expected from activities associated 

with the existing uses. Intermediateterm 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 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 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 

Food Quality Protection Act (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 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 no 

quantitative evidence for increased 

susceptibility following prenatal and/or 

postnatal exposure. However, there was 

qualitative evidence for increased 

susceptibility of fetuses in the rat and 

rabbit developmental studies. In the rat 

study, 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. 

In the rabbit study, increases in 

resorptions and post-implantation losses 

and decrease in mean litter size was 

seen in the presence of decreases in 

body weight and food consumption in 

maternal animals. Thus, in both species, 

the developmental effect was 

considered to be qualitatively more 

severe than maternal effects (i.e., 

qualitative evidence for susceptibility). 

Nevertheless, the degree of concern for 

these effects is low, and there are no 

residual uncertainties for prenatal 

toxicity in both rats and rabbits for the 

following reasons: 

i. In both studies, there are clear 

NOAELs/LOAELs for developmental 

and maternal toxicities. 

ii. Developmental effects were seen in 

the presence of maternal toxicity. 

iii. The effects were only seen at the 

high dose. 

iv. In rats, developmental effects were 

seen at a dose which approached the 

limit-dose. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 


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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 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 

or 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 uncertainty factors to account 

for neurotoxicity. 

iii. Although there is qualitative 

evidence of increased susceptibility in 

the prenatal developmental studies in 

rats and rabbits, as discussed in Unit 

III.D.2., there are no residual 

uncertainties after establishing toxicity 

endpoints and the degree of concern for 

pre- and/or postnatal toxicity is low. 

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 postapplication 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 population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). For 

linear cancer risks, EPA calculates the 

lifetime probability of acquiring cancer 

given the estimated aggregate exposure. 

Short-term, intermediate-term, 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, 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 

5.5% of the cPAD for all children 1–2 

years old, the population group 

receiving the greatest exposure. Chronic 

residential exposure to residues of 

halosulfuron-methyl is not expected. 

Therefore, the chronic aggregate risk 

would be equivalent to the chronic 

dietary exposure estimate. 

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. Residential exposure for use in 

the aggregate assessment of adults and 

children 1 to <2 years old reflects the 

combined post-application dermal plus 

hand-to-mouth exposures from turf 

treated with liquid applications of 

halosulfuron-methyl. Because EPA’s 

level of concern for halosulfuron-methyl 

is a MOE of 100 or below, these 

estimates of aggregate risk do not exceed 

the Agency’s level 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 

pathway. Because there is no 

intermediate-term residential exposure, 

the intermediate-term aggregate risk 

would be equivalent to the chronic 

dietary exposure estimate. Chronic 

dietary exposure has already been 

assessed under the appropriately 

protective cPAD (which is at least as 

protective as the equivalent POD value 

used to assess intermediate-term risk), 

no further assessment of intermediateterm risk is necessary. 

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 

An adequate analytical method is 

available for enforcement of tolerances 

for halosulfuron-methyl residues in 

plants. The gas chromatography (GC) 

method quantifies halosulfuron-methyl 

as its rearrangement ester (RRE; 1-Hpyrazole-4-carboxylic acid, 3-chloro-5- 

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

1-methyl, methyl ester) using 

thermionic-specific detection (TSD, 

nitrogen specific). For confirmation, the 

RRE can be determined by gas 

chromatography mass spectroscopic 

detection (GC/MS). 

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 

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 


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Federal Register / Vol. 78, No. 167 / Wednesday, August 28, 2013 / Rules and Regulations 53051 

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 

Codex MRLs established for residues of 

halosulfuron-methyl in/on any 

commodity. 

V. Conclusion 

Therefore, tolerances are established 

for residues of the herbicide 

halosulfuron-methyl, methyl 5-[(4,6- 

dimethoxy-2-pyrimidiny)amino] 

carbonylaminosulfonyl]-3-chloro-1- 

methyl-1H-pyrazole-4-carboxylate, 

including its metabolites and 

degradates, in or on the commodities 

artichoke at 0.05 ppm and caneberry 

subgroup 13–07A at 0.05 ppm. 

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: August 14, 2013. 

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, add alphabetically the 

following commodities to the table in 

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

§ 180.479 Halosulfuron-methyl; tolerances 

for residues. 

(a) * * * 

(2) * * * 

Commodity Parts per 

million 

* * * * * 

Artichoke ..................................... 0.05 

* * * * * 

Caneberry subgroup 13–07A ..... 0.05 

* * * * * 

* * * * * 

[FR Doc. 2013–20906 Filed 8–27–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–1018; FRL–9396–8] 

Ethyl-2E,4Z-Decadienoate (Pear Ester); 

Exemption From the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of the biochemical 

pesticide ethyl-2E,4Z-decadienoate 

(pear ester) in or on all food 

commodities. This regulation eliminates 

the need to establish a maximum 

permissible level for residues of ethyl2E,4Z-decadienoate (pear ester). 

DATES: This regulation is effective 

August 28, 2013. Objections and 

requests for hearings must be received 

on or before October 28, 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–2011–1018, 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 


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