52236 Federal Register / Vol. 77, No. 168 / Wednesday, August 29, 2012 / Rules and Regulations 

REGULATION FOR THE CONTROL OF ATMOSPHERIC POLLUTION

Puerto Rico regulation 

Commonwealth 

effective date 

EPA approval date Comments 

*******

Rule 102—Definitions .............. 2/18/11 8/29/12, [Insert FR page citation].Puerto Rico’s Environmental Public Policy Act Law No. 9 of 

June 18, 1970 was replaced with Law 416 of September 

22, 2004. 

* * * * * * * 

Rule 111—Applications, Public 

Hearings and Public Notice.

2/18/11 8/29/12, [Insert FR page citation].Puerto Rico’s Environmental Public Policy Act Law No. 9 of 

June 18, 1970 was replaced with Law 416 of September 

22, 2004. 

* * * * * * * 

Rule 115— Penalties ............... 2/18/11 8/29/12, [Insert FR page citation].Puerto Rico’s Environmental Public Policy Act Law No. 9 of 

June 18, 1970 was replaced with Law 416 of September 

22, 2004. 

Rule 116— Public Nuisance .... 2/18/11 8/29/12, [Insert FR page citation].Puerto Rico’s Environmental Public Policy Act Law No. 9 of 

June 18, 1970 was replaced with Law 416 of September 

22, 2004. 

* * * * * * * 

Appendix A, Hazardous Air 

Pollutants—Section 112(b) 

of the Clean Air Act.

2/18/11 8/29/12, [Insert FR page citation].

[FR Doc. 2012–19961 Filed 8–28–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0564; FRL–9360–2] 

Thifensulfuron Methyl; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of thifensulfuron 

methyl in or on chicory roots and 

chicory tops. 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 29, 2012. Objections and 

requests for hearings must be received 

on or before October 29, 2012, 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–2011–0564, is 

available at http://www.regulations.gov 

or at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in EPA 

West, 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: 

Andrew Ertman, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; email address: 

ertman.andrew@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). 

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. 

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–2011–0564 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 29, 2012. 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 that does not 

contain any 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 a copy of 

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Federal Register / Vol. 77, No. 168 / Wednesday, August 29, 2012 / Rules and Regulations 52237 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2011–0564, 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 statue. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), Mail Code: 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. 

II. Summary of Petitioned-for Tolerance 

In the Federal Register of August 26, 

2011 (76 FR 53372) (FRL–8884–9), EPA 

issued a notice pursuant to FFDCA 

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

announcing the filing of a pesticide 

petition (PP 1E7885) by IR–4, 500 

College Rd. East, Suite 201W, Princeton, 

NJ 08540. The petition requested that 40 

CFR 180.439 be amended by 

establishing tolerances for residues of 

the herbicide thifensulfuron methyl, 

methyl-3-[[[[(4-methoxy-6-methyl-1,3,5- 

triazin-2-yl) 

amino]carbonyl]amino]sulfonyl]-2- 

thiophenecarboxylate, in or on chicory, 

roots at 0.01 parts per million (ppm) and 

chicory, tops at 0.01 ppm. That notice 

referenced a summary of the petition 

prepared by E.I. du Pont de Nemours 

and 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 thifensulfuron 

methyl including exposure resulting 

from the tolerances established by this 

action. EPA’s assessment of exposures 

and risks associated with thifensulfuron 

methyl 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. 

Thifensulfuron methyl has mild to 

low acute toxicity when administered 

via the oral, inhalation and dermal 

routes of exposure. It has moderate to 

low toxicity with respect to eye and skin 

irritation and is not a dermal sensitizer. 

Most findings in the submitted studies 

related to decreases in body weights, 

body weight gains, or organ weights (a 

reflection of the lower body weights 

compared with control weights). There 

were increased liver weights in male 

dogs and increased thyroid/parathyroid 

weights in female dogs. There were no 

gross or histopathological changes 

reported in any of the studies. 

In the rat developmental study, there 

were no maternal effects at the highest 

dose tested (HDT). The rabbit 

developmental study showed a decrease 

in maternal body weights at the HDT. 

There were no developmental effects at 

the HDT. In the 2-generation rat 

reproduction study there were no 

parental, reproductive or offspring 

effects. There was an increase in 

quantitative susceptibility in the rat 

developmental study, based on 

decreased mean fetal body weights, and 

an increase in the incidence of small 

renal papillae (only at the highest dose 

level). 

Neurotoxicity was not observed in 

any of the submitted studies, including 

the recently submitted neurotoxicity 

studies which are currently under 

review. Based on the lack of 

neurotoxicity in the submitted studies, 

a developmental neurotoxicity study 

(DNT) is not required. A decrease in 

spleen weight was noted only in middose males in the subchronic rat study, 

and was considered a potential sign of 

immunotoxicity. However, in the 

recently submitted immunotoxicity 

study in female rats, dosing with 

thifensulfuron methyl did not affect any 

immunotoxicity parameters up to the 

HDT of 529 milligrams//kilograms/day. 

Thifensulfuron methyl is classified as 

‘‘not likely to be carcinogenic to 

humans,’’ based on acceptable chronic/ 

carcinogenicity studies in rats and mice 

at doses that are considered to be 

adequate, and not excessive for the 

determination of carcinogenic potential; 

there were no tumors observed in the 

studies, and the only adverse effects 

were decreased body weights and body 

weight gains. The available 

mutagenicity studies in vivo and in vitro 

show that thifensulfuron methyl is 

neither mutagenic nor clastogenic. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by thifensulfuron-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 titled ‘‘Thifensulfuron 

Methyl. Human Health Risk Assessment 

for the Proposed Use of the Herbicide on 

Chicory’’ on pages 30–33 in docket ID 

number EPA–HQ–OPP–2011–0564. 

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 

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52238 Federal Register / Vol. 77, No. 168 / Wednesday, August 29, 2012 / Rules and Regulations 

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 thifensulfuron methyl 

used for human risk assessment is 

shown in the following Table. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR THIFENSULFURON 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 = 159 mg/kg/day ..

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

aRfD = 1.59 mg/kg/day .....

aPAD = 1.59 mg/kg/day 

Developmental oral toxicity in rats. 

LOAEL = 725 mg/kg/day, based on an increased incidence of small renal papillae. 

Chronic dietary ....................

(All populations) ...................

NOAEL= 4.3 mg/kg/day ....

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

cRfD = 0.043 mg/kg/day ...

cPAD = 0.043 mg/kg/day 

Carcinogenicity oral toxicity in mice. 

LOAEL = 128 mg/kg/day, based on decreased body 

weight and body weight gain. 

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 thifensulfuron methyl, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing thifensulfuron methyl 

tolerances in 40 CFR 180.439. EPA 

assessed dietary exposures from 

thifensulfuron 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 

thifensulfuron 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 assumed 100 percent crop 

treated (PCT) and tolerance level 

residues for all commodities. 

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 100 PCT and tolerance level 

residues for all commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that thifensulfuron 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 

thifensulfuron 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 thifensulfuron methyl in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of thifensulfuron 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 (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

thifensulfuron methyl for acute 

exposures are estimated to be 4.429 

parts per billion (ppb) for surface water 

and 0.0972 ppb for ground water. For 

chronic exposures for non-cancer 

assessments the EDWCs are estimated to 

be 1.5 ppb for surface water and 0.0972 

ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 4.429 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 1.5 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). 

Thifensulfuron methyl is not 

registered for any specific use patterns 

that would result in residential 

exposure. 

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 thifensulfuron 

methyl to share a common mechanism 

of toxicity with any other substances, 

and thifensulfuron 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 

thifensulfuron 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. 

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Federal Register / Vol. 77, No. 168 / Wednesday, August 29, 2012 / Rules and Regulations 52239 

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 toxicology 

database for thifensulfuron methyl 

includes rat and rabbit prenatal 

developmental toxicity studies and a 2- 

generation reproduction toxicity study 

in rats. There was evidence of increased 

quantitative susceptibility in the rat 

developmental toxicity study. At the 

HDT, decreased mean fetal weights, and 

an increase in incidence of small renal 

papillae were observed in the absence of 

maternal toxicity. There was no 

indication of pre- or post-natal 

susceptibility in the rabbit 

developmental or rat reproduction 

studies. 

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 

thifensulfuron methyl is complete. 

ii. There is no indication that 

thifensulfuron 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 was evidence of 

increased quantitative susceptibility in 

the rat developmental study, the 

Agency’s degree of concern for the 

increased susceptibility is low because 

it was only observed in the rat 

developmental toxicity study and not 

seen in the rabbit developmental or 

reproduction studies, and was observed 

at doses considerably higher than the 

doses chosen for risk assessment; in 

addition, there was a clear NOAEL for 

the fetal effects, and therefore EPA’s risk 

assessment is protective of the potential 

susceptibility. 

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 

thifensulfuron methyl in drinking water. 

These assessments will not 

underestimate the exposure and risks 

posed by thifensulfuron 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 

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 

thifensulfuron methyl will occupy less 

than 1% of the aPAD for females 13–49 

years old, the only population subgroup 

of concern. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to thifensulfuron 

methyl from food and water will utilize 

1.4% of the cPAD for children 3–5 years 

old, the population group receiving the 

greatest exposure. There are no 

residential uses for thifensulfuron 

methyl. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

A short- and intermediate-term 

adverse effect was identified; however, 

thifensulfuron methyl is not registered 

for any use patterns that would result in 

either short- and/or intermediate-term 

residential exposure. Short- and 

intermediate-term risk is assessed based 

on short- and intermediate-term 

residential exposure plus chronic 

dietary exposure. Because there is no 

short- and/or 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 short- and 

intermediate-term risk), no further 

assessment of short- and intermediateterm risk is necessary, and EPA relies on 

the chronic dietary risk assessment for 

evaluating short- and intermediate-term 

risk for thifensulfuron methyl. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

thifensulfuron methyl is not expected to 

pose a cancer risk to humans. 

5. 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 

thifensulfuron methyl residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(liquid chromatograpy/mass 

spectrometry/mass spectrometry (LC/ 

MS/MS)) is available to enforce the 

tolerance expression. The method may 

be requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

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. The Codex has not 

established a MRL for thifensulfuron 

methyl in or on chicory roots and/or 

tops. 

V. Conclusion 

Therefore, tolerances are established 

for residues of thifensulfuron methyl, 

methyl-3-[[[[(4-methoxy-6-methyl-1,3,5-

triazin-2-ylamino]carbonyl]amino]

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52240 Federal Register / Vol. 77, No. 168 / Wednesday, August 29, 2012 / Rules and Regulations 

sulfonyl]-2-thiophenecarboxylate, in or 

on chicory roots at 0.01 ppm and 

chicory tops at 0.01 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) (Pub. L. 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: August 17, 2012. 

Daniel J. Rosenblatt, 

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 180.439 is amended by 

alphabetically adding the following 

commodities to the table in paragraph 

(a) to read as follows: 

§ 180.439 Thifensulfuron methyl; 

tolerances for residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Chicory, roots ....................... 0.01 

Chicory, tops ......................... 0.01 

* * * * * 

* * * * * 

[FR Doc. 2012–21356 Filed 8–28–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0521; FRL–9360–5] 

Pendimethalin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of pendimethalin 

in or on multiple commodities which 

are identified and discussed later in this 

document. Interregional Research 

Project No. 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 29, 2012. Objections and 

requests for hearings must be received 

on or before October 29, 2012, 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–2011–0521, 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: 

Andrew Ertman, Registration Division, 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; email address: 

ertman.andrew@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 

mstockstill on DSK4VPTVN1PROD with RULES