Federal Register / Vol. 77, No. 246 / Friday, December 21, 2012 / Rules and Regulations 75561 

III. Why is this correction issued as a 

final rule? 

Section 553 of the Administrative 

Procedure Act (APA) (5 U.S.C. 

553(b)(3)(B)) provides that, when an 

agency for good cause finds that notice 

and public procedure are impracticable, 

unnecessary, or contrary to the public 

interest, the agency may issue a final 

rule without providing notice and an 

opportunity for public comment. EPA 

has determined that there is good cause 

for making this technical correction 

final without prior proposal and 

opportunity for comment, because this 

action merely corrects erroneous crop 

group names and an erroneous tolerance 

level that were due to an inadvertent 

error. Both the correct crop group names 

and tolerance level received prominent 

notice in the published notice of the 

petition and in EPA’s preamble to the 

final rule. EPA finds that this 

constitutes good cause under 5 U.S.C. 

553(b)(3)(B). 

IV. Do any of the statutory and 

Executive Order reviews apply to this 

action? 

No. For a detailed discussion 

concerning the statutory and executive 

order reviews, refer to Unit VI. of the 

October 3, 2007 final rule. 

V. 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: December 12, 2012. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR part 180 is 

corrected 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 Section 180.628, the table to 

paragraph (a) is amended as follows: 

■ i. Remove the entries for Cotton, 

undelinted seed; Lunaria, seed; 

Rapeseed subgroup 20B; Sunflower 

subgroup 20C; Vegetable, foliage of 

legume, group 7, forage; and Vegetable, 

foliage of legume, group 7, hay. 

■ ii. Add alphabetically entries for 

Rapeseed subgroup 20A; Sunflower 

subgroup 20B; and Vegetable, foliage of 

legume, group 7. 

The added entries read as follows: 

§ 180.628 Chlorantraniliprole; tolerances 

for residues. 

(a) General. * * * 

Commodity Parts per 

million 

*****

Rapeseed subgroup 20A .... 2 .0 

*****

Sunflower subgroup 20B .... 2 .0 

*****

Vegetable, foliage of legume, group 7 ................... 90 

*****

* * * * * 

[FR Doc. 2012–30850 Filed 12–20–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0010; FRL–9372–4] 

Quinclorac; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of quinclorac in 

or on berry, low growing, except 

strawberry, subgroup 13–07 H and 

rhubarb. Interregional Research Project 

Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 21, 2012. Objections and 

requests for hearings must be received 

on or before February 19, 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–2012–0010, 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: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; email address: 

nollen.laura@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. 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. 

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 

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75562 Federal Register / Vol. 77, No. 246 / Friday, December 21, 2012 / Rules and Regulations 

identify docket ID number EPA–HQ– 

OPP–2012–0010 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 19, 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– 

2012–0010, 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 April 4, 

2012 (77 FR 20334) (FRL–9340–4), 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 1E7957) by IR–4, 500 

College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.463 be 

amended by establishing tolerances for 

residues of the herbicide quinclorac, 

3,7-dichloro-8-quinolinecarboxylic acid, 

in or on berry, low growing, except 

strawberry, subgroup 13–07H at 1.1 

parts per million (ppm) and rhubarb at 

0.4 ppm. That document referenced a 

summary of the petition prepared on 

behalf of IR–4 by BASF Corporation, the 

registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

the tolerance levels for the proposed 

commodities. The reason for these 

changes is explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue * * *.’’ 

Consistent with 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 quinclorac 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with quinclorac 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. 

Quinclorac has a low order of acute 

toxicity via the oral, dermal, and 

inhalation routes of exposure. It is not 

a skin irritant, but is a mild eye irritant 

and tested positive for dermal 

sensitization. Following subchronic 

exposures to quinclorac, signs of 

toxicity included decreased body weight 

gains, increased water intake, increased 

liver enzymes, and focal chronic 

interstitial nephritis (rats). Chronic toxic 

effects included body weight decrement, 

increase in kidney and liver weights, 

and hydropic degeneration of the 

kidneys (dogs). At high doses, chronic 

toxicity also included increased 

incidences of pancreatic acinar cell 

hyperplasia and adenomas in rats. There 

was no evidence of neurotoxicity in any 

acute, subchronic and chronic studies 

for quinclorac. 

There was no increased qualitative or 

quantitative fetal or offspring 

susceptibility in the prenatal 

developmental or postnatal 

reproduction studies. Developmental 

toxicity in the rabbit consisted of 

increased resorptions, post-implantation 

loss, decreased number of live fetuses, 

and reduced fetal body weight. These 

effects occurred at higher doses than the 

maternal effects of decreased food 

consumption and increased water 

consumption and decreased body 

weight gain. In the rat, no 

developmental toxicity was observed up 

to the highest dose tested (HDT). In the 

2-generation rat reproduction study, 

parental toxicity and offspring toxicity 

occurred at the same dose. Parental 

toxicity consisted of reduced body 

weight in both sexes during premating 

and lactation periods, and offspring 

toxicity consisted of decreased pup 

weight, developmental delays, and 

possible marginal effect on pup 

viability. No reproductive toxicity 

occurred up to the HDT in this study. 

Quinclorac is not mutagenic in 

bacterial assays and does not cause 

unscheduled DNA damage in primary 

rat hepatocytes. There is also no 

evidence of a genotoxic response in 

whole animal test systems (in vivo 

mouse bone marrow micronucleus 

assay) and was negative in a mammalian 

cell in vitro cytogenetic chromosomal 

aberration assay in Chinese hamster 

ovary cells. Quinclorac produced an 

equivocal increase in the incidence of 

one type of benign tumor (pancreatic 

acinar cell adenomas) in only one sex of 

one species of animals (male Wistar 

rats). There was no evidence of 

carcinogenicity in mice or female rats. 

Based on this limited evidence on 

cancer, a quantification of cancer risk is 

not warranted because the chronic RfD 

will adequately account for all chronic 

effects, including carcinogenicity, that 

may result from exposure to quinclorac. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by quinclorac as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

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Federal Register / Vol. 77, No. 246 / Friday, December 21, 2012 / Rules and Regulations 75563 

www.regulations.gov in document, 

‘‘Quinclorac: First Risk Assessment In 

Support of Registration Review and for 

New Proposed Use on Rhubarb and 

Berry, low growing, except Strawberry, 

Subgroup 13–07H,’’ pp. 62–65 in docket 

ID number EPA–HQ–OPP–2012–0010. 

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 quinclorac used for 

human risk assessment is shown in 

following Table. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR QUINCLORAC 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 13–49 years 

of age).

NOAEL = 200 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 2.0 mg/kg/ 

day.

aPAD = 2.0 mg/kg/day 

Developmental toxicity study in rabbits. 

LOAEL = 600 mg/kg/day based on increased 

early resorptions and postimplantation loss, decreased live fetuses, decreased fetal body 

weight. 

Acute dietary (General population including infants and children).Not applicable. An endpoint for acute dietary exposure to the general population was not selected because there was no available endpoint attributable to a single exposure that was appropriate for 

this scenario (effects observed in the available studies are presumed to require more than one exposure). 

Chronic dietary (All populations) ......... NOAEL= 37.5 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.38 mg/ 

kg/day.

cPAD = 0.38 mg/kg/day 

Carcinogenicity study in mice. 

LOAEL = 150 mg/kg/day based on decreased 

body weight. 

Inhalation short-term (1 to 30 days) .... Oral study NOAEL= 70 

mg/kg/day (inhalation 

absorption rate = 

100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ...... Developmental toxicity study in rabbits. 

LOAEL = 200 mg/kg/day based on decreased 

maternal body weight gain and food consumption, and increased water consumption. 

Incidental oral short-term (1 to 30 

days).

NOAEL= 70 mg/kg/day

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ...... Developmental toxicity study in rabbits. 

LOAEL = 200 mg/kg/day based on decreased 

maternal body weight gain and food consumption, and increased water consumption. 

Cancer (Oral, dermal, inhalation) ........ The chronic RfD will adequately account for all chronic effects, including carcinogenicity, that may result 

from exposure to quinclorac. 

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 quinclorac, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

quinclorac tolerances in 40 CFR 

180.463. EPA assessed dietary 

exposures from quinclorac 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. EPA identified such an effect 

(increased early resorptions and postimplantation loss, decreased live 

fetuses, and decreased fetal body weight 

in developmental toxicity study in 

rabbits) for the population subgroup 

females 13 to 49 years old; however, no 

such effect was identified for the general 

population, including infants and 

children. 

In estimating acute dietary exposure 

for females 13–49, the population group 

identified as having an acute dietary 

exposure, EPA used Dietary Exposure 

Evaluation Model software with the 

Food Commodity Intake Database 

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(DEEM–FCID) Version 3.16, which uses 

food consumption data from the U.S. 

Department of Agriculture’s National 

Health and Nutrition Examination 

Survey, What We Eat in America, 

(NHANES/WWEIA), conducted from 

2003–2008. As to residue levels in food, 

EPA assumed 100 percent crop treated 

(PCT) and tolerance-level residues for 

all commodities. In addition, DEEM 

version 7.81 default processing factors 

were used when appropriate. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA’s 2003–2008 NHANES/ 

WWEIA. As to residue levels in food, 

EPA assumed 100 PCT and tolerancelevel residues for all commodities. In 

addition, DEEM version 7.81 default 

processing factors were used when 

appropriate. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to quinclorac. Cancer risk 

was assessed using the same exposure 

estimates as discussed in Unit III.C.1.ii. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for quinclorac. 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 quinclorac in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of quinclorac. 

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 I Rice Model, 

Version 1.0, the estimated drinking 

water concentrations (EDWCs) of 

quinclorac for surface water are 

estimated to be 511 parts per billion 

(ppb) for acute and chronic exposures. 

Based on the Screening Concentration 

in Ground Water (SCI GROW) model, 

the EDWCs for ground water are 

estimated to be 29 ppb for acute and 

chronic exposures. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute and chronic dietary risk 

assessments, the water concentration 

value of 511 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). 

Quinclorac is currently registered for 

the following uses that could result in 

residential exposures: Turf grass and 

ornamentals. EPA assessed residential 

exposure using the following 

assumptions: Short-term inhalation 

exposures for residential handlers from 

mixing, loading, and applying 

quinclorac to residential turf and shortterm postapplication incidental oral 

exposures (hand-to-mouth activities) of 

children from contact with treated turf. 

Intermediate-term exposures resulting 

from adult handler and postapplication 

exposures were not assessed due to a 

lack of a dermal point of departure. 

Incidental oral scenarios for children are 

considered to be short-term only. 

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 quinclorac to share 

a common mechanism of toxicity with 

any other substances, and quinclorac 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that quinclorac 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 toxicology database for quinclorac 

consists of developmental toxicity 

studies in rats and rabbits and a 2- 

generation reproduction study in rats. 

There is no indication of increased 

qualitative or quantitative susceptibility 

of rats or rabbit fetuses to in utero and/ 

or postnatal exposure in the 

developmental and reproductive 

toxicity data. 

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 quinclorac 

is complete. 

ii. There is no indication that 

quinclorac is a neurotoxic chemical and 

there is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. There is no evidence that 

quinclorac results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

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 quinclorac in 

drinking water. EPA used similarly 

conservative assumptions to assess 

incidental oral exposures (hand-tomouth activities) of toddlers to 

quinclorac. These assessments will not 

underestimate the exposure and risks 

posed by quinclorac. 

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 

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Federal Register / Vol. 77, No. 246 / Friday, December 21, 2012 / Rules and Regulations 75565 

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 

quinclorac will occupy 1.6% of the 

aPAD for females 13–49, the population 

group for which a potential acute risk 

was identified. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to quinclorac 

from food and water will utilize 8.9% of 

the cPAD for infants less than 1 year of 

age, 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 

quinclorac 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). Quinclorac 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 

quinclorac. 

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 2,100 for adults and 1,600 for 

children 1–2 years old. Because EPA’s 

level of concern for quinclorac 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, quinclorac is not 

registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm 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 intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

quinclorac. 

5. Aggregate cancer risk for U.S. 

population. Based on the discussion in 

Unit III.A., EPA has concluded that the 

cPAD is protective of possible cancer 

effects. 

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 quinclorac 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate gas chromatography with 

electron capture detection (GC/ECD) 

method (BASF Method A8902), 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 quinclorac. 

C. Revisions to Petitioned-for Tolerances 

Based on analysis of the residue field 

trial data supporting the petition, EPA 

revised the proposed tolerances on 

berry, low growing, except strawberry, 

subgroup 13–07H from 1.1 ppm to 1.5 

ppm and rhubarb from 0.4 ppm to 0.5 

ppm. The Agency revised these 

tolerance levels based on analysis of the 

residue field trial data using the 

Organization for Economic Co-operation 

and Development (OECD) tolerance 

calculation procedures. 

V. Conclusion 

Therefore, tolerances are established 

for residues of quinclorac, 3,7-dichloro8-quinolinecarboxylic acid, in or on 

berry, low growing, except strawberry, 

subgroup 13–07H at 1.5 ppm; and 

rhubarb at 0.5 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 

mstockstill on DSK4VPTVN1PROD with 

75566 Federal Register / Vol. 77, No. 246 / Friday, December 21, 2012 / Rules and Regulations 

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: December 12, 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 § 180.463, add alphabetically the 

following commodities to the table in 

paragraph (a) to read as follows: 

§ 180.463 Quinclorac; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Berry, low growing, except 

strawberry, subgroup 13– 

07H .................................... 1.5 

* * * * * 

Rhubarb ................................ 0.5 

Commodity Parts per 

million 

* * * * * 

* * * * * 

[FR Doc. 2012–30851 Filed 12–20–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2012–0740; FRL–9373–8] 

RIN 2070–AB27 

Significant New Use Rule on Certain 

Chemical Substances; Withdrawal of 

Significant New Use Rules 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is withdrawing 

significant new use rules (SNURs) 

promulgated under the Toxic 

Substances Control Act (TSCA) for 

chemical substances which were the 

subject of premanufacture notices 

(PMNs). EPA published these SNURs 

using direct final rulemaking 

procedures. EPA received notices of 

intent to submit adverse comments on 

these rules. Therefore, the Agency is 

withdrawing these SNURs, as required 

under the expedited SNUR rulemaking 

process. EPA intends to publish in the 

near future proposed SNURs for these 

eight chemical substances under 

separate notice and comment 

procedures. 

DATES: This final rule is effective 

January 2, 2013. 

FOR FURTHER INFORMATION CONTACT: 

For technical information contact: 

Kenneth Moss, Chemical Control 

Division (7405M), Office of Pollution 

Prevention and Toxics, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001; 

telephone number: (202) 564–9232; 

email address: Moss.Kenneth@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCAHotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Does this action apply to me? 

A list of potentially affected entities is 

provided in the Federal Register of 

November 2, 2012 (77 FR 66149) (FRL– 

9366–7). If you have questions regarding 

the applicability of this action to a 

particular entity, consult the technical 

person listed under FOR FURTHER

INFORMATION CONTACT. 

II. What rule is being withdrawn? 

In the Federal Register of November 

2, 2012 (77 FR 66149), EPA issued 

several direct final SNURs, including 

SNURs for the chemical substances that 

are the subject of this withdrawal. These 

direct final rules were issued pursuant 

to the procedures in 40 CFR part 721, 

subpart D. In accordance with 

§ 721.160(c)(3)(ii), EPA is withdrawing 

the rule issued for eight chemical 

substances which were the subject of 

PMNs P–11–327, P–11–328, P–11–329, 

P–11–330, P–11–331, P–11–332, P–12– 

298, and P–12–299, because the Agency 

received notices of intent to submit 

adverse comments. EPA intends to 

publish a proposed SNUR for these 

chemical substances under separate 

notice and comment procedures. 

For further information regarding 

EPA’s expedited process for issuing 

SNURs, interested parties are directed to 

40 CFR part 721, subpart D, and the 

Federal Register of July 27, 1989 (54 FR 

31314). The record for the direct final 

SNURs for the chemical substances that 

are being withdrawn was established at 

EPA–HQ–OPPT–2012–0740. That 

record includes information considered 

by the Agency in developing these rules 

and the notices of intent to submit 

adverse comments. 

III. How do I access the docket? 

To access the electronic docket, 

please go to http://www.regulations.gov 

and follow the online instructions to 

access docket ID number EPA–HQ– 

OPPT–2012–0740. Additional 

information about the Docket Facility is 

provided under ADDRESSES in the 

Federal Register of November 2, 2012 

(77 FR 66149). If you have questions, 

consult the technical person listed 

under FOR FURTHER INFORMATION

CONTACT. 

IV. Statutory and Executive Order 

Reviews 

This final rule revokes or eliminates 

an existing regulatory requirements and 

does not contain any new or amended 

requirements. As such, the Agency has 

determined that this withdrawal will 

not have any adverse impacts, economic 

or otherwise. The statutory and 

executive order review requirements 

applicable to the direct final rules were 

discussed in the Federal Register of 

November 2, 2012 (77 FR 66149). Those 

review requirements do not apply to 

this action because it is a withdrawal 

mstockstill on DSK4VPTVN1PROD with