Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Rules and Regulations 71523 

Summary of This Action 

All sources subject to the 

requirements of 40 CFR parts 60, 61, 

and 63 are also subject to the equivalent 

requirements of the above-mentioned 

state or local agencies. 

This document informs the public of 

delegations to the above-mentioned 

agencies of the above-referenced Federal 

regulations. 

Authority 

This document is issued under the 

authority of sections 101, 110, 112, and 

301 of the CAA, as amended (42 U.S.C. 

7401, 7410, 7412, and 7601). 

Dated: November 8, 2013. 

Karl Brooks, 

Regional Administrator, Region 7. 

[FR Doc. 2013–28243 Filed 11–27–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0429; FRL–9902–15] 

Quinclorac; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of quinclorac in 

or on rapeseed, subgroup 20A. BASF 

Corporation requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 29, 2013. Objections and 

requests for hearings must be received 

on or before January 28, 2014, 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–2012–0429, 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: 

RDFRNotices@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–2012–0429 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 January 28, 2014. 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– 

2012–0429, 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. 

II. Summary of Petitioned-for Tolerance 

In the Federal Register of July 25, 

2012 (77 FR 43562) (FRL–9353–6), 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 2E8035) by BASF 

Corporation, 26 Davis Drive, P.O. Box 

13528, Research Triangle Park, NC 

27709–3528. 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 

rapeseed, subgroup 20A at 1.0 parts per 

million (ppm). That document 

referenced a summary of the petition 

prepared 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. 

EPA has revised this tolerance level 

based on analysis of the residue field 

trial data using the Organization for 

Economic Co-operation and 

Development (OECD) tolerance 

calculation procedures. The reason for 

this change is explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 


sroberts on DSK5SPTVN1PROD with RULES
71524 Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Rules and Regulations 

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 low acute toxicity by 

oral, inhalation, and dermal routes of 

exposure. It is minimally irritating to 

the eye and non-irritating to the skin. 

Quinclorac is a skin sensitizer. 

Subchronic toxicity includes, 

decreased body weight gains, increased 

water intake, increased liver enzymes, 

and focal chronic interstitial nephritis 

(rats). Chronic toxic effects include body 

weight decrement, increase in kidney, 

and liver weights, and hydropic 

degeneration of the kidneys (dogs). At 

high doses, chronic toxicity also 

includes increased incidences of 

pancreatic acinar cell hyperplasia, and 

adenomas (rats). Neurotoxic effects were 

not observed in any of the acute, 

subchronic and chronic studies with 

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 much 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 at 

the highest dose tested (HDT) (438 

milligrams/kilogram/day (mg/kg/day)). 

In the 2-generation 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. Offspring toxicity 

consisted of decreased pup weight, 

developmental delays and a possible 

marginal effect on pup viability. No 

reproductive toxicity occurred at the 

HDT (480 mg/kg/day). 

There are no mutagenicity concerns. 

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). 

Quinclorac was negative in a 

mammalian cell in vitro cytogenetic 

chromosomal aberration assay in 

Chinese hamster ovary cells (CHO). 

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 of 

cancer, a quantification of cancer risk is 

not warranted because the chronic 

reference dose (RfD) will adequately 

account for all chronic effects, including 

carcinogenicity, likely to result from 

exposure to quinclorac. 

Neurotoxic effects were not observed 

in any of the acute, subchronic and 

chronic studies with quinclorac. Due to 

lack of evidence of neurotoxic effects, 

the Agency has determined that no 

acute, subchronic, or developmental 

neurotoxicity studies are required for 

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:// 

www.regulations.gov in document 

‘‘Quinclorac: Risk Assessment to 

Support Permanent Tolerance for 

Rapeseed Subgroup 20A without U.S. 

Registration’’ in docket ID number EPA– 

HQ–OPP–2012–0429. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern (LOC) to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which 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 

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 

Table 1 of this unit. 


sroberts on DSK5SPTVN1PROD with RULES
Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Rules and Regulations 71525 

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 13–50 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. These fetal effects are 

presumed to occur after a single dose. 

Acute dietary ..........................................

(General population including infants 

and children).

None ..................... None ..................... No acute dietary endpoint selected based on the absence 

of an appropriate endpoint attributed to a single dose. 

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. 

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. 

Dermal short-term ..................................

(1 to 30 days) .........................................

None ..................... None ..................... No adverse effects were seen in dermal studies 

Dermal intermediate-term .......................

(1 to 6 months) .......................................

None ..................... None ..................... Same 

Inhalation short-term (1 to 30 days) .......

and intermediate-term (1 to 6 months) ..

Inhalation (or oral) 

study.

NOAEL = 70 mg/ 

kg/day (inhalation absorption 

rate = 100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC 

for MOE = 100.

Developmental toxicity study in rabbits. 

Maternity toxicity LOAEL = 200 mg/kg/day based on decreased maternal body weight gain and food consumption, and increased water consumption. 

Inhalation ................................................

(1 to 6 months) .......................................

None ..................... None ..................... Long-term inhalation exposure is not anticipated under 

current use scenarios. 

Cancer (Oral, dermal, inhalation) ........... Quantification of risk using the chronic RfD will adequately account for all chronic effects, including 

carcinogenicity, which 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 = 

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

chronic). RfD = reference dose. 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. Such effects were identified 

for quinclorac. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 2003–2008 National Health and 

Nutrition Examination Survey, What We 

Eat in America (NHANES/WWEIA). As 

to residue levels in food, the acute 

dietary assessment assumes 100% crop 

treated (PCT) along with tolerance or 

maximum residue level estimates for 

quinclorac and its methyl ester 

metabolite. It used dietary exposure 

evaluation model (DEEM) default 

processing factors and an empirical 

processing factor for oil commodities of 

rapeseed subgroup 20A. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the food 

consumption data from the USDA 2003– 

2008, NHANES/WWEIA. As to residue 

levels in food, the chronic dietary 

assessment used the same residue 

levels, processing factors and 100 PCT 

assumptions used in the acute dietary 

assessment. 

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. 


sroberts on DSK5SPTVN1PROD with RULES
71526 Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Rules and Regulations 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for quinclorac. Tolerance or maximum 

residue levels for quinclorac and its 

methyl ester metabolite 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 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 POD. 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 

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 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 tolerance or 

maximum residue levels for residues of 

concern and assumed 100 PCT. 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-to-mouth 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 

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 and its methyl ester 

metabolite will occupy 1.6% of the 

aPAD for females age 13 to 49 years old, 

the population group receiving the 

greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to quinclorac and 

its methyl ester metabolite 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 


sroberts on DSK5SPTVN1PROD with RULES
Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Rules and Regulations 71527 

(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 to 2 years old. Because EPA’s 

LOC 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. As explained in Unit III.A., 

the cPAD is protective of all effects, 

including carcinogenicity. Based on the 

chronic risk assessment described in 

Unit III.E.2., there is no concern for any 

potential carcinogenic effects from 

quinclorac. 

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 

Adequate enforcement methodology 

for quinclorac (liquid chromatography 

with tandem mass spectrometric 

detection (LC/MS/MS) method (BASF 

method D9708/1) and quinclorac methyl 

ester LC/MS/MS method (BASF method 

D9806/02) are 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 the data submitted with the 

petition, EPA is revising the proposed 

tolerances in or on rapeseed subgroup 

20A from 1.0 ppm to 1.5 ppm. The 

Agency revised this tolerance level 

based on analysis of the residue field 

trial data using the Organization for 

Economic Co-operation and 

Development (OECD) tolerance 

calculation procedures. Additionally, 

the Agency determined that the 

tolerance expression for proposed 

tolerance on rapeseed subgroup 20A 

should include quinclorac methyl ester. 

The qualitative nature of quinclorac 

residues in plants was considered 

adequately understood for the currently 

registered crops, based upon the 

metabolism studies on rice, sorghum, 

and wheat. Additional metabolism data 

were submitted for quinclorac on canola 

to support use on rapeseed. This study 

showed a significant level of quinclorac 

methyl ester. The qualitative nature of 

quinclorac residues in livestock is also 

understood based upon the adequate 

goat and poultry metabolism studies. In 

earlier risk assessments, EPA had 

concluded that parent is the only 

residue of concern in both plant and 

livestock commodities for purposes of 

the tolerance expression and risk 

assessment. For the current action, 

because of the significant level of 

quinclorac methyl ester found, the 

Agency concluded that the residue of 

concern on canola is quinclorac and its 

methyl ester. 

V. Conclusion 

Therefore, tolerances are established 

for residues of the herbicide quinclorac, 

including its metabolites and 

degradates, in or on the following 

commodity. Compliance with the 

tolerance levels specified in this 

paragraph is to be determined by 

measuring only quinclorac, 3,7- 

dichloro-8-quinolinecarboxylic acid, 

and its methyl ester, methyl-3,7- 

dichloro-8-quinolinecarboxylate, 

calculated as the stoichiometric 

equivalent of quinclorac, in or on 

rapeseed, subgroup 20A at 1.5 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 


sroberts on DSK5SPTVN1PROD with RULES
71528 Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Rules and Regulations 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

9, 2000) do not apply to this final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: November 22, 2013. 

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. In § 180.463: 

■ a. Designate the text of paragraph (a) 

as paragraph (a)(1). 

■ b. Add new paragraph (a)(2). 

The amendments read as follows: 

§ 180.463 Quinclorac; tolerances for 

residues. 

(a) * * * 

(2) Tolerances are established for 

residues of the herbicide quinclorac, 

including its metabolites and 

degradates, in or on the commodity in 

the following table. Compliance with 

the tolerance levels specified in this 

paragraph is to be determined by 

measuring only quinclorac, 3,7- 

dichloro-8-quinolinecarboxylic acid, 

and its methyl ester, methyl-3,7- 

dichloro-8-quinolinecarboxylate, 

calculated as the stoichiometric 

equivalent of quinclorac, in or on the 

commodity. 

Commodity Parts per million 

Rapeseed, subgroup 20A1 ........................................................................................................................................ 1.5 

1There are no U.S. Registrations. 

* * * * * 

[FR Doc. 2013–28640 Filed 11–27–13; 8:45 am] 

BILLING CODE 6560–50–P 

GENERAL SERVICES 

ADMINISTRATION 

41 CFR Part 102–118 

[FRM Change 2013–01; FMR Case 2013– 

102–3; Docket No. 2013–0014; Sequence 

No. 1] 

RIN 3090–AJ39 

Federal Management Regulation 

(FMR); Transportation Payment and 

Audit 

AGENCY: Office of Government-wide 

Policy (OGP), General Services 

Administration (GSA). 

ACTION: Final rule. 

SUMMARY: GSA is amending the Federal 

Management Regulation (FMR) to 

update the name and contact 

information of the Civilian Board of 

Contract Appeals (CBCA) from the 

previously named General Services 

Board of Contract Appeals (GSBCA). 

DATES: Effective Date: November 29, 

2013. 

FOR FURTHER INFORMATION CONTACT: For 

clarification of content, contact Lee 

Gregory, Office of Government-wide 

Policy, at 202–501–1533. Please cite 

FMR Case 2013–102–3. For information 

pertaining to status or publication 

schedules, contact the Regulatory 

Secretariat (MVCB), 1800 F Street NW., 

Washington, DC 20405, 202–501–4755. 

SUPPLEMENTARY INFORMATION: 

A. Background 

The Civilian Board of Contract 

Appeals (CBCA) was established on 

January 6, 2007, pursuant to section 847 

of the National Defense Authorization 

Act for Fiscal Year 2006, Public Law 

109–163, 119 Stat. 3391. That portion of 

the statute is now incorporated into the 

2011 codification of the Contract 

Disputes Act, 41 U.S.C. 7101–7109, and 

the section specifically addressing the 

establishment of the CBCA is 

incorporated into 41 U.S.C. 7105(b)(1) 

‘‘There is established in the General 

Services Administration the Civilian 

Board of Contract Appeals.’’ Although 

the Board is functionally located within 

U.S. General Services Administration as 

of July 8, 2011, ‘‘GSA’’ is not part of its 

name. 

This final rule amends FMR part 102– 

118 (41 CFR part 102–118) by removing 

the term ‘‘General Services Board of 

Contract Appeals’’ and adding the term 

‘‘Civilian Board of Contract Appeals 

(CBCA)’’ in its place. 

B. Executive Orders 12866 and 13563 

Executive Orders (E.O.s) 12866 and 

13563 direct agencies to assess all costs 

and benefits of available regulatory 

alternatives, and if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). E.O. 13563 emphasizes the 

importance of quantifying both costs 

and benefits, of reducing costs, of 

harmonizing rules, and of promoting 

flexibility. This is not a significant 

regulatory action, and therefore, will not 

be subject to review under Section 6(b) 

of E.O. 12866, Regulatory Planning and 

Review, dated September 30, 1993. This 

final rule is not a major rule under 5 

U.S.C. 804. 

C. Regulatory Flexibility Act 

While these revisions are substantive, 

this final rule would not have a 


sroberts on DSK5SPTVN1PROD with RULES