Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / Rules and Regulations 51485 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. 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) (Public Law 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). 

XII. 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: September 29, 2009. 

G. Jeffrey Herndon, 

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 § 180.920, the table is amended 

by adding alphabetically the following 

inert ingredient to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * * * 

Ammonium chloride 

(CAS Reg. No. 

12125–02–9) 

Carrier/ 

nutrient 

* * * * * * * 

[FR Doc. E9–24161 Filed 10–6–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0518; FRL–8434–3] 

Quinclorac; Pesticide Tolerance for 

Emergency Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

time-limited tolerance for residues of 

quinclorac in or on cranberry. This 

action is in response to EPA’s granting 

of an emergency exemption under 

section 18 of the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA) 

authorizing use of the pesticide on 

cranberries. This regulation establishes 

a maximum permissible level for 

residues of quinclorac in this food 

commodity. The time-limited tolerance 

expires and is revoked on December 31, 

2012. 

DATES: This regulation is effective 

October 7, 2009. Objections and 

requests for hearings must be received 

on or before December 7, 2009, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0518. All documents in the 

docket are listed in the docket index 

available in http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Marcel Howard, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6784; e-mail address: 

Howard.Marcel@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: 

• Crop production (NAICS code 

111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of 40 CFR part 180 


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51486 Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / Rules and Regulations 

through the Government Printing 

Office’s e-CFR cite at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

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. The EPA procedural 

regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

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–2009–0518 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before December 7, 2009. 

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 that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2009–0518, by one of 

the following methods: 

• Federal eRulemaking Portal: 

http://www.regulations.gov. Follow the 

on-line instructions for submitting 

comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

EPA, on its own initiative, in 

accordance with sections 408(e) and 

408(l)(6) of FFDCA, 21 U.S.C. 346a(e) 

and 346a(1)(6), is establishing a timelimited tolerance for residues of the 

herbicide quinclorac, 3,7-dichloro-8- 

quinolinecarboxylic acid, in or on 

cranberries at 15.0 parts per million 

(ppm). This time-limited tolerance 

expires and is revoked on December 31, 

2012. EPA will publish a document in 

the Federal Register to remove the 

revoked tolerances from the CFR. 

Section 408(l)(6) of FFDCA requires 

EPA to establish a time-limited 

tolerance or exemption from the 

requirement for a tolerance for pesticide 

chemical residues in food that will 

result from the use of a pesticide under 

an emergency exemption granted by 

EPA under section 18 of FIFRA. Such 

tolerances can be established without 

providing notice or period for public 

comment. EPA does not intend for its 

actions on section 18 related timelimited tolerances to set binding 

precedents for the application of section 

408 of FFDCA and the new safety 

standard to other tolerances and 

exemptions. Section 408(e) of FFDCA 

allows EPA to establish a tolerance or an 

exemption from the requirement of a 

tolerance on its own initiative, i.e., 

without having received any petition 

from an outside party. 

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. . . .’’ 

Section 18 of FIFRA authorizes EPA 

to exempt any Federal or State agency 

from any provision of FIFRA, if EPA 

determines that ‘‘emergency conditions 

exist which require such exemption.’’ 

EPA has established regulations 

governing such emergency exemptions 

in 40 CFR part 166. 

III. Emergency Exemption for 

Quinclorac on Cranberries and FFDCA 

Tolerances 

The Massachusetts Department of 

Agriculture Resources (MDAR) 

requested the use of quinclorac through 

an emergency exemption to control 

dodder on cranberries. According to 

MDAR, dodder is a serious and 

devastating pest in commercial 

cranberry production. The MDAR stated 

that currently available herbicides are 

inadequate for dodder control and 

growers have experienced at least a 50% 

yield loss due to dodder infestation. 

After having reviewed the submission, 

EPA determined that emergency 

conditions exist for this State, and that 

the criteria for an emergency exemption 

are met. EPA has authorized under 

FIFRA section 18 the use of quinclorac 

on cranberries for control of dodder in 

Massachusetts. 

As part of its evaluation of the 

emergency exemption application, EPA 

assessed the potential risks presented by 

residues of quinclorac in or on 

cranberries. In doing so, EPA considered 

the safety standard in section 408(b)(2) 

of FFDCA, and EPA decided that the 

necessary tolerance under section 

408(l)(6) of FFDCA would be consistent 

with the safety standard and with 

FIFRA section 18. Consistent with the 

need to move quickly on the emergency 

exemption in order to address an urgent 

non-routine situation and to ensure that 

the resulting food is safe and lawful, 

EPA is issuing this tolerance without 

notice and opportunity for public 

comment as provided in section 

408(l)(6) of FFDCA. Although these 

time-limited tolerances expire and are 

revoked on December 31, 2012, under 

section 408(l)(5) of FFDCA, residues of 

the pesticide not in excess of the 

amounts specified in the tolerance 

remaining in or on cranberries after that 

date will not be unlawful, provided the 

pesticide was applied in a manner that 

was lawful under FIFRA, and the 

residues do not exceed a level that was 

authorized by these time-limited 

tolerances at the time of that 

application. EPA will take action to 

revoke these time-limited tolerances 

earlier if any experience with, scientific 

data on, or other relevant information 

on this pesticide indicate that the 

residues are not safe. 

Because these time-limited tolerances 

are being approved under emergency 

conditions, EPA has not made any 

decisions about whether quinclorac 

meets FIFRA’s registration requirements 

for use on cranberries or whether 

permanent tolerances for this use would 

be appropriate. Under these 

circumstances, EPA does not believe 

that this time-limited tolerance decision 

serves as a basis for registration of 

quinclorac by a State for special local 

needs under FIFRA section 24(c). Nor 

does this tolerance serve as the basis for 

persons in any State other than 


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Massachusetts to use this pesticide on 

these crops under FIFRA section 18 

absent the issuance of an emergency 

exemption applicable within that State. 

For additional information regarding the 

emergency exemption for quinclorac, 

contact the Agency’s Registration 

Division at the address provided under 

FOR FURTHER INFORMATION CONTACT. 

IV. 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 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 expected as a result 

of this emergency exemption request 

and the time-limited tolerance for 

residues of quinclorac on cranberries at 

15.0 ppm. EPA’s assessment of 

exposures and risks associated with 

establishing time-limited tolerances 

follows. 

A. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

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 greater than that 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 can be found at 

http://www.regulations.gov in the 

document Quinclorac. Human Health 

Risk Assessment for the Proposed Food/ 

Feed Use of the Herbicide (Associated 

with Section 18 Registation) on 

Cranberries in Massachusetts, pages 14– 

41 in docket ID number EPA–HQ–OPP– 

2009–0518. 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to quinclorac, EPA considered 

exposure under the time-limited 

tolerances established by this action 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. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States 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 (% CT) and 

tolerance-level residues for all 

agricultural commodities. Default 

processing factors from Dietary 

Exposure Evaluation Model (DEEM) 

7.81 were used (for dried beef and 

cranberry juice) in the analyses. 

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% CT, 

along with tolerance-level residues for 

all agricultural commodities. Default 

processing factors from DEEM 7.81 were 

used (for dried beef and cranberry juice) 

in the analyses. 

iii. Cancer. Based on an evaluation 

under the 1986 Agency Cancer 

Assessment Guidelines and the results 

of carcinogenicity studies in rats and 

mice, EPA has classified quinclorac as 

‘‘not classifiable as to carcinogenicity to 

humans.’’ The results indicate that there 

was equivocal evidence of an increase 

in the incidence of pancreatic acinar 

cell adenomas in the male rat only, and 

no increase in female rats nor in mice. 

A quantification of cancer risk is not 

warranted because the chronic reference 

dose is approximately 1,200-fold lower 

than the dose that induced the benign 

pancreatic tumors. Therefore, EPA 

considers the chronic assessment to be 

protective of potential cancer impacts. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for quinclorac. Tolerance level residues 

and/or 100% CT 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 modified Tier I 

Provisional Cranberry Model (PRZM 

and EXAMS models are not based on 

typical properties of cranberry bogs, 

which involves flooding) and Screening 

Concentration in Ground Water (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

quinclorac for acute exposures and 

chronic exposures for non-cancer 

assessments are estimated to be 0.077 

parts per billion (ppb) and 0.070 ppb, 

respectively, for surface water and 0.019 

ppb for both acute and chronic (noncancer) ground water. 


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Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

both acute and chronic dietary risk 

assessment, the water concentration 

value of 0.077 ppb was used to assess 

the contribution to drinking water. 

Conservative assumptions used in these 

model estimates help ensure that the 

outputs are protective of most 

environments associated with 

agricultural uses; thus, the estimates are 

expected to exceed peak values found in 

the environment in most cases. 

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 use that could result in 

residential exposures: turf and lawns. 

EPA assessed residential exposure using 

the following assumptions for toddlers: 

i. Five percent of the application rate 

has been used to calculate the day-zero 

turf transferable residue (TTR) levels 

used for assessing risks from hand-tomouth exposures, since quincloracspecific turf transferable residue study 

data are not available; 

ii. Twenty percent of the application 

rate has been used to calculate the dayzero turf transferable residue (TTR) 

residue levels used for assessing risks 

from object-to-mouth exposures (a 

higher percent transfer has been used 

for object-to-mouth behaviors, because it 

involves a teething action believed to be 

more analogous to DFR/leaf wash 

sample collection, where 20% is also 

used); 

iii. Three year-old toddlers are 

expected to weigh 15 kilograms 

(representing an average weight from 

years 1 to 6); 

iv. Hand-to-mouth exposures are 

based on a frequency of 20 events/hour, 

and a surface area per event of 20 square 

centimeters, representing the palm-side 

surfaces of three fingers; 

v. Saliva extraction efficiency is 50%, 

meaning that every time the hand goes 

in the mouth, approximately half of the 

residues on the hand are removed; 

vi. Object-to-mouth exposures are 

based on a 25 square centimeter surface 

area; 

vii. Exposure durations for turfgrass 

scenarios are estimated to be 2 hours, 

based on information in HED’s Exposure 

Factors Handbook; and 

viii. Soil residues are contained in the 

top centimeter, and soil density is 0.67 

milliliters per gram. 

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 the policy statements 

released by EPA’s Office of Pesticide 

Programs concerning common 

mechanism determinations and 

procedures for cumulating effects from 

substances found to have a common 

mechanism on EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

C. 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 SF. In applying this provision, 

EPA either retains the default value of 

10X, or uses a different additional SF 

when reliable data available to EPA 

support the choice of a different factor. 

2. Prenatal and postnatal sensitivity. 

There is no qualitative evidence of 

increased prenatal and/or postnatal 

susceptibility and, due to the marginal 

nature of the effects observed on pup 

viability in the multigeneration 

reproductive toxicity study, no residual 

uncertainties with regard to prenatal 

toxicity following in utero exposures of 

rats or rabbits to quinclorac 

(developmental toxicity studies), and 

prenatal and/or postnatal exposure of 

rats to quinclorac (reproductive toxicity 

study) at the estimated aggregate 

exposure levels. Furthermore, the 

exposure levels selected for use in risk 

assessment are measurably lower than 

the NOAEL from the multigeneration 

study, and therefore protective against 

the marginal effects seen in pups. 

3. Conclusion. EPA has determined 

that reliable data show that 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 sufficiently complete to inform the 

determination for the FQPA safety 

factor. Although recent changes to 40 

CFR part 158 make acute and 

subchronic neurotoxicity testing 

(OPPTS Harmonized Guideline 

870.6200), and immunotoxicity testing 

(OPPTS Harmonized Guideline 

870.7800) required for pesticide 

registration, the available data for 

quinclorac do not show the potential for 

immunotoxic nor neurotoxic effects. 

However, future registration actions 

may require additional toxicity studies. 

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 for purposes 

of this time-limited tolerance. 

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. 

EPA made conservative (protective) 

assumptions in the ground water and 

surface water modeling used to assess 

exposure to quinclorac in drinking 

water. EPA used similarly conservative 

assumptions to assess post-application 

exposure of children as well as 

incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by quinclorac. 

D. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases 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 POD to 

ensure that the MOE called for by the 


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product of all applicable UFs is not 

exceeded. 

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 less than 1% of 

the aPAD for females age 13 to 49, 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 

from food and water will utilize 3% of 

the cPAD for children 1 to 2 years of 

age, the population group receiving the 

greatest exposure, while the general U.S. 

population utilizes 2% of the cPAD. 

Quinclorac is not expected to pose a 

chronic dietary risk for the general 

population (including infants and 

children). The chronic risk estimates for 

all populations, resulting from aggregate 

exposure to quinclorac in food and 

drinking water, is below EPA’s chronic 

LOC, and therefore not of concern. 

3. Short-term and intermediate-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). 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

non-dietary, non-occupational exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Because short- and 

intermediate-term exposure may occur 

as a result of quinclorac use in 

residential settings, both assessments 

were based on toddler exposure from an 

oral route: hand-to-mouth, object-tomouth, and incidental soil ingestion. 

The oral MOEs for residential postapplication exposure of toddlers range 

from 6,300 to 1,800,000. The combined 

MOE of 5,000 is greater than the LOC. 

These values are greater than the LOC 

(100) for the short-term and 

intermediate-term risk assessment and 

therefore not of concern. The postapplication exposure scenarios from the 

use on turf represent worst-case 

estimates of exposure and risk. To 

evaluate short- and intermediate-term 

aggregate risk, EPA has included the 

post-application combined MOE (5,000) 

with the MOE derived from chronic 

dietary exposure estimates (to reflect 

background dietary exposure). The 

behaviors associated with postapplication exposures are applicable to 

toddlers, so only those age groups 

(infants, children 1–2 years of age, and 

children 3–5 years of age) have been 

assessed for short- and intermediateterm aggregate risk. Aggregate MOEs are 

all greater than 100 (MOEs range from 

2,900 to 2,700), and are therefore below 

EPA’s short-term and intermediate-term 

LOC. 

4. Aggregate cancer risk for U.S. 

population. Quinclorac has been 

classified as ‘‘not classifiable as to 

carcinogenicity to humans.’’ Therefore, 

aggregate cancer risk from quinclorac is 

not of concern. 

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 quinclorac 

residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate analytical methods, 

utilizing gas chromatography with 

electron capture detection (GC/ECD), are 

available to enforce the tolerance 

expression on plant (BASF Method 

A8902; MRID# 41063537) and animal 

(BASF Method 268/1; MRID# 41063536) 

commodities. Both methods have 

undergone successful Agency method 

validation trials, and have been 

submitted to FDA for publication in 

PAM II as the tolerance enforcement 

methods. The limit of quantitation 

(LOQ) for both methods is 0.05 ppm in 

all matrices. Furthermore, FDA has 

reported that quinclorac can be detected 

by Multiresidue Protocol B. No 

additional data are needed. 

B. International Residue Limits 

There are currently no established 

Codex, Canadian, or Mexican maximum 

residue limits for residues of quinclorac 

in/on cranberry. 

VI. Conclusion 

Therefore, a time-limited tolerance is 

established for residues of quinclorac, 

3,7-dichloro-8-quinolinecarboxylic acid, 

in or on cranberry at 15.0 ppm. This 

tolerance expires and is revoked on 

December 31, 2012. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under sections 408(e) and 408(l)(6) of 

FFDCA. 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 in accordance with 

sections 408(e) and 408(l)(6) of FFDCA, 

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 section 408(n)(4) of FFDCA. 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) (Public Law 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). 

VIII. 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 


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51490 Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / Rules and Regulations 

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: September 25, 2009. 

Lois Rossi, 

Acting Director, 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 180.463 is amended by 

revising paragraph (b) to read as follows: 

§ 180.463 Quinclorac; tolerances for 

residues. 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances specified in the 

following table are established for 

residues of quinclorac, 3,7-dichloro-8- 

quinolinecarboxylic acid in or on the 

specified agricultural commodities, 

resulting from use of the pesticide 

pursuant to FIFRA section 18 

emergency exemptions. The tolerances 

expire and are revoked on the date 

specified in the table. 

Commodity Parts per 

million 

Expiration/ 

revocation 

date 

Cranberry .......... 15.0 12/31/12 

* * * * * 

[FR Doc. E9–24188 Filed 10–06–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0713; FRL–8793–2] 

Pyraclostrobin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

pyraclostrobin and its desmethoxy 

metabolite, expressed as parent 

compound, in or on coffee, bean, green 

at 0.3 parts per million (ppm; this is a 

new import tolerance); fruit, stone, 

group 12 at 2.5 ppm (this is an increase 

in the existing domestic tolerance); 

sorghum, grain, forage at 5.0 ppm; 

sorghum, grain, grain at 0.60 ppm; and 

sorghum, grain, stover at 0.80 ppm (the 

sorghum tolerances are new domestic 

tolerances). BASF Corporation 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

October 7, 2009. Objections and 

requests for hearings must be received 

on or before December 7, 2009, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0713. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: John 

Bazuin, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7381; e-mail address: 

bazuin.john@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may potentially be 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). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also 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.gpoaccess.gov/ecfr. 

To access the OPPTS Harmonized 

Guidelines referenced in this document, 

go directly to the guidelines at http:// 

www.epa.gov/opptsfrs/home/ 

guidelin.htm. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 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–2008–0713 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before December 7, 2009. 

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 


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