14738 Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 

Act of 1995 (UMRA), 2 U.S.C. 1531– 

1538 for state, local, or tribal 

governments or the private sector. This 

action imposes no enforceable duty on 

any state, local, or tribal governments or 

the private sector. Therefore, this action 

is not subject to the requirements of 

sections 202 and 205 of the UMRA. This 

action is also not subject to the 

requirements of section 203 of UMRA 

because it contains no regulatory 

requirements that might significantly or 

uniquely affect small governments. This 

action only delays the effective date of 

the December 5, 2008 rule and does not 

impose any additional enforceable duty. 

E. Executive Order 13132: Federalism 

Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999), requires EPA to develop an 

accountable process to ensure 

‘‘meaningful and timely input by state 

and local officials in the development of 

regulatory policies that have federalism 

implications.’’ ‘‘Policies that have 

federalism implications’’ is defined in 

the Executive Order to include 

regulations that have ‘‘substantial direct 

effects on the states, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government.’’ 

This action does not have federalism 

implications. It will not have substantial 

direct effects on the states, on the 

relationship between the national 

government and the states, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132. This action will 

not impose direct compliance costs on 

state or local governments, and will not 

preempt state law. Thus, Executive 

Order 13132 does not apply to this 

action. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action does not have tribal 

implications, as specified in Executive 

Order 13175 (59 FR 22951, November 9, 

2000). It will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this action. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

EPA interprets Executive Order 13045 

(62 FR 19885, April 23, 1997) as 

applying to those regulatory actions that 

concern health or safety risks, such that 

the analysis required under section 5– 

501 of the Executive Order has the 

potential to influence the regulation. 

This action is not subject to Executive 

Order 13045 (62 FR 19885, April 23, 

1997) because it is not economically 

significant as defined in Executive 

Order 12866, and because the Agency 

does not believe the environmental 

health or safety risks addressed by this 

action presents a disproportionate risk 

to children. 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This action is not subject to Executive 

Order 13211, ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) because it is 

not a significant regulatory action under 

Executive Order 12866. 

I. National Technology Transfer and 

Advancement Act 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (NTTAA) (Pub. L. 104–113; 

section 12(d) (15 U.S.C. 272 note) 

directs EPA to use voluntary consensus 

standards (VCS) in its regulatory 

activities unless to do so would be 

inconsistent with applicable law or 

otherwise impractical. VCS are 

technical standards (e.g., materials 

specifications, test methods, sampling 

procedures, and business practices) that 

are developed or adopted by VCS 

bodies. NTTAA directs EPA to provide 

Congress, through OMB, explanations 

when EPA decides not to use available 

and applicable VCS. This action does 

not involve technical standards. 

Therefore, EPA did not consider the use 

of any VCS. 

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

Executive Order 12898 (59 FR 7629, 

February 16, 1994) establishes Federal 

executive policy on environmental 

justice. Its main provision directs 

Federal agencies, to the greatest extent 

practicable and permitted by law, to 

make environmental justice part of their 

mission by identifying and addressing, 

as appropriate, disproportionately high 

and adverse human health or 

environmental effects of their programs, 

policies, and activities on minority 

populations and low-income 

populations in the United States. 

EPA has determined that this action 

will not have disproportionately high 

and adverse human health or 

environmental effects on minority or 

low-income populations because it does 

not affect the level of protection 

provided to human health or the 

environment. 

K. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801, et seq., as added by the 

Small Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. Section 808 allows 

the issuing agency to make a rule 

effective sooner than otherwise 

provided by the CRA if the agency 

makes a good cause finding that notice 

and public procedure is impracticable, 

unnecessary, or contrary to the public 

interest. This determination must be 

supported by a brief statement. 5 U.S.C. 

808(2). As stated previously, EPA has 

made such a good cause finding, 

including the reasons therefore. EPA 

will submit a report containing this rule 

and other required information to the 

United States Senate, the United States 

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). 

Dated: March 26, 2009. 

Lisa P. Jackson, 

Administrator. 

[FR Doc. E9–7301 Filed 3–31–09; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0362; FRL–8405–2] 

Quinoxyfen; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of quinoxyfen in 

or on artichoke, globe; fruit, stone, 

group 12; squash, winter; pumpkin; and 

gourd, edible. This regulation also 

deletes the established cherry, sweet; 

Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 14739 

and cherry, tart tolerances, as they will 

be superseded by inclusion in the stone 

fruit crop group. This regulation 

additionally deletes the time-limited 

tolerances for pumpkin; winter squash; 

and melon subgroup 9A, as the 

tolerances expired on December 31, 

2007. Interregional Research Project 

Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective April 

1, 2009. Objections and requests for 

hearings must be received on or before 

June 1, 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–2008–0362. 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: 

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; e-mail 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. 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 

cite at http://www.gpoaccess.gov/ecfr. 

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–2008–0362 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 June 1, 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 this copy, 

identified by docket ID number EPA– 

HQ–OPP–2008–0362, 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. Petition for Tolerance 

In the Federal Register of June 4, 2008 

(73 FR 31862) (FRL–8365–3), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 8E7325) by 

Interregional Research Project Number 4 

(IR–4), 500 College Rd. East, Suite 201 

W, Princeton, NJ 08540. The petition 

requested that 40 CFR 180.588 be 

amended by establishing tolerances for 

residues of the fungicide quinoxyfen, 

5,7-dichloro-4-(4- 

fluorophenoxy)quinoline, in or on 

artichoke, globe at 1.4 parts per million 

(ppm); fruit, stone, group 12 at 0.70 

ppm; squash, winter at 0.20 ppm; 

pumpkin at 0.20 ppm; and gourd, edible 

at 0.20 ppm. IR–4 additionally proposed 

to remove the established tolerances for 

the residues of quinoxyfen in or on the 

food commodities cherry, sweet; and 

cherry, tart at 0.30 ppm. That notice 

referenced a summary of the petition 

prepared on behalf of IR–4 by Dow 

AgroSciences LLC, the registrant, which 

is available to the public in the docket, 

http://www.regulations.gov There were 

no comments received in response to 

the notice of filing. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

14740 Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 

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 section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, 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 the petitioned-for 

tolerances for residues of quinoxyfen on 

artichoke, globe at 1.4 ppm; fruit, stone, 

group 12 at 0.70 ppm; squash, winter at 

0.20 ppm; pumpkin at 0.20 ppm; and 

gourd, edible at 0.20 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing tolerances 

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. 

The existing quinoxyfen data indicate 

that it possesses low acute toxicity via 

the oral, dermal and inhalation routes. 

It is a mild eye irritant and dermal 

sensitizer, but it is not a dermal irritant. 

The primary target organs affected by 

quinoxyfen are the liver and kidney. 

Subchronic effects in rats and mice 

included increased liver weights, 

hepatocellular hypertrophy and 

individual cell hepatocellular necrosis, 

and chronic effects in the dog included 

increased liver weights, increased 

alkaline phosphatase levels and 

increased incidences of slight 

microscopic hepatic lesions. Kidney 

effects were noted only in the rat 

combined chronic/carcinogenicity 

study, resulting in an increased severity 

of chronic progressive 

glomerulonephropathy in males. Rabbits 

were much more susceptible to the 

effects of quinoxyfen than any other 

species. Systemic effects observed in the 

rabbit developmental study included 

inanition, loss of body weight, perineal 

soiling, blood in the cage pan associated 

with urine, and abortions. 

Long-term dietary administration of 

quinoxyfen did not result in an overall 

treatment-related increase in incidence 

of tumor formation in rats or mice. As 

a result, EPA classified quinoxyfen as 

‘‘not likely to be carcinogenic to 

humans.’’ Quinoxyfen did not show 

evidence of mutagenicity in in vitro or 

in vivo studies. No evidence of 

neurotoxicity or neuropathology was 

seen in any of the submitted studies, 

including the acute and subchronic 

neurotoxicity studies. 

The toxicology data for quinoxyfen 

provides no indication of increased 

susceptibility, as compared to adults, of 

rat and rabbit fetuses to in utero 

exposure in developmental studies. No 

maternal or developmental toxicity was 

observed in the rat developmental 

toxicity study. The rabbit 

developmental toxicity study included 

maternal toxic effects (inanition, 

decreased body weight and weight gain, 

decreased fecal output, perineal soiling, 

blood in the cage pan associated with 

urine, and abortions) at the same dose 

as developmental effects (increased 

abortions). In the 2–generation 

reproduction study conducted with rats, 

increased quantitative susceptibility of 

offspring (minimally reduced pup 

weights) was noted in the absence of 

maternal toxicity at the high dose. There 

was no evidence of immunotoxicity in 

the database. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by quinoxyfen 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 

‘‘Quinoxyfen. Human Health Risk 

Assessment for the Proposed Food Use 

of Quinoxyfen on Stone Fruits Crop 

Group 12 (excluding Cherry), Artichoke, 

Winter Squash, (Pumpkin and Edible 

Gourds),’’ at pages 45–48 in docket ID 

number EPA–HQ–OPP–2008–0362. 

B. 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 NOAEL in the toxicology study 

identified as appropriate for use in risk 

assessment. However, if a NOAEL 

cannot be determined, 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-term, 

intermediate-term, 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 quinoxyfen used for 

human risk assessment can be found at 

http://www.regulations.gov in document 

‘‘Quinoxyfen. Human Health Risk 

Assessment for the Proposed Food Use 

of Quinoxyfen on Stone Fruits Crop 

Group 12 (excluding Cherry), Artichoke, 

Winter Squash, (Pumpkin and Edible 

Gourds),’’ at pages 25–26 in docket ID 

number EPA–HQ–OPP–2008–0362. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to quinoxyfen, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing quinoxyfen tolerances in 40 

CFR 180.588. EPA assessed dietary 

exposures from quinoxyfen 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. 

No such effects were identified in the 

toxicological studies for quinoxyfen; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 14741 

Continuing Survey of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA used tolerance-level 

residues, Dietary Exposure Evaluation 

Model (DEEM) default processing 

factors, and assumed 100 percent crop 

treated (PCT) for all proposed 

commodities. 

iii. Cancer. Based upon lack of 

evidence of carcinogenicity in rats and 

mice by all routes of exposure, EPA has 

classified quinoxyfen as ‘‘not likely to 

be carcinogenic to humans;’’ therefore, a 

quantitative exposure assessment to 

evaluate cancer risk is unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for quinoxyfen. 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 quinoxyfen in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of quinoxyfen. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefed1/models/ 

water/index.htm. 

Based on the First Index Reservoir 

Screening Tool (FIRST) model for 

surface water, and the Screening 

Concentration in Ground Water (SCIGROW) model for ground water, the 

estimated drinking water concentrations 

(EDWCs) of quinoxyfen for surface 

water are estimated to be 9.9 parts per 

billion (ppb) for acute exposures, and 

0.66 ppb for chronic exposures. For 

ground water, the estimated drinking 

water concentration is 0.0034 ppb. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 0.66 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). 

Quinoxyfen is not registered for any 

specific use patterns that would result 

in residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found quinoxyfen to 

share a common mechanism of toxicity 

with any other substances, and 

quinoxyfen does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that quinoxyfen 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 website 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 data for quinoxyfen 

provides no indication of increased 

susceptibility, as compared to adults, of 

rat and rabbit fetuses to in utero 

exposure in developmental studies up 

to the limit dose of 1,000 milligrams/ 

kilogram/day (mg/kg/day). In the multigeneration rat reproduction study, 

offspring effects were noted at the high 

dose of 100 mg/kg/day tested 

(minimally reduced F1a pup weights) in 

the absence of maternal toxicity at the 

same level; thereby showing 

quantitative evidence of increased 

susceptibility in rat offspring. However, 

concern is low since: 

i. The effects in pups are wellcharacterized with a clear NOAEL of 20 

mg/kg/day. 

ii. The pup effects are minimal at the 

LOAEL and only noted in the first 

generation offspring. 

iii. The doses and endpoints selected 

for regulatory purposes would address 

the concerns of the pup effects noted in 

the rat reproduction study. 

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 

quinoxyfen is complete except for 

immunotoxicity testing. Recent changes 

to 40 CFR part 158 make 

immunotoxicity testing (OPPTS 

Guideline 870.7800) required for 

pesticide registration; however, the 

existing data are sufficient for endpoint 

selection for exposure/risk assessment 

scenarios, and for evaluation of the 

requirements under the FQPA. The 

available data for quinoxyfen do not 

show potential for immunotoxic effects. 

Therefore, EPA does not believe that 

conducting the immunotoxicity study 

will result in a NOAEL lower than the 

NOAEL of 20 mg/kg/day already set for 

quinoxyfen. Consequently, an 

additional database uncertainty factor 

does not need to be applied. 

ii. There is no indication that 

quinoxyfen is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. Although there is quantitative 

evidence of increased susceptibility of 

offspring (minimally reduced pup 

weights) in the absence of maternal 

effects in the rat multi-generation 

reproduction study, the Agency did not 

identify any residual uncertainties after 

establishing toxicity endpoints and 

traditional UFs to be used in the risk 

assessment. Therefore, there are no 

residual concerns regarding 

developmental effects in the young. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

Dietary food exposure assessments were 

performed based on 100% crop treated 

and tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground water and surface water 

modeling used to assess exposure to 

quinoxyfen in drinking water. These 

assessments will not underestimate the 

exposure and risks posed by 

quinoxyfen. 

E. 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 

14742 Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Shortterm, intermediate-term, and chronicterm 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 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. No acute dietary endpoint was 

identified for any segment of the United 

States (U.S.) population. Therefore, 

quinoxyfen is not expected to pose an 

acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to quinoxyfen 

from food and water will utilize 2% of 

the cPAD for children 1 to 2 years old, 

the population group receiving the 

greatest exposure. There are no 

residential uses for quinoxyfen to 

consider. 

3. Short-term and intermediate-term 

risk. Short-term and intermediate-term 

aggregate exposure takes into account 

short-term and intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Quinoxyfen is not registered for any 

use patterns that would result in 

residential exposure. Therefore, the 

short-term and intermediate-term 

aggregate risk is the sum of the risk from 

exposure to quinoxyfen through food 

and water and will not be greater than 

the chronic aggregate risk. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in mice and 

rats at doses that were judged to be 

adequate to assess the carcinogenic 

potential, quinoxyfen was classified as 

‘‘not likely to be carcinogenic to 

humans.’’ Therefore, quinoxyfen is not 

expected to pose a cancer risk to 

humans. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to quinoxyfen 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography with massselective detection (GC-MSD)) 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; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

There are no Mexican maximum 

residue limits (MRLs) established for 

residues of quinoxyfen in crops 

associated with this review. Codex 

MRLs exist for quinoxyfen on cherry, 

sweet and tart at 0.4 ppm; and Canadian 

MRLs exist for cherry, sweet and tart at 

0.3 ppm. However, the proposed 

tolerance for fruit, stone, group 12 (0.70 

ppm), of which cherry is a part, cannot 

be harmonized with the Codex or 

Canadian MRLs on these commodities 

because field trial data supporting the 

stone fruit group tolerance shows 

residue levels that are higher than 0.4 

ppm. 

V. Conclusion 

Therefore, tolerances are established 

for residues of quinoxyfen, 5,7-dichloro4-(4-fluorophenoxy)quinoline, in or on 

artichoke, globe at 1.4 ppm; fruit, stone, 

group 12 at 0.70 ppm; squash, winter at 

0.20 ppm; pumpkin at 0.20 ppm; and 

gourd, edible at 0.20 ppm. This 

regulation also deletes the established 

tolerances in or on cherry, sweet; and 

cherry, tart, as they are superseded by 

inclusion in fruit, stone, group 12. This 

regulation additionally deletes the timelimited tolerances for pumpkin; winter 

squash; and melon subgroup 9A, as the 

tolerances expired on December 31, 

2007. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA 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 section 408(d) 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). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 14743 

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: March 19, 2009. 

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. Section 180.588 is amended in 

paragraph (a), by removing the 

commodities ‘‘Cherry, sweet’’ and 

‘‘Cherry, tart’’; and by alphabetically 

adding the following commodities to the 

table; and in paragraph (b), by removing 

all of the commodities and reserving the 

paragraph designation and heading to 

read as follows: 

§ 180.588 Quinoxyfen; tolerances for 

residues. 

(a) * * * 

Commodity Parts per million 

Artichoke, globe .............. 1.4 

Fruit, stone, group 12 ..... 0.70 

*****

Gourd, edible .................. 0.20 

*****

Pumpkin .......................... 0.20 

Squash, winter ................ 0.20 

*****

(b) Section 18 emergency exemptions. 

[Reserved] 

* * * * * 

[FR Doc. E9–7046 Filed 3–31–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0097; FRL–8407–2] 

Captan, 2,4-D, Dodine, DCPA, 

Endothall, Fomesafen, Propyzamide, 

Ethofumesate, Permethrin, Dimethipin, 

and Fenarimol; Technical Amendment 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule; technical 

amendment. 

SUMMARY: EPA issued a final rule in the 

Federal Register of September 12, 2007, 

revoking, revising, and establishing 

certain tolerances. This document is 

being issued to correct a terminology 

omission associated with DCPA and 

onions. 

DATES: This final rule is effective April 

1, 2009. 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2007–0097. 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: Jane 

Smith, Special Review and 

Reregistration Division (7508P), Office 

of Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001; telephone number: (703) 308– 

0048; e-mail address: smith.janescott@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

The Agency included in the final rule 

a list of those who may be potentially 

affected by this action. If you have 

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 and Other Related 

Information? 

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. 

II. What Does this Technical 

Amendment Do? 

EPA issued a notice of proposed 

rulemaking in the Federal Register of 

June 6, 2007 (72 FR 31221) (FRL–8122– 

7), that proposed to revoke, revise, and 

establish certain tolerances for captan, 

2,4-D, dodine, DCPA, endothall, 

fomesafen, propyzamide, ethofumesate, 

permethrin, dimethipin, and fenarimol. 

On page 31228, third column, first full 

paragraph, the Agency stated the 

following: 

. . . EPA is proposing to revise commodity 

terminology and tolerances to conform to 

current Agency practice in 40 CFR 180.185(a) 

for the combined residues of the herbicide 

DCPA and its metabolites MTP and TCP 

(calculated as DCPA) in or on melon, honey 

dew to muskmelon; and onion to onion, bulb 

. . . . 

The June 6, 2007 Federal Register 

publication was intended only to update 

commodity terminology, and not to 

revoke or revise the scope of existing 

tolerances. The existing tolerance for 

‘‘onion’’ covered both ‘‘onion, bulb’’ and 

‘‘onion, green’’ as defined under current 

commodity terminology. The reference 

to ‘‘onion, green’’ was inadvertently 

omitted from both the June 6, 2007 

proposed rule and the final rule 

published on September 12, 2007 (72 FR 

52013) (FRL–8142–2). Use on both 

‘‘onion, bulb’’ and ‘‘onion, green’’ 

continues to be permitted according to 

labels of currently registered DCPA 

products, and the required safety 

findings for the residues permitted 

under the tolerance were made taking 

into account both types of onions. 

Therefore, 40 CFR 180.185(a) is 

amended by establishing a tolerance for 

DCPA in/on onion, green at 1.0 ppm to 

effectuate EPA’s original intention in 

the proposed and final rules changing 

terminology only. 

III. Why is this Technical Amendment 

Issued as a Final Rule? 

Section 553 of the Administrative 

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

553(b)(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 today’s technical 

amendment final without prior proposal 

and opportunity for comment, because 

this action merely corrects a drafting 

error in the rulemaking that was