37612 Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations 

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). 

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 

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: July 21, 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 § 180.910, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.910 Inert ingredients used preharvest and post-harvest; exemptions from 

the requirement of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

***** * *

Ethylene oxide adducts of 2,4,7,9-tetramethyl-5-decynediol, 

the ethylene oxide content averages 3.5, 10 or 30 moles 

(CAS Reg. No. 9014–85–1) 

..................................................... Surfactants, related adjuvants of surfactants 

***** * *

* * * * * ■ 3. In §180.930, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

***** * *

Ethylene oxide adducts of 2,4,7,9-tetramethyl-5-decynediol, 

the ethylene oxide content averages 3.5, 10 or 30 moles 

(CAS Reg. No. 9014–85–1) 

..................................................... Surfactants, related adjuvants of surfactants 

***** * *

* * * * * 

[FR Doc. E9–17958 Filed 7–28–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0556; FRL–8420–6] 

Fenpyroximate; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

fenpyroximate in or on raw agricultural 

commodities (RAC): Vegetables, 

fruiting, group 8 at 0.20 ppm; okra at 

0.20 ppm; melon subgroup 9A at 0.10 

ppm; and cucumber at 0.10 ppm. The 

Interregional Research Project Number 4 

(IR-4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective July 

29, 2009. Objections and requests for 

hearings must be received on or before 

September 28, 2009, and must be filed 

in accordance with the instructions 


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Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations 37613 

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–2008–0556. 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: 

Sidney Jackson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7610; e-mail address: 

jackson.sidney@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–2008–0556 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 September 28, 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–2008–0556, 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 August 13, 

2008 (73 FR 47186) (FRL–8375–8), 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 8E7365) by IR-4, 

500 College Road East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.566 be 

amended by establishing tolerances for 

residues of the insecticide 

fenpyroximate, (E)-1,1-dimethylethyl 4- 

[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol4-yl) methylene] amino]oxy]methyl] 

benzoate and its Z-isomer, (Z)-1,1- 

dimethylethyl 4-[[[[(1,3-dimethyl-5- 

phenoxy-1H-pyrazol-4-yl)methylene] 

amino]oxy] methyl] benzoate in or on 

food commodities vegetables, fruiting, 

group 08 at 0.20 ppm; okra at 0.20 ppm; 

melon subgroup 09A at 0.03 ppm; and 

cucumber at 0.05 ppm. That notice 

referenced a summary of the petition 

prepared by Nichino America, Inc., of 

Wilmington, DE 19808, 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. 

Based upon review of available field 

trial residue data supporting the 

petition, EPA determined that the 

proposed tolerance levels for certain 

crops should be revised as follows: 

Melon subgroup 9A increased from 0.03 

ppm to 0.10 ppm and cucumber 

increased from 0.05 ppm to 0.10 ppm. 

The reasons for these changes are 

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 

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 


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37614 Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations 

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 combined residues of 

fenpyroximate and its Z-isomer in or on 

food commodities vegetables, fruiting, 

group 8 at 0.20 ppm; okra at 0.20 ppm; 

melon subgroup 9A at 0.10 ppm; and 

cucumber at 0.10 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 their 

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. 

Fenpyroximate has moderate oral and 

inhalation toxicity. It has low dermal 

toxicity and is not an eye or skin 

irritant. Fenpyroximate is a slight to 

moderate skin sensitizer by the 

maximization test method. 

Subchronic oral toxicity studies in the 

rat show the primary effects included 

decreased body-weight and weight gain 

at the lowest observed adverse effect 

level (LOAEL) while there were 

hematological effects at higher doses. In 

the 21–day dermal toxicity study in rats, 

there were clinical signs in the females 

(including red nose/mouth/nasal 

discharge); decreased body-weights, 

body-weight gains, and food 

consumption in males and females; and 

increased liver weights and 

hepatocellular necrosis in the females. 

In the subchronic oral dog study, there 

was bradycardia observed at the LOAEL. 

This effect was present at 6 weeks (first 

time point measured) and did not 

appear to increase in severity with time. 

Also observed at this dose level were 

diarrhea, decreased body-weight, bodyweight gain, and food consumption. At 

higher doses, there was also emesis. The 

highest dose resulted in first- and 

second-degree heart block, increased 

urea concentration, decreased glucose 

and altered plasma electrolyte levels 

among other signs of toxicity. 

In the chronic oral rat and mouse 

studies, signs of toxicity were similar to 

those in the oral subchronic rat study. 

The chronic dog study also revealed 

signs of toxicity including bradycardia, 

diarrhea, decreased body-weight gain, 

and food consumption. 

The 2-generation reproductive 

toxicity study indicated that maternal 

(decreased body-weight) and offspring 

toxicity (decreased lactational weight 

gain) occurred at the same dose, 

suggesting no evidence of sensitivity or 

susceptibility. Reproductive parameters 

were not affected in this 2-generation 

reproduction study. The rat and rabbit 

developmental toxicity studies were 

tested at doses that produced minimal 

maternal toxicity. 

There are no neurotoxicity studies 

other than a negative delayed acute 

neurotoxicity study in the hen. There 

was no indication of neurotoxicity 

present in any of the existing 

subchronic or chronic toxicity studies. 

There was no concern for mutagenic 

activity in several studies including: 

Salmonella, E. Coli, in vitro mammalian 

cell gene mutation assay at the HGPRT 

locus, mammalian cell chromosome 

aberration assay, in vivo mouse bone 

marrow micronucleus assay, DNA repair 

disk diffusion assay, and an 

unscheduled DNA synthesis assay. 

There was no evidence of 

carcinogenic potential in either the rat 

or mouse study. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fenpyroximate 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 

Fenpyroximate. Petition for the 

Establishment of Permanent Tolerances 

for Residues on Fruiting Vegetable (crop 

Group 8), Okra. Human Health Risk 

Assessment, dated 12/23/2008, page 14 

in docket ID number EPA–HQ–OPP– 

2008–0556–0004. 

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 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 fenpyroximate used for 

human risk assessment can be found at 

http://www.regulations.gov in document 

Fenpyroximate. Petition for the 

Establishment of Permanent Tolerances 

for Residues on Fruiting Vegetable (Crop 

Group 8), Okra. Human Health Risk 

Assessment, dated 12/23/2008, page 12 

in docket ID number EPA–HQ–OPP– 

2008–0556–0004. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fenpyroximate, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing fenpyroximate tolerances in (40 

CFR 180.566). EPA assessed dietary 

exposures from fenpyroximate 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. An acute dietary-exposure 

assessment was conducted for females 

13–49 years old. Since an effect of 

concern attributable to a single dose in 

toxicity studies was not identified for 

the general U.S. population, an acute 

dietary-exposure assessment was not 


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performed for subgroups other than 

females 13–49 years old. 

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 conducted acute dietary 

analysis for fenpyroximate assuming 

100 percent crop treated (PCT) and 

existing and proposed tolerance-level 

residues for all commodities. DEEM 

(ver. 7.81) default processing factors 

were assumed for all commodities 

excluding apple, pear, and grape juice 

(0.11x); grape, raisin (2.7x); orange, 

grapefruit, tangerine, lemon and lime 

juice (0.06x); tomato paste (1.0x) and 

puree (1.0x); and peppermint and 

spearmint oil (0.08x). The petitioner 

submitted adequate tomato processing 

data indicating that residues of 

fenpyroximate per se did not 

concentrate in tomato paste or puree as 

all processing factors were <1.0x. 

Residues of the Z-isomer did not 

concentrate in tomato puree; however, 

residues of Z-isomer concentrated 

slightly in tomato paste. When residues 

are combined, the average processing 

factors were <0.89x for tomato paste and 

<0.57x for tomato puree. Default 

processing factor of 1.0x was assumed 

for both tomato paste and tomato puree. 

Available data support processing 

factors presented in Unit C.1. for stated 

commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

assumed 100 PCT and existing and 

proposed tolerance-level residues for all 

commodities. DEEM (ver. 7.81) default 

processing factors were assumed with 

the exceptions listed in Unit C.1. 

iii. Cancer. Fenpyroximate is 

classified as ‘‘not likely to be a human 

carcinogen.’’ There was no evidence of 

carcinogencity in mice studies or in 

combined chronic/carcinogenicity 

studies in the rat. In addition, bacterial 

reverse mutation and in vitro 

mammalian cell gene mutation studies 

showed no mutagenic effects. Therefore, 

a cancer dietary exposure assessment 

was not performed. 

The assumption of 100 PCT and 

tolerance level residues was made for all 

registered and proposed commodity 

uses of fenpyroximate. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fenpyroximate in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

fenpyroximate. 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. 

The nature of fenpyroximate residues 

in plants and animals is understood. 

The residues of concern for plants are 

fenpyroximate and its Z-isomer (also 

referred to as M-1). The residues of 

concern for livestock milk, fat, meat and 

meat by-products are parent and 

multiple metabolites. Livestock 

residues, however, are not relevant to 

this petition. EPA determined that the 

residues in plants and livestock raw 

agricultural commodities for the 

purposes of tolerance enforcement and 

risk assessment are the parent 

compound, fenpyroximate, plus its Zisomer and metabolites and that parent, 

Z-isomer and metabolite M-3 should be 

considered as residues of concern in 

drinking water. Based on the proposed 

application rates and the environmental 

fate properties of fenpyroximate, some 

surface and ground water contamination 

may occur. However, the risk of water 

contamination from parent compound is 

relatively low, based on its high 

sorption potential. Unlike parent 

compound, the sorption of the M-3 

metabolite is much less, and it may 

move into water resources more readily. 

Environmental fate data indicate that 

parent and its Z-isomer are stable to 

photolysis in soil and immobile in soil. 

Major degradates formed in the aqueous 

layer were M-3 (50%), M-8 (36%), M-16 

(4-hydroxymethylbenzoic acid, 58%) 

and M-11 (25 to 30%), and M-3 (>10%), 

M-11 (25 to 30%) and M8 (16 to 19%) 

in the soil. However, data from a field 

dissipation study showed M3 (32%) 

being the only significant degradate 

found in the field. Based on the 

structural similarity between parent and 

M-3, the Agency concluded that parent 

and M-3 should be included in the risk 

assessment. 

The EDWCs were Tier 1 estimates for 

ground water using the Screening 

Concentration in Ground Water (SCIGROW) model and surface water using 

the First Index Reservoir Screening Tool 

(FIRST) model for fenpyroximate and its 

metabolites. The models utilized an 

application rate of 0.2 lb ai/A with 2 

applications per season. 

Based on the FIRST, and SCI-GROW 

models, the EDWCs of fenpyroximate 

for acute exposures are estimated to be 

8.74 parts per billion (ppb) for surface 

water and 0.001 ppb for ground water. 

For chronic exposures for non-cancer 

assessments are estimated to be 0.51 

ppb for surface water and 0.001 ppb for 

ground water. Parent, Z-isomer and 

metabolite M-3 are of concern in water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 8.74 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 0.51 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). 

Fenpyroximate 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 fenpyroximate to 

share a common mechanism of toxicity 

with any other substances, and 

fenpyroximate does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that fenpyroximate 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 


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37616 Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations 

data are available to EPA support the 

choice of a different factor. 

2. Prenatal and postnatal sensitivity. 

There is no concern for pre- and/or postnatal toxicity resulting from exposure to 

fenpyroximate. There is no evidence 

(qualitative or quantitative) of increased 

susceptibility following pre- and postnatal exposure in adequate 

developmental toxicity studies in the rat 

and rabbit and a two-generation 

reproduction study in the rat. 

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 

fenpyroximate is adequate to 

characterize potential pre-natal and 

post-natal risk for infants and children. 

Acceptable/guideline studies for 

developmental toxicity in rats and 

rabbits and reproduction toxicity in rats 

are available for FQPA assessment. 

EPA began requiring functional 

immunotoxicity testing of all food and 

non-food use pesticides on December 

26, 2007. Since this requirement went 

into effect relatively recently, these 

studies are not yet available for 

fenpyroximate. In the absence of 

specific immunotoxicity studies, EPA 

has evaluated the available 

fenpyroximate toxicity database to 

determine whether an additional 

database uncertainty factor is needed to 

account for potential immunotoxicity. 

No evidence of immunotoxicity was 

found. Due to the lack of evidence of 

immunotoxicity for fenpyroximate, EPA 

does not believe that conducting 

immunotoxicity testing will result in a 

NOAEL less than the cRfD NOAEL of 

0.97 mg/kg bw/day already established 

for fenpyroximate, and an additional 

factor (UFDB) for database uncertainties 

is not needed to account for potential 

immunotoxicity. 

Acute and subchronic neurotoxocity 

testing in rats is also required as a result 

of changes made to the pesticide data 

requirements in December of 2007. 

Although neurotoxicity studies in rats 

have not yet been submitted, there is no 

evidence of neurotoxicity in any study 

in the toxicity database for 

fenpyroximate. Therefore, EPA has 

concluded that an additional 

uncertainty factor is not needed to 

account for the lack of these data. 

The residue chemistry and 

environmental fate databases are 

complete. 

ii. There is no indication that 

fenpyroximate 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 

fenpyroximate results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2–generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues for existing and 

proposed uses. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to fenpyroximate in 

drinking water. These assessments will 

not underestimate the exposure and 

risks posed by fenpyroximate. 

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 

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 

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. Using the exposure assumptions 

discussed in this unit for acute 

exposure, the acute dietary exposure 

from food and water to fenpyroximate 

will occupy 6.6% of the aPAD for 

(females 13–49 years) the only 

population group of interest. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to fenpyroximate 

from food and water will utilize 38% of 

the cPAD for (children 1–2 years old) 

the population group receiving the 

greatest exposure. There are no 

residential uses for fenpyroximate. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Fenpyroximate is not registered for 

any use patterns that would result in 

residential exposure. Therefore, the 

short-term aggregate risk is the sum of 

the risk from exposure to fenpyroximate 

through food and water and will not be 

greater than the chronic aggregate risk. 

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). 

Fenpyroximate is not registered for 

any use patterns that would result in 

intermediate-term residential exposure. 

Therefore, the intermediate-term 

aggregate risk is the sum of the risk from 

exposure to fenpyroximate through food 

and water, which has already been 

addressed, and will not be greater than 

the chronic aggregate risk. 

5. Aggregate cancer risk for U.S. 

population. Fenpyroximate is classified 

as not likely to be carcinogenic to 

humans. Therefore, fenproximate is not 

expected to pose a cancer risk. 

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 

fenpyroximate residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate enforcement method is 

available for determination of 

fenpyroximate residues of concern in 

plants. A gas chromatography method 

with nitrogen/phosphorus detection 

(GC/NPD), Method S19, has passed an 

Agency validation. Method S19 has a 

limit of quantitation of 0.10 ppm for the 

combined residues of fenpyroximate 

and its Z-isomer. 

Adequate enforcement methodology 

(gas chromatography (GC/NPD) 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 

Codex and Mexican maximum 

residue limits (MRLs) are established for 

residues of fenpyroximate per se in/on 

several crop commodities but not for the 

crops requested. Harmonization with 

the other Codex and Mexican MRLs is 

not possible because the U.S. tolerance 

expressions include additional 

metabolites/isomers. There are currently 

no established Canadian MRLs. 


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Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations 37617 

C. Revisions to Petitioned-For 

Tolerances 

Based upon available data supporting 

petitioned-for tolerances, the Agency 

revised and/or modified the petitions as 

proposed in the notice of filing, as 

follows: 

1. Proposed tolerance level for melon 

subgroup 9A at 0.03 ppm was increased 

to 0.10 ppm. Available residue data for 

cantaloupe, the representative crop, are 

adequate to fulfill data requirements. 

The number and locations of field trials 

conducted are in accordance with EPA 

Guideline 860.1500, and the trials 

reflect the proposed use pattern. The 

residue data were not entered into the 

Agency’s tolerance spreadsheet because 

all treated samples bore combined 

residues below the limit of quantitation 

(LOQ) of <0.10 ppm. The available data 

for cantaloupe will support a tolerance 

of 0.10 ppm (the combined LOQs of the 

enforcement method for the parent 

compound and the Z-isomer) for 

fenpyroximate residues in/on melon 

subgroup 9A. 

2. The Agency modified the proposed 

tolerance for residues in/on cucumber 

from 0.05 ppm to 0.10 ppm based on 

available residue data. Residue data 

include field trials where a single foliar 

application of fenpyroximate at 

maximum proposed seasonal rate was 

made. Results show that the maximum 

combined residues of fenpyroximate 

and its Z-isomer in/on cucumbers was 

<0.03 ppm at 7–day PHI. 

These data were entered into the 

Agency’s tolerance spreadsheet as 

specified by the Guidance for Setting 

Pesticide Tolerances Based on Field 

Trial Data SOP to determine an 

appropriate tolerance level. The Agency 

determined that the appropriate RAC 

tolerance for cucumber is 0.10 ppm (the 

combined LOQs of the enforcement 

method for the parent compound and 

the Z-isomer). 

V. Conclusion 

Therefore, tolerances are established 

for combined residues of fenpyroximate, 

(E)-1,1-dimethylethyl 4-[[[[(1,3- 

dimethyl-5-phenoxy-1H-pyrazol-4-yl) 

methylene] amino]oxy]methyl] benzoate 

and its Z-isomer, (Z)-1,1-dimethylethyl 

4-[[[[(1,3-dimethyl-5-phenoxy-1Hpyrazol-4-yl)methylene] amino]oxy] 

methyl] benzoate in or on food 

commodities: vegetables, fruiting, group 

8 at 0.20 ppm; okra at 0.20 ppm; melon 

subgroup 9A at 0.10 ppm; and 

cucumber at 0.10 ppm. 

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. 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: July 20, 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. Section 180.566 is amended by 

revising the term ‘‘residues’’ to read 

‘‘combined residues’’ in introductory 

paragraphs (a)(1), (a)(2) and (a)(3); and 

by alphabetically adding the following 

commodities to the table in paragraph 

(a)(1) to read as follows: 

§180.566 Fenpyroximate; tolerances for 

residues. 

(a) General. (1) * * * 


sroberts on DSKD5P82C1PROD with RULES
37618 Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations 

Commodity Parts per million 

*** * *

Cucumber ................................................................................................................ 0.10 

*** * *

Melon subgroup 9A ................................................................................................. 0.10 

*** * *

Okra ......................................................................................................................... 0.20 

*** * *

Vegetable, fruiting, group 8 ..................................................................................... 0.20 

* * * * * 

[FR Doc. E9–17942 Filed 7–28–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0189; FRL–8427–3] 

S-Abscisic Acid; Temporary 

Exemption From the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

temporary exemption from the 

requirement of a tolerance for residues 

of the biochemical pesticide S-Abscisic 

Acid, (S)-5-(1-hydroxy-2,6,6-trimethyl4-oxo-1-cyclohex-2-enyl)-3-methylpenta-(2Z,4E)-dienoic Acid in or on 

leafy vegetables, herbs and spices, pome 

fruit, stone fruit, grapes and pineapples 

when applied/used as a plant regulator 

in accordance with the terms of 

Experimental Use Permit (EUP) 73049– 

EUP–7. Valent BioSciences Corporation 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting the temporary 

tolerance exemption. This regulation 

eliminates the need to establish a 

maximum permissible level for residues 

of S-Abscisic Acid, (S)-5-(1-hydroxy2,6,6-trimethyl-4-oxo-1-cyclohex-2- 

enyl)-3-methyl-penta-(2Z,4E)-dienoic 

Acid for the uses permitted under EUP 

73049–EUP–7. The temporary tolerance 

exemption expires on August 7, 2012. 

DATES: This regulation is effective July 

29, 2009. Objections and requests for 

hearings must be received on or before 

September 28, 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–2009–0189. 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: 

Chris Pfeifer, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–0031; e-mail address: 

pfeifer.chris@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 

through the Government Printing 

Office’s e-CFR site 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. 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–2009–0189 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 September 28, 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–2009–0189, by one of 

the following methods. 


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