Federal Register / Vol. 74, No. 56 / Wednesday, March 25, 2009 / Rules and Regulations 12601 

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: February 24, 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 180.603 is amended by 

revising paragraph (b) to read as follows: 

§ 180.603 Dinotefuran; tolerances for 

residues. 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances specified in the 

following table are established for 

combined residues of Dinotefuran, [ N 

-methyl- N ′-nitro- N′′ -((tetrahydro-3- 

furanyl)methyl)guanidine] and its 

metabolites DN [1-methyl-3-(tetrahydro3-furylmethyl)guanidine] and UF [1- 

methyl-3-(tetrahydro-3- 

furylmethyl)urea], expressed as 

dinotefuran in or on the specified 

agricultural commodities, resulting from 

use of the pesticide pursuant to FFIFRA 

section 18 emergency exemptions. The 

tolerances expire and are revoked on the 

date specified in the table. 

Commodity Parts per million Expiration/ 

revocation date 

Rice, grain .................................................................................................................................................... 2.8 12/31/09 

* * * * * 

[FR Doc. E9–6253 Filed 3–24–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006-0875; FRL–8400–8] 

Fenpropathrin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fenpropathrin 

in or on almond, hulls at 4.5 parts per 

million (ppm); cherry, sweet, at 5.0 

ppm; cherry, tart at 5.0 ppm; fruit, 

stone, crop group 12 (except cherry) at 

1.4 ppm; nuts, tree, crop group 14 at 

0.10 ppm; pistachio at 0.10 ppm, PP 

4E6867; avocado at 1.0 ppm; black 

sapote at 1.0 ppm; canistel at 1.0 ppm; 

maney sapote at 1.0 ppm; mango at 1.0 

ppm; papaya at 1.0 ppm; sapodilla at 1.0 

ppm; star apple at 1.0 ppm, PP 6E7066; 

caneberry, subgroup 13-07A at 12 ppm; 

and olive at 5.0 ppm, PP 7E7298. In 

addition, the Agency is deleting a timelimited tolerance on currant at 15 ppm 

which had an expiration date of 12/31/ 

2008. 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 

March 25, 2009. Objections and requests 

for hearings must be received on or 

before May 26, 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–2006–0875. 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 


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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–2006–0875 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 May 26, 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–2006–0875, 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. Petitioned for Tolerance 

In the Federal Register of November 

15, 2006, (71 FR 66520) (FRL–8102–5), 

and February 6, 2008 (73 FR 6964) 

(FRL–8350–9), EPA issued a notice 

pursuant to section 408(d)(3) of FFDCA, 

21 U.S.C. 346a(d)(3), announcing the 

filing of pesticide petitions (PP 4E6867, 

6E7066, and 7E7298) by IR-4, 500 

College Rd. East, Suite 201 W, 

Princeton, NJ 08540. The petitions 

requested that 40 CFR 180.466 be 

amended by establishing tolerances for 

residues of the insecticide, 

fenpropathrin, (alpha-cyano-3-phenoxybenzyl 2,2,3,3- 

tetramethylcyclopropanecarboxylate), in 

or on fruit, stone, group 12 (except 

cherry) at 5.0 ppm; nut, tree, group 14 

at 0.10 ppm, pistachio at 0.10 ppm, and 

almond hulls at 5.0 ppm, PP 4E6867; 

avocado, black sapote, canistel, mamey 

sapote, mango, papaya, sapodilla, star 

apple at 1.0 ppm; barley, grain at 0.30 

ppm; barley, hay at 2.5 ppm; and barley, 

straw at 4.5 ppm, PP 6E7066; caneberry 

subgroup 13-07A at 12 ppm and olives 

at 5 ppm, PP 7E7298. That notice 

referenced a summary of the petition 

prepared by Valent, U.S.A., 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 filings. 

Based upon review of the data 

supporting the petitions listed in this 

Unit, EPA has made certain 

modifications including revisions to 

proposed tolerance levels, scope of 

proposed crop groups, existing tolerance 

levels, proposed commodity definitions, 

as follows: Changed the proposed 

tolerance for fruit, stone, group 12 to 

fruit, stone, group 12 (except cherry) 

and revised the tolerance level from 5.0 

to 1.4 ppm; established an individual 

tolerance for cherry, sweet at 5.0 ppm, 

and cherry, tart at 5.0 ppm; changed the 

proposed tolerance for nut, tree, group 

14 (including pistachio) to nut, tree, 

group 14; established an individual 

tolerance for pistachio at 0.10 ppm; 

revised the tolerance level for almond, 

hulls from 5.0 to 4.5 ppm, and corrected 

the commodity definition for caneberry, 

subgroup 13-07A. Additionally, at this 

time, the Agency is not making a 

decision on the proposed tolerances for 

barley, grain at 0.30 ppm, barley, hay at 

2.5 ppm, and barley, straw at 4.5 ppm 

pending submission and review of a 

barley processing study. 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 

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 fenpropathrin 

in or on almond, hulls at 4.5 ppm; 

cherry, sweet at 5.0 ppm; cherry, tart at 

5.0 ppm; fruit, stone, group 12 at 1.4 

ppm; nut, tree, group 14 at 0.10 ppm; 

avocado at 1.0 ppm; black sapote at 1.0 

ppm; canistel at 1.0 ppm; maney sapote 

at 1.0 ppm; mango at 1.0 ppm; papaya 

at 1.0 ppm; sapodilla at 1.0 ppm; star 

apple at 1.0; caneberry, subgroup 13- 

07A at 12 ppm; olive at 5.0 ppm; and 

pistachio at 0.10 ppm. EPA’s assessment 

of exposures and risks associated with 

establishing tolerances follows. 

A. Toxicological Profile 

The database for fenpropathrin is not 

complete, but it does provide adequate 

information to characterize toxicity. 

Acute neurotoxicity, subchronic 

neurotoxicity, and developmental 

neurotoxicity studies have been 

submitted and reviewed since the 

previous risk assessment. These studies 

were classified acceptable/guideline and 


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were considered during endpoint 

selection. 

Fenpropathrin exhibits high toxicity 

through the oral and dermal routes of 

exposure. Acute inhalation toxicity has 

not been determined for fenpropathrin. 

Because of the chemical’s low vapor 

pressure, sufficient test material could 

not be generated to elicit a toxic 

response during the inhalation studies. 

Fenpropathrin is a mild eye irritant, but 

does not cause dermal irritation in 

rabbits or skin sensitization in guinea 

pigs. 

Clinical signs of toxicity observed in 

rats and dogs following subchronic 

exposure included tremors, ataxia, 

salivation, and hypersensitivity. 

Decreased body weights and food 

consumption are more general 

responses to dietary consumption in rats 

and dogs. Pregnant rabbits exposed to 

fenpropathrin during a developmental 

study also exhibited neurotoxic signs 

including tremors, shakiness, 

unsteadiness, and flicking limbs. 

Chronic dietary exposure to 

fenpropathrin produced no treatmentrelated effects in mice. Following 

chronic exposure, rats and dogs showed 

evidence of neurotoxicity that was 

consistent with the effects that were 

seen after subchronic exposures. There 

was no evidence of carcinogenicity in 

either the rat or mouse long-term dietary 

studies. Fenpropathrin is not mutagenic 

in bacteria or cultured mammalian cells. 

This chemical is neither clastogenic nor 

damaging to DNA. Fenpropathrin is 

classified as ‘‘not likely to be 

carcinogenic to humans.’’ 

Developmental studies in rats and 

rabbits showed no evidence of increased 

susceptibility in fetuses as compared to 

maternal animals following exposure to 

fenpropathrin in utero. Maternal 

animals of both species exhibited 

clinical signs of neurotoxicity. In rats, 

reduced body weight gains were also 

present. In neither study did doserelated changes in fecundity, fertility, 

implantations, number of abortions, or 

early or late resorptions occur. The only 

anomaly noted for either species was an 

increased incidence of asymmetrical or 

incomplete ossification of the fifth or 

sixth sternebrae in rat fetuses. A twogeneration reproduction study in rats, 

likewise, did not show an increased 

sensitivity to fenpropathrin in pups as 

compared to adults. 

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. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by fenpropathrin as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

can be found at http:// 

www.regulations.gov in document 

‘‘Fenpropathrin. Human health risk 

assessment for the proposed uses on 

barley, stone fruit (Crop Group 12), tree 

nuts (Crop Group 14), pistachio, 

caneberries (Crop Subgroup 13-07A), 

and star apple, dated 11/26/2008’’, page 

13 in docket ID number EPA–HQ–OPP– 

2006–0875–0005. 

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 fenpropathrin used for 

human risk assessment can be found at 

http://www.regulations.gov in document 

‘‘Fenpropathrin. Human health risk 

assessment for the proposed uses on 

barley, stone fruit (Crop Group 12), tree 

nuts (Crop Group 14), pistachio, 

caneberries (Crop Subgroup 13-07A), 

and star apple, dated 11/26/2008, page 

19 in docket ID number EPA–HQ–OPP– 

2006–0875–0005. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fenpropathrin, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing fenpropathrin tolerances in (40 

CFR 180.466). EPA assessed dietary 

exposures from fenpropathrin 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. 

Acute dietary exposure assessments 

were conducted using the Dietary 

Exposure Evaluation Model (DEEMFCID, Version 2.03), which uses food 

consumption information from the 

United States Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). A 

partially refined acute probabilistic 

dietary exposure analysis was 

performed for fenpropathrin. As to 

residue levels in food, EPA’s analysis 

was based on tolerance level residues 

for some commodities, crop field trial 

data (only for apricots, nectarines, 

apples, cherries, grapes, peaches, pears, 

and plums), processing factors, and the 

assumption of 100% percent crop 

treated for all registered and proposed 

commodity uses. As a result, the Agency 

considers these analyses to be refined, 

but not highly refined. 

ii. Chronic exposure. Chronic dietary 

exposure assessments were conducted 

using the DEEM-FCID, (Version 2.03), 

which uses food consumption data from 

the USDA 1994–1996 and 1998 CSFII. 

As to residue levels in food, EPA’s 

analysis was based on tolerance level 

residues for some commodities, crop 

field trial data (only for apricots, 

nectarines, apples, cherries, grapes, 

peaches, pears, and plums), processing 

factors, and the assumption of 100% 

percent crop treated for all registered 

and proposed commodity uses. As a 


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result, the Agency considers these 

analyses to be refined, but not highly 

refined. 

iii. Cancer. An exposure assessment 

to evaluate cancer risk is unnecessary. 

There is no evidence of carcinogenicity 

in either the rat or mouse long-term 

dietary studies. Fenpropathrin is not 

mutagenic in bacteria or cultured 

mammalian cells. The chemical is 

neither clastogenic nor damaging to 

DNA. Fenpropathrin is classified as 

‘‘not likely to be carcinogenic to 

humans.’’ 

iv. Anticipated residue and percent 

crop treated (PCT) information. Section 

408(b)(2)(E) of FFDCA authorizes EPA 

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to FFDCA section 408(f)(1) 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

required by FFDCA section 408(b)(2)(E) 

and authorized under FFDCA section 

408(f)(1). Data will be required to be 

submitted no later than 5 years from the 

date of issuance of these tolerances. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

The Agency used PCT information as 

follows: 

The assumption of 100% PCT was 

made for all registered and proposed 

commodity uses. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fenpropathrin in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

fenpropathrin. 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 Screening 

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

estimated drinking water concentrations 

(EWDC) of fenpropathrin for acute 

exposures are estimated to be 10.3 parts 

per billion (ppb) for surface water and 

0.005 ppb for ground water. The EWDCs 

for chronic exposures is estimated to be 

1.81 ppb for surface water and 0.005 

ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the DEEM-FCID. For acute dietary 

risk assessment, the peak water 

concentration value of 10.3 ppb was 

used to assess the contribution of 

drinking water. For chronic dietary risk 

assessment, the annual average 

concentration of 1.8 ppb was used to 

assess the contribution of 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). 

Fenpropathrin is not registered for 

any specific use patterns that would 

result in residential exposure. No new 

residential uses are associated with the 

petitioned-for tolerances. 

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 considers 

‘‘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 fenpropathrin to 

share a common mechanism of toxicity 

with any other substances, and 

fenpropathrin does not appear to 

produce a toxic metabolite produced by 

other substances. 

Fenpropathrin is a member of the 

pyrethroid class of pesticides. Although 

all pyrethroids alter nerve function by 

modifying the normal biochemistry and 

physiology of nerve membrane sodium 

channels, EPA is not currently following 

a cumulative risk approach based on a 

common mechanism of toxicity for the 

pyrethroids. Although all pyrethroids 

interact with sodium channels, there are 

multiple types of sodium channels and 

it is currently unknown whether the 

pyrethroids have similar effects on all 

channels. The Agency does not have a 

clear understanding of effects on key 

downstream neuronal function, e.g., 

nerve excitability, nor does it 

understand how these key events 

interact to produce their compoundspecific patterns of neurotoxicity. There 

is ongoing research by EPA and 

pyrethroid registrants to evaluate the 

differential biochemical and 

physiological actions of pyrethroids in 

mammals. When the results of the 

research are available, the Agency will 

consider this research and make a 

determination of common mechanism 

as a basis for assessing cumulative risk. 

Information regarding EPA’s procedures 

for cumulating effects from substances 

found to have a common mechanism 

can be found on 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 

Food Quality Protection Act (FQPA) 

safety factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There are no concerns or residual 

uncertainties for pre-and/or post-natal 

toxicity resulting from exposure to 

fenpropathrin. There is no evidence 

(qualitative or quantitative) of increased 

susceptibility following in utero and/or 

pre-natal or post-natal exposure in 

adequate developmental toxicity studies 

in rats or rabbits, a 2-generation 

reproduction study in rats, and a 

developmental neurotoxicity study in 

rats. 

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 

fenpropathrin is adequate for FQPA 


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Federal Register / Vol. 74, No. 56 / Wednesday, March 25, 2009 / Rules and Regulations 12605 

determination. The database for 

fenpropathrin is not complete, but it 

does provide adequate information to 

characterize toxicity/endpoint selection 

for infants and children including 

acceptable acute neurotoxicity, 

subchronic neurotoxicity, and 

developmental neurotoxicity studies. 

Based on recently revised EPA Part 158 

Guidelines, an immunotoxicology study 

in rats must be submitted to the Agency. 

However, because there was no 

indication of immunotoxicity in the 

toxicity database, an additional 10x 

database uncertainty factor is not 

considered necessary in order to be 

protective of potential immunotoxic 

effects. 

ii. The toxicity data, including a 

developmental neurotoxicity study, 

showed no increase in qualitative or 

quantitative susceptibility in fetuses and 

pups with in utero and/or post-natal 

exposure to fenpropathrin. 

iii. There are no residual uncertainties 

identified in the exposure databases. 

Dietary food exposure assessments were 

performed based on 100% PCT, 

tolerance-level residues for existing and 

proposed uses, and field trial data. The 

exposure databases (dietary food and 

drinking water) are complete and the 

exposure assessment for each potential 

exposure scenario includes all 

metabolites and/or degradates of 

concern and does not underestimate the 

potential exposure for infants and 

children. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to fenpropathrin in 

drinking water. These assessments will 

not underestimate the exposure and 

risks posed by fenpropathrin. 

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. Dietary (food + water) 

consumption is the only source of 

exposure to fenpropathrin that is 

expected to result in acute exposure. 

Therefore, the acute aggregate risk 

estimates are equivalent to the acute 

dietary exposure discussed in Unit III. 

Acute aggregate risk is below EPA’s 

level of concern for the general U.S. 

population and all population 

subgroups. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

fenpropathrin will occupy 53% of the 

aPAD for children 1-2 years, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to fenpropathrin 

from food and water will utilize 41% of 

the cPAD for children 1-2 years, the 

population group receiving the greatest 

exposure. There are no residential uses 

for fenpropathrin. 

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). 

Fenpropathrin 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 fenpropathrin 

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). 

Fenpropathrin 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 fenpropathrin 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. Aggregate cancer risk is not 

a concern because fenpropathrin is 

classified as ‘‘not likely to be 

carcinogenic to humans.’’ 

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 

fenpropathrin residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

There are adequate enforcement 

methods for fenpropathrin. The 

methods use gas chromatography using 

an electron capture detector (GC/ECD), 

for the determination of fenpropathrin 

residues in/on plants (RM-22-4, revised 

5/3/93) and animals (RM-22A-1). The 

limit of detection (LOD) for Method RM22-4 is 0.01 ppm. 

The methods may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; email address: residuemethods@epa.gov. 

B. International Residue Limits 

Codex and Mexican maximum 

residue limits (MRLs) are established for 

residues of fenpropathrin, but no limits 

are listed for the crop commodities 

addressed herein. No Canadian MRLs 

are established for fenpropathrin. 

C. Revisions to Petitioned-For 

Tolerances 

Based upon review of available data 

supporting these petitions, EPA revised 

the tolerance levels, added or deleted 

tolerances, corrected commodity 

definitions, or otherwise modified the 

petitions as proposed in the notice of 

filings, as follows: 

• EPA did not include cherries in the 

proposed tolerance on fruit, stone, crop 

group 12 because of the significant 

difference in residue levels on cherries 

compared to other commodities in the 

crop group. Instead, EPA established an 

individual tolerance for cherry, sweet at 

5.0 ppm, and cherry, tart at 5.0 ppm. 

• Based on available field trials 

residue data, analyzed under the 

Guidance for Setting Pesticide 

Tolerances Based on Field Trial Data 

SOP, the Agency revised the tolerance 

level from 5.0 to 1.4 ppm for fruit, stone, 

group 12 (except cherry). 

• EPA did not include pistachios in 

the proposed tolerance on tree nuts, 

crop group 14 because of pistachios are 

not currently part of that crop group. 

Instead EPA established an individual 

tolerance for pistachios at 0.10 ppm. 

• Based on available field trials 

residue data, analyzed under the 

Guidance for Setting Pesticide 

Tolerances Based on Field Trial Data 

SOP, the Agency revised the tolerance 

level for almond, hulls from 5.0 to 4.5 

ppm. 

• Corrected commodity definition of 

the proposed tolerance on caneberry 

subgroup 13A to caneberry, subgroup 

13-07A to reflect how the crop group is 

defined in the applicable regulations. 


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V. Conclusion 

Therefore, tolerances are established 

for residues of the insecticide, 

fenpropathrin, (alpha-cyano-3-phenoxybenzyl 2,2,3,3- 

tetramethylcyclopropanecarboxylate), in 

or on almond, hulls at 4.5 ppm; cherry, 

sweet at 5.0 ppm; cherry, tart at 5.0 

ppm; fruit, stone, crop group 12 (except 

cherry) at 1.4 ppm; nut, tree, crop group 

14 at 0.10 ppm; avocado at 1.0 ppm; 

black sapote at 1.0 ppm; canistel at 1.0 

ppm; maney sapote at 1.0 ppm; mango 

at 1.0 ppm; papaya at 1.0 ppm; sapodilla 

at 1.0 ppm; star apple at 1.0; caneberry, 

subgroup 13-07A at 12.0 ppm; olive at 

5.0 ppm; and pistachio at 0.10 ppm. In 

addition, the Agency is deleting a timelimited tolerance on currant at 15 ppm 

which had an expiration date of 12/31/ 

2008. 

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: February 24, 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. 466 is amended by 

alphabetically adding the following 

commodities to the table in paragraph 

(a) and by removing the text in 

paragraph (b) and reserving the heading. 

§ 180.466 Fenpropathrin; tolerances for 

residues. 

* * * * * 

Commodity Parts per million 

Almond, hulls ........... 4.5 

Avocado ................... 1.0 

* * * * * 

Caneberry subgroup 

13-07A.

12 

Canistel .................... 1.0 

* * * * * 

Cherry, sweet .......... 5.0 

Cherry, tart .............. 5.0 

* * * * * 

Fruit, stone, crop 

group 12, except 

cherry.

1.4 

* * * * * 

Mango ...................... 1.0 

* * * * * 

Nut, tree, crop group 

14.

0.10 

Olive ........................ 5.0 

Papaya .................... 1.0 

* * * * * 

Pistachio .................. 0.10 

* * * * * 

Sapodilla .................. 1.0 

Sapote, black ........... 1.0 

Sapote, mamey ....... 1.0 

* * * * * 

Star apple ................ 1.0 

(b) Section 18 emergency exemptions. 

[Reserved] 

* * * * * 

[FR Doc. E9–6412 Filed 3–24–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–1202; FRL–8403–7] 

Propiconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

propiconazole in or on beet, garden, 

roots at 0.30 ppm; beet, garden, tops at 


sroberts on PROD1PC70 with RULES