54922 Federal Register / Vol. 71, No. 182 / Wednesday, September 20, 2006 / Rules and Regulations 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism(64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 11, 2006. 

James Jones, 

Director, Office of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.621 is added to read as 

follows: 

§ 180.621 Dithianon; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the fungicide 

dithianon, (5,10-dihydro-5,10- 

dioxonaphtho(2,3-b)-1,4-dithiin-2,3- 

dicarbonitrile) in or on the following 

commodities: 

Commodity Parts per million 

Fruit, pome, group 111 .......................................................................................................................... 5 

Hop, dried cones1 .................................................................................................................................. 100 

1No U.S. registration as of September 5, 2006. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. E6–15460 Filed 9–19–06; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0613.; FRL–8089–2] 

Etofenprox; Pesticide Tolerances for 

Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

time-limited tolerances for residues of 

etofenprox (2-[ethoxyphenyl]-2- 

methylpropyl-3-phenoxy benzyl ether) 

in or on rice grain and rice straw. This 

action is associated with an emergency 

exemption under section 18 of the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) authorizing 

use of the pesticide on rice. This 

regulation establishes a maximum 

permissible level for residues of 

etofenprox in these food commodities. 

The tolerances expire and are revoked 

on December 31, 2009. 

DATES: This regulation is effective 

September 20, 2006. Objections and 

requests for hearings must be received 

on or before November 20, 2006, 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–2006–0613. All documents in the 

docket are listed on the regulations.gov 

website. 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 either in the electronic docket 

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

available in hard copy, at the Office of 

Pesticide Programs (OPP) Regulatory 

Public Docket in Rm. S–4400, One 

Potomac Yard (South Building), 2777 S. 

Crystal Drive Arlington, VA. The hours 

of operation of this Docket Facility are 

from 8:30 a.m. to 4 p.m., Monday 


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Federal Register / Vol. 71, No. 182 / Wednesday, September 20, 2006 / Rules and Regulations 54923 

through Friday, excluding legal 

holidays. The Docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Libby Pemberton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9364; e-mail address: Sec–18– 

Mailbox@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 an electronic 

copy of this Federal Register document 

through the electronic docket 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 pilot e–CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the FFDCA, as 

amended by the FQPA, 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–2006–0613 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 November 20, 2006. 

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–2006–0613, 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 Building), 2777 S. 

Crystal Drive, Arlington, VA. Deliveries 

are only accepted during the Docket’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 telephone number is (703) 305–

5805. 

II. Background and Statutory Findings 

EPA, on its own initiative, in 

accordance with sections 408(e) and 408 

(l)(6) of the Federal Food, Drug, and 

Cosmetic Act (FFDCA), 21 U.S.C. 

346a(e) and (l)(6), is establishing 

tolerances for residues of the insecticide 

etofenprox (2-[ethoxyphenyl]-2- 

methylpropyl-3-phenoxy benzyl ether) 

or on rice grain at 0.01 parts per million 

(ppm) and rice straw at 0.02 ppm. These 

tolerances expire and are revoked on 

December 31, 2009. EPA will publish a 

document in the Federal Register to 

remove the revoked tolerance from the 

Code of Federal Regulations (CFR). 

Section 408(l)(6) of the FFDCA 

requires EPA to establish a time-limited 

tolerance or exemption from the 

requirement for a tolerance for pesticide 

chemical residues in food that will 

result from the use of a pesticide under 

an emergency exemption granted by 

EPA under section 18 of FIFRA. Such 

tolerances can be established without 

providing notice or period for public 

comment. EPA does not intend for its 

actions on section 18 related tolerances 

to set binding precedents for the 

application of section 408 of the FFDCA 

and the new safety standard to other 

tolerances and exemptions. Section 

408(e) of the FFDCA allows EPA to 

establish a tolerance or an exemption 

from the requirement of a tolerance on 

its own initiative, i.e., without having 

received any petition from an outside 

party. 

Section 408(b)(2)(A)(i) of the 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 the 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 the FFDCA requires EPA 

to give special consideration to 

exposure of infants and children to the 

pesticide chemical residue in 

establishing a tolerance and to ‘‘ensure 

that there is a reasonable certainty that 

no harm will result to infants and 

children from aggregate exposure to the 

pesticide chemical residue. . . .’’

Section 18 of the FIFRA authorizes 

EPA to exempt any Federal or State 

agency from any provision of FIFRA, if 

EPA determines that ‘‘emergency 

conditions exist which require such 

exemption.’’ This provision was not 

amended by the Food Quality Protection 

Act of 1996 (FQPA). EPA has 

established regulations governing such 

emergency exemptions in 40 CFR part 

166. 

III. Emergency Exemption for 

Etofenprox on Rice and FFDCA 

Tolerances 

The Applicant asserts that the current 

emergency situation with respect to 

weevil management has arisen primarily 

from the continuing, and probably 

increasing, practice of cultivating 

crawfish in ponds in close proximity to 

rice fields in southern Louisiana. The 

great majority of crawfish ponds (at least 

75%) are close enough to rice fields to 

be affected by the management practices 

used in rice. All of the insecticides 

currently registered for use against the 


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54924 Federal Register / Vol. 71, No. 182 / Wednesday, September 20, 2006 / Rules and Regulations 

rice water weevil in Louisiana are toxic 

to crawfish. The use of etofenprox for 

weevil control has one significant 

advantage over currently used liquid 

products in that it is formulated as a 

granular and thus there is far less 

potential for drift. The Applicant states 

that the estimated economic loss if no 

effective weevil controls are available is 

over 8 million dollars. 

EPA has authorized under FIFRA 

section 18 the use of etofenprox on rice 

for control of rice water weevil 

(Lissorhoptrus oryzophilus) in 

Louisiana. After having reviewed the 

submission, EPA concurs that 

emergency conditions exist for this 

State. 

As part of its assessment of this 

emergency exemption, EPA assessed the 

potential risks presented by residues of 

etofenprox in or on rice grain and rice 

straw. In doing so, EPA considered the 

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

the FFDCA, and EPA decided that the 

necessary tolerance under section 

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

consistent with the safety standard and 

with FIFRA section 18. Consistent with 

the need to move quickly on the 

emergency exemption in order to 

address an urgent non-routine situation 

and to ensure that the resulting food is 

lawful, EPA is issuing these tolerances 

without notice and opportunity for 

public comment as provided in section 

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

tolerances expire and are revoked on 

December 31, 2009, under section 

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

pesticide not in excess of the amounts 

specified in these tolerances remaining 

in or on rice grain or rice straw after that 

date will not be unlawful, provided the 

pesticide is applied in a manner that 

was lawful under FIFRA, and the 

residues do not exceed a level that was 

authorized by these tolerances at the 

time of that application. EPA will take 

action to revoke these tolerances earlier 

if any experience with, scientific data 

on, or other relevant information on this 

pesticide indicate that the residues are 

not safe. 

Because these time-limited tolerances 

are being approved under emergency 

conditions, EPA has not made any 

decisions about whether etofenprox 

meets EPA’s registration requirements 

for use on rice or whether permanent 

tolerances for this use would be 

appropriate. Under these circumstances, 

EPA does not believe that these 

tolerances serve as a basis for 

registration of etofenprox by a State for 

special local needs under FIFRA section 

24(c). Nor do these tolerances serve as 

the basis for any State other than 

Louisiana to use this pesticide on this 

crop under section 18 of FIFRA without 

following all provisions of EPA’s 

regulations implementing FIFRA section 

18 as identified in 40 CFR part 166. For 

additional information regarding the 

emergency exemption for etofenprox, 

contact the Agency’s Registration 

Division at the address provided under 

FOR FURTHER INFORMATION CONTACT. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of the 

FFDCA and a complete description of 

the risk assessment process, see http:// 

www.epa.gov/fedrgstr/EPA-PEST/1997/ 

November/Day-26/p30948.htm. 

Consistent with section 408(b)(2)(D) 

of the 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 etofenprox and to make 

a determination on aggregate exposure, 

consistent with section 408(b)(2) of the 

FFDCA, for time-limited tolerances for 

residues of etofenprox in or on rice 

grain at 0.01 ppm and rice straw at 0.02 

ppm. EPA’s assessment of the dietary 

exposures and risks associated with 

establishing the tolerances follows. 

A. Toxicological Endpoints 

The dose at which no adverse effects 

are observed (the NOAEL) from the 

toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological 

endpoint. However, the lowest dose at 

which adverse effects of concern are 

identified (the LOAEL) is sometimes 

used for risk assessment if no NOAEL 

was achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect 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. An UF of 100 is 

routinely used, 10X to account for 

interspecies differences and 10X for 

intra species differences. 

For dietary risk assessment (other 

than cancer) the Agency uses the UF to 

calculate an acute or chronic reference 

dose (acute RfD or chronic RfD) where 

the RfD is equal to the NOAEL divided 

by the appropriate UF (RfD = NOAEL/ 

UF). Where an additional safety factor 

(SF) is retained due to concerns unique 

to the FQPA, this additional factor is 

applied to the RfD by dividing the RfD 

by such additional factor. The acute or 

chronic Population Adjusted Dose 

(aPAD or cPAD) is a modification of the 

RfD to accommodate this type of FQPA 

SF. 

For non-dietary risk assessments 

(other than cancer) the UF is used to 

determine the level of concern (LOC). 

For example, when 100 is the 

appropriate UF (10X to account for 

interspecies differences and 10X for 

intraspecies differences) the LOC is 100. 

To estimate risk, a ratio of the NOAEL 

to exposures (margin of exposure (MOE) 

= NOAEL/exposure) is calculated and 

compared to the LOC. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify 

carcinogenic risk. The Q* approach 

assumes that any amount of exposure 

will lead to some degree of cancer risk. 

A Q* is calculated and used to estimate 

risk which represents a probability of 

occurrence of additional cancer cases 

(e.g., risk is expressed as 1 x 106 or one 

in a million). Under certain specific 

circumstances, MOE calculations will 

be used for the carcinogenic risk 

assessment. In this non-linear approach, 

a ‘‘point of departure’’ is identified 

below which carcinogenic effects are 

not expected. The point of departure is 

typically a NOAEL based on an 

endpoint related to cancer effects 

though it may be a different value 

derived from the dose response curve. 

To estimate risk, a ratio of the point of 

departure to exposure (MOEcancer = point 

of departure/exposures) is calculated. A 

summary of the toxicological endpoints 

for etofenprox used for human risk 

assessment is shown in the following 

Table: 


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Federal Register / Vol. 71, No. 182 / Wednesday, September 20, 2006 / Rules and Regulations 54925 

DOSES AND TOXICOLOGICAL ENDPOINTS FOR ETOFENPROX

Exposure/Scenario 

Dose Used in Risk Assessment, Interspecies, 

Intraspecies and any Traditional UF 

FQPA SF and Level of 

Concern for Risk Assessment Study and Toxicological Effects 

Acute Dietary (females 13-49 

years of age) 

Not selected NA No toxicological endpoint attributable to a single exposure was identified in the available 

toxicology studies. 

Acute Dietary (General population including infants and 

children) 

Not selected NA No toxicological endpoint attributable to a single exposure was identified in the available 

toxicology studies. 

Chronic Dietary (All populations) NOAEL = 3.7 mg/kg/day 

Chronic RfD = 0.037 mg/kg/ 

day 

FQPA SF = 1x cPAD = 

Chronic RfD/Special FQPA 

SF = 0.037 mg/kg/day 

Combined Chronic Toxicity/Carcinogenicity 

Study in Rat (MRID No. 40449707) 

LOAEL = 25.5 mg/kg/day based on increased 

thyroid weights. Related to increased liver 

weights and histopathology changes in liver 

and thyroid that occurred at the higher dose. 

Incidental Oral Short-Term (1 - 

30 days) 

NOAEL =100 mg/kg/day 

UF = 100 

LOC for MOE = 100 Developmental Toxicity in Rabbit (MRID No. 

45210602) 

LOAEL = 300 mg/kg/day based on decreased 

body weights, body weight gains, and food 

consumption (maternal toxicity). 

Incidental Oral IntermediateTerm (1 - 6 months) NOAEL = 20 mg/kg/day UF = 

100 

LOC for MOE = 100 Subchronic Oral Toxicity in Rat (MRID No. 

40449703) 

LOAEL = 120 mg/kg/day based on decreased 

body weight gain, increased liver and thyroid 

weights with corresponding histopathology, 

changes in hematology and clinical chemistry. 

Dermal (All durations) NA NA No systemic toxicity was identified in the dermal 28–day study; Highest Dose Tested 

was 1,000 mg/kg/day. 

Inhalation (All durations) NOAEL =10.6 mg/kg/day 

UF = 100 

LOC for MOE = 100 

Residential 

LOC for MOE = 100 

Occupational 

13–Week Inhalation Toxicity in Rat (MRID No. 

40449705) 

LOAEL = 52.3 mg/kg/day based on organ 

weight changes and histopathological 

changes in liver, adrenals and thyroid. 

Cancer (oral, dermal, inhalation) Classification: ‘‘Not likely to be carcinogenic to humans at doses that do not alter rat thyroid hormone homeostasis.’’

UF = uncertainty factor, FQPA SF = Any additional safety factor retained due to concerns unique to the FQPA, NOAEL = no observed adverse 

effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, MOE 

= margin of exposure, LOC = level of concern, NA = Not Applicable 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Risk assessments were 

conducted by EPA to assess dietary 

exposures from etofenprox in food as 

follows: 

i. Acute exposure. Acute dietary risk 

assessments are performed for a fooduse pesticide if a toxicological study has 

indicated the possibility of an effect of 

concern occurring as a result of a one 

day or single exposure. An acute risk 

assessment was not performed. No 

toxicological endpoint attributable to a 

single (acute) dietary exposure was 

identified. 

ii. Chronic exposure.In conducting 

this chronic dietary risk assessment the 

Dietary Exposure Evaluation Model 

(DEEMTM) analysis evaluated the 

individual food consumption as 

reported by respondents in the USDA 

1994–1996 nationwide Continuing 

Surveys of Food Intake by Individuals 

(CSFII) and accumulated exposure to 

the chemical for each commodity. The 

following assumptions were made for 

the chronic exposure assessments: The 

concentration of etofenprox in rice 

commodities is assumed at tolerance 

level and 100 percent of rice grown is 

assumed to be treated. 

iii. Cancer. Etofenprox has been 

classified as, ‘‘Not likely to be 

carcinogenic to humans at doses that do 

not alter rat thyroid hormone 

homeostasis.’’ In 1989, the EPA 

classified etofenprox as a ‘‘Group C 

Possible Human Carcinogen’’ based on 

thyroid tumors in rats. In 1996 the EPA 

evaluated additional information 

submitted by the registrant, Mitsui 

Toatsu, regarding the carcinogenic 

potential of etofenprox. Its objective was 

to demonstrate a threshold mechanism 

for the thyroid tumors in rats. In 2005, 

an additional 4–week dietary 

investigative study on thyroid function 

and hepatic microsomal enzyme 

induction in rats was reviewed by the 

EPA. In 2005, the Agency considered if 

the additional study along with the 

previously submitted data provided 

sufficient information to support reevaluation of etofenprox’s 

carcinogenicity status. In consideration 

of these new data, and in accordance 

with the EPA Final Guidelines for 

Carcinogen Risk Assessment, etofenprox 

was classified as ‘‘Not likely to be 


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54926 Federal Register / Vol. 71, No. 182 / Wednesday, September 20, 2006 / Rules and Regulations 

carcinogenic to humans at doses that do 

not alter rat thyroid hormone 

homeostasis.’’ This decision was based 

on the following considerations: 

a. Treatment-related thyroid follicular 

cell tumors were seen in both male and 

female rats at 4,900 ppm, which was 

considered to be adequate, and not 

excessive, to assess carcinogenicity; 

b. No treatment-related tumors were 

seen in male or female mice when tested 

at a dose that was considered adequate 

to assess carcinogenicity; 

c. There is no mutagenicity concern 

for etofenprox form in vivo or in vitro 

assays; 

d. The non-neoplastic toxicological 

evidence (i.e., thyroid growth and 

thyroid hormonal changes) indicated 

that etofenprox was inducing a 

disruption in the thyroid-pituitary 

hormonal status; and 

e. Rats are substantially more 

sensitive than humans to the 

development of thyroid follicular cell 

tumors in response to thyroid hormone 

imbalance. The overall weight-of-theevidence was considered sufficient to 

indicate that etofenprox induced 

thyroid follicular tumors through an 

antithyroid mode of action; The 

quantification of carcinogenic potential 

is not applicable. Therefore, no risk 

quantification is required. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

etofenprox in drinking water. Because 

the Agency does not have 

comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the physical characteristics of 

etofenprox. 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 provisional refined rice 

models (Method A and B) and SCIGROW models, the estimated 

environmental concentrations (EECs) of 

etofenprox for chronic exposures are 

estimated to be 2.5 parts per billion 

(ppb) for surface water and 0.002 ppb 

for ground water. 

The estimated drinking water 

concentrations (EDWCs) for etofenprox 

were directly entered into the dietary 

exposure model DEEM-FCIDTM. For 

chronic dietary risk assessment, the 

annual average concentration of 2.5 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). 

Etofenprox is currently registered for 

use on the following residential nondietary sites: Outdoor (yard/patio), spoton pet treatment, indoor foggers, and 

crack and crevice/spot treatment to 

control a variety of crawling and flying 

insect pests. The residential risk 

assessment was conducted using the 

following exposure assumptions: 

Average food and drinking water 

exposures are aggregated with exposures 

to toddlers from inhalation and hand-tomouth activities following the use of an 

indoor total-release fogger and hand-tomouth from contact with a companion 

cat treated with the etofenprox spot-on 

product. Aggregate assessment for 

adults combines average food and water 

exposures for the total U.S. population 

with adult handler and post application 

inhalation exposures from the use of the 

indoor total-release fogger. These 

residential uses are believed to be the 

ones most likely to co-occur 

(comprehensive flea treatment 

approach), and also present the most 

conservative (worst-case) scenario for 

potential aggregate exposures. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of the 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.’’

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

etofenprox and any other substances 

and etofenprox does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

not assumed that etofenprox has a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see the policy statements 

released by EPA’s Office of Pesticide 

Programs concerning common 

mechanism determinations and 

procedures for cumulating effects from 

substances found to have a common 

mechanism on EPA’s website at http:// 

www.epa.gov/pesticides/cumulative/. 

C. Safety Factor for Infants and Children 

1. In general. Section 408 of the 

FFDCA provides that EPA shall apply 

an additional tenfold 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 data base on 

toxicity and exposure unless EPA 

determines that a different margin of 

safety will be safe for infants and 

children. Margins of safety are 

incorporated into EPA risk assessments 

either directly through use of a MOE 

analysis or through using uncertainty 

(safety) factors in calculating a dose 

level that poses no appreciable risk to 

humans. 

2. Developmental toxicity studies. A 

prenatal developmental toxicity study 

in rabbits showed no quantitative/ 

qualitative evidence of increased 

susceptibility in offspring. In the rabbit 

study the developmental effects were 

seen at doses that resulted in maternal 

deaths at the high dose. Additionally, 

the rabbit developmental study showed 

increased abortions, decreased maternal 

body weights, body weight gains and 

food consumption. In the rabbit study, 

the maternal LOAEL (300 milligram/ 

kilogram/day (mg/kg/day)) is equal to 

the developmental LOAEL. In the 1–

generation/developmental study in rats, 

increased susceptibility in the offspring 

was not observed. In the rat 

developmental study, the maternal 

LOAEL was equal to the developmental 

LOAEL. 

3. Reproductive toxicity study. The 2–

generation reproduction study in rats 

did not show evidence of quantitative/ 

qualitative susceptibility in offspring. In 

this study rats showed decreased pup 

weights, increased thyroid, liver and 

kidney weights with corresponding 

pathological changes in pups, and 

clinical signs of pups during most of the 

lactation period which included body 

tremors, distended abdomen, lethargy, 

unsteady gait, and abnormal 

movements. However, except for 

thyroid weight in female pups, all of 

these effects occurred at the highest 

dose tested (HDT). The effects on organ 

weights carried over to the adults of 

both the F1 and F2 generations with 

corresponding centrilobular hepatocyte 

enlargement and increased thyroidal 

epithelial height in the HDT group of 

the F1 generation. At the high dose, 

parents (F0) had similar effects on their 

organs as the pups: increased liver, 

thyroid, and kidney weights with 

pathological changes in the kidney. The 

parental LOAEL was equal to the 

offspring LOAEL in the 2–generation 

reproduction study in rats. 


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Federal Register / Vol. 71, No. 182 / Wednesday, September 20, 2006 / Rules and Regulations 54927 

4. Prenatal and postnatal sensitivity. 

There is no indication of increased 

quantitative/qualitative evidence of 

susceptibility of the offspring in the 

developmental rat or rabbit studies or in 

the 2–gen reproduction study in the rat. 

Developmental effects were seen at 

doses that caused maternal toxicity. No 

developmental effects were seen in the 

rat 1–generation/developmental study. 

In the 2–generation reproduction 

toxicity study, there was no evidence of 

quantitative and qualitative 

susceptibility because the presence of 

toxicity in the offspring occurred at the 

level of parental toxicity (increased 

organs weights and associated 

pathological changes occurred in both 

the pups and parents). In the 

developmental neurotoxicity study in 

rats, the observed eye abnormalities 

associated with body injuries could not 

be disassociated from possible altered 

treatment-related maternal behavior that 

resulted in injury to the pups. 

5. Conclusion. The toxicology 

database for etofenprox is essentially 

complete. The data are sufficient for 

endpoint selection for exposure/risk 

assessment scenarios and for evaluation 

of the requirements under the Food 

Quality Protection Act (FQPA). 

Evidence of quantitative and qualitative 

susceptibility of offspring were not 

observed, and therefore, the FQPA 10x 

safety factor was reduced to 1x. 

D. Aggregate Risks and Determination of 

Safety 

The Agency currently has two ways to 

estimate total aggregate exposure to a 

pesticide from food, drinking water, and 

residential uses. First, a screening 

assessment can be used, in which the 

Agency calculates drinking water levels 

of comparison (DWLOCs) which are 

used as a point of comparison against 

estimated drinking water concentrations 

(EDWCs). The DWLOC values are not 

regulatory standards for drinking water, 

but are theoretical upper limits on a 

pesticide’s concentration in drinking 

water in light of total aggregate exposure 

to a pesticide in food and residential 

uses. More information on the use of 

DWLOCs in dietary aggregate risk 

assessments can be found at http:// 

www.epa.gov/oppfead1/trac/science/ 

screeningsop.pdf. 

More recently the Agency has used 

another approach to estimate aggregate 

exposure through food, residential and 

drinking water pathways. In this 

approach, modeled surface and ground 

water EDWCs are directly incorporated 

into the dietary exposure analysis, along 

with food. This provides a more realistic 

estimate of exposure because actual 

body weights and water consumption 

from the CSFII are used. The combined 

food and water exposures are then 

added to estimated exposure from 

residential sources to calculate aggregate 

risks. The resulting exposure and risk 

estimates are still considered to be high 

end, due to the assumptions used in 

developing drinking water modeling 

inputs. 

1. Acute risk. An acute risk 

assessment was not performed. No 

toxicological endpoint attributable to a 

single (acute) dietary exposure was 

identified. Therefore, acute risk from 

etofenprox exposure to is not expected. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to etofenprox from food 

and water will utilize <1% of the cPAD 

for the U.S. population, and <1% of the 

cPAD for all infants (<1 year old), the 

subpopulation at greatest exposure. 

Based on the use pattern, chronic 

residential exposure to residues of 

etofenprox is not expected. Therefore, 

EPA does not expect the aggregate 

exposure to exceed 100% of the cPAD. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Etofenprox is currently registered for 

use(s) that could result in short-term 

residential exposure and the Agency has 

determined that it is appropriate to 

aggregate chronic food and water and 

short-term exposures for etofenprox. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that 

food, water and residential exposures 

aggregated result in aggregate MOEs of 

960 for adults and 350 for inhalation 

and 560 for incidental oral for toddlers. 

These aggregate MOEs do not exceed the 

Agency’s level of concern for aggregate 

exposure to food, water and residential 

uses. Therefore, EPA does not expect 

short-term aggregate exposure to exceed 

the Agency’s level of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account non-dietary, nonoccupational exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Etofenprox is currently registered for 

use(s) that could result in intermediateterm residential exposure and the 

Agency has determined that it is 

appropriate to aggregate chronic food 

and water and intermediate-term 

exposures for etofenprox. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

food, water, and residential exposures 

aggregated result in aggregate MOEs of 

960 for adults and 130 for toddlers. 

These aggregate MOEs do not exceed the 

Agency’s level of concern for aggregate 

exposure to food, water, and residential 

uses. Therefore, EPA does not expect 

intermediate-term aggregate exposure to 

exceed the Agency’s level of concern. 

5. Aggregate cancer risk for U.S. 

population. Etofenprox has been 

classified as, ‘‘not likely to be 

carcinogenic to humans at doses that do 

not alter rat thyroid hormone 

homeostasis.’’ Therefore, etofenprox 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, and to infants and children 

from aggregate exposure to etofenprox 

residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate enforcement 

methodology (gas chromatography) is 

available to enforce the tolerance 

expression. The method may be 

requested from: Team Leader, 

Emergency Response Team, Risk 

Integration, Minor Use, Emergency 

Response Branch (7505P) 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460; telephone number: (703) 

308–8179; e-mail address: 

britten.anthony@epa.gov. 

B. International Residue Limits 

Etofenprox is in the CODEX system 

with a residue definition of etofenprox 

(fat soluble), but without an MRL on 

rice. 

VI. Conclusion 

Therefore, time-limited tolerances are 

established for residues of etofenprox 

(2-[ethoxyphenyl]-2-methylpropyl-3- 

phenoxy benzyl ether), in or on rice, 

grain at 0.01ppm and rice, straw at 0.02 

ppm. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes timelimited tolerances under section 408 of 

the FFDCA. The Office of Management 

and Budget (OMB) has exempted these 

types of actions from review under 

Executive Order 12866, entitled 

Regulatory Planning and Review (58 FR 

51735, October 4, 1993). Because this 

rule has been exempted from review 

under Executive Order 12866 due to its 

lack of significance, this rule is not 

subject to Executive Order 13211, 

Actions Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 


rwilkins on PROD1PC63 with RULES
54928 Federal Register / Vol. 71, No. 182 / Wednesday, September 20, 2006 / Rules and Regulations 

22, 2001). 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., or 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). 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); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

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). Since 

tolerances and exemptions that are 

established on the basis of a FIFRA 

section 18 exemption under section 408 

of the 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. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers, and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of the 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

VIII. Congressional Review Act 

The Congressional Review Act, 5 

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

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 8, 2006. 

James Jones, 

Director, Office of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—AMENDED 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.620 is added to read as 

follows: 

§ 180.620 Etofenprox; tolerances for 

residues. 

(a) General. [Reserved] 

(b) Section 18 emergency exemptions. 

Time-limited tolerances are established 

for residues of etofenprox (2- 

[ethoxyphenyl]-2-methylpropyl-3- 

phenoxy benzyl ether) in connection 

with use of the pesticide under section 

18 emergency exemptions granted by 

EPA. The tolerances will expire and are 

revoked on the dates specified in the 

following table. 

Commodity Parts per 

million 

Expiration/ 

revocation 

date 

Rice, grain ........ 0.01 12/31/09 

Rice, straw ........ 0.02 12/31/09 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 06–8004 Filed 9–19–06; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0617; FRL–8091–6] 

Pantoea Agglomerans Strain E325; 

Exemption from the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of the Pantoea 

agglomerans strain E325 on apples and 

pears when applied/used as a microbial 

pesticide. Northwest Agricultural 

Products submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), as amended by 

the Food Quality Protection Act of 1996 

(FQPA), requesting an exemption from 

the requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of Pantoea agglomerans 

strain E325. 

DATES: This regulation is effective 

September 20, 2006. Objections and 

requests for hearings must be received 

on or before November 20, 2006, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 


rwilkins on PROD1PC63 with RULES