Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 55277 

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 petition 

under section 408(d) of the FFDCA, 

such as the exemption 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. The 

Agency hereby certifies that this rule 

will not have significant negative 

economic impact on a substantial 

number of small entities. 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. 

X. 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 9, 2005. 

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 180.1259 is added to 

subpart D to read as follows: 

§ 180.1259 Reynoutria sachalinensis 

extract; exemption from the requirement of 

a tolerance. 

Residues of the biochemical pesticide 

Reynoutria sachalinensis extract, when 

derived from the whole plant extract, 

are exempt from the requirement of a 

tolerance in or on all food commodities. 

[FR Doc. 05–18725 Filed 9–20–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0074; FRL–7736–2] 

Iprovalicarb; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of Iprovalicarb in 

or on tomatoes. Bayer CropScience AG 

requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA). 

DATES: This regulation is effective 

September 21, 2005. Objections and 

requests for hearings must be received 

on or before November 21, 2005. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VI. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2005–

0074. All documents in the docket are 

listed in the EDOCKET index athttp:// 

www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., 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 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This docket facility is 

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

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Mary L. Waller, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9354; e-mail 

address:waller.mary@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 

55278 Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111), 

e.g., agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS code 

112), e.g., cattle ranchers and farmers, 

dairy cattle farmers, livestock farmers. 

• Food manufacturing (NAICS code 

311), e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

code 32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

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 underFOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document and Other Related 

Information? 

In addition to using EDOCKET (http:// 

www.epa.gov/edocket/), you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 180 is available at E-CFR 

Beta Site Two at http:// 

www.gpoaccess.gov/ecfr/. 

II. Background and Statutory Findings 

In the Federal Register of April 8, 

2005 (70 FR 18001) (FRL–7703–8), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 3E6578) by Bayer 

CropScience AG, 2 T.W. Alexander 

Drive; Research Triangle Park, NC 

27709. The petition requested that 40 

CFR 180.581 be amended by 

establishing a tolerance for residues of 

the fungicide iprovalicarb, [1- 

methylethyl [(1S)-2-methyl-1-[[[1-(4- 

methylphenyl) ethyl] amino] carbonyl] 

propyl] carbamate], in or on tomatoes at 

1.0 parts per million (ppm). That notice 

included a summary of the petition 

prepared by Bayer CropScience AG, the 

registrant. Comments were received on 

the notice of filing. EPA’s response to 

these comments is discussed in Unit 

IV.C. below. 

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. . . .’’

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 FFDCA 

and a complete description of the risk 

assessment process, seehttp:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm 

III. Aggregate Risk Assessment and 

Determination of Safety 

Consistent with 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, 

consistent with section 408(b)(2) of 

FFDCA, for a tolerance for residues of 

iprovalicarb on tomatoes at 1.0 ppm. 

EPA’s assessment of exposures and risks 

associated with establishing the 

tolerance follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. Specific 

information on the studies received and 

the nature of the toxic effects caused by 

iprovalicarb as well as the no observed 

adverse effect level (NOAEL) and the 

lowest observed adverse effect level 

(LOAEL) from the toxicity studies can 

be found at http://www.epa.gov/edocket. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, 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 level 

of concern (LOC). 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. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify nonthreshold hazards such as cancer. The 

Q* approach which assumes that any 

amount of exposure will lead to some 

degree of cancer risk, estimates risk in 

terms of the probability of occurrence of 

additional cancer cases. More 

information can be found on the general 

principles that EPA uses in risk 

characterization at http://www.epa.gov/ 

oppfead1/trac/science/. 

A summary of the toxicological 

endpoints for iprovalicarb used for 

human risk assessment is discussed in 

Unit III.B. of the final rule published in 

the Federal Register of August 22, 2002 

(67 FR 54351) (FRL–7194–3). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. A tolerance has been 

established (40 CFR 180.581) for the 

residues of iprovalicarb, in or on grapes. 

Risk assessments were conducted by 

EPA to assess dietary exposures from 

iprovalicarb in food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1–day or single 

exposure. 

No such effects were identified in the 

toxicological studies for iprovalicarb; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the Dietary Exposure 

Evaluation Model software with the 

Food Commodity Intake Database 

(DEEM-FCIDTM), both of which 

incorporate food consumption data as 

Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 55279 

reported by respondents in the USDA 

1994–1996 and 1998 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: Assessments were based 

on tolerance-level residues in/on grape 

commodities, anticipated residue (AR) 

values for tomato commodities, DEEM 

default processing factors, and 100% 

crop treated (100% CT) assumptions. 

The AR used for tomatoes was 0.5 ppm, 

or half the proposed tolerance level of 

1.0 ppm for harmonization purposes. 

iii. Cancer. The cancer dietary 

exposure analysis was based on the 

same assumptions as the chronic dietary 

exposure analysis. 

iv. Anticipated residue and percent 

crop treated (PCT)information. 

Section 408(b)(2)(E) of the 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 chemicals 

that have been measured in food. If EPA 

relies on such information, EPA must 

pursuant to section 408(f)(1) require 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. Following the initial data 

submission, EPA is authorized to 

require similar data on a time frame it 

deems appropriate. For the present 

action, EPA will issue such data call-ins 

for information relating to anticipated 

residues as are required by FFDCA 

section 408(b)(2)(E) and authorized 

under FFDCA section 408(f)(1). Such 

Data Call-Ins will be required to be 

submitted no later than 5 years from the 

date of issuance of this tolerance. 

2. Dietary exposure from drinking 

water. There is no expectation that 

exposure to iprovalicarb residues would 

occur via drinking water. This action is 

for a tolerance on imported tomatoes 

only, and there are no registered uses of 

iprovalicarb in the United States. 

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). 

Iprovalicarb is not registered for use on 

any sites that would result in residential 

exposure. 

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.’’

Although iprovalicarb is a carbamate 

compound, it is not a member of the 

class of insecticides known as the Nmethyl carbamates for which the 

Agency is presently conducting a 

cumulative risk assessment. The 

common mechanism determination for 

the N-methyl carbamates was based on 

shared structural characteristics and 

their shared ability to cause 

neurotoxicity through the inhibition of 

acetylcholinesterase (AChE) by 

carbamylation of the serine hydroxyl 

group located in the active site of the 

enzyme. Iprovalicarb does not fit these 

characteristics and therefore should not 

be included in the N-methyl carbamate 

common mechanism group nor should 

it be included in the N-methyl 

carbamate cumulative risk assessment. 

The Agency has concluded that other 

subgroups of carbamates do not share a 

common mechanism of toxicity. 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 athttp:// 

www.epa.gov/pesticides/cumulative/. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408 of 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 based on reliable data 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 margin of exposure analysis or 

through using uncertainty (safety) 

factors in calculating a dose level that 

poses no appreciable risk to humans. In 

applying this provision, EPA either 

retains the default value of 10X when 

reliable data do not support the choice 

of a different factor, or, if reliable data 

are available, EPA uses a different 

additional safety factor value based on 

the use of traditional uncertainty factors 

and/or special FQPA safety factors, as 

appropriate. 

2. Prenatal and postnatal sensitivity. 

There is no evidence for increased 

succeptability of fetuses to in utero 

exposure to iprovalicarb in either the rat 

developmental or rabbit developmental 

studies. There is qualitative evidence of 

susceptibility in the multi-generation 

reproduction study in the rat. However, 

it was concluded that there is a low 

degree of concern (and no residual 

uncertainty) for the effects seen because: 

i. The increased susceptibility 

(decrease in pup survival) was seen only 

at the highest dose tested (2,074 

milligram/kilogram/day (mg/kg/day)) 

which is twice the limit dose. 

ii. The decrease in pup survival was 

seen only in 1–generation (F1, not 

replicated in F2). 

iii. There are clearly defined 

NOAELs/LOAELs for parental and 

offspring toxicity. 

iv. The effects seen in the offspring 

occurred at a much higher dose (192 

mg/kg/day) than that used to establish 

the Chronic RfD (NOAEL of 2.62 mg/kg/ 

day). Furthermore, the Agency 

concluded that a developmental 

neurotoxicity study is not required. No 

treatment-related toxicologically 

significant sign of neurotoxicity were 

observed in any available studies on 

iprovalicarb. 

3. Conclusion. There is a complete 

toxicity data base for iprovalicarb and 

exposure data are complete or are 

estimated based on data that reasonably 

accounts for potential exposures. 

Additionally the Agency concludes that 

there are reliable data that indicate there 

are no (residual) concerns for the 

prenatal and/or postnatal toxicity 

following exposure to iprovalicarb. 

Therefore, no additional safety factor 

(1X) is necessary to protect the safety of 

infants and children. 

E. Aggregate Risks and Determination of 

Safety 

1. Acute risk. An endpoint 

attributable to a single dose was not 

identified for any population subgroups. 

Therefore, no acute risk is expected. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to iprovalicarb from food 

will utilize 8.4% of the cPAD for the 

U.S. population, [9.9 %] of the cPAD for 

all infants (< 1 year), and 37% of the 

cPAD for children (1-2 years). There are 

no residential uses for iprovalicarb that 

result in chronic residential exposure to 

iprovalicarb. In addition, there is no 

potential for chronic dietary exposure to 

iprovalicarb in drinking water. EPA 

does not expect the aggregate exposure 

(dietary only) to exceed 100% of the 

cPAD, as shown in Table of this unit: 

55280 Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 

TABLE 1.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO IPROVALICARB

Population/Subgroup cPAD (mg/kg/day) % cPAD (Food) 

U.S. population 0.026 8.4 

All Infants (< 1 yr) 0.026 9.9 

Children 1-2 yrs 0.026 37 

3. Short-term risk. Iprovalicarb is not 

registered for use on any sites that 

would result in residential exposure. 

Therefore, the aggregate risk is the sum 

of the risk from food and water, which 

do not exceed the Agency’s level of 

concern. 

4. Intermediate-term risk. Iprovalicarb 

is not registered for use on any sites that 

would result in residential exposure. 

Therefore, the aggregate risk is the sum 

of the risk from food and water, which 

do not exceed the Agency’s level of 

concern. 

5. Aggregate cancer risk for U.S. 

population. The lifetime cancer risk 

from iprovalicarb dietary exposure is 

determined for the U.S. population 

(total) only. The estimated exposure to 

iprovalicarb is 0.002189 mg/kg/day. 

Applying the Q1* of 4.47 x 10-4 (mg/kg/ 

day)-1 to the exposure value results in 

a cancer risk estimate of 9.74 x 10-7. 

This risk is negligible, and does not 

exceed the Agency’s level of concern. 

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 iprovalicarb 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(HLPC/MS) is available to enforce the 

tolerance expression. The method may 

be requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

Iprovalicarb is not in the Codex 

system. There are no MRLs in Mexico. 

The Agency is recommending a 1.0 ppm 

tolerance on tomatoes in order to 

harmonize with the existing 1.0 mg/kg 

provisional maximum residue limit 

(MRL) for iprovalicarb on tomatoes in 

the European Union. 

C. Response to Comments 

Comments were received from a 

private citizen on April 17, 2005 

objecting to the sale and use of this 

product. The comments further stated 

that no long term or combined tests 

have been done to show complete 

safety. The Agency response is as 

follows: The petitioner did not request 

registration of iprovalicarb in the U.S. 

The petitioner is seeking an import 

tolerance which would allow tomatoes 

treated in foreign countries to be 

imported into the U.S. The U.S. cannot 

regulate the sale and the use of a 

pesticide in a foreign country. The 

Agency had sufficient data, including 

chronic, long-term data, to support a 

determination that there is reasonable 

certainty that no harm will result from 

dietary exposure to residues of 

iprovalicarb. 

V. Conclusion 

Therefore, the tolerance is established 

for residues of iprovalicarb, [[1- 

methylethyl [(1S)-2-methyl-1-[[[1-(4- 

methylphenyl) ethyl] amino] carbonyl] 

propyl carbamate, in or on tomatoes at 

1.0 ppm. 

VI. Objections and Hearing Requests 

Under section 408(g) of FFDCA, as 

amended by 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. 

Although the procedures in those 

regulations require some modification to 

reflect the amendments made to FFDCA 

by FQPA, EPA will continue to use 

those procedures, with appropriate 

adjustments, until the necessary 

modifications can be made.The new 

section 408(g) of FFDCA provides 

essentially the same process for persons 

to ‘‘object’’ to a regulation for an 

exemption from the requirement of a 

tolerance issued by EPA under new 

section 408(d) of FFDCA, as was 

provided in the old sections 408 and 

409 of FFDCA. However, the period for 

filing objections is now 60 days, rather 

than 30 days. 

A. What Do I Need to Do to File an 

Objection or Request a Hearing? 

You must file your objection or 

request a hearing on this regulation in 

accordance with the instructions 

provided in this unit and in 40 CFR part 

178. To ensure proper receipt by EPA, 

you must identify docket ID number 

OPP–2005–0074 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 21, 2005. 

1. Filing the request. Your objection 

must specify the specific provisions in 

the regulation that you object to, and the 

grounds for the objections (40 CFR 

178.25). If a hearing is requested, the 

objections must include a statement of 

the factual issue(s) on which a hearing 

is requested, the requestor’s contentions 

on such issues, and a summary of any 

evidence relied upon by the objector (40 

CFR 178.27). Information submitted in 

connection with an objection or hearing 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice. 

Mail your written request to: Office of 

the Hearing Clerk (1900L), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. You may also deliver 

your request to the Office of the Hearing 

Clerk in Suite 350, 1099 14th St., NW., 

Washington, DC 20005. The Office of 

the Hearing Clerk is open from 8 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Office of the Hearing 

Clerk is (202) 564–6255. 

2. Copies for the Docket. In addition 

to filing an objection or hearing request 

with the Hearing Clerk as described in 

Unit VI.A., you should also send a copy 

of your request to the PIRIB for its 

inclusion in the official record that is 

described in ADDRESSES. Mail your 

copies, identified by docket ID number 

OPP–2005–0074, to: Public Information 

Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 55281 

and Records Integrity Branch, 

Information Technology and Resource 

Management Division (7502C), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460–

0001. In person or by courier, bring a 

copy to the location of the PIRIB 

described in ADDRESSES. You may also 

send an electronic copy of your request 

via e-mail to: opp-docket@epa.gov. 

Please use an ASCII file format and 

avoid the use of special characters and 

any form of encryption. Copies of 

electronic objections and hearing 

requests will also be accepted on disks 

in WordPerfect 6.1/8.0 or ASCII file 

format. Do not include any CBI in your 

electronic copy. You may also submit an 

electronic copy of your request at many 

Federal Depository Libraries. 

B. When Will the Agency Grant a 

Request for a Hearing? 

A request for a hearing will be granted 

if the Administrator determines that the 

material submitted shows the following: 

There is a genuine and substantial issue 

of fact; there is a reasonable possibility 

that available evidence identified by the 

requestor would, if established resolve 

one or more of such issues in favor of 

the requestor, taking into account 

uncontested claims or facts to the 

contrary; and resolution of the factual 

issue(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32). 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

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 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 

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 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. 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 

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. 801et 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 12, 2005. 

Meredith F. Laws, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—AMENDED 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.581 is amended by 

alphabetically adding ‘‘tomatoes’’ in the 

table in paragraph (a) and by revising 

footnote 1 to read as follows: 

§ 180.581 Iprovalicarb; tolerances for 

residues. 

(a) * * * 

55282 Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 

Commodity Parts per million 

*****

Tomatoes1 ............ 1.0 

1There is no U.S. registration as of September 1, 2005. 

* * * * * 

[FR Doc. 05–18828 Filed 9–20–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2004–0246; FRL–7734–3] 

Lindane; Tolerance Actions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is revoking specific 

existing tolerances for the insecticide 

lindane because, following receipt of 

registrant requests, the Agency canceled 

their associated Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA) 

registrations in the United States. 

DATES: This regulation is effective 

September 21, 2005. However, certain 

regulatory actions will not occur until 

the date specified in the regulatory text. 

Objections and requests for hearings 

must be received on or before November 

21, 2005. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit IV. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2004–

0246. All documents in the docket are 

listed in the EDOCKET index at http:// 

www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., 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 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This docket facility is 

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

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Joseph Nevola, Special Review and 

Reregistration Division (7508C), Office 

of Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460–

0001; telephone number: (703) 308–

8037; e-mail address: 

nevola.joseph@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), 

e.g., agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS code 

112), e.g., cattle ranchers and farmers, 

dairy cattle farmers, livestock farmers. 

• Food manufacturing (NAICS code 

311), e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

code 32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

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 underFOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document and Other 

RelatedInformation? 

In addition to using EDOCKET (http:// 

www.epa.gov/edocket/), you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings 

athttp://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 180 is available at E-CFR 

Beta Site Two at http:// 

www.gpoaccess.gov/ecfr/. 

II. Background 

A. What Action is the Agency Taking? 

In the Federal Register of April 15, 

2005 (70 FR 20035) (FRL–7702–2), EPA 

proposed to revoke certain tolerances 

for residues of the insecticide lindane. 

Also, the proposal of April 15, 2005, 

provided a 60–day comment period 

which invited public comment for 

consideration and for support of 

tolerance retention under the Federal 

Food, Drug, and Cosmetic Act (FFDCA) 

standards. 

The tolerances revoked in this final 

rule are no longer necessary to cover 

residues of the relevant pesticide in or 

on domestically treated commodities or 

commodities treated outside but 

imported into the United States. It is 

EPA’s general practice to revoke those 

tolerances and tolerance exemptions for 

residues of pesticide active ingredients 

on crop uses for which there are no 

active registrations under FIFRA, unless 

any person in comments on the 

proposal indicates a need for the 

tolerance or tolerance exemption to 

cover residues in or on imported 

commodities or domestic commodities 

legally treated. 

EPA has historically been concerned 

that retention of tolerances that are not 

necessary to cover residues in or on 

legally treated foods may encourage 

misuse of pesticides within the United 

States. Thus, it is EPA’s policy to issue 

a final rule revoking those tolerances for 

residues of pesticide chemicals for 

which there are no active registrations 

under FIFRA, unless any person 

commenting on the proposal 

demonstrates a need for the tolerance to 

cover residues in or on imported 

commodities or domestic commodities 

legally treated. 

Generally, EPA will proceed with the 

revocation of these tolerances on the 

grounds discussed in Unit II.A. if one of 

the following conditions applies: 

1. Prior to EPA’s issuance of a section 

408(f) order requesting additional data 

or issuance of a section 408(d) or (e) 

order revoking the tolerances on other 

grounds, commenters retract the 

comment identifying a need for the 

tolerance to be retained. 

2. EPA independently verifies that the 

tolerance is no longer needed. 

3. The tolerance is not supported by 

data that demonstrate that the tolerance 

meets the requirements under FQPA. 

Today’s final rule does not revoke 

those tolerances for which EPA received 

comments stating a need for the 

tolerance to be retained. In response to 

the proposal published in the Federal 

Register of April 15, 2005 (70 FR 

20035), EPA received comments during 

the 60–day public comment period, as 

follows: 

Comments by private citizens. One 

private citizen stated that all lindane 

tolerances should be revoked. Another 

private citizen expressed a general