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 

Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 55283 

concern about the use of lindane as a 

pharmaceutical product. 

Comment by the Washington Toxics 

Coalition (WTC). The WTC supports 

EPA’s action to revoke remaining crop 

tolerances for lindane. The WTC stated 

that it had earlier submitted, along with 

the Pesticide Action Network North 

America (PANNA) and Alaska 

Community Action on Toxics (ACAT), a 

petition dated March 31, 2005, to EPA 

which requested the revocation of all 

tolerances for lindane. The WTC stated 

its opposition to the continued use of 

lindane as a pharmaceutical product 

and registration of lindane for seed 

treatment. The WTC expressed a 

concern for lindane pesticide risks to 

farmworkers, children, mothers, 

indigenous people, and animals. 

Comment by Technology Sciences 

Group Incorporated (TSG). On behalf of 

its client, Crompton Corporation 

(currently known as Chemtura) who is 

a registrant of lindane seed treatment 

products, TSG agreed with revocation of 

lindane tolerances associated with 

canceled lindane uses and retention of 

livestock fat tolerances to accommodate 

lindane seed treatment uses. TSG 

disagreed with the petition by PANNA, 

et. al., and stated that revocation of the 

livestock fat tolerances would be 

counterproductive because of the 

existing seed treatment uses. 

Agency response. None of the 

commenters took issue with the 

Agency’s proposal to revoke certain 

lindane tolerances which were no 

longer needed or whose associated food 

uses were no longer current or 

registered in the United States. To the 

extent that commenters raise issues 

relevant to the establishment of 

tolerances for the seed treatment uses, 

EPA will consider those comments 

during assessment of seed treatment 

tolerances, which will be completed by 

August 2006. 

It is EPA’s general practice to revoke 

tolerances for residues of pesticide 

active ingredients on crop uses for 

which there are no active registrations 

under FIFRA, unless any person, in 

comments submitted on the proposal, 

indicates a need for the tolerance to 

cover residues in or on imported 

commodities or domestic commodities 

legally treated. 

There are lindane end-use active 

registrations for seed treatments on 

cereal grains which are eligible for 

reregistration, provided that mitigation 

measures specified in the July 31, 2002, 

Lindane Registration Eligibility Decision 

(RED) are implemented and the Agency 

can establish tolerances for the seed 

treatment uses of lindane. These 

mitigation measures include the 

following actions: prohibition of dust 

formulations on certain crops, reduction 

of maximum application rates, addition 

of personal protective equipment 

requirements, and the establishment of 

a 24–hour restricted re-entry interval. 

The establishment of seed treatment 

tolerances is conditioned on EPA’s 

ability to make a determination that 

establishing the new tolerances meets 

the safety standard in FFDCA. 

Currently, it is possible that livestock 

feed may be derived from grain grown 

from lindane-treated seed and residues 

of lindane in livestock would be 

expected. Consequently, the Agency 

believes that the existing livestock fat 

tolerances for lindane per se must be 

maintained until and unless the grain 

seed treatment uses are no longer 

registered. If the Agency is unable to 

make a safety finding that would 

support the establishment of tolerances 

on wheat, barley, oats, rye, corn, and 

sorghum for lindane residues resulting 

from seed treatment only, it will take 

steps to cancel the grain seed treatment 

registrations and propose revocation of 

the livestock fat tolerances. The Agency 

intends to complete its assessment of 

the seed treatment uses on or prior to 

August 3, 2006. 

The proposal of April 15, 2005, did 

not address the pharmaceutical use of 

lindane. Lindane is an ectoparasiticide 

and ovicide. The U.S. Food and Drug 

Administration (FDA) has the primary 

responsibility for regulating human 

ectoparasite pharmaceutical treatments. 

Information regarding such use is 

available through the FDA’s Center for 

Drug’s Division of Drug Information at 

http://www.fda.gov/cder/Offices/DDI/ 

default.htm. 

Therefore, EPA is implementing 

tolerance recommendations made 

during the reregistration and tolerance 

reassessment processes (including 

follow-up on canceled or additional 

uses of pesticides). As part of the 

reregistration and tolerance 

reassessment processes, EPA is required 

to determine whether each of the 

amended tolerances meets the safety 

standards under the Food Quality 

Protection Act (FQPA). The safety 

finding determination of ‘‘reasonable 

certainty of no harm’’ is found in detail 

in each RED and Report on FQPA 

Tolerance Reassessment Progress and 

Interim Risk Management Decision 

(TRED) for the active ingredient. REDs 

and TREDs propose certain tolerance 

actions to be implemented to reflect 

current use patterns, to meet safety 

findings and change commodity names 

and groupings in accordance with new 

EPA policy. Printed copies of the REDs 

and TREDs may be obtained from EPA’s 

National Service Center for 

Environmental Publications (EPA/ 

NSCEP), P.O. Box 42419, Cincinnati, 

OH 45242–2419, telephone 1–800–490–

9198; fax 1–513–489–8695; internet at 

http://www.epa.gov/ncepihom/ and 

from the National Technical Information 

Service (NTIS), 5285 Port Royal Road, 

Springfield, VA 22161, telephone 1–

800–553–6847 or (703) 605–6000; 

internet at http://www.ntis.gov/. 

Electronic copies of REDs and TREDs 

are available on the internet at http:// 

www.epa.gov/pesticides/reregistration/ 

status.htm. 

Additional information can be found 

in the Lindane RED and the Residue 

Chemistry Chapter document which 

supports the RED. A copy of the 

Lindane RED and Residue Chemistry 

Chapter are found in the Administrative 

Record and hard copies are available in 

the public docket OPP–2002–0202, 

while an electronic copy is available 

through EPA’s electronic public docket 

and comment system, EPA Dockets at 

http://www.epa.gov/edocket/. You may 

search for docket ID number OPP–2002–

0202, then click on that docket ID 

number to view the Lindane RED 

support documents. 

EPA is revoking certain specific 

existing tolerances for lindane because 

there are no longer any active 

registrations under FIFRA for uses on 

their associated commodities. Except for 

some seed treatment registrations, all 

other food use registrations for the 

insecticide lindane were canceled 

because EPA accepted the registrants’

requests for voluntary cancellation. 

EPA made amendments to delete 

mushroom and nectarine uses from 

lindane registrations effective on March 

29, 1999, and registrant sale and 

distribution of existing stocks was 

permitted for a period of 18 months; i.e., 

until September 29, 2000. EPA believes 

that end users have had sufficient time, 

more than 4 years, to exhaust those 

existing stocks and for treated 

commodities to have cleared the 

channels of trade. Therefore, the Agency 

is revoking the tolerances in 40 CFR 

180.133 for residues of the insecticide 

lindane in or on mushroom and 

nectarine. 

EPA made amendments to delete 

apricot, asparagus, avocado, eggplant, 

grape, guava, mango, pear, pecans, 

pepper, pineapple, quince, strawberry, 

and tomato uses from lindane 

registrations effective on July 26, 1999, 

and registrant sale and distribution of 

existing stocks was permitted for a 

period of 18 months; i.e., until January 

26, 2001. EPA believes that end users 

have had sufficient time, more than 4 

years, to exhaust those existing stocks 

55284 Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 

and for treated commodities to have 

cleared the channels of trade. Therefore, 

the Agency is revoking the tolerances in 

40 CFR 180.133 for residues of the 

insecticide lindane in or on apricot, 

asparagus, avocado, eggplant, grape, 

guava, mango, pear, pecans, pepper, 

pineapple, quince, strawberry, and 

tomato. 

EPA made registration cancellations, 

which included plums among their 

affected commodity uses, effective on 

March 22, 2000, and registrant sale and 

distribution of existing stocks was 

permitted for 1–year after the 

cancellation requests were received by 

the Agency; i.e., until June 9, 2000. EPA 

believes that end users have had 

sufficient time, more than 5 years, to 

exhaust those existing stocks and for 

treated commodities to have cleared the 

channels of trade. Therefore, the Agency 

is revoking the tolerances in 40 CFR 

180.133 for residues of the insecticide 

lindane in or on plum and plum, prune, 

fresh. 

EPA made registration cancellations, 

which included apples, cherries, and 

peaches among their affected 

commodity uses, effective on May 9, 

2000, and registrant sale and 

distribution of existing stocks was 

permitted for 1–year after the 

cancellation requests were received by 

the Agency; i.e., until August 18, 2000. 

EPA believes that end users have had 

sufficient time, more than 5 years, to 

exhaust those existing stocks and for 

treated commodities to have cleared the 

channels of trade. Therefore, the Agency 

is revoking the tolerances in 40 CFR 

180.133 for residues of the insecticide 

lindane in or on apple, cherry, and 

peach. 

EPA made amendments to delete 

spinach, celery, collards, kale, kohlrabi, 

lettuce, mustard greens, and Swiss 

chard uses from a lindane registration 

effective on December 10, 2002, and 

registrant sale and distribution of 

existing stocks was permitted for a 

period of 18 months; i.e., until June 10, 

2004. EPA believes that end users have 

had sufficient time to exhaust existing 

stocks and for treated commodities to 

have cleared the channels of trade. 

Because the proposed expiration/ 

revocation dates of June 10, 2005, are 

now past, EPA is revoking the 

tolerances in 40 CFR 180.133 for 

residues of the insecticide lindane in or 

on celery, collards, kale, kohlrabi, 

lettuce, mustard greens, spinach, and 

Swiss chard, all effective on the date of 

publication of this final rule in the 

Federal Register. 

EPA made amendments to delete seed 

treatment uses for broccoli, Brussels 

sprouts, cabbage, and cauliflower from a 

lindane registration effective on 

February 25, 2005. However, registrant 

sale and distribution of existing stocks 

was permitted for a period of 18 months 

after the October 26, 2004, approval of 

the revision; i.e., until April 26, 2006. 

The Agency believes that end users will 

have sufficient time to exhaust existing 

stocks and for treated commodities to 

have cleared the channels of trade by 

April 26, 2007. Therefore, EPA is 

revoking the tolerances in 40 CFR 

180.133 for residues of the insecticide 

lindane in or on broccoli, Brussels 

sprouts, cabbage, and cauliflower with 

expiration/revocation dates of April 26, 

2007. 

EPA made amendments to delete 

cucumber, cantaloupe, watermelon, 

okra, onions, pumpkin, and squash uses 

from lindane registrations effective on 

August 17, 2002, and registrant sale and 

distribution of existing stocks was 

permitted for a period of 18 months; i.e., 

until February 17, 2004. EPA believes 

that end users have had sufficient time 

to exhaust existing stocks and for 

treated commodities to have cleared the 

channels of trade. Because the proposed 

expiration/revocation dates of June 10, 

2005, are now past, EPA is revoking the 

tolerances in 40 CFR 180.133 for 

residues of the insecticide lindane in or 

on cucumber, melon, okra, onion (dry 

bulb), pumpkin, squash, and squash, 

summer, all effective on the date of 

publication of this final rule in the 

Federal Register. 

Because some tolerances will remain 

codified in 40 CFR 180.133 with 

expiration/revocation dates, a revision 

of the residue definition for lindane is 

needed in order to harmonize with the 

International Union of Pure and 

Applied Chemistry (IUPAC) 

nomenclature. Therefore, EPA is 

amending the tolerance expression in 40 

CFR 180.133 from residues of lindane 

(gamma isomer of benzene 

hexachloride) to lindane (gamma isomer 

of 1,2,3,4,5,6-hexachlorocyclohexane). 

B. What is the Agency’s Authority for 

Taking this Action? 

EPA’s general practice is to revoke 

tolerances for residues of pesticide 

active ingredients on crops for which 

FIFRA registrations no longer exist and 

on which the pesticide may therefore no 

longer be used in the United States. 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. Nonetheless, EPA will establish 

and maintain tolerances even when 

corresponding domestic uses are 

canceled if the tolerances, which EPA 

refers to as ‘‘import tolerances,’’ are 

necessary to allow importation into the 

United States of food containing such 

pesticide residues. However, where 

there are no imported commodities that 

require these import tolerances, the 

Agency believes it is appropriate to 

revoke tolerances for unregistered 

pesticides in order to prevent potential 

misuse. 

C. When Do These Actions Become 

Effective? 

With the exception of certain lindane 

tolerances which EPA is revoking with 

specific expiration/revocation dates, the 

actions in this final rule become 

effective on the date of publication of 

this final rule in the Federal Register 

because the specific lindane tolerances 

revoked herein are no longer needed or 

are associated with food uses that have 

been canceled for several years. The 

Agency believes that treated 

commodities have had sufficient time 

for passage through the channels of 

trade. 

Any commodities listed in the 

regulatory text of this document that are 

treated with the pesticides subject to 

this final rule, and that are in the 

channels of trade following the 

tolerance revocations, shall be subject to 

FFDCA section 408(1)(5), as established 

by the FQPA. Under this section, any 

residues of these pesticides in or on 

such food shall not render the food 

adulterated so long as it is shown to the 

satisfaction of the Food and Drug 

Administration that: (1) The residue is 

present as the result of an application or 

use of the pesticide at a time and in a 

manner that was lawful under FIFRA, 

and (2) the residue does not exceed the 

level that was authorized at the time of 

the application or use to be present on 

the food under a tolerance or exemption 

from tolerance. Evidence to show that 

food was lawfully treated may include 

records that verify the dates that the 

pesticide was applied to such food. 

III. Are There Any International Trade 

Issues Raised by this Final Action? 

EPA is working to ensure that the U.S. 

tolerance reassessment program under 

FQPA does not disrupt international 

trade. EPA considers Codex Maximum 

Residue Limits (MRLs) in setting U.S. 

tolerances and in reassessing them. 

MRLs are established by the Codex 

Committee on Pesticide Residues, a 

committee within the Codex 

Alimentarius Commission, an 

international organization formed to 

promote the coordination of 

international food standards. When 

possible, EPA seeks to harmonize U.S. 

tolerances with Codex MRLs. EPA may 

Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 55285 

establish a tolerance that is different 

from a Codex MRL; however, FFDCA 

section 408(b)(4) requires that EPA 

explain in a Federal Register document 

the reasons for departing from the 

Codex level. EPA’s effort to harmonize 

with Codex MRLs is summarized in the 

tolerance reassessment section of 

individual REDs. EPA has developed 

guidance concerning submissions for 

import tolerance support (65 FR 35069, 

June 1, 2000) (FRL–6559–3). This 

guidance will be made available to 

interested persons. Electronic copies are 

available on the internet at http:// 

www.epa.gov/. On the Home Page select 

‘‘Laws and Regulations,’’ then select 

‘‘Regulations and Proposed Rules’’ and 

then look up the entry for this document 

under ‘‘Federal Register—

Environmental Documents.’’ You can 

also go directly to the ‘‘Federal 

Register’’ listings at http:// 

www.epa.gov/fedrgstr/. 

IV. 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–2004–0246 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 issues(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 IV.A.1., 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–2004–0246, to: Public Information 

and Records Integrity Branch, 

Information Resources and Services 

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 email 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 

issues(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32). 

V. Statutory and Executive Order 

Reviews 

In this final rule EPA is revoking 

specific tolerances established under 

FFDCA section 408. The Office of 

Management and Budget (OMB) has 

exempted this type of action (i.e., a 

tolerance revocation for which 

extraordinary circumstances do not 

exist) 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 as required by 

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 other 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 104–13, section 12(d) (15 

U.S.C. 272 note). Pursuant to the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.), the Agency 

previously assessed whether revocations 

of tolerances might significantly impact 

a substantial number of small entities 

and concluded that, as a general matter, 

these actions do not impose a significant 

economic impact on a substantial 

number of small entities. This analysis 

55286 Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 

was published on December 17, 1997 

(62 FR 66020), and was provided to the 

Chief Counsel for Advocacy of the Small 

Business Administration. Taking into 

account this analysis, and available 

information concerning the pesticides 

listed in this rule, the Agency hereby 

certifies that this final rule will not have 

a significant economic impact on a 

substantial number of small entities. 

Specifically, as per the 1997 notice, EPA 

has reviewed its available data on 

imports and foreign pesticide usage and 

concludes that there is a reasonable 

international supply of food not treated 

with canceled pesticides. Furthermore, 

for the pesticides named in this final 

rule, the Agency knows of no 

extraordinary circumstances that exist 

as to the present revocations that would 

change EPA’s previous analysis. 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. 

VI. 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 12, 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. In section 180.133, paragraph (a) is 

revised to read as follows: 

§ 180.133 Lindane; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the 

insecticide lindane (gamma isomer of 

1,2,3,4,5,6-hexachlorocyclohexane) in or 

on raw agricultural commodities as 

follows: 

Commodity Parts per 

million 

Expiration/ 

Revocation 

Date 

Broccoli ............. 1.0 4/26/07 

Brussels sprouts 1.0 4/26/07 

Cabbage ........... 1.0 4/26/07 

Cattle, fat .......... 7.0 None 

Cauliflower ........ 1.0 4/26/07 

Goat, fat ............ 7.0 None 

Hog, fat ............. 4.0 None 

Horse, fat .......... 7.0 None 

Sheep, fat ......... 7.0 None 

* * * * * 

[FR Doc. 05–18829 Filed 9–20–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0259; FRL–7737–9] 

Boscalid; Pesticide Tolerances for 

Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

time-limited tolerance for residues of 

boscalid, 3-pyridinecarboxamide, 2- 

chloro-N-(4′-chloro[1,1′-biphenyl]-2-yl) 

in or on tangerines. This action is in 

response to EPA’s granting of an 

emergency exemption under section 18 

of the Federal Insecticide, Fungicide, 

and Rodenticide Act (FIFRA) 

authorizing use of the pesticide on 

mandarin oranges and mandarin 

hybrids. ‘‘Tangerines’’ is the accepted 

regulatory term used for these crops and 

a tolerance on tangerines covers both 

mandarin oranges and mandarin 

hybrids. This regulation establishes a 

maximum permissible level for residues 

of boscalid in this food commodity. The 

tolerance will expire and is revoked on 

December 31, 2008. 

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 VII. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2005–

0259. 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