This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

60320

Vol. 69, No. 195

Friday, October 8, 2004

DEPARTMENT OF AGRICULTURE 

Federal Crop Insurance Corporation 

7 CFR Part 457 

RIN 0563–AB80 

Common Crop Insurance Regulations; 

Nursery Crop Insurance Provisions

AGENCY: Federal Crop Insurance 

Corporation, USDA.

ACTION: Proposed rule; extension of 

comment period. 

SUMMARY: The Federal Crop Insurance 

Corporation (FCIC) is extending the 

comment period for the proposed rule to 

amend the Nursery Crop Insurance 

Provisions. The proposed rule was 

published in the Federal Register on 

August 9, 2004, (69 FR 48166) and the 

comment period was scheduled to end 

on October 8, 2004. The comment 

period will be extended 45 days and 

will now end on November 22, 2004.

DATES: Written comments and opinions 

on this proposed rule will be accepted 

until close of business November 22, 

2004, and will be considered when the 

rule is to be made final.

ADDRESSES: Interested persons are 

invited to submit written comments to 

the Director, Product Development 

Division, Federal Crop Insurance 

Corporation, United States Department 

of Agriculture, 6501 Beacon Drive, Stop 

0812, Kansas City, MO 64133. 

Comments titled Nursery Crop 

Insurance Provisions may be sent via 

the Internet to 

DirectorPDD@rm.fcic.usda.gov, or the 

Federal eRulemaking Portal: http://

www.regulations.gov. Follow the online 

instructions for submitting comments. A 

copy of each response will be available 

for public inspection and copying from 

7 a.m. to 4:30 p.m., CST, Monday 

through Friday, except holidays, at the 

above address.

FOR FURTHER INFORMATION CONTACT:

Stephen Hoy, Risk Management 

Specialist, Research and Development, 

Product Development Division, Federal 

Crop Insurance Corporation, at the 

Kansas City, MO, address listed above, 

telephone (816) 926–7730.

SUPPLEMENTARY INFORMATION: On August 

9, 2004, FCIC published in the Federal 

Register (69 FR 48166) a proposed rule 

to amend the Nursery Crop Insurance 

Provisions and Nursery Peak Inventory 

Endorsement to improve coverage of 

nursery plants. FCIC also proposed to 

add a Rehabilitation Endorsement for 

Field grown plants that will recover 

from an insured cause of loss. FCIC 

provided a 60-day comment period that 

is scheduled to end October 8, 2004. 

Due to the hurricanes and subsequent 

inclement weather in the southeast and 

eastern United States, FCIC is extending 

the comment period an additional 45 

days to ensure the public has an 

adequate opportunity to review and 

comment on the proposed rule. The 

comment period for the proposed rule is 

extended to November 22, 2004.

Signed in Washington, DC, on October 5, 

2004. 

Ross J. Davidson, Jr., 

Manager, Federal Crop Insurance 

Corporation.

[FR Doc. 04–22740 Filed 10–7–04; 8:45 am] 

BILLING CODE 3410–08–P

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9, 23, 163, 177, 178, 179, 

and 180 

[OPP–2003–0176; FRL–7308–2] 

Updating Generic Pesticide Chemical 

Tolerance Regulations

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: This action proposes to 

update the generic provisions in 40 CFR 

parts 9, 23, 163, 177–180 pertaining to 

pesticide chemical tolerances and 

exemptions from the requirement of a 

tolerance under section 408 of the 

Federal Food, Drug, and Cosmetic Act. 

This update is necessary due to various 

changes made in the underlying statute 

by the Food Quality Protection Act of 

1996. The proposed amendments are 

primarily procedural in nature.

DATES: Comments must be received on 

or before December 7, 2004.

ADDRESSES: Submit your comments, 

identified by docket ID number OPP–

2003–0176, by one of the following 

methods: 

• Federal eRulemaking Portal: http://

www.regulations.gov/. Follow the online instructions for submitting 

comments. 

• Agency Website: http://

www.epa.gov/edocket/. EDOCKET, 

EPA’s electronic public docket and 

comment system, is EPA’s preferred 

method for receiving comments. Follow 

the on-line instructions for submitting 

comments. 

• E-mail: Comments may be sent by 

e-mail to opp-docket@epa.gov, 

Attention: Docket ID Number OPP–

2003–0176. 

• Mail: Public Information and 

Records Integrity Branch (PIRIB) 

(7502C), Office of Pesticide Programs 

(OPP), Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001, Attention: 

Docket ID Number OPP–2003–0176. 

• Hand Delivery: Public Information 

and Records Integrity Branch (PIRIB), 

Office of Pesticide Programs (OPP), 

Environmental Protection Agency, Rm. 

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

Arlington, VA, Attention: Docket ID 

Number OPP–2003–0176. Such 

deliveries are only accepted during the 

Docket’s normal hours of operation, and 

special arrangements should be made 

for deliveries of boxed information. 

Instructions: Direct your comments to 

docket ID number OPP–2003–0176. 

EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at http://

www.epa.gov/edocket/, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through EDOCKET, 

regulations.gov, or e-mail. The EPA 

EDOCKET and the regulations.gov 

websites are ‘‘anonymous access’’ 

systems, which means EPA will not 

know your identity or contact 

information unless you provide it in the 

body of your comment. If you send an 

e-mail comment directly to EPA without 

going through EDOCKET or 

regulations.gov, your e-mail address

Federal Register / Vol. 69, No. 195 / Friday, October 8, 2004 / Proposed Rules 60321

will be automatically captured and 

included as part of the comment that is 

placed in the public docket and made 

available on the Internet. If you submit 

an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. For additional information 

about EPA’s public docket visit 

EDOCKET on-line or see the Federal 

Register of May 31, 2002 (67 FR 38102) 

(FRL–7181–7). 

Docket: 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:

Jonathan Fleuchaus, Office of General 

Counsel, Mail code 2333A, Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460; 

telephone number: (202) 564–5628; fax 

number: (202) 564–5644; e-mail address: 

fleuchaus.jonathan@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 111) 

• Animal production (NAICS 112) 

• Food manufacturer (NAICS 311) 

• Pesticide manufacturer (NAICS 

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 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 is available at E-CFR Beta Site 

Two at http://www.gpoaccess.gov/ecfr/. 

C. What Should I Consider as I Prepare 

My Comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through EDOCKET, 

regulations.gov, or e-mail. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD ROM that 

you mail to EPA, mark the outside of the 

disk or CD ROM as CBI and then 

identify electronically within the disk or 

CD ROM the specific information that is 

claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When submitting comments, remember 

to: 

i. Identify the rulemaking by docket 

ID number and other identifying 

information (subject heading, Federal 

Register date, and page number). 

ii. Follow directions. The Agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

iii. Explain why you agree or disagree, 

suggest alternatives, and substitute 

language for your requested changes. 

iv. Describe any assumptions and 

provide any technical information and/

or data that you used. 

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

vi. Provide specific examples to 

illustrate your concerns, and suggest 

alternatives. 

vii. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

viii. Make sure to submit your 

comments by the comment period 

deadline identified. 

II. Background 

A. What Action is the Agency Taking? 

EPA is proposing to amend various 

sections of 40 CFR parts 9, 23, 163, and 

177-180 to make them consistent with 

the changes to section 408 of the Federal 

Food, Drug, and Cosmetic Act, 21 U.S.C. 

346a, contained in the Food Quality 

Protection Act of 1996 (FQPA). 

EPA is proposing to revoke 40 CFR 

part 163 in its entirety. Part 163 

addresses ‘‘certifications of usefulness’’

for pesticide chemicals. In amending 

section 408, the FQPA dropped all 

requirements pertaining to certifications 

of usefulness. EPA is proposing several 

general changes throughout parts 177–

180. These changes are: 

1. Remove most references to FFDCA 

section 409. The FQPA consolidated 

FFDCA regulation of pesticides, for the 

most part, under FFDCA section 408. 

See 21 U.S.C. 346a(a)(1). Previously, 

pesticide residues in processed food 

were regulated, in part, under FFDCA 

section 409. Most references in 40 CFR 

parts 177–180 to section 409 thus have 

become obsolete and are proposed to be 

removed. This includes 40 CFR part 177 

in its entirety because it is devoted to 

providing procedures for establishing 

regulations under section 409. 

2. Remove most references to ‘‘food 

additives.’’ Because ‘‘food additives’’ are 

addressed by section 409 and not 

section 408, for similar reasons, most 

references to ‘‘food additives’’ are 

proposed to be removed. See 21 U.S.C. 

348. 

3. Revise statutory cross-references 

where appropriate. In some instances, 

the FQPA moved various provisions in 

section 408 to different subsections. For 

example, the procedures pertaining to 

filing objections are now located in 

section 408(g) not section 408(d) as they 

were previously. These cross-references 

are proposed to be corrected. 

4. Remove provisions addressing 

advisory committees. Previously, 

section 408 had a provision permitting 

affected parties to request the formation 

of science advisory panels regarding 

tolerance actions. Because this 

provision was dropped by the FQPA, 

EPA is proposing to remove the 

implementing regulations.

60322 Federal Register / Vol. 69, No. 195 / Friday, October 8, 2004 / Proposed Rules 

5. Remove provisions addressing the 

time requirements for acting on 

petitions. Previously, section 408 

required action on petitions in certain 

timeframes. Because this provision was 

dropped by the FQPA, EPA is proposing 

to remove implementing regulations 

concerning these timeframes. 

6. Revise changed statutory time 

periods. In a few instances, the FQPA 

revised statutory time periods 

pertaining to actions concerning 

tolerances. For example, the period in 

which objections to final tolerance rules 

can be made was extended from 30 to 

60 days. See 21 U.S.C. 346a(g)(2). EPA 

is proposing to change its regulations to 

be consistent with the statute. 

7. Remove obsolete references to the 

‘‘Registration Division.’’ 40 CFR part 180 

contains several references to the 

Registration Division of the Office of 

Pesticide Programs. Because tolerance 

activities are now divided among 

several divisions in the Office of 

Pesticide Programs, the references to the 

Registration Division may be confusing, 

and EPA is proposing to either replace 

these references with a reference to ‘‘the 

Agency’’ or simply delete them, as 

appropriate. Although this change is not 

directly responsive to the FQPA 

changes, the potential confusion that 

might be caused by the obsolete 

references was deemed important to 

correct at this time. 

8. Correct Agency addresses. 40 CFR 

178.25(a)(5) and 180.33(m) currently list 

obsolete addresses for mailings to the 

Agency. These addresses are proposed 

to be corrected. 

Other changes involving individual 

sections include: 

1. 40 CFR 178.35. This provision 

addresses modification or revocation of 

a tolerance regulation on the basis of 

objections filed with the Agency. EPA is 

proposing to change the language in this 

section to track the language in new 

section 408(g)(2)(C). See 21 U.S.C. 

346a(g)(2). 

2. 40 CFR 180.1(f). The FQPA 

amended the provision addressing the 

manner in which pesticide chemical 

tolerances written for raw agricultural 

commodities apply to processed foods 

manufactured from those commodities. 

This provision is commonly referred to 

as the ‘‘flow-through’’ provision because 

it generally legalizes residues in 

processed food that are not higher than 

the residue levels permitted in the raw 

agricultural commodity. See 21 U.S.C. 

346a(a)(2). EPA is proposing to amend 

40 CFR 180.1(f) to track the language in 

new section 408(a)(2). 

EPA calls attention to the fact that one 

of the changes in the flow-through 

provision, and thus in the revised 40 

CFR 180.1(f), is that it no longer focuses 

on whether processed food is ‘‘ready to 

eat.’’ For many years prior to the 

passage of the FQPA, EPA determined 

the need for processed food tolerances 

without regard to whether the processed 

food was ‘‘ready to eat’’ or not, despite 

statutory language specifying that the 

flow-through provision applied to 

‘‘ready to eat’’ processed food. This led 

to the establishment of several 

processed food tolerances that were 

unnecessary because the tolerances 

were established on not ‘‘ready to eat’’

commodities and when these 

commodities underwent further 

processing to reach the ‘‘ready to eat’’

stage, residues declined below the raw 

agricultural commodity tolerance. 

Shortly before passage of the FQPA, 

EPA revoked several tolerances on not 

‘‘ready to eat’’ processed foods on the 

ground they were not necessary given 

the existing raw agricultural commodity 

tolerance level and the level of residues 

present in the ‘‘ready to eat’’ processed 

food. As part of the tolerance 

reassessment process required by the 

FQPA, EPA will determine if such 

tolerances need to be reestablished and, 

if so, take steps to reinstate such 

tolerances. In the meantime, because 

section 408(j)(3) preserves the 

effectiveness of raw agricultural 

commodity tolerances in existence at 

the time of passage of the FQPA, EPA 

believes that the raw agricultural 

commodity tolerances corresponding to 

the revoked not ‘‘ready to eat’’

processed food tolerances should be 

enforced under the pre-FQPA ‘‘flowthrough’’ provision thus not subjecting 

not ‘‘ready to eat’’ processed food to a 

changed regulatory environment. 

Otherwise, the effect of these raw 

agricultural commodity tolerances will 

not be maintained as specified by 

section 408(j)(3). 

3. 40 CFR 180.2. New section 408(k) 

mandates that pesticide chemicals 

regarded by the Administrator as 

generally recognized as safe (GRAS) 

shall be regarded as exempt from the 

requirement for a tolerance. This section 

further directs EPA to indicate, by 

regulation, which substances have been 

converted from GRAS to being covered 

by a tolerance exemption. 40 CFR 180.2 

now contains a listing of GRAS 

substances. Pursuant to section 408(k), 

EPA is proposing in this action to create 

tolerance exemptions in separate 

sections of 40 CFR part 180 for all but 

three of these substances (citric acid, 

fumaric acid, and sodium chloride). The 

remainder of 40 CFR 180.2, which 

contains procedures for obtaining GRAS 

status is proposed to be deleted. Citric 

acid, fumaric acid, and sodium chloride 

are the subject of a separate rulemaking 

intended to create tolerance exemptions 

for these substances in 40 CFR 180.950. 

4. 40 CFR 180.7. Three important, 

specific changes are proposed for 40 

CFR 180.7. First, it is proposed that this 

section be expanded from addressing 

tolerances just for raw agricultural 

commodities to tolerances for raw 

agricultural commodities and processed 

foods. This is consistent with the 

changes in the FQPA which expanded 

section 408 to include pesticide 

chemical tolerances for processed foods. 

See 21 U.S.C. 346a(a)(1). Second, EPA is 

proposing to expand the requirements 

pertaining to petition contents 

consistent with the expanded statutory 

language in the FQPA, including the 

requirement that the petition contain a 

summary. See 21 U.S.C. 346a(d)(2). 

Third, EPA is specifying that the full 

text of the petitioner’s summary of its 

petition will be added to EPA’s 

Electronic Public Docket (http://

www.epa.gov/edocket) and requiring 

that a specific reference to the internet 

address for the summary be included in 

the Notice of Filing. To date, EPA has 

published the full text of the petitioner’s 

summary in the Federal Register notice 

announcing the Notice of Filing. EPA is 

proposing to include the petitioner’s 

summary in the Notice of Filing Federal 

Register notice through a reference and 

to publish the summary on its internet 

website because petition ‘‘summaries’’

have expanded, in many instances, well 

beyond the concept of a petition 

summary and could be better described 

as the petition itself. Rather than 

continue to add these lengthy 

documents to the Federal Register or 

attempt to influence how petitioners 

prepare such summaries, EPA believes 

that publication in the Electronic Public 

Docket on its internet website, with a 

reference to that internet site address in 

the Federal Register, conforms to the 

statute and provides the public with the 

greatest amount of information in a 

manner that is readily accessible. 

Other changes to 40 CFR 180.7 

include: (1) Amending paragraph (b) to 

be in the form of a list of requirements 

for a petition rather than a model letter 

to the Registration Division; (2) 

amending paragraph (d) to drop now 

meaningless provisions pertaining to the 

date a petition is deemed to be filed; 

and (3) amending paragraph (e) to 

update the language regarding 

publication of a petitioner-provided 

summary of the petition. 

5. 40 CFR 180.29. Previously, FFDCA 

section 408 contained different 

procedures for pesticide registrants and 

other parties. 40 CFR 180.29, in part,

Federal Register / Vol. 69, No. 195 / Friday, October 8, 2004 / Proposed Rules 60323

implemented the procedures for 

establishing tolerances pertaining to 

non-registrants. The new FFDCA section 

408(d) requires all parties to follow the 

same petition process. See 21 U.S.C. 

346a(d). EPA is proposing to remove the 

old procedures in 40 CFR 180.29 that 

have been dropped from the statute. 

Similar changes are proposed for 40 

CFR 180.32 addressing modification and 

revocation of tolerances. 

6. 40 CFR 180.30. The FQPA 

expanded and clarified the exclusive 

judicial review procedures under 

section 408. See 21 U.S.C. 346a(h). EPA 

is proposing to revise 40 CFR 180.30 to 

track the statutory changes regarding 

this topic. 

7. 40 CFR 180.31. The FQPA changed 

the procedures for establishing 

temporary tolerances for experimental 

use of pesticides under the Federal 

Insecticide, Fungicide, and Rodenticide 

Act, 7 U.S.C. 136 et seq. See 21 U.S.C. 

346a(r). EPA is proposing to modify 40 

CFR 180.31 to reflect these statutory 

changes. In brief, the FQPA requires that 

temporary tolerances be established 

under the same procedures pertaining to 

all except emergency tolerances. 

8. 40 CFR 180.32. The language in 40 

CFR 180.32 of the regulations is 

proposed to be modified to make it 

consistent with the FQPA. Existing 40 

CFR 180.32 speaks in terms of 

‘‘amendment’’ and ‘‘repeal’’ of 

tolerances, whereas the FQPA describes 

such actions as ‘‘modifications’’ and 

‘‘revocations.’’

9. 40 CFR 23.10. The language in this 

section is proposed to be modified to 

conform the statutory citations to the 

new subsection in section 408 governing 

judicial review and to conform the 

language pertaining to reviewable 

actions to the language of section 408’s 

revised judicial review provision. 

10. 40 CFR 9.1. Now obsolete 40 CFR 

parts 163 and 177 are proposed to be 

removed from the table in 40 CFR part 

9. 

The Agency is also considering minor 

adjustments to 40 CFR part 180 to 

accommodate recent legislation 

concerning pesticide registration and 

tolerance fees. See Pesticide Registration 

Improvement Act of 2003, Public Law 

108–199 (HR 2673). 

B. What is the Agency’s Authority for 

Taking this Action? 

These changes are being proposed 

under EPA’s authority in FFDCA section 

408(e)(1)(C) to establish general 

procedures and requirements to 

implement section 408. 

III. Regulatory Assessment 

Requirements 

This proposed rule makes several 

changes in the EPA regulations 

governing pesticide tolerances and 

exemptions from tolerance. The 

amendments are procedural in nature 

and, for the most part, correct the CFR 

so that it is consistent with FFDCA 

section 408, as amended by the FQPA, 

and EPA’s ongoing implementation of 

FFDCA. Other than making EPA 

regulations more accurate, these 

amendments are not expected to have 

any impact on regulated parties or the 

public. Accordingly, these amendments 

are not subject to review under 

Executive Order 12866, entitled 

Regulatory Planning and Review (58 FR 

51735, October 4, 1993), as a significant 

regulatory action. Because this proposed 

rule has been exempted from review 

under Executive Order 12866 due to its 

lack of significance, this proposed 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 proposed 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, as detailed above, these 

amendments will have no detrimental 

impact on regulated parties or the 

public, EPA certifies under the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.) that the amendments 

will not have a significant 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 proposed 

rule is directed at pesticide 

manufacturers and others who seek to 

establish, modify, or revoke pesticide 

tolerances and exemptions, 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 proposed 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 

proposed 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 proposed rule.

List of Subjects in 40 CFR Parts 9, 163, 

177, 178, 179, 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides

60324 Federal Register / Vol. 69, No. 195 / Friday, October 8, 2004 / Proposed Rules 

and pests, Reporting and recordkeeping 

requirements.

Dated: September 20, 2004. 

Susan B. Hazen, 

Acting Assistant Administrator, Office of 

Prevention, Pesticides and Toxic Substances.

Therefore, 40 CFR chapter I is 

amended as follows:

PART 9—[AMENDED] 

1. The authority citation for part 9 

continues to read as follows:

Authority: 7 U.S.C. 135 et seq., 136–136y; 

15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671; 

21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 

U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 

1321, 1326, 1330, 1342, 1344, 1345 (d) and 

(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 

1971–1975 Comp. p. 973; 42 U.S.C. 241, 

242b, 243, 246, 300f, 300g, 300g–1, 300g–2, 

300g–3, 300g–4, 300g–5, 300g–6, 300j–1, 

300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., 

6901–6992k, 7401–7671q, 7542, 9601–9657, 

11023, 11048.

§ 9.1 [Amended] 

2. Section 9.1 is amended by 

removing the entries and center 

headings for parts 163 and 177 in the 

table.

PART 23—[AMENDED] 

3. The authority citation for part 23 

continues to read as follows:

Authority: Clean Water Act, 33 U.S.C. 

1361(a), 1369(b); Clean Air Act, 42 U.S.C. 

7601(a)(1), 7607(b); Resource, Conservation 

and Recovery Act, 42 U.S.C. 6912(a), 6976; 

Toxic Substances Control Act, 15 U.S.C. 

2618; Federal Insecticide, Fungicide, and 

Rodenticide Act, 7 U.S.C. 136n(b), 136w(a); 

Safe Drinking Water Act, 42 U.S.C. 300j–

7(a)(2), 300j–9(a); Atomic Energy Act, 42 

U.S.C. 2201, 2239; Federal Food, Drug, and 

Cosmetic Act, 21 U.S.C. 371(a), 346a, 348; 28 

U.S.C. 2112(a), 2343, 2344.

4. Section 23.10 is revised to read as 

follows:

§ 23.10 Timing of Administrator’s action 

under the Federal Food, Drug, and 

Cosmetic Act. 

Unless the Administrator otherwise 

explicitly provides in a particular order, 

the time and date of the entry of a 

regulation issued under section 21 

U.S.C. 346a(e)(1)(C), or any order issued 

under 21 U.S.C. 346a(f)(1)(C) or 21 

U.S.C. 346a(g)(2)(C), or any regulation 

that is the subject of such an order, 

shall, for purposes of 21 U.S.C. 346a(h), 

be at 1 p.m. eastern time (standard or 

daylight, as appropriate) on the date that 

is for a Federal Register document, 2 

weeks after the date when the document 

is published in the Federal Register, or 

for any other document, 2 weeks after it 

is signed.

PART 163—[REMOVED] 

5. Part 163 is removed.

PART 177—[REMOVED] 

6. Part 177 is removed.

PART 178—[AMENDED] 

7. The authority citation for part 178 

continues to read as follows:

Authority: 21 U.S.C. 346a, 348, 371(a); 

Reorg. Plan No. 3 of 1970.

8. Section 178.20 is amended by 

revising paragraph (a) to read as follows:

§ 178.20 Right to submit objections and 

requests for a hearing. 

(a) On or before the 60th day after the 

date of publication in the Federal 

Register of an order under part 180 of 

this chapter establishing, modifying, or 

revoking a regulation, or denying all or 

any portion of a petition, a person 

adversely affected by such order or 

petition denial may submit, in 

accordance with § 178.25, one or more 

written objections to the order (or to the 

action that is the subject of the order).

* * * * *

9. Section 178.25 is amended by 

revising paragraphs (a)(7) and (b)(2) to 

read as follows:

§ 178.25 Form and manner of submission 

of objections. 

(a) * * * 

(7) Be received by the Hearing Clerk 

not later than the close of business of 

the 60th day following the date of the 

publication in the Federal Register of 

the order to which the objection is taken 

(or, if such 60th day is a Saturday, 

Sunday, or Federal holiday, not later 

than the close of business of the next 

government business day after such 

60th day).

* * * * *

(b) * * * 

(2) For personal delivery, the Office of 

the Hearing Clerk is located at: Room 

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

Arlington, VA. 

10. Section 178.35 is amended as 

follows: 

a. By revising paragraph (a). 

b. By revising ‘‘rule’’ to read ‘‘order’’

in paragraph (b). 

c. By revising the section heading.

§ 178.35 Modification or revocation of 

regulation or prior order. 

(a) If the Administrator determines 

upon review of an objection or request 

for hearing that the regulation or prior 

order in question should be modified or 

revoked, the Administrator will publish 

an order setting forth any revision to the 

regulation or prior order that the 

Administrator has found to be 

warranted.

* * * * *

11. Section 178.37 is amended by 

revising the introductory text of 

paragraph (a) and paragraph (c) to read 

as follows:

§ 178.37 Order responding to objections 

on which a hearing was not requested or 

was denied. 

(a) The Administrator will publish in 

the Federal Register an order under 

FFDCA section 408(g)(2)(B) or section 

408(g)(2)(C) setting forth the 

Administrator’s determination on each 

denial of a request for a hearing, and on 

each objection submitted under § 178.20 

on which:

* * * * *

(c) Each order published under 

paragraph (a) of this section must state 

its effective date. 

12. Section 178.65 is revised to read 

as follows:

§ 178.65 Judicial review. 

An order issued under § 178.37 is 

final agency action reviewable in the 

courts as provided by FFDCA sections 

408(h), as of the date of entry of the 

order, which shall be determined in 

accordance with §§ 23.10 and 23.11 of 

this chapter. The failure to file a petition 

for judicial review within the period 

ending on the 60th day after the date of 

the entry of the order constitutes a 

waiver under FFDCA section 408(h) of 

the right to judicial review of the order 

and of any regulation promulgated by 

the order.

§ 178.70 [Amended] 

13. Section 178.70 is amended by 

removing paragraphs (a)(2) and (a)(3) 

and redesignating existing paragraphs 

(a)(4) through (a)(8) as paragraphs (a)(2) 

through (a)(6), respectively.

PART 179—[AMENDED] 

14. The authority citation for part 179 

continues to read as follows:

Authority: 21 U.S.C. 346a, 348, 371(a); 

Reorg. Plan No. 3 of 1970.

§ 179.20 [Amended] 

15. Section 179.20(a)(3) is amended 

by removing the phrase ‘‘§ 177.81 or ’’.

§ 179.24 [Amended] 

16. Section 179.24 is amended by 

removing ‘‘177,’’ and removing the 

comma after ‘‘1978’’ in paragraph (a).

Federal Register / Vol. 69, No. 195 / Friday, October 8, 2004 / Proposed Rules 60325

§ 179.83 [Amended] 

17. Section 179.83 is amended by 

revising ‘‘parts 177, or 180’’ to read 

‘‘part 180’’ in paragraph (a)(1). 

18. Section 179.91 is amended by 

revising paragraph (b) to read as follows:

§ 179.91 Burden of going forward; burden 

of persuasion.

* * * * *

(b) The party or parties who contend 

that a regulation satisfies the criteria of 

section 408 of the FFDCA has the 

burden of persuasion in the hearing on 

that issue, whether the proceeding 

concerns the establishment, 

modification, or revocation of a 

tolerance or exemption from the 

requirement for a tolerance.

§ 179.125 [Amended] 

19. Section 179.125 is amended by 

revising ‘‘408(i) or 409(g)(1)’’ wherever 

it appears to read ‘‘408(h)’’ in paragraph 

(a).

§ 179.130 [Amended] 

20. Section 179.130 is amended by 

removing paragraphs (a)(2) and (a)(3) 

and redesignating existing paragraphs 

(a)(4) through (a)(12) as paragraphs 

(a)(2) through (a)(10), respectively.

PART 180—[AMENDED] 

21. The authority citation for part 180 

continues to read as follows:

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

371.

22. Section 180.1 is amended by 

removing paragraph (d), redesignating 

existing paragraphs (e) through (p) as 

paragraphs (d) through (o), respectively, 

and revising newly designated 

paragraph (e) to read as follows:

§ 180.1 Definitions and interpretations.

* * * * *

(e) Where a raw agricultural 

commodity bearing a pesticide chemical 

residue that has been exempted from the 

requirement of a tolerance, or which is 

within a tolerance permitted under 

section 408, is used in preparing a 

processed food, the processed food will 

not be considered unsafe within the 

meaning of sections 402 and 408(a), 

despite the lack of a tolerance or 

exemption for the pesticide chemical 

residue in the processed food, if: 

(1) The pesticide chemical has been 

used in or on the raw agricultural 

commodity in conformity with a 

tolerance under this section; 

(2) The pesticide chemical residue has 

been removed to the extent possible in 

good manufacturing practice; and 

(3) The concentration of the pesticide 

chemical residue in the processed food 

is not greater than the tolerance 

prescribed for the pesticide chemical 

residue on the raw agricultural 

commodity.

* * * * *

§ 180.2 [Removed] 

23. Section 180.2 is removed. 

24. The undesignated center heading 

that precedes § 180.7 and § 180.7 are 

revised to read as follows:

Procedure for Filing Petitions Seeking 

the Establishment, Modification, or 

Revocation of Tolerances or 

Exemptions

§ 180.7 Petitions proposing tolerances or 

exemptions for pesticide residues in or on 

raw agricultural commodities or processed 

foods. 

(a) Petitions to be filed with the 

Agency under the provisions of section 

408(d) shall be submitted in duplicate. 

If any part of the material submitted is 

in a foreign language, it shall be 

accompanied by an accurate and 

complete English translation. The 

petition shall be accompanied by an 

advance deposit for fees described in 

§ 180.33. The petition shall state the 

petitioner’s mail address to which 

notice of objection under section 

408(g)(2) may be sent. The petition must 

be signed by the petitioner or by his 

attorney or agent, or (if a corporation) by 

an authorized official. 

(b) Petitions shall include the 

following information: 

(1) An informative summary of the 

petition and of the data, information, 

and arguments submitted or cited in 

support of the petition. Both a paper 

and electronic copy of the summary 

should be submitted. The electronic 

copy should be formatted according to 

the Office of Pesticide Programs’ current 

standard for electronic data submission 

as specified at http://www.epa.gov/

oppfead1/eds/edsgoals.htm. 

(2) A statement that the petitioner 

agrees that such summary or any 

information it contains may be 

published as a part of the notice of filing 

of the petition to be published under 

section 408(d)(3) and as a part of a 

proposed or final regulation issued 

under section 408. 

(3) The name, chemical identity, and 

composition of the pesticide chemical 

residue and of the pesticide chemical 

that produces the residue. 

(4) Data showing the recommended 

amount, frequency, method, and time of 

application of the pesticide chemical. 

(5) Full reports of tests and 

investigations made with respect to the 

safety of the pesticide chemical, 

including full information as to the 

methods and controls used in 

conducting those tests and 

investigations. 

(6) Full reports of tests and 

investigations made with respect to the 

nature and amount of the pesticide 

chemical residue that is likely to remain 

in or on the food, including a 

description of the analytical methods 

used. (See § 180.34 for further 

information about residue tests.) 

(7) Proposed tolerances for the 

pesticide chemical residue if tolerances 

are proposed. 

(8) Practicable methods for removing 

any amount of the residue that would 

exceed any proposed tolerance. 

(9) A practical method for detecting 

and measuring the levels of the 

pesticide chemical residue in or on the 

food, or for exemptions, a statement 

why such a method is not needed. 

(10) If the petition relates to a 

tolerance for a processed food, reports of 

investigations conducted using the 

processing method(s) used to produce 

that food. 

(11) Such information as the 

Administrator may require to make the 

determination under section 

408(b)(2)(C). 

(12) Such information as the 

Administrator may require on whether 

the pesticide chemical may have an 

effect in humans that is similar to an 

effect produced by a naturally occurring 

estrogen or other endocrine effects. 

(13) Information regarding exposure 

to the pesticide chemical residue due to 

any tolerance or exemption already 

granted for such residue. 

(14) Information concerning any 

maximum residue level established by 

the Codex Alimentarius Commission for 

the pesticide chemical residue 

addressed in the petition. If a Codex 

maximum residue level has been 

established for the pesticide chemical 

residue and the petitioner does not 

propose that this level be adopted, a 

statement explaining the reasons for this 

departure from the Codex level. 

(15) Such other data and information 

as the Administrator requires by 

regulation to support the petition. 

(16) Reasonable grounds in support of 

the petition. 

(c) The data specified under 

paragraphs (b)(1) through (b)(16) of this 

section should be on separate sheets or 

sets of sheets, suitably identified. If such 

data have already been submitted with 

an earlier application, the present 

petition may incorporate it by reference 

to the earlier one. 

(d) Except as noted in paragraph (e) of 

this section, a petition shall not be

60326 Federal Register / Vol. 69, No. 195 / Friday, October 8, 2004 / Proposed Rules 

accepted for filing if any of the data 

prescribed by section 408(d) are lacking 

or are not set forth so as to be readily 

understood. The availability to the 

public of information provided to, or 

otherwise obtained by, the Agency 

under this part shall be governed by part 

2 of this chapter. The Administrator 

shall make the full text of the summary 

referenced in paragraph (b)(1) of this 

section available to the public in the 

Environmental Protection Agency 

Electronic Docket at http://

www.epa.gov/edocket no later than 

publication in the Federal Register of 

the notice of the petition filing. 

(e) The Administrator shall notify the 

petitioner within 15 days after its 

receipt of acceptance or nonacceptance 

of a petition, and if not accepted the 

reasons therefor. If petitioner desires, 

the petitioner may supplement a 

deficient petition after notification as to 

deficiencies. If the petitioner does not 

wish to supplement or explain the 

petition and requests in writing that it 

be filed as submitted, the petition shall 

be filed and the petitioner so notified. 

(f) A notice of the filing of a petition 

for a pesticide chemical residue 

tolerance that the Administrator 

determines has met the requirements of 

paragraph (b) of this section shall be 

published in the Federal Register by the 

Administrator within 30 days after such 

determination. The notice shall state the 

name of the pesticide chemical residue 

and the commodities for which a 

tolerance is sought and announce the 

availability of a description of the 

analytical methods available to the 

Administrator for the detection and 

measurement of the pesticide chemical 

residue with respect to which the 

petition is filed or shall set forth the 

petitioner’s statement of why such a 

method is not needed. The notice shall 

explicitly reference the specific address 

in the Agency’s Electronic Docket (http:/

/www.epa.gov/edocket) where the full 

text of the summary required in 

paragraph (b) of this section and refer 

interested parties to this document for 

further information on the petition. The 

full text of the summary may be omitted 

from the notice. 

(g) The Administrator may request a 

sample of the pesticide chemical at any 

time while a petition is under 

consideration. The Administrator shall 

specify in its request for a sample of the 

pesticide chemical, a quantity which it 

deems adequate to permit tests of 

analytical methods used to determine 

residues of the pesticide chemical and 

of methods proposed by the petitioner 

for removing any residues of the 

chemical that exceed the tolerance 

proposed. 

(h) The Administrator shall 

determine, in accordance with the Act, 

whether to issue an order that 

establishes, modifies, or revokes a 

tolerance regulation (whether or not in 

accord with the action proposed by the 

petitioner), or whether to publish a 

proposed tolerance regulation and 

request public comment thereon under 

§ 180.29. The Administrator shall 

publish in the Federal Register such 

order or proposed regulation. After 

receiving comments on any proposed 

regulation, the Administrator may issue 

an order that establishes, modifies, or 

revokes a tolerance regulation. An order 

published under this section shall 

describe briefly how to submit 

objections and requests for a hearing 

under part 178 of this chapter. A 

regulation issued under this section 

shall be effective on the date of 

publication in the Federal Register

unless otherwise provided in the 

regulation. 

25. Section 180.8 is revised to read as 

follows:

§ 180.8 Withdrawal of petitions without 

prejudice. 

In some cases the Administrator will 

notify the petitioner that the petition, 

while technically complete, is 

inadequate to justify the establishment 

of a tolerance or the tolerance requested 

by petitioner. This may be due to the 

fact that the data are not sufficiently 

clear or complete. In such cases, the 

petitioner may withdraw the petition 

pending its clarification or the obtaining 

of additional data. This withdrawal may 

be without prejudice to a future filing. 

A deposit for fees as specified in 

§ 180.33 shall accompany the 

resubmission of the petition. 

26. Section 180.9 is revised to read as 

follows:

§ 180.9 Substantive amendments to 

petitions. 

After a petition has been filed, the 

petitioner may submit additional 

information or data in support thereof, 

but in such cases the petition will be 

given a new filing date.

§§ 180.10, 180.11 and 180.12 [Removed] 

27. Sections 180.10, 180.11 and 

180.12 are removed. 

28. The undesignated center heading 

that precedes § 180.29, and § 180.29 are 

revised to read as follows:

Establishment, Modification, and 

Revocation of Tolerance on Initiative of 

Administrator; Judicial Review; 

Temporary Tolerances; Modification 

and Revocation of Tolerances; Fees

§ 180.29 Establishment, modification, and 

revocation of tolerance on initiative of 

Administrator. 

(a) Upon the Administrator’s own 

initiative, the Administrator may 

propose, under section 408(e) of the 

Federal Food, Drug, and Cosmetic Act, 

the issuance of a regulation establishing 

a tolerance for a pesticide chemical or 

exempting it from the necessity of a 

tolerance, or a regulation modifying or 

revoking an existing tolerance or 

exemption. 

(b) The Administrator shall provide a 

period of not less than 60 days for 

persons to comment on the proposed 

regulation, except that a shorter period 

for comment may be provided if the 

Administrator for good cause finds that 

it would be in the public interest to do 

so and states the reasons for the finding 

in the notice of proposed rulemaking. 

(c) After reviewing any timely 

comments received, the Administrator 

may by order establish, modify, or 

revoke a tolerance regulation, which 

order and regulation shall be published 

in the Federal Register. An order 

published under this section shall state 

that persons may submit objections and 

requests for a hearing in the manner 

described in part 178 of this chapter. 

(d) Any final regulation issued under 

this section shall be effective on the date 

of publication in the Federal Register

unless otherwise provided in the 

regulation. 

29. Section 180.30 is revised to read 

as follows:

§ 180.30 Judicial review. 

(a) Under section 408(h) of the 

FFDCA, judicial review is available in 

the United States Courts of Appeal as to 

the following actions: 

(1) Regulations establishing general 

procedures and requirements under 

FFDCA section 408(e)(1)(C). 

(2) Orders issued under FFDCA 

section 408(f)(1)(C) requiring the 

submission of data. 

(3) Orders issued under FFDCA 

section 408(g)(2)(C) ruling on objections 

to establishment, modification, or 

revocation of a tolerance or exemption 

under FFDCA section 408(d)(4), or any 

regulation that is the subject of such an 

order. The underlying action here is 

Agency disposition of a petition seeking 

the establishment, modification, or 

revocation of a tolerance or exemption. 

(4) Orders issued under FFDCA 

section 408(g)(2)(C) ruling on objections

Federal Register / Vol. 69, No. 195 / Friday, October 8, 2004 / Proposed Rules 60327

to the denial of a petition under FFDCA 

section 408(d)(4). 

(5) Orders issued under FFDCA 

section 408(g)(2)(C) ruling on objections 

to the establishment, modification, 

suspension, or revocation of a tolerance 

or exemption under FFDCA section 

408(e)(1)(A) or (e)(1)(B). The underlying 

action here is the establishment, 

modification, suspension, or revocation 

of a tolerance or exemption upon the 

initiative of EPA including EPA actions 

pursuant to FFDCA sections 

408(b)(2)(B)(v), 408(b)(2)(E)(ii), 

408(d)(4)(C)(ii), 408(l)(4), and 408(q)(1). 

(6) Orders issued under FFDCA 

section 408(g)(2)(C) ruling on objections 

to the revocation or modification of a 

tolerance or exemption under FFDCA 

section 408(f)(2) for noncompliance 

with requirements for the submission of 

data. 

(7) Orders issued under FFDCA 

section 408(g)(2)(C) ruling on objections 

to rules issued under FFDCA sections 

408(n)(3) and 408(d) or (e) regarding 

determinations pertaining to State 

authority to establish regulatory limits 

on pesticide chemical residues. 

(8) Orders issued under FFDCA 

section 408(g)(2)(C) ruling on objections 

to orders issued under FFDCA section 

408(n)(5)(C) authorizing States to 

establish regulatory limits not identical 

to certain tolerances or exemptions. 

(b) Any issue as to which review is or 

was obtainable under paragraph (a) of 

this section shall not be the subject of 

judicial review under any other 

provision of law. In part, this means 

that, for the Agency actions subject to 

the objection procedure in FFDCA 

section 408(g)(2), judicial review is not 

available unless an adversely affected 

party exhausts these objection 

procedures, and any petition procedures 

preliminary thereto. 

30. Section 180.31 is revised to read 

as follows:

§ 180.31 Temporary tolerances. 

(a) A temporary tolerance (or 

exemption from a tolerance) established 

under the authority of section 408(r) of 

the Act shall be deemed to be a 

tolerance (or exemption from the 

requirement of a tolerance) for the 

purposes of section 408(a)(1) or (a)(2) of 

the Act and for the purposes of § 180.30. 

(b) A request for a temporary 

tolerance or a temporary exemption 

from a tolerance by a person who has 

obtained or is seeking an experimental 

permit for a pesticide chemical under 

the Federal Insecticide, Fungicide, and 

Rodenticide Act shall be accompanied 

by such data as are available on subjects 

outlined in § 180.7(b) and an advance 

deposit to cover fees as provided in 

§ 180.33. 

(c) To obtain a temporary tolerance, a 

requestor must comply with the petition 

procedures specified in FFDCA section 

408(d) and § 180.7 except as provided in 

this section. 

(d) A temporary tolerance or 

exemption from a tolerance may be 

issued for a period designed to allow the 

orderly marketing of the raw 

agricultural commodities produced 

while testing a pesticide chemical under 

an experimental permit issued under 

authority of the Federal Insecticide, 

Fungicide, and Rodenticide Act if the 

Administrator concludes that the safety 

standard in FFDCA section 408(b)(2) or 

(c), as applicable, is met. Subject to the 

requirements of section 408(e), a 

temporary tolerance or exemption from 

a tolerance may be revoked if the 

experimental permit is revoked, or may 

be revoked at any time if it develops 

that the application for a temporary 

tolerance contains a misstatement of a 

material fact or that new scientific data 

or experience with the pesticide 

chemical indicates that it does not meet 

the safety standard in FFDCA section 

408(b)(2) or (c), as applicable. 

(e) Conditions under which a 

temporary tolerance is established shall 

include: 

(1) A limitation on the amount of the 

chemical to be used on the designated 

crops permitted under the experimental 

permit. 

(2) A limitation for the use of the 

chemical on the designated crops to 

bona fide experimental use by qualified 

persons as indicated in the experimental 

permit. 

(3) A requirement that the person or 

firm which obtains the experimental 

permit for which the temporary 

tolerance is established will 

immediately inform the Environmental 

Protection Agency of any reports on 

findings from the experimental use that 

have a bearing on safety. 

(4) A requirement that the person or 

firm which obtained the experimental 

permit for which the temporary 

tolerance is established will keep 

records of production, distribution, and 

performance for a period of 2 years and, 

on request, at any reasonable time, make 

these records available to any 

authorized officer or employee of the 

Environmental Protection Agency. 

31. Section 180.32 is revised to read 

as follows:

§ 180.32 Procedure for modifying and 

revoking tolerances or exemptions from 

tolerances. 

(a) The Administrator on his/her own 

initiative may propose the issuance of a 

regulation modifying or revoking a 

tolerance for a pesticide chemical 

residue on raw agricultural commodities 

or processed foods or modifying or 

revoking an exemption from tolerance 

for such residue. 

(b) Any person may file with the 

Administrator a petition proposing the 

issuance of a regulation modifying or 

revoking a tolerance or exemption from 

a tolerance for a pesticide chemical 

residue. The petition shall furnish 

reasonable grounds for the action 

sought. Reasonable grounds shall 

include an explanation showing 

wherein the person has a substantial 

interest in such tolerance or exemption 

from tolerance and an assertion of facts 

(supported by data if available) showing 

that new uses for the pesticide chemical 

have been developed or old uses 

abandoned, that new data are available 

as to toxicity of the chemical, or that 

experience with the application of the 

tolerance or exemption from tolerance 

may justify its modification or 

revocation. Evidence that a person has 

registered or has submitted an 

application for the registration of an 

pesticide under the Federal Insecticide, 

Fungicide, and Rodenticide Act will be 

regarded as evidence that the person has 

a substantial interest in a tolerance or 

exemption from the requirement of a 

tolerance for a pesticide chemical that 

consists in whole or in part of the 

pesticide. New data should be furnished 

in the form specified in § 180.7(b) for 

submitting petitions, as applicable. 

(c) The procedures for completing 

action on an Administrator-initiated 

proposal or a petition shall be those 

specified in §§ 180.29 and 180.7, as 

applicable. 

32. Section 180.33 is amended as 

follows: 

a. In paragraphs (a), (b), (c), and (h) 

remove the phrase ‘‘or request’’. 

b. Remove paragraph (j) and 

redesignate existing paragraphs (k) 

through (p) as paragraphs (j) through (o), 

respectively. 

c. In newly designated paragraph (j) 

revise ‘‘408(d)(5) or (e)’’ to read 

‘‘408(h)’’. 

d. In newly designated paragraph (l) 

remove the phrase ‘‘Registration 

Division (7505C),’’. 

e. In newly designated paragraph (m) 

remove the phrase ‘‘Registration 

Division, (7505C),’’. 

f. Revise paragraph (f) and the third 

sentence of newly designated paragraph 

(l) to read as follows:

§ 180.33 Fees.

* * * * *

(f) Each petition for revocation of a 

tolerance shall be accompanied by a fee

60328 Federal Register / Vol. 69, No. 195 / Friday, October 8, 2004 / Proposed Rules 

of $10,125. Such fee is not required 

when, in connection with the change 

sought under this paragraph, a petition 

is filed for the establishment of new 

tolerances to take the place of those 

sought to be revoked and a fee is paid 

as required by paragraph (a) of this 

section.

* * * * *

(l) * * * A fee of $2,025 shall 

accompany every request for a waiver or 

refund, as specified in paragraph (m) of 

this section, except that the fee under 

this paragraph shall not be imposed on 

any person who has no financial interest 

in any action requested by such person 

under paragraphs (a) through (j) of this 

section.***

* * * * *

33. Section 180.40 is amended by 

revising the last sentence in paragraph 

(f) to read as follows:

§ 180.40 Tolerances for crop groups.

* * * * *

(f) * * * Processing data will be 

required prior to establishment of a 

group tolerance, and tolerances will not 

be granted on a group basis as to 

processed foods prepared from crops 

covered by the group tolerance.

* * * * *

34. Section 180.1229 is added to 

subpart D to read as follows:

§ 180.1229 Benzaldehyde; exemption from 

the requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of benzaldehyde when used as a bee 

repellant in the harvesting of honey. 

35. Section 180.1230 is added to 

subpart D to read as follows:

§ 180.1230 Ferrous sulfate; exemption 

from the requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of ferrous sulfate. 

36. Section 180.1231 is added to 

subpart D to read as follows:

§ 180.1231 Lime; exemption from the 

requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of lime. 

37. Section 180.1232 is added to 

subpart D to read as follows:

§ 180.1232 Lime-sulfur; exemption from 

the requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of lime-sulfur. 

38. Section 180.1233 is added to 

subpart D to read as follows:

§ 180.1233 Potassium sorbate; exemption 

from the requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of potassium sorbate. 

39. Section 180.1234 is added to 

subpart D to read as follows:

§ 180.1234 Sodium carbonate; exemption 

from the requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of sodium carbonate. 

40. Section 180.1235 is added to 

subpart D to read as follows:

§ 180.1235 Sodium hypochlorite; 

exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of sodium hypochlorite. 

41. Section 180.1236 is added to 

subpart D to read as follows:

§ 180.1236 Sulfur; exemption from the 

requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of sulfur. 

42. Section 180.1237 is added to 

subpart D to read as follows:

§ 180.1237 Sodium metasilicate; 

exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of sodium metasilicate when used as 

plant desiccants, so long as the 

metasilicate does not exceed 4% by 

weight in aqueous solution. 

43. Section 180.1238 is added to 

subpart D to read as follows:

§ 180.1238 Oil of lemon; exemption from 

the requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of oil of lemon when used as a 

postharvest fungicide. 

44. Section 180.1239 is added to 

subpart D to read as follows:

§ 180.1239 Oil of orange; exemption from 

the requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of oil of orange when used as a 

postharvest fungicide.

[FR Doc. 04–22584 Filed 10–7–04; 8:45 am] 

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 52 and 81 

[AZ104–0069; FRL–7823–6] 

Approval and Promulgation of 

Implementation Plans and Designation 

of Areas for Air Quality Planning 

Purposes; Arizona

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing to approve 

the Maricopa Association of 

Governments (MAG) serious area carbon 

monoxide (CO) state implementation 

plan (SIP) for the Maricopa County CO 

nonattainment area (the metropolitan 

Phoenix area, Arizona) as meeting the 

Clean Air Act (CAA) requirements for 

serious CO nonattainment areas. We are 

also proposing to approve the MAG CO 

redesignation request and maintenance 

plan for the Maricopa County CO 

nonattainment area as meeting CAA 

requirements for redesignation requests 

and maintenance plans. In addition, we 

are proposing to make a boundary 

change under Section 107 of the CAA to 

take the Gila River Indian Community 

(GRIC) out of the Maricopa County 

maintenance area. The portion of the 

Gila River Indian Community which is 

currently in the Maricopa County CO 

nonattainment area will be 

‘‘unclassifiable/attainment’’ for CO, and 

will not be subject to the MAG CO 

Redesignation Request and Maintenance 

Plan.

DATES: Written comments must be 

received at the address below on or 

before November 8, 2004.

ADDRESSES: Formal written comments 

should be mailed or emailed to Wienke 

Tax, Office of Air Planning (AIR–2), 

U.S. Environmental Protection Agency, 

Region 9, 75 Hawthorne Street, San 

Francisco, CA 94105–3901, 

tax.wienke@epa.gov. Comments may 

also be submitted through the Federal 

Register Web site at http://

www.regulations.gov. We prefer 

electronic comments. 

You can inspect copies of EPA’s 

Federal Register document and 

technical support documents (TSD) at 

our Region 9 office during normal 

business hours (see address above). Due 

to increased security, we suggest that 

you call at least 24 hours prior to 

visiting the Regional Office so that we 

can make arrangements to have 

someone meet you. The Federal 

Register document and TSD are also 

available as electronic files on EPA’s