Federal Register / Vol. 66, No. 109 / Wednesday, June 6, 2001 / Rules and Regulations 30321

this part, entry into this safety zone is

prohibited unless authorized by the

Coast Guard Captain of the Port Detroit,

or his designated on-scene

representative.

Dated: May 29, 2001.

S.P. Garrity,

Commander, U.S. Coast Guard, Captain of

the Port Detroit.

[FR Doc. 01–14231 Filed 6–5–01; 8:45 am]

BILLING CODE 4910–15–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301130; FRL–6783–3]

RIN 2070–AB78

Bacillus thuringiensis Cry1F Protein

and the Genetic Material Necessary for

its Production in Corn; Exemption

from the Requirement of a Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited exemption from the

requirement of a tolerance for residues

of the plant-pesticides Bacillus

thuringiensis Cry1F protein and the

genetic material necessary for its

production in corn on field corn, sweet

corn, and popcorn when applied/used

as a plant-pesticide. Mycogen Seeds c/

o Dow AgroSciences LLC submitted a

petition to EPA under the Federal Food,

Drug, and Cosmetic Act, as amended by

the Food Quality Protection Act of 1996,

requesting an exemption from the

requirement of a tolerance.

DATES: This regulation is effective June

6, 2001. Objections and requests for

hearings, identified by docket control

number OPP–301130, must be received

by EPA, on or before August 6, 2001.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, electronically, or in person. Please

follow the detailed instructions for each

method as provided in Unit IX. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301130 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Mike Mendelsohn, c/o Product

Manager (PM) 90, Biopesticides and

Pollution Prevention Division (7511C),

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

308–8715; and e-mail address:

mendelsohn.mike @epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

Categories NAICS Examples of Potentially Affected Entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

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 the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/. A frequently

updated electronic version of 40 CFR

part 180 is available at http://

www.access.gpo.gov/nara/cfr/

cfrhtml_180/Title_40/40cfr180_00.html,

a beta site currently under development.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301130. The official record

consists of the documents specifically

referenced in this action, and other

information related to this action,

including any information claimed as

Confidential Business Information (CBI).

This official record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the official record

does not include any information

claimed as CBI. The public version of

the official record, which includes

printed, paper versions of any electronic

comments submitted during an

applicable comment period is available

for inspection in the Public Information

and Records Integrity Branch (PIRIB),

Rm. 119, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA, from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The PIRIB

telephone number is (703) 305–5805.

II. Background and Statutory Findings

In the Federal Register of March 2,

2000 (65 FR 11311) (FRL–6494–3), EPA

issued a notice pursuant to section 408

of the Federal Food, Drug, and Cosmetic

Act (FFDCA), 21 U.S.C. 346a(e), as

amended by the Food Quality Protection

Act (FQPA) (Public Law 104–170)

announcing the filing of a pesticide

tolerance petition, petition number

0F6078, by Mycogen Seeds c/o Dow

AgroSciences LLC, 9330 Zionsville

Road, Indianapolis, IN 46268–1054.

This notice included a summary of the

petition prepared by the petitioner

Mycogen Seeds c/o Dow AgroSciences

LLC. There were no comments received

in response to the notice of filing.

The petition requested that 40 CFR

part 180 be amended by establishing an

exemption from the requirement of a

tolerance for residues of the plant

pesticide Bacillus thuringiensis Cry1F

protein and the genetic material

necessary for its production in plants in

or on all food commodities. While this

final rule is limited to Cry1F in or on

corn, the Agency may at future dates

issue final rules for Cry1F protein plantpesticides on plant agricultural

commodities in addition to corn.

III. Risk Assessment

Pursuant to section 408(c)(2)(A)(i) of

the FFDCA, EPA may establish of leave

in effect an exemption from the

requirement for a tolerance (the legal

limit for a pesticide chemical residue in

or on a food) only if EPA determines

that the tolerance exemption is ‘‘safe.’’

With respect to an exemption for a

pesticide chemical residue, section

408(c)(2)(A)(ii) defines ‘‘safe’’ to mean

that ‘‘there is a reasonable certainty that

no harm will result from aggregate

exposure to the pesticide chemical

residue, including all anticipated

dietary exposures and all other

exposures for which there is reliable

30322 Federal Register / Vol. 66, No. 109 / Wednesday, June 6, 2001 / Rules and Regulations

information.’’ This includes exposure

through drinking water and in

residential settings, but does not include

occupational exposure. Section

408(b)(2)(C) requires EPA to give special

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance or

tolerance exemption and to ‘‘ensure that

there is a reasonable certainty that no

harm will result to infants and children

from aggregate exposure to the pesticide

chemical residue....’’ Additionally,

section 408(b)(2)(D) requires that the

Agency consider ‘‘available

information’’ concerning, inter alia, the

cumulative effects of a particular

pesticide’s residues and ‘‘other

substances that have a common

mechanism of toxicity.’’

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides. Second, EPA examines

exposure to the pesticide through food,

drinking water, and through other

exposures that occur as a result of

pesticide use in residential settings.

IV. Toxicological Profile

Pursuant to section 408(b)(2)(D) of

FFDCA, EPA has reviewed the available

scientific data and other relevant

information in support of this action

and considered its validity,

completeness, and reliability and the

relationship of this information to

human risk. EPA has also considered

available information concerning the

variability of the sensitivities of major

identifiable subgroups of consumers,

including infants and children.

Data have been submitted

demonstrating the lack of mammalian

toxicity at high levels of exposure to the

pure Cry1F protein. These data

demonstrate the safety of the products at

levels well above maximum possible

exposure levels that are reasonably

anticipated in the crops. This is similar

to the Agency position regarding

toxicity and the requirement of residue

data for the microbial Bacillus

thuringiensis products from which this

plant-pesticide was derived. See 40 CFR

158.740(b)(2)(i). For microbial products,

further toxicity testing and residue data

are triggered by significant acute effects

in studies such as the mouse oral

toxicity study, to verify the observed

effects and clarify the source of these

effects (Tiers II and III).

The acute oral toxicity data submitted

support the prediction that the Cry1F

protein would be non-toxic to humans.

Male and female mice (5 of each) were

dosed with 15% (w/v) of the test

substance, which consisted of Bacillus

thuringiensis var. aizawai Cry1F protein

at a net concentration of 11.4%. Two

doses were administered approximately

an hour apart to achieve the dose

totaling 33.7 mL/kg body weight.

Outward clinical signs and body

weights were observed and recorded

throughout the 14 day study. Gross

necropsies performed at the end of the

study indicated no findings of toxicity.

No mortality or clinical signs were

noted during the study. An LD50 was

estimated at >5,050 mg/kg body weight

of this microbially produced test

material. The actual dose administered

contained 576 mg Cry1F protein/kg

body weight. At this dose, no LD50 was

demonstrated as no toxicity was

observed. Cry1F maize seeds contain

0.0017 to 0.0034 mg of Cry1F/gram of

corn kernel tissue.

When proteins are toxic, they are

known to act via acute mechanisms and

at very low dose levels (Sjoblad, Roy D.,

et al. ‘‘Toxicological Considerations for

Protein Components of Biological

Pesticide Products,’’ Regulatory

Toxicology and Pharmacology 15L, 3–9

(1992). Therefore, since no effects were

shown to be caused by the plantpesticides, even at relatively high dose

levels, the Cry1F protein is not

considered toxic. Further, amino acid

sequence comparisons showed no

similarity between Cry1F protein to

known toxic proteins available in public

protein databases.

Since Cry1F is a protein, allergenic

sensitivities were considered. Current

scientific knowledge suggests that

common food allergens tend to be

resistant to degradation by heat, acid,

and proteases, may be glycosylated and

present at high concentrations in the

food.

Data has been submitted which

demonstrates that the Cry1F protein is

rapidly degraded by gastric fluid in vitro

and is non-glycosylated. In a solution of

Cry1F:pepsin at a molar ratio of 1:100,

complete degradation of Cry1F to amino

acids and small peptides occurred in 5

minutes. A heat lability study

demonstrated the loss of bioactivity of

Cry1F protein to neonate tobacco

budworm larvae after 30 minutes at 75

°C. Studies submitted to EPA done in

laboratory animals have not indicated

any potential for allergic reactions to

Bacillus thuringiensis or its

components, including the δ—

endotoxin of the crystal protein.

Additionally, a comparison of amino

acid sequences of known allergens

uncovered no evidence of any homology

with Cry1F, even at the level of 8

contiguous amino acids residues.

The potential for the Cry1F protein to

be a food allergen is minimal.

Regarding toxicity to the immune

system, the acute oral toxicity data

submitted support the prediction that

the Cry1F protein would be non-toxic to

humans. When proteins are toxic, they

are known to act via acute mechanisms

and at very low dose levels (Sjoblad,

Roy D., et al. ‘‘Toxicological

Considerations for Protein Components

of Biological Pesticide Products,’’

Regulatory Toxicology and

Pharmacology 15, 3–9 (1992). Therefore,

since no effects were shown to be

caused by the plant-pesticides, even at

relatively high dose levels, the Cry1F

protein is not considered toxic.

V. Aggregate Exposures

Pursuant to FFDCA section

408(b)(2)(D)(vi), EPA considers available

information concerning aggregate

exposures from the pesticide residue in

food and all other non-occupational

exposures, including drinking water

from ground water or surface water and

exposure through pesticide use in

gardens, lawns, or buildings (residential

and other indoor uses).

The Agency has considered available

information on the aggregate exposure

levels of consumers (and major

identifiable subgroups of consumers) to

the pesticide chemical residue and to

other related substances. These

considerations include dietary exposure

under the tolerance exemption and all

other tolerances or exemptions in effect

for the plant-pesticide chemical residue,

and exposure from non-occupational

sources. Exposure via the skin or

inhalation is not likely since the plantpesticide is contained within plant

cells, which essentially eliminates these

exposure routes or reduces these

exposure routes to negligible. Oral

exposure, at very low levels, may occur

from ingestion of processed corn

products and, potentially, drinking

water. However a lack of mammalian

toxicity and the digestibility of the

plant-pesticides have been

demonstrated. The use sites for the

Cry1F protein are all agricultural for

control of insects. Therefore, exposure

via residential or lawn use to infants

and children is not expected. Even if

negligible exposure should occur, the

Agency concludes that such exposure

would present no risk due to the lack of

toxicity demonstrated for the Cry1F

protein.

VI. Cumulative Effects

Pursuant to FFDCA Section

408(b)(2)(D)(v), EPA has considered

available information on the cumulative

effects of such residues and other

substances that have a common

mechanism of toxicity. These

Federal Register / Vol. 66, No. 109 / Wednesday, June 6, 2001 / Rules and Regulations 30323

considerations included the cumulative

effects on infants and children of such

residues and other substances with a

common mechanism of toxicity.

Because there is no indication of

mammalian toxicity to these plantpesticides, we conclude that there are

no cumulative effects for the Cry1F

protein.

VII. Determination of Safety for U.S.

Population, Infants and Children

A. Toxicity and Allergenicity

Conclusions

The data submitted and cited

regarding potential health effects for the

Cry1F protein include the

characterization of the expressed Cry1F

protein in corn, as well as the acute oral

toxicity, heat stability, and in vitro

digestibility of the proteins. The results

of these studies were determined

applicable to evaluate human risk and

the validity, completeness, and

reliability of the available data from the

studies were considered.

Adequate information was submitted

to show that the Cry1F test material

derived from microbial cultures was

biochemically and, functionally similar

to the protein produced by the plantpesticide ingredients in corn.

Production of microbially produced

protein was chosen in order to obtain

sufficient material for testing.

The acute oral toxicity data submitted

supports the prediction that the Cry1F

protein would be non-toxic to humans.

When proteins are toxic, they are known

to act via acute mechanisms and at very

low dose levels (Sjoblad, Roy D., et al.

‘‘Toxicological Considerations for

Protein Components of Biological

Pesticide Products,’’Regulatory

Toxicology and Pharmacology 15,’’ 3–9

(1992)). Since no effects were shown to

be caused by Cry1F protein, even at

relatively high dose levels >5,050 mg

test substance/kg body weight; 576 mg

Cry1F/kg body weight), the Cry1F

protein is not considered toxic. This is

similar to the Agency position regarding

toxicity and the requirement of residue

data for the microbial Bacillus

thuringiensis products from which this

plant-pesticide was derived. See 40 CFR

158.740(b)(2)(i). For microbial products,

further toxicity testing and residue data

are triggered by significant acute effects

in studies such as the mouse oral

toxicity study to verify the observed

effects and clarify the source of these

effects (Tiers II and III).

Although Cry1F expression level data

were required for an environmental fate

and effects assessment, residue

chemistry data were not required for a

human health effects assessment of the

subject plant-pesticide ingredients

because of the lack of mammalian

toxicity.

Both (1) available information

concerning the dietary consumption

patterns of consumers (and major

identifiable subgroups of consumers

including infants and children); and (2)

safety factors which, in the opinion of

experts qualified by scientific training

and experience to evaluate the safety of

food additives, are generally recognized

as appropriate for the use of animal

experimentation data were not

evaluated. The lack of mammalian

toxicity at high levels of exposure to the

Cry1F protein demonstrates the safety of

the product at levels well above possible

maximum exposure levels anticipated

in the crop.

The genetic material necessary for the

production of the plant-pesticides active

ingredients are the nucleic acids (DNA,

RNA) which comprise (1) genetic

material encoding these proteins and (2)

their regulatory regions. Regulatory

regions are the genetic material, such as

promoters, terminators, and enhancers,

that control the expression of the

genetic material encoding the proteins.

DNA and RNA are common to all forms

of plant and animal life and the Agency

knows of no instance where these

nucleic acids have been associated with

toxic effects related to their

consumption as a component of food.

These ubiquitous nucleic acids, as they

appear in the subject active ingredient,

have been adequately characterized by

the applicant. Therefore, no mammalian

toxicity is anticipated from dietary

exposure to the genetic material

necessary for the production of the

subject active plant pesticidal

ingredients.

B. Infants and Children Risk

Conclusions

FFDCA section 408(b)(2)(C) provides

that EPA shall assess the available

information about consumption patterns

among infants and children, special

susceptibility of infants and children to

pesticide chemical residues and the

cumulative effects on infants and

children of the residues and other

substances with a common mechanism

of toxicity. In addition, FFDCA section

408(B)(2)(C) also provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

pre- and post-natal toxicity and the

completeness of the database unless

EPA determines that a different margin

of safety will be safe for infants and

children.

In this instance, based on all the

available information, the Agency

concludes that there is a finding of no

toxicity for the Cry1F protein and the

genetic material necessary for its

production. Thus, there are no threshold

effects of concern and, as a result, the

provision requiring an additional

margin of safety does not apply. Further,

the provisions of consumption patterns,

special susceptibility, and cumulative

effects do not apply.

C. Overall Safety Conclusion

There is a reasonable certainty that no

harm will result from aggregate

exposure to the U.S. population,

including infants and children, to the

Cry1F protein and the genetic material

necessary for its production. This

includes all anticipated dietary

exposures and all other exposures for

which there is reliable information.

The Agency has arrived at this

conclusion because, as discussed above,

no toxicity to mammals has been

observed for the plant-pesticides.

VIII. Other Considerations

A. Endocrine Disruptors

The pesticidal active ingredients are

proteins, derived from sources that are

not known to exert an influence on the

endocrine system. Therefore, the

Agency is not requiring information on

the endocrine effects of these plantpesticides at this time.

B. Analytical Method

A validated method for extraction and

direct enzyme linked immunosorbent

assay analysis of Cry1F in corn grain has

been submitted and found acceptable by

the Agency.

C. Codex Maximum Residue Level

No Codex maximum residue levels

exists for the plant-pesticides Bacillus

thuringiensis Cry1F protein and the

genetic material necessary for its

production in corn.

IX. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as

amended by the FQPA, any person may

file an objection to any aspect of this

regulation and may also request a

hearing on those objections. The EPA

procedural regulations that 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 the

FFDCA by the FQPA of 1996, EPA will

continue to use those procedures, with

appropriate adjustments, until the

necessary modifications can be made.

The new section 408(g) provides

essentially the same process for persons

to ‘‘object’’ to a regulation for an

30324 Federal Register / Vol. 66, No. 109 / Wednesday, June 6, 2001 / Rules and Regulations

exemption from the requirement of a

tolerance issued by EPA under new

section 408(d), as was provided in the

old FFDCA sections 408 and 409.

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 control

number OPP–301130 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 August 6, 2001.

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 (1900), Environmental

Protection Agency, Ariel Rios Bldg.,

1200 Pennsylvania Ave., NW.,

Washington, DC 20460. You may also

deliver your request to the Office of the

Hearing Clerk in Rm. C400, Waterside

Mall, 401 M St., SW., Washington, DC

20460. 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) 260–

4865.

2. Tolerance fee payment. If you file

an objection or request a hearing, you

must also pay the fee prescribed by 40

CFR 180.33(i) or request a waiver of that

fee pursuant to 40 CFR 180.33(m). You

must mail the fee to: EPA Headquarters

Accounting Operations Branch, Office

of Pesticide Programs, P.O. Box

360277M, Pittsburgh, PA 15251. Please

identify the fee submission by labeling

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee

requirement ‘‘when in the judgement of

the Administrator such a waiver or

refund is equitable and not contrary to

the purpose of this subsection.’’ For

additional information regarding the

waiver of these fees, you may contact

James Tompkins by phone at (703) 305–

5697, by e-mail at

tompkins.jim@epa.gov, or by mailing a

request for information to Mr. Tompkins

at Registration Division (7505C), Office

of Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

If you would like to request a waiver

of the tolerance objection fees, you must

mail your request for such a waiver to:

James Hollins, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

3. Copies for the Docket. In addition

to filing an objection or hearing request

with the Hearing Clerk as described in

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

of your request to the PIRIB for its

inclusion in the official record that is

described in Unit I.B.2. Mail your

copies, identified by docket number

OPP–301130, 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. In person or by courier, bring

a copy to the location of the PIRIB

described in Unit I.B.2. You may also

send an electronic copy of your request

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

Please use an ASCII file format and

avoid the use of special characters and

any form of encryption. Copies of

electronic objections and hearing

requests will also be accepted on disks

in WordPerfect 6.1/8.0 or ASCII file

format. Do not include any CBI in your

electronic copy. You may also submit an

electronic copy of your request at many

Federal Depository Libraries.

B. When Will the Agency Grant a

Request for a Hearing?

A request for a hearing will be granted

if the Administrator determines that the

material submitted shows the following:

There is a genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

X. Regulatory Assessment

Requirements

This final rule establishes an

exemption from the tolerance

requirement under FFDCA section

408(d) in response to a petition

submitted to the Agency. The Office of

Management and Budget (OMB) has

exempted these types of actions from

review under Executive Order 12866,

entitled Regulatory Planning and

Review (58 FR 51735, October 4, 1993).

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

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 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 104–113, section

12(d) (15 U.S.C. 272 note). Since

tolerances and exemptions that are

established on the basis of a petition

under FFDCA section 408(d), such as

the tolerance exemption in this final

rule, do not require the issuance of a

proposed rule, the requirements of the

Regulatory Flexibility Act (RFA) (5

U.S.C. 601 et seq.) do not apply. 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

Federal Register / Vol. 66, No. 109 / Wednesday, June 6, 2001 / Rules and Regulations 30325

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 FFDCA section 408(n)(4).

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.

XI. Submission to Congress and the

Comptroller General

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: May 18, 2001.

Marcia E. Mulkey,

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), 346(a) and

371.

2. Section 180.1217 is added to

subpart D to read as follows:

§ 180.1217 Bacillus thuringiensis Cry1F

Protein and the Genetic Material Necessary

for its Production in Corn; exemption from

the requirement of a tolerance.

Bacillus thuringiensis Cry1F protein

and the genetic material necessary for

its production in corn are exempt from

the requirement of a tolerance when

used as plant-pesticides in the food and

feed commodities of field corn, sweet

corn and popcorn. ‘‘Genetic material

necessary for its production’’ means the

genetic material which comprise:

genetic material encoding the Cry1F

protein and its regulatory regions.

‘‘Regulatory regions’’ are the genetic

material, such as promoters,

terminators, and enhancers, that control

the expression of the genetic material

encoding the Cry1F protein.

[FR Doc. 01–13837 Filed 6–5–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301134; FRL–6785–5]

RIN 2070–AB78

Clethodim; Time-Limited Pesticide

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues/

combined residues of clethodim in or on

alfalfa forage, alfalfa hay, dry beans,

peanut hay, peanut meal, peanuts,

tomato paste, and tomato puree. Valent

U.S.A. Corporation requested this

tolerance under the Federal Food, Drug,

and Cosmetic Act, as amended by the

Food Quality Protection Act of 1996.

The tolerance will expire on April 30,

2003.

DATES: This regulation is effective June

6, 2001. Objections and requests for

hearings, identified by docket control

number OPP–301134 must be received

by EPA on or before August 6, 2001.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VI.. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301134 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Joanne I. Miller, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 305–6224; and e-mail

address: miller.joanne@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

Categories NAICS Examples of Potentially Affected Entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

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 the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://