33260 Federal Register / Vol. 65, No. 100 / Tuesday, May 23, 2000 / Rules and Regulations

Clean Air Act. Today’s correction has no

bearing on the other three rules that

were finalized in our January 13, 2000

action. We believe these rules are

consistent with the relevant policy and

guidance regarding enforceability,

RACT, and SIP relaxations.

Under Executive Order 12866 (58 FR

51735, October 4, 1993), this action is

not a ‘‘significant regulatory action’’

and, is therefore not subject to review by

the Office of Management and Budget.

In addition, this action does not impose

any enforceable duty or contain any

unfunded mandate as described in the

Unfunded Mandates Reform Act of 1995

(Public Law 104–4), or require prior

consultation with State officials as

specified by Executive Order 12875 (58

FR 58093, October 28, 1993), or involve

special consideration of environmental

justice related issues as required by

Executive Order 12898 (59 FR 7629,

February 16, 1994).

Under 5 U.S.C. 801(a)(1)(A) as added

by the Small Business Regulatory

Enforcement Fairness Act of 1996, EPA

submitted 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 General Accounting

Office prior to publication of this rule in

today’s Federal Register. This rule is

not a ‘‘major rule’’ as defined by 5

U.S.C. 804(2).

List of Subjects in 40 CFR Part 52

Environmental protection, Air

pollution control, Hydrocarbons,

Incorporation by reference,

Intergovernmental relations, Nitrogen

dioxide, Ozone, Reporting and

recordkeeping requirements, Volatile

organic compounds.

Dated: May 9, 2000.

Keith Takata,

Acting Regional Administrator, Region IX.

Subpart F of part 52, Chapter I, Title

40 of the Code of Federal Regulations is

amended as follows:

PART 52—[AMENDED]

Subpart F—California

1. The authority citation for part 52

continues to read as follows:

Authority: 42 U.S.C. 7401 et seq.

§ 52.220 [Amended]

2. Section 52.220 is amended by

removing paragraph (c)(179)(H).

[FR Doc. 00–12785 Filed 5–22–00; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300507A FRL–6556–2]

RIN 2070–AB78

Vinclozolin; Order Denying Objections

to Issuance of Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final order.

SUMMARY: EPA is denying the objections

filed by the Natural Resources Defense

Council to a final rule issued July 18,

1997, which announced the issuance of

a tolerance for use of vinclozolin on

succulent (snap) beans under section

408 of the Federal Food, Drug, and

Cosmetic Act. The objections are denied

because the tolerances have expired and

consequently the objections are now

moot.

DATES: This denial of the objections is

effective on May 23, 2000.

FOR FURTHER INFORMATION CONTACT:

Deanna Scher, Reregistration Division

(7508C), Office of Pesticide Programs,

Environmental Protection Agency, Ariel

Rios Bldg., 1200 Pennsylvania Ave.,

NW., Washington, DC 20460; telephone

number: (703) 308–7043; fax number:

(703) 308–7042; e-mail address:

scher.deanna@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

This action is directed to the public

in general. However, this action is of

particular interest to Earthjustice Legal

Defense Fund, the organization that

filed objections to the vinclozolin

tolerance granted for snap beans in 1997

on behalf of Natural Resources Defense

Council, American Federation of Labor

and Congress of Industrial

Organizations, Environmental Working

Group, Pineros y Campesinos Unidos

del Noroeste, and Northwest Coalition

for Alternatives to Pesticides. This

action is also of interest to BASF

Corporation, the manufacturer of

vinclozolin, as well as users of

vinclozolin products. Since various

different entities may be interested in

this action, the Agency has not

attempted to describe all the specific

entities that may be affected by this

action. If you have any questions

regarding the applicability of this action

to a particular entity, consult the person

listed in the FOR FURTHER INFORMATION

CONTACT section.’’

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’’ 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/.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–300507A. The official record

consists of the documents specifically

referenced in this action, any public

comments received during an applicable

comment period, 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

A. What Action Is the Agency Taking?

On September 15, 1997, the Natural

Resources Defense Council (‘‘NRDC’’)

filed a series of objections and hearing

requests in regard to EPA’s issuance of

a tolerance for the pesticide vinclozolin

on succulent (snap) beans under section

408 of the Federal Food, Drug, and

Cosmetic Act (‘‘FFDCA’’), 21 U.S.C.

346a. Because that tolerance expired on

October 1, 1999, those objections are

now moot and are denied on that

ground.

B. What Is the Agency’s Authority for

Taking This Action?

Section 408 of the FFDCA authorizes

the establishment by regulation of

maximum permissible levels of

pesticides in foods. Such regulations are

Federal Register / Vol. 65, No. 100 / Tuesday, May 23, 2000 / Rules and Regulations 33261

commonly referred to as ‘‘tolerances.’’

Without such a tolerance or an

exemption from the requirement of a

tolerance, a food containing a pesticide

residue is ‘‘adulterated’’ under section

402 of the FFDCA and may not be

legally moved in interstate commerce.

21 U.S.C. 331, 342. Monitoring and

enforcement of pesticide tolerances are

carried out by the U.S. Food and Drug

Administration (FDA) and the U.S.

Department of Agriculture (USDA).

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

allows EPA to establish a tolerance only

if EPA determines that the tolerance is

‘‘safe.’’ Section 408(b)(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 information.’’ This includes

dietary exposure through food and

drinking water and exposure other than

dietary that occurs in non-occupational

settings. In making safety

determinations, EPA is required to

consider, among other things, ‘‘available

information concerning the cumulative

effects of the pesticide chemical residue

and other substances that have a

common mechanism of toxicity.’’ 21

U.S.C. 346a(b)(2)(D)(v).

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 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. . . .’’ 21 U.S.C.

346a(b)(2)(C). For pesticides that pose a

threshold effect, EPA is directed to

apply ‘‘an additional tenfold margin of

safety . . . to take into account potential

pre- and post-natal toxicity and

completeness of the data with respect to

exposure and toxicity to infants and

children.’’ [hereinafter referred to as

‘‘the children’s safety factor’’] Id. This

provision additionally specifies that

EPA ‘‘may use a different margin of

safety for the pesticide chemical residue

only if, on the basis of reliable data,

such margin will be safe for infants and

children.’’ Id.

The procedure for establishing

tolerance regulations is generally

initiated by pesticide manufacturers

through the filing with EPA of a petition

requesting the establishment of a

tolerance. See 21 U.S.C. 346a(d). EPA is

required to publish notice of this

petition as well as a summary of the

petition prepared by the petitioner. Id.

346a(d)(3). After evaluation of the

petition, EPA may issue a final tolerance

regulation, a proposed tolerance

regulation, or an order denying the

petition. Id. 346a(d)(4). Once a final

tolerance regulation is issued, any

person may, within 60 days, file written

objections to any aspect of this

regulation and may also request a

hearing on issues of fact raised by the

objections. Id. 346a(g).

EPA regulations specify that if a

hearing is requested, the objections

must include a statement of the factual

issues on which a hearing is requested,

the requestor’s contentions on such

issues, and a summary of any evidence

relied upon by the requestor. 40 CFR

178.27. A request for a hearing will be

granted if the Administrator determines

that the material submitted shows the

following: There is 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 in the manner sought by the

requestor would be adequate to justify

the action requested. 40 CFR 178.32.

EPA’s regulations specify that if no

hearing is requested, or a requested

hearing is denied, EPA will publish in

the Federal Register its determination

on each objection submitted. 40 CFR

178.37(a).

III. Regulatory and Procedural History

Vinclozolin is a fungicide produced

by BASF Corporation. Vinclozolin is

registered under the Federal Insecticide,

Fungicide, and Rodenticide Act

(FIFRA), 7 U.S.C. 136 et seq., for use on

various fruits and vegetables and

corresponding tolerances have been

established under the FFDCA. For many

years prior to 1997, vinclozolin was

approved for use on succulent beans in

several states under an emergency

exemption under FIFRA. Prior to 1997,

vinclozolin was also registered for use

on turf in residential areas as well as

parks, school grounds, and recreational

areas.

In July 1997, in response to a petition

submitted by BASF Corporation, EPA

issued a tolerance for vinclozolin on

succulent beans (62 FR 38464, July 18,

1997) (FRL–5727–9). That tolerance

contained an expiration/revocation date

of October 1, 1999. In connection with

the establishment of the succulent bean

tolerance, BASF requested that EPA

terminate BASF’s vinclozolin FIFRA

registrations on tomatoes, grapes, and

plums including plums grown for

prunes as well as on residential turf and

turf in parks, school grounds, and

recreational areas (except for golf

courses) and to revoke associated

FFDCA tolerances. See 62 FR 43327,

August 13, 1997.

On September 15, 1997, NRDC filed

two objections to this tolerance and

requested a hearing regarding several

issues raised by its objections. NRDC’s

two objections were that EPA failed:

(1) To use the statutorily mandated

tenfold safety factor to account for

infants’ and children’s exposures to and

toxic risks from vinclozolin; and

(2) To incorporate into its assessment

of noncancer risks the available

information on cumulative exposures to

other similar chemicals. Objections at

16.

NRDC argued that EPA was required

to use the tenfold safety factor because,

among other reasons, there exist data

gaps concerning vinclozolin’s neurobehavioral effects. Objections at 23–24.

On January 16, 1998, EPA provided

an initial response to NRDC’s hearing

requests. EPA stated that an initial

review of the hearing requests indicated

that requests would have to be denied

under EPA’s regulations. EPA noted that

the issues on which NRDC had sought

a hearing ‘‘rather than being factual

claims accompanied by contentions as

required by the regulations, are more in

the nature of interrogatories or

discovery requests.’’ EPA made clear

that ‘‘[t]he purpose of an evidentiary

hearing is to ‘receive factual evidence

relevant to material issues of fact raised

by the objections,’ FFDCA section

408(g)(2)(B), not to determine whether

such evidence or issues of fact exist.’’

Nonetheless, because NRDC claimed it

had not had access to the full

administrative record for the tolerance,

EPA made that record available and

gave NRDC 60 days to withdraw or

revise its hearing requests. In response,

NRDC, in a filing dated March 31, 1998,

submitted revised hearing requests on

its original objections.

Subsequent to EPA’s initial response,

several important developments

occurred in connection with EPA’s

FIFRA reregistration efforts as to

vinclozolin that impact the vinclozolin

succulent bean tolerance. First, EPA

scientists recommended that EPA use

the additional tenfold safety factor for

the protection of children in conducting

its assessment of in utero acute risk to

the human fetus. Second, BASF

requested that EPA terminate FIFRA

registrations for vinclozolin on stone

fruits and strawberries and revoke the

associated tolerances. See 63 FR 40710,

June 30, 1998. Additionally, during the

FIFRA reregistration process EPA had

altered its conclusion regarding the dose

at which no adverse effects had

33262 Federal Register / Vol. 65, No. 100 / Tuesday, May 23, 2000 / Rules and Regulations

occurred in a critical developmental

study. On July 31, 1998, EPA requested

both NRDC and BASF to comment on

whether these developments affected

the revised hearing requests. In separate

letters dated September 9, 1998, BASF

and NRDC took opposite positions on

the viability of the hearing requests.

NRDC contended that these

developments ‘‘have virtually no effect

on the pending objections and hearing

request.’’ BASF argued that the hearing

requests were either moot or not

justified.

In August 1999, NRDC filed two

declarations that NRDC asserted

‘‘substantiated the data gaps described

in NRDC’s submissions.’’ In a letter

accompanying these declarations, NRDC

stated that the declarations made an

evidentiary hearing on its objections

unnecessary. Accordingly, by that letter,

NRDC withdrew its hearing requests

and asked that EPA rule on its

objections as submitted.

IV. Order Responding to Objections

The tolerance for vinclozolin on

succulent beans to which NRDC filed

objections has now expired. NRDC’s

objections to that tolerance are thus

moot and are therefore denied.

The fact that EPA did not

substantively respond to NRDC’s

objections during the existence of the

tolerance does not mean that EPA did

not consider these objections. To the

contrary, NRDC’s objections related

directly to changes in the way EPA now

assesses the risk vinclozolin poses. For

example, the centerpiece of NRDC’s

objections was a challenge to EPA’s

decision in approving the tolerance that

the additional tenfold factor for the

protection of infants and children was

unnecessary to assure to safety to

infants and children. Following NRDC’s

objections, that decision has been

revised on two occasions since the

issuance of the succulent bean

tolerance. First, as detailed in EPA’s

July 31, 1998 letter to NRDC, EPA

scientists recommended that EPA use

the additional tenfold safety factor for

the protection of children in conducting

its assessment of in utero acute risk to

the human fetus. That position

remained unsatisfactory to NRDC and

its August 1999 declarations, in essence,

argued that the tenfold factor should be

applied more broadly. After considering

the declarations and the attached

scientific literature, EPA scientists

recommended that due to, among other

things, the lack of neurotoxicity data,

the additional tenfold factor should be

used in all risk assessments for

vinclozolin.

V. Regulatory Assessment

Requirements

As indicated previously, this action

announces the Agency’s final decision

regarding an objection filed under

section 408 of FFDCA. As such, this

action is an adjudication and not a rule.

The regulatory assessment requirements

imposed on rulemakings do not,

therefore, apply to this action.

VI. 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, does not apply

because this action is not a rule for

purposes of 5 U.S.C. 804(3).

List of Subjects in 40 CFR Part 180

Environmental protection.

Dated: May 19, 2000.

Marcia E. Mulkey,

Director, Office of Pesticide Programs.

[FR Doc. 00–12962 Filed 5–22–00; 8:45 am]

BILLING CODE 6560–50–P

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

49 CFR Parts 209 and 230

[FRA Docket No. RSSL–98–1, Notice No.

5]

Inspection and Maintenance Standards

for Steam Locomotives

AGENCY: Federal Railroad

Administration (FRA), Department of

Transportation (DOT).

ACTION: Notice of public meeting.

SUMMARY: On November 17, 1999, FRA

published the final rule on inspection

and maintenance of steam locomotives

(65 FR 62828). The Inspection and

Maintenance Standards for Steam

Locomotives, Title 49, Code of Federal

Regulations (CFR), parts 209 and 230,

which took effect on January 18, 2000,

sets forth new inspection and

implementation requirements. FRA is

holding a public meeting to explain the

implementation schedule and general

requirements for inspection and

maintenance of steam locomotives

under the rule. This meeting will also

provide interested parties with the

opportunity to discuss the rule and ask

questions of the presenters. All parties

interested in the new rule on inspection

and maintenance of steam locomotives

are invited to attend this meeting.

DATES: The meeting will be held on July

27, 2000, at 8 a.m.

ADDRESSES: The meeting will be held on

July 27, 2000, in room 570 of the Bishop

Henry Whipple Federal Building, One

Federal Drive, Fort Snelling, Minnesota

55111–4007.

FOR FURTHER INFORMATION CONTACT:

George Scerbo, Motive Power &

Equipment Specialist, Office of

Safety, FRA, 1120 Vermont Avenue

NW, Washington, DC 20590

(telephone 202–493–6249); or

Paul F. Byrnes, Trial Attorney, Office of

Chief Counsel, FRA, 1120 Vermont

Avenue NW, Washington, DC 20590

(202–493–6032).

Grady C. Cothen,

Deputy Associate Administrator for Safety

Standards and Program Development.

[FR Doc. 00–12950 Filed 5–22–00; 8:45 am]

BILLING CODE 4910–06–P