Federal Register / Vol. 62, No. 166 / Wednesday, August 27, 1997 / Proposed Rules 45377

TABLE 1.—ARRANGEMENT OF VALIDATION MEASUREMENTS FOR STATISTICAL ANALYSIS.—Continued

Measurement (or average) Time Spiked (ppm) di spiked Unspiked

(ppm)

di

unspiked

5 ...................................................................................................... .................... S5 U5

6 ...................................................................................................... .................... S6 S6–S5 U6 U6–U5

7 ...................................................................................................... .................... S7 U7

8 ...................................................................................................... .................... S8 S8–S7 U8 U8–U7

9 ...................................................................................................... .................... S9 U9

10 .................................................................................................... .................... S10 S10–S9 U10 U10–U9

11 .................................................................................................... .................... S11 U11

12 .................................................................................................... .................... S12 S12–S11 U12 U12–U11

Average¥> ..................................................................................... .................... Sm Mm

TABLE 2.—T-VALUES

n-1a t-value n-1a t-value n-1a t-value n-1a t-value

11 2.201 17 2.110 23 2.069 29 2.045

12 2.179 18 2.101 24 2.064 30 2.042

13 2.160 19 2.093 25 2.060 40 2.021

14 2.145 20 2.086 26 2.056 60 2.000

15 2.131 21 2.080 27 2.052 120 1.980

16 2.120 22 2.074 28 2.048 ∞ 1.960

(a) n is the number of independent pairs of measurements (a pair consists of one spiked and its corresponding unspiked measurement). Either

discreet (independent) measurements in a single run, or run averages can be used.

[FR Doc. 97–22508 Filed 8–26–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300540; FRL–5739–6]

RIN 2070–AB18

Vinclozolin; Proposed Revocation of

Tolerances for Deleted Uses

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed Revocation of

Tolerances.

SUMMARY: EPA is proposing the

revocation of tolerances for uses of the

fungicide vinclozolin which were

recently deleted from the vinclozolin

labels.

DATES: Public comments, identified by

the docket control number [OPP–

300540] must be received on or before

October 27, 1997.

ADDRESSES: By mail, submit comments

to Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), Office of

Pesticide Programs, 401 M St., SW.,

Washington, DC 20460. In person

deliver comments to Room 1132, Crystal

Mall #2, 1921 Jefferson Davis Highway,

Arlington VA.

Comments and data may also be

submitted electronically by following

the instructions under Unit VII. of this

document. No Confidential Business

Information (CBI) should be submitted

through e-mail.

FOR FURTHER INFORMATION CONTACT: By

mail: Mark Wilhite, Special Review

Branch (7508W), Special Review and

Reregistration Division, Office of

Pesticide Programs, U.S. Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20046. Office location,

telephone number, and e-mail: Special

Review Branch, 3rd floor, 2800 Crystal

Drive, Arlington, VA, (703) 308–8586; email: wilhite.mark@epamail.epa.gov.

SUPPLEMENTARY INFORMATION:

I. Background Information

Vinclozolin (trade names Ronilan,

Curalan, and Ornilan) is a fungicide first

registered in 1981 to control various

types of rot caused by Botrytis spp.,

Sclerotinia spp, and other types of mold

and blight causing organisms, on

strawberries, lettuce (all types),

stonefruit, raspberries, onions,

succulent beans, and turf in recreational

areas, golf courses, commercial and

industrial sites. Vinclozolin is also

registered for use on ornamentals in

green houses and nurseries. When BASF

requested amendment of its labels to

include a use for succulent beans, BASF

also requested deletion of several food

and non-food uses from its vinclozolin

registrations. These deletions were

announced in the Federal Register

Notice of August 13, 1997 (62 FR

43327).

II. Proposed Revocation of Tolerances

This notice proposes to revoke the

tolerances for the food uses deleted from

the vinclozolin registrations. EPA is

proposing to revoke these tolerances

because there are no active registrations

associated with them. These revocations

include the tolerances for the raw

agricultural commodities tomatoes,

plums, prunes, and grapes other than

wine grapes, the food additive

tolerances for raisins and prunes, and

the animal feed tolerance for grape

pomace. Revocation of the tolerances for

fresh plums and prunes requires that the

tolerance for stonefruits be changed to

stonefruits, except plums and prunes.

To revoke tolerances for grapes other

than wine grapes, the tolerance will be

revised to wine grapes.

III. Legal Authority

The Federal Food, Drug, and Cosmetic

Act (FFDCA), 21 U.S.C. 301 et seq., as

amended by the Food Quality Protection

Act of 1996 (FQPA), Pub. L. 104–170,

authorizes the establishment of

tolerances (maximum residue levels),

exemptions from the requirement of a

tolerance, modifications in tolerances,

and revocation of tolerances for residues

of pesticide chemicals in or on raw

agricultural commodities and processed

foods pursuant to section 408, 21 U.S.C.

346(a). Without a tolerance or

exemption, food containing pesticide

residues is considered to be unsafe and

therefore ‘‘adulterated’’ under section

402(a) of the FFDCA, and hence may not

legally be moved in interstate commerce

(21 U.S.C. 331(a) and 342(a)).

Under FFDCA section 408(e)(A), the

Administrator may issue a regulation

revoking a tolerance for a pesticide
45378 Federal Register / Vol. 62, No. 166 / Wednesday, August 27, 1997 / Proposed Rules

chemical residue. Before such a

regulation may become final the

Administrator must issue a notice of

proposed rulemaking and provide a

period of not less than 60 days for

public comment. Abandonment of uses

constitutes reasonable grounds for

revoking a tolerance. [40 CFR 180.32(b)]

IV. Regulatory Background

It is EPA’s general practice to propose

revocation of tolerances for residues of

pesticide active ingredients for which

FIFRA registrations no longer exist. In

accordance with FFDCA section 408,

however, EPA will not revoke any

tolerance or exemption proposed for

revocation if any person will commit to

support its retention, and if retention of

the tolerance will meet the tolerance

standard established under FQPA.

Generally, interested parties commit to

support the retention of such tolerances

in order to permit treated commodities

to be legally imported into the United

States, since raw agricultural

commodities or processed food or feed

commodities containing pesticide

residues not covered by a tolerance or

exemption are considered to be

adulterated and subject to seizure.

Tolerances and exemptions

established for pesticide chemicals with

FIFRA registrations cover residues in or

on both domestic and imported

commodities. To retain these tolerances

and exemptions for import purposes

only, EPA must make a finding that the

tolerances and exemptions are safe. To

make this safety finding, EPA needs

data and information indicating that

there is a reasonable certainty that no

harm will result from aggregate

exposure to the pesticide residues

covered by the tolerances and

exemptions.

EPA determines on a case-by-case

basis the data required to determine that

a tolerance or exemption is safe, and in

general requires the same technical

chemistry and toxicology data for

tolerances without related U.S.

registrations as are required to support

U.S. food-use registrations and any

resulting tolerances or exemptions. (See

40 CFR part 158 for EPA’s data

requirements to support domestic use of

a pesticide and the establishment and

maintenance of a tolerance. At a future

date, EPA will announce its import

tolerance policy.) In most cases, EPA

also requires residue chemistry data

(crop field trials) that are representative

of growing conditions in exporting

countries in the same manner that EPA

requires representative residue

chemistry data from different U.S.

regions to support domestic use of a

pesticide and any resulting tolerance(s)

or exemption(s). Good Laboratory

Practice (GLP) requirements for studies

submitted in support of tolerances and

exemptions for import purposes only

are the same as for domestic purposes;

i.e., the studies are required to either

fully meet GLP standards, or have

sufficient justification presented to

show that deviations from GLP

requirements do not significantly affect

the results of the studies.

Under FFDCA section 408(f), if EPA

determines that additional data are

needed to support continuation of a

tolerance, EPA may require that those

data be submitted by registrants under

FIFRA section 3(c)(2)(B), or by other

persons by order after opportunity for

hearing.

Section 408(f) of the FFDCA states

that if EPA determines that additional

data are needed to support the

continuation of an existing tolerance or

exemption, EPA shall issue a notice

that:

1. Requests that any parties identify

their interest in supporting the tolerance

or exemption.

2. Solicits the submission of data and

information from interested parties.

3. Describes the data and information

needed to retain the tolerance or

exemption.

4. Outlines how EPA will respond to

the submission of supporting data.

5. Provides time frames and deadlines

for the submission of such data and

information.

Monitoring and enforcement of

pesticide tolerances and exemptions are

carried out by the U.S. Food and Drug

Administration (FDA) and the U.S.

Department of Agriculture (USDA). This

includes monitoring for pesticide

residues in or on commodities imported

into the United States. It is generally

FDA’s enforcement policy to not

consider imported foods with residues

adulterated until three years after the

effective date of the revocation.

V. Proposed Actions

This notice proposes to revoke the

tolerances listed below. EPA is

proposing these revocations because

EPA has deleted their uses from the

registrations for the pesticide chemical

associated with the tolerances, and it is

EPA’s general practice to propose

revocation of those tolerances for

residues of pesticide chemicals for

which there are no active registrations.

VI. Effective Dates

These proposed revocations will

become effective 30 days following the

publication in the Federal Register of a

final rule revoking the tolerances. FDA’s

enforcement policy is, in most cases, to

not consider imported foods with

residues adulterated until 3 years after

the effective date of the revocation. Prior

to the August 1996 amendment of the

FFDCA, it was generally the practice of

EPA in similar instances to establish an

effective date for each tolerance

revocation that took into consideration

the time needed for legally treated food

to pass entirely through the channels of

trade. That is no longer necessary

because under section 408(l)(5), food

lawfully treated will not be rendered

adulterated despite the lack of a

tolerance, so long as the residue on the

food complies with the tolerance in

place at the time of treatment.

VII. Public Comment Procedures

EPA invites interested persons to

submit written comments, information,

or data in response to this proposed

rule. Comments must be submitted by

October 27, 1997. Comments must bear

a docket control number. Three copies

of the comments should be submitted to

either location listed under

‘‘ADDRESSES’’ at the beginning of this

notice.

In formation submitted as a comment

concerning this notice may be claimed

confidential by marking any or all that

information as Confidential Business

Information (CBI). EPA will not disclose

information so marked, except in

accordance with procedures set forth in

40 CFR part 2. A second copy of such

comments, with CBI deleted, also must

be submitted for inclusion in the public

record. EPA may publicly disclose

without prior notice information not

marked confidential.

After consideration of comments, EPA

will issue a final rule. Such rule will be

subject to objections. Failure to file an

objection within the appointed period

will constitute waiver of the right to

raise in future proceedings issues

resolved in the final rule.

This proposal provides 60 days for

any interested person to request that a

tolerance be retained. If EPA receives a

comment to that effect, EPA will not

revoke the tolerance, but will take steps

to ensure the submission of supporting

data and will issue an order in the

Federal Register under FFDCA section

408(f). The order would specify the data

needed, the time frames for its

submission, and would require that

within 90 days some person or persons

notify EPA that they will submit the

data. Thereafter, if the data are not

submitted as required, EPA will take

appropriate action under FIFRA or

FFDCA.
Federal Register / Vol. 62, No. 166 / Wednesday, August 27, 1997 / Proposed Rules 45379

VIII. Rulemaking Record

The official record for this proposed

revocation, as well as the public

version, has been established for this

document under docket control number

[OPP–300540] (including comments and

data submitted electronically as

described below). A public version of

this record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

inspection from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays. The official record is located

at the address in ‘‘ADDRESSES’’ at the

beginning of this document.

Electronic comments can be sent

directly to EPA at:

opp-docket@epamail.epa.gov

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Comment and data will

also be accepted on disks in

Wordperfect 5.1 file format or ASCII file

format. All comments and data in

electronic form must be identified by

the docket number OPP–300540.

Electronic comments on this document

may be filed at many Federal Depository

Libraries.

IX. Regulatory Assessment

Requirements

Executive Order 12866

Under Executive Order 12866 (58 FR

51735, October 4, 1993), EPA must

determine whether the regulatory action

is ‘‘significant’’ and therefore subject to

review by the Office of Management and

Budget and the requirements of the

Executive Order. Under section 3(f),

E.O. 12866 defines a ‘‘significant

regulatory action’’ as an action that is

likely to result in a rule: (1) having an

annual effect on the economy of $100

million or more, or adversely and

materially affecting a sector of the

economy, productivity, competition,

jobs, the environment, public health or

safety, or state, local, or tribal

governments or communities; (2)

creating serious inconsistency or

otherwise interfering with an action

taken or planned by another agency; (3)

materially altering the budgetary

impacts of entitlement, grants, user fees,

or loan programs or the rights and

obligations of recipients thereof; or (4)

raising novel legal or policy issues

arising out of legal mandates, the

President’s priorities, or principles set

forth in this Executive Order.

Pursuant to the terms of E.O. 12866,

EPA has determined that this proposed

rule is not a significant regulatory action

and, since this action does not impose

any information collection requirements

subject to approval under the Paperwork

Reduction Act (44 U.S.C. 3501 et seq.),

it is 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 mandates’’ as described in

Title II of the Unfunded Mandates

Reform Act of 1995 (Pub. L. 104–4), or

require prior consultation as specified

by Executive Order 12875 (58 FR 58093,

October 28, 1993), entitled Enhancing

the Intergovernmental Partnership, or

special considerations as required by

Executive Order 12898 (59 FR 7629,

February 16, 1994).

Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA)

generally requires an agency to conduct

a regulatory flexibility analysis of any

rule subject to notice and comment

rulemaking requirements unless the

agency certifies that the rule will not

have a significant economic impact on

a substantial number of small entities.

Small entities include small businesses,

small not-for-profit enterprises, and

small governmental jurisdictions.

Absent extraordinary circumstances,

EPA believes that revocation of a

tolerance after use of the pesticide

becomes illegal in this country will not

have a significant impact on a

substantial number of small entities.

In the case of domestically grown

food, the tolerance revocations proposed

today will have no economic impact.

The associated pesticide registered uses

have already been canceled. Since U.S.

growers may no longer use the pesticide

in those ways, revoking the tolerance

should have no effect on food grown in

the United States after cancellation of

the registered uses of the pesticide. As

for food grown before the cancellation

occurred, it will not be considered

adulterated if it was treated in a way

that complied with the tolerance in

effect at the time of treatment.

Revocation has a greater potential to

affect foreign-grown food, since the uses

of the pesticide prohibited in the United

States may still be lawful in other

countries. If foreign growers use the

pesticide in the ways prohibited in the

United States, the food they grow will

be considered adulterated once the

tolerance is revoked. However, while

revocation may have an economic effect

on foreign growers that import food to

the United States, the RFA is concerned

only with the effect of U.S. regulations

on domestic small entities.

Revocation may also have an effect on

domestic importers of foreign-grown

food to the extent their suppliers use

pesticides in ways that result in

residues no longer allowed in the

United States. However, EPA believes

that the effect on U.S. importers will be

minimal. Theoretically, U.S. importers

could face higher food prices and

transactions costs. The revocation of a

particular tolerance, though, is unlikely

to have a significant impact on the price

of a commodity on the international

market. Transaction costs may occur as

a result of having to find alternative

suppliers of food untreated with

pesticides for which tolerances were

revoked. Affected importers would have

the options of finding other suppliers in

the same country or in other countries,

or inducing the same supplier to switch

to alternative pest controls. Given the

existence of these options, EPA expects

any price increases or transaction costs

resulting from revocations will be

minor. Any such impacts will be further

reduced by the FDA’s enforcement

policy of not considering imported

foods with residues adulterated until, in

most cases, three years after the effective

date of the revocation. EPA has

reviewed its available data on imports

and foreign pesticide usage and

concludes that there is a reasonable

international supply of food not treated

with the revoked pesticide, generally

within the same countries from which

the relevant commodities are currently

imported.

Moreover, whatever the effect on U.S.

importers of foreign-grown food, EPA

believes that it would be inappropriate

and inconsistent with the purpose of the

RFA to ameliorate that effect. To the

extent any adverse effect occurs, it will

be the result of foreign growers using

pesticides in ways not allowed in the

U.S. Domestic growers have no choice

but to refrain from using pesticides in

ways prohibited by U.S. law. U.S.

growers and those who follow them in

the chain of commerce— distributors

and consumers—will bear the cost of

complying with U.S. law. For EPA to

somehow address the economic effect of

the revocation on U.S. distributors of

foreign-grown food would potentially

give those distributors a competitive

advantage over distributors of U.S.-

grown food, and that advantage could

potentially translate to a competitive

advantage for foreign growers over

domestic growers. The RFA was enacted

in part to preserve competition in the

marketplace, and it would be perverse

to implement it in a way that creates

competitive inequities, particularly

between United States and foreign

products.

Finally, EPA notes that potential

increased costs to importers would not

be cognizable as grounds for not

revoking the tolerance. Because no
45380 Federal Register / Vol. 62, No. 166 / Wednesday, August 27, 1997 / Proposed Rules

extraordinary circumstances exist as to

the present revocation that would

change EPA’s above analysis, I certify

that this action will not have a

significant economic impact on a

substantial number of small entities.

List of Subjects 40 CFR Part 180

Environmental protection,

Vinclozolin, Administrative practice

and procedure, Agricultural

commodities, Pesticides and pests,

Reporting and record keeping

requirements.

Dated: August 18, 1997.

Lois Rossi,

Director, Special Review and Reregistration

Division, Office of Pesticide Programs.

Therefore, it is proposed that 40 CFR

part 180 be amended to read as follows:

PART 180—[AMENDED]

1. In part 180:

a. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 346a and 371.

b. Section 180.380 is amended by

revising paragraph (a) to read as follows:

§ 180.380 Vinclozolin; tolerances for

residues.

(a) General. Tolerances are

established for the combined residues of

the fungicide vinclozolin (3-(3,5-

dichlorophenyl)-5-ethenyl-5-methyl-2,4-

oxazolidinedione) and its metabolites

containing the 3,5-dichloroaniline

moiety in or on the food commodities in

the table below. There are no U.S.

registrations for Belgian endive, tops,

cucumbers, grapes (wine), kiwi, pepper

(bell) as of July 30, 1997. The tolerances

will expire and are revoked on the

date(s) listed in the following table:

Commodity Parts per

million

Expiration/Revocation

Date

Beans, succulent .......................................................................................................................................... 2.0 10/1/99

Belgian endive, tops ..................................................................................................................................... 5.0 None

Cucumbers ................................................................................................................................................... 1.0 None

Grapes, (wine) .............................................................................................................................................. 6.0 None

Kiwifruit ......................................................................................................................................................... 10.0 None

Lettuce, head ............................................................................................................................................... 10.0 None

Lettuce (leaf) ................................................................................................................................................ 10.0 None

Onions (dry bulb) ......................................................................................................................................... 1.0 None

Peppers (bell) ............................................................................................................................................... 3.0 None

Raspberries .................................................................................................................................................. 10.0 None

Stonefruits except plums/fresh prunes ........................................................................................................ 25.0 None

Strawberries ................................................................................................................................................. 10.0 None

* * * * *

[FR Doc. 97–22808 Filed 8-26-97; 8:45 am]

BILLING CODE 6560-50-P

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Parts 2 and 15

[ET Docket No. 94–124; FCC 97–267]

Use of Radio Frequencies Above 40

GHz for New Radio Applications

AGENCY: Federal Communications

Commission.

ACTION: Proposed rule.

SUMMARY: By this Fourth Notice of

Proposed Rule Making (4th NPRM) the

Commission proposes to amend the

rules to provide a spectrum etiquette for

operation of unlicensed services in the

59–64 GHz frequency. The Commission

seeks comment on the proposed

spectrum etiquette.

DATES: Comments must be filed on or

before September 26, 1997, and reply

comments must be filed October 14,

1997. Interested parties wishing to

comment on the information collections

should submit comments September 26,

1997.

ADDRESSES: Comments and reply

comments should be sent to the Office

of the Secretary, Federal

Communications Commission,

Washington D.C. 20554. In addition to

filing comments with the Secretary, a

copy of any comments on the

information collections contained

herein should be submitted to Judy

Boley, Federal Communications

Commission, Room 234, 1919 M Street,

N.W., Washington, D.C. 20554, or via

electronic mail to jboley@fcc.gov.

FOR FURTHER INFORMATION CONTACT: John

A. Reed (202) 418–2455 or Rodney P.

Conway (202) 418–2904. Via electronic

mail: jreed@fcc.gov or rconway@fcc.gov,

Office of Engineering and Technology,

Federal Communications Commission.

For additional information concerning

the information collections, or copies of

the information collections contained in

this NPRM contact Judy Boley at (202)

418–0217, or via electronic mail at

jboley@fcc.gov.

SUPPLEMENTARY INFORMATION: This is a

summary of the Commission’s Fourth

Notice of Proposed Rule Making, ET

Docket 94–124, FCC 97–267, adopted

July 28, 1997, and released August 14,

1997.

This NPRM contains proposed or

modified information collections subject

to the Paperwork Reduction Act of 1995

(PRA), Public Law 104–13. The general

public, and other Federal agencies are

invited to comment on the proposed or

modified information collections

contained in this proceeding.

A full text of this Commission

decision is available for inspection and

copying during normal business hours

in the FCC Reference Center (Room

239), 1919 M Street, N.W., Washington,

D.C., and also may be purchased from

the Commission’s duplication

contractor, International Transcription

Service, phone (202) 857–3800,

facsimile (202) 857–3805, 1231 20th

Street, N.W. Washington, D.C. 20036.

Summary of the 4th NPRM

1. In the Second Notice of Proposed

Rule Making, 61 FR 14041, March 29,

1996, the Commission requested

comment regarding a spectrum etiquette

for operation in the 59–64 GHz band.

The Commission provided one year for

a spectrum etiquette to be submitted

and encouraged industry to form a

working group to develop a spectrum

etiquette to permit efficient use of the

59–64 GHz band. In response, the

Millimeter Wave Communications

Working Group (MWCWG) was formed

and proposed a Spectrum Etiquette for

equipment operating in the 59–64 GHz

band. The MWCWG proposed Spectrum

Etiquette can be accessed at [http://

www.fcc.gov/oet/dockets/et94–124/].

MWCWG seeks adoption of its proposal

to permit efficient use of the spectrum

by enabling greater frequency reuse and

lowering the probability of interference.