51030 Federal Register / Vol. 62, No. 189 / Tuesday, September 30, 1997 / Rules and Regulations

rubber’’ includes natural rubber latex,

dry natural rubber, and synthetic latex

or synthetic rubber that contains natural

rubber in its formulation.

(1) The term ‘‘natural rubber latex’’

means rubber that is produced by the

natural rubber latex process that

involves the use of natural latex in a

concentrated colloidal suspension.

Products are formed from natural rubber

latex by dipping, extruding, or coating.

(2) The term ‘‘dry natural rubber’’

means rubber that is produced by the

dry natural rubber process that involves

the use of coagulated natural latex in the

form of dried or milled sheets. Products

are formed from dry natural rubber by

compression molding, extrusion, or by

converting the sheets into a solution for

dipping.

(3) The term ‘‘contacts humans’’

means that the natural rubber contained

in a device is intended to contact or is

likely to contact the user or patient. This

includes contact when the device that

contains natural rubber is connected to

the patient by a liquid path or an

enclosed gas path; or the device

containing the natural rubber is fully or

partially coated with a powder, and

such powder may carry natural rubber

proteins that may contaminate the

environment of the user or patient.

(c) Devices containing natural rubber

shall be labeled as set forth in

paragraphs (d) through (h) of this

section. Each required labeling

statement shall be prominently and

legibly displayed in conformance with

section 502(c) of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

352(c)).

(d) Devices containing natural rubber

latex that contacts humans, as described

in paragraph (b) of this section, shall

bear the following statement in bold

print on the device labeling:

‘‘Caution: This Product Contains Natural

Rubber Latex Which May Cause Allergic

Reactions.’’

This statement shall appear on all

device labels, and other labeling, and

shall appear on the principal display

panel of the device packaging, the

outside package, container or wrapper,

and the immediate device package,

container, or wrapper.

(e) Devices containing dry natural

rubber that contacts humans, as

described in paragraph (b) of this

section, that are not already subject to

paragraph (d) of this section, shall bear

the following statement in bold print on

the device labeling:

‘‘This Product Contains Dry Natural

Rubber.’’

This statement shall appear on all

device labels, and other labeling, and

shall appear on the principal display

panel of the device packaging, the

outside package, container or wrapper,

and the immediate device package,

container, or wrapper.

(f) Devices that have packaging

containing natural rubber latex that

contacts humans, as described in

paragraph (b) of this section, shall bear

the following statement in bold print on

the device labeling:

‘‘Caution: The Packaging of This Product

Contains Natural Rubber Latex Which May

Cause Allergic Reactions.’’

This statement shall appear on the

packaging that contains the natural

rubber, and the outside package,

container, or wrapper.

(g) Devices that have packaging

containing dry natural rubber that

contacts humans, as described in

paragraph (b) of this section, shall bear

the following statement in bold print on

the device labeling:

‘‘The Packaging of This Product Contains

Dry Natural Rubber.’’

This statement shall appear on the

packaging that contains the natural

rubber, and the outside package,

container, or wrapper.

(h) Devices that contain natural

rubber that contacts humans, as

described in paragraph (b) of this

section, shall not contain the term

‘‘hypoallergenic’’ on their labeling.

(i) Any affected person may request

an exemption or variance from the

requirements of this section by

submitting a citizen petition in

accordance with § 10.30 of this chapter.

(j) Any device subject to this section

that is not labeled in accordance with

paragraphs (d) through (h) of this

section and that is initially introduced

or initially delivered for introduction

into interstate commerce after the

effective date of this regulation is

misbranded under sections 201(n) and

502(a), (c), and (f) of the act (21 U.S.C.

321(n) and 352(a), (c), and (f)).

Dated: September 22, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–25728 Filed 9–29–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF STATE

22 CFR Part 41

[Public Notice 2610]

Bureau of Consular Affairs; Visas:

Passports and Visas Not Required for

Certain Nonimmigrants

AGENCY: Bureau of Consular Affairs,

DOS.

ACTION: Interim rule with request for

comments.

SUMMARY: Section 217 of the

Immigration and Nationality Act (INA),

as amended, extends the Visa Waiver

Pilot Program (VWPP) to nationals of all

countries that qualify under the

provisions of the Pilot Program and

which are designated by the Secretary of

State and the Attorney General as

countries whose nationals benefit from

the waiver of the nonimmigrant B–1/B–

2 visa requirement. This interim rule

eliminates probationary entry status in

the pilot program, designates Ireland

(the only country formerly designated as

a participating country with

probationary status) as a permanent

participating country and extends the

VWPP to Slovenia.

DATES: This interim rule is effective

September 30, 1997. Written comments

are invited and must be received on or

before October 30, 1997.

ADDRESSES: Written comments may be

submitted, in duplicate, to the Chief,

Legislation and Regulations Division,

Visa Services, Room L–603C,

Department of State, Washington, D.C.

20520–0106.

FOR FURTHER INFORMATION CONTACT: H.

Edward Odom, Chief, Legislation and

Regulations Division, Visa Office,

Department of State, Washington, D.C.

20522–0113 (202) 663–1203.

SUPPLEMENTARY INFORMATION: This

interim rule amends Part 41, Title 22 of

the Code of Federal Regulations

concerning visas for nonimmigrants

pursuant to section 217 of the

Immigration and Nationality Act, 8

U.S.C. 1187, as amended by Pub. L.

103–415, (108 Stat. 4299, October

25,1994), Pub. L. 103–416, (108 Stat.

4305, October 25, 1994), and Pub. L.

104–208, (110 Stat. 3009–702,

September 30, 1996).

Pub. L. 99–603

Section 313 of the Immigration

Reform and Control Act of 1986 (IRCA),

Pub. L. 99–603, amended the INA by

adding a new section 217 (8 U.S.C.

1187). Section 217 provides for a

nonimmigrant visa waiver pilot program

(VWPP) which waives the

nonimmigrant visa requirement for the

admission of certain aliens into the

United States for a period not to exceed

ninety days. This original provision

authorized the participation of eight

countries in the VWPP to be designated

by the Secretary of State and the

Attorney General, acting jointly from

among countries meeting specific

criteria. These original qualifying

countries included: France; the Federal
Federal Register / Vol. 62, No. 189 / Tuesday, September 30, 1997 / Rules and Regulations 51031

Republic of Germany; Italy; Japan; the

Netherlands; Sweden; Switzerland; and

the United Kingdom. (See Federal

Register publications 53 FR 24903–

24904, June 30, 1988; 53 FR 50161–

50162, December 13, 1988; and 54 FR

27120–27121, June 27, 1989.)

Pub. L. 101–649

On November 29, 1990, the President

signed the Immigration Act of 1990

(Pub. L. 101–649, 104 Stat. 4978).

Section 201 revised the VWPP set forth

in section 313 of IRCA (Sec. 217 INA,

8 U.S.C. 1187). It removed the eightcountry cap and extended the

provisions of the VWPP to all countries

that meet the qualifying criteria of the

Visa Waiver Pilot Program and were

designated by the Secretary of State and

the Attorney General in consultation

with the Secretary of State as Pilot

Program countries thereunder.

Effective October 1, 1991, Andorra,

Austria, Belgium, Denmark, Finland,

Iceland, Liechtenstein, Luxembourg,

Monaco, New Zealand, Norway, San

Marino, and Spain, having met all of the

requirements for participants in the

nonimmigrant Visa Waiver Pilot

Program, were added as participants in

the Program. (See 56 FR 46716–46717,

September 13, 1991.) Brunei was

designated as a participant in the Visa

Waiver Pilot Program in an interim rule

published at 58 FR 40581–40586 of the

Federal Register of July 26, 1993.

Pub. L. 103–415

Section 1(m) of Pub. L. 103–415 again

amended section 217 of the INA to

extend the Visa Waiver Pilot Program

through September 30, 1995.

Pub. L. 103–416

Section 210 of the Immigration and

Nationality Technical Corrections Act of

1994 (INTC) (Pub. L. 103–416) amended

section 217 of the INA extending the

Visa Waiver Pilot Program to September

30, 1996. Section 211 of INTC created

and established criteria for a new

probationary qualification status for

countries which met the criteria for that

status under the VWPP and which were

designated by the Secretary of State and

the Attorney General, acting jointly, as

countries whose nationals benefitted

from the waiver of the nonimmigrant

B–1/B–2 visa requirement.

The Department published an interim

rule [59 FR 15872] to implement the

provisions of sections 210 and 211 (Pub.

L. 103–416) on March 28, 1995. Ireland

was determined to be the only country

which met the criteria set forth for such

probationary qualification status. On

July 8, 1996 Argentina was added as a

non-probationary VWPP country (61 FR

35628–35629) and Australia became a

non-probationary participating country

on July 29, 1996 (61 FR 39318).

Pub. L. 104–208

On September 30, 1996 the President

signed Pub. L. 104–208, the Illegal

Immigration Reform and Immigrant

Responsibility Act of 1996, (IIRIRA).

Section 635 of this law again amended

INA 217 by extending the Program until

September 30, 1997. This law also

named the Attorney General as the

principal designator of VWPP countries,

eliminated probationary VWPP

qualification status and made countries

then in such status (Ireland being the

only country) permanent participating

VWPP countries subject to the same

disqualification criteria established for

other VWPP countries.

Requirements for VWPP Participation

For a country to qualify as a

participant in the VWPP, the country

must agree to waive the visa

requirement for nationals of the United

States entering for business or pleasure

for ninety (90) days or less, must meet

statutorily prescribed limits on visa

refusal rates for the prior two year

period as well as the prior year; must

meet statutorily prescribed limits on

rates of exclusion at ports of entry and

on overstay rates, and must have a

machine readable passport program.

The Attorney General, in consultation

with the Secretary of State, has

determined that Slovenia has met these

requirements, and Slovenia, therefore, is

added effective September 30, 1997 as a

participating country in the Visa Waiver

Pilot Program. (See the Immigration and

Naturalization Service rule also

published in this issue of the Federal

Register.)

Interim Rule

The implementation of this rule as an

interim rule, with a 30-day provision for

post-promulgation public comments, is

based upon the ‘‘good cause’’ exceptions

set forth at 5 U.S.C. 553(b)(B) and

553(d)(3). Because this rule will

facilitate tourist and business travel to

and from Slovenia, delay for prepromulgation public comment would be

contrary to the public interest. This rule

will, therefore, become effective upon

publication in the Federal Register.

In accordance with 5 U.S.C. 605(b)

(Regulatory Flexibility Act), it is

certified that this rule does not have a

‘‘significant adverse economic impact’’

on a substantial number of small

entities, because it is inapplicable. This

rule is exempt from E.O. 12866

(Regulatory Planning and Review) but

has been coordinated with the

Immigration and Naturalization Service

because action by the Attorney General

is required under section 217 of the

INA, as amended. The rule imposes no

reporting or record-keeping action from

the public requiring the approval of the

Office of Management and Budget under

the Paperwork Reduction Act. This rule

has been reviewed as required by E.O.

12988 (Civil Justice Reform) and is

certified to be in compliance therewith.

List of Subjects in 22 CFR Part 41

Aliens, Nonimmigrants, Visas,

Passports, Temporary Visitors, Waivers.

This interim rule, with request for

comments, amends Part 41, Title 22 by

eliminating the pilot program which

allowed countries to participate in the

Program with probationary status and

by adding Ireland and Slovenia to the

list of participating countries in the Visa

Waiver Pilot Program.

PART 41—[AMENDED]

1. The authority citation for Part 41

continues to read:

Authority: 8 U.S.C. 1104.

2. Accordingly, paragraph (l) of § 41.2

is revised to read as follows:

§ 41.2 Waiver by the Secretary of State and

Attorney General of passport and/or visa

requirements for certain categories of

nonimmigrants.

* * * * *

(l) Visa waiver pilot program. (1)

Notwithstanding the provisions of

paragraphs (a) through (k) of this

section, a visa is not required of any

person who seeks admission to the

United States for a period of 90 days or

less as a visitor for business or pleasure

and who is eligible to apply for

admission to the United States as a Visa

Waiver Pilot Program applicant.

(2) Countries designated as pilot

program countries under paragraph

(l)(1), of this section are: the United

Kingdom (effective July 1, 1988); Japan

(effective December 15, 1988); France

and Switzerland (effective July 1, 1989);

The Federal Republic of Germany and

Sweden (effective July 15, 1989); Italy

and The Netherlands (effective July 29,

1989); Andorra, Austria, Belgium,

Denmark, Finland, Iceland,

Liechtenstein, Luxembourg, Monaco,

New Zealand, Norway, San Marino, and

Spain (effective October 1, 1991); Brunei

(effective July 29, 1993); Ireland

(effective April 1, 1995); Argentina

(effective July 8, 1996); Australia

(effective July 29, 1996) and Slovenia

(effective September 30, 1997).

* * * * *
51032 Federal Register / Vol. 62, No. 189 / Tuesday, September 30, 1997 / Rules and Regulations

Dated: September 25, 1997.

Mary A. Ryan,

Assistant Secretary for Consular Affairs.

[FR Doc. 97–25951 Filed 9–29–97; 8:45 am]

BILLING CODE 4710–06–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300554; FRL–5744–8]

RIN 2070-AB78

Carfentrazone-ethyl; Temporary

Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

temporary tolerance for combined

residues of the herbicide carfentrazoneethyl (ethyl-alpha-2-dichloro-5-[4-

(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1-yl]-4-

fluorobenzenepropanoate) and its major

wheat metabolites in or on corn (fodder,

forage, and grain) and wheat (grain, hay,

and straw). FMC requested this

tolerance under the Federal Food, Drug,

and Cosmetic Act (FFDCA), as amended

by the Food Quality Protection Act of

1966 (Pub. L. 104–170).

DATES: This regulation is effective

September 30, 1997. Objections and

requests for hearings must be received

by EPA on or before December 1, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, OPP–300554,

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, OPP–

300554], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1 file format

or ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket control number OPP–300554.

No Confidential Business Information

(CBI) should be submitted through email. Electronic copies of objections and

hearing requests on this rule may be

filed online at many Federal Depository

Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Joanne I. Miller, Product Manager,

Registration Division (7505C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. Office location,

telephone number, and e-mail address:

Crystal Mall #2, 1921 Jefferson Davis

Hwy., Arlington, VA, (703) 305–6224, email: miller.joanne@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of May 16, 1997 (62 FR

27040) (FRL–5717–4), EPA issued a

notice pursuant to section 408 of the

Federal Food, Drug, and Cosmetic Act

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

the filing of a pesticide petition (PP) for

tolerance by FMC Corporation, 1735

Market St., Philadelphia, PA 19103.

This notice included a summary of the

petition prepared by FMC Corporation,

the registrant. There were no comments

received in response to the notice of

filing. The petition requested that 40

CFR part 180 be amended by

establishing a temporary tolerance for

combined residues of the herbicide

carfentrazone-ethyl (ethyl-alpha-2-

dichloro-5-[4-(difluoromethyl)-4,5-

dihydro-3-methyl-5-oxo-1H-1,2,4-

triazol-1-yl]-4-

fluorobenzenepropanoate), and its

metabolite in or on field corn forage,

fodder, and grain at 0.15 ppm; and for

wheat hay, straw, and grain at 0.20 ppm

part per million (ppm). This tolerance

will expire on May 8, 1998. This

tolerance request was submitted along

with an application for an experimiental

use permit (EUP). The EUP proposed

the experimental use of carfentrazoneethyl on corn and wheat. Under FIFRA,

section 5 for experimental use permits,

a temporary tolerance level must be

established if a pesticide may

reasonably be expected to result in any

residue in or on food or feed use.

I. Risk Assessment and Statutory

Findings

New section 408(b)(2)(A)(i) of the

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) 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

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 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. . . .’’

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

Second, EPA examines exposure to the

pesticide through the diet (e.g., food and

drinking water) and through exposures

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

(sometimes called a ‘‘safety factor’’) of

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than