31642 Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 /Rules and Regulations

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997).

Since this extension of an existing

time-limited tolerance does 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. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

actions published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

IV. Submission to Congress and the

General Accounting Office

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 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 26, 1998.

James Jones,

Director, Registration Division, 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. 346a and 371.

§ 180.431 [Amended]

2. In § 180.431, by amending the

tolerance listed for ‘‘Canola’’ in the table

under paragraph (b) by changing the

date ‘‘7/31/98’’ to read ‘‘1/31/00’’.

[FR Doc. 98–15172 Filed 6–9–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300656; FRL–5789–7]

RIN 2070–AB78

Polyvinyl Chloride; Tolerance

Exemption

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes an

exemption from the requirement of a

tolerance for residues of polyvinyl

chloride when used as an inert

ingredient carrier in pesticide

formulations applied to growing crops

or raw agricultural commodities after

harvest. American Cyanamid Company

requested this exemption from the

requirement of a tolerance under the

Federal Food, Drug and Cosmetic Act

(FFDCA), as amended by the Food

Quality Protection Act of 1996 (Pub. L.

104–170).

DATES: This regulation is effective June

10, 1998. Objections and requests for

hearings must be received by EPA on or

before August 10, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, OPP–300656,

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–

300656, must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), 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. 119, 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 5.1/6.1 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–300656.

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: Bipin Gandhi, Registration

Division 7505W, Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location, telephone

number, and e-mail address: Fourth

Floor, CS#1, 2800 Crystal Drive,

Arlington, VA, (703) 308–8380, e-mail:

gandhi.bipin@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of August 29, 1997 (62

FR 45804) (FRL–5738–2), 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 pesticide petition (PP)

3E4246 for a tolerance exemption by

American Cyanamid Company,

Agricultural Products Research

Division, P.O. Box 400, Princeton, NJ

08543–0400. This notice included a

summary of the petition prepared by

American Cyanamid Company, the

petitioner. There were no comments

received in response to the notice of

filing.

The petition requested that 40 CFR

180.1001 be amended by establishing an

exemption from the requirement of a

tolerance for residues of polyvinyl

chloride when used as an inert

ingredient carrier in pesticide

formulations applied to growing crops

or raw agricultural commodities after

harvest.

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the Federal Food, Drug,

and Cosmetic Act (FFDCA), 21 U.S.C.

301 et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act

(FIFRA), 7 U.S.C. 136 et seq. The FQPA

amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities
Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 /Rules and Regulations 31643

under a new section 408 with a new

safety standard and new procedures.

New section 408(c)(2)(A)(i) allows

EPA to establish an exemption from the

requirement of a tolerance for a

pesticide chemical residue on food only

if EPA determines that the exemption is

‘‘safe.’’ 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 information.’’ This includes

exposure through drinking water, but

does not include occupational exposure.

Section 408(c)(2)(B) requires EPA to

give special consideration to exposure

of infants and children to the pesticide

chemical residue in establishing an

exemption from the requirement of

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’’ and specifies factors

EPA is to consider in establishing an

exemption.

II. Inert Ingredient Definition

Inert ingredients are all ingredients

that are not active ingredients as defined

in 40 CFR 153.125 and include, but are

not limited to, the following types of

ingredients (except when they have a

pesticidal efficacy of their own):

solvents such as alcohols and

hydrocarbons; surfactant such as

polyoxyethylene polymers and fatty

acids; carriers such as clay and

diatomaceous earth; thickeners such as

carrageenan and modified cellulose;

wetting, spreading, and dispersing

agents; propellants in aerosol

dispensers; microencapsulating agents;

and emulsifiers. The term ‘‘inert’’ is not

intended to imply nontoxicity; the

ingredient may or may not be

chemically active. Generally, EPA has

exempted inert ingredients from the

requirement of a tolerance based on the

low toxicity of the individual inert

ingredients.

III. Risk Assessment and Statutory

Findings

EPA establishes exemptions from the

requirement of a tolerance only in those

cases where it can be clearly

demonstrated that the risks from

aggregate exposure to pesticide

chemical residues under reasonably

foreseeable circumstances will pose no

appreciable risks to human health. In

order to determine the risks from

aggregate exposure to pesticide inert

ingredients, the Agency considers the

toxicity of the inert ingredient in

conjunction with possible exposure to

residues of the inert ingredient in food,

drinking water, and other

nonoccupational exposures. If EPA is

able to determine that a finite tolerance

is not necessary to ensure that there is

a reasonable certainty that no harm will

result from aggregate exposure to the

inert ingredient, an exemption from the

requirement of a tolerance may be

established.

IV. Aggregate Risk Assessment and

Determination of Safety

Consistent with section 408(b)(2)(D),

EPA has reviewed the available

scientific data and other relevant

information in support of this action.

EPA has sufficient data to assess the

hazards of polyvinyl chloride and to

make a determination on aggregate

exposure, consistent with section

408(b)(2), for a tolerance exemption for

residues on polyvinyl chloride on

growing crops and raw agricultural

commodities after harvest. EPA’s

assessment of the dietary exposures and

risks associated with establishing these

tolerances follows.

The data submitted in the petitions

and other relevant material have been

evaluated. As part of the EPA policy

statement on inert ingredients published

in the Federal Register of April 22, 1987

(52 FR 13305) (FRL–3190–1), the

Agency set forth a list of studies which

would generally be used to evaluate the

risks posed by the presence of an inert

ingredient in a pesticide formulation.

However, where it can be determined

without that data that the inert

ingredient will present minimal or no

risk, the Agency generally does not

require some or all of the listed studies

to rule on the proposed tolerance or

exemption from the requirement of a

tolerance for an inert ingredient.

A. Toxicological Profile

In the case of certain chemical

substances that are defined as

‘‘polymers,’’ the Agency has established

a set of criteria which identify categories

of polymers that present low risk. These

criteria (described in 40 CFR 723.250)

identify polymers that are relatively

unreactive and stable compared to other

chemical substances as well as polymers

that typically are not readily absorbed.

These properties generally limit a

polymer’s ability to cause adverse

effects. In addition, these criteria

exclude polymers about which little is

known. The Agency believes that

polymers meeting these criteria will

present minimal or no risk. Polyvinyl

chloride (PVC) conforms to the

definition of polymer given in 40 CFR

723.250(b) and meets the following

criteria that are used to identify low risk

polymers:

1. PVC is not a cationic polymer, nor

is it reasonably anticipated to become a

cationic polymer in a natural aquatic

environment.

2. PVC contains as an integral part of

its composition the atomic elements

carbon, chlorine, and hydrogen.

3. PVC does not contain as an

integral part of its composition, except

as impurities, any elements other than

those listed in 40 CFR section 723.250

(d)(2)(ii).

4. PVC is not designed, nor is it

reasonably anticipated to substantially

degrade, decompose, or depolymerize.

5. PVC is not manufactured or

imported from monomers and/or other

reactants that are not already included

on the Toxic Substance Control Act

(TSCA) Chemical Substance Inventory

or manufactured under an applicable

TSCA section 5 exemption.

6. PVC is not a water absorbing

polymer.

7. PVC does not contain any group

as reactive functional groups.

8. The minimum number-average

molecular weight of PVC is listed as

29,000 daltons. Substances with

molecular weights greater than 400

generally are not absorbed through the

intact skin, and substances with

molecular weights greater than 1,000

generally are not absorbed through the

intact gastrointestinal (GI) tract.

Chemicals not absorbed through the

skin or GI tract generally are incapable

of eliciting a toxic response.

9. PVC has a minimum numberaverage molecular weight of 29,000 and

contains less than 2 percent oligomeric

material below molecular weight 500

and less than 5 percent oligomeric

material below 1,000 molecular weight.

In addition, PVC is approved by the

Food and Drug Administration (FDA)

under 21 CFR for contact with food as

a component in adhesives (21 CFR

175.105), coatings (21 CFR 175.320),

and paper and paperboard (21 CFR

176.180). PVC is also approved by FDA

as an indirect food additive used as a

basic component of acrylic (21 CFR

177.1010) and cellophane (21 CFR

177.1200) polymers. PVC is also cleared

for use as water pipe for potable water

as per FFDCA 201(s).

Based on the conformance of

polyvinyl chloride to the above criteria,

no mammalian toxicity is anticipated

from dietary, inhalation or dermal

exposure to polyvinyl chloride.

B. Exposures and Risks

1. From food and feed uses, drinking

water, and non-dietary exposures. For

the purposes of assessing the potential
31644 Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 /Rules and Regulations

dietary exposure, EPA considered that

under this tolerance exemption

polyvinyl chloride could be present in

all raw and processed agricultural

commodities and drinking water and

that non-occupational, non-dietary

exposure was possible. EPA concluded

that, based on this chemical’s

categorization as a polymer conforming

to the definition of a polymer under 40

CFR 723.250(b) that also meet the

criteria used to identify low risk

polymers, there are no concerns for risks

associated with any potential exposure

scenarios that are reasonably

foreseeable.

2. Cumulative exposure to substances

with common mechanism of toxicity.

Section 408(b)(2)(D)(v) requires that,

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

In the case of polyvinyl chloride, the

lack of expected toxicity of this

substance based on its conformance to

the definition of polymers as given in 40

CFR 723.250(b) as well as the criteria

that identify low risk polymers results

in no expected cumulative effects; a

cumulative risk assessment is therefore

not necessary.

C. Aggregate Risks and Determination of

Safety for U.S. Population

Based on this chemical’s conformance

to the definition of a polymer given in

40 CFR 723.250(b) as well as the criteria

that are used to identify low risk

polymers, EPA concludes that there is a

reasonable certainty that no harm to the

U.S. population will result from

aggregate exposure to polyvinyl

chloride. EPA believes this compound

presents no dietary risk under

reasonably foreseeable circumstances.

D. Aggregate Risks and Determination of

Safety for Infants and Children

FFDCA section 408 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 postnatal toxicity and the

completeness of the database unless

EPA determines that a different margin

of safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a MOE

analysis or through using uncertainty

(safety) factors in calculating a dose

level that poses no appreciable risk to

humans.

Due to the low expected toxicity of

polyvinyl chloride, EPA has not used a

safety factor analysis in assessing the

risk of this compound. For the same

reasons the additional safety factor is

unnecessary.

V. Other Considerations

The Agency proposes to establish an

exemption from the requirement of a

tolerance without any numerical

limitation; therefore, the Agency has

concluded that analytical methods are

not required for enforcement purposes

for polyvinyl chloride.

There are no Codex Alimentarius

Commission (Codex), Canadian or

Mexican residue limits for polyvinyl

chloride.

VI. Conclusion

Therefore, an exemption from the

requirement of a tolerance is established

for residues of polyvinyl chloride.

VII. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under new

section 408(e) and (l)(6) as was provided

in the old section 408 and in section

409. However, the period for filing

objections is 60 days, rather than 30

days. EPA currently has procedural

regulations which govern the

submission of objections and hearing

requests. These regulations will require

some modification to reflect the new

law. However, until those modifications

can be made, EPA will continue to use

those procedural regulations with

appropriate adjustments to reflect the

new law.

Any person may, by August 10, 1998,

file written objections to any aspect of

this regulation and may also request a

hearing on those objections. Objections

and hearing requests must be filed with

the Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). 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).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

Confidential Business Information (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.

VIII. Public Record and Electronic

Submissions

EPA has established a record for this

rulemaking under docket control

number [OPP–300656] (including any

comments and data submitted

electronically). 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 public record is located in

Rm. 119 of the Public Information and

Records Integrity Branch, Information

Resources and Services Division

(7502C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

Electronic comments may 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.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.
Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 /Rules and Regulations 31645

IX. 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)

(Pub. L. 104–4). Nor does it require any

prior consultation as specified by

Executive Order 12875, entitled

Enhancing the Intergovernmental

Partnership (58 FR 58093, October 28,

1993), or special considerations as

required by Executive Order 12898,

entitled Federal Actions to Address

Environmental Justice in Minority

Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997).

The Agency has previously assessed

whether establishing tolerances,

exemptions from tolerances, raising

tolerance levels or expanding

exemptions might adversely impact

small entities and concluded, as a

generic matter, that there is no adverse

economic impact. The factual basis for

the Agency’s generic certification for

tolerance actions published on May 4,

1981 (46 FR 24950) and was provided

to the Chief Counsel for Advocacy of the

Small Business Administration.

X. Submission to Congress and the

General Accounting Office

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 the rule in

the 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 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and record keeping

requirements.

Dated: May 21, 1998.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

PART 180 — [AMENDED]

Therefore, 40 CFR chapter I is

amended as follows:

1. The authority citation for part 180

continues to read as follows:

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

2. In section 180.1001 the table in

paragraph (c) is amended by adding

alphabetically the following inert

ingredient to read as follows:

§ 180.1001 Exemption from the requirement

of a tolerance.

* * * * *

(c) * * *

Inert ingredients Limits Uses

* * * * * * *

Polyvinyl chloride

(CAS Reg. No.

9002–86–2),

minimum number average

molecular

weight (in amu)

29,000.

.............. Carrier

* * * * * * *

* * * * *

[FR Doc. 98–15174 Filed 6–9–98; 8:45 am]

BILLING CODE 6560–50–F

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 2

[ET Docket No. 94–45; FCC 98–96]

Marketing and Equipment

Authorizations

AGENCY: Federal Communications

Commission.

ACTION: Final rule.

SUMMARY: By this Memorandum

Opinion and Order, the Commission

amends its regulations to increase the

number of radio frequency products that

can be imported, prior to receiving a

grant of equipment authorization, for

the purpose of testing and evaluation or

demonstration at industry trade shows.

This increase applies only to products

designed to be operated within one of

the allocated radio services and under

the provisions of license issued by the

Commission. In addition, manufacturers

operating equipment for demonstration

or evaluation purposes will be

permitted to operate under the authority

of a local FCC licensed service provider

on the condition that the licensee gives

the manufacturer permission to operate

in this manner and accepts

responsibility for the operation of the

equipment. These amendments to the

regulations respond to a Petition for

Reconsideration and Clarification, filed

by Ericsson, Inc.

EFFECTIVE DATE: August 10, 1998.

FOR FURTHER INFORMATION CONTACT: John

A. Reed, Office of Engineering and

Technology, (202) 418–2455.

SUPPLEMENTARY INFORMATION: This is a

summary of the Commission’s

Memorandum Opinion and Order in ET

Docket No. 94–45, adopted May 14,

1998, and released May 28, 1998. The

complete text of this Memorandum

Opinion and Order 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 Services, Inc., (202) 857–

3800, 1231 20th Street, N.W.,

Washington, D.C. 20036.

Summary of the Memoranudum

Opinion and Order

1. In the Memorandum Opinion and

Order, the Commission amended part 2

of its rules regarding the importation

and operation of radio frequency (RF)

devices. Previously, the rules limited

the importation of RF products, prior to

receiving a grant of equipment

authorization, to no more than 200 units

for testing and evaluation purposes and

to no more than 10 units for

demonstrations at trade shows. A

greater number could be imported only

if written authorization was first

obtained from the Chief, Office of

Engineering and Technology, FCC.

2. Ericsson, Inc. filed a Petition for

Reconsideration and Clarification to the

Report and Order (‘‘R&O’’) in this

proceeding, 62 FR 10466, March 7,

1997. It requested that the above