29646 Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations

F. Petitions for Judicial Review

Under section 307(b)(1) of the Clean

Air Act, petitions for judicial review of

this action must be filed in the United

States Court of Appeals for the

appropriate circuit by July 31, 1998.

Filing a petition for reconsideration by

the Administrator of this final rule does

not affect the finality of this rule for the

purposes of judicial review nor does it

extend the time within which a petition

for judicial review must be filed, and

shall not postpone the effectiveness of

such rule or action. This action may not

be challenged later in proceedings to

enforce its requirements (see section

307(b)(2)).

G. Executive Order 13045

Protection of Children from

Environmental Health Risks and Safety

Risks. Executive Order 13045 (62 FR

19885, April 23, 1997), applies to any

rule that is (1) likely to be

‘‘economically significant’’ as defined

under Executive Order 12866, and (2)

the Agency has reason to believe that

the environmental health or safety risk

addressed by the rule may have a

disproportionate effect on children. If a

regulatory action meets both criteria, the

Agency must evaluate the

environmental health or safety effects of

the planned rule on children, and

explain why the planned regulation is

preferable to other potentially effective

and reasonably feasible alternatives

considered by the Agency.

This rule is not subject to E.O. 13045,

‘‘Protection of Children from

Environmental Health Risks and Safety

Risks’’ because this is not an

‘‘economically significant’’ regulatory

action as defined by E.O. 12866, and

because it does not involve decisions on

environmental health or safety risks that

may disproportionately affect children.

List of Subjects in 40 CFR Part 62

Environmental protection,

Administrative practice and procedure,

Air pollution control, Intergovernmental

relations, Methane, Municipal solid

waste landfills, Nonmethane organic

compounds, Reporting and

recordkeeping requirements.

Dated: May 21, 1998.

Carol Rushin,

Acting Regional Administrator, Region VIII.

40 CFR part 62 is amended as follows:

PART 62—[AMENDED]

1. The authority citation for part 62

continues to read as follows:

Authority: 42 U.S.C. 7401–7642.

2. Subpart ZZ is added to read as

follows:

Subpart ZZ—Wyoming

Sec.

62.12600 Identification of plan.

62.12601 Identification of sources.

62.12602 Effective date.

Subpart ZZ—Wyoming

Landfill Gas Emissions From Existing

Municipal Solid Waste Landfills

§ 62.12600 Identification of plan.

Section 35, ‘‘Municipal Solid Waste

Landfills,’’ of the Wyoming Air Quality

Standards and Regulations and

associated documentation submitted by

the State on February 13, 1998.

§ 62.12601 Identification of sources.

The plan applies to all existing

municipal solid waste landfills for

which construction, reconstruction, or

modification was commenced before

May 30, 1991 that accepted waste at any

time since November 8, 1987 or that

have additional capacity available for

future waste deposition, as described in

40 CFR part 60, subpart CC.

§ 62.12602 Effective date.

The effective date of the plan for

municipal solid waste landfills is July

31, 1998.

[FR Doc. 98–14435 Filed 5–29–98; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 721

[OPPTS–50630A; FRL–5789–5]

RIN 2070–AB27

Sinorhizobium meliloti strain RMBPC2; Significant New Use Rule

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is issuing a significant

new use rule (SNUR) under section

5(a)(2) of the Toxic Substances Control

Act (TSCA) for the microorganism

described as Sinorhizobium meliloti

strain RMBPC-2 which is the subject of

premanufacture notice (PMN) P–92–

403. This rule will require persons who

intend to manufacture, import, or

process this microorganism for a

significant new use to notify EPA at

least 90 days before commencing any

manufacturing, importing, or processing

activities for a use designated by this

SNUR as a significant new use. The

required notice would provide EPA

with the opportunity to evaluate the

intended use and, if necessary, to

prohibit or limit that activity before it

can occur.

DATES: This rule is effective July 1,

1998.

FOR FURTHER INFORMATION CONTACT:

Susan B. Hazen, Director,

Environmental Assistance Division

(7408), Office of Pollution Prevention

and Toxics, Environmental Protection

Agency, Rm. E–531, 401 M St., SW.,

Washington, DC 20460, telephone: (202)

554–1404, TDD: (202) 554–0551; e-mail:

TSCA-Hotline@epamail.epa.gov.

SUPPLEMENTARY INFORMATION:

Electronic Availability: Electronic

copies of this document are available

from the EPA Home Page at the Federal

Register-Environmental Documents

entry for this document under ‘‘Laws

and Regulations’’ (http://www.epa.gov/

fedrgstr/).

This SNUR would require persons to

notify EPA at least 90 days before

commencing the manufacture, import,

or processing of the microorganism

identified in PMN P–92–403 for the

significant new uses designated herein.

The required notice would provide EPA

with information with which to evaluate

an intended use and associated

activities.

I. Authority

Section 5(a)(2) of TSCA (15 U.S.C.

2604(a)(2)) authorizes EPA to determine

that a use of a chemical substance is a

‘‘significant new use.’’ EPA must make

this determination by rule after

considering all relevant factors,

including those listed in section 5(a)(2)

of TSCA. Once EPA determines that a

use of a chemical substance is a

significant new use, section 5(a)(1)(B) of

TSCA requires persons to submit a

notice to EPA at least 90 days before

they manufacture, import, or process the

chemical substance for that use. Section

26(c) of TSCA authorizes EPA to take

action under section 5(a)(2) of TSCA

with respect to a category of chemical

substances. EPA interprets the

definition of ‘‘chemical substance’’

under TSCA to include microorganisms

as stated in the Federal Register of April

11, 1997 (62 FR 17910) (FRL–5577–2),

June 26, 1986 (51 FR 23324), and

December 31, 1984 (49 FR 50886).

Persons subject to this SNUR would

comply with the same notice

requirements and EPA regulatory

procedures as submitters of

premanufacture notices under section

5(a)(1) of TSCA. In particular, these

requirements include the information

submission requirements of TSCA

section 5(b) and (d)(1), the exemptions

authorized by TSCA section 5(h)(1),

(h)(2), (h)(3), and (h)(5), and the
Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations 29647

regulations at 40 CFR part 720. Once

EPA receives a SNUR notice, EPA may

take regulatory action under TSCA

section 5(e), 5(f), 6, or 7 to control the

activities for which it has received a

SNUR notice. If EPA does not take

action, section 5(g) of TSCA requires

EPA to explain in the Federal Register

its reasons for not taking action.

Persons who intend to export a

substance identified in a proposed or

final SNUR are subject to the export

notification provisions of TSCA section

12(b). The regulations that interpret

TSCA section 12(b) appear at 40 CFR

part 707.

II. Applicability of General Provisions

General regulatory provisions

applicable to SNURs are codified at 40

CFR part 721, subpart A. On July 27,

1988 (53 FR 28354) and July 27, 1989

(54 FR 31298), EPA promulgated

amendments to the general provisions

which apply to this SNUR. In the

Federal Register of August 17, 1988 (53

FR 31248), EPA promulgated a ‘‘User

Fee Rule’’ (40 CFR part 700) under the

authority of TSCA section 26(b).

Provisions requiring persons submitting

SNUR notices to submit certain fees to

EPA are discussed in detail in that

Federal Register document. Interested

persons should refer to these documents

for further information.

III. Background

EPA published a proposed SNUR for

the microorganism described as

Sinorhizobium meliloti strain RMBPC-2,

which is the subject of premanufacture

notice (PMN) P–92–403, in the Federal

Register of March 10, 1998 (63 FR

11643) (FRL–5765–6). The background

and reasons for the SNUR are set forth

in the preamble to the proposed rule.

EPA proposed the significant new use as

follows: Any manufacturer or importer

who has not previously submitted a

premanufacture notice or significant

new use notice for this microorganism

must submit a significant new use

notice 90 days before engaging in any

commercial activity while any

manufacturer or importer who has

previously submitted a premanufacture

notice or a significant new use notice for

this microorganism must submit a

significant new use notice before

manufacturing, importing, or processing

greater than a maximum production

volume of 500,000 pounds (lbs) in any

consecutive 12-month period.

The Agency received no public

comment concerning the proposed rule.

As a result EPA is issuing the final rule

as proposed.

IV. Objectives and Rationale of the Rule

EPA is issuing this SNUR for a

specific microorganism which has

undergone premanufacture review to

ensure that:

(1) EPA will receive notice of any

company’s intent to manufacture,

import, or process the microorganism

for a significant new use before that

activity begins.

(2) EPA will have an opportunity to

review and evaluate data submitted in a

significant new use notice (SNUN)

before the notice submitter begins

manufacturing, importing, or processing

the microorganism for a significant new

use.

(3) When necessary, to prevent

potential unreasonable risks, EPA will

be able to respond to a SNUN by issuing

a TSCA section 5(e) consent order to

regulate prospective manufacturers,

importers, or processors of the

microorganism before a significant new

use of that substance occurs.

(4) All manufacturers, importers, and

processors of the same microorganism

which is subject to a TSCA section 5(e)

consent order are subject to similar

requirements.

Issuance of a SNUR for a

microorganism does not signify that the

substance is listed on the TSCA

Inventory and that its manufacture

would not require a PMN.

Manufacturers, importers, and

processors are responsible for ensuring

that a microorganism subject to a final

SNUR is listed on the TSCA Inventory.

V. Applicability of SNUR to Uses

Occurring Before Effective Date of the

Final SNUR

EPA has decided that the intent of

section 5(a)(1)(B) of TSCA is best served

by designating a use as a ‘‘significant

new use’’ as of the date of proposal,

rather than as of the effective date of the

rule. If uses which had commenced

between the date of proposal and the

effective date of this rulemaking were

considered ongoing, rather than new,

any person could defeat the SNUR by

initiating a significant new use before

the effective date. This would make it

difficult for EPA to establish SNUR

notice requirements. Thus, persons who

begin commercial manufacture, import,

or processing of the microorganism for

uses that would be regulated through

this SNUR after the proposal date,

would have to cease any such activity

before the effective date of this rule. To

resume their activities, such persons

would have to comply with all

applicable SNUR notice requirements

and wait until the notice review period,

including all extensions, expires. EPA,

not wishing to unnecessarily disrupt the

activities of persons who begin

commercial manufacture, import, or

processing for a proposed significant

new use before the effective date of the

SNUR, has promulgated provisions to

allow such persons to comply with the

proposed SNUR before it is

promulgated. If a person meets the

conditions of advance compliance as

codified at § 721.45(h) (53 FR 28354,

July 17, 1988), the person is considered

to have met the requirements of the final

SNUR for those activities. If persons

who begin commercial manufacture,

import, or processing of the

microorganism between proposal and

the effective date of the SNUR do not

meet the conditions of advance

compliance, they must cease that

activity before the effective date of the

rule. To resume their activities, these

persons would have to comply with all

applicable SNUR notice requirements

and wait until the notice review period,

including all extensions, expires.

VI. Economic Analysis

EPA has evaluated the potential costs

of establishing significant new use

notice requirements for potential

manufacturers, importers, and

processors of the microorganism subject

to this rule. EPA’s complete economic

analysis is available in the rulemaking

record for this final rule (OPPTS–

50630A).

VII. Public Record and Electronic

Submissions

The official record for this

rulemaking, as well as the public

version, has been established for this

rulemaking under docket control

number OPPTS–50630A (including

comments and data submitted

electronically). In addition, extensive

information for this microorganism can

also be found in OPPTS docket number

51786, which contains materials

concerning the TSCA section 5(a)

review of PMN P–92–403. A public

version of this record, including

printed, paper versions of electronic

comments, which does not include any

information claimed as Confidential

Business Information (CBI), is available

for inspection from 12 noon to 4 p.m.,

Monday through Friday, excluding legal

holidays. The official rulemaking record

is located in the TSCA Nonconfidential

Information Center Rm. NE–B607, 401

M St., SW., Washington, DC.

VIII. Regulatory Assessment

Requirements

Under Executive Order 12866,

entitled ‘‘Regulatory Planning and

Review’’ (58 FR 51735, October 4, 1993),
29648 Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations

this action is not a ‘‘significant

regulatory action’’ subject to review by

the Office of Management and Budget

(OMB). 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 (UMRA) (Pub. L. 104–4), or require

prior consultation with State officials as

also specified in Executive Order 12875,

entitled ‘‘Enhancing the

Intergovernmental Partnership’’ (58 FR

58093, October 28, 1993). Nor does it

involve special considerations of

environmental justice related issues 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 additional 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).

According to the Paperwork

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

seq., an agency may not conduct or

sponsor, and a person is not required to

respond to a collection of information

that requires OMB approval under the

PRA, unless it has been approved by

OMB and displays a currently valid

OMB control number. The OMB control

numbers for EPA’s regulations, after

initial display in the preamble of the

final rules, are listed in 40 CFR part 9.

The information collection requirements

related to this action have already been

approved by OMB pursuant to the PRA

under OMB control number 2070–0012

(EPA ICR No. 574). This action does not

impose any burden requiring additional

OMB approval.

If an entity were to submit a

significant new use notice to the

Agency, the annual burden is estimated

to average between 30 and 170 hours

per response. This burden estimate

includes the time needed to review

instructions, search existing data

sources, gather and maintain the data

needed, and complete, review, and

submit the required significant new use

notice.

Send any comments about the

accuracy of the burden estimate and any

suggested methods for minimizing

respondent burden, including through

the use of automated collection

techniques, to the Director, OPPE

Regulatory Information Division, U.S.

Environmental Protection Agency (Mail

Code 2137), 401 M St., SW.,

Washington, DC 20460, with a copy to

the Office of Information and Regulatory

Affairs, Office of Management and

Budget, 725 17th St., NW., Washington,

DC 20503, marked ‘‘Attention: Desk

Officer for EPA.’’ Please remember to

include the OMB control number in any

correspondence, but do not submit any

completed forms to these addresses.

In addition, pursuant to section 605(b)

of the Regulatory Flexibility Act (RFA)

(5 U.S.C. 601 et seq.), the Agency has

previously certified, as a generic matter,

that the promulgation of a SNUR does

not have a significant adverse economic

impact on a substantial number of small

entities. The Agency’s generic

certification for promulgation of new

SNURs appears on June 2, 1997 (62 FR

29684) (FRL–5597–1) and was provided

to the Chief Counsel for Advocacy of the

Small Business Administration.

IX. 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, the

Agency has 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 721

Environmental protection, Chemicals,

Hazardous substances, Reporting and

recordkeeping requirements.

Dated: May 20, 1998.

Charles M. Auer,

Director, Chemical Control Division, Office

of Pollution Prevention and Toxics.

Therefore, 40 CFR part 721 is

amended as follows:

PART 721—[AMENDED]

1. The authority citation for part 721

continues to read as follows:

Authority: 15 U.S.C. 2604, 2607, and

2625(c).

2. By adding new § 721.9518 to

subpart E to read as follows:

§ 721.9518 Sinorhizobium meliloti strain

RMBPC-2.

(a) Microorganism and significant new

uses subject to reporting. (1) The

microorganism identified as

Sinorhizobium meliloti strain RMBPC-2

(PMN P–92–403) is subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Commercial activities before

submitting a TSCA section 5(a) notice.

For any manufacturer or importer who

has not previously submitted a

premanufacture notice or significant

new use notice for this microorganism,

the significant new use is any use.

(ii) Commercial activities after

submitting a TSCA section 5(a) notice.

For any manufacturer or importer who

has previously submitted a

premanufacture notice or a significant

new use notice for this microorganism,

the significant new use is manufacture,

import, or processing greater than a

maximum production volume of

500,000 lbs in any consecutive 12-

month period.

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Persons who must report. Section

721.5 applies to this section except for

§ 721.5(a)(2). A person who intends to

manufacture or import this substance

for commercial purposes must have

submitted a premanufacture notice or

submit a significant new use notice.

(2) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a) and (i) are applicable to

manufacturers and importers of this

substance.

(3) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

[FR Doc. 98–14439 Filed 5–29–98; 8:45 am]

BILLING CODE 6560–50–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

42 CFR Parts 441 and 489

[HCFA–1152–1–F]

RIN 0938–AI86

Medicare and Medicaid Programs;

Surety Bond Requirements for Home

Health Agencies

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Final rule.

SUMMARY: This final rule revises several

provisions of an earlier final rule

concerning surety bond requirements

published in the Federal Register on

January 5, 1998 (63 FR 292). This rule

also establishes the surety bond

submission compliance date, as

described in a notice of intent and in a

final rule concerning surety bond

requirements published in the Federal

Register on March 4, 1998 (63 FR 10730

and 10732). The March 4 documents

advised the public that we intended to