Proposed Test Rule for Hazardous Air Pollutants; Extension of Comment Period on Proposed Rule and Extension of Period for Receipt of Proposals for Enforceable Consent Agreements for Pharmacokinetics Studies

Federal RegisterOct 18, 1996

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 799

[OPPTS-42187C; FRL-5571-3]

RIN 2070-AC76

Proposed Test Rule for Hazardous Air Pollutants; Extension of

Comment Period on Proposed Rule and Extension of Period for Receipt of

Proposals for Enforceable Consent Agreements for Pharmacokinetics

Studies

AGENCY: Environmental Protection Agency (EPA).

ACTION: Extension of comment period on proposed test rule and extension

of period for receipt of proposals for enforceable consent agreements

for pharmacokinetics studies.

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SUMMARY: EPA is extending the public comment period from December 23,

1996 to January 31, 1997 on the proposed rule to require manufacturers

and processors of 21 hazardous air pollutants (HAPs) to test these

substances for certain health effects. This proposed rule was published

in the Federal Register on June 26, 1996 (61 FR 33178) (FRL-4869-1). In

addition, the deadline for receipt of proposals for enforceable consent

agreements (ECAs) regarding the performance of pharmacokinetics (PK)

studies which would permit extrapolation from oral data to predict risk

from inhalation exposure for the HAPs is being extended from October

24, 1996 to November 25, 1996.

DATES: Written comments on the proposed rule must be received by EPA

on or before January 31, 1997. Written proposals for ECAs for PK

studies must be received by EPA on or before November 25, 1996.

ADDRESSES: Submit three copies of written comments on the proposed HAPs

test rule, identified by document control number (OPPTS-42187A; FRL-

[[Page 54384]]

4869-1) and three copies of proposals for PK studies, identified by

document control number (OPPTS-42187B; FRL-4869-1) to: U.S.

Environmental Protection Agency, Office of Pollution Prevention and

Toxics (OPPT), Document Control Office (7407), Rm. G-099, 401 M St.,

SW., Washington, DC, 20460.

A public version of the official rulemaking record supporting this

action, excluding confidential business information (CBI), is available

for inspection at the TSCA Nonconfidential Information Center, Rm. NE-

B607, 401 M St., SW., Washington, DC 20460, from 12 noon to 4 p.m.,

Monday through Friday, except on legal holidays.

All comments which contain information claimed as CBI must be

clearly marked as such. Three sanitized copies of any comments

containing information claimed as CBI must also be submitted and will

be placed in the public record for this rulemaking. Persons submitting

information any portion of which they believe is entitled to treatment

as CBI by EPA must assert a business confidentiality claim in

accordance with 40 CFR 2.203(b) for each such portion. This claim must

be made at the time that the information is submitted to EPA. If a

submitter does not assert a confidentiality claim at the time of

submission, EPA will consider this as a waiver of any confidentiality

claim and the information may be made available to the public by EPA

without further notice to the submitter.

Comments and data may also be submitted in electronic form by

sending electronic mail (e-mail) to: [email protected]. Such

comments and data must be submitted in an ASCII file avoiding the use

of special characters and any form of encryption. Comments and data

will also be accepted on disks in WordPerfect in 5.1 file format or

ASCII file format. All comments and data in electronic form must be

identified by (OPPTS-42187A)(FRL-4869-1). No information claimed as CBI

should be submitted through e-mail. Comments in electronic form may be

filed online at many federal depository libraries.

The official record of this action, as well as the public version,

will be maintained in paper form. EPA will transfer all comments

received electronically into paper form and will place the paper copies

in the official record. The official record is the paper record

maintained at the address listed at the beginning of the ``ADDRESSES''

section of this notice.

FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,

Environmental Assistance Division (7408), Rm. ET-543B, Office of

Pollution Prevention and Toxics, U.S. Environmental Protection Agency,

401 M St., SW., Washington, DC 20460; telephone: (202) 554-1404; TDD:

(202) 554-0551; e-mail: TSCA-Hotline @epamail.epa.gov.

For technical information contact: Robert A. Reiley, Project

Manager, Chemical Control Division (7405), Office of Pollution

Prevention and Toxics, U.S. Environmental Protection Agency, 401 M St.,

SW., Washington, DC, 20460; telephone: (202) 260-1105; fax: (202) 260-

1096; e-mail: [email protected].; or Gary Timm, Senior

Technical Advisor, Chemical Control Division (7405), Office of

Pollution Prevention and Toxics, U.S. Environmental Protection Agency,

401 M St., SW., Washington, DC 20460; telephone: (202) 260-1105; fax:

(202) 260-8168; e-mail: [email protected].

SUPPLEMENTARY INFORMATION: The HAPs rule proposed testing, under

section 4(a) of the Toxic Substances Control Act (TSCA), of: 1,1'-

biphenyl, carbonyl sulfide, chlorine, chlorobenzene, chloroprene,

cresols [3 isomers], diethanolamine, ethylbenzene, ethylene dichloride,

ethylene glycol, hydrochloric acid, hydrogen fluoride, maleic

anhydride, methyl isobutyl ketone, methyl methacrylate, naphthalene,

phenol, phthalic anhydride, 1,2,4-trichlorobenzene, 1,1,2-

trichloroethane, and vinylidene chloride. EPA would use the data

generated under the rule to implement several provisions of section 112

of the Clean Air Act and to meet other EPA data needs and those of

other Federal agencies. EPA is extending the period for public comment

on the proposed rule from December 23, 1996 to January 31, 1997.

In addition, in the HAPs proposal, EPA solicited proposals for ECAs

regarding the performance of pharmacokinetics studies which would

permit extrapolation from oral data to predict effects from inhalation

exposure. EPA is extending the period for receipt of proposals for ECAs

for PK studies from October 24, 1996 to November 25, 1996.

EPA is extending the period for submitting proposals for ECAs as a

result of requests by several members of the public for additional time

to submit such proposals. EPA is extending the comment period on the

proposed rule to allow adequate time for comments on the proposed rule

to be submitted after the Agency has considered the ECA proposals.

List of Subjects in 40 CFR Part 799

Environmental Protection, Chemicals, Hazardous substances,

Reporting and recordkeeping requirements.

Dated: October 15, 1996.

Charles M. Auer,

Director, Chemical Control Division, Office of Pollution Prevention and

Toxics.

[FR Doc. 96-26813 Filed 10-17-96; 8:45 am]

BILLING CODE 6560-50-F

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.

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Proposed Test Rule for Hazardous Air Pollutants; Extension of Comment Period on Proposed Rule and Extension of Period for Receipt of Proposals for Enforceable Consent Agreements for Pharmacokinetics Studies · 61 FR 54383 | Frix