18078 Federal Register / Vol. 60, No. 68 / Monday, April 10, 1995 / Proposed Rules

(i) If a change that does not meet the

criteria in paragraph (g)(4) of this

section is made to a process unit subject

to subparts H and I of this part, and the

change causes equipment to become

subject to the provisions of subpart H of

this part, then the owner or operator

shall comply with the requirements of

subpart H of this part for the equipment

as expeditiously as practicable, but in

no event later than 3 years after the

equipment becomes subject.

(1) The owner or operator shall

submit to the Administrator for

approval a compliance schedule, along

with a justification for the schedule.

(2) The Administrator shall approve

the compliance schedule or request

changes within 120 calendar days of

receipt of the compliance schedule and

justification.

* * * * *

15. Section 63.191 is amended by

adding in alphabetical order definitions

for ‘‘bench-scale batch process,’’

‘‘process unit,’’ and ‘‘source’’ to

paragraph (b) and revising the definition

of ‘‘pharmaceutical production process’’

in paragraph (b) to read as follows:

§ 63.191 Definitions.

(b) * * *

Bench-scale batch process means a

batch process (other than a research and

development facility) that is capable of

being located on a laboratory bench top.

This bench-scale equipment will

typically include reagent feed vessels, a

small reactor and associated product

separator, recovery and holding

equipment. These processes are only

capable of producing small quantities of

product.

* * * * *

Pharmaceutical production process

means a process that synthesizes

pharmaceutical intermediate or final

products using carbon tetrachloride or

methylene chloride as a reactant or

process solvent. Pharmaceutical

production process does not mean

process operations involving

formulation activities, such as tablet

coating or spray coating of drug

particles, or solvent recovery.

* * * * *

Process unit means the equipment

assembled and connected by pipes or

ducts to process raw materials and to

manufacture a product. For the

purposes of this subpart, process unit

includes all unit operations and

associated equipment (e.g., reactors and

associated product separators and

recovery devices), associated unit

operations (e.g., extraction columns),

any feed and product storage vessels,

and any transfer racks for distribution of

final product.

* * * * *

Source means the collection of

equipment listed in § 63.190(d) to which

this subpart applies as determined by

the criteria in § 63.190. For purposes of

subparts H and I of this part, the term

affected source as used in subpart A of

this part has the same meaning as the

term source defined in this definition.

* * * * *

[FR Doc. 95–8201 Filed 4–7–95; 8:45 am]

BILLING CODE 6560–50–P

40 CFR Part 63

[AD-FRL–5182–5]

RIN 2060–AC19

National Emission Standards for

Hazardous Air Pollutants for Source

Categories: Organic Hazardous Air

Pollutants From the Synthetic Organic

Chemical Manufacturing Industry and

Other Processes Subject to the

Negotiated Regulation for Equipment

Leaks

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: This action proposes to

correct errors and clarify regulatory text

of the ‘‘National Emission Standards for

Hazardous Air Pollutants for Source

Categories: Organic Hazardous Air

Pollutants from the Synthetic Organic

Chemical Manufacturing Industry and

Other Processes Subject to the

Negotiated Regulation for Equipment

Leaks,’’ which was issued as a final rule

on April 22, 1994 and June 6, 1994. This

rule is commonly known as the

Hazardous Organic NESHAP or the

HON. Because the revisions merely

correct errors and clarify regulatory text

the Agency does not anticipate receiving

adverse comments. Consequently the

revisions are also being issued as a

direct final rule in the final rules section

of this Federal Register. If no significant

adverse comments are timely received,

no further action will be taken with

respect to this proposal and the direct

final rule will become final on the date

provided in that action.

DATES: Comments. Comments must be

received on or before May 10, 1995,

unless a hearing is requested by April

20, 1995. If a hearing is requested,

written comments must be received by

May 25, 1995.

Public Hearing. Anyone requesting a

public hearing must contact the EPA no

later than April 20, 1995. If a hearing is

held, it will take place on April 25,

1995, beginning at 10:00 a.m.

ADDRESSES: Comments. Comments

should be submitted (in duplicate, if

possible) to: Air and Radiation Docket

and Information Center (6102),

Attention Docket Number A–90–20 (see

docket section below), room M–1500,

U.S. Environmental Protection Agency,

401 M Street, SW, Washington, D.C.

20460. The EPA requests that a separate

copy also be sent to the contact person

listed below.

Public Hearing. If a public hearing is

held, it will be held at the EPA’s Office

of Administration Auditorium, Research

Triangle Park, North Carolina. Persons

interested in attending the hearing or

wishing to present oral testimony

should notify Mrs. Kim Teal, U.S.

Environmental Protection Agency,

Research Triangle Park, N.C. 27711,

telephone (919) 541–5580.

Docket. Dockets No. A–90–20 and A–

89–10, containing the supporting

information for the original NESHAP

and this action, are available for public

inspection and copying between 8:00

a.m. and 5:30 p.m., Monday through

Friday, at the EPA’s Air and Radiation

Docket and Information Center,

Waterside Mall, room M–1500, first

floor, 401 M Street SW, Washington, DC

20460, or by calling (202) 260–7548 or

260 -7549. A reasonable fee may be

charged for copying.

FOR FURTHER INFORMATION CONTACT: Dr.

Janet S. Meyer, Emission Standards

Division (MD–13), U.S. Environmental

Protection Agency, Office of Air Quality

Planning and Standards, Research

Triangle Park, North Carolina 27711,

telephone number (919) 541–5254.

SUPPLEMENTARY INFORMATION: If no

significant, adverse comments are

timely received, no further activity is

contemplated in relation to this

proposed rule and the direct final rule

in the final rules section of this Federal

Register will automatically go into effect

on the date specified in that rule. If

significant adverse comments are timely

received on any provision, that

provision of the direct final rule will be

withdrawn and all public comment

received on that provision will be

addressed in a subsequent final rule

based on the relevant portions of this

proposed rule. Because the Agency will

not institute a second comment period

on this proposed rule, any parties

interested in commenting should do so

during this comment period.

For further supplemental information,

the detailed rationale, and the rule

provisions, see the information

provided in the direct final rule in the
Federal Register / Vol. 60, No. 68 / Monday, April 10, 1995 / Proposed Rules 18079

final rules section of this Federal

Register.

Executive Order 12866 Review

The HON rule promulgated on April

22, 1994 was considered ‘‘significant’’

under Executive Order 12866 and a

regulatory impact analysis (RIA) was

prepared. Today’s proposed revisions

clarify the rule and do not add any

additional control requirements. The

EPA believes that these revisions would

have a negligible impact on the results

of the RIA and the change is considered

to be within the uncertainty of the

analysis.

Regulatory Flexibility Act

The Regulatory Flexibility Act of 1980

requires the identification of potentially

adverse impacts of Federal regulations

upon small business entities. The Act

specifically requires the completion of a

Regulatory Flexibility Analysis in those

instances where small business impacts

are possible. Because this rulemaking

imposes no adverse economic impacts,

a Regulatory Flexibility Analysis has not

been prepared.

List of Subjects in 40 CFR Part 63

Environmental protection, Air

pollution control, Hazardous

substances, Reporting and

recordkeeping requirements.

Dated: March 28, 1995.

Carol M. Browner,

Administrator.

[FR Doc. 95–8200 Filed 4–7–95; 8:45 am]

BILLING CODE 6560–50–P

40 CFR Part 799

[OPPTS–42111E, FRL–4927–8]

RIN 2070–AB94

Test Rule; Office of Water Chemicals

Proposed Withdrawal of Certain

Testing Requirements

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing to withdraw

certain testing requirements for two of

the chemical substances listed in the

Office of Water chemicals test rule

published in the Federal Register of

November 10, 1993 (58 FR 59667). EPA

required specified health effects testing

for the two chemical substances because

the substances are produced in

substantial quantities and there may be

substantial exposure to these

substances, there are insufficient data to

determine or predict the health effects

from exposure to these substances in

drinking water, and the testing required

is necessary to determine or predict

these health effects. EPA believes that

data recently made available to it are

sufficient to determine or predict the

health effects posed by short and longterm exposures to 1,1-dichloroethane in

drinking water and are sufficient to

determine or predict the health effects

posed by long-term exposures to 1,1,2,2-

tetrachloroethane in drinking water.

Therefore, EPA is proposing the

withdrawal of the 90–day subchronic

testing requirement for 1,1,2,2-

tetrachloroethane and the 90–day and

14–day testing requirements for 1,1-

dichloroethane.

DATES: Written comments must be

received by EPA on or before May 10,

1995.

ADDRESSES: Submit written comments,

identified by the document control

number (OPPTS–42111E) in triplicate

to: TSCA Document Receipts Office

(Mail stop 7407), Office of Pollution

Prevention and Toxics, Environmental

Protection Agency, Rm. ET G–99, 401 M

St., SW., Washington, DC, 20460. A

public version of the administrative

record supporting this action, without

confidential business information, is

available for inspection at the above

address from 12 p.m. to 4 p.m., Monday

through Friday, except legal holidays.

FOR FURTHER INFORMATION CONTACT:

James G. Willis, Acting Director,

Environmental Assistance Division

(7408), Office of Pollution Prevention

and Toxics, 401 M St., SW.,

Washington, DC 20460, (202) 554–1404,

TDD (202) 554–0551.

SUPPLEMENTARY INFORMATION: EPA is

proposing to withdraw the 90–day

subchronic testing requirement for

1,1,2,2-tetratchloroethane and the 90–

day and 14–day testing requirements for

1,1-dichloroethane in the Office of

Water chemicals test rule referenced

above.

I. Proposed Modification

Pursuant to section 4 of the Toxic

Substances Control Act (TSCA), EPA

proposed a test rule in the Federal

Register of May 24, 1990 (55 FR 21393)

and finalized the test rule in the Federal

Register of November 10, 1993 (58 FR

59667), finding that four chemical

substances; chloroethane (CAS No. 75–

00–3); 1,1-dichloroethane (CAS No. 75–

34–3); 1,1,2,2-tetrachloroethane (CAS

No. 79–34–5); and 1,3,5-

trimethylbenzene (CAS No. 108–67–8)

are produced in substantial quantities

and that there may be substantial

exposure to these substances, that there

are insufficient data to determine or

predict the health effects from short and

long-term exposures to the substances in

drinking water, and that testing is

required to determine or predict the

health effects from short and long-term

exposures. Thus, EPA required subacute

toxicity (oral 14–day repeated dose) and

subchronic (oral 90–day) toxicity tests.

The data from these studies would be

used to develop Health Advisories

(HA’s) for the four unregulated drinking

water contaminants that are monitored

under section 1445 of the Safe Drinking

Water Act (SDWA).

EPA has recently received requests to

withdraw all or part of the testing

required for two substances, 1,1-

dichloroethane and 1,1,2,2-

tetrachloroethane. On June 28, 1994, the

Halogenated Solvents Industry Alliance

(HSIA) requested that EPA revoke the

subchronic (oral 90–day) toxicity test

requirements for 1,1,2,2-

tetrachloroethane (Ref. 1). This request

was based on the availability of a 90–

day subchronic toxicity drinking water

study of 1,1,2,2-tetrachloroethane

conducted in rats and mice by the

National Toxicology Program (Ref. 2).

EPA reviewed this study and believes

that the study is sufficient to meet the

90–day subchronic toxicity test required

under the test rule and to establish longterm Health Advisories for the Office of

Water (OW) (Ref. 3). Therefore, EPA

believes it is appropriate to withdraw

the 90–day subchronic testing

requirements for 1,1,2,2-

tetrachloroethane.

HSIA also requested that EPA

withdraw the 14– and 90–day

subchronic toxicity testing required

under the test rule for 1,1-

dichloroethane. This request was based

on a study conducted by Muralidhara et

al. (Ref. 6) that characterizes the acute

(24 hour), subacute (5 and 10 days), and

the subchronic (90 days) toxicity

potential of 1,1-dichloroethane. EPA

reviewed the study and believes the

study is sufficient to determine or

predict both the short and long-term

effects of exposure to 1,1-dichloroethane

(Ref. 7). Therefore, EPA believes it is

appropriate to withdraw both the 14–

and 90–day subchronic toxicity tests

required for 1,1-dichloroethane under

the test rule for the OW substances.

EPA is providing 30 days from

publication of this proposed

modification for submission of written

comments on the elimination of the

subchronic toxicity (oral 90–day) test

requirement for 1,1,2,2-

tetrachloroethane and of both the

subacute (oral 14–day repeated dose)

and subchronic (oral 90–day) toxicity

test requirements for 1,1,2,2-

tetrachloroethane. If the 30 day deadline

passes and no public comments have