Federal Register / Vol. 58, No. 85 / Wednesday, May 5, 1993 / Notices

ENVIRONMENTAL PROTECTION

AGENCY

[OPPTS-41038;, FR"5]3-41

Thirty-First Report of the TSCA

Interagency Testing Committee to the

Administrator; Receipt of Report,

Request for Comments, Opportunity to

Initiate Negotiations for TSCA Section

4 Testing Consent Agreements

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: The TSCA Interagency

Testing Committee (ITC), established

under section 4(e) of the Toxic

Substances Control Act (TSCA).

transmitted its Thirty-First Report to the

Administrator of EPA on January 28,

1993. This report Is included with this

notice. As noted in this Report, the ITC

revised the Priority Testing List by

adding one group of 24 chemicals to the

list for priority consideration by the

EPA Administrator for promulgation of

test rules under section 4(a) of the Act.

These chemicals are designated for

response within 12 months. Therefore,

in response to the ITC's designation,

EPA will either initiate rulemaking

under section 4(a) of TSCA, enter into

a testing consent agreement, or publish

a Federal Register notice explaining the

reasons for not initiating such

rulemaking within 12 months. The ITC

is also revising the recommendations for

two chemical groups that were

recommended in the ITC's TwentyEighth Report. The propylene glycol

ethers and esters group is revised by the

addition of 2 chemicals and the removal

of 29. The methyl ethylene glycol ethers

and esters group is modified by the

removal of eight chemicals. The ITC's

reasons for revising these chemical

groups are stated in the Thirty-First

Report. There are no recommended with

intent-to-designate chemicals or

chemical groups in the Thirty-First

Report. EPA invites interested persons

to submit written comments on the

Report. en addition, EPA is soliciting

interested parties for participation in or

monitoring of a consent agreement

process for the chemicals that were

designated for dermal absorption

testing. EPA is also inviting

manufacturers and/or processors of

chemical substances who wish to

participate in testing negotiations for the

chemicals designated for dermal

absorption testing to develop and

submit testing consent agreement

proposals to EPA.

DATES: Written comments on the ThirtyFirst ITC Report must be received by

June 4, 1993. Written testing proposals

must be received by July 6, 1993.

Written notice of interest in being

designated an "interested party" to the

development or monitoring of a consent

agreement for the chemicals designated

for dermal absorption testing must be

received by July 6, 1993. Those

submitting written testing proposals

will be considered "interested parties"

and do not have to submit separate

written notice. EPA will contact all

"interested parties" and advise them of

meeting dates.

ADDRESSES: Send six copies of written

submissions to: TSCA Docket Receipts

(TS-790), Office of Pollution Prevention

and Toxics, Environmental Protection

Agency, Rm. ET G-102, 401 M St., SW.,

Washington, DC 20460. Submissions

should bear the document control

number (OPPTS-41038; FRL-4583-4).

The public record supporting this

action, including comments, is available

for public inspection in Rm. ET G-102

at the address noted above from 8 a.m.

to noon and 1 p.m. to 4 p.m., Monday

through Friday, except legal holidays.

FOR FURTHER INFORMATION CONTACT:

Susan B. Hazen, Director,

Environmental Assistance Division {TS799), Office of Pollution Prevention and

Toxics, Environmental Protection

Agency, 401 M Street, SW., Rm. E543B, Washington, DC 20460, (202)

554-1404, TDD (202) 554-0551.

SUPPLEMENTARY INFORMATION:

Electronic Availability:. This document,

along with a complete list of Chemical

Abstract Service numbers, and chemical

names of chemicals and chemicals in

groups on the TSCA section 4(e)Priority

Testing List, is available as an electronic

file on The Federal Bulletin Board at 9

a.m. on the date of publication in the

Federal Register. By modem dial 202-

512-1387 or call 202-512-1530 for

disks or paper copies.This file Is also

available in Postscript, Wordperfect and

ASCII. The list of chemical abstract

Service numbers, and chemical names

of chemicals and chemicals in groups

on the TSCA section 4(e) Priority

Testing List, is available in Wordperfect

and ASCII.

I. Background

TSCA ( 15 U.S.C. 2601 et seq.)

authorizes the Administrator of EPA to

promulgate regulations under section

4(a) requiring testing of chemical

substances and mixtures ("chemicals")

in order to develop data relevant to

determining whether such chemicals

may present unreasonable risks to

health or the environment Section 4(e)

of TSCA established the Interagency

Testing Committee (ITC) to recommend

chemicals and chemical groups to the

Administrator of EPA for priority testing

consideration. Section 4(e) directs the

ITC to revise the TSCA section 4(e)

Priority Testing List at least every 6

months. The most recent revisions to

this List are included in the ITC's

Thirty-First Report. The Report was

received by the Administrator on

January 28,1993, and is included with

this notice. The Report adds 1 group of

24 chemicals to the TSCA section 4(e)

Priority Testing List and revises the

recommendations for 2 chemical groups

that were recommended in the ITC's

Twenty-Eighth Report.

H. Written and Oral Comments on

Recommendations

EPA invites interested persons to

submit detailed comments on the ITC's

new recommendations. The Agency Is

interested in receiving information

concerning additional or ongoing health

and safety studies on the subject

chemicals as well as Information

relating to the human and

environmental exposure to these

chemicals.

A notice will be published at a later

date in the Federal Register adding the

substances recommended in the ITC's

Thirty-First Report to the TSCA section

8(d) Health andSafety Data Reporting

Rule (40 CFR part 716), which requires

the reporting of unpublished health and

safety studies on the listed chemicals.

That notice will also add the chemicals

to the TSCA section 8(a) Preliminary

Assessment Information Rule (40 CFR

part 712). The section 8(a) rule requires

the reporting of production volume, use,

exposure, and release information on

the listed chemicals.

III. Status of List

The ITC's Thirty-First Report notes

the addition of one chemical group to

the Priority Testing List and the revision

of the recommendations for two

chemical groups in the Twenty-Eighth

Report. The current TSCA section 4(e)

Priority Testing List contains 24

chemicals and 24 chemical groups; 1

chemical group and 11 chemicals are

designated for priority testing

consideration.

IV. Testing Consent Agreements

1. Solicitation of Interested Parties.

EPA's procedures for requiring the

testing of chemical substances under

section 4 of TSCA at 40 CFR 790.22,

includes the adoption of enforceable

consent agreements and the

promulgation of test rules. EPA has on

numerous occasions been approached

by chemical companies interested in

negotiating consent agreements for

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testing ITC chemicals or chemical

groups. As a result of these requests,

EPA is now Inviting persons Interested

in participating in or monitoring negotiations on the chemicals

designated in the Thirty-First ITC

Report to notify EPA in writing. Those

who respond to this solicitation by the

deadline established in this notice will

have the status of "interested parties"

and will be afforded opportunities to

participate in the negotiation process.

These "interested parties" wil not incur

any obligations by being designated

"interested parties."

2. Solicitation of testing proposals for

consent agreement negotiations. EPA is

also now soliciting testing proposals for

a consent agreement to perform dermal

absorption testing on the 24 chemical

substances designated In the ThirtyFirst Report. Following publication of

this notice, manufacturers and/or

processors have 60 days to develop and

submit testing proposals for any of the

chemical substances designated In the

Thirty-First Report that they wish EPA

to consider as candidates for consent

agreement negotiations.

Federal scientists from a number of

the ITC's statutory and liaison

organizations including the Consumer

Product Safety Commission.

Environmental Protection Agency, Food

and Drug Administration, National

Institute for Occupational Safety and

Health, and Occupational Safety and

Health Administration, have developed

a proposed federally-harmonized test

protocol that will provide data needed

by several U. S. Government

Organizations represented on the ITC.

This proposed protocol is entitled "Protocol for in vitro Percutaneous

Absorption Studies" and is available to

the public through the TSCA Docket

Receipts and the Environmental

Assistance Division listed above. This

document should be reviewed before

submitting any testing proposals in

response to this notice.

For additional technical information

on this testing protocol contact Dr. John

D. Walker, Executive Director, TSCA

Interagency Testing Committee, (202)

260-1820.

All testing proposals submitted

should descrie the testing to be

performed and explain any deviations

from the federally harmonized test

protocol that are necessary to assure the

development of reliable percutaneous

absorption data.

EPA will review the submissions and

select the most promising submissions

as candidates for negotiation.

Submissions that fully address the ITC's

concerns will have a higher chance of

success than those that do not fully

address all data needs.

3. Negotiatibn of testing program and

development of a testing consent

agreement. EPA will follow the

negotiation procedures under 40 CFR

790.22, and to the extent feasible, the

timetable outlined in 40 CFR part 790,

Appendix A to subpart B.

In the case of the 24 substances

designated for priority testing

consideration in the Thirty-First ITC

Report. EPA believes that obtaining testing through the development of

consent agreements would be most

feasible if interested manufacturers

organized a testing consortium. Because

of the straightforward and relatively

inexpensive nature of the recommended

tests for each of the substances (i.e.,

dermal absorption tests), and the costs

to EPA and industry that would be

incurred should many consent

* agreements be pursued, EPA believes

that negotiating with an organized group

of manufacturers may be the most

efficient means to obtain the needed

testing.

For additional information about

process or negotiations contact Frank

Kover, Chief. Chemical Testing and

Information Branch. (202) 260-8130.

Authority. 15 U.S.C 2603.

Dated: April 23, 1993.

Charles K. Auer,

Director, Chemical Control Division, Office

of Pollution Prevention and Toxics.

Thirty-First Report of the TSCA

Interagency Testing Committee to the

Administrator, Environmental

Protection Agency

Summary. The Interagency Testing

Committee (ITC) was created under

Section 4(e) of the Toxic Substances

Control Act (TSCA) as an independent

advisory committee to the

Administrator of the U.S.

Environmental Protection Agency (EPA)

on setting priorities for the testing of

chemicals. The Committee maintains

the TSCA section 4(e) Priority Testing

List and transmits revisions of the List

* as a Report to the EPA Administrator at

least every 6 months for action and

publication in the Federal Register.

This Report presents the ITC's revisions

to the Priority Testing List resulting from

Its deliberations during the reporting

period May through November 1992.

This revision designates a group of 24

chemicals of regulatory interest to the

Occupational Safety and Health

Administration (OSHA) for dermal

absorption testing. Also, two groups of

chemicals previously recommended are

revised. The propylene glycol ethers

and esters group is revised by adding 2

chemicals and removing 29. The methyl

ethylene glycol ethers and esters group

is modified by removing eight

chemicals.

TABLE 1.-REVISIONS TO THE TSCA SECTION 4(E) PRIORITYTESTING UST

Group Action Date Concern

OSHA Chemicals with no dermal absoql data (listed In Table 2) ....... Designated ...... 1/93 Dermal absorption testing

Propylene glyc ete nd este rs (revised) ........................ Recommended 1/93 nrmaton solicitedl

Me e ne glyco ethers and trs (revised). ............ Recommended 1/93 Information solicited

Chapter 1-Introduction

1.1 Background. Since its creation in

1976 under Section 4(e) of the Toxic

Substances Control Act (Public Law 94-

469, 90 StaL 2003 at seq., 15 U.S.C. 2601

et seq.), the TSCA Interagency Testing

Committee (ITC) has sent 30 semiannual Reports to the Administrator of

tho U.S. Environmental Protection

Agency (EPA) to advise on setting

priorities for the testing of chemicals.

These Reports have been published in

the Federal Register and are also

available from the Committee. In this,

its Thirty-First Report the Committee

revises its Prionrty Testing List with the

addition of one groupand the revision

of two groups already on the List. A

short version of the Priority Testing List

appears at the end of this Report. The

complete Priority Testing List with all

individual chemicals in each group is

available upon request from the

Committee (address and phone number

given below) or, electronically available

on The Federal Bulletin Board (see

preamble for the phone number).

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The Committee meets monthly and

produces its Reports with the help of

staff and technical contract support

provided by EPA. Committee

membership and support personnel are

listed at the end of this Report.

Upon receipt of the ITCs Reports, the

EPA's Office of Pollution Prevention

and Toxics issues information gathering

rules under Sections 8(a) and 8(d) of

TSCA. These rules require that

manufacturers and producers submit (1)

production and exposure data and (2)

health and safety studies, respectively,

within 2 months of the rule's effective

date. These submissions are indexed

and stored in data bases by EPA and are

then available for review by the ITC and

others.

1.2 ITC's activities during this

reporting period. For the period May 28,

1992 to November 5, 1992, the ITC had

six meetings. Chemical groups

previously recommended after

nomination by the National Institute of

Occupational Safety and Health

(NIOSH) were reviewed. The individual

chemicals comprising these groups are

here modified. The ITC also accepted

the request of the Occupational Safety

and Health Administration (OSHA) to

determine testing needs for industrial

chemicals which may cause harm to

exposed workers by absorption through

the skin.

1.3. Revision of Previously

Recommended Groups. In the ITC's

Twenty-Eighth Report, groups of

propylne glycol ethers and esters and

methyl ethylene glycol ethers and esters

were added to the TSCA section 4(e)

Priority Testing List for reproductive

effects and developmental toxicity

testing based on concerns raised by

NIOSH (56 FR 41212, August 19, 1991).

NIOSH is concerned with glycol ethers

and their esters that are metabolized in

humans to known reproductive

toxicants. The original groups of glycol

ethers and esters were selected from

industrial chemicals to which workers

are exposed, and the groups were

expanded by adding structurally similar

compounds through a substructure

search of the ITC's Substructure-based

Computerized Chemical Selection

Exrt System (SuCCSES).

g this reporting period, NIOSH

commented that not all of these

chemicals are of concern because of

their possible metabolism to

reproductive toxicants. The ITC

reconsidered the individual members of

the groups. Upon review of available

metabolism data and consideration of

possible structure/activity relationships,

the ITC decided to remove some

chemicals from both groups. A chemical

was removed if: (1) it is expected to be

metabolized to tricarboxylic acid cycle

intermediates and therefore of lower

concern: (2) It is not expected to be

metabolized to reproductive toxicants;

(3) there are fewer than 1,000 workers

exposed, according to the National

Occupational Exposure Survey; or (4)

other human exposure (mostly through

consumer uses) is not considered likely.

The Consumer Product Safety

Commission (CPSC) expressed an

interest in retaining 'some of the

propylene and methyl ethylene glycol

ethers and esters on the Priority Testing

List and adding two chemicals in order

to obtain information submitted under

TSCA Sections 8(a) and 8(d). The ITC

has a concern that some of these

chemicals are likely to be used in

consumer products as replacements for

ethylene glycol ethers and has no

metabolism data available. As a result,

the ITC retains some members of both

groups on the List and adds two

chemicals.

Chapter 2-Actions taken by the ITC in

this Report

2.1 Designated chemicals. OSHAnominated chemicals for which no

dermal toxicity data are available.

L Rationale for the Designation

OSHA has established Permissible

Exposure Limits (PELs) to protect

workers from industrial chemicals. In

general, PELs are based on inhalation of

airborne dusts and vapors. In those

cases where skin absorption could be

harmful, the chemicals with PELs are

assigned "skin designations." OSHA

requested that the ITC help identify

chemicals which lack sufficient data for

OSHA to determine the need for skin

designations and to use their authority

to recommend chemicals for priority

testing consideration by EPA to obtain

these data. To assign a skin designation,

OSHA requires acute dermal studies

and sufficient dermal absorption data to

determine the total exposure of workers.

The ITC identified 24 chemicals for

which no dermal toxicity or absorption

data could be located and which are

potentially testable under TSCA. These

chemicals are listed in the following

Table 2:

TABLE 2.-OSHA CHEMICALS DESIGNATED FOR DERMAL ABSORPTION TESTING

CAS No. Chemical Name

60-29-7 ..... Ethyl other

7&45- ..... tesy alcohol

76-22-2 ..... Camphor

78-92- . eo-Butyl alcohol

TABLE 2.--OSHA CHEMICALS DESIGNATED FOR DERMAL ABSORPTION TESTING--Continued

CAS No. Chenrcal Name

79-20-9 ..... Meth acetate

97-77--8 ..... D flram

100-25-4 . p.Dlntrobenzene

105-46-4 ... seo-Butyl acetate

106-42-3 ... p-Xylene

107-31-3 ... Methy fomate

107-66-4 ... Dibutyt phosphate

108-03-2 ... 1-Nitropropane

108-87-2 ... Methylcyclohexane

109-6"... Pentane

110-83-8 ... Cyclohexene

111-84-2 ... Nonane

123-92-2 ... Isoamyl acetate

142-82-5 ... PHeptane

287-92-3 ... Cyclopentane

532-27-4 ... a-Chloroacetophenone

540-88-5 ... terl-Butyl acetate

628-63-7 ... n-Amyl acetate

7631-90-. Sodium bisulfite

7681-67-4. Sodium metabisufite

ff. Recommended Tests

The group of chemicals listed in Table

2 above are designated for dermal

absorption testing.

I. Supporting Information

In Its January 19, 1989 Air

Contaminants Rule (54 FR 2332), OSHA

stated that:

The purpose of having the skin designation

is to prevent the same toxic effects that the

chemical causes through inhalation. The

inhalation limit is based on keeping exposure

below the limit which will create a

significant risk of material impairment of

health. If skin absorption is possible, an

employee might be below the inhalation

limit; however, the additional body burden

through skin absorption may create the

material impairment which the limit

attempts to reduce.

In September 1991, OSHA presented

a list of 658 chemical substances and

mixtures (its Z-1-A Table in 54 FR

2332-2983) to the ITC to assess the

availability of dermal absorption data

and the need for testing that could be

recommended under TSCA. The ITC

reviewed the list and determined that

145 polymers, pesticides, complex

mixtures, and chlorofluorocarbons

(CFCs) are not suitable candidates for

consideration because they are not

suitable for testing, they are regulated

under other Federal authorities, or they

are not regulable under TSCA. The

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remaining chemicals were divided into

two groups based on production

volume: greater or less than I million

pounds, based on the 1989 production

figures from the EPA Inventory.

Chemicals that are vapors at ambient

temperature, are highly reactive, have

low toxicity, are members of chemical chemicals were identified as having no

groups, or have dermal LD50 values dermal toxicity data and are here

reported in the Registry of Toxic Effects . designated for dermal absorption

of Chemical Substances were identified testing. The following Figure 1 diagrams

in each of the production groups and are the selection process.

deferred for future ITC review. A group guma aoo N

of 16 high and 8 low production

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