17658 Federal Register / Vol. 63, No. 68 /Thursday, April 9, 1998 / Notices

ENVIRONMENTAL PROTECTION

AGENCY

[OPPTS–41049; FRL–5773–5]

Forty-First Report of the TSCA

Interagency Testing Committee to the

Administrator; Receipt of Report and

Request for Comments

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 Forty-First Report to the

Administrator of the EPA on November

28, 1997. In the Forty-First Report,

which is included with this notice, the

ITC revised the TSCA section 4(e)

Priority Testing List by recommending

29 alkylphenol ethoxylates,

alkylphenols, and polyalkylphenols and

removing 6 alkylphenols, 10 diaryl

ethers, and 3 siloxanes.

There are no designated or

recommended with intent-to-designate

chemicals or chemical groups in the

Forty-First Report. EPA invites

interested persons to submit written

comments on the Report.

DATES: Written comments must be

received on or before May 11, 1998.

ADDRESSES: Each comment must bear

the docket control number OPPTS–

41048. All comments should be sent in

triplicate to: OPPT Document Control

Officer (7407), Office of Pollution

Prevention and Toxics, Environmental

Protection Agency, 401 M St., SW., Rm.

G–099, East Tower, Washington, DC

20460.

Comments and data may also be

submitted electronically to: oppt.

ncic@epamail.epa.gov. Follow the

instructions under Unit IV of this

notice. No Confidential Business

Information (CBI) should be submitted

through e-mail.

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 notice. Persons

submitting information on 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.

FOR FURTHER INFORMATION CONTACT:

Susan B. Hazen, Director,

Environmental Assistance Division

(7408), Office of Pollution Prevention

and Toxics, Environmental Protection

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

DC 20460, telephone: (202) 554–1404,

TDD: (202) 554–0551, e-mail: TSCAHotline@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received the TSCA Interagency Testing

Committee’s Forty-First Report to the

Administrator.

I. Background

TSCA (Pub. L. 94–469, 90 Stat. 2003

et seq. (15 U.S.C. 260l et seq.))

authorizes the Administrator of the EPA

to promulgate regulations under section

4(a) requiring testing of chemicals and

chemical groups in order to develop

data relevant to determining the risks

that such chemicals and chemical

groups may present to health or the

environment. Section 4(e) of TSCA

established the ITC to recommend

chemicals and chemical groups to the

Administrator of the 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.

II. The ITC Forty-First Report

The most recent revisions to the

Priority Testing List are included in the

ITC’s Forty-First Report. The Report was

received by the EPA Administrator on

November 28, 1997, and is included in

this notice. Twenty-nine alkylphenol

ethoxylates, alkylphenols, and

polyalkylphenols are being

recommended because:

1. TSCA production and importation

volumes are reported in the

multimillion pound range.

2. Releases to the environment can

occur from wastewater treatment and

agricultural uses.

3. Alkylphenol ethoxylates can

degrade to alkylphenols, which can

persist in the environment and be

highly toxic to aquatic organisms.

4. Exposure to alkylphenols and

alkylphenol ethoxylates may affect

endocrine and other important human

and animal system functions.

Alkylphenol ethoxylates, alkylphenols,

and polyalkylphenols are being

recommended to determine if there are

unpublished studies that contain data to

meet the needs of the U.S. Government

organizations represented on the ITC

and to complete the list of alkylphenols

and alkylphenol ethoxylates that were

recommended in the ITC’s 37th Report

(61 FR 4188, February 2, 1996)(FRL–

4991–6), and 39th Report (62 FR 8578,

February 25, 1997)(FRL–5580–9).

III. Status of the Priority Testing List

The current TSCA section 4(e) Priority

Testing List contains 11 chemical

groups; of these, 4 chemical groups were

designated for testing.

IV. Public Record and Electronic

Submissions

The official record for this notice, as

well as the public version, has been

established for this notice under docket

control number OPPTS–41048

(including comments and data

submitted electronically as described

below). 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 12 noon

to 4 p.m., Monday through Friday,

excluding legal holidays. The official

record is located in the TSCA

Nonconfidential Information Center,

Rm. NE–B607, 401 M St., SW.,

Washington, DC.

Electronic comments can be sent

directly to EPA at:

oppt.ncic@epamail.epa.gov

Electronic comments must be

submitted as 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 5.1/6.1 or ASCII file

format. All comments and data in

electronic form must be identified by

the docket control number OPPTS–

41048. Electronic comments on this

notice may be filed online at many

Federal Depository Libraries.

List of Subjects

Environmental protection, Chemicals,

Hazardous substances.

Authority: 15 U.S.C. 2603.

Dated: April 1, 1998.

Charles M. Auer,

Director, Chemical Control Division, Office

of Pollution Prevention and Toxics.

Administrator, U.S. Environmental

Protection Agency

Summary

This is the 41st Report of the TSCA

Interagency Testing Committee (ITC) to

the Administrator of the U.S.

Environmental Protection Agency

(EPA). In this Report, the ITC is revising

its TSCA section 4(e) Priority Testing

List by recommending 29 alkylphenols,
Federal Register / Vol. 63, No. 68 /Thursday, April 9, 1998 / Notices 17659

alkylphenol ethoxylates, and

polyalkylphenols and removing 6

alkylphenols, 3 siloxanes, and 10 diaryl

ethers. The revised TSCA section 4(e)

Priority Testing List follows as Table 1.

Table 1.—The TSCA Section 4(e) Priority Testing List (November 1997)1

Report Date Chemical/Group Action

26 ......................... May 1990 ........................... 8 Isocyanates .................................................. Recommended with intent-to-designate

27 ......................... November 1990 ................. 62 Aldehydes ................................................... Recommended with intent-to-designate

28 ......................... May 1991 ........................... Chemicals with low confidence Reference

Dose (RfD).

Acetone

Thiophenol

Designated

30 ......................... May 1992 ........................... 5 Siloxanes ...................................................... Recommended

31 ......................... January 1993 ..................... 24 Chemicals with insufficient dermal absorption rate data.Designated

32 ......................... May 1993 ........................... 32 Chemicals with insufficient dermal absorption rate data.Designated

35 ......................... November 1994 ................. 24 Chemicals with insufficient dermal absorption rate data.Designated

36 ......................... May 1995 ........................... 9 High Production Volume Chemicals

(HPVCs).

Recommended

37 ......................... November 1995 ................. 22 Alkylphenols and alkylphenol ethoxylates Recommended

39 ......................... November 1996 ................. 23 Nonylphenol ethoxylates2 .......................... Recommended

41 ......................... November 1997 ................. 29 Alkylphenols, alkylphenol ethoxylates, and

polyalkyphenols2.

Recommended

1The list of discrete chemicals currently on the Priority Testing List is available from the Executive Director of the ITC. 2Data requested under the ITC’s Voluntary Information Submissions Policy described in this Report.

I. Background

The TSCA ITC was established by

section 4(e) of the Toxic Substances

Control Act (TSCA) ‘‘to make

recommendations to the Administrator

respecting the chemical substances and

mixtures to which the Administrator

should give priority consideration for

the promulgation of a rule for testing

under section 4(a).... At least every six

months..., the Committee shall make

such revisions in the Priority Testing

List as it determines to be necessary and

to transmit them to the Administrator

together with the Committee’s reasons

for the revisions’’ (Pub. L. 94–469, 90

Stat. 2003 et seq., 15 U.S.C. 2601 et

seq.). The ITC recommends chemical

substances for information reporting,

screening, and testing to meet the data

needs of its member U.S. Government

organizations. Since its creation in 1976,

the ITC has submitted 40 semi-annual

(May and November) Reports to the EPA

Administrator transmitting the Priority

Testing List and its revisions. ITC

Reports are published in the Federal

Register; they are available from http:/

/www.epa.gov/fedrgstr or the ITC. The

ITC meets monthly and produces its

revisions of the Priority Testing List

with the help of staff and technical

contract support provided by EPA. ITC

members and support personnel are

listed at the end of this Report.

II. TSCA Section 8 Reporting

A. TSCA Section 8 Rules

Following receipt of the ITC’s Report

and addition of chemicals to the Priority

Testing List, the EPA’s Office of

Pollution Prevention and Toxics (OPPT)

promulgates TSCA section 8(a)

Preliminary Assessment Information

Reporting (PAIR) and TSCA section 8(d)

Health and Safety Data (HaSD) rules for

new chemicals added to the Priority

Testing List. These rules require

producers and importers of chemicals

recommended by the ITC to submit

production and exposure reports under

TSCA section 8(a) and producers,

importers, and processors of chemicals

recommended by the ITC to submit

unpublished health and safety studies

under TSCA section 8(d). These TSCA

section 8(a) reports and section 8(d)

studies must be submitted to EPA

within 60 days of the rules’ effective

date. TSCA section 8(a) reports and 8(d)

submissions are indexed in databases

maintained by the ITC and the EPA,

respectively.

B. ITC’s Use of TSCA Section 8 Data

To determine if revisions to the

Priority Testing List are necessary, the

ITC reviews the TSCA section 8(a) and

8(d) information and other available

data on chemicals and chemical groups

(e.g., TSCA section 4(a) and 4(d) studies,

TSCA section 8(c) submissions, TSCA

section 8(e) ‘‘substantial risk’’ notices,

‘‘For Your Information’’ (FYI)

submissions to EPA, unpublished data

submitted to U.S. Government

organizations represented on the ITC,

and published papers). Revisions can

include changing recommendations to

designations, modifying

recommendations, or removing

chemicals from the Priority Testing List.

C. Policy Promoting More Efficient Use

of TSCA Section 8 Resources

In its 40th Report (62 FR 30580, June

4, 1997)(FRL–5718–3), the ITC proposed

a policy promoting more efficient use of

TSCA section 8(d) resources. The ITC

received comments on its policy from

the Chemical Manufacturers Association

(CMA) (Ref. 2, Russell, 1997). In

response to these comments, the ITC has

revised the policy, now referred to as

the ITC’s Voluntary Information

Submissions Policy (VISP).

Under the VISP, the ITC will now:

1. Request specific information

necessary to meet information needs of

U.S. Government organizations

represented on the ITC (e.g., specific

health and ecological effects data, use

information, etc.).

2. List studies that the ITC is not

requesting (e.g., studies on waste

streams).

3. Provide an opportunity for

producers, importers, processors, and

users of chemicals recommended by the

ITC or a consortium representing those

producers, importers, processors, and

users to notify the ITC Executive

Director in writing (by e-mail or letter)

that studies will be provided voluntarily

to the ITC as ITC FYI submissions. This
17660 Federal Register / Vol. 63, No. 68 /Thursday, April 9, 1998 / Notices

notification must be received within 30

days of the date the ITC Report is

published in the Federal Register.

4. Ask those producers, importers,

processors, and users of chemicals who

notify the ITC (see Unit II.C.3. of this

Report) to provide the EPA with an

electronic list (table) of studies within

60 days of the date the ITC Report is

published in the Federal Register and

ITC FYI submissions within 90 days of

the date the ITC Report is published in

the Federal Register. The electronic

table should contain columns for the

Chemical Abstracts Service (CAS)

Registry number, chemical name, study

date, study title, Document Control

Number (DCN), and a column indicating

whether the study will be submitted on

disk as a WordPerfect 6.1 file or as a

hard copy. The EPA will add DCNs to

the table and send it back to the

submitter and to the ITC Executive

Director. In addition, the EPA will send

to each submitter of the electronic table,

adhesive labels containing DCNs. These

labels should be affixed to the first page

of each ITC FYI study submitted as a

hard copy, not a document containing

multiple studies, or the first page of an

ITC FYI study printed from an

electronic copy (only a hard copy of the

first page of each electronic study

should be submitted).

5. Encourage producers, importers,

processors, and users who submit an

electronic table of studies to submit the

TSCA electronic cover sheet (including

an abstract) for each study to the EPA

within 90 days of the date the ITC

Report is published in the Federal

Register. The TSCA electronic cover

sheet is available from http://

www.epa.gov/opptintr/itc. The DCN

should be recorded on each TSCA

electronic cover sheet. CBI must not be

recorded on the TSCA electronic cover

sheet and must not be sent by e-mail.

Individual TSCA electronic cover sheets

must be sent by e-mail to

oppt.ncic@epamail.epa.gov. The EPA

will send each final TSCA electronic

cover sheet to the ITC Executive

Director. Multiple TSCA electronic

cover sheets (one for each study) can be

sent on 3 1⁄2 disks or a CD ROM; the

disks or CD ROM should be mailed to

the Document Processing Center (7407),

ET–G–099, Office of Pollution

Prevention and Toxics, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. For those

producers, importers, processors, and

users who submit a TSCA electronic

cover sheet for each study, the ITC will

extend the deadline for providing ITC

FYI submissions to 120 days from the

date the ITC Report is published in the

Federal Register.

6. Request that two hard copies of

each ITC FYI study (or preferably one

disk or CD ROM containing each study

as a WordPerfect 6.1 file) should be

mailed to the Document Processing

Center (7407), ET–G–099, Attn: FYI

Coordinator, Office of Pollution

Prevention and Toxics, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. It is not

necessary to submit cover letters for

each ITC FYI study because:

a. A TSCA electronic cover sheet

bearing a DCN would have been

submitted for each ITC FYI study.

b. The first page of the ITC FYI study

would bear the adhesive label

containing the pre-assigned DCN. EPA

will provide the ITC Executive Director

with an electronic (preferable) or hard

copy of each ITC FYI study.

III. ITC’s Dialogue Group Activities

During This Reporting Period (May

1997 to November 1997)

A. Alkylphenols and Alkylphenol

Ethoxylates

The ITC-CMA Alkylphenols and

Ethoxylates Dialogue Group was formed

by the ITC’s Alkylphenols and

Ethoxylates Subcommittee and the

CMA’s Alkylphenols and Ethoxylates

Panel. The Dialogue Group was

established in March 1996 to facilitate

the ITC’s retrieval of information on

uses, exposures, and health and

ecological effects of alkylphenols and

alkylphenol ethoxylates and the CMA’s

understanding of data needed by the

U.S. Government organizations

represented on the ITC. Since the

establishment of this Dialogue Group,

numerous activities have occurred (see

the ITC’s 38th Report (61 FR 39832, July

30, 1996)(FRL–5379–2), 39th Report (62

FR 8578, February 25, 1997)(FRL–5580–

9), and 40th Report. During this

reporting period, the Dialogue Group

met to discuss:

1. Results of a qualitative survey of

Panel member companies regarding

production or importation of

alkylphenols, alkylphenol ethoxylates,

and polyalkylphenols.

2. TSCA section 8(d) studies

submitted for alkyphenols and

alkyphenol ethoxylates recommended

in the 37th Report (FRL–4991–6) (61 FR

4188, February 2, 1996).

3. Data needs of U.S. Government

organizations represented on the ITC.

4. Ongoing and planned studies

sponsored by the Panel.

5. Development of Structure Activity

Relationships (SARs).

6. Voluntary testing processes that

might be used to provide needed data.

In its survey of member companies,

the Panel identified 29 alkylphenols,

alkylphenol ethoxylates, and

polyalkylphenols out of 74 remaining

on the Priority Testing List that were

produced, imported, or used in 1995,

but recommended that the results of this

informal survey should not be viewed as

representative of the entire industry.

The Dialogue Group acknowledged that

about 500 TSCA section 8(d) studies

were submitted in equal numbers by

Panel member companies and nonPanel member companies for the

alkylphenols and alkylphenol

ethoxylates recommended in the 37th

Report. Most of those studies provided

data on acute toxicity, dermal irritation,

or eye irritation of mixtures containing

alkylphenols and alkylphenol

ethoxylates.

The ITC members proposed studies to

address the data needs for alkylphenols

and alkylphenol ethoxylates (see Unit

IV.A.1.d. of this Report). The Panel

described planned studies that may

meet some of the data needs listed in

Unit IV.A.1.d. of this Report.

Development of SARs, voluntary testing

and uses of alkylphenols and

alkylphenol ethoxylates will be

discussed in more detail in future

Dialogue Group meetings. The Dialogue

Group acknowledged that during the

past 10 years, the Panel has sponsored

many studies to evaluate the safety of

alkylphenols and alkylphenol

ethoxylates.

B. Isocyanates

The ITC-CMA Isocyanates Dialogue

Group was formed by the ITC’s

Isocyanates Subcommittee and CMA’s

Diisocyanates Panel. The Dialogue

Group was established in November

1996 to facilitate the ITC’s retrieval of

information on uses, exposures, and

health effects of isocyanates and the

CMA’s understanding of data needed by

the U.S. Government organizations

represented on the ITC. Since the

establishment of this Dialogue Group,

numerous activities have occurred (see

the ITC’s 38th, 39th, and 40th Reports).

This Dialogue Group continues to

discuss production, commercial uses,

and health and safety data for 8 of 43

isocyanates that were recommended in

the ITC’s 26th Report (55 FR 23050,

June 5, 1990).

C. Siloxanes

The ITC-Silicones Environmental

Health and Safety Council (SEHSC)

Dialogue Group was formed by the ITC’s

Siloxanes Subcommittee and SEHSC.

This Dialogue Group was established in

March 1993 to facilitate the ITC’s

retrieval of information on uses,

exposures, and health effects of

siloxanes and the SEHSC’s
Federal Register / Vol. 63, No. 68 /Thursday, April 9, 1998 / Notices 17661

understanding of data needed by the

U.S. Government organizations

represented on the ITC. Since the

establishment of this Dialogue Group,

numerous activities have occurred (see

the ITC’s 37th, 38th, 39th, and 40th

Reports). During this reporting period,

the Dialogue Group met to discuss

ongoing reproductive effects,

biochemical toxicology,

pharmacokinetic, metabolism, and

immunology studies of siloxanes

sponsored by SEHSC member

companies. The studies sponsored by

these companies are being conducted on

5 of 56 siloxanes that were

recommended in the ITC’s 30th Report

(57 FR 30608, July 9, 1992).

IV. Revisions to the TSCA Section 4(e)

Priority Testing List

Revisions to the TSCA section 4(e)

Priority Testing List are summarized in

Table 2.

Table 2.—Revisions to the TSCA Section 4(e) Priority Testing List

CAS No. Chemical name Action Date

Alkylphenols and Alkylphenol Ethoxylates Recommended November 1997

C5 Alkylphenols do do

136–81–2 ........................ Phenol, 2-pentyl- .................................................................................. do do

3279–27–4 ...................... Phenol, 2-(1,1-dimethylpropyl)- ............................................................ do do

25735–67–5 .................... Phenol, 4-sec-pentyl- ............................................................................ do do

26401–74–1 .................... Phenol, 2-sec-pentyl- ............................................................................ do do

C6 Alkylphenols do do

2446–69–7 ...................... Phenol, 4-hexyl- .................................................................................... do do

C7 Alkylphenols do do

1987–50–4 ...................... Phenol, 4-heptyl- .................................................................................. do do

72624–02–3 .................... Phenol, heptyl derivs. ........................................................................... do do

84605–25–4 .................... Phenol, 1-methylhexyl derivs. .............................................................. do do

C8 Alkylphenols do do

140–66–9 ........................ Phenol, 4-(1,1,3,3-tetramethylbutyl)- .................................................... do do

71902–25–5 .................... Phenol, octenylated .............................................................................. do do

C9 Alkylphenols do do

68081–86–7 .................... Phenol, nonyl derivs. ............................................................................ do do

91672–41–2 .................... Phenol, 2-nonyl-, branched .................................................................. do do

C10 Alkylphenols do do

27157–66–0 .................... Phenol, decyl- ....................................................................................... do do

C12 Alkylphenols do do

74499–35–7 .................... Phenol, (tetrapropenyl) derivs. ............................................................. do do

C14 Alkylphenols do do

70682–80–3 .................... Phenol, tetradecyl- ................................................................................ do do

C16 Alkylphenols do do

2589–78–8 ...................... Phenol, 4-hexadecyl- ............................................................................ do do

25401–86–9 .................... Phenol, 2-hexadecyl- ............................................................................ do do

C18–C30 Alkylphenols do do

68784–24–7 .................... Phenol, C18–C30–alkyl derivs. ............................................................... do do

Monosubstituted Polyalkylphenols do do

68954–70–1 .................... Phenol, polyethylene derivs. ................................................................ do do

68891–67–8 .................... Phenol, polypropene derivs. ................................................................. do do

68908–55–4 .................... Phenol, polybutene derivs. ................................................................... do do

112375–88–9 .................. Phenol, polyisobutylene derivs. ............................................................ do do

112375–89–0 .................. Phenol, poly(2,4,4-trimethylpentene) derivs. ........................................ do do

C8 Alkylphenol Ethoxylates do do

9004–87–9 ...................... Poly(oxy-1,2-ethanediyl), α-(isooctylphenyl)-ω-hydroxy- ...................... do do

9063–89–2 ...................... Poly(oxy-1,2-ethanediyl), α-(octylphenyl)-ω-hydroxy- .......................... do do

C12 Alkylphenol Ethoxylates do do

9014–92–0 ...................... Poly(oxy-1,2-ethanediyl), α-(dodecylphenyl)-ω-hydroxy- ..................... do do

26401–47–8 .................... Poly(oxy-1,2-ethanediyl), α-(4-dodecylphenyl)-ω-hydroxy- .................. do do

C13 Alkylphenol Ethoxylates do do

61723–87–3 .................... Poly(oxy-1,2-ethanediyl), α-(tridecylphenyl)-ω-hydroxy- ...................... do do

C16 Alkylphenol Ethoxylates do do

59911–95–4 .................... Poly(oxy-1,2-ethanediyl), α-(4-hexadecylphenyl)-ω-hydroxy- .............. do do

Alkylphenols Removed do

1322–69–6 ...................... (1,1,3,3-Tetramethylbutyl)phenol (mixed isomers) ............................... do do

29932–96–5 .................... (1,1,3,3-Tetramethylbutyl)phenol (mixed isomers) ............................... do do
17662 Federal Register / Vol. 63, No. 68 /Thursday, April 9, 1998 / Notices

Table 2.—Revisions to the TSCA Section 4(e) Priority Testing List—Continued

CAS No. Chemical name Action Date

30105–54–5 .................... (1,1,3,3-Tetramethylbutyl)phenol (mixed isomers) ............................... do do

62744–41–6 .................... (1,1,3,3-Tetramethylbutyl)phenol (mixed isomers) ............................... do do

1300–16–9 ...................... Nonylphenol (mixed isomers) ............................................................... do do

1331–57–3 ...................... Dodecylphenol (mixed isomers) ........................................................... do do

Diaryl Ethers do do

101–84–8 ........................ 1,1’-Oxybisbenzene .............................................................................. do do

3586–14–9 ...................... 1-Methyl-3-phenoxybenzene ................................................................ do do

13826–35–2 .................... 3-Phenoxybenzenemethanol ................................................................ do do

28299–41–4 .................... 1,1’-Oxybis[methylbenzene] ................................................................. do do

28984–89–6 .................... Phenoxy-1,1’-biphenyl .......................................................................... do do

42874–96–4 .................... 2-Chloro-1-(3-methylphenoxy)-4-(trifluoromethyl)benzene ................... do do

50594–77–9 .................... 3-[2-Chloro-4-(trifluoromethyl)phenoxy] phenol, acetate ...................... do do

51632–16–7 .................... 1-(Bromomethyl)-3-phenoxybenzene ................................................... do do

63734–62–3 .................... 3-[2-Chloro-4-(trifluoromethyl)phenoxy]benzoic acid ............................ do do

72252–48–3 .................... 3-[2-Chloro-4-(trifluoromethyl)phenoxy] benzoic acid, potassium salt do do

Siloxanes do do

107–51–7 ........................ Octamethyltrisiloxane (L3) .................................................................... do do

141-62–8 ......................... Decamethyltetrasiloxane (L4) ............................................................... do do

141–63–9 ........................ Dodecamethylpentasiloxane (L5) do do

A. Chemicals Added to the Priority

Testing List

1. Alkylphenols, alkylphenol

ethoxylates, and polyalkylphenols—a.

Recommendation. Add 29 alkylphenols,

alkylphenol ethoxylates, and

polyalkylphenols to the Priority Testing

List to obtain information to meet U.S.

Government data needs.

b. Rationale for recommendation.

Twenty-nine alkylphenols, alkylphenol

ethoxylates, and polyalkylphenols are

being recommended because:

i. TSCA production and importation

volumes are reported in the multimillion pound range.

ii. Releases to the environment can

occur from wastewater treatment and

agricultural uses.

iii. Alkylphenol ethoxylates can

degrade to alkylphenols, which can

persist in the environment and be

highly toxic to aquatic organisms.

iv. Exposure to alkylphenols and

alkylphenol ethoxylates may affect

endocrine and other important human

and animal system functions.

Alkylphenols, alkylphenol ethoxylates,

and polyalkylphenols are being

recommended to determine if there are

unpublished studies that contain data to

meet the needs of the U.S. Government

organizations represented on the ITC

and to complete the list of alkylphenols

and alkylphenol ethoxylates that were

recommended in the ITC’s 37th and

39th Reports.

c. Supporting information. As noted

in the 37th, 38th, and 39th Reports, ITC

used its Substructure-based

Computerized Chemical Selection

Expert System (SuCCSES) to identify

the alkylphenols and alkylphenol

ethoxylates that were added to the

Priority Testing List. Following the SAR

rationale for adding alkylphenols and

alkylphenol ethoxylates to the Priority

Testing List that was described in the

37th Report, only 29 alkylphenols,

alkylphenol ethoxylates, and

polyalkylphenols with a single-alkyl

chain in either the para or ortho

position are being added to the Priority

Testing List in this Report. One of the

alkylphenols being added to the Priority

Testing List (4-(1,1,3,3-

tetramethylbutyl)phenol, CAS No. 140–

66–9) was added to the Priority Testing

List in the ITC’s 11th Report (47 FR

54626, December 3, 1982) and removed

from the Priority Testing List in the 13th

Report (48 FR 55674, December 14,

1983) because the producers conducted

chemical fate and aquatic toxicity

testing. It is being added to the Priority

Testing List at this time to obtain

information to meet other U.S.

Government data needs.

d. Implementation of ITC’s VISP

promoting more efficient use of TSCA

section 8(d) resources. The ITC is

implementing its VISP (to promote more

efficient use of TSCA section 8(d)

resources) for 23 nonylphenol

ethoxylates recommended in its 39th

Report and the 29 alkylphenols,

alkylphenol ethoxylates, and

polyalkylphenols added to the Priority

Testing List in this Report.

Under its VISP, the ITC requests:

1. Specific information to meet data

needs of U.S. Government organizations

represented on the ITC:

a. Fish and amphibian

multigeneration reproductive effects

data.

b. Avian acute toxicity data (oral

feeding and egg exposure studies).

c. Avain reproductive effects data.

d. Fish and wildlife field data.

e. Bioaccumulation or bioavailability

data.

f. Health effects data, including

absorption, toxicokinetics, systemic

toxicity, endocrine disruption,

reproductive effects, and

carcinogenicity data.

g. SARs to estimate effects or

degradation.

Data needs 1a–1e and 1g are also

applicable to the alkylphenols and

alkylphenol ethoxylates recommended

in the 37th Report for which the ITC has

reviewed unpublished studies

submitted under TSCA section 8(d) and

determined that they do not meet U.S.

Government data needs listed in Unit

IV.A.1.d.1.a.-g. of this Report.

2. No submissions on the following:

a. Any data on non-isomeric mixtures

containing <90% of the recommended

alkylphenols, alkylphenol ethoxylates,

or polyalkylphenols, Exception:

Absorption data.

b. Dermal irritation data.

c. Eye irritation data.

d. Corrosivity data.

e. Data on waste streams.

3. The EPA to revoke the TSCA

section 8(a) PAIR and TSCA section 8(d)

HaSD rules for the ITC’s 38th Report for

which EPA published a stay on

December 11, 1996 (61 FR 65186)( FRL–

5577–6) (Ref. 1, Fung, 1997). In its 39th

Report, the ITC eliminated the use of

alternate CAS numbers for nonylphenol

ethoxylates recommended in the 38th

Report.

4. The EPA not to promulgate TSCA

section 8(d) HaSD rules for the
Federal Register / Vol. 63, No. 68 /Thursday, April 9, 1998 / Notices 17663

nonylphenol ethoxylates recommended

in the ITC’s 39th Report and the

alkylphenols, alkylphenol ethoxylates,

and polyalkylphenols added to the

Priority Testing List in this 41st Report

(Ref. 1, Fung, 1997).

5. Producers, importers, processors,

and users of alkylphenols, alkylphenol

ethoxylates, and polyalkylphenols

recommended by the ITC in its 37th,

39th, and 41st Reports or a consortium

representing those producers, importers,

processors, and users to follow the

generic procedures listed in Unit II.C.3–

6 of this Report.

6. The EPA to promulgate (upon

receipt of a letter from the ITC Chair) a

TSCA section 8(d) HaSD rule for the

alkylphenols and alkylphenol

ethoxylates recommended in the 39th

and 41st Reports. The ITC will submit

this letter if there is no notification of

intent to submit studies or if studies

voluntarily submitted are insufficient to

satisfy data needs.

As noted in Unit III.A. of this Report,

the ITC has reviewed reports and

studies submitted in response to the

PAIR and HaSD rules promulgated for

alkylphenols and alkylphenol

ethoxylates recommended in the 37th

Report. Based on its review, the ITC

recognizes that there are many nonCMA Panel member companies that

produce, import, process, or use

alkylphenols and alkylphenol

ethoxylates. The ITC encourages all

companies to submit studies following

the procedures described in the VISP.

B. Chemicals Removed From the Priority

Testing List

1. Alkylphenols and Alkylphenol

Ethoxylates. The ITC is removing six

alkylphenols from the Priority Testing

List that were recommended in the 37th

Report. The rationales for these

removals are listed in Table 3.

Table 3.— Alkylphenols Being Removed From the Priority Testing List

CAS No. Chemical name Rationale

1322–69–6 (1,1,3,3-Tetramethylbutyl)phenol(mixed isomers) Already represented by (1,1,3,3-

tetramethylbutyl)phenol (mixed isomers) (CAS No.

27193–28–8) and no data submitted in response

to TSCA section 8(a) PAIR rule (61 FR 7421,

February 28, 1996)(FRL–4996–9) .

29932–96–5 (1,1,3,3-Tetramethylbutyl)phenol (mixed isomers) do

30105–54–5 (1,1,3,3-Tetramethylbutyl)phenol (mixed isomers) do

62744–41–6 (1,1,3,3-Tetramethylbutyl)phenol (mixed isomers) do

1300–16–9 Nonylphenol (mixed isomers) Already represented by nonylphenol (mixed isomers) (CAS No. 25154–52–3) and no data submitted in response to TSCA section 8(a) PAIR

rule (61 FR 7421, February 28, 1996).

1331–57–3 Dodecylphenol (mixed isomers) Already represented by dodecylphenol (mixed isomers) (CAS No. 27193–86–8) and no data submitted in response to TSCA section 8(a) PAIR

rule (61 FR 7421, February 28, 1996).

2. Diaryl ethers—a. Rationale for

removal. The ITC is removing 10 diaryl

ethers from the Priority Testing List

(Table 2) because:

i. There are no current U.S.

Government data needs.

ii. Routine uses are not likely to result

in environmental releases or exposures

to workers, consumers, or the general

population.

iii. There is information to predict

water solubilities, vapor pressures,

atmospheric, and aquatic half lives,

rodent acute toxicities, irritancy

potential, aquatic toxicity, and binding

to estrogen receptor(s).

b. Supporting information. In its 29th

Report (56 FR 67424, December 30,

1991), the ITC recommended a group of

14 alkyl, bromo, chloro, and hydroxymethyl diaryl ethers for physical

chemical properties, biodegradation

rate, health effects, and ecological

effects screening tests. The 14 diaryl

ethers were selected from 261 aryl

ethers (55 diaryl ethers) by using

SuCCSES. The 14 were selected because

of their potential to intercalate with

DNA (56 FR 67424, December 30, 1991).

SuCCSES is used by the ITC to identify

chemicals with shared substructures

and associated health or ecological

effects (Ref. 4, Walker, 1991; Ref. 5,

Walker, 1995). The ITC removed 4 of the

previously recommended diaryl ethers

from the Priority Testing List in its 35th

Report (59 FR 67596, December 29,

1994).

The ITC reviewed all the PAIR reports

and all the TSCA section 8(d) studies

and concluded that the 10 remaining

diaryl ethers were likely to be used as

intermediates or starting materials, but

not as end products. The ITC estimated

that these diaryl ethers should:

1. Be metabolized through ortho or

para hydroxylation.

2. Have water solubilities ≤20

milligram/liter (mg)/(L).

3. Have vapor pressures ≤2 x 10-2

millimeter Mercury (mm)(Hg)

@ 25 °C.

4. Have atmospheric-half lives <1 day.

5. Have aquatic-half lives <1 week.

6. Have low-binding affinity for

estrogen receptor(s).

To analyze existing data, the ITC

organized the 10 remaining diaryl ethers

into 2 SuCCSES categories:

1. Non-fluoromethyl diaryl ethers.

2. Trifluoromethyl diaryl ethers.

Based on available data, the ITC

estimated that non-fluoromethyl diaryl

ethers (alkyl, aryl, bromo, diaryl ether,

and hydroxymethyl diaryl ethers) would

have rodent oral LD50 values >2 gram/

kilogram (g)/(kg) and that most would

be mild irritants, be negative in an Ames

assay, have low-oncogenicity potential,

and have LC50 values <1 mg/L for

aquatic organisms. The ITC recognized

that 1-methyl-3-phenoxybenzene could

have marginal oncogenicity potential

based on a positive Ames assay and that

1-(bromomethyl)-3-phenoxybenzene

could have moderate oncogenicity

potential based on its structural

relationship to benzyl chloride, a known

alkylating agent.

During its review of data for these

chemicals, the ITC used SuCCSES to

identify three additional nonfluoromethyl alkyl diaryl ethers:
17664 Federal Register / Vol. 63, No. 68 /Thursday, April 9, 1998 / Notices

1. Phenoxytetrapropylene benzene

(mixture of isomers) (CAS No. 68938–

96–5).

2. Decylphenoxybenzene (mixture of

isomers) (CAS No. 69834–17–9).

3. 1,1’-Oxybis-benzene,

tetrapropylene derivatives (mixture of

isomers) (CAS No. 119345–02–7). At the

present time, ITC is deferring these

chemicals based on the data reviewed

for other diaryl alkyl ethers.

Based on available data, the ITC

estimated that trifluoromethyl diaryl

ethers would have rodent oral LD50

values >1 g/kg and that most would be

mild irritants, be negative in an Ames

assay, have low-moderate oncogenicity

potential and have LC50 values >1 mg/

L for aquatic organisms. The ITC

recognized that the trifluoromethyl

diaryl ethers are structurally similar to

diaryl ether herbicides except they lack

a nitro group (Acifluorfen,

Fomesafen, Lactofen, and

Oxyfluorfen) or a branched carboxylic

acid group (Verdict). The ITC is aware

of the possibility that the

trifluoromethyl diaryl ether moiety may

play a possible receptor-mediated role

in oncogenicity.

3. Silicone chemicals—a. Rationale

for removal. The ITC is removing

octamethyltrisiloxane (L3, CAS No. 107–

51–7), decamethyltetrasiloxane (L4, CAS

No. 141–62–8), and

dodecamethylpentasiloxane (L5, CAS

No. 141–63–9) from the Priority Testing

List because:

i. Annual production and importation

volumes are less than 1 million pounds.

ii. Routine uses are not likely to result

in substantial environmental releases or

human exposurures.

b. Supporting information. Fifty-six

siloxanes were recommended for health

effects testing in the ITC’s 30th Report

(57 FR 30608, July 9, 1992) to meet the

data needs of the U.S. Government

organizations represented on the ITC.

After this recommendation, the ITC’s

Siloxanes Subcommittee and the

Silicones Environmental Health and

Safety Council (SEHSC) established a

Dialogue Group to develop a TSCA Test

Submissions database (TSCATS)-

compatible computer file of physical

and chemical properties, health effects

and use data, and to develop health

effects data to meet the needs of the U.S.

Government organizations represented

on the ITC. The ITC-SEHSC computer

file has been used by other

organizations and serves as the

prototype TSCA section 8 database for

the EPA’s TSCA Electronic Commerce

Workgroup. The ITC accepted a letter of

commitment (LOC) from the SEHSC to

discuss ongoing and planned siloxanes

testing that is being conducted to meet

the data needs described in the ITC’s

30th Report (Ref. 3, SEHSC, 1996). The

testing (on the 5 siloxanes remaining on

the Priority Testing List) is being

conducted voluntarily as part of an

April 9, 1996, Memorandum of

Understanding (MOU) between EPA and

the Dow Corning Corporation; the MOU

describes a model Product Stewardship

program. The LOC provides the ITC and

SEHSC member companies the

opportunity to discuss protocols,

planned and ongoing studies, and to

meet as often as necessary with Dow

Corning Corporation and the SEHSC

until the testing program has been

completed.

As a result of continuing discussions,

the ITC removed 43 of the previously

recommended siloxanes chemicals from

the Priority Testing List in its 37th

Report and five siloxanes from the

Priority Testing List in its 39th Report.

The ITC is removing three linear

siloxanes (L3, L4, and L5) from the

Priority Testing List in this Report

(Table 2). L3, L4, and L5 have annual

production and import volumes less

than 1 million pounds and are used

primarily for industrial and/or

commercial applications such as solvent

cleaning, carriers, water displacement,

and polyurethane foam blowing that are

not likely to result in substantial

environmental releases or human

exposures.

The five siloxanes remaining on the

Priority Testing List are shown in Table

4.

Table 4.—Siloxanes Remaining on

the Priority Testing List

CAS No. Chemical name

Cyclic Siloxanes

556–67–2 ... Octamethylcyclotetrasiloxane

(D4)

541–02–6 ... Decamethylcyclopentasiloxane

(D5)

540–97–6 ... Dodecamethylcyclohexasiloxane (D6)

Linear Siloxanes

107–46–0 ... Hexamethyldisiloxane (L2)

Polymers

63148–62–9 Dimethyl silicones and

siloxanes

V. References

1. Fung, V.A. September 15, 1997,

letter from Dr. Victor A. Fung, ITC

Chairperson to the Honorable Carol M.

Brown, Administrator, U.S.

Environmental Protection Agency, 401

M St., SW., Washington, DC.

2. Russell, S. July 7, 1997, E-mail from

Steven Russell, Esq. to Dr. John D.

Walker. ‘‘Comments of the Chemical

Manufacturers Association on the 40th

Report of the TSCA Interagency Testing

Committee before the U.S.

Environmental Protection Agency.’’.

3. SEHSC. July 26, 1996, Letter of

Commitment from Bill Smock,

Executive Director, SEHSC, 1767

Business Center Drive, Suite 302,

Reston, VA to John Walker, Executive

Director, ITC, U.S. Environmental

Protection Agency (7401), 401 M St.,

SW., Washington, DC.

4. Walker, J.D. Chemical selection by

the TSCA Interagency Testing

Committee: Use of computerized

substructure searching to identify

chemical groups for health effects,

chemical fate and ecological effects

testing. The Science of the Total

Environment 109/110:691–700 (1991).

5. Walker, J.D. Estimation Methods

Used by the TSCA Interagency Testing

Committee to Prioritize Chemicals for

Testing: Exposure and Biological Effects

Scoring and Structure Activity

Relationships. Toxicology Modeling

1:123–141 (1995).

VI. TSCA Interagency Testing

Committee

Statutory Organizations and Their

Representatives

Council on Environmental Quality

Brad Campbell, Member

Douglas Sanders, Alternate

Department of Commerce

Edward White, Member

Environmental Protection Agency

Paul Campanella, Member

David R. Williams, Alternate

National Cancer Institute

Victor Fung, Member, Chair

Harry Seifried, Alternate

National Institute of Environmental Health

Sciences

William Eastin, Member, Vice Chair

H.B. Matthews, Alternate

National Institute for Occupational Safety

and Health

Albert E. Munson, Member

Christine Sofge, Alternate

National Science Foundation

Linda Duguay, Member

Occupational Safety and Health

Administration

Lyn Penniman, Member

Liaison Organizations and Their

Representatives

Agency for Toxic Substances and Disease

Registry

William Cibulas, Member

Consumer Product Safety Commission

Val H. Schaeffer, Member

Lakshmi C. Mishra, Alternate

Department of Agriculture
Federal Register / Vol. 63, No. 68 /Thursday, April 9, 1998 / Notices 17665

Clifford P. Rice, Alternate

Department of Defense

David A. Macys, Member

Department of the Interior

Barnett A. Rattner, Member

Food and Drug Administration

Edwin J. Matthews, Member

Raju Kammula, Alternate

National Library of Medicine

Vera Hudson, Member

National Toxicology Program

NIEHS, FDA, and NIOSH Members

Counsel

Mary Ellen Levine, Office of General

Counsel, EPA

Technical Support Contractor

Syracuse Research Corporation

ITC Staff

John D. Walker, Executive Director

Norma S.L. Williams, Executive

Assistant

TSCA Interagency Testing Committee,

U.S. EPA/OPPT (MC/7401) 401 M St.,

SW., Washington, DC 20460, Phone:

202–260–1825, Fax: 202–260–7895, Email: walker.johnd@epamail.epa.gov.

[FR Doc. 98–9396 Filed 4–8–98; 8:45 am]

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