### 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,

### 17659 Federal Register / Vol. 63, No. 68 /Thursday, April 9, 1998 / Notices

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 ethoxylates 2

.......................... Recommended 41

......................... November 1997

................. 29 Alkylphenols, alkylphenol ethoxylates, and polyalkyphenols 2

. Recommended

1 The list of discrete chemicals currently on the Priority Testing List is available from the Executive Director of the ITC.

2 Data 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 byPanel 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

### 17661 Federal Register / Vol. 63, No. 68 /Thursday, April 9, 1998 / Notices

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
C 5 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
C 6 Alkylphenols do do

2446–69–7

...................... Phenol, 4-hexyl-

.................................................................................... do do
C 7 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
C 8 Alkylphenols do do

140–66–9

........................ Phenol, 4-(1,1,3,3-tetramethylbutyl)-

.................................................... do do 71902–25–5

.................... Phenol, octenylated

.............................................................................. do do
C 9 Alkylphenols do do

68081–86–7

.................... Phenol, nonyl derivs.

............................................................................ do do 91672–41–2

.................... Phenol, 2-nonyl-, branched

.................................................................. do do
C 10 Alkylphenols do do

27157–66–0

.................... Phenol, decyl-

....................................................................................... do do
C 12 Alkylphenols do do

74499–35–7

.................... Phenol, (tetrapropenyl) derivs.

............................................................. do do
C 14 Alkylphenols do do

70682–80–3

.................... Phenol, tetradecyl-

................................................................................ do do
C 16 Alkylphenols do do

2589–78–8

...................... Phenol, 4-hexadecyl-

............................................................................ do do 25401–86–9

.................... Phenol, 2-hexadecyl-

............................................................................ do do
C 18–C 30 Alkylphenols do do

68784–24–7

.................... Phenol, C 18–C 30–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
C 8 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
C 12 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
C 13 Alkylphenol Ethoxylates do do

61723–87–3

.................... Poly(oxy-1,2-ethanediyl), α-(tridecylphenyl)- ω-hydroxy-

...................... do do
C 16 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

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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 (L 3 ) .................................................................... 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 importationvolumes 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

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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 ITCrecognizes 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 of14 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 toidentify three additional nonfluoromethyl alkyl diaryl ethers:

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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 (D 4) 541–02–6

... Decamethylcyclopentasiloxane (D 5 ) 540–97–6

... Dodecamethylcyclohexasiloxane (D 6)
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

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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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