75544 Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Notices

ENVIRONMENTAL PROTECTION

AGENCY

[OPPTS–41053; FRL–6399–5]

Forty-Fifth 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 Toxic Substances Control

Act (TSCA) Interagency Testing

Committee (ITC) transmitted its FortyFifth Report to the Administrator of the

EPA on November 30, 1999. In the 45th

Report, which is included with this

notice, the ITC: Describes an EPA effort

to organize mostly discrete organic

chemicals from the TSCA Inventory into

non-Confidential Business Information

(CBI) production/importation volume

categories; announces the public

availability of information on chemicals

that are being screened for persistence

and bioconcentration potential; requests

information from the manufacturers,

importers, and processors of these

chemicals; and removes 119 chemicals

from the Priority Testing List.

EPA invites interested persons to

submit written comments on the Report.

DATES: Comments, identified by docket

control number OPPTS–41053, must be

received on or before January 2, 2001.

ADDRESSES: Comments may be

submitted by mail, electronically, or in

person. Please follow the detailed

instructions for each method as

provided in Unit I. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, it is imperative

that you identify docket control number

OPPTS–41053 in the subject line on the

first page of your response.

FOR FURTHER INFORMATION CONTACT: For

general information contact: Barbara

Cunningham, Acting Director,

Environmental Assistance Division

(7408), Office of Pollution Prevention

and Toxics, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (202) 554–1404; e-mail address:

TSCA-Hotline@epa.gov.

For technical information contact:

John D. Walker, ITC Executive Director

(7401), Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (202) 260–1825; fax: (202) 260–

7895; e-mail address:

walker.johnd@epa.gov

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This notice is directed to the public

in general. It may, however, be of

particular interest to you if you

manufacture (defined by statute to

include import) and/or process TSCAcovered chemicals and you may be

identified by the North American

Industrial Classification System

(NAICS) codes 325 and 32411. Because

this notice is directed to the general

public and other entities may also be

interested, the Agency has not

attempted to describe all the specific

entities that may be interested in this

action. If you have any questions

regarding the applicability of this action

to a particular entity, consult the

technical person listed under FOR

FURTHER INFORMATION CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document or Other Related Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/.

You may also access additional

information about the ITC and the TSCA

testing program through the web site for

Office of Pollution Prevention and

Toxics (OPPT) at http://www.epa.gov/

opptintr/, or go directly to the ITC Home

Page at http://www.epa.gov/opptintr/

itc/.

2. In person. The Agency has

established an official record for this

action under docket control number

OPPTS–41053. The official record

consists of the documents specifically

referenced in this action, any public

comments received during an applicable

comment period, and other information

related to this action, including any

information claimed as CBI. This official

record includes the documents that are

physically located in the docket, as well

as the documents that are referenced in

those documents. The public version of

the official record does not include any

information claimed as CBI. The public

version of the official record, which

includes printed, paper versions of any

electronic comments submitted during

an applicable comment period, is

available for inspection in the TSCA

Nonconfidential Information Center,

North East Mall Rm. B-607, Waterside

Mall, 401 M St., SW., Washington, DC.

The Center is open from noon to 4 p.m.,

Monday through Friday, excluding legal

holidays. The telephone number for the

Center is (202) 260–7099.

C. How and to Whom Do I Submit

Comments?

You may submit comments through

the mail, in person, or electronically. To

ensure proper receipt by EPA, it is

imperative that you identify docket

control number OPPTS–41053 in the

subject line on the first page of your

response.

1. By mail. Submit your comments to:

Document Control Office (7407), Office

of Pollution Prevention and Toxics

(OPPT), Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460.

2. In person or by courier. Deliver

your comments to: OPPT Document

Control Office (DCO) in East Tower Rm.

G–099, Waterside Mall, 401 M St., SW.,

Washington, DC. The DCO is open from

8 a.m. to 4 p.m., Monday through

Friday, excluding legal holidays. The

telephone number for the DCO is (202)

260–7093.

3. Electronically. You may submit

your comments electronically by e-mail

to: oppt.ncic@epa.gov, or mail your

computer disk to the address identified

above. Do not submit any information

electronically that you consider to be

CBI. 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 standard disks in

WordPerfect 6.1/8.0 or ASCII file

format. All comments in electronic form

must be identified by docket control

number OPPTS–41053. Electronic

comments may also be filed online at

many Federal Depository Libraries.

D. How Should I Handle CBI

Information That I Want to Submit to

the Agency?

Do not submit any information

electronically that you consider to be

CBI. You may claim information that

you submit to EPA in response to this

document as CBI by marking any part or

all of that information as CBI.

Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

In addition to one complete version of

the comment that includes any

information claimed as CBI, a copy of

the comment that does not contain the

information claimed as CBI must be

submitted for inclusion in the public

version of the official record.

Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Notices 75545

Information not marked confidential

will be included in the public version

of the official record without prior

notice. If you have any questions about

CBI or the procedures for claiming CBI,

please consult the technical person

listed under FOR FURTHER INFORMATION

CONTACT.

E. What Should I Consider as I Prepare

My Comments for EPA?

We invite you to provide your views

and comments on the ITC 45th Report.

You may find the following suggestions

helpful for preparing your comments:

1. Explain your views as clearly as

possible.

2. Describe any assumptions that you

used.

3. Provide copies of any technical

information and/or data you used that

support your views.

4. Provide specific examples to

illustrate your concerns.

5. Make sure to submit your

comments by the deadline in this

notice.

6. To ensure proper receipt by EPA,

be sure to identify the docket control

number assigned to this action in the

subject line on the first page of your

response. You may also provide the

name, date, and Federal Register

citation.

II. Background

The Toxic Substances Control Act

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

authorizes the Administrator of the EPA

to promulgate regulations under TSCA

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) of TSCA directs the ITC to

revise the TSCA section 4(e) Priority

Testing List at least every 6 months.

1. The ITC’s 45th Report. The 45th

Report was received by the EPA

Administrator on November 30, 1999,

and is included in this notice. In the

45th Report, the ITC:

i. Describes an EPA effort to organize

mostly discrete organic chemicals from

the TSCA Inventory into non-CBI

production/importation volume

categories.

ii. Announces the public availability

of information on chemicals that are

being screened for persistence and

bioconcentration potential.

iii. Requests information from the

manufacturers, importers, and

processors of these chemicals.

2. Status of the Priority Testing List.

The current TSCA section 4(e) Priority

Testing List as of November 1999 can be

found in Table 1 of the 45th ITC Report

which is included in this notice. In the

45th ITC Report, the ITC removed 119

chemicals from the TSCA section 4(e)

Priority Testing List. These chemicals

are discussed in the 45th Report.

List of Subjects

Environmental protection, Chemicals,

Hazardous substances.

Dated: November 20, 2000.

Charles M. Auer,

Director, Chemical Control Division, Office

of Pollution Prevention and Toxics.

Forty-Fifth Report of the TSCA

Interagency Testing Committee to the

Administrator, U.S. Environmental

Protection Agency

Table of Contents

Summary

I. Background

II. TSCA Section 8 Reporting

A. TSCA Section 8 Rules

B. ITC’s Use of TSCA Section 8 and ‘‘Other

Information’’

C. Promoting More Efficient Use of

Information Submission Resources

D. Request to Promulgate a TSCA Section

8(d) Rule

III. ITC’s Activities During This Reporting

Period (May to November 1999)

A. Organizing TSCA Inventory Chemicals

into Production/Importation Volume

Categories

B. Screening Chemicals for Persistence and

Bioconcentration Potential

C. Soliciting Measured Bioconcentration Data

for Chemicals With BCFs >1,000

D. Soliciting Use and Exposure Information

IV. Revisions to the TSCA Section 4(e)

Priority Testing List

A. Chemicals Removed From the Priority

Testing List

1. Isocyanates

2. Aldehydes

3. Chemicals with insufficient dermal

absorption rate data

V. References

VI. TSCA Interagency Testing Committee

Summary

This is the 45th 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:

1. Describing an EPA effort to organize

mostly discrete organic chemicals from the

TSCA Inventory into non-Confidential

Business Information (CBI) production/

importation volume categories.

2. Announcing the public availability of

information on chemicals that are being

screened for persistence and

bioconcentration potential.

3. Requesting information from the

manufacturers, importers, and processors of

these chemicals by February 29, 2000.

4. Removing 119 chemicals from the

Priority Testing List.

The revised TSCA section 4(e) Priority

Testing List follows as Table 1.

TABLE 1.—THE TSCA SECTION 4(E) PRIORITY TESTING LIST (NOVEMBER 1999)1

Report Date Chemical/group Action

28 May 1991 Chemicals with Low Confidence Reference Dose (RfD) Designated

Acetone

Thiophenol

30 May 1992 5 Siloxanes Recommended

31 January 1993 13 Chemicals with insufficient dermal absorption rate data Designated

32 May 1993 16 Chemicals with insufficient dermal absorption rate data Designated

35 November 1994 4 Chemicals with insufficient dermal absorption rate data Designated

37 November 1995 16 Alkylphenols and 3 alkylphenol polyethoxylates2 Recommended

39 November 1996 15 Nonylphenol ethoxylates and 8 alkylphenol polyethoxylates2 Recommended

41 November 1997 18 Alkylphenols, 5 polyalkyphenols and 6 alkylphenol

polyethoxylates2

Recommended

42 May 1998 3-Amino-5-mercapto-1,2,4-triazole2 Recommended

42 May 1998 Glycoluril2 Recommended

42 May 1998 Methylal2 Recommended

42 May 1998 Ethyl silicate2 Recommended

1 The Priority Testing List is available from the ITC’s web site (http://www.epa.gov/opptintr/itc).

75546 Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Notices

2 Data requested through the ITC’s Voluntary Information Submissions Innovative Online Network (VISION) (see http://www.epa.gov/opptintr/

itc/vision.htm).

I. Background

The 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 to

the Priority Testing List as it determines to be

necessary and transmit them to the

Administrator together with the Committee’s

reasons for the revisions’’ (Public Law 94–

469, 90 Stat. 2003 et seq. (15 U.S.C. 2601 et

seq.)). Since its creation in 1976, the ITC has

submitted 44 semi-annual (May and

November) Reports to the EPA Administrator

transmitting the Priority Testing List and its

revisions. In 1989, the ITC began

recommending chemical substances for

information reporting, screening, and testing

to meet the data needs of its member U.S.

Government organizations. ITC Reports are

available from the ITC’s web site (http://

www.epa.gov/opptintr/itc) within a few days

of submission to the Administrator and from

http://www.epa.gov/fedrgstr after publication

in the Federal Register. The ITC meets

monthly and produces its revisions to the

Priority Testing List with administrative and

technical support from the ITC staff and

contract support provided by EPA. ITC

members and staff 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 by

the EPA Administrator 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

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 rules are

automatically promulgated by OPPT unless

requested not to do so by the ITC.

B. ITC’s Use of TSCA Section 8 and ‘‘Other

Information’’

The ITC reviews the TSCA section 8(a)

PAIR reports, TSCA section 8(d) HaSD

studies and ‘‘other information’’ that

becomes available after the ITC adds

chemicals to the Priority Testing List. ‘‘Other

information’’ includes 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,

ITC voluntary submissions, unpublished data

submitted to U.S. Government organizations

represented on the ITC, published papers, as

well as use, exposure, effects, and persistence

data that are voluntarily submitted to the ITC

by manufacturers, importers, processors, and

users of chemicals recommended by the ITC.

The ITC reviews this information and

determines if data needs should be revised,

if chemicals should be removed from the

Priority Testing List, or if recommendations

should be changed to designations.

C. Promoting More Efficient Use of

Information Submission Resources

VISION is accessible through the world

wide web (http://www.epa.gov/opptintr/itc/

vision.htm). VISION includes the Voluntary

Information Submissions Policy (VISP) and

links to the TSCA Electronic HaSD Reporting

Form (http://www.epa.gov/opptintr/

newchms/hasd.htm). The VISP provides

examples of data needed by ITC member U.S.

Government organizations, examples of

studies that should not be submitted, the 60–

, 90–, and 120–day milestones for submitting

information, guidelines for using the TSCA

Electronic HaSD Reporting Form and

instructions for electronically submitting full

studies. The TSCA Electronic HaSD

Reporting Form is used to provide electronic

information on ITC voluntary submissions,

TSCA section 8(d) studies (to meet data

needs of the ITC member U.S. Government

organizations), FYI, and TSCA section 8(e)

studies.

In conjunction with this Report, the ITC

will be announcing the public availability of

information on chemicals that are being

screened for persistence and

bioconcentration potential and requesting

specific use and exposure data for these

chemicals from the manufacturers, importers,

and processors. In addition, the ITC is

requesting measured bioconcentration data

for chemicals with estimated

bioconcentration factors (BCFs) >1,000 from

the manufacturers, importers, and processors

of these chemicals. The ITC is requesting that

the use, exposure, and bioconcentration data

be submitted before February 29, 2000,

consistent with the 90–day milestone of the

VISP (http://www.epa.gov/opptintr/itc/

visp.htm) for submitting data through the

TSCA Electronic HaSD Reporting Form.

D. Request to Promulgate a TSCA Section

8(d) Rule

The ITC encourages producers, importers,

processors, and users of its recommended

chemicals to use VISION to voluntarily

provide electronic information and establish

a dialogue with the ITC to discuss needed

data. If the ITC does not receive voluntary

electronic information submissions to meet

its data needs, then it will ask the EPA to

promulgate a TSCA section 8(d) HaSD rule to

determine if there are unpublished data to

meet those needs. The ITC strongly

encourages those companies that must

respond to a TSCA section 8(d) rule to

provide data by using the TSCA Electronic

HaSD Reporting Form. At this time, the ITC

is not adding any chemicals to the Priority

Testing List and therefore not requesting the

EPA to promulgate a TSCA section 8(d) rule.

III. ITC’s Activities During This Reporting

Period (May to November 1999)

A. Organizing TSCA Inventory Chemicals

into Production/Importation Volume

Categories

The EPA will be organizing discrete

organic chemicals from the TSCA Inventory

into non-Confidential Business Information

(CBI) production/importation volume

categories based on information submitted to

EPA under the Inventory Update Rules

(IURs). These categories could include:

Very Low Production Volume (VLPV)—no

production/importation volume data

reported to EPA.

Low Production Volume (LPV)—

production/importation volumes ≥10,000

pounds (lbs) and <100,000 lbs.

Moderate Production Volume (MPV)—

production/importation volumes ≥100,000

lbs and <1 million lbs.

High Production Volume (HPV)—

production/importation volumes ≥1 million

lbs and <1 billion lbs.

Very High Production Volume (VHPV)—

production/importation volumes ≥1 billion

lbs.

These categories are currently based on

data reported to EPA in response to the 1986,

1990, 1994, or 1998 IURs (EPA, 1986, 1990,

1994, or 1998). It should be noted that the

VLPV and LPV categories were created to

accommodate a flexible lowest-reporting

threshold. Based on the 1986, 1990, 1994,

and 1998 IURs the lowest-reporting threshold

is 10,000 lbs. However, based on a proposed

IUR, this threshold could increase to 25,000

lbs in 2002 (EPA, 1999a).

B. Screening Chemicals for Persistence and

Bioconcentration Potential

During this reporting period, the ITC

implemented strategies to screen chemicals

for persistence and bioconcentration

potential. These strategies are referred to as

Degradation Effects Bioconcentration

Information Testing Strategies (DEBITS)

because they facilitate testing for the

availability of degradation, ecological, or

human health effects and bioconcentration

information. DEBITS can be applied to any

group of discrete organic chemicals. This

Report describes the use of DEBITS to screen

discrete organic TSCA Inventory chemicals

with U.S. production or importation volumes

>10,000 lbs/year for persistence and

bioconcentration potential (Figure 1).

Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Notices 75547

75548 Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Notices

The ITC will continue to develop DEBITS

as part of an effort to screen chemicals for

potential to persist, bioconcentrate, and

cause ecological or human health effects. As

part of this effort, Structure-Activity

Relationships (SARs) are likely to be created

to predict toxicity and promote more efficient

use of chemical testing resources. SARs are

used to screen for chemicals that are

structurally related to chemicals which are

known to be toxic or for which the mode of

toxic action is known, but for which there are

few, if any, toxicity data, especially data that

are of interest to the U.S. Government

organizations represented on the ITC.

1. Incorporating non-CBI production/

importation volume categories into DEBITS.

Non-CBI production/importation volume

categories were incorporated into DEBITS to

facilitate creation of SARs that can predict

toxicity across production/importation

volume categories, e.g., predicting toxicity of

LPV or MPV chemicals from structurally

related HPV or VHPV chemicals. The nonCBI production/importation volume

categories that were incorporated into

DEBITS were developed from 1986, 1990,

and 1994 IUR data, because only these data

were available when the ITC implemented

DEBITS. These data were reported for 12,557

mostly discrete organic chemicals with

production/importation volumes >10,000 lbs

that were associated with 4 non-CBI

production/importation volume categories

(Figure 1).

The ITC recognizes the historical

significance of obtaining basic ecological

effects, environmental fate or health effects

data on chemicals with international

production or importation volumes >1

million lbs/year that was established by the

Organization for Economic Cooperation and

Development (OECD) Screening Information

Data Set (SIDS) program (http://

www.oecd.org). The ITC also recognizes the

relevance of EPA’s HPV Chemical Challenge

program (http://www.epa.gov/opptintr/

chemrtk/volchall.htm) to continue that

tradition for chemicals with U.S. production

or importation volumes >1 million lbs/year.

Nonetheless, the ITC realizes the importance

of considering chemicals in VLPV, LPV, and

MPV categories, because they are likely to

have: Even fewer basic ecological effects,

environmental fate or health effects data,

speciality chemical uses in consumer or

other end-use products, and a need for SARs

that can be used to predict persistence,

bioconcentration, or toxicity from chemicals

in HPV and VHPV categories that are related

by structure or mode of toxic action and for

which data are available or being developed

through the OECD SIDS, HPV Chemical

Challenge, and related programs.

2. Predicting persistence. The ITC used

estimates of ultimate aerobic biodegradation

potential (degradation of a chemical by

microorganisms (mostly bacteria) under

aerobic conditions to carbon dioxide and

cellular material) as a preliminary screen to

predict a chemical’s persistence in the

environment. Syracuse Research

Corporation’s BIOWIN program was used to

provide aerobic biodegradation probability

predictions (http://esc-plaza.syrres.com/

interkow/biodeg.htm). These predictions

were based on expert opinions that different

structural groups could be used to estimate

a chemical’s biodegradation potential

(Boethling et al., 1994). As a criterion for

persistence, the ITC selected chemicals with

biodegradation probabilities <2 because it has

been predicted that these chemicals would

persist for at least 2–3 months in sediment,

soil, and water. This screening criterion is

more conservative than the 2–month

persistence half-life criterion used by EPA

(EPA, 1999b). Quantitative Structure Activity

Relationships (QSARs) described by Howard

et al. (2000) were used to estimate

persistence in air.

3. Screening chemicals for

bioconcentration potential. The ITC used log

octanol-water partition coefficients (log P)

values between 3–6 to select a group of nonionic, discrete organic chemicals that could

be screened for bioconcentration potential.

Log P values 3–6 were based on data of

Bintein and Devillers (1993). Syracuse

Research Corporation’s KOWWIN program

was used to provide measured and estimated

log P values (http://esc-plaza.syrres.com/

interkow/logkow.htm). The KOWWIN

program is based on data indicating that

different structural groups quantitatively

contribute to a chemical’s ability to partition

to water or octanol (Meylan and Howard,

1995).

A BCF is the ratio of the concentration of

a chemical in tissues of organisms (almost

always aquatic organisms and mostly fish) to

the concentration of a chemical in water at

steady state. Syracuse Research Corporation’s

BCFWIN program was used to provide

measured and estimated BCF values (http://

esc-plaza.syrres.com/interkow/bcfwin.htm).

The program is based on the methods of

Meylan et al. (1999). The ITC used a BCF

>1,000 to screen chemicals for

bioconcentration potential. A BCF >1,000 is

used by the EPA, International Joint

Commission (IJC) and others (EPA, 1999b;

IJC, 1993) .

Of the 12,557 chemicals with production/

importation volumes >10,000 lbs, 435 have

biodegradation probabilities <2 and log P

values of 3–6, 355 have BCFs ≤1,000 and 80

have BCFs >1,000 (Figure 1).

C. Soliciting Measured Bioconcentration Data

for Chemicals With BCFs >1,000

Of the 80 chemicals with BCFs >1,000, the

ITC will list chemicals with estimated BCFs

on its web site and provide opportunities for

manufacturers, importers, and processors of

these chemicals to voluntarily submit

measured bioconcentration data through

VISION using the TSCA Electronic HaSD

Reporting Form (see Unit II. C. of this Report

for more details). The ITC would appreciate

receiving any measured bioconcentration

data and information on methods for making

those measurements before February 29,

2000, after which time, the ITC will consider

asking EPA to promulgate a TSCA section

8(d) rule to require submission of these data.

D. Soliciting Use and Exposure Information

Several sources were searched in an

attempt to obtain use information for the 435

chemicals (Ashford, 1994; Budavari, 1996;

Clayton and Clayton, 1993–1994; KirkOthmer, 1991–1998; Lewis, 1993; Ullmann,

1985–1994). In addition, sites on the world

wide web and EPA’s Use Cluster Scoring

System were searched. Uses were identified

for only about one third of the 435 chemicals;

they were general and may not be current.

The ITC needs more specific information on

uses and exposures for many of these

chemicals to evaluate potential for

environmental releases and human

exposures, e.g., are any of the chemicals used

as on-site intermediates in closed production

processes. Without this information, the ITC

can only use production/importation volume

categories as indicators of potential

environmental releases and human

exposures.

The ITC will list chemicals for which it

needs current use and exposure information

on its web site to provide an opportunity for

manufacturers, importers, and processors of

these chemicals to voluntarily provide more

specific use and exposure information. This

information should be submitted through

VISION using section 3.2 of the TSCA

Electronic HaSD Reporting Form (see Unit II.

C. of this Report). The ITC will consider any

use and exposure information that is

submitted before February 29, 2000, after

which time, the ITC will consider asking EPA

to promulgate a TSCA section 8(a) rule to

require submission of data.

IV. Revisions to the TSCA Section 4(e)

Priority Testing List

A. Chemicals Removed From the Priority

Testing List

1. Isocyanates. In its 26th Report, the ITC

added 43 isocyanates to the Priority Testing

List and recommended them for physical and

chemical property testing based on U.S.

Government data needs (55 FR 23050, June

5, 1990). In its 35th and 37th Reports, the ITC

removed 28 and 5 isocyanates from the

Priority Testing List, respectively (59 FR

67596, December 29, 1994 (FRL–4923–2); 61

FR 4188, February 2, 1996 (FRL–4991–6)). In

its 37th Report, the ITC also solicited

consumer use information for 9 of 10

isocyanates (9 diisocyanates) remaining on

the Priority Testing List and announced that

the review of isocyanates was being

expanded from information on physical and

chemical properties to exposures, health

effects and SARs. In November 1996, the ITC

established a Dialogue Group with the

Diisocyanates Panel of the Chemical

Manufacturers Association (CMA). The Panel

provided the ITC with unpublished physical

and chemical property data and as a result

2 more isocyanates were removed from the

Priority Testing List in the ITC’s 40th Report

(62 FR 30580, June 4, 1997 (FRL–5718–3)). In

addition, the Panel provided the ITC with

extensive product use information on the

diisocyanates. At this time, the ITC is

removing the remaining eight isocyanates

from the Priority Testing List, because:

i. Two of the eight isocyanates are being

tested under the OECD SIDS program.

ii. The requested consumer use

information has been provided to the ITC.

iii. All eight isocyanates remaining on the

Priority Testing List are in the EPA’s HPV

Chemical Challenge program. The SIDS and

HPV programs are likely to provide basic

Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Notices 75549

ecological effects, environmental fate, and

health effects data for these eight isocyanates.

2. Aldehydes. In its 27th Report, the ITC

added 89 aldehydes to the Priority Testing

List and recommended them for ecological

effects testing based on U.S. Government data

needs. In addition, the ITC deferred testing

for 429 aldehydes because they had

production/importation volumes <10,000 lbs

in 1986 (56 FR 9534, March 6, 1991). In its

35th Report, the ITC removed 27 of the 89

aldehydes from the Priority Testing List. In

this 45th Report, the ITC is removing the

remaining 62 aldehydes from the Priority

Testing List because 10 of 62 aldehydes are

being tested under the OECD SIDS program,

30 are in the EPA’s HPV Chemical Challenge

program or because SARs have been created

(since the chemicals were recommended) to

predict some ecological effects

(Karabunarliev et al., 1996; Schultz et al.,

1994; Walker and Printup, 2000; Walker et

al., 2000). The SIDS and HPV programs and

SARs are likely to provide basic data for

some of these 62 aldehydes.

3. Chemicals with insufficient dermal

absorption rate data. In its 31st, 32nd, and 35th

Reports, the ITC added 24, 34, and 25

chemicals, respectively, to the Priority

Testing List and designated them for testing

to develop dermal absorption rate data based

on U.S. Government data needs (58 FR

26898, May 5, 1993; 58 FR 38490, July 16,

1993; 59 FR 67596, December 29, 1994). In

previous Reports, the ITC removed 3 of the

designated chemicals from the Priority

Testing List (59 FR 35720, July 13, 1994

(FRL–4870–4); 60 FR 42982, August 17, 1995

(FRL–4965–6)). In this 45th Report, the ITC is

removing 11, 16 and 20 chemicals (a total of

47 chemicals) from the Priority Testing List,

that were designated in the ITC’s 31st, 32nd,

and 35th Reports, respectively. The ITC is

removing 47 of the 80 chemicals on the

Priority Testing List with insufficient dermal

absorption rate data, because EPA published

a June 9, 1999, Federal Register notice (64 FR

31074) (FRL–5760–3) proposing dermal

absorption rate testing for these chemicals.

V. References

1. Ashford, R.D. (1994). Ashford’s

Dictionary of Industrial Chemicals:

Properties, Production, Uses. London,

England. Wavelength Publications Ltd.

2. Bintein, S. and Devillers, J. (1993).

Nonlinear Dependence of Fish

Bioconcentration on n-Octanol/Water

Partition Coefficient. SAR and QSAR.

Environmental Research. 1:29–39.

3. Boethling, R.S.; Howard, P.H.; Meylan,

W.M.; Stiteler, W.; Beauman, J.; and Tirado,

N. (1994). Group contribution method for

predicting probability and rate of aerobic

biodegradation. Environmental Science and

Technology. 28:459–65.

4. Budavari, S., et al (1996). The Merck

Index: An Encyclopedia of Chemicals And

Drugs. 12th Ed. Whitehouse Station, NJ.

Merck and Company, Inc.

5. Clayton, G.D. and Clayton, F.E. (1993–

1994). Patty’s Industrial Hygiene and

Toxicology. 4th Ed. John Wiley and Sons,

New York City, NY. Vol. IIA–IIF.

6. Howard, P.H.; Walker, J. D.; Boethling,

R.S.; and Meylan, W. M. (2000). Persistent,

Bioaccumulative and Toxic Substances

(PBTS): Role of Quantitative Structure

Activity Relationships (QSARs) in the

Identification of Persistent Substances. J.D.

Walker (Ed.) Handbook on Quantitative

Structure Activity Relationships (QSARs) for

Predicting Environmental Fate of Chemicals.

SETAC Press. Pensacola, FL. In Press.

7. IJC (1993). A Strategy for the Virtual

Elimination of Persistent Toxic Substances.

Vol. 1, Report of the Virtual Elimination Task

Force to the IJC.

8. Karabunarliev, S.; Mekenyan, O.G.;

Karcher, W.; Russom, C.L.; and Bradbury,

S.P. (1996). Quantum-chemical descriptors

for estimating the acute toxicity of

electrophiles to the fathead minnow

(Pimephales promelas): An analysis based on

molecular mechanisms. Quantitative

Structure-Activity Relationship. 15:302–310.

9. Kirk-Othmer Encyclopedia of Chemical

Technology. (1991–1998). 4th Ed. Vol. 1 to 25.

New York City, NY. John Wiley and Sons.

10. Lewis, R.J.S.R. (1993). Hawley’s

Condensed Chemical Dictionary. 12th Ed.

New York City, NY. Van Nostrand Reinhold

Company.

11. Meylan, W.M. and P.H. Howard.

(1995). Atom/fragment contribution method

for estimating octanol-water partition

coefficients. Journal of Pharmacological

Science. 84:83–92.

12. Meylan, W.M.; Howard, P.H.;

Boethling, R.S.; Aronson, D.; Printup, H.; and

Gouchie, S. (1999). Improved method for

estimating bioconcentration/bioaccumulation

factor from octanol/water partition

coefficient. Environmental Toxicology and

Chemistry. 18:664–672.

13. Russom, C.L.; Bradbury, S.P.; Braiders,

S.J.; Hammermeister, D.E.; and Drummond,

R.A. (1997). Predicting modes of toxic action

from chemical structure: Acute toxicity in the

fathead minnow (Pimephales Promelas).

Environmental Toxicology and Chemistry.

16(5):948–967.

14. Schultz, T. W.; Bryant, S. E.; and Lin,

D. T. 1994. Structure-toxicity relationships

for Tetrahymena: Aliphatic Aldehydes.

Bulletin of Environmental Contamination

and Toxicology. 52(2):279–285.

15. Ullmann’s Encyclopedia of Industrial

Chemistry. (1985–1994). 5th Ed. Vol. A1–A28

Deerfield Beach, FL. VCH Publishers.

16. EPA. (1986). Partial Updating of TSCA

Inventory Data Base; Production and Site

Reports. Federal Register (51 FR 21438–

21452, June 12, 1986).

17. EPA. (1990). Partial Updating of TSCA

Inventory Data Base; Production and Site

Reports; Technical Amendment. Federal

Register (55 FR 39586–39588, September 27,

1990).

18. EPA. (1994). Partial Updating of TSCA

Inventory Data Base; Production and Site

Reports; Technical Amendment. Federal

Register (59 FR 30652–30654, October 24,

1994 (FRL–4910–4)).

19. EPA. (1998). Partial Updating of TSCA

Inventory Data Base; Production and Site

Reports; Technical Amendment. Federal

Register (63 FR 45950–45953, August 28,

1998 (FRL–6028–3)).

20. EPA. (1999a). TSCA Inventory Update

Rule Amendments; Proposed Rule. Federal

Register (64 FR 46772–46812, August 26,

1999 (FRL–6097–4)).

21. EPA. (1999b). Category for persistent,

bioaccumulative and toxic new chemical

substances. Federal Register (64 FR 60194–

60204, November 4, 1999 (FRL–6097–7)).

22. Walker, J.D. and Printup, H. (2000).

Using the Substructure-based Computerized

Chemical Selection Expert System

(SuCCSES) to analyze aldehydes I.

Development of structural subclasses and

structure activity relationships (SARs). J.D.

Walker (Ed). Handbook on Quantitative

Structure Activity Relationships (QSARs) for

Predicting Ecological Effects of Chemicals.

SETAC Press. Pensacola, FL. In Press.

23. Walker, J.D.; Printup, H.;

Karabunarliev, S.H.; Mekenyan, O.G.; and

Veith, G.D. (2000). Using the Substructurebased Computerized Chemical Selection

Expert System (SuCCSES) to analyze

aldehydes II. Development of quantitative

structure activity relationships (QSARs). J.D.

Walker (Ed). Handbook on Quantitative

Structure Activity Relationships (QSARs) for

Predicting Ecological Effects of Chemicals.

SETAC Press. Pensacola, FL. In Press.

VI. TSCA Interagency Testing Committee

Statutory Organizations and Their

Representatives

Council on Environmental Quality

Brad Campbell, Member

Department of Commerce

National Institute of Standards and

Technology

Barbara C. Levin, Alternate

National Oceanographic and

Atmospheric Administration

Nancy Foster, Member

Teri Rowles, Alternate

Richard S. Artz, Alternate

Environmental Protection Agency

Paul Campanella, Member

David R. Williams, Alternate

National Cancer Institute

Harry Seifried, Member

Victor Fung, Alternate

National Institute of Environmental Health

Sciences

William Eastin, Member, Chair

H.B. Matthews, Alternate

National Institute for Occupational Safety

and Health

Albert E. Munson, Member

Mark Toraason, Alternate

National Science Foundation

A. Frederick Thompson, Member

Marge Cavanaugh, Alternate

Occupational Safety and Health

Administration

Val H. Schaeffer, Member

Lyn Penniman, Alternate

Liaison Organizations and Their

Representatives

Agency for Toxic Substances and Disease

Registry

William Cibulas, Member

Consumer Product Safety Commission

Jacqueline Ferrante, Member, Vice

Chair

Department of Agriculture

Clifford P. Rice, Member

Department of Defense

Barbara Larcom, Member

Janet Whaley, Alternate

Jose ́ Centeno, Alternate

75550 Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Notices

Department of the Interior

Barnett A. Rattner, Member

Food and Drug Administration

Raju Kammula, Member

Ronald Lorentzen, Alternate

David Hatten, Alternate

National Library of Medicine

Vera W. Hudson, Member

National Toxicology Program

NIEHS, FDA, and NIOSH Members

Counsel

Scott Sherlock, OPPT, EPA

Technical Support Contractor

Syracuse Research Corporation

ITC Staff

John D. Walker, Executive Director

Norma S. L. Williams, Executive

Assistant

TSCA Interagency Testing Committee,

Office of Pollution Prevention and Toxics

(7401), Environmental Protection Agency,

1200 Pennsylvania Ave., NW., Washington,

DC 20460; telephone: (202) 260–1825; fax:

(202) 260–7895; e-mail address:

williams.norma@epa.gov; url: http://

www.epa.gov/opptintr/itc.

[FR Doc. 00–30545 Filed 11–30–00; 8:45 am]

BILLING CODE 6560–50–S