[Federal Register Volume 65, Number 232 (Friday, December 1, 2000)]
[Notices]
[Pages 75544-75550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-30545]



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Part VI





Environmental Protection Agency





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Forty-Fifth Report of the TSCA Interagency Testing Committee to the 
Administrator, Receipt of Report and Request for Comments; Notice

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

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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.

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SUMMARY:  The Toxic Substances Control Act (TSCA) Interagency Testing 
Committee (ITC) transmitted its Forty-Fifth 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: [email protected].
    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: [email protected]

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 TSCA-covered 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: [email protected], 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.

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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 45\th\ 
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 45\th\ Report. The 45\th\ Report was received by the 
EPA Administrator on November 30, 1999, and is included in this notice. 
In the 45\th\ 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 45\th\ ITC Report which is included in this notice. In the 
45\th\ ITC Report, the ITC removed 119 chemicals from the TSCA section 
4(e) Priority Testing List. These chemicals are discussed in the 45\th\ 
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        Designated
                                                                Confidence Reference
                                                                Dose (RfD)
                                                                 Acetone
                                                                 Thiophenol
30                                    May 1992                 5 Siloxanes               Recommended
31                                    January 1993             13 Chemicals with         Designated
                                                                insufficient dermal
                                                                absorption rate data
32                                    May 1993                 16 Chemicals with         Designated
                                                                insufficient dermal
                                                                absorption rate data
35                                    November 1994            4 Chemicals with          Designated
                                                                insufficient dermal
                                                                absorption rate data
37                                    November 1995            16 Alkylphenols and 3     Recommended
                                                                alkylphenol
                                                                polyethoxylates\2\
39                                    November 1996            15 Nonylphenol            Recommended
                                                                ethoxylates and 8
                                                                alkylphenol
                                                                polyethoxylates\2\
41                                    November 1997            18 Alkylphenols, 5        Recommended
                                                                polyalkyphenols and 6
                                                                alkylphenol
                                                                polyethoxylates\2\
42                                    May 1998                 3-Amino-5-mercapto-1,2,4- Recommended
                                                                triazole\2\
42                                    May 1998                 Glycoluril\2\             Recommended
42                                    May 1998                 Methylal\2\               Recommended
42                                    May 1998                 Ethyl silicate\2\         Recommended
----------------------------------------------------------------------------------------------------------------
1 The Priority Testing List is available from the ITC's web site (http://www.epa.gov/opptintr/itc).

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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).

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[GRAPHIC] [TIFF OMITTED] TN01DE00.023


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    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 non-CBI 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 non-ionic, 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; Kirk-Othmer, 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

[[Page 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 Substructure-based 
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

[[Page 75550]]

    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: [email protected]; 
url: http://www.epa.gov/opptintr/itc.

[FR Doc. 00-30545 Filed 11-30-00; 8:45 am]
BILLING CODE 6560-50-S