[Federal Register Volume 65, Number 232 (Friday, December 1, 2000)]
[Notices]
[Pages 75552-75561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-30546]



[[Page 75551]]

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Part VII





Environmental Protection Agency





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Forty-Sixth 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

[[Page 75552]]


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ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-41054; FRL-6594-7]


Forty-Sixth 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-Sixth Report to the Administrator 
of the EPA on May 25, 2000. In the 46\th\ Report, which is included 
with this notice, the ITC: Solicits information on uses, exposures, 
ecological effects, environmental fate, and health effects on 3 classes 
of structurally related chemicals (4 polychlorophenols and 
polychlorobenzenethiols, 8 chlorotrifluoromethylphenoxy benzenes, and 
50 perfluorinated chemicals) that have potential to persist and 
bioconcentrate; requests more detailed exposure and use information be 
included in the TSCA Electronic Hazard and Safety Data Reporting Form; 
adds 8 nonylphenol polyethoxylate degradation products to the Priority 
Testing List; and removes 4 alkylphenols and 15 alkylphenol ethoxylates 
from the Priority Testing List.
    EPA invites interested persons to submit written comments on the 
Report.

DATES:  Comments, identified by docket control number OPPTS-41054, 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-41054 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: <a href="/cdn-cgi/l/email-protection#5400071715791c3b20383d3a31143124357a333b22"><span class="__cf_email__" data-cfemail="0c585f4f4d21446378606562694c697c6d226b637a">[email protected]</span></a>.
    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: <a href="/cdn-cgi/l/email-protection#681f0904030d1a46020700060c280d1809460f071e"><span class="__cf_email__" data-cfemail="6c1b0d0007091e4206030402082c091c0d420b031a">[email protected]</span></a>.

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 the 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-41054. 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 Confidential Business Information (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-41054 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: <a href="/cdn-cgi/l/email-protection#6f001f1f1b41010c060c2f0a1f0e41080019"><span class="__cf_email__" data-cfemail="355a4545411b5b565c56755045541b525a43">[email protected]</span></a>, 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-41054. 
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

[[Page 75553]]

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. 
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 46\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 46\th\ Report. The 46\th\ Report was received by the 
EPA Administrator on May 25, 2000, and is included in this notice. In 
the 46\th\ Report, the ITC:
    i. Solicits information on uses, exposures, ecological effects, 
environmental fate, and health effects on 3 classes of structurally 
related chemicals (4 polychlorophenols and polychlorobenzenethiols, 8 
chlorotrifluoromethylphenoxy benzenes, and 50 perfluorinated chemicals) 
that have potential to persist and bioconcentrate.
    ii. Requests more detailed exposure and use information be included 
in the TSCA Electronic Hazard and Safety Data Reporting Form.
    2. Status of the Priority Testing List. The current TSCA section 
4(e) Priority Testing List as of May 2000 can be found in Table 1 of 
the 46\th\ ITC Report which is included in this notice. In the 46\th\ 
ITC Report, the ITC added 8 nonylphenol polyethoxylate degradation 
products and removed 4 alkylphenols and 15 alkylphenol ethoxylates from 
the Priority Testing List.

 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-Sixth 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 (November 1999 to 
April 2000): Information Solicitations
A. Polychlorophenols and Polychlorobenzenethiols
B. Chlorotrifluoromethylphenoxy Benzenes
C. Perfluorinated Chemicals
IV. Revisions to the TSCA Section 4(e) Priority Testing List
A. Chemicals Added to the Priority Testing List: Nonylphenol 
Polyethoxylate Degradation Products
B. Chemicals Removed from the Priority Testing List: Alkylphenols 
and Alkylphenol Ethoxylates
V. References
VI. The TSCA Interagency Testing Committee

Summary

    This is the 46<SUP>th</SUP> Report of the TSCA Interagency 
Testing Committee (ITC) to the Administrator of the U.S. 
Environmental Protection Agency (USEPA). The ITC described 
Degradation Effects Bioconcentration Information Testing Strategies 
(DEBITS) in its 45<SUP>th</SUP> Report as strategies to test for the 
availability of degradation, ecological or human health effects, and 
bioconcentration information for chemicals with potential to 
persist, bioconcentrate, and cause ecological or health effects. The 
ITC implemented DEBITS to identify three classes of structurally 
related chemicals that have potential to persist and bioconcentrate. 
These three classes (and number of chemicals associated with each 
class in parentheses) include polychlorophenols and 
polychlorobenzenethiols (4), chlorotrifluoromethylphenoxy benzenes 
(8), and perfluorinated chemicals (50). In this Report the ITC is:
    1. Soliciting uses, exposures, ecological effects, environmental 
fate, and health effects information on these three classes.
    2. Requesting more detailed exposure and use information be 
included in the TSCA Electronic Hazard and Safety Data Reporting 
Form.
    3. Adding 8 nonylphenol polyethoxylate degradation products to 
the Priority Testing List.
    4. Removing 4 alkylphenols and 15 alkylphenol ethoxylates 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 (May 2000)
----------------------------------------------------------------------------------------------------------------
               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            10 Alkylphenols and 2     Recommended
                                                                alkylphenol
                                                                polyethoxylates
39                                    November 1996            8 Nonylphenol             Recommended
                                                                ethoxylates

[[Page 75554]]

 
41                                    November 1997            18 Alkylphenols, 5        Recommended
                                                                polyalkylphenols and 6
                                                                alkylphenol
                                                                polyethoxylates*
42                                    May 1998                 3-Amino-5-mercapto-1,2,4- Recommended
                                                                 triazole*
42                                    May 1998                 Glycoluril*               Recommended
42                                    May 1998                 Methylal*                 Recommended
42                                    May 1998                 Ethyl silicate*           Recommended
46                                    May 2000                 8 Nonylphenol             Recommended
                                                                polyethoxylate
                                                                degradation products*
----------------------------------------------------------------------------------------------------------------
* 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 45 
semi-annual (May and November) Reports to the EPA Administrator 
transmitting the Priority Testing List and its revisions. 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, ITC members, and their U.S. Government 
organizations 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 and from 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

    The Voluntary Information Submissions Innovative Online Network 
(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/.er/
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 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 submissions, 
and TSCA section 8(e) studies.
    In its 45<SUP>th</SUP> Report, the ITC stated that use and 
exposure information should be submitted through VISION using 
section 3.2 of the TSCA Electronic HaSD Reporting Form (Confidential 
Business Information (CBI) should NOT be submitted on the TSCA 
Electronic HaSD Reporting Form). Since then the ITC Director has 
received numerous requests to provide more details on the type of 
use and exposure information needed by the ITC. In response to these 
requests, the ITC asked EPA to include the following use and 
exposure information in section 3.2 of the TSCA Electronic HaSD 
Reporting Form:
    <bullet> Manufacturing or processing procedures (batch, 
continuous, closed, open, etc.).
    <bullet> Product (raw-material, site-limited intermediate, end-
use, etc.).
    <bullet> Type of end use (consumer product, industrial product, 
consumer and industrial product).
    <bullet> Percent of chemical in end-use product.
    <bullet> Average concentrations in air, water and soil within 
the borders of manufacturing and processing facilities.
    <bullet> Number of people likely to be exposed during chemical 
manufacturing and average exposure concentrations.
    <bullet> Number of people likely to be exposed during chemical 
processing and average exposure concentrations.
    <bullet> Number of people likely to be exposed during chemical 
use and average exposure concentrations.

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.

III. ITC's Activities During This Reporting Period (November 1999 to 
April 2000): Information Solicitations

    In its 45<SUP>th</SUP> Report, the ITC discussed its strategies 
to screen chemicals for persistence and bioconcentration potential 
(http://www.epa.gov/opptintr/itc). These strategies are referred to 
as Degradation Effects Bioconcentration Information Testing 
Strategies (DEBITS). DEBITS provides a means to prioritize chemicals 
based on degradation, ecological or human health effects, and 
bioconcentration information. Briefly the ITC screened 12,557 
chemicals and used criteria to identify 435 chemicals with potential 
to persist and bioconcentrate (see Figure 1 in 45<SUP>th</SUP> 
Report).
    Since the 45<SUP>th</SUP> Report was delivered to the EPA 
Administrator on November 30, 1999, the ITC used DEBITS to further 
prioritize these 435 chemicals. The ITC used DEBITS to identify a 
subset of 112 chemicals with bioconcentration factors (BCFs) >250. 
These and structurally related chemicals with BCF <250 were placed 
in chemical classes and screened for the existence of ecological 
effects, health effects, and environmental fate

[[Page 75555]]

data. A BCF of 250 has been used by the EPA as a lower ``threshold'' 
to identify substances with potential to bioconcentrate. From these 
112 chemicals, the ITC reviewed 42 chemicals which had BCF >250 and 
production/importation volumes between 100,000 and 1,000,000 pounds 
reported in response to the 1986, 1990, 1994, or 1998 EPA Inventory 
Update Rules. The ITC is interested in identifying structurally 
related classes of chemicals for testing which have a suspicion of 
toxicity but lack adequate screening data. The ITC is also 
interested in utilizing Structure Activity Relationships (SARs) to 
predict the toxicity of untested chemicals in these structural 
classes. Although High Production Volume (HPV) chemicals with 
production/importation volumes >1,000,000 pounds are expected to 
have screening data developed as part of the EPA's HPV Chemical 
Challenge (http://www.epa.gov/opptintr/chemrtk/volchall.htm) and 
OECD SIDS (http://www.oecd.org/) programs, they were included in 
groups of structurally related chemicals in order to provide 
additional opportunities to develop SARs. In a few instances, 
stucturally related chemicals not previously identified by DEBITS 
were also included in a chemical class, if there were data useful 
for establishing SARs.
    In this reporting period, three classes of chemicals:
    1. Polychlorophenols and polychlorobenzenethiols.
    2. Chlorotrifluoromethylphenoxy benzenes.
    3. Perfluorinated chemicals have emerged from DEBITS as classes 
of specific interest.
    The ITC is seeking information on uses, exposures, health 
effects, and ecological effects from the manufacturers, importers, 
and processors of those chemicals in order to determine whether any 
of them should be added to the Priority Testing List. It is 
requested that solicited information be electronically submitted 
before August 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. DEBITS will 
continue to be implemented in the future to prioritize chemicals 
with potential to persist and bioconcentrate.

A. Polychlorophenols and Polychlorobenzenethiols

    1. Background. Polychlorophenols and polychlorobenzenethiols 
includes pentachlorothiophenol (Chemical Abstract Service (CAS) 
number (No.) 133-49-3) and tetrachloropyrocatechol (CAS No. 1198-55-
6). Pentachlorothiophenol is one of the 42 chemicals with BCF >250 
and production/importation volume between 100,000 and 1,000,000 
pounds. Tetrachloropyrocatechol is one of the 435 chemicals that 
satisfy the DEBITS production/importation, persistence, and 
bioconcentration potential criteria described by the ITC in its 
45<SUP>th</SUP> Report. The ITC used available data for 2 
structurally related chemicals, pentachlorophenol (CAS No. 87-86-5) 
and hexachlorobenzene (CAS No. 118-74-1), to evaluate suspicion of 
potential ecological and health effects of pentachlorothiophenol and 
tetrachloropyrocatechol.
    Pentachlorothiophenol meets the DEBITS criteria; it has an 
ultimate predicted aerobic biodegradation rate of >2-3 months and an 
estimated log octanol-water partition coefficient of 5.91, and an 
estimated BCF of 7,066.There are limited health effects data on 
pentachlorothiophenol except mild eye irritation in the standard 
Draize test and an intraperitoneal LD<INF>50</INF> of 100 milligram/
kilogram (mg/kg) in mice. The ITC has no ecological effects data on 
pentachlorothiophenol. However, pentachlorothiophenol is a 
metabolite of hexachlorobenzene and pentachlorophenol. It is formed 
as a result of glutathione conjugation (Hahn et al, 1988, 1989; 
Linko et al, 1986; Mehendale et al, 1975; Rozman et al, 1977). It 
has been detected in the urine of human populations exposed to 
hexachlorobenzene (To-Figueras et al., 1992, 1997). The 
carcinogenicity, reproductive effects, and development toxicities of 
pentachlorophenol and hexachlorobenzene are well known (ATSDR, 1996; 
Chhabra et al., 1999). The ITC believes pentachlorothiophenol may 
present a suspicion of toxicity given the metabolic relationship and 
structural similarity to hexachlorobenzene and pentachlorophenol.
    Tetrachloropyrocatechol also meets the DEBITS criteria; it has 
an ultimate predicted aerobic biodegradation rate of >2-3 months and 
an estimated log octanol-water partition coefficient of 4.29, and a 
measured BCF of 316-5,011.There is very little known about the 
health effects of tetrachloropyrocatechol, except for severe eye 
irritation in the Draize tests and an oral LD<INF>50</INF> in mice 
of 318 mg/kg. However, tetrachloropyrocatechol is a metabolite of 
pentachlorophenol. A fathead minnow LC<INF>50</INF> value of 1 mg/
Liter (L) (highly toxic) from 96-hour flow-through tests has been 
reported (Russom et al., 1997) and six TSCA section 8(d) studies 
were submitted where tetrachloropyrocatechol was a component of the 
test substance, biologically treated bleached kraft mill effluent. 
It is predicted to inhibit cellular respiration as an uncoupler of 
oxidative phosphorylation. The ITC believes tetrachloropyrocatechol 
may present a suspicion of toxicity given the metabolic relationship 
and structural similarity to pentachlorophenol.
    Information Profiles for pentachlorothiophenol and 
tetrachloropyrocatechol are posted on the ITC's web site (http://www.epa.gov/opptintr/itc).
    2. Information needs. The ITC needs more information on uses and 
data on exposures, environmental releases, pharmacokinetics, 
subchronic toxicity, reproductive and developmental effects, 
carcinogenicity, and ecological effects for pentachlorothiophenol 
and tetrachloropyrocatechol. The ITC also needs mutagenicity data 
for pentachlorothiophenol. If the information is not voluntarily 
obtained, the ITC will consider adding these chemicals to the 
Priority Testing List in its next Report to the EPA Administrator so 
that final TSCA section 8(a) and 8(d) rules are promulgated by EPA.

B. Chlorotrifluoromethylphenoxy Benzenes

    1. Background. The chlorotrifluoromethylphenoxy benzenes is a 
structural class of eight chemicals that satisfy the DEBITS 
persistence and bioconcentration potential and production/
importation criteria described by the ITC in its 45<SUP>th</SUP> 
Report (Table 2). Four of the chlorotrifluoromethylphenoxy benzenes 
are among the 42 chemicals with BCF >250 and production/importation 
volume between 100,000 and 1,000,000 pounds; p-toluidine, 5-
chloro-.alpha.,.alpha.,.alpha.-trifluoro-2-nitro-N-phenyl (CAS No. 
1806-24-2) has a production/importation volume <100,000 pounds.

                                                     Table 2.--Chlorotrifluoromethylphenoxy Benzenes
--------------------------------------------------------------------------------------------------------------------------------------------------------
             CAS No.                         Chemical name                   HPV\2\           Estimated BCF      Fish\3\ LC<INF>50</INF> mg/L   NO<INF>2</INF> on benzene ring
--------------------------------------------------------------------------------------------------------------------------------------------------------
1806-24-2                         p-Toluidine, 5-chloro-              No                   2380                 2.22                 Yes
                                   .alpha.,.alpha.,.alpha.-trifluoro-
                                   2-nitro-N-phenyl
42874-63-5                        Phenol, 5-[2-chloro-4-              No                   879                                       Yes
                                   (trifluoromethyl)phenoxy]-2-nitro-
 
42874-96-4                        Benzene, 2-chloro-1-(3-             No                   2696                 1.96                 No
                                   methylphenoxy)-4-
                                   (trifluoromethyl)-
77501-63-4                        5-(2-Chloro-4-                      No                   1009                                      Yes
                                   (trifluoromethyl)phenoxy)-2-nitro-
                                   2-ethoxy-1-methyl-2-oxoethyl
                                   ester (lactofen)\1\
88185-22-2                        Benzoic acid, 3-[2-chloro-4-        No                   1692                 0.668                No
                                   (trifluoromethyl)phenoxy]-, 2-
                                   ethoxy-1-methyl-2-oxo
50594-44-0                        Phenol, 5-(2-chloro-4-              Yes                  362                  0.39                 Yes
                                   (trifluoromethyl)phenoxy)-2-nitro-
                                   , acetate\1\
50594-77-9                        Phenol, 3-(2-chloro-4-              Yes                  500                  0.17                 No
                                   (trifluoromethyl)phenoxy-),
                                   acetate\1\
63734-62-3                        Benzoic acid,3-(2-chloro-4-         Yes                  3                    2.20                 No
                                   (trifluoromethyl)phenoxy)-\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 The ITC is not soliciting information on lactofen (077501-63-4) or HPV chemicals; ITC is relying on information from EPA's HPV chemical challenge
  program to provide data on HPV category chemicals.

[[Page 75556]]

 
2 HPV = High Production Volume; chemicals with U.S. production/importation volumes >1 million pounds, e.g., those chemicals in EPA's HPV chemical
  challenge program (http://www.epa.gov/opptintr/chemrtk/volchall.htm).
3 Fish LC<INF>50</INF> data are all from 96-hour flow though tests with fathead minnows using measured chemical concentrations.

    One member of the class, lactofen (CAS No. 77501-63-4) is a 
well-studied herbicide, considered to be a probable human carcinogen 
by the USEPA. Lactofen or 5-(2-chloro-4-(trifluoromethyl)phenoxy)-2-
nitro-2-ethoxy-1-methyl-2-oxo ethyl ester was found to increase the 
incidence of liver tumors in CD-1 mice and hepatic neoplastic 
nodules and preneoplastic focii in Sprague-Dawley rats (PPG 
Industries, 1985a,b). On the basis of these findings, the USEPA 
concluded that lactofen met the critieria of a category B2 probable 
human carcinogen (http://ace.orst.edu/cgi-bin/mfs/01/pips/lactofen.htm). A number of other hepatic, renal, and hematologic 
effects have been reported in CD-1 mice, Sprague-Dawley rats, and 
beagle dogs after repeated dosing. Lactofen caused developmental 
effects in a 2-generation reproductive study using CD rats (PPG 
Industries, 1983) and when fed to pregnant Sprague-Dawley rats (PPG 
Industries, 1982). Lactofen was administered in the diet for all 
these studies. Mixed results have been obtained in genotoxicity 
testing. As a result of the oncogenicity and other adverse health 
effects associated with lactofen, there is a heightened concern for 
potential toxicity of the other seven chlorotrifluoromethylphenoxy 
benzenes which have not been as extensively investigated.
    Six chlorotrifluoromethylphenoxy benzenes had fish 
LC<INF>50</INF> values; all were less than or equivalent to about 1 
mg/L; chemicals with LC<INF>50</INF> values 1 mg/L are considered 
``highly toxic'' to aquatic organisms. Four 
chlorotrifluoromethylphenoxy benzenes had a nitro group on the 
benzene ring (Table 2). Estimates from the EPA's Cancer Expert 
System (Lai et al.,1996; Woo et al., 1995, 1998) suggested that 
chlorotrifluoromethylphenoxy benzenes with a nitro group on the 
benzene ring might have higher carcinogenicity potential than 
chlorotrifluoromethylphenoxy benzenes with no nitro group on the 
benzene ring. Data are needed to validate these suggestions. In 
addition, the ITC has determined that health effects data are 
indexed in TOXLINE or the Registry of Toxic Effects of Chemical 
Substances (RTECS) for three chlorotrifluoromethylphenoxy benzenes: 
Phenol, 5-(2-chloro-4-(trifluoromethyl)phenoxy)-2-nitro- (CAS No. 
42874-63-5); phenol, 3-(2-chloro-4-(trifluoromethyl)phenoxy)-, 
acetate (CAS No. 50594-77-9); and benzoic acid, 3-(2-chloro-4-
(trifluoromethyl)phenoxy)- (CAS No. 63734-62-3). For the latter 2 
chlorotrifluoromethylphenoxy benzenes acute and genetoxicity studies 
were submitted to the EPA as a result of a TSCA section 8(d) rule 
that was promulgated for the chlorotrifluoromethylphenoxy benzenes 
(CAS No. 42874-96-4, 50594-77-9, and 63734-62-3) that were 
previously added to the Priority Testing List in the ITC's 
29<SUP>th</SUP> Report published in the Federal Register of December 
30, 1991 (56 FR 67424) (FRL-4007-6) as trifluoromethyl diaryl ethers 
and then removed from the Priority Testing List in the 
41<SUP>st</SUP> Report published in the Federal Register of April 9, 
1998 (63 FR 17658) (FRL-5773-5). TOXLINE, RTECS, and TSCA section 
8(d) studies for phenol, 5-(2-chloro-4-(trifluoromethyl)phenoxy)-2-
nitro- (CAS No. 42874-63-5); phenol, 3-(2-chloro-4-
(trifluoromethyl)phenoxy)-, acetate (CAS No. 50594-77-9); and 
benzoic acid, 3-(2-chloro-4-(trifluoromethyl)phenoxy)- (CAS No. 
63734-62-3) have been considered by the ITC. An Information Profile 
for 5-(2-chloro-4-(trifluoromethyl)phenoxy)-2-nitro- is posted on 
the ITC's web site (http://www.epa.gov/opptintr/itc).
    2. Information needs. The ITC needs information on uses, 
exposures, environmental releases, ecological effects, 
pharmacokinetics, subchronic toxicity, reproductive and 
developmental effects, mutagenicity, and carcinogenicity for four 
chlorotrifluoromethylphenoxy benzenes, except lactofen and the three 
HPV chemicals (Table 2). If the information is not voluntarily 
obtained, the ITC will consider adding these chemicals to the 
Priority Testing List in its next Report to the EPA Administrator, 
so that final TSCA section 8(a) and 8(d) rules are promulgated by 
EPA.

C. Perfluorinated Chemicals

    1. Background. The ITC is interested in 50 perfluorinated 
chemicals, because:
    i. The carbon-fluorine bond is highly stable and likely to 
persist.
    ii. There is potential for long-range atmospheric transport, 
persistence, bioconcentration, and bioaccumulation.
    iii. There are few publicly available data on ecological 
effects, health effects, wildlife exposures, or human exposures.
    Forty-eight perfluorinated chemicals were assigned to 10 
structural classes while two did not fit any structural class. 
Thirty-eight perfluorinated chemicals satisfy the DEBITS persistence 
(ultimate biodegradation >2-3 months) and bioconcentration potential 
(log octanol-water partition coefficient 3-6) and production/
importation criteria described by the ITC in its 45<SUP>th</SUP> 
Report. An additional 12 (identified by an asterisk in Tables 3, 4, 
7, 10, and 11) were selected from TSCA section 8(e) submissions 
because they were structurally related to the 38 perfluorinated 
chemicals and may be useful in developing SARs. The 12 structurally 
related perfluorinated chemicals from TSCA section 8(e) submissions 
include chemicals that:
    i. Are present in human and animal blood.
    ii. Are pesticide active ingredients.
    iii. Cause tumors and developmental toxicity in animal studies.
    iv. Are metabolites of the 38 perfluorinated chemicals that 
satisfy the DEBITS criteria.
    Estimated BCFs and Henry's Law Constants (HLCs) for 
perfluorinated chemicals were based on associated or non-hydrolyzed 
chemical structures. Estimated BCFs for the 50 perfluorinated 
chemicals range from 3 to 26,000. HLCs ranged from 10<SUP>3</SUP> to 
10<SUP>-</SUP>\10\ atm m<SUP>3</SUP>/mole. Approximately half of the 
perfluorinated chemicals had estimated HLCs 
><SUP>10</SUP><SUP>-</SUP>\2\ atm m<SUP>3</SUP>/mole, suggesting 
they could evaporate and be susceptible to long-range transport. The 
perfluoroalkyl iodides are likely to undergo rapid photolysis in the 
atmosphere, leading to possibly long-lived degradation products. 
Estimated BCFs and HLCs for perfluorinated chemicals are listed in 
Tables 3-13. Information Profiles for non-HPV perfluorinated 
chemicals for which there were publicly available toxicity data are 
posted on the ITC's web site (http://www.epa.gov/opptintr/itc). The 
ITC is continuing to evaluate information on uses, exposures, 
environmental fate, ecological effects, and health effects of 
perfluorinated chemicals.

                                   Table 3.--Perfluoroalkyl Acids and Salts\1\
----------------------------------------------------------------------------------------------------------------
             CAS No.                          Chemical name                     BCF                  HLC
----------------------------------------------------------------------------------------------------------------
000335-77-3                        1-Decanesulfonic acid,               10                   3.03E-01
                                    1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,
                                    9,10,10,10-heneicosafluoro-
001763-23-1                        1-Octanesulfonic acid,               56                   1.10E-02
                                    1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
                                    heptadecafluoro-*
002795-39-3                        1-Octanesulfonic acid,               56                   1.10E-02
                                    1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
                                    heptadecafluoro-, potassium salt*
003825-26-1                        Ammonium perfluorooctanoate*         56                   9.10E-02
003871-99-6                        1-Hexanesulfonic acid,               3                    3.97E-04
                                    1,1,2,2,3,3,4,4,5,5,6,6,6-
                                    tridecafluoro-, potassium salt*
021615-47-4                        Hexanoic acid, undecafluoro-,        3                    3.29E-03
                                    ammonium salt*
029457-72-5                        1-Octanesulfonic acid,               56                   1.10E-02
                                    1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
                                    heptadecafluoro-, lithium salt
----------------------------------------------------------------------------------------------------------------
* TSCA 8(e) submission
1 It should be noted that methods used to estimate BCF and HLC were based on associated chemical structures. The
  salts of carboxylic and sulfonic acids are expected to exist as dissociated structures in the environment; the
  dissociated structure will be more water-soluble and likely to have a lower BCF and HLC than the associated
  structure.


[[Page 75557]]


                                      Table 4.--Perfluoroalkyl Sulfonamides
----------------------------------------------------------------------------------------------------------------
             CAS No.                          Chemical name                     BCF                  HLC
----------------------------------------------------------------------------------------------------------------
000754-91-6                        1-Octanesulfonamide,                 10000                1.84E-03
                                    1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
                                    heptadecafluoro-
001691-99-2                        1-Octanesulfonamide,                 5543                 5.72E-07
                                    1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
                                    heptadecafluoro-N-(2-hydroxyethyl)-
                                    N-ethyl-
004151-50-2                        1-Octanesulfonamide, ethyl-          500                  5.37E+00
                                    1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
                                    heptadecafluoro-*
024448-09-7                        1-Octanesulfonamide,                 26000                4.30E-04
                                    1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-
                                    heptadecafluoro-N-(2-hydroxyethyl)-
                                    N-methyl-*
034449-89-3                        1-Butanesulfanamide, ethyl-          206                  7.50E-07
                                    1,1,2,2,3,3,4,4,4-nonafluoro-N-(2-
                                    hydroxyethyl)-
034454-97-2                        1-Butanesulfonamide,                 86                   5.65E-07
                                    1,1,2,2,3,3,4,4,4-nonafluoro-N-(2-
                                    hydroxyethyl)-N-methyl-
034455-03-3                        1-Hexanesulfonamide, ethyl-          6331                 2.07E-05
                                    1,1,2,2,3,3,4,4,5,5,6,6,6-
                                    tridecafluoro-N-(2-hydroxyethyl)-
067584-55-8                        2-Propanoic acid, 2-                 961                  1.94E-05
                                    [methyl[(nonalfuorobutyl)sulfonyl]
                                    amino]ethyl ester
067584-56-9                        2-Propenoic acid, 2-methyl           5330                 1.02E-04
                                    (undecafluoropentyl)sulfonyl amino
                                    ethyl ester
068555-72-6                        1-Pentanesulfonamide, ethyl-         1142                 3.94E-06
                                    1,1,2,2,3,3,4,4,5,5,5-undecafluoro-
                                    N-(2-hydroxyethyl)-
068555-74-8                        1,1,2,2,3,3,4,4,5,5,5-Undecafluoro-  478                  2.97E-06
                                    N-(2-hydroxyethyl)-N-methylpentane-
                                    1-sulphonamide
068555-75-9                        1-Hexanesulfonamide,                 2651                 1.56E-05
                                    1,1,2,2,3,3,4,4,5,5,6,6,6-
                                    tridecafluoro-N-(2-hydroxyethyl)-N-
                                    methyl-
068555-77-1                        1-Butanesulfonamide, 3-              465                  4.63E-06
                                    (dimethylamino)propyl-
                                    1,1,2,2,3,3,4,4,4-nonafluoro-
----------------------------------------------------------------------------------------------------------------
* TSCA 8(e) submission.


                             Table 5.--Perfluorinated Quaternary Ammonium Chemicals
----------------------------------------------------------------------------------------------------------------
             CAS No.                          Chemical name                     BCF                  HLC
----------------------------------------------------------------------------------------------------------------
001652-63-7                        1-Propanaminium,3-                   6                    4.04E-10
                                    (((heptadecafluorooctyl)sulfonyl)a
                                    mino)-N,N,N-trimethyl-, iodide
038006-74-5                        1-Propanaminium,3-                   6                    4.04E-10
                                    [[(heptadecafluorooctyl)sulfonyl]a
                                    mino]-N,N,N-trimethyl-, chloride
----------------------------------------------------------------------------------------------------------------


                                           Table 6.--Perfluoroalkanes
----------------------------------------------------------------------------------------------------------------
             CAS No.                          Chemical name                     BCF                  HLC
----------------------------------------------------------------------------------------------------------------
000076-19-7                         Octafluoropropane                    50                  3.30E+01
000678-26-2                        Dodecafluoropentane                  488                  3.50E+03
002994-71-0                         Hexafluoro-1,2-                      145                  2.05E+03
                                    bis(trifluoromethyl)cyclobutane
----------------------------------------------------------------------------------------------------------------


                                          Table 7.--Fluoroalkyl Ethers
----------------------------------------------------------------------------------------------------------------
             CAS No.                          Chemical name                     BCF                  HLC
----------------------------------------------------------------------------------------------------------------
000755-73-7                         2,2,3,3-Tetrafluoro-3-methoxy-       3                    4.30E-05
                                    propionic acid methyl ester*
001623-05-8                        Propane, 1,1,1,2,2,3,3-heptafluoro-  76                   8.74E+00
                                    3-[(trifluoroethyenyl)oxy]-
003330-14-1                        Propane, 1-(1-(difluoro(1,2,2,2-      7355                4.99E+00
                                    tetrafluoroethoxy)methyl)-1,2,2,2-
                                    tetrafluoroethoxy)-1,1,2,2,3,3,3-
                                    heptafluoro-
003330-15-2                        Heptafluoropropyl 1,2,2,2-            151                 3.90E+00
                                    tetrafluoroethyl ether
063863-43-4                        Propanoic acid, 3-1-                  327                  2.55E-03
                                    difluoro(trifluoroethenyl)oxy
                                    methyl-1,2,2,2-tetrafluoroethoxy-
                                    2,2,3,3-tetrafluoro-, methyl ester
104147-32-2                        3,5-Dichloro-4-(1,1,2,2-             160                  1.29E-06
                                    tetrafluoroethoxy)aniline
----------------------------------------------------------------------------------------------------------------
* TSCA 8(e) submission.


                                          Table 8.--Fluoroalkyl Iodides
----------------------------------------------------------------------------------------------------------------
             CAS No.                          Chemical name                     BCF                  HLC
----------------------------------------------------------------------------------------------------------------
000423-39-2                        1-Iodoperfluorobutane                1193                 4.99E+01
002043-55-2                         1,1,1,2,2,3,3,4,4-Nonafluoro-6-      6809                1.11E+01
                                    iodohexane
068188-12-5                        Perfluoroalkyl(C2-C18)ethyl iodide   1228                 2.11E+00
----------------------------------------------------------------------------------------------------------------


                                 Table 9.--Gamma, Omega-Perfluoroalkyl Alcohols
----------------------------------------------------------------------------------------------------------------
             CAS No.                          Chemical name                     BCF                  HLC
----------------------------------------------------------------------------------------------------------------
000647-42-7                         3,3,4,4,5,5,6,6,7,7,8,8,8-           4064                 1.50E-01
                                    Tridecafluoro-1-octanol
002043-47-2                         3,3,4,4,5,5,6,6,6-Nonafluoro1-       132                  5.42E-03
                                    hexanol
068391-08-2                        2-Perfluoroalkyl (C6-C12) ethanol     3092                 9.99E-02
----------------------------------------------------------------------------------------------------------------


                                  Table 10.--Perfluoroalkyl Sulfonyl Fluorides
----------------------------------------------------------------------------------------------------------------
             CAS No.                          Chemical name                     BCF                  HLC
----------------------------------------------------------------------------------------------------------------
000375-72-4                         Nonafluorobutanesulfonyl fluoride    5364                 8.91E-02

[[Page 75558]]

 
000421-20-5                         Methyl fluorosulfonate*              2                    5.00E-05
068156-06-9                        Cyclohexanesulfonyl fluoride,         7741                 7.57E+00
                                    decafluoro(pentafluoroethyl)-
068318-34-3                         Cyclohexanesulfonyl fluoride,        1396                1.44E+00
                                    decafluoro(trifluoromethyl)-
----------------------------------------------------------------------------------------------------------------
* TSCA 8(e) submission.


                                    Table 11.--Perfluoroglycol Acid Fluorides
----------------------------------------------------------------------------------------------------------------
             CAS No.                          Chemical name                     BCF                  HLC
----------------------------------------------------------------------------------------------------------------
004089-58-1                        Propanoyl fluoride, 2,3,3,3-         4709                 7.55E-05
                                    tetrafluoro-2-(1,1,2,3,3,3-
                                    hexafluoro-2-(1,1,2,2-tetrafluoro-
                                    2-(fluorosulfonyl)ethoxy)propoxy)-
001422-71-5                        3-Pentanone, 1,1,2,2,4,4,5,5-        3                    4.27E-05
                                    octafluoro-1,5-dimethoxy-*
069116-71-8                        Methyl 2,2-difluromalonyl fluoride*   3                   1.50E-05
069116-72-9                        Propanoic acid, 2,2,3,3-tetrafluoro- 2                    1.30E-04
                                    3-1,2,2,2-tetrafluoro-1-
                                    (fluorocarbonyl)ethoxy-, methyl
                                    ester*
069116-73-0                        Propanoic acid, 3-(2-(1,2-difluoro-   121                 1.70E-04
                                    2-oxo-1-(trifluoromethyl)ethoxy)-
                                    1,2,2-trifluoro-1-
                                    (trifluoromethyl)ethoxy)-2,2,3,3-
                                    tetrafluoro-, methyl ester
----------------------------------------------------------------------------------------------------------------
* TSCA 8(e) submission
1 It should be noted that methods used to estimate BCF and HLC were based on non-hydrolyzed chemical structures.
  Certain perfluoroglycol acid fluorides are expected to rapidly hydrolyze (within an hour, depending upon
  chemical concentration) in the environment; the hydrolysis products will be more water-soluble and likely to
  have a lower BCF and HLC than the non-hydrolyzed structure.


                               Table 12.--Perfluoroalkyl Carboxylic Acid Fluorides
----------------------------------------------------------------------------------------------------------------
             CAS No.                          Chemical name                     BC F                 HLC
----------------------------------------------------------------------------------------------------------------
000335-66-0                        Pentadecylfluorooctanoyl fluoride     3011                2.58E+02
000375-84-8                        Tridecafluoroheptanoyl fluoride      543                  4.91E+01
----------------------------------------------------------------------------------------------------------------


                     Table 13.--Perfluorinated Chemicals Not Assigned to a Structural Class
----------------------------------------------------------------------------------------------------------------
               CAS No.                      Chemical name                 BCF                      HLC
----------------------------------------------------------------------------------------------------------------
019430-93-4                           1-Hexene,                 1393                     1.11E+02
                                       3,3,4,4,5,5,6,6,6-
                                       nonafluoro-
068140-20-5                           Perfluoroalkyl (C4-C10)   1606                     5.26E+00
                                       ethyl mercaptan
----------------------------------------------------------------------------------------------------------------

    2. Information needs. The ITC needs measured BCFs, HLCs, and 
bioaccumulation data for most of the perfluorinated chemicals. 
Information on uses, exposures, health effects, and ecological 
effects is needed for perfluoroalkyl acids and salts, perfluoroalkyl 
sulfonamides, perfluorinated quaternary ammonium chemicals, 
perfluoroalkanes, fluoroalkyl ethers, fluoroalkyl iodides, gamma, 
omega-perfluoroalkyl alcohols, perfluoroalkyl sulfonyl fluorides, 
perfluoroglycol acid fluorides, perfluoroalkyl carboxylic acid 
fluorides, 1-hexene, 3,3,4,4,5,5,6,6,6-nonafluoro- (CAS No. 19430-
93-4), and perfluoroalkyl (C4-C10) ethyl mercaptan (CAS No. 68140-
20-5). For the perfluoroalkyl iodides, the ITC needs information on 
possible long-lived atmospheric degradation products. ITC is not 
soliciting information on two perfluoroalkyl sulfonamides that are 
in the EPA's HPV Challenge Program, 1-octanesulfonamide, 
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8- heptadecafluoro-N-(2-
hydroxyethyl)-N-ethyl- (CAS No. 1691-99-2) and 1-octanesulfonamide, 
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-
hydroxyethyl)-N-methyl- (CAS No. 24448-09-7) and the pesticides, 
lithium perfluorooctane sulfonate (LPOS) or 1-octanesulfonic acid, 
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-, lithium salt 
(CAS No. 29457-72-5) (see http://www.epa.gov/opprd001/factsheets/factsht2.htm) and Sulfuramid or 1-octanesulfonamide, -ethyl-
1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro- (CAS No. 4151-50-
2) (see http://www.epa.gov/opp).

IV. Revisions to the TSCA Section 4(e) Priority Testing List

A. Chemicals Added to the Priority Testing List: Nonylphenol 
Polyethoxylate Degradation Products

    1. Recommendation. Add 8 nonylphenol polyethoxylate degradation 
products to the Priority Testing List to obtain information to meet 
U.S. Government data needs.
    2. Rationale for recommendation. Alkylphenols, polyalkylphenols, 
alkylphenol ethoxylates, and alkylphenol polyethoxylates were 
recommended in the ITC's 37<SUP>th</SUP> (61 FR 4188, February 2, 
1996) (FRL-4991-6), 39<SUP>th</SUP> (62 FR 8578, February 25, 1997) 
(FRL-5580-9), and 41<SUP>st</SUP> Reports. Nonylphenol 
polyethoxylates were recommended in the ITC's 39<SUP>th</SUP> 
Report. Recent studies have measured nonylphenol polyethoxylate 
degradation products in wastewater effluents and surrounding aquatic 
systems (Bennett and Metcalfe, 2000; Hale et al., 2000). Some of 
these products can cause neuroendocrine-mediated effects in fish at 
low parts per billion (ppb) concentrations. One nonlylphenol 
polyethoxylate degradation product, branched 4-nonylphenol (mixed 
isomers) (CAS No. 84852-15-3) was previously recommended in the 
ITC's 37<SUP>th</SUP> Report. As a result of these findings and to 
meet U.S. Government data needs for these chemicals, the ITC is 
adding 8 nonlylphenol polyethoxylate degradation products to the 
Priority Testing List (Table 14).

 Table 14.--Nonylphenol Polyethoxylate Degradation Products Being Added
                      to the Priority Testing List
------------------------------------------------------------------------
                                         Nonylphenol polyethoxylate
              CAS No.                        degradation product
------------------------------------------------------------------------
104-35-8                            4-nonylphenol ethoxylate (NP1EO)
20427-84-3                          4-nonylphenol diethoxylate (NP2EO)

[[Page 75559]]

 
                                    4-nonylphenol triethoxylate (NP3EO)
                                    4-nonylphenol tetraethoxylate
                                     (NP4EO)
3115-49-9                           4-nonylphenoxy acetic acid (NP1EC)
106807-78-7                         4-nonylphenoxy ethoxy acetic acid
                                     (NP2EC)
108241-00-5                         4-nonylphenoxy diethoxy acetic acid
                                     (NP3EC)
                                    4-nonylphenoxy triethoxy acetic acid
                                     (NP4EC)
------------------------------------------------------------------------

    3. Supporting information. Recent studies have documented that 
nonylphenol polyethoxylate degradation products can act as in vitro 
and in vivo estrogen agonists in fish and amphibians (Jobling and 
Sumpter, 1993; Jobling et al., 1996; Kloas et al., 1999). While most 
of these studies were conducted with nonylphenol and octylphenol, 
there is evidence to suggest that nonylphenol polyethoxylate 
degradation products (short-chain ethoxylates and carboxylates) can 
also act to disrupt neuroendocrine function.
    i. Effects. Exposure of male fathead minnows to nonylphenol at 
1.1 ppb caused an increase in the number and size of sertoli cells 
and germ cell syncytia (Miles-Richardson et al., 1999). In the same 
study, exposure of fathead minnows to 5.5 ppb nonylphenol 
polyethoxylate consisting of primarily 7-11 carbon ethoxylate 
chains, no changes in number and size of sertoli cells and germ cell 
syncytia were detected, but shorter carbon ethoxylate chains (1-4 
carbons) were not tested. In the same laboratory, exposure of 
fathead minnows to 0.05 ppb nonylphenol caused significant increases 
in plasma vitellogenin and estradiol (Giesy et al., 2000).
    Exposure of male rainbow trout to 30 ppb octylphenol, 
nonylphenol, 4-nonylphenoxy acetic acid (NP1EC), and 4-nonylphenol 
diethoxylate (NP2EO) caused increases in serum vitellogenin and 
inhibition in testicular growth (Jobling et al., 1996). Octylphenol 
was the most potent followed by nonylphenol, NP2EO, and NP1EC. A 
lowest-observed-effect-concentration (LOEC) was not determined for 
NP2EO or NP1EC, but the 30 ppb exposure concentrations for NP1EC and 
NP2EO are well below total concentrations of carboxylates and 
ethoxylates reported for many of the effluents in the midwestern 
United States that are discussed below. Exposure of female rainbow 
trout to 1 ppb nonylphenol and NP2EO and 10 ppb NP1EC reduced growth 
(Ashfield et al., 1998).
    ii. Environmental concentrations. Despite data suggesting that 
nonylphenolpolyethoxylate metabolites may biodegrade (Staples et 
al., 1999), recent studies demonstrated that nonylphenol 
polyethoxylate effluent and effluent dominated stream concentrations 
may exceed LOEC concentrations reported in the literature. Barber et 
al. (1999) estimated nonylphenol polyethoxylate degradation products 
in seven midwest sewage treatment plant effluents and in one 
effluent-dominated stream (Des Plaines River, IL) approximately 100 
killometers (km) downstream of the major nonylphenol polyethoxylate 
sources. Generally effluents had nonylphenol polyethoxylate 
degradation product concentrations greater than 50 ppb with NPE2C 
the predominant form in most effluents and in the effluent dominated 
stream. Nonylphenol concentrations in the Des Plaines River slightly 
exceeded 1 ppb. Naylor et al. (1996) and Field and Reed (1996) 
estimated nonylphenol, total nonylphenol ethoxylate, and NP1EC-NP4EC 
(4-nonylphenoxy triethoxy acetic acid) concentrations in 15 pulp and 
paper mill and 6 sewage treatment plant effluents to the Fox River, 
WI. Total nonylphenol ethoxylate typically exceeded 50 ppb in all 
effluents, while nonylphenol concentrations were generally greater 
than 1 ppb. The nonylphenol carboxylates concentrations were always 
greater than 15 and 140 ppb in the pulp and paper mill and sewage 
treatment effluents, respectively. Nonylphenol and total nonylphenol 
ethoxylate Fox River concentrations near Green Bay were 0.582 and 
2.78 ppb, respectively, while the total nonylphenol carboxylate 
concentration was 13.5 ppb. Nonylphenol carboxylates were shown to 
persist for considerable distances downstream. In addition to these 
existing data, EPA is sponsoring ongoing programs to sample sediment 
and fish in the midwestern United States.
    4. Information needs. Data are needed to determine the LOECs (in 
comparison to estradiol) of branched 4-nonylphenol (mixed isomers), 
4-nonylphenol ethoxylate (NP1EO), 4-nonylphenol diethoxylate 
(NP2EO), 4-nonylphenol triethoxylate (NP3EO), 4-nonylphenol 
tetraethoxylate (NP4EO), 4-nonylphenoxy acetic acid (NP1EC), 4-
nonylphenoxy diethoxy acetic acid (NP2EC), 4-nonylphenoxy triethoxy 
acetic acid (NP3EC), and 4-nonylphenoxy tetraethoxy acetic acid 
(NP4EC) causing neuroendocrine effects in aquatic organisms. Data 
are also needed to determine whether nonylphenol polyethoxylate 
degradation products have the potential to interfere with growth and 
metamorphosis of amphibians (e.g., tadpoles).

B. Chemicals Removed From the Priority Testing List: Alkylphenols 
and Alkylphenol Ethoxylates

    1. Background. In this Report, the ITC is removing 4 
alkylphenols (APs) and 15 alkylphenol ethoxylates (APEs) from the 
Priority Testing List. The 4 APs were added to the Priority Testing 
List in the ITC's 37<SUP>th</SUP> Report; the 15 APEs were added to 
the Priority Testing List in the ITC's 39<SUP>th</SUP> Report. 
Submission of TSCA section 8(d) studies for APs added to the 
Priority Testing List in the ITC's 37<SUP>th</SUP> Report were 
required by a TSCA section 8(d) HaSD rule (61 FR 7421, February 28, 
1996) (FRL-4991-6). TSCA section 8(d) and FYI studies for APEs added 
to the Priority Testing List in the ITC's 39<SUP>th</SUP> Report 
were voluntarily submitted in response to information solicitations 
discussed in the ITC's <SUP>39</SUP><SUP>th</SUP> Report.
    2. Removal rationale. The APs and APEs being removed from the 
Priority Testing List are listed in Table 15. Three APs and 13 APEs 
are being removed because no domestic production or importation 
volumes were reported to the USEPA in response to any of the 1986, 
1990, 1994, and 1998 Information Update Rules (IURs) or the 2000 
PAIR rule. Production/importation volumes were reported for one AP 
and two APEs in the 1990 IUR but not in the subsequent 1994 and 1998 
IURs or the 2000 PAIR rule. These three chemicals are also being 
removed because of insufficient production.

                      Table 15.--APs and APEs Being Removed From the Priority Testing List
----------------------------------------------------------------------------------------------------------------
             CAS No.                          Chemical name                   Category        Removal rationale
----------------------------------------------------------------------------------------------------------------
104-43-8                           4-Dodecylphenol                      AP                   b
3884-95-5                          2-(1,1,3,3-Tetramethylbutyl)phenol   AP                   a, b
31195-95-6                         Isobutylphenol (mixed isomers)       AP                   a, b
54932-78-4                         4-(2,2,3,3-Tetramethylbutyl)phenol   AP                   a, b
7311-27-5                          2-[2-[2-[2-(4-                       APE                  a, b
                                    Nonylphenoxy)ethoxy]ethoxy]ethoxy]
                                    ethanol
20636-48-0                         14-(4-Nonylphenoxyl)-3,6,9,12-       APE                  a, b
                                    tetraoxatetradecan-1-ol
26264-02-8                         14-(Nonylphenoxyl)-3,6,9,12-         APE                  a, b
                                    tetraoxatetradecan-1-ol

[[Page 75560]]

 
26571-11-9                         26-(4-Nonylphenoxyl)-                APE                  b
                                    3,6,9,12,15,18,21,24-
                                    octaoxahexacosan-1-ol
27176-93-8                         2-[2-(4-                             APE                  a, b
                                    Nonylphenoxyl)ethoxyl]ethanol
27177-01-1                         17-(Nonylphenoxyl)-3,6,9,12,15-      APE                  a, b
                                    pentaoxaheptadecan-1-ol
27177-05-5                         23-(Nonylphenoxy)-3,6,9,12,15,18,21- APE                  a, b
                                    heptaoxatricosan-1-ol
27177-08-8                         29-(Nonylphenoxy)-                   APE                  b
                                    3,6,9,12,15,18,21,24,27-
                                    nonaoxanonacosan-1-ol
51938-25-1                         Poly(oxy-1,2-ethanediyl), .alpha.-   APE                  a, b
                                    (2-nonylphenyl)-.omega.-hydroxy-
65455-72-3                         29-(Isononylphenoxy)-                APE                  a, b
                                    3,6,9,12,15,18,21,24,27-
                                    nonaoxanonacosan-1-ol
152143-22-1                        Poly(oxy-1,2-ethanediyl), .alpha.-   APE                  a, b
                                    (4-nonylphenyl)-.omega.-hydroxy-,
                                    branched, phosphates
                                   Nonoxynol-2                          APE                  a, b
                                   Nonoxynol-3                          APE                  a, b
                                   Nonoxynol-7                          APE                  a, b
                                   .alpha.-(4-Nonylphenol)-.omega.-     APE                  a, b
                                    hydroxypoly(oxyethylene)
----------------------------------------------------------------------------------------------------------------
a No domestic production or importation volumes were reported to the USEPA in response to 1986, 1990, 1994, and
  1998 IURs (indicating that volumes were less than 10,000 pounds per site in 1985, 1989, 1993, and 1997).
b No domestic production or importation volumes were reported to the USEPA in response to the January 11, 2000,
  PAIR rule published in the Federal Register (65 FR 1548) (FRL-5777-2) (indicating that volumes were less than
  1,000 pounds per site in 1999).

V. References

    1. Ashfield, L.A., Pottinger, T.G., and Sumpter, J.P. 1998. 
Exposure of female juvenile rainbow trout to alkylphenolic compounds 
results in modification to growth and ovosomatic index. 
Environmental Toxicology and Chemistry 17:679-686.
    2. Agency for Toxic Substances and Disease Registry (ATSDR). 
1996. Toxicological Profile for Hexachlorobenzene. ATSDR. Atlanta, 
Georgia.
    3. Barber, L.B., Brown, G.K., and Zaugg, S.D. 1999. Potential 
endocrine disrupting chemicals in treated municipal wastewater and 
river water, Upper Midwest, USA. In: Keith, L., Jones-Lepp, T., and 
Needham, L. (Eds) Analysis of Environmental Endocrine Disruptors, 
American Chemical Society Symposium Series No. 747. American 
Chemical Society. Washington, DC.
    4. Bennet, E.R. and Metcalfe, C.D. 2000. Distribution of 
degradation products of alkylphenol ethoxylates near sewage 
treatment plants in the Lower Great Lakes, North America. 
Environmental Toxicology and Chemistry 19:784-792.
    5. Chhabra, R.S., Maronpot, R.M., Bucher, J.R., Haseman, J.K., 
Toft, J.D., and Hejtmancik, M.R. 1999. Toxicology and carcinogenesis 
studies of pentachlorophenol in rats. Toxicological Science 48:14-
20.
    6. Field, J. F. and Reed, R. L. 1996. Nonylphenol polyethoxy 
carboxylate metabolites of nonionic surfactants in paper mill 
effluents, municipal sewage treatment plant effluents and river 
waters. Environmental Science and Technology 30:3544-3550.
    7. Giesy, J.P., Pierens S.L., Miles-Richardson S., Kramer, V.J., 
Snyder, S.S., Nichols, K.M., Snyder, E., Villenueve, D.A., and 
Giesy, J.P. 2000. Effects of 4-Nonylphenol on Fecundity and 
Biomarkers of Estrogenicity in Fathead Minnows (Pimephales 
promelas). Environmental Toxicology and Chemistry 19:1368-1377.
    8. Hahn, M.E, Gasiewicz, T.A, Linko, P., and Goldstein, J.A. 
1988. The role of the Ah locus in hexachlorobenzene-induced 
porphyria: Studies in congenic C57BL/6J mice. Biochemical Journal 
254:245-254.
    9. Hahn, M.E, Goldstein, J.A, Linko, P., and Gasiewicz, T.A. 
1989. Interaction of hexachlorobenzene with the receptor for 
2,3,7,8-tetrachlorodibenzo-p-dioxin in vitro and in vivo. Archives 
of Biochemistry and Biophysics 270:344-355.
    10. Hale, R.C., Smith, C.L., De Fur, P.O., Harvey, E., Bush, 
E.O., La Guardia, M.J., and Vadas, G.G. 2000. Nonylphenols in 
sediments and effluents associated with diverse wastewater outfalls. 
Environmental Toxicology and Chemistry 19:946-952.
    11. Jobling, S. and Sumpter, J. P. 1993. Detergent compounds in 
sewage treatment plant effluents are weakly oestrogenic to fish: an 
in vitro study using rainbow trout hepatocytes. Aquatic Toxicology 
27:361-372.
    12. Jobling, S., Sheahan, D., Osborne, J.A., Matthiessen, P., 
and Sumpter, J.P. 1996. Inhibition of testicular growth in rainbow 
trout (Oncorhynchus mykiss) exposed to estrogenic alkylphenolic 
compounds. Environmental Toxicology and Chemistry 15:194-202.
    13. Kloas, W., Lutz, I., and Einspanier, R. 1999. Amphibians as 
a model to study endocrine disruptors: II. Estrogenic activity of 
environmental chemicals in vitro and in vivo. Science of the Total 
Environment 225:59-68.
    14. Lai, D.Y., Woo, Y.T., Argus, M.F., and Arcos, J.C.1996. 
Cancer risk reduction through mechanism-based molecular design of 
chemicals. pp. 62-73. In: S.C. DeVito and R.L. Garrett, (Eds) 
Designing Safer Chemicals, ACS Symposium Series No. 640, American 
Chemical Society, Washington, DC.
    15. Linko, P., Yeowell, H.N., Gasiewicz, T.A., and Goldstein, 
J.A.1986. Induction of cytochrome P-450 isozymes by 
hexachlorobenzene in rats and aromatic hydrocarbon (Ah)-responsive 
mice. Journal of Biochemical Toxicology 1:95-107.
    16. Mehendale, H.M., Fields, M., and Matthews, H.B. 1975. 
Metabolism and effects of hexachlorobenzene on hepatic microsomal 
enzymes in the rat. Journal of Agriculture and Food Chemistry 
23:261-265.
    17. Miles-Richardson, S.R., Pierens, S.L., Nichols, K.M., 
Kramer, V.J., Snyder, E.M., Snyder, S.A., Render, J.A., Fitzgerald, 
S.D., and Giesy, J.P. 1999. Effects of waterborne exposure to 4-
nonylphenol and nonylphenol ethoxylate on secondary sex 
characteristics and gonads of fathead minnows (Pimephales promelas). 
Environmental Research A80:S122-S137.
    18. Naylor, C.G., Williams, J. B., Varineau, P. T., Webb, D. A., 
and Sanders, D. F. 1996. Nonylphenol ethoxylates in an industrial 
river. 4<SUP>th</SUP> CEISO World Surfactants Congress, Volume 4.
    19. PPG Industries. 1982. MRID No. 00117566. Available from EPA. 
Write to FOI, EPA, Washington, DC 20460.
    20. PPG Industries. 1983. MRID No. 00132885. Available from EPA. 
Write to FOI, EPA, Washington, DC 20460.
    21. PPG Industries. 1985a. MRID No. 00150343, 00150366. 
Available from EPA. Write to FOI, EPA, Washington, DC 20460.
    22. PPG Industries. 1985b. MRID No. 00132883, 00150329. 
Available from EPA. Write to FOI, EPA, Washington, DC 20460.
    23. Rozman, K., Mueller W., Coulston, F., and Korte, F. 1977. 
Long-term feeding study of hexachlorobenzene in rhesus monkeys. 
Chemosphere 6:81-84.
    24. 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 16:948-967.
    25. Staples, C.A., Williams, J.B., Blessing, R.L., and Varineau, 
P.T. 1999. Measuring the biodegradability of nonylphenol ether 
carboxylates, octylphenol ether carboxylates and nonylphenol. 
Chemosphere 38:2029-2039.
    26. Woo, Y.T., Lai, D.Y., Argus, M.F., and Arcos, J.C. 1995. 
Development of structure-activity relationship rules for predicting 
carcinogenic potential of chemicals. Toxicology Letters 79:219-228.
    27. Woo, Y.T., Lai, D.Y., Argus, M.F., and Arcos, J.C. 1998. An 
integrative approach of combining mechanistically complementary 
short-term predictive tests as a basis for assessing the 
carcinogenic potential of chemicals. Journal of Environmental 
Science and Health C16:101-122.

VI. TSCA Interagency Testing Committee

    Statutory Organizations and Their Representatives

    Council on Environmental Quality

[[Page 75561]]

    Department of Commerce
          National Institute of Standards and Technology
            Robert Huie, Member
            Barbara C. Levin, Alternate
          National Oceanographic and Atmospheric Administration
            Nancy Foster, Member
            Teri Rowles, Alternate
    Environmental Protection Agency
        Paul Campanella, Member
        David R. Williams, Alternate
    National Cancer Institute
        Victor Fung, Alternate
    National Institute of Environmental Health Sciences
        Scott Masten, Member
        William Eastin, 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, Chair
        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
        Treye Thomas, Alternate
    Department of Agriculture
        Clifford P. Rice, Member
    Department of Defense
        Barbara Larcom, Member
        Kenneth Still, Alternate
        Jose Centeno, Alternate
    Department of the Interior
        Barnett A. Rattner, Member, Vice Chair
    Food and Drug Administration
        Ronald Lorentzen, Member
        Raju Kammula, Alternate
        David Hatten, Alternate
    National Library of Medicine
        Vera W. Hudson, Member
    National Toxicology Program
        NIEHS, FDA, and NIOSH Members
    Counsel
        Scott Sherlock, Office of Pollution Prevention and Toxics, 
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 number: 
(202) 260-1825; fax number: (202) 260-7895; e-mail address: 
<a href="/cdn-cgi/l/email-protection#a2d5cbcececbc3cfd18ccccdd0cfc3e2c7d2c38cc5cdd4"><span class="__cf_email__" data-cfemail="ceb9a7a2a2a7afa3bde0a0a1bca3af8eabbeafe0a9a1b8">[email protected]</span></a>; url: http://www.epa.gov/opptintr/itc.

[FR Doc. 00-30546 Filed 11-30-00; 8:45 am]
BILLING CODE 6560-50-S


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