PFOS. March 6, 2002. 46th Report of the TSCA Interagency Testing Committee. Request for Comments. Federal Register.

FLUORIDE ACTION NETWORK PESTICIDE PROJECT

PFOS. March 6, 2002. Federal Register.
Forty-Ninth Report of the TSCA Interagency Testing Committee.
Request for Comments.

http://www.epa.gov/EPA-TOX/2002/March/Day-06/t5317.htm

[Federal Register: March 6, 2002 (Volume 67, Number 44)]
[Notices]
[Page 10297-10307]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06mr02-112]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY
[OPPTS-41057; FRL-6820-8]

Forty-Ninth Report of the TSCA Interagency Testing Committee to
the Administrator of the Environmental Protection Agency; Receipt of
Report and Request for Comments

AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Toxic Substances Control Act (TSCA) Interagency Testing
Committee (ITC) transmitted its Forty-Ninth Report to the Administrator
of EPA on November 27, 2001. In the 49\th\ ITC Report, which is
included with this notice, the ITC rescinds its request to EPA to add 8
nonylphenol polyethoxylate degradation products to the TSCA section
8(a) Preliminary Assessment Information Reporting (PAIR) rule, adds
stannane, dimethylbis[(1-oxoneodecyl)oxy]- (CAS No. 68928-76-7) to the
Priority Testing List and solicits voluntary information on this
chemical under the Voluntary Information Submission Policy (VISP) as
part of the ITC's ongoing effort to evaluate chemicals with potential
to persist and bioconcentrate. The ITC also solicits voluntary
information on 17 perfluorinated alcohols, esters, iodides, acids, and
salts that are considered by the ITC to be possible replacement
chemicals for perfluorooctylsufonates. Finally, the ITC removes 5
siloxanes from the Priority Testing List as a result of a successful
dialogue with the Silicones Environmental Health and Safety Council
(SEHSC) and implementation of an EPA-SEHSC Product Stewardship Program.

DATES: Comments, identified by docket control number OPPTS-41057, must
be received on or before April 5, 2002.

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-41057 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
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone numbers: (202) 554-1404; e-mail address: TSCA-
Hotline@epa.gov.
For technical information contact: John D. Walker, ITC Executive
Director (7401M), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460; telephone number: (202) 564-7526; fax:
(202) 564-7528; e-mail address: walker.johnd@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This notice is directed to the public in general. It may, however,
be of particular interest to you if you manufacture (defined by statute
to include import) and/or process 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 Prevention,
Pesticides and Toxic Substances (OPPTS) at http://www.epa.gov/opptsfrs/
home/opptsim.htm/, 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-41057. 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-41057 in the subject line on
the first page of your response.
1. By mail. Submit your comments to: Document Control Office
(7407M), 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 EPA East Building Rm. 6428, 1201 Constitution
Ave., NW., 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) 564-8930.
3. Electronically. You may submit your comments electronically by
e-mail to: oppt.ncic@epa.gov, or mail your computer disk to the address
identified above. Do not submit any information electronically that you
consider to be CBI. Electronic comments must be submitted as an ASCII
file avoiding the use of special characters and any form of encryption.
Comments and data will also be accepted on standard disks in
WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic
form must be identified by docket control number OPPTS-41057.
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

[[Page 10299]]

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. 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 49\th\ ITC
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. Offer alternatives for improvement.
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.

A. The 49\th\ ITC Report

The 49\th\ ITC Report was transmitted to EPA's Administrator on
November 27, 2001, and is included in this notice.
In the 49\th\ ITC Report, the ITC:
1. Rescinds its request to EPA to add 8 nonylphenol polyethoxylate
degradation products to the TSCA section 8(a) PAIR rule.
2. Adds stannane, dimethylbis[(1-oxoneodecyl)oxy]- (CAS No. 68928-
76-7) to the Priority Testing List and solicits voluntary information
on this chemical under VISP as part of the ITC's ongoing effort to
evaluate chemicals with potential to persist and bioconcentrate.
3. Solicits voluntary information on 17 perfluorinated alcohols,
esters, iodides, acids, and salts that are considered by the ITC to be
possible replacement chemicals for perfluorooctylsufonates.
4. Removes 5 siloxanes from the Priority Testing List as a result
of a successful dialogue with the SEHSC and implementation of an EPA-
SEHSC Product Stewardship Program.

B. Status of the Priority Testing List

The current TSCA 4(e) Priority Testing List as of November 2001 can
be found in Table 1 of the 49\th\ ITC Report which is included in this
notice.

List of Subjects

Environmental protection, Chemicals, Hazardous substances.

Dated: February 26, 2002.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.

Forty-Ninth 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 Reporting Rules
B. ITC's Use of TSCA Section 8 and Other Information
C. Promoting More Efficient Use of Information Submission Resources
D. Coordinating Information Requests
E. Requests to Promulgate TSCA Section 8(a) Preliminary Assessment
Information Reporting (PAIR) and Section 8(d) Health and Safety Data
Reporting (HaSDR) Rules
III. ITC's Activities During this Reporting Period (May to October
2001)
A. Continued Review of Degradation Effects Bioconcentration Information
Testing Strategies (DEBITS) Chemicals
B. Information Solicitations: Perfluorinated Alcohols, Esters, Iodides,
Acids, and Salts
IV. Revisions to the TSCA Section 4(e) Priority Testing List
A. Chemicals Added to the Priority Testing List: Stannane,
dimethylbis[(1-oxoneodecyl)oxy]-
B. Chemicals Removed From the Priority Testing List: Siloxanes
V. References
VI. The TSCA Interagency Testing Committee

SUMMARY

This is the 49\th\ 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 rescinding its request to the EPA to
add 8 nonylphenol polyethoxylate degradation products to the TSCA
section 8(a) Preliminary Assessment Information Reporting (PAIR) rule.
The ITC is adding stannane, dimethylbis[(1-oxoneodecyl)oxy]- to the
Priority Testing List and soliciting voluntary information under the
Voluntary Information Submission Policy (VISP) as part of the ongoing
effort to evaluate chemicals with potential to persist and
bioconcentrate. The ITC is also soliciting voluntary information on
perfluorinated alcohols, esters, iodides, acids and salts that are
considered possible replacement chemicals for perfluorooctylsufonates
(PFOS). The ITC is removing 5 siloxanes from the Priority Testing List
as a result of a successful dialogue with the Silicones Environmental
Health and Safety Council (SEHSC) and implementation of a EPA-SEHSC
Product Stewardship Program. The revised TSCA section 4(e) Priority
Testing List follows as Table 1.

[[Page 10300]]

Table 1.--The TSCA Section 4(e) Priority Testing List (November 2001)
----------------------------------------------------------------------------------------------------------------
Report No. Date Chemical/Group Action
----------------------------------------------------------------------------------------------------------------
28.................................. May 1991............... Chemicals with low Designated
confidence reference
dose (RfD).
Acetone...............
Thiophenol............
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.......... 12 Alkylphenols and Recommended
alkylphenol ethoxylates.
39.................................. November 1996.......... 8 Nonylphenol Recommended
ethoxylates.
41.................................. November 1997.......... 7 Alkylphenols and Recommended
alkylphenol ethoxylates.
42.................................. May 1998............... 3-Amino-5-mercapto-1,2,4- Recommended
triazole.
42.................................. May 1998............... Glycoluril.............. Recommended
46.................................. May 2000............... 8 Nonylphenol Recommended
polyethoxylate
degradation products.
47.................................. November 2000.......... 37 Indium chemicals..... Recommended
47.................................. November 2000.......... Pentachlorothiophenol... Recommended
47.................................. November 2000.......... Tetrachloropyrocatechol. Recommended
47.................................. November 2000.......... p-Toluidine, 5-chloro- Recommended
.alpha.,.alpha.,.alpha.-
trifluoro-2-nitro-N-
phenyl.
47.................................. November 2000.......... Benzoic acid, 3-[2- Recommended
chloro-4-
(trifluoromethyl)phenox
y]-, 2-ethoxy-1-methyl-
2-oxoethyl ester.
47.................................. November 2000.......... 3 Chloroalkenes......... Recommended
48.................................. May 2001............... 5 Chlorinated Recommended
trihalomethyl pyridines.
48.................................. May 2001............... 2 Trihaloethylidene Recommended
bisbenzenes.
48.................................. May 2001............... 3-Chlorotrifluralin..... Recommended
48.................................. May 2001............... 4 Recommended
Trichlorophenyldihydrop
yrazols.
49.................................. November 2001.......... Stannane, dimethylbis[(1- Recommended
oxoneodecyl)oxy]-.
----------------------------------------------------------------------------------------------------------------

I. Background

The ITC was established by section 4(e) of 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 48 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 Reporting Rules

Following receipt of the ITC's Report (and the revised Priority
Testing List) by the EPA Administrator, the EPA's Office of Pollution
Prevention and Toxics (OPPT) promulgates TSCA section 8(a) PAIR and
TSCA section 8(d) Health and Safety Data Reporting (HaSDR) rules for
chemicals added to the Priority Testing List. The PAIR rule requires
producers and importers of Chemical Abstract Service (CAS)-numbered
chemicals added to the Priority Testing List to submit production and
exposure reports under TSCA section 8(a). The HaSDR rule requires
producers, importers and processors of all chemicals (including those
with no CAS numbers) added to the Priority Testing List to submit
unpublished health and safety studies under TSCA section 8(d) that must
be in compliance with the revised HaSDR rule (63 FR 15765, April 1,
1998) (FRL-5750-4). All submissions must be received by the EPA within
90 days of the reporting rules Federal Register publication date. The
reporting rules are automatically promulgated by OPPT unless otherwise
requested by the ITC. It is an ITC policy, for most chemicals that are
added to the Priority Testing List, to delay automatic promulgation of
HaSDR rules to allow voluntary submission of studies of specific
interest (see Unit II.C. of this Report for further details).

B. ITC's Use of TSCA Section 8 and Other Information

The ITC reviews the TSCA section 8(a) PAIR rule reports, TSCA
section 8(d) HaSDR rule 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; and 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

To promote more efficient use of information submission resources,
the ITC developed the Voluntary Information Submissions Policy (VISP).
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 HaSDR Form and instructions for electronically submitting
full studies. The TSCA Electronic HaSDR Form can be used to provide
information electronically on ITC voluntary submissions, TSCA section
8(d) studies, FYI submissions, and TSCA section 8(e) studies. VISP is

[[Page 10301]]

described in the ITC's 41\st\ Report (63 FR 17658, April 9, 1998) (FRL-
5773-5) and is accessible through the world wide web (http://
www.epa.gov/opptintr/itc/visp.htm). To facilitate the implementation of
VISP, the ITC developed the Voluntary Information Submissions
Innovative Online Network (VISION). VISION is described in the ITC's
42\nd\ Report (63 FR 42554, August 7, 1998) (FRL-5797-8) and is
accessible through the world wide web (http://www.epa.gov/opptintr/itc/
vision.htm). VISION includes the VISP and links to the TSCA Electronic
HaSDR Form (http://www.epa.gov/opptintr/.er/hasd.htm) including revised
section 3.2 of the TSCA Electronic HaSD Reporting Form to provide more
use and exposure information (see the ITC's 46\th\ Report for details;
65 FR 75552, December 1, 2000) (FRL-6594-7).
The ITC requests that chemical producers, importers, processors,
and users provide information electronically via VISION on chemicals
for which the ITC is soliciting voluntary information. To enhance
visibility, the ITC will be adding all chemicals to the Priority
Testing List for which it is soliciting voluntary information. If the
ITC does not receive voluntary information submissions to meet its data
needs according to the procedures in VISP, the ITC may then request
that EPA promulgate the appropriate TSCA sections 8(a) and 8(d)
reporting rules to determine if there are unpublished data to meet
those needs. The ITC requests that those companies responding to a TSCA
section 8(d) HaSDR rule, provide data by using the TSCA Electronic
HaSDR Form.

D. Coordinating Information Requests

To avoid duplicate reporting, the ITC carefully coordinates its
information solicitations and reporting requirements with other
national and international testing programs, e.g., the National
Toxicology Program, the Organization for Economic Cooperation and
Development (OECD) Screening Information Data Set (SIDS) program and
the EPA's High Production Volume (HPV) Challenge. The ITC is currently
focusing its efforts on persistent non-HPV chemicals that have exposure
potential, but few, if any, publicly available ecological or health
effects data. The ITC is working with the EPA's Persistent
Bioaccumulative Toxics (PBT), Endocrine Disruption and
perfluoroctylsulfonate chemicals workgroups to identify data-poor,
potentially toxic chemicals to complement the objectives of those
programs.

E. Requests to Promulgate TSCA Section 8(a) Preliminary Assessment
Information Reporting (PAIR) and Section 8(d) (HaSDR) Rules

In its 47\th\ Report, the ITC asked the EPA to add 8 nonylphenol
polyethoxylate degradation products to the TSCA section 8(a) PAIR rule
(66 FR 17768, April 4, 2001) (FRL-6763-6). Since that Report the ITC
has obtained additional information on these chemicals from the EPA and
the Alkylphenols & Ethoxylates Research Council (APERC).
At this time, the ITC is rescinding its request to add 8
nonylphenol polyethoxylate degradation products to the TSCA section
8(a) PAIR rule, because:
1. No production or importation volumes for any of the 8
nonylphenol polyethoxylate degradation products were reported to EPA in
response to the 1986, 1990, 1994, or 1998 Inventory Update Rules (IURs)
and
2. A November 14, 2000, letter from APERC stated that none of the 8
nonylphenol polyethoxylate degradation products have been or are being
manufactured or processed for commercial purposes (Ref . 1, APERC,
2000). The 8 nonylphenol polyethoxylate degradation products are listed
in Table 2.

Table 2.--Nonylphenol Polyethoxylate Degradation Products for which the
ITC is Rescinding its Request for Addition to the TSCA Section 8(a) PAIR
Rule
------------------------------------------------------------------------
Nonylphenol polyethoxylate
CAS No. degradation products
------------------------------------------------------------------------
104-35-8.......................... 4-nonylphenol ethoxylate (NP1EO);
Ethanol, 2-(4-nonylphenoxy)-*
20427-84-3........................ 4-nonylphenol diethoxylate (NP2EO);
Ethanol, 2-[2-(4-
nonylphenoxy)ethoxy]-
51437-95-7........................ 4-nonylphenol triethoxylate (NP3EO);
Ethanol, 2-[2-[2-(4-
nonylphenoxy)ethoxy]ethoxy]-
7311-27-5......................... 4-nonylphenol tetraethoxylate
(NP4EO); Ethanol, 2-[2-[2-[2-(4-
nonylphenoxy)ethoxy]ethoxy]ethoxy]-
3115-49-9......................... 4-nonylphenoxy acetic acid (NP1EC);
Acetic acid, (4-nonylphenoxy)-
106807-78-7....................... 4-nonylphenoxy ethoxy acetic acid
(NP2EC); Acetic acid, [2-(4-
nonylphenoxy)-ethoxy]-
108149-59-3....................... 4-nonylphenoxy diethoxy acetic acid
(NP3EC); Acetic acid, [2-[4-
nonylphenoxy)ethoxy]ethoxy]-
184007-22-5....................... 4-nonylphenoxy triethoxy acetic acid
(NP4EC); Acetic acid, [2-[2-[2-(4-
nonylphenoxy)ethoxy]ethoxy]ethoxy]-

------------------------------------------------------------------------
\*\ Names following the semicolon are TSCA-preferred names.

At this time, the ITC is requesting that EPA not promulgate a TSCA
section 8(d) HaSDR rule for stannane, dimethylbis[(1-oxoneodecyl)oxy]-.
The ITC is making this request to allow ORTEP and the producers,
importers, processors, and users of stannane, dimethylbis [(1-
oxoneodecyl)oxy]- an opportunity to voluntarily provide the requested
information (see Units III. and IV. of this Report).

III. ITC's Activities During this Reporting Period (May to October
2001)

A. Continued Review of Degradation Effects Bioconcentration Information
Testing Strategies (DEBITS) Chemicals

In its 45\th\ through 48\th\ Reports, the ITC described its
strategies to screen and evaluate chemicals with persistence and
bioconcentration potential. These activities are referred to as DEBITS.
DEBITS provides a means to prioritize chemicals for information
reporting and testing based on degradation and bioconcentration
potential and availability of effects data.
During this reporting period, the ITC continued to implement DEBITS
by reviewing moderate production volume (MPV) chemicals (production or
importation volumes between 100,000 and 1,000,000 pounds) with
estimated or measured bioconcentration factors (BCFs) > 250 and
structurally related non-MPV chemicals. The ITC reviewed 95 chemicals
during this reporting period including 48 chemicals for which
information was solicited from manufacturers and trade associations
(Table 3).

[[Page 10302]]

Table 3.--DEBITS Chemicals for Which Information was Solicited From
Manufacturers and Trade Associations During this Reporting Period
------------------------------------------------------------------------
CAS No. Chemical name Structural class
------------------------------------------------------------------------
61260-55-7 1,2-Bis((2,2,6,6- 2,2,6,6-
tetramethyl- Tetramethylpiperi
piperidin-4- dines
yl)aminoethyl)etha
ne.
82919-37-7..................... Decanedioic acid, 2,2,6,6-
methyl 1,2,2,6,6- Tetramethylpiperi
pentamethyl-4- dines
piperidinyl ester.
110843-97-5.................... 1,5- 2,2,6,6-
Dioxaspiro[5.5]und Tetramethylpiperi
ecane-3,3- dines
dicarboxylic acid,
bis(2,2,6,6-
tetramethyl-4-
piperidinyl) ester.
1552-42-7...................... 6-(Dimethylamino)- 3,3-
3,3-bis(4- Diphenylisobenzof
(dimethylamino)phe uranones
nyl)-1(3H)-
isobenzofuranone.
52830-74-7..................... 6-(Dimethylamino)-3- 3,3-
(4- Diphenylisobenzof
(dimethylamino)phe uranones
nyl)-1(3H)-
Isobenzofuranone,
3-(2,4-
bis(dimethylamino)
phenyl-.
15715-19-2..................... Quino [2,3-b]
6,13-
acridine-7,14- Dihydroquinacrido
dione, 4,11- nes
dichloro-5,6,12,13-
tetrahydro-.
51085-07-5..................... Quino[2,3- 6,13-
b]acridine-7,14- Dihydroquinacrido
dione, 2,9- nes
dichloro-5,6,12,13-
tetrahydro-.
81-33-4........................ Anthra[2,1,9- Anthra[2,1,9-
def:6,5,10- def:6,5,10-
d'e'f']diisoquinol d'e'f']diisoquino
ine- line-1,3,8,10
1,3,8,10(2H,9H)- (2H,9H)-tetrones
tetrone.
5521-31-3...................... Anthra[2,1,9- Anthra[2,1,9-
def:6,5,10- def:6,5,10-
d'e'f']diisoquinol d'e'f']diisoquino
ine- line-1,3,8,10
1,3,8,10(2H,9H)- (2H,9H)-tetrones
tetrone, 2,9-
dimethyl-.
6424-77-7...................... Anthra[2,1,9- Anthra[2,1,9-
def:6,5,10- def:6,5,10-
d'e'f']diisoquinol d'e'f']diisoquino
ine- line-1,3,8,10
1,3,8,10(2H,9H)- (2H,9H)-tetrones
tetrone, 2,9-bis(4-
methoxyphenyl)-.
67923-45-9..................... Thiocyanic acid, Anthra[2,1,9-
(1,3,8,10- def:6,5,10-
tetrahydro- d'e'f']diisoquino
1,3,8,10- line-1,3,8,10
tetraoxoanthra (2H,9H)-tetrones
(2,1,9-def:6,5,10-
d'e'f')diisoquinol
ine-2,9-diyl)di-
3,1-phenylene
ester.
2716-10-1...................... Benzenamine, 4,4'- Bis[(4-
[1,4- aminophenyl)methy
phenylenebis(1- l]benzenes
methylethylidene)]
bis-.
25834-80-4..................... 2,4-Bis[(4- Bis[(4-
aminophenyl)methyl aminophenyl)methy
]benzenamine. l]benzenes
2379-74-0...................... Benzo[b]thiophen- Bisindolones and
3(2H)-one, 6- Bisbenzothiopheno
chloro-2-(6-chloro- nes
4-methyl-3-
oxobenzo[b]thien-
2(3H)-ylidene)-4-
methyl-.
85702-64-3..................... 3H-Indol-3-one, 5,7- Bisindolones and
dibromo-2-(5-bromo- Bisbenzothiopheno
7-chloro-1,3- nes
dihydro-3-oxo-2H-
indol-2-ylidene)-
1,2-dihydro-.
82-68-8........................ Pentachloronitroben Halo nitrobenzenes
zene. (chloronitrobenze
nes)
29091-09-6..................... 2,4-Dichloro-3,5- Halo nitrobenzenes
dinitrobenzotriflu (chloronitrobenze
oride. nes)
121-17-5....................... Benzene, 1-chloro-2- Halo nitrobenzenes
nitro-4- (trihalomethylnit
(trifluoromethyl)-. robenzenes)
6379-46-0...................... Benzene, 2,3,4- Halo nitrobenzenes
trichloro-1,5- (trihalomethylnit
dinitro-. robenzenes)
319-84-6....................... alpha- Halogenated
Hexachlorocyclohex cyclohexanes
ane.
30554-72-4..................... Cyclohexane, Halogenated
tetrabromodichloro- cyclohexanes
.
30554-73-5..................... Cyclohexane, Halogenated
tribromotrichloro-. cyclohexanes
68258-90-2..................... Heptachlorocyclopen Halogenated
tane. cyclopentanes
68258-91-3..................... Hexachlorocyclopent Halogenated
ane. cyclopentanes
91-78-1........................ s-Triazine, Hexahydrotriazines
hexahydro-1,3,5-
triphenyl-.
6281-14-7...................... 1,3,5- Hexahydrotriazines
Tricyclohexylhexah
ydro-s-triazine.
68083-44-3..................... 1,3,5-Triazine, Hexahydrotriazines
hexahydro-1,3,5-
tris(2-
methylphenyl)-,
trihydrochloride.
5915-41-3...................... 2-tert-Butylamino-4- N-(1,1-
chloro-6- Dimethylethyl)-N'-
ethylamino-s- ethyl-1,3,5-
triazine. triazine-2,4-
diamines
33693-04-8..................... N-(1,1- N-(1,1-
dimethylethyl)-N'- Dimethylethyl)-N'-
ethyl-6-methoxy- ethyl-1,3,5-
1,3,5-triazine-2,4- triazine-2,4-
diamine. diamines
20749-68-2..................... 12H-Phthaloperin-12- Phthaloperinone
one, 8,9,10,11- Type Compounds
tetrachloro-.
68296-59-3..................... 7H-Benzimidazo[2,1- Phthaloperinone
a]benz[de]isoquino Type Compounds
lin-7-one, 9(or
10)-methoxy-.
980-26-7....................... 2,9- Quinacridones
Dimethylquinacrido
ne.
1047-16-1...................... 5,12- Quinacridones
Dihydroquino[2,3-
b]acridine-7,14-
dione.
3089-16-5...................... Quino [2,3-b]
Quinacridones
acridine-7,14-
dione, 4,11-
dichloro-5,12-
dihydro-.
3089-17-6...................... Quino[2,3- Quinacridones
b]acridine-7,14-
dione, 2,9-
dichloro-5,12-
dihydro-.
68-36-0........................ Benzene, 1,4- Simple
bis(trichloromethy polyhalomethylben
l)-. zenes
328-84-7....................... Benzene, 1,2- Simple
dichloro-4- polyhalomethylben
(trifluoromethyl)-. zenes
5216-25-1...................... 4- Simple
Chlorobenzotrichlo polyhalomethylben
ride. zenes
25641-99-0..................... 1,2- Simple
Bis(dichloromethyl polyhalomethylben
)benzene. zenes
30359-53-6..................... Benzene, 1-(2,2,2- Simple
trichloroethyl)-3- polyhalomethylben
(trifluoromethyl). zenes
78068-85-6..................... 2-Chloro-1-fluoro-4- Simple
(trifluoromethyl)b polyhalomethylben
enzene. zenes
467-63-0....................... Benzenemethanol, 4- Tris(aminoaryl)met
(dimethylamino)- hanes
alpha,alpha-bis[4-
(dimethylamino)phe
nyl]-.
603-48-5....................... Benzenamine, Tris(aminoaryl)met
4,4',4''- hanes
methylidynetris
[N,N-dimethyl-.
65294-17-9..................... Methylium, tris[4- Tris(aminoaryl)met
(dimethylamino)phe hanes
nyl]-, salt with 3-
[[4-
(phenylamino)pheny
l]azo]benzenesulfo
nic acid (1:1).

[[Page 10303]]

68155-73-7..................... Benzenesulfonic Tris(aminoaryl)met
acid, 2-[bis[4- hanes
[ethyl[(3-
sulfophenyl)methyl
]amino]phenyl]meth
yl].
71173-64-3..................... Methylium, bis-[4- Tris(aminoaryl)met
(dimethylamino) hanes
phenyl][4-[(2-
hydroxyethyl)amino
]
phenyl]-.
515-03-7....................... Sclareol
68928-76-7..................... Stannane,
dimethylbis[(1-
oxoneodecyl)oxy]-
------------------------------------------------------------------------

The ITC reviewed information on the chemicals in Table 3 from the
Color Pigments Manufacturers Association (CPMA) and the Ecological and
Toxicological Association of Dyes and Organic Pigments Manufacturers
(ETAD) and the companies that were previously or are currently
manufacturing these chemicals. The ITC learned that many low production
volume (LPV) chemicals (production/importation volumes between 10,000
and 100,000 pounds) were no longer produced or imported. Some of the
chemicals are still produced but only used as chemical intermediates.
Because of limited production or use, the ITC is not requesting
additional information for 46 of these 48 chemicals, at this time.
However, the ITC is continuing to review information for 2 of these
48 chemicals, 2,9-dimethylquinacridone or quino[2,3-b]acridine-7,14-
dione, 5,12-dihydro-2,9-dimethyl- (CAS No. 980-26-7) and stannane,
dimethylbis[(1-oxoneodecyl)oxy]- (CAS No. 68928-76-7) (Table 3). The
ITC requested additional information on 2,9-dimethylquinacridone from
CPMA and ETAD and is adding stannane, dimethylbis[(1-oxoneodecyl)oxy]-
to the Priority Testing List (see Unit IV. of this Report).
The ITC reviewed 47 other chemicals satisfying the DEBITS criteria
listed in the 45\th\ ITC Report published in the Federal Register of
December 1, 2000 (65 FR 75544) (FRL-6399-5). It was determined that
there is a substantial amount of health and ecological effects data
available for 6 chemicals (Table 4). There is testing being planned
under EPA's HPV Challenge or the OECD SIDS program for 5 chemicals
(Table 5). There was no production or importation volumes reported to
EPA in response to the 1998 IUR for 36 chemicals with bioconcentration
potential (Table 6). The ITC is not requesting additional information
on these 47 chemicals, at this time.

Table 4.--DEBITS Chemicals with Substantial Effects Data
------------------------------------------------------------------------
CAS No. Chemical name Structural class
------------------------------------------------------------------------
101-14-4....................... Benzenamine, 4,4'- Bis(3-chloro-4-
methylenebis [2- aminophenyl)s
chloro-.
91-94--1....................... Benzidine, 3,3'- Bis(3-chloro-4-
dichloro-. aminophenyl)s
1330-38-7...................... Copper, [dihydrogen Copper
phthalocyaninedisu phthalocyanines
lfonato(2-)]-,
disodium salt.
147-14-8....................... Copper Copper
phthalocyanine. phthalocyanines
3380-34-5...................... 5-Chloro-2-(2,4-
dichlorophenoxy)ph
enol (Triclosan)
129-00-0....................... Pyrene
------------------------------------------------------------------------

Table 5.--DEBITS Chemicals in the EPA's HPV Challenge or the (OECD)
(SIDS) Program
------------------------------------------------------------------------
CAS No. Chemical name Structural class
------------------------------------------------------------------------
7328-97-4...................... Oxirane,2,2',2'',2' Glycidyl ethers
''-[1,2-
ethanediylidenetet
rakis (4,1-
phenyleneoxymethyl
ene)]tetrakis-.
6472-82-8...................... Acetamide, N- Spiro[isobenzofura
[(3.beta.,4.beta., n-1(3H),9'-
5.alpha.,16.alpha. [9H]xanthen]-3-
,20S)-16- ones
(acetyloxy)-3-
(dimethylamino)-4-
(hydroxymethyl)-
4,14-dimethyl-9,19-
cylcopregn-6-en-20-
yl]-N-methyl-.
632-79-1....................... Tetrabromophthalic 1,2-Dicarboxy-
anhydride. 3,4,5,6-
tetrahalobenzenes
117-08-8....................... Tetrachlorophthalic 1,2-Dicarboxy-
anhydride. 3,4,5,6-
tetrahalobenzenes
3468-63-1...................... 1-[(2,4- 1-
Dinitrophenyl)azo]- [(Dinitrophenyl)a
2-naphthalenol. zo]-2-
naphthalenols
------------------------------------------------------------------------

Table 6.--DEBITS Chemicals with Bioconcentration Potential, but no
Production or Importation Volumes Reported to EPA in Response to the
1998 IUR
------------------------------------------------------------------------
CAS No. Chemical name Structural class
------------------------------------------------------------------------
25357-79-3..................... Tetrabromophthalic 1,2-Dicarboxy-
acid disodium salt. 3,4,5,6
tetrahalobenzenes
59756-57-9..................... 2-Propanone, 1- 1-Phenyl-3-
phenyl-3- 3- (trifluoromethyl)
[trifluoromethyl)p phenyl-2-
henyl]
-. propanones
89768 -05 -8................... Benzenebutanenitril 1-Phenyl-3-
e, .beta.-oxo- (trifluoromethyl)
.alpha.-phenyl-3- phenyl-2-
(trifluoromethyl)-. propanones
147-82-0....................... 2,4,6- 2,6-
Tribromoaniline. Dibromoanilines

[[Page 10304]]

92484-07-6..................... 2-Butenediamide, 2,6-
N,N'-bis(2,4,6- Dibromoanilines
tribromophenyl)-,
(E)-.
6372-69-6...................... Phenothiazin-5-ium, 3,7-
3,7- Bis(dimethylamino
bis(dimethylamino)- )pheno(thia or
, chloride, compd. oxa)zin-5-ium
with zinc chloride
(ZnCl2).
345-92-6....................... Bis(4- 4,4'-Substituted
fluorophenyl)metha benzophenones
none.
81-42-5........................ 1,4-Diamino-2,3- Diaminoanthraquino
dichloro-9,10- nes
anthracenedione.
81-49-2........................ 1-Amino-2,4-dibromo- Diaminoanthraquino
9,10- nes
anthracenedione.
3443-90-1...................... Benzenesulfonic Diaminoanthraquino
acid, 2,2'-[(9,10- nes
dihydro-9-10-dioxo-
1,4-
anthracenediyl)dii
mino]bis(5-methyl-.
6397-02-0...................... 2- Diaminoanthraquino
Anthracenesulfonic nes
acid, 1-amino-9,10-
dihydro-9,10-dioxo-
4-[(2,4,6-
trimethylphenyl)am
ino]-, monosodium
salt.
68227-79-2..................... Benzenesulfonic Diaminoanthraquino
acid, 2-[[9,10- nes
dihydro-4-[(4-
methylphenyl)amino
]-9,10-dioxo-1-
anthracenyl]
amino]-5-methyl-,
monoammonium salt.
68834-02-6..................... 2- Diaminoanthraquino
Anthracenesulfonic nes
acid, 1-amino-4-
[[4-[[(4-
methylphenyl)sulfo
nyl]oxy]phenyl]ami
no]- 9,10-dihydro-
9,10-dioxo.
6130-72-9...................... 1,1,3-tris[p-(2,3- Glycidyl ethers
epoxypropoxy)pheny
l]propane.
67786-03-2..................... 2,2'-[[[2- Glycidyl ethers
(Oxiranylmethoxy)
phenyl]
methylene]
bis (4,1-
phenyleneoxymethyl
ene)]
bis-.
26619-69-2..................... 2H-2, 4a- Glycidyl ethers
Methanonaphthalene
, 8,8a-
epoxyoctahydro-
1,1,5,5-
tetramethyl-, (2S,
4aR, 8R, 8aS) - (-
) -.
103490-06-8.................... Oxiranemethanamine, Glycidyl ethers
N,N'-[1,4-
phenylenebis[(1-
methylethylidene)-
4,1-
phenylene]]bis[N-
(oxiranylmethyl)-.
28517-81-9..................... Benzenesulfonic Hydroxyamino
acid, ((1-amino- anthraquinones
9,10-dihydro-4-
hydroxy-9,10-dioxo-
2-anthracenyl)oxy)
(1,1-
dimethylpropyl).
27177-08-8..................... 3,6,9,12,15,18,21,2 Polyethoxylated
4,27- nonylphenols
Nonaoxanonacosan-1-
ol, 29-
(nonylphenoxy)-.
66197-78-2..................... 3,6,9,12,15,18,21,2 Polyethoxylated
4-Octaoxahexacosan- nonylphenols
1-ol, 26-
(nonylphenoxy)-,
dihydrogen
phosphate.
6262-21-1...................... 3',4',5',6'- Spiro[isobenzofura
Tetrachlorofluores n-1(3H),9'-
cein. [9H]xanthen]-3-
ones
17372-87-1..................... 2',4',5',7'- Spiro[isobenzofura
Tetrabromo-3',6'- n-1(3H),9'-
dihydroxyspiro[iso [9H]xanthen]-3-
benzofuran- ones
1(3H),9'-
[9H]xanthen]-3-
one, disodium salt.
24460-06-8..................... Spiro Spiro[isobenzofura
[isobenzofuran- n-1(3H),9'-
1(3H),9'-[9H]
[9H]xanthen]-3-
xanthen]-3-one, 2'- ones
amino-6'-
(diethylamino)-.
69898-41-5..................... Furo[3,4-b]pyridin- Spiro[isobenzofura
7(5H)-one, 5-[4- n-1(3H),9'-
(diethylamino)-2- [9H]xanthen]-3-
ethoxyphenyl]-5-(1- ones
ethyl-2-methyl-1H-
indol-3-yl)-.
2712 -83-6..................... Butyranilide,2,2,3,
3,4,4,4-
heptafluoro-
2'hydroxy-4'-nitro-

5610-94-6...................... 1-
Naphthalenesulfoni
c acid, 6-diazo-
5,6-dihydro-5-oxo-
, 4-benzoyl-1,2,3-
benzenetriyl ester
39635-79-5..................... Phenol, 4,4'-
sulfonylbis [2,6-
dibromo-
57000-78-9..................... 2-Butanone, 1-
chloro-1-(4-
chlorophenoxy)-3,3-
dimethyl-
61219-95-2..................... 2,2-Dichloro-N-2-
propenyl-N-[3-
(trifluoromethyl)p
henyl]acetamide
61792-00-5..................... 9,10-
Anthracenedione,
1,8-bis(2,4-
dinitrophenoxy)-
4,5-dinitro-
63467-15-2..................... 1(2H)-
Quinolinepropanami
de, 6-(2,2-
dicyanoethenyl)-
3,4-dihydro-
2,2,4,7-
tetramethyl-N-
phenyl-
66332-96-5..................... a,a
,a-
Trifluoro-3'-
isopropoxy-o-
toluanalide
68318-35-4..................... 2,7-
Naphthalenedisulfo
nic acid, 4-amino-
3-[[4'-[(2,4-
dihydroxyphenyl)az
o]-3,3'-
dimethyl[1,1'-
biphenyl]-4-
yl]azo]-5-hydroxy-
6-[(4-
sulfophenyl)azo]-,
trisodium salt
72850-64-7..................... 5-
Thiazolecarboxylic
acid, 2-chloro-4-
(trifluoromethyl)-
, phenylmethyl
ester
93964-25-1..................... 11H-
Benzo[a]carbazole-
3-carboxamide, 2-
hydroxy-N-(4-
methoxy-2-
methylphenyl)-,
monosodium salt
97886-45-8..................... 3,5-
Pyridinedicarbothi
oic acid, 2-
(difluoromethyl)-4-
(2-methylpropyl)-6-
(trifluoromethyl)-
, S,S-dimethyl
ester
------------------------------------------------------------------------

[[Page 10305]]

B. Information Solicitations: Perfluorinated Alcohols, Esters, Iodides,
Acids, and Salts

On May 25, 2000, the ITC delivered its 46\th\ Report to the EPA
Administrator and solicited use, exposure, environmental fate, health
effects, and ecological effects information on 50 perfluorinated
chemicals (65 FR 75552, December 1, 2000) (FRL-6594-7) that were
identified during the implementation of DEBITS. Since then the EPA has
convened several public meetings to discuss chemicals containing
perfluorooctyl sulfonates (PFOS) and proposed a significant new use
rule (SNUR) under TSCA section 5(a)(2) for 90 chemical substances,
including: Perfluorooctanesulfonic acid (PFOSA) and certain of its
salts (PFOSS), perfluorooctanesulfonyl fluoride (PFOSF), certain higher
and lower homologues of PFOSA and PFOSF, and certain other chemical
substances, including polymers, that contain PFOSA and its homologues
as substructures (65 FR 62319, October 18, 2000) (FRL-6745-5). All of
these chemical substances were referred to collectively as PFOS in this
proposed rule.
The EPA and other U.S. Government organizations represented on the
ITC are continuing to evaluate perfluorinated chemicals. Consequently,
the ITC in cooperation with the EPA identified 17 additional
perfluorinated chemicals, not named in the ITC's 46\th\ Report, the
EPA's SNUR or the EPA's HPV Challenge, that are possible replacements
for some uses of PFOS-containing chemicals. These 17 perfluorinated
chemicals had production volumes greater than 10,000 pounds, but less
than 1 million pounds (based on 1998 IUR, non-CBI data). The 17
additional perfluorinated chemicals are listed in Tables 7-10.

Table 7.--Perfluoroalkyl Alcohols
------------------------------------------------------------------------
CAS No. Chemical name
------------------------------------------------------------------------
865-86-1.......................... 1-Dodecanol,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,1
1,11,12,12,12-heneicosafluoro-
39239-77-5........................ 1-Tetradecanol,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,1
1,11,12,12,13,13,14,14,14-
pentacosafluoro-
60699-51-6........................ 1-Hexadecanol,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,1
1,11,12,12,13,13,14,14,15,15,16,16,
16-nonacosafluoro-
65104-67-8........................ 1-Octadecanol,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,1
1,11,12,12,13,13,14,14,15,15,16,16,
17,17,18,18,18-tritriacontafluoro-
------------------------------------------------------------------------

Table 8.--Perfluoroalkyl Esters
------------------------------------------------------------------------
CAS No. Chemical name
------------------------------------------------------------------------
17741-60-5........................ 2-Propenoic acid,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,1
1,11,12,12,12-
heneicosafluorododecyl ester
27905-45-9........................ 2-Propenoic acid,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,1
0-heptadecafluorodecyl ester
34362-49-7........................ 2-Propenoic acid,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,1
1,11,12,12,13,13,14,14,15,15,16,16,
16-nonacosafluorohexadecyl ester
34395-24-9........................ 2-Propenoic acid,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,1
1,11,12,12,13,13,14,14,14-
pentacosafluorotetradecyl ester
65150-93-8........................ 2-Propenoic acid,
3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,1
1,11,12,12,13,13,14,14,15,15,16,16,
17,17,18,18,18-
tritriacontafluorooctadecyl ester
------------------------------------------------------------------------

Table 9.--Perfluoroalkyl Iodides
------------------------------------------------------------------------
CAS No. Chemical name
------------------------------------------------------------------------
2043-54 -1........................ Dodecane,
1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9
,9,10,10-heneicosafluoro-12-iodo-
2043 -57 -4....................... Octane, 1,1,1,2,2,3,3,4,4,5,5,6,6-
tridecafluoro-8-iodo-
30046 -31 -2...................... Tetradecane,
1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9
,9,10,10,11,11,12,12-
pentacosafluoro-14-iodo-
65104 -63 -4...................... Eicosane,
1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9
,9,10,10,11,11,12,12,13,13,14,14,15
,15,16,16,17,17,18,18-
heptatriacontafluoro-20-iodo-
65150 -94 -9...................... Octadecane,
1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9
,9,10,10,11,11,12,12,13,13,14,14,15
,15,16,16-tritriacontafluoro-18-
iodo-
65510 -55 -6...................... Hexadecane,
1,1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9
,9,10,10,11,11,12,12,13,13,14,14-
nonacosafluoro-16-iodo-
------------------------------------------------------------------------

Table 10.--Perfluoroalkyl Acids and Salts
------------------------------------------------------------------------
CAS No. Chemical name
------------------------------------------------------------------------
335-67-1.......................... Octanoic acid, pentadecafluoro
54950-05-9........................ Butanedioic acid, sulfo-, 1,4-
bis(3,3,4,4,5,5,6,6,7,7,8,8,8,-
tridecafluorooctyl)ester, sodium
salt
------------------------------------------------------------------------

[[Page 10306]]

The ITC needs use, exposure, health effects, ecological effects,
and bioconcentration information for the 17 perfluorinated chemicals in
Tables 7-10 to address the data needs of U.S. Government member
organizations.

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

A. Chemicals Added to the Priority Testing List: Stannane,
dimethylbis[(1-oxoneodecyl)oxy]-

1. Recommendation. Stannane, dimethylbis[(1-oxoneodecyl)oxy]- (CAS
No. 68928-76-7) is being recommended to obtain data on use, exposure,
environmental fate, health effects, and ecological effects data.
2. Rationale for recommendation. Stannane, dimethylbis[(1-
oxoneodecyl)oxy]- is a MPV chemical that is predicted to persist and
bioconcentrate; the estimated BCF is 8,600. The 1998 IUR indicates that
100,000 to 1,000,000 pounds of stannane, dimethylbis [(1-
oxoneodecyl)oxy]- were produced or imported in the United States but
the ITC has no use and exposure information. A recent TSCA section 8(e)
submission reported a rat oral LD₅₀ of 894 milligram/
kilogram (mg/kg) body weight (Ref. 2, Crompton Corporation, 2001).
Signs of toxicity, including neurotoxic effects, were observed in this
rat oral gavage study. The ITC has no other effects data and no
environmental fate data, including no data on hydrolysis rates or
products.
3. Supporting information. Organotin compounds as a broad class
have an abundance of health and ecological effects data. Though the
types of effects vary among different organotins, immunotoxicity,
neurotoxicity and developmental and reproductive effects have been
observed in mammalian studies. The ITC is aware that the Organotin
Environmental Program (ORTEP) has proposed to conduct tests on several
organotin compounds under the EPA's HPV Challenge. However, stannane,
dimethylbis[(1-oxoneodecyl)oxy]-, a MPV chemical was not included in
that program. As noted above, stannane, dimethylbis[(1-
oxoneodecyl)oxy]- has a rat oral LD₅₀ of 894 mg/kg body
weight. To establish the oral LD₅₀, rats received single
oral gavage doses of 592; 1,000; or 1,690 mg/kg Fomrez UL-28 (90.6%
dimethylbis[(1-oxoneodecyl)oxy]-stannane). One of 10, 6/10, and 10/10
rats died at 592; 1,000; and 1,690 mg/kg, respectively. Most of the
animals exhibited hypoactivity, and abnormal excreta, along with
impaired muscle coordination, tremors, and/or hypothermia in 17, 16,
and 9 animals, respectively. Five of the 9 surviving animals at 592 mg/
kg appeared normal by day 12, while the remaining 4 animals exhibited
hair loss, hypoactivity, impaired muscle coordination, partial eye
closing, hypothermia, hyper-reactivity to touch, and/or dried red
material around the nose at study termination. The 4 surviving animals
at 1,000 mg/kg exhibited tremors, impaired muscle coordination, hyper-
reactivity to touch, and/or distended abdomen until study termination.
4. Information needs. The ITC needs use, exposure, ecological
effects, and environmental fate data and more health effects data. If
the ITC does not receive voluntary information submissions to meet its
data needs according to the procedures in VISP, the ITC may then
request that EPA promulgate a TSCA section 8(d) HaSDR rule to determine
if there are unpublished data to meet those needs.

B. Chemicals Removed From the Priority Testing List: Siloxanes

To meet the data needs of the U.S. Government organizations
represented on the ITC, 56 siloxanes were recommended for health
effects testing in the ITC's 30\th\ Report (57 FR 30608, July 9, 1992)
(FRL-4071-4). After this recommendation, the ITC's Siloxanes
Subcommittee and the Silicones Environmental Health and Safety Council
(SEHSC) established a Dialogue Group to develop health effects data.
The health effects data are being developed under an April 9, 1996,
Memorandum of Understanding (MOU) between EPA and the Dow Corning
Corporation and a Product Stewardship Program between EPA and SEHSC.
Since the establishment of this Dialogue Group, numerous activities
have occurred resulting in the removal of 51 of the 56 siloxanes on the
Priority Testing List (see the ITC's 37\th\, 38\th\, 39\th\, 40\th\,
and 41\st\ Reports). During this reporting period, the SEHSC provided
the ITC with a list of reports (health effects studies) that have been
submitted to EPA since the implementation of the product stewardship
program. The list includes reports on the 5 siloxanes being removed
from the Priority Testing List. The list of reports, EPA's Document
Control Number (DCN), and the key findings of these reports are
available on the SEHSC's website (http://www.sehsc.com/). SEHSC will
include study summaries of the listed reports on its website by April
2002. Full copies of the listed reports are available from the EPA's
Nonconfidential Information Center (NCIC) under docket control number
OPTS-42071A. On its website, SEHSC also included a list of the
publications that are available in the peer-reviewed literature on the
health and safety data that have been developed under the siloxane
product stewardship program. As a result of these activities the ITC is
removing the 5 siloxanes from the Priority Testing List (Table 11).

Table 11.--Siloxanes Being Removed From the Priority Testing List
------------------------------------------------------------------------
CAS No. Chemical name
------------------------------------------------------------------------
Cyclic Siloxanes
556-67-2.......................... Octamethylcyclotetrasiloxane (D₄)
541-02-6.......................... Decamethylcyclopentasiloxane (D₅)
540-97-6.......................... Dodecamethylcyclohexasiloxane (D₆)
------------------------------------------------------------------------
Linear Siloxanes
107-46-0.......................... Hexamethyldisiloxane (L₂)
------------------------------------------------------------------------
Polymers
63148-62-9........................ Dimethyl silicones and siloxanes
------------------------------------------------------------------------

[[Page 10307]]

V. References

1. APERC. 2000. November 14, 2000, letter from Barbara S. Losey,
Deputy Director, APERC to Dr. John D. Walker, Director, TSCA
Interagency Testing Committee.
2. Crompton Corporation. 2001. TSCA section 8(e) submission letter
dated July 25, 2001. EPA Doc. No. 88-010000204. Fiche No. 8EHQ-0792-
606.

VI. The TSCA Interagency Testing Committee

Statutory Organizations and Their Representatives

Council on Environmental Quality
Vacant

Department of Commerce

National Institute of Standards and Technology
Robert Huie, Member
Barbara C. Levin, Alternate

National Oceanographic and Atmospheric Administration
Thomas P. O'Connor, Member
Teri Rowles, Alternate

Environmental Protection Agency
Paul Campanella, Member
David R. Williams, Alternate

National Cancer Institute
Alan Poland, Member
David Longfellow, Alternate

National Institute of Environmental Health Sciences
Scott Masten, Member, Chair
William Eastin, Alternate

National Institute for Occupational Safety and Health
Mark Toraason, Member
David Lynch, Alternate

National Science Foundation
A. Frederick Thompson, Member
Marge Cavanaugh, Alternate

Occupational Safety and Health Administration
Val H. Schaeffer, Member, Vice Chair
Lyn Penniman, Alternate

Liaison Organizations and Their Representatives

Agency for Toxic Substances and Disease Registry
William Cibulas, Member
Stephanie Miles-Richardson, Alternate

Consumer Product Safety Commission
Jacqueline Ferrante, Member
Treye Thomas, Alternate

Department of Agriculture
Clifford P. Rice, Member
Laura L. McConnell, Alternate

Department of Defense
Barbara Larcom, Member
Kenneth Still, Alternate
Jose Centeno, Alternate

Department of the Interior
Barnett A. Rattner, Member

Food and Drug Administration
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) 564-7527; fax: (202) 564-
7528; e-mail address: williams.norma@epa.gov; url: http://www.epa.gov/
opptintr/itc.

[FR Doc. 02-5317 Filed 3-5-02; 8:45 am]
BILLING CODE 6560-50-S