[Federal Register Volume 70, Number 158 (Wednesday, August 17, 2005)]
[Notices]
[Pages 48418-48421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-16297]


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ENVIRONMENTAL PROTECTION AGENCY

[OPPT-2002-0009; FRL-7728-6]


Dibasic Esters (DBEs) EPA Program Review; Notice of Availability 
and Solicitation of Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Under section 4 of the Toxic Substances Control Act (TSCA), 
EPA issued a testing consent order that incorporates an enforceable 
consent agreement (ECA) regarding dimethyl succinate (DMS, Chemical 
Abstract Service (CAS) No. 106-65-0), dimethyl glutarate (DMG, CAS No. 
1119-40-0), and dimethyl adipate (DMA, CAS No. 627-93-0) known 
collectively as Dibasic Esters (DBEs). The companies subject to this 
ECA agreed to conduct toxicity testing that was intended to satisfy 
certain toxicological data needs identified by EPA and the Consumer 
Product Safety Commission (CPSC). The results of this testing can be 
used to develop a more complete toxicological profile of DBEs and to 
assess certain potential human health risks posed by DBEs present in 
certain industrial and consumer products, including paint stripper 
formulations. This notice announces that EPA has initiated the program 
review component of the DBEs ECA testing program and solicits public 
comment on the need for a third, and final, phase of testing involving 
in vivo dermal penetration rate testing. Comments will be considered in 
EPA's decision on whether or not to proceed with the third phase of 
testing under the ECA.

DATES: Comments, identified by docket identification (ID) number OPPT-
2002-0009, must be received on or before September 16, 2005.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby 
Lintner, Regulatory Coordinator, Environmental Assistance Division 
(7408M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: [email protected].
    For technical information contact: George Semeniuk, Chemical 
Control Division (7405M), Office Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (202) 564-8174; e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you use DBEs or 
DBEs-containing products, such as hand cleaners or consumer-oriented 
paint strippers, or manufacture (including

[[Page 48419]]

import), process, or distribute such products in commerce. Other 
interested parties may also include persons who are or may be required 
to conduct testing of chemical substances under TSCA. Potentially 
affected entities may include, but are not limited to:
     Manufacturers of artificial synthetic fibers and filaments 
(NAICS 3252), e.g., manufacturers of nylon.
     Manufacturers of paint removal products (NAICS 325510), 
e.g., formulators of consumer paint strippers.
     Manufacturers of soap and cleaning compounds (NAICS 
32561), e.g., formulators of DBEs-containing hand cleaners.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. 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 Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket ID number OPPT-2002-0009. The official public 
docket consists of the documents specifically referenced in this 
action, any public comments received, and other information related to 
this action. Although a part of the official docket, the public docket 
does not include Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute. The official 
public docket is the collection of materials that is available for 
public viewing at the EPA Docket Center, Rm. B102-Reading Room, EPA 
West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket 
Center is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, 
excluding legal holidays. The EPA Docket Center Reading Room telephone 
number is (202) 566-1744 and the telephone number for the OPPT Docket, 
which is located in EPA Docket Center, is (202) 566-0280.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is available for viewing in EPA's electronic public docket. 
Although not all docket materials may be available electronically, you 
may still access any of the publicly available docket materials through 
the docket facility identified in Unit I.B.1. EPA intends to work 
towards providing electronic access to all of the publicly available 
docket materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and To Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPPT-2002-0009. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or

[[Page 48420]]

other contact information unless you provide it in the body of your 
comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID Number OPPT-2002-0009. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Document Control Office (7407M), 
Office of Pollution Prevention and Toxics (OPPT), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    3. By hand delivery or courier. Deliver your comments to: OPPT 
Document Control Office (DCO) in EPA East Bldg., Rm. 6428, 1201 
Constitution Ave., NW., Washington, DC. Attention: Docket ID Number 
OPPT-2002-0009. 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.

D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is 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 docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket 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 on the various options we 
propose, new approaches we have not considered, the potential impacts 
of the various options (including possible unintended consequences), 
and any data or information that you would like the Agency to consider 
during the development of the final action. 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. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the notice.
    7. Make sure to submit your comments by the deadline in this 
notice.
    8. To ensure proper receipt by EPA, be sure to identify the docket 
ID 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

A. Why are DBEs the Subject of Health Effects Testing?

    In the early 1990s, CPSC was conducting an investigation of 
consumer-oriented paint stripper formulations and seeking health and 
safety information that would permit a comparison of the risks posed by 
available paint stripping products. At the time, DBE-based products 
were being promoted in advertising and product labeling as ``safe'' 
alternatives to other consumer paint strippers that contained solvents, 
such as methylene chloride. CPSC was concerned that the limited 
toxicity database on DBEs would not adequately support claims regarding 
their safety and certain gaps in the DBEs toxicity database prevented a 
comparison of its risks with other paint stripper products.
    To help CPSC address these data needs, EPA implemented a procedure 
it had previously developed under the authority of section 4 of TSCA 
(15 U.S.C. 2603) to obtain needed testing through the development of an 
ECA (See 40 CFR part 790). In a notice published in the Federal 
Register of March 22, 1995 (60 FR 15143) (FRL-4943-6), EPA set forth 
its and CPSC's concerns for DBE's toxicity and exposure, indicated the 
type of testing that EPA and CPSC believed was needed to address data 
gaps, and solicited proposals from parties interested in conducting DBE 
toxicity testing under the terms of an ECA. In response, the Dibasic 
Esters Group (DBEs Group), comprised of Aceto Corporation, E.I. du Pont 
de Nemours and Company, and Solutia, Inc., provided EPA with a database 
of health effects studies that had been conducted previously on DBEs, 
indicated its interest in conducting additional needed health effects 
testing, and submitted a testing proposal\1\. While the DBEs Group's 
initial proposal did not meet the expectations of EPA and CPSC, a 
second proposal submitted by the DBEs Group, while not addressing all 
data needs initially identified by EPA and CPSC particularly with 
regard to a cancer bioassay and a 2-generation reproductive toxicity 
study, was found to constitute an adequate basis for entering into 
negotiation of an ECA. Following an announcement in the Federal 
Register of December 20, 1996 (61 FR 67332) (FRL-5578-9) EPA held a 
public meeting on January 29, 1997, in Washington, DC and began 
negotiation of an ECA addressing DBE toxicity testing.
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    \1\ On February 4, 2003, E. I. DuPont de Nemours and Company 
notified EPA that it had transferred its DBEs business and test 
sponsorship responsibilities under the ECA to DuPont Textiles and 
Interiors. On July 23, 2004, DuPont Textile and Interiors notified 
EPA that it had transferred its DBEs business and obligations under 
the ECA to INVISTA S.[aacute] r.l., a subsidiary of Koch Industries. 
Constituting minor modifications of the ECA, both notifications 
included ECA signatures pages that had been endorsed by their 
respective company officials.
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B. What Does the DBEs ECA Require?

    The ECA and a consent order incorporating the ECA were announced in 
the Federal Register of August 5, 1999 (64 FR 42692) (FRL-6090-6). The 
testing program set forth in the ECA consisted of three phases. The 
first phase (initial base toxicity testing) focused on testing 
individual DBEs and DBE mixtures and included:

[[Page 48421]]

     A 90-day subchronic inhalation toxicity study.
     A 14-day dermal toxicity study.
     Genotoxicity (gene mutation and chromosomal effects) 
studies.
    The second phase (program review testing) consisted of:
     A developmental toxicity study.
     An in vitro dermal penetration study.
    Test results from the first and second phases are contained in the 
docket for this testing action. Whether or not a third phase of testing 
would be required that would focus on in vivo dermal penetration rate 
testing is to be determined by EPA, with input from CPSC, after its 
review of the program's test results, recommendations submitted by the 
DBEs Group and any comments received from the public in response to 
this notice.

C. What Did the DBEs Group Recommend Regarding Phase 3 Testing?

    Following the submission of test results obtained under phase 2 
testing, the DBEs Group submitted its recommendation in a letter dated 
May 14, 2003, arguing that in vivo dermal penetration rate testing was 
not needed (See Dibasic Esters Group. Letter concerning the need for 
additional dermal studies involving DBEs submitted to the TSCA Public 
Docket Office, EPA May 14, 2003). The DBEs Group stated the following 
in support of its position: ``Since the 14-day dermal study confirmed a 
lack of systemic toxicity in rats, and given that the in vitro dermal 
study established that DBEs, when applied alone as a single solvent 
system or as part of a 1:3:1 blend [DMS:DMG:DMA], penetrated rat skin 
significantly faster compared to human skin, the DBEs Group has 
concluded that it is unnecessary to conduct additional dermal 
experiments with DBEs. The DBEs Group does recognize that had systemic 
toxicity been noted in the 14-day dermal study, accompanied by target 
organ effects, an in vivo dermal study using radio[-]labeled DBE could 
be justified, exclusive of the in vitro dermal penetration rate 
differences reported for rat and human skin.''

III. What Will Occur Once Program Review Has Been Completed?

    The primary outcome of the program review will be an EPA decision 
on whether or not the DBEs Group should proceed to sponsor in vivo 
dermal penetration rate testing, and, if so, the specific protocol that 
would be followed in such testing, including the identification of the 
DBEs or DBE mixture to be studied. On completing its review, including 
the consideration of comments submitted in response to this notice, EPA 
will notify the DBEs Group of its decision regarding phase 3 testing by 
letter, which will also be entered in the public docket.
    Accordingly, EPA specifically requests public comment on the need 
for, and, if there is thought to be a need, the specific nature of, in 
vivo dermal penetration rate testing for individual DBEs or mixtures of 
DBE. Comments that support such testing should provide a clear 
rationale for such testing and specify how the testing should be 
conducted, identifying test species and target organ(s), if 
appropriate. EPA understands that the 1:3:1 [DMS:DMG:DMA] blend of DBEs 
is a mixture common to many DBE-containing consumer products and 
industrial solvent products and was the subject of some of the tests 
conducted under the first two phases of ECA testing.

List of Subjects

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.


    Dated: August 10, 2005.
Linda Gerber,
Acting Director, Chemical Control Division, Office of Pollution 
Prevention and Toxics.

[FR Doc. 05-16297 Filed 8-16-05; 8:45 am]
BILLING CODE 6560-50-S