05-16297. Dibasic Esters (DBEs) EPA Program Review; Notice of Availability and Solicitation of Comments

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

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: [phone]; e-mail address: [e-mail].

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: [phone]; e-mail address: [e-mail].

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 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 [phone] and the telephone number for the OPPT Docket, which is located in EPA Docket Center, is [phone].

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 other contact information unless you provide it in the body of your comment.

ii. E-mail. Comments may be sent by e-mail to [e-mail], 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 [phone].

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.

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:

• 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.

Footnotes

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.á 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.