01-31248. Approval of Test Marketing Exemption for Certain New Chemicals; With Comment Period

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces EPA's approval of applications for test marketing exemption (TME) under section 5(h)(1) of the Toxic Substances Control Act (TSCA) and 40 CFR 720.38. EPA has designated these applications as TME-02-01, TME-02-02, and TME-02-03. The test marketing conditions are described in the TME applications and in this notice.

DATES:

Approval of these TMEs are effective December 12, 2001. Written comments will be received until January 3, 2002.

ADDRESSES:

Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit III. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS-59380 and the TME numbers TME-02-01, TME-02-02, and TME-02-03 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

For general information contact: Barbara Cunningham, Director, Office of Program Management and Evaluation, Office of Pollution Prevention and Toxics (7401M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: [phone]; e-mail address: [e-mail].

For technical information contact: Miriam Wiggins-Lewis, New Chemicals Prenotice Branch, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

This action is directed in particular to the chemical manufacturer and/or importer who submitted the TMEs to EPA. This action may, however, be of interest to the public in general. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by 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.

II. How Can I Get Additional Information, Including Copies of this Document or Other Related Documents?

A. 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/​.

B. In person. The Agency has established an official record for this action under docket control number OPPTS-59380. 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 of the Center is [phone].

III. How and to Whom Do I Submit Comments?

The notice of receipt was published late in the 45-day review period; however, an opportunity to submit comments is being offered at this time. 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-59380 in the subject line on the first page of your response. The complete nonconfidential document is available in the TSCA Nonconfidential Information Center at the address in Unit II.B. between noon and 4 p.m., Monday through Friday, excluding holidays. EPA may modify or revoke the test marketing exemptions if comments are received which cast significant doubt on its finding that the test marketing activities will not present an unreasonable risk of injury.

A. 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.

B. In person or by courier. Deliver your comments to: OPPT Document Control Office (DCO) in EPA East Building, Room 6428, 1201 Constitution Avenue, NW., Washington, DC 20004. 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].

C. Electronically. You may submit your comments electronically by e-mail to: [e-mail] 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-59380. Electronic comments may also be filed online at many Federal Depository Libraries.

IV. How Should I Handle CBI Information That I Want to Submit to the Agency?

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. 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 identified under FOR FURTHER INFORMATION CONTACT.

V. What Should I Consider as I Prepare My Comments for EPA?

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 proposed rule or collection activity.

7. Make sure to submit your comments by the deadline in this document.

8. 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.

VI. What is the Agency's Authority for Taking this Action?

Section 5(h)(1) of TSCA and 40 CFR 720.38 authorizes EPA to exempt persons from premanufacture notification (PMN) requirements (under TSCA section 5(a)(1)(A) and 40 CFR Part 720) and permit them to manufacture or import new chemical substances for test marketing purposes, if the Agency finds that the manufacture, processing, distribution in commerce, use, and disposal of the substances for test marketing purposes will not present an unreasonable risk of injury to health or the environment. EPA may impose restrictions on test marketing activities and may modify or revoke a test marketing exemption upon receipt of new information which casts significant doubt on its finding that the test marketing activity will not present an unreasonable risk of injury.

VII. What Action is the Agency Taking?

EPA has approved the above-referenced TMEs. EPA has determined that test marketing the new chemical substances, under the conditions set out in the TME applications and in this notice, will not present any unreasonable risk of injury to health or the environment.

VIII. What Restrictions Apply to these TMEs?

The test market time period, production volume, number of customers, and use must not exceed specifications in the applications and this notice. All other conditions and restrictions described in the applications and in this notice must also be met.

TME-02-01, TME-02-02, and TME-02-03

Date of Receipt: October 12, 2001.

Notice of Receipt: December 7, 2001 (66 FR 63537), (FRL-6815-6).

Applicant: Westvaco.

Chemical: TME-02-01: Butyl acylate, polymer with styrene and methylamino chloride compounds, acetic acid salt.

TME-02-02: Butyl acylate, polymer with styrene and methylamino chloride compounds, lactic acid salt.

TME-02-03: Butyl acylate, polymer with styrene and methylamino chloride compounds, nitric acid salt.

Use: Binding agent in paper coatings.

Production Volume: Confidential.

Number of Customers: Eight.

Test Marketing Period: 365 days, commencing on first day of commercial manufacture of any of these three TMEs.

The following additional restrictions apply to these TMEs. A bill of lading accompanying each shipment must state that the use of these substances are restricted to that approved in the TMEs. In addition, the applicant shall maintain the following records until 5 years after the date they are created, and shall make them available for inspection or copying in accordance with section 11 of TSCA:

1. Records of the quantity of each TME substance produced and the date of manufacture.

2. Records of dates of the shipments to each customer and the quantities supplied in each shipment.

3. Copies of the bill of lading that accompanies each shipment of the TME substances.

IX. What was EPA's Risk Assessment for these TMEs?

EPA identified concerns for potential lung toxicity to workers and environmental toxicity to aquatic organisms. However, these concerns were adequately mitigated because of expected low exposures to workers, lack of releases to surface water, and reduction of aquatic toxicity in the presence of total organic carbon. Therefore, EPA has determined that these test marketing activities will not present an unreasonable risk of injury to human health or the environment.

X. Can EPA Change Its Decision on these TMEs in the Future?

Yes. The Agency reserves the right to rescind approval or modify the conditions and restrictions of an exemption should any new information that comes to its attention cast significant doubt on its finding that the test marketing activities will not present any unreasonable risk of injury to human health or the environment.

List of Subjects

• Environmental protection
• Test marketing exemptions

Dated: December 12, 2001.

Rebecca S. Cool,

Chief, New Chemicals Prenotice Branch, Office of Pollution Prevention and Toxics.