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Approval of Test Marketing Exemption for a Certain New Microorganism

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Environmental Protection Agency (EPA).




This notice announces EPA's approval of an application for test marketing exemption (TME) under section 5(h)(1) of the Toxic Substances Control Act (TSCA) and 40 CFR part 725, subpart F. EPA has designated this application as TME-06-09. The test marketing conditions are described in the TME application and in this notice.


Approval of this TME became effective December 21, 2006.

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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:

For technical information contact: Audrey Binder, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-9033; e-mail address:

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I. General Information

A. Does this Action Apply to Me?

This action is directed in particular to the microorganism manufacturer who submitted the TME 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.

B. How Can I get Copies of this Document and Other Related Information?

1. Docket. EPA has established a docket for this action under docket ID number EPA-HQ-OPPT-2007-1019. All documents in the docket are listed in the docket's index at Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at, or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at​fedrgstr.

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

Section 5(h)(1) of TSCA and 40 CFR part 725, subpart F authorizes EPA to exempt persons from Microbial Commercial Activity Notification (MCAN) requirements and permit them to manufacture or import new microorganisms for test marketing purposes, if the Agency finds that the manufacture, processing, distribution in commerce, use, and disposal of the microorganisms 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.

III. What Action is the Agency Taking?

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

IV. What Restrictions Apply to this TME?

The test market time period, production volume, and use must not exceed specifications in the application and this notice. All other conditions and restrictions described in the application and in this notice must also be met. Impacts to the environment must also be managed as described in the TME as amended.


Date of Receipt: September 14, 2006.

Notice of Receipt: October 13, 2006 (71 FR 60517) (FRL-8099-3).

Applicant: Confidential.

Microorganism: Organic acid producing organism.

Use: Industrial manufacture of an organic acid.

Production Volume: Confidential.

Number of Customers: Confidential.

Test Marketing Period: Duration as specified in TME application, commencing on first day of commercial manufacture.

The following additional restrictions apply to this TME. A bill of lading accompanying each shipment must state that the use of the microorganism is restricted to that approved in the TME. 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 the TME microorganism 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 microorganism.

V. What was EPA's Risk Assessment for this TME?

Under the conditions required for this TME, EPA identified no significant health or environmental concerns for Start Printed Page 29320the test market microorganism. Therefore, the test market activities will not present any unreasonable risk of injury to human health or the environment.

VI. Can EPA Change Its Decision on this TME 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.

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List of Subjects

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Dated: March 15, 2007.

Rebecca S. Cool,

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

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[FR Doc. E7-10067 Filed 5-24-07; 8:45 am]