Document ID: EPA-HQ-OPPT-2006-1019-0001
Agency: epa
Document Type: Notice
Title: Approval of Test Marketing Exemption for a Certain New Microorganism
Posted Date: 2007-05-25T04:00Z

[Federal Register: May 25, 2007 (Volume 72, Number 101)]
[Notices]               
[Page 29319-29320]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25my07-48]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2007-1019; FRL-8119-9]

 
Approval of Test Marketing Exemption for a Certain New 
Microorganism

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: 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.

DATES: Approval of this TME became effective December 21, 2006.

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: 
TSCA-Hotline@epa.gov.

    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: binder.audrey@epa.gov.

SUPPLEMENTARY INFORMATION:

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 http://www.regulations.gov. 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 
http://www.regulations.gov, 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 http://www.epa.gov/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.

    TME-06-09.
    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

[[Page 29320]]

the 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.

List of Subjects

    Environmental protection, Test marketing exemptions.

    Dated: March 15, 2007.
Rebecca S. Cool,
Chief, New Chemicals Notice Management Branch, Office of Pollution 
Prevention and Toxics.
[FR Doc. E7-10067 Filed 5-24-07; 8:45 am]

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