[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
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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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