[Federal Register Volume 59, Number 53 (Friday, March 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6392]
[[Page Unknown]]
[Federal Register: March 18, 1994]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPPT-59332; FRL-4760-8]
Certain Chemicals Approval of a Test Marketing Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
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 720.38. EPA has designated
this application as TME-94-5. The test marketing conditions are
described below.
DATES: Effective Dates: February 15, 1994.
Written comments will be received until April 4, 1994.
FOR FURTHER INFORMATION CONTACT: Shirley Howard, New Chemicals Branch,
Chemical Control Division (7405), Office of Pollution Prevention and
Toxics, Environmental Protection Agency, Rm. E-611, 401 M St. SW.,
Washington, DC 20460, (202) 260-3780.
SUPPLEMENTARY INFORMATION: Section 5(h)(1) of TSCA authorizes EPA to
exempt persons from premanufacture notification (PMN) requirements 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 human 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.
EPA hereby approves TME-94-5. EPA has determined that test
marketing of the new chemical substance described below, under the
conditions set out in the TME application, and for the time period and
restrictions specified below, will not present an unreasonable risk of
injury to human health or the environment. The Production volume and
the number of customers must not exceed that specified in the
application. All other conditions and restrictions, including the
stated use and the worker protection provisions described in the
application, in the accompanying Material Safety Data Sheet, and in
this notice must be met.
Inadvertently, notice of receipt of the application was not
published. Therefore, an opportunity to submit comments is being
offered at this time. The complete nonconfidential document is
available in the TSCA Nonconfidential Information Center (NCIC), Rm.
ETG-102 at the above address between 12:00 noon and 4 p.m., Monday
through Friday, excluding legal holidays. EPA may modify or revoke the
test marketing exemption if comments are received which cast
significant doubt on its finding that the test marketing activities
will not present an unreasonable risk of injury.
The following additional restrictions apply to TME-94-5.
1. A bill of lading accompanying each shipment must state that
the use of the substance is restricted to that approved in the TME.
2. During manufacturing and processing of the substance at any
site controlled by the Company, any person under the control of the
Company, including employees and contractors, who may be exposed to the
substance shall use a NIOSH-approved respirator.
3. The applicant must ensure that employees are provided with
information and training on the TME substance. This information and
training must be provided at the time of each employee's initial
assignment to a work area containing the TME substance and whenever the
substance is introduced into the employee's work area for the first
time.
4. The company must affix a label to each container of the
substance or formulations containing the substance during manufacturing
and processing. The label shall include, at a minimum, the following
statement:
WARNING: Breathing of this substance may be harmful. Chemicals
similar in structure to (insert appropriate name) have been found to
cause genetic defects. To protect yourself, you must wear a NIOSH-
approved respirator.
5. If the applicant wishes to distribute the TME substance
outside the Company for purposes of processing, the applicant must
obtain in writing from the outside processor, an agreement to comply
with the same worker protection, worker training, and labeling
requirements applicable to the applicant.
6. 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:
a. Records of the quantity of the TME substance produced and
the date of manufacture.
b. Records of dates of the shipments to each customer and the
quantities supplied in each shipment.
c. Copies of the labels affixed to containers of the substance
or formulations containing the substance.
d. Copies of the bill of lading that accompanies each shipment
of the TME substance.
e. A copy of the written agreements with processors outside the
Company agreeing to comply with the same worker protection, worker
training, and labeling requirements applicable to the applicant.
T-94-5
Date of Receipt: December 27, 1993. The extended comment period
will close April 4, 1994.
Applicant: Confidential.
Chemical: (G) Complex reaction product of t-butyl,
dihydroxycarbopolycycle and bis (dimethylaminosubstituted)
carbomonocyle.
Use: (G) Internal component of manufactured contained use -
consumer article.
Production Volume: 900 kg.
Number of Customers: Confidential.
Test Marketing Period: Eighteen months. Commencing on first day of
commercial manufacture.
Risk Assessment: EPA identified human health concerns for
mutagenicity based on data on an analogous chemical substance. However,
the health concerns were mitigated by requiring workers potentially
exposed to the TME substance via inhalation to wear a NIOSH-approved
respirator. EPA identified aquatic toxicity based on analogous
substance. However, during manufacturing, processing, and or use, the
PMN substance is not expected to be released to the aquatic environment
in significant amounts. Therefore, the Agency has determined that the
test market activities will not present an unreasonable risk of injury
to health or the environment.
The Agency reserves the right to rescind approval or modify the
conditions and restrictions of an exemption should any new information
come to its attention which casts significant doubt on its finding that
the test marketing activities will not present an unreasonable risk of
injury to health or the environment.
List of Subjects
Environmental protection, Test marketing exemptions.
Dated: February 15, 1994.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
[FR Doc. 94-6392 Filed 3-17-94; 8:45 am]
BILLING CODE 6560-50-F
