[Federal Register Volume 61, Number 117 (Monday, June 17, 1996)]
[Notices]
[Pages 30610-30611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15284]
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ENVIRONMENTAL PROTECTION AGENCY
[OPPT-59353; FRL-5378-1]
Certain Chemicals; Approval of a Test Marketing Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces EPA's approval of an application for a
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-96-4. The test marketing conditions are
described below.
DATES: This notice becomes effective June 7, 1996. Written comments
will be received until July 2, 1996.
ADDRESSES: Written comments, identified by the docket number [OPPT-
59353] and the specific TME number should be sent to: TSCA
nonconfidential center (NCIC), Office of Pollution Prevention and
Toxics, Environmental Protection Agency, Rm. NEB-607 (7407), 401 M St.,
SW., Washington, DC 20460, (202) 554-1404, TDD (202) 554-0551.
Comments and data may be submitted electronically by sending
electronic mail (e-mail) to: [email protected]. 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 disks in WordPerfect in 5.1 file format or ASCII file
format. All comments and data in electronic form must be identified
[OPPT-59353]. No Confidential Business Information (CBI) should be
submitted through e-mail. Electronic comments on this notice may be
filed online at many Federal Depository Libraries. Additional
information on electronic submissions can be found under
``SUPPLEMENTARY INFORMATION''.
FOR FURTHER INFORMATION CONTACT: Shirley D. Howard, New Chemicals
Branch, Chemical Control Division (7405), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, Rm. E-447, 401
M St., SW., Washington, DC 20460, (202) 260-3780; e-mail:
H[email protected].
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-96-4. 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. Production volume, use, and
the number of customers must not exceed that specified in the
application. All other conditions and restrictions described in the
application and in this notice must be met.
A notice of receipt of this application was not published in
advance of approval. Therefore, an opportunity to submit comments is
being offered at this time. 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-96-4:
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, processing, and use of the substance at
any site controlled by the Applicant, any person under the control of
the Applicant, including employees and contractors, who may be dermally
exposed to the substance shall use:
a. Gloves determined by the Applicant to be impervious to the
substance under the conditions of exposure, including the duration of
exposure. The Applicant shall make this determination either by testing
the gloves under the conditions of exposure
[[Page 30611]]
or by evaluating the specifications provided by the manufacturer of the
gloves. Testing or evaluation of specifications shall include
consideration of permeability, penetration, and potential chemical and
mechanical degradation by the PMN substance and associated chemical
substances;
b. Clothing which covers any other exposed areas of the arms,
legs, and torso; and
c. Chemical safety goggles or equivalent eye protection.
3. The Applicant must affix a label to each container of the
substance or formulations containing the substance. The label shall
include, at a minimum, the following statement:
WARNING: Contact with skin may be harmful. Similar chemicals
have been found to cause acute health effects, cancer, mutagenicity,
blood effects, and developmental toxicity in laboratory animals. To
protect yourself, you must wear protective gloves, clothing, and
goggles.
4. The Applicant must obtain or develop a Material Safety Data
Sheet (MSDS) for the TME substance. The MSDS shall comply with 29 CFR
1910.1200(g).
5. 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 bill of lading that accompanies each shipment
of the substance.
d. Copies of any determination under paragraph 2.a. above that
the protective gloves used by the Applicant are impervious to the
substance.
e. Copies of the labels affixed to containers of the substance
or formulations containing the substance.
f. Copies of the MSDS for the TME substance.
T-96-4
Date of Receipt: April 18, 1996. The extended comment period will
close (insert date 15 days after date of publication in the Federal
Register).
Applicant: Confidential.
Chemical: (G) Alkylated-nitrosated-Benzene.
Use: Pesticide Intermediate.
Production Volume: Confidential.
Number of Customers: Confidential.
Test Marketing Period: 12 months, commencing on first day of
commercial manufacture.
Risk Assessment: EPA identified concerns for acute toxicity,
methemoglobinemia, oncogenicity, developmental toxicity, and
mutagenicity based on analogous chemical substances. However, during
manufacturing, processing, and use, exposure to workers will be
prevented by protective gloves, clothing, and goggles. Therefore, the
test market activities will not present an unreasonable risk of injury
to human health.
Although EPA expects the TME substance to be toxic to aquatic
organisms, no releases of the TME substance to surface waters are
expected because it will be completely consumed in the reaction process
and any residuals will be recycled. Therefore, the test market
activities will not present an unreasonable risk of injury to 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.
A record has been established for this notice under docket number
[OPPT-59353] (including comments and data submitted electronically as
described above). A public version of this record, including printed
versions of electronic comments, which does not include any information
claimed as CBI, is available for inspection from 12 noon to 4 p.m.,
Monday through Friday, excluding legal holidays. The public record is
located in the TSCA nonconfidential information center (NCIC), Rm. NEB-
607, 401 M St., SW., Washington, DC 20460.
The official record of this notice, as well as the public version,
as described above will be kept in paper form. Accordingly, EPA will
transfer all comments received electronically into printed, paper form
as they are received and will place the paper copies in the official
record which will also include all comments submitted directly in
writing. The official record is the paper record maintained at the
address in ``ADDRESSES'' at the beginning of this document.
List of Subjects
Environmental protection, test marketing exemptions.
Dated: June 7, 1996.
Paul J. Campanella,
Chief, New Chemicals Branch, Office of Pollution Prevention and Toxics.
[FR Doc. 96-15284 Filed 6-14-96; 8:45 am]
BILLING CODE 6560-50-F