96-15284. Certain Chemicals; Approval of a Test Marketing Exemption

[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, [phone], TDD [phone].
    Comments and data may be submitted electronically by sending 
electronic mail (e-mail) to: [e-mail]. 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, [phone]; e-mail: 
[e-mail].

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]
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