[Federal Register Volume 59, Number 73 (Friday, April 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9155]
[[Page Unknown]]
[Federal Register: April 15, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
[OPPTS-59335A; FRL-4775-5]
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
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-94-8. The test marketing conditions are
described below.
EFFECTIVE DATE: April 8, 1994.
FOR FURTHER INFORMATION CONTACT: Robert Wright, III, New Chemicals
Branch, Chemical Control Division (7405), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, Rm. E-611, 401
M St. SW., Washington, D.C. 20460, (202) 260-7800.
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-94-8. 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.
The following additional restrictions apply to TME-94-8.
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 use 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 dermally exposed to the
substance shall use:
a. Gloves determined by the Company to be impervious to the
substance under the conditions of exposure, including the duration of
exposure. The Company shall make this determination either by testing
the gloves under the conditions of exposure 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 TME 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 Company 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. Chemicals similar in
structure to (insert appropriate name) have been found to cause
irritation to membranes, corrosion and acute toxicity. To protect
yourself, you must wear protective gloves, clothing, and goggles.
4. 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 producedand 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 substance.
e. Copies of any determination under paragraph 2.a. above that
the protective gloves used by the Company are impervious to the
substance.
TME-94-8
Date of Receipt: February 22, 1994.
Notice of Receipt: April 8, 1994 (59 FR 16812).
Applicant: Confidential.
Chemical: (G) Alkylamine salt.
Use: (G) Dispersion aid.
Production Volume: Confidential.
Number of Customers: Confidential.
Test Marketing Period: Confidential. Commencing on first day of
commercial manufacture.
Risk Assessment: EPA identified human health concerns for
irritation to membranes, corrosion and acute toxicity based on test
data on a similar substance submitted with the test market exemption
notice. However, the health concerns were mitigated by requiring
workers who may be dermally exposed to the TME substance to wear
gloves, goggles and protective clothing. Therefore, the test market
activities will not present any unreasonable risk of injury to human
health.
EPA also identified environmental concerns for the TME substance.
Based on test data on analogous aliphatic amine compounds, EPA expects
toxicity to aquatic organisms to occur at a concentration of 1 part-
per-million TME substance in surface waters. However, results of a
Probablistic Dilution Model (PDM) indicated that the TME substance
would not present an unreasonable risk to the aquatic environment.
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 exemption.
Dated: April 8, 1994.
Charles M. Auer,
Director, Chemical Control Division, Pollution Prevention and Toxics.
[FR Doc. 94-9155 Filed 4-14-94; 8:45 am]
BILLING CODE 6560-50-F
