Certain Chemicals Approval of a Test Marketing Exemption

ENVIRONMENTAL PROTECTION AGENCY

[OPPT-59332; FRL-4760-8]

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-94-5. 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