Title 40

SECTION 720.38

720.38 Exemptions for test marketing.

§ 720.38 Exemptions for test marketing.

(a) Any person may apply for an exemption to manufacture or import a new chemical substance for test marketing. EPA may grant the exemption if the person demonstrates that the chemical substance will not present an unreasonable risk to injury to health or the environment as a result of the test marketing.

(b) Persons applying for a test-marketing exemption should provide the following information:

(1) All existing data regarding health and environmental effects of the chemical substance, including physical/chemical properties or, in the absence of such data, a discussion of toxicity based on structure-activity relationships (SAR) and relevant data on chemical analogues.

(2) The maximum quantity of the chemical substance which the applicant will manufacture or import for test marketing.

(3) The maximum number of persons who may be provided the chemical substance during test marketing.

(4) The maximum number of persons who may be exposed to the chemical substance as a result of test marketing, including information regarding duration and route of such exposures.

(5) A description of the test-marketing activity, including its length and how it can be distinguished from full-scale commercial production and research and development.

(6) A fee payment identity number, as required in 40 CFR 700.45(g)(4).

(c) In accordance with section 5(h)(6) of the Act, after EPA receives an application for exemption under this section, the Agency will file with the Office of the Federal Register a notice containing a summary of the information provided in the application, to the extent it has not been claimed confidential.

(d) No later than 45 days after EPA receives an application, the Agency will either approve or deny the application. Thereafter, EPA will publish a notice in the Federal Register explaining the reasons for approval or denial.

(e) In approving an application for exemption, EPA may impose any restrictions necessary to ensure that the substance will not present an unreasonable risk of injury to health and the environment as a result of test marketing.

(f) When applying for a test marketing exemption, persons are subject to fees in accordance with 40 CFR 700.45.

[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993; 83 FR 52719, Oct. 17, 2018]

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