[Code of Federal Regulations]
[Title 40, Volume 28]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR720.38]

[Page 121]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 720--PREMANUFACTURE NOTIFICATION--Table of Contents
 
                        Subpart B--Applicability
 
Sec. 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.
    (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.

[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993]