[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: 40CFR720.36]

[Page 120-121]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 720--PREMANUFACTURE NOTIFICATION--Table of Contents
 
                        Subpart B--Applicability
 
Sec. 720.36  Exemption for research and development.

    (a) This part does not apply to a chemical substance if the 
following conditions are met:
    (1) The chemical substance is manufactured or imported only in small 
quantities solely for research and development.
    (2) The manufacturer or importer notifies all persons in its employ 
or to whom it directly distributes the chemical substance, who are 
engaged in experimentation, research, or analysis on the chemical 
substance, including the manufacture, processing, use, transport, 
storage, and disposal of the substance associated with research and 
development activities, of any risk to health, identified under 
paragraph (b) of this section, which may be associated with the 
substance. The notification must be made in accordance with paragraph 
(c) of this section.
    (3) The chemical substance is used by, or directly under the 
supervision of, a technically qualified individual.
    (b)(1) To determine whether notification under paragraph (a)(2) of 
this section is required, the manufacturer or importer must review and 
evaluate the following information to determine whether there is reason 
to believe there is any potential risk to health which may be associated 
with the chemical substance:
    (i) Information in its possession or control concerning any 
significant adverse reaction by persons exposed to the chemical 
substance which may reasonably be associated with such exposure.
    (ii) Information provided to the manufacturer or importer by a 
supplier or any other person concerning a health risk believed to be 
associated with the substance.
    (iii) Health and environmental effects data in its possession or 
control concerning the substance.
    (iv) Information on health effects which accompanies any EPA rule or 
order issued under sections 4, 5, or 6 of the Act that applies to the 
substance and of which the manufacturer or importer has knowledge.
    (2) When the research and development activity is conducted solely 
in a laboratory and exposure to the chemical substance is controlled 
through the implementation of prudent laboratory practices for handling 
chemical substances of unknown toxicity, and any distribution, except 
for purposes of disposal, is to other such laboratories for further 
research and development activity, the information specified in 
paragraph (b)(1) of this section need not be reviewed and evaluated. 
(For purposes of this paragraph, a laboratory is a contained research 
facility where relatively small quantities of chemical substances are 
used on a non-production basis, and where activities involve the use of 
containers for reactions, transfers, and other handling of substances 
designed to be easily manipulated by a single individual.)
    (c)(1) The manufacturer or importer must notify the persons 
identified in paragraph (a)(2) of this section by means of a container 
labeling system, conspicuous placement of notices in areas where 
exposure may occur, written notification to each person potentially 
exposed, or any other method of notification which adequately informs 
persons of health risks which the manufacturer or importer has reason to 
believe may be associated with the substance, as determined under 
paragraph (b)(1) of this section.
    (2) If the manufacturer or importer distributes a chemical substance 
manufactured or imported under this section to persons not in its 
employ, the manufacturer or importer must in written form:
    (i) Notify those persons that the substance is to be used only for 
research and development purposes.
    (ii) Provide the notice of health risks specified in paragraph 
(c)(1) of this section.
    (3) The adequacy of any notification under this section is the 
responsibility of the manufacturer or importer.
    (d) A chemical substance is not exempt from reporting under this 
part if any amount of the substance, including as part of a mixture, is 
processed, distributed in commerce, or used, for any commercial purpose 
other than research and development, except where the chemical substance 
is processed, distributed in commerce, or used only as an impurity or as 
part of an article.

[[Page 121]]

    (e) Quantities of the chemical substance, or of mixtures or articles 
containing the chemical substance, remaining after completion of 
research and development activities may be:
    (1) Disposed of as a waste in accordance with applicable Federal, 
state, and local regulations, or
    (2) Used for the following commercial purposes:
    (i) Burning it as a fuel.
    (ii) Reacting or otherwise processing it to form other chemical 
substances for commercial purposes, including extracting component 
chemical substances.
    (f) Quantities of research and development substances existing 
solely as impurities in a product or incorporated into an article, in 
accordance with paragraph (d) of this section, and quantities of 
research and development substances used solely for commercial purposes 
listed in paragraph (e) of this section, are not subject to the 
requirements of paragraphs (a), (b), and (c) of this section, once 
research and development activities have been completed.
    (g) A person who manufactures or imports a chemical substance in 
small quantities solely for research and development is not required to 
comply with the requirements of this section if the person's exclusive 
intention is to perform research and development activities solely for 
the purpose of determining whether the substance can be used as a 
pesticide.

[51 FR 15102, Apr. 22, 1986]