[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: 40CFR721.47]

[Page 156-157]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 721.47  Conditions for research and development exemption.

    (a) A person who manufactures, imports, or processes a chemical 
substance identifies in subpart E of this part for a significant new use 
identified in subpart E of this part is not subject to the notification 
requirements of Sec. 721.25 if the following conditions are met:
    (1) The person manufactures, imports, or processes the substance for 
the significant new use in small quantities solely for research and 
development.
    (2) The manufacturer, importer, or processor 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, importer, or processor must 
review and evaluate the following information to determine whether there 
is reason to believe there is any risk to health which may be associated 
with the chemicals 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, importer, or 
processor 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 section 4, 5, or 6 of the Act that applies to the 
substance and of which the manufacturer, importer, or processor 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 (b)(2), a laboratory is defined as a 
contained research facility where relatively small quantities of 
chemical substances are used on a pro-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, importer, or processor 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, 
importer, or processor has reason to believe may be associated with the 
substance, as determined under paragraph (b)(1) of this section.
    (2) If the manufacturer, importer, or processor distributes a 
chemical substance manufactured, imported, or processed under this 
section to persons not in its employ, the manufacturer, importer, or 
processor must in written form:

[[Page 157]]

    (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, importer, or processor.
    (d) 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, to the extent the disposal activity is not 
identified as a significant new use for the substance in subpart E of 
this part, or
    (2) Used for a commercial purpose, to the extent the use is not 
identified as a significant new use of the substance in subpart E of 
this part.
    (e)(1) Persons who manufacture, import, or process a chemical 
substance under this section must retain the following records:
    (i) Copies of or citations to information reviewed and evaluated 
under paragraph (b)(1) of this section to determine the need to make any 
notification of risk.
    (ii) Documentation of the nature and method of notification under 
paragraph (c)(1) of this section including copies of any labels or 
written notices used.
    (iii) Documentation of prudent laboratory practices used instead of 
notification and evaluation under paragraph (b)(2) of this section.
    (iv) The names and addresses of any persons other than the 
manufacturer, importer, or processor to whom the substance is 
distributed, the identity of the substance, the amount distributed, and 
copies of the notifications required under paragraph (c)(2) of this 
section.
    (2) [Reserved]

[53 FR 28361, July 27, 1988, as amended at 58 FR 34204, June 23, 1993]