[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: 40CFR725.235]

[Page 492-493]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 725--REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS
--Table of Contents
 
      Subpart E--Exemptions for Research and Development Activities
 
Sec. 725.235  Conditions of exemption for activities conducted inside a 
structure.

    (a) Determination of risks. To determine whether notification under 
Sec. 725.234(e) is required, the manufacturer, importer, or processor 
must do one of the following:
    (1) For research conducted in accordance with the NIH Guidelines, 
the manufacturer, importer, or processor must meet the conditions laid 
out at IV-B-4-d of the NIH Guidelines; or
    (2) For all other research conducted in accordance with 
Sec. 725.234, 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 
microorganism:
    (i) Information in its possession or control concerning any 
significant adverse reaction of persons exposed to the microorganism 
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 microorganism.
    (iii) Health and environmental effects data in its possession or 
control concerning the microorganism.
    (iv) Information on health effects which accompanies any EPA rule or 
order issued under TSCA section 4, 5, or 6 of the Act that applies to 
the microorganism and of which the manufacturer, importer, or processor 
has knowledge.
    (b) Notification to employees and others. (1) The manufacturer, 
importer, or processor must notify the persons identified in 
Sec. 725.234(e) 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 microorganism, as determined under paragraph (a) of 
this section.
    (2) If the manufacturer, importer, or processor distributes a 
microorganism manufactured, imported, or processed under this section to 
persons not in its employ, the manufacturer, importer, or processor must 
in written form:
    (i) Notify those persons that the microorganism is to be used only 
for research and development purposes and the requirements of 
Sec. 725.234 are to be met.
    (ii) Provide the notice of health risks specified in paragraph 
(b)(1) of this section.
    (3) The adequacy of any notification under this section is the 
responsibility of the manufacturer, importer, or processor.
    (c) Recordkeeping. (1) For research conducted in accordance with the 
NIH Guidelines, a person who manufactures, imports, or processes a 
microorganism under this section must retain the following records:
    (i) Documentation that the NIH Guidelines have been adhered to. Such 
documentation shall include:
    (A) For experiments subject to Institutional Biosafety Committee 
review, or notification simultaneous with initiation of the experiment, 
the information submitted for review or notification, along with 
standard laboratory records, shall satisfy the recordkeeping 
requirements specified in Sec. 725.234(d)(3).
    (B) For experiments exempt from Institutional Biosafety Committee 
review or notification simultaneous with initiation of the experiment, 
documentation of the exemption, along with standard laboratory records, 
shall satisfy the recordkeeping requirement specified in 
Sec. 725.234(d)(3).
    (ii) Documentation of how the following requirements are satisfied 
under the NIH Guidelines:
    (A) Copies or citations to information reviewed and evaluated to 
determine the need to make any notification of risk.
    (B) Documentation of the nature and method of notification of risk, 
including copies of any labels or written notices used.
    (C) The names and addresses of any persons other than the 
manufacturer,

[[Page 493]]

importer, or processor to whom the substance is distributed, the 
identity of the microorganism, the amount distributed, and copies of the 
notifications required.
    (2) For all other research conducted in accordance with 
Sec. 725.234, a person who manufacturers, imports, or processes a 
microorganism under this section, must maintain the following records:
    (i) Records describing selection and use of containment and/or 
inactivation controls required by Sec. 725.234(d)(3) and certification 
by an authorized official required by Sec. 725.234(d)(2) for each 
microorganism.
    (ii) Copies or citations to information reviewed and evaluated under 
paragraph (a) of this section to determine the need to make any 
notification of risk.
    (iii) Documentation of the nature and method of notification under 
paragraph (b)(1) of this section, including copies of any labels or 
written notices used.
    (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 microorganism, the amount distributed, 
and copies of the notifications required under paragraph (b)(2) of this 
section.