[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: 40CFR725.234]

[Page 491-492]
 
                   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. 725.234  Activities conducted inside a structure.

    A person who manufactures, imports, or processes a microorganism is 
not subject to the reporting requirements under subpart D of this part 
if all of the following conditions are met:
    (a) The microorganism is manufactured, imported, or processed solely 
for research and development activities.
    (b) The microorganism is used by, or directly under the supervision 
of, a technically qualified individual, as defined in Sec. 725.3. The 
technically qualified individual must maintain documentation of the 
procedures selected to comply with paragraph (d) of this section and 
must ensure that the procedures are used.
    (c) There is no intentional testing of a microorganism outside of a 
structure, as structure is defined in Sec. 725.3.
    (d) Containment and/or inactivation controls. (1) Selection and use 
of containment and/or inactivation controls inside a structure for a 
particular microorganism shall take into account the following:
    (i) Factors relevant to the organism's ability to survive in the 
environment.
    (ii) Potential routes of release in air, solids and liquids; in or 
on waste materials and equipment; in or on people, including maintenance 
and custodial personnel; and in or on other organisms, such as insects 
and rodents.
    (iii) Procedures for transfer of materials between facilities.
    (2) The technically qualified individual's selection of containment 
and/or inactivation controls shall be approved and certified by an 
authorized official (other than the TQI) of the institution that is 
conducting the test prior to the commencement of the test.
    (3) Records shall be developed and maintained describing the 
selection and use of containment and/or inactivation controls, as 
specified in Sec. 725.235(c). These records, which must be maintained at 
the location where the research and development activity is being 
conducted, shall be submitted to EPA upon written request and within the 
time frame specified in EPA's request.
    (4) Subsequent to EPA review of records in accordance with paragraph 
(d)(3) of this section, changes to the containment/inactivation controls 
selected under paragraph (d)(1) of this section must be made upon EPA 
order. Failure to comply with EPA's order shall result in automatic loss 
of eligibility for an exemption under this section.
    (e) The manufacturer, importer, or processor notifies all persons in 
its employ or to whom it directly distributes the microorganism, who are 
engaged in experimentation, research, or analysis on the microorganism, 
including the manufacture, processing, use, transport, storage, and 
disposal of the microorganism associated with research and development 
activities, of

[[Page 492]]

any risk to health, identified under Sec. 725.235(a), which may be 
associated with the microorganism. The notification must be made in 
accordance with Sec. 725.235(b).