[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: 40CFR725.255]

[Page 495]
 
                   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. 725.255  Information to be included in the TERA.

    (a) To review a TERA, EPA must have sufficient information to permit 
a reasoned evaluation of the health and environmental effects of the 
planned test in the environment. The person seeking EPA approval must 
submit all information known to or reasonably ascertainable by the 
submitter on the microorganism(s) and the research and development 
activity, including information not listed in paragraphs (c), (d), and 
(e) of this section that the person believes will be useful for EPA's 
risk assessment. The TERA must be in writing and must include at least 
the information described in the following paragraphs.
    (b) When specific information is not submitted, an explanation of 
why such information is not available or not applicable must be 
included.
    (c) Persons applying for a TERA, must include the submitter 
identification and microorganism identity information required for MCANs 
in Sec. 725.155(c), (d)(1), and (d)(2).
    (d) Persons applying for a TERA must submit phenotypic and 
ecological characteristics information required in Sec. 725.155(d)(3) as 
it relates directly to the conditions of the proposed research and 
development activity.
    (e) Persons applying for a TERA must also submit the following 
information about the proposed research and development activity:
    (1) A detailed description of the proposed research and development 
activity. (i) The objectives and significance of the activity and a 
rationale for testing the microorganisms in the environment.
    (ii) Number of microorganisms released (including viability per 
volume if applicable) and the method(s) of application or release.
    (iii) Characteristics of the test site(s), including location, 
geographical, physical, chemical, and biological features, proximity to 
human habitation or activity, and description of site characteristics 
that would influence dispersal or confinement.
    (iv) Target organisms (if the microorganism(s) to be tested has an 
intended target), including identification of each target organism and 
anticipated mechanism and result of interaction.
    (v) Planned start date and duration of each activity.
    (vi) If State and/or local authorities have been notified of the 
activity, evidence of notification.
    (2) Information on monitoring, confinement, mitigation, and 
emergency termination procedures. (i) Confinement procedures for the 
activity, access and security measures, and procedures for routine 
termination of the activity.
    (ii) Mitigation and emergency procedures.
    (iii) Measures to detect and control potential adverse effects.
    (iv) Name of principal investigator and chief of site personnel 
responsible for emergency procedures.
    (v) Personal protective equipment, engineering controls, and 
procedures to be followed to minimize dispersion of the microorganism(s) 
by people, machinery, or equipment.
    (vi) Procedures for disposal of any articles, waste, clothing, 
machinery, or other equipment involved in the experimental release, 
including methods for inactivation of the microorganism(s), containment, 
disinfection, and disposal of contaminated items.