[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: 40CFR725.270]

[Page 496]
 
                   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. 725.270  EPA review of the TERA.

    General procedures for review of all submissions under this part are 
contained in Secs. 725.28 through 725.60. In addition, the following 
procedures apply to EPA review of applications submitted under this 
subpart:
    (a) Length of the review period. (1) The review period for the TERA 
will be 60 days from the date the Document Control Officer for the 
Office of Pollution Prevention and Toxics receives a complete TERA, or 
the date EPA determines the TERA is complete under Sec. 725.33, unless 
EPA finds good cause for an extension under Sec. 725.56.
    (2) A submitter shall not proceed with the research and development 
activity described in the TERA unless and until EPA provides written 
approval of the TERA. A submitter may receive early approval if a review 
is completed in less than 60 days.
    (b) EPA decision regarding proposed TERA activity. (1) A decision 
concerning a TERA under this subpart will be made by the Administrator, 
or a designee.
    (2) If EPA determines that the proposed research and development 
activity for the microorganism does not present an unreasonable risk of 
injury to health or the environment, EPA will notify the submitter that 
the TERA is approved and that the submitter can proceed with the 
proposed research and development activity described in the TERA.
    (3) EPA may include requirements and conditions in its approval of 
the TERA that would be stated in the TERA approval under paragraph (c) 
of this section.
    (4) If EPA concludes that it cannot determine that the proposed 
research and development activity described in the TERA will not present 
an unreasonable risk of injury to health or the environment, EPA will 
deny the TERA and will provide reasons for the denial in writing.
    (c) TERA approval. (1) A TERA approval issued by EPA under this 
section is legally binding on the TERA submitter.
    (2) When EPA approves a TERA, the submitter must conduct the 
research and development activity only as described in the TERA and in 
accordance with any requirements and conditions prescribed by EPA in its 
approval of the TERA.
    (3) Any person who fails to conduct the research and development 
activity as described in the TERA and in accordance with any 
requirements and conditions prescribed by EPA in its approval of the 
TERA under this section, shall be in violation of sections 5 and 15 of 
the Act and be subject to civil and criminal penalties under section 16 
of the Act.