[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: 40CFR725.250]

[Page 494-495]
 
                   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. 725.250  Procedural requirements for the TERA.

    General requirements for all submissions under this part are 
contained in subparts A through C of this part. In addition, the 
following requirements apply to TERAs submitted under this subpart:
    (a) When to submit the TERA. Each person who is eligible to submit a 
TERA under this subpart must submit the TERA at least 60 calendar days 
before the person intends to initiate the proposed research and 
development activity.
    (b) Contents of the TERA. Each person who submits a TERA under this 
subpart must provide the information and test data described in 
Secs. 725.255 and 725.260. In addition, the submitter must supply 
sufficient information to enable EPA to evaluate the effects of all 
activities for which approval is requested.
    (c) A person may submit a TERA for one or more microorganisms and 
one or more research and development activities, including a research 
program.
    (d) EPA will either approve the TERA, with or without conditions, or 
disapprove it under procedures established in this subpart.
    (e) The manufacturer, importer, or processor who receives a TERA 
approval must comply with all terms of the approval, as well as 
conditions described in the TERA, and remains liable for compliance with 
all terms and conditions, regardless of who conducts the research and 
development activity. Any person conducting the research and development 
activity approved under the TERA must comply with all terms of the TERA 
approval, as well as the conditions described in the TERA.
    (f) Recordkeeping. Persons submitting a TERA must comply with the 
recordkeeping requirements of Sec. 725.65. In addition, the following 
requirements apply to TERAs:
    (1) Each person submitting a TERA under this part must retain 
documentation of information contained in the TERA for a period of 3 
years from the date that the results of the study are submitted to the 
Agency.

[[Page 495]]

    (2) Summaries of all data, conclusions, and reports resulting from 
the conduct of the research and development activity under the TERA must 
be submitted to the EPA address identified in Sec. 725.25(c) within 1 
year of the termination of the activity.