[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: 40CFR725.239]

[Page 493-494]
 
                   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. 725.239  Use of specific microorganisms in activities conducted outside 
a structure.

    (a) Bradyrhizobium japonicum. To qualify for an exemption under this 
section, all of the following conditions must be met for a test 
involving Bradyrhizobium japonicum:
    (1) Characteristics of recipient microorganism. The recipient 
microorganism is limited to strains of Bradyrhizobium japonicum.
    (2) Modification of traits. (i) The introduced genetic material must 
meet the criteria for poorly mobilizable listed in Sec. 725.421(c).
    (ii) The introduced genetic material must consist only of the 
following components:
    (A) The structural gene(s) of interest, which have the following 
limitations:
    (1) For structural genes encoding marker sequences, the gene is 
limited to the aadH gene, which confers resistance to the antibiotics 
streptomycin and spectinomycin.
    (2) For traits other than antibiotic resistance, the structural gene 
must be limited to the genera Bradyrhizobium and Rhizobium.
    (B) The regulatory sequences permitting the expression of solely the 
gene(s) of interest.

[[Page 494]]

    (C) Associated nucleotide sequences needed to move genetic material, 
including linkers, homopolymers, adaptors, transposons, insertion 
sequences, and restriction enzyme sites.
    (D) The vector nucleotide sequences needed for vector transfer.
    (E) The vector nucleotide sequences needed for vector maintenance.
    (3) Limitations on exposure. (i) The test site area must be no more 
than 10 terrestrial acres.
    (ii) The technically qualified individual must select appropriate 
methods to limit the dissemination of modified Bradyrhizobium japonicum.
    (b) Rhizobium meliloti. To qualify for an exemption under this 
section, all of the following conditions must be met for a test 
involving Rhizobium meliloti:
    (1) Characteristics of recipient microorganism. The recipient 
microorganism is limited to strains of Rhizobium meliloti.
    (2) Modification of traits. (i) The introduced genetic material must 
meet the criteria for poorly mobilizable listed in Sec. 725.421(c) of 
this part.
    (ii) The introduced genetic material must consist only of the 
following components:
    (A) The structural gene(s) of interest, which have the following 
limitations:
    (1) For structural genes encoding marker sequences, the gene is 
limited to the aadH gene, which confers resistance to the antibiotics 
streptomycin and spectinomycin.
    (2) For traits other than antibiotic resistance, the structural gene 
must be limited to the genera Bradyrhizobium and Rhizobium.
    (B) The regulatory sequences permitting the expression of solely the 
gene(s) of interest.
    (C) Associated nucleotide sequences needed to move genetic material, 
including linkers, homopolymers, adaptors, transposons, insertion 
sequences, and restriction enzyme sites.
    (D) The vector nucleotide sequences needed for vector transfer.
    (E) The vector nucleotide sequences needed for vector maintenance.
    (3) Limitations on exposure. (i) The test site area must be no more 
than 10 terrestrial acres.
    (ii) The technically qualified individual must select appropriate 
methods to limit the dissemination of modified Rhizobium meliloti.