[Code of Federal Regulations]
[Title 40, Volume 21]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR158.65]

[Page 86]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 158--DATA REQUIREMENTS FOR REGISTRATION--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 158.65  Biochemical and microbial pesticides.

    Biochemical and microbial pesticides are generally distinguished 
from conventional chemical pesticides by their unique modes of action, 
low use volume, target species specificity or natural occurrence. In 
addition, microbial pesticides are living entities capable of survival, 
growth reproduction and infection. Biochemical and microbial pesticides 
are subject to a different set of data requirements, as specified in 
Secs. 158.165 and 158.170, respectively.
    (a) Biochemical pesticides. Biochemical pesticides include, but are 
not limited to, products such as semichemicals (e.g. insect pheromones), 
hormones (e.g., insect juvenile growth hormones), natural plant and 
insect regulators, and enzymes. When necessary the Agency will evaluate 
products on an individual basis to determine whether they are 
biochemical or conventional chemical pesticides.
    (b) Microbial pesticides. (1) Microbial pesticides include microbial 
entities such as bacteria, fungi, viruses, and protozoans. The data 
requirements apply to all microbial pesticides, including those that are 
naturally-occurring as well as those that are genetically modified. Each 
``new'' variety, subspecies, or strain of an already registered 
microbial pest control agent must be evaluated, and may be subject to 
additional data requirements.
    (2) Novel microbial pesticides (i.e., genetically modified or non-
indigenous microbial pesticides) will be subject to additional data or 
information requirements on a case-by-case basis depending on the 
particular micro-organism, its parent microorganism, the proposed 
pesticide use pattern, and the manner and extent to which the organism 
has been genetically modified. Additional requirements may include 
information on the genetic engineering techniques used, the identity of 
the inserted or deleted gene segment (base sequence data or enzyme 
restriction map of the gene), information on the control region of the 
gene in question, a description of the ``new'' traits or characteristics 
that are intended to be expressed, tests to evaluate genetic stability 
and exchange, and/or selected Tier II environmental expression and 
toxicology tests.
    (3) Pest control organisms such as insect predators, nematodes, and 
macroscopic parasites are exempt from the requirements of FIFRA as 
authorized by section 25(b) of FIFRA and specified in Sec. 152.20 (a) of 
this chapter.

[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988]