[Code of Federal Regulations]
[Title 40, Volume 22]
[Revised as of July 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR180.1011]

[Page 552-553]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 180_TOLERANCES AND EXEMPTIONS FROM TOLERANCES FOR PESTICIDE CHEMICALS 
IN FOOD--Table of Contents
 
                  Subpart D_Exemptions From Tolerances
 
Sec. 180.1011  Viable spores of the microorganism Bacillus thuringiensis 
Berliner; exemption from the requirement of a tolerance.

    (a) For the purposes of this section the microbial insecticide for 
which exemption from the requirement of a tolerance is being established 
shall have the following specifications:
    (1) The microorganism shall be an authentic strain of Bacillus 
thuringiensis Berliner conforming to the morphological and biochemical 
characteristics of Bacillus thuringiensis as described in Bergey's 
Manual of Determinative Bacteriology, Eighth Edition.
    (2) Spore preparations of Bacillus thuringiensis Berliner shall be 
produced by pure culture fermentation procedures with adequate control 
measures during production to detect any changes from the 
characteristics of the parent strain or contamination by other 
microorganisms.
    (3) Each lot of spore preparation, prior to the addition of other 
materials, shall be tested by subcutaneous injection of at least 1 
million spores into each of five laboratory test mice weighing 17 grams 
to 23 grams. Such test shall show no evidence of infection or injury in 
the test animals when observed for 7 days following injection.
    (4) Spore preparations shall be free of the Bacillus thuringiensis 
[beta]-exotoxin when tested with the fly larvae toxicity test 
(``Microbial Control of Insects and Mites,'' R.P.M. Bond et al., p. 280 
ff., 1971). This specification can be satisfied either by determining 
that each master seed lot brought into production is a Bacillus 
thuringiensis strain

[[Page 553]]

which does not produce [beta]-exotoxin under standard manufacturing 
conditions or by periodically determining that [beta]-exotoxin 
synthesized during spore production is eliminated by the subsequent 
spore-harvesting procedure.
    (b) Exemption from the requirement of a tolerance is established for 
residues of the microbial insecticide Bacillus thuringiensis Berliner, 
as specified in paragraph (a) of this section, in or on beeswax and 
honey and all other raw agricultural commodities when it is applied 
either to growing crops, or when it is applied after harvest in 
accordance with good agricultural practices.

[36 FR 22540, Nov. 25, 1971, as amended at 38 FR 19045, July 17, 1973; 
42 FR 28540, June 3, 1977; 45 FR 43721, June 30, 1980; 45 FR 56347, Aug. 
25, 1980]