Microbial Pesticide Test Guidelines
OPPTS
885.4380
Honey Bee Testing,
Tier I
This guideline is one of
a series of test guidelines that have been developed by the Office of
Prevention, Pesticides and Toxic Substances, United States Environmental
Protection Agency for use in the testing of pesticides and toxic substances,
and the development of test data that must be submitted to the Agency
for review under Federal regulations.
The Office of Prevention, Pesticides
and Toxic Substances (OPPTS) has developed this guideline through
a process of harmonization that blended the testing guidance and requirements
that existed in the Office of Pollution
Prevention and Toxics (OPPT) and appeared in Title 40, Chapter
I, Subchapter R of the Code of Federal Regulations (CFR), the Office of Pesticide Programs
(OPP) which appeared in publications of the  National Technical Information Service (NTIS).
and the guidelines published by the Organization for Economic Cooperation
and Development (OECD).
The purpose of harmonizing
these guidelines into a single set of OPPTS guidelines is to minimize
variations among the testing procedures that must be performed to meet
the data requirements of the U. S. Environmental Protection Agency under
the Toxic
Substances Control Act (15 U.S.C.
2601) and the Federal
Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136, et
seq.).
(a)
Scope
(1)
Applicability. This guideline is intended to meet testing
requirements of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) (7 U.S.C. 136, et seq.).
(2)
Background. The source material used in developing this
harmonized OPPTS test guideline is OPP guideline 154A-24.
(b)
When required.
Data on the toxicity/pathogenicity
of a microbial pest control agent (MPCA) are required when the proposed
use pattern indicates that honey bees may be exposed to the pesticide,
and for each manufacturing-use product that may be used legally to formulate
such an end-use product. See 40 CFR 158.50
and 158.740 to determine whether these data must be submitted.
(c)
Test standards.
In addition to satisfying
the applicable general test standards outlined in OPPTS 885.0001,
the following apply:
(1)
Test substance. The actual form of the material to be
regarded as the test substance is discussed in OPPTS 885.0001.
In addition, any substances used to enhance virulence should be tested
along with the test substance.
(2)
Test species. Testing shall be performed on the honey
bee, Apis mellifera.
(3)
Age. When the MPCA may be expected to affect insect
larvae, test insects should include honey bee larvae.
(4)
Route of exposure. When the MPCA may be expected to
act by a dietary route of exposure or are particles of such a size that
they might be carried back to the hive like pollen, the honey bees must
be dosed orally. Testing in the hive may be necessary.
(5)
Controls. A concurrent control group is recommended
and should be treated with microbe-free (or nonviable microbe) material
from the culture system used for propagation of the MPCA.
(6)
Duration of test. Control and treated bees should be
observed for at least 30 days after dosing.
(d)
Reporting and evaluation of data.
The reporting requirements
are the same as those specified in OPPTS 885.0001.
(e)
Tier progression
(1) Data derived from Tier
I testing will be used in conjunction with available information on
use pattern, host range, and other factors, to assess potential for
adverse effects. If data indicate that the potential for adverse effects
exists, Tier II testing will be required as specified in 40 CFR 158.740.
In some cases, a subchronic test may serve to better understanding of
the effects observed at the Tier I level and alleviate the need for
Tier II testing.
(2) If toxic or pathogenic
effects are not observed in this study, additional testing is ordinarily
not necessary.
(f)
References.
The following references
are provided for use in the development of acceptable test protocols for
conducting a honey bee toxicity/pathogenicity test with a microbial pest
control agent:
(1) Davidson, E.W.
et al. Effect of Bacillus sphaericus strain SSII-1
on honey bees, Apis mellifera. Journal of Invertebrate Pathology
29:344-346 (1977).
(2) Menapace, D.M.
et al. Adult honey bees are not susceptible to infection by
Nosema locustae. Journal of Economic Entomology 71:304- 306
(1978).
(3) Morton, H.L.
et al. Effect of alfalfa looper nuclear polyhedrosis virus
in honey bees. Journal of Invertebrate Pathology 25:139-140 (1975).
(4) Hitchcock,
J.D. et al. Pathogenicity of Bacillus pulvifaciens
to honey bee larvae of various ages (Hymenoptera: Apidae). Journal of
Kansas Entomological Society 52:238-246 (1979).
United States
Environmental Protection Agency Prevention, Pesticides and Toxic Substances
(7101) EPA 712-C-96-337 February 1996
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