United States Prevention, Pesticides EPA712-C-96-345
Environmental Protection and Toxic Substances February 1996
Agency (7101)
&EPA Microbial Pesticide
Test Guidelines
OPPTS 885.4750
Aquatic Ecosystem Test
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INTRODUCTION
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 pub-
lished 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. Environ-
mental Protection Agency under the Toxic Substances Control Act (15
U.S.C. 2601) and the Federal Insecticide, Fungicide and Rodenticide Act
(7U.S.C. I36,etseq.).
Final Guideline Release: This guideline is available from the U.S.
Government Printing Office, Washington, DC 20402 on The Federal Bul-
letin Board. By modem dial 202-512-1387, telnet and ftp:
fedbbs.access.gpo.gov (IP 162.140.64.19), internet: http://
fedbbs.access.gpo.gov, or call 202-512-0132 for disks or paper copies.
This guideline is also available electronically in ASCII and PDF (portable
document format) from the EPA Public Access Gopher (gopher.epa.gov)
under the heading "Environmental Test Methods and Guidelines."
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OPPTS 885.4750 Aquatic ecosystem test.
(a) Scope—(1) Applicability. This guideline is intended to meet test-
ing 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 har-
monized OPPTS test guideline is OPP guideline 154A-29.
(b) Test standards. Specific requirements will be established on a
case-by-case basis. Data sufficient to satisfy the general test standards in
OPPTS 885.0001, and following:
(1) Test substance. The actual form of the material to be tested is
described in OPPTS 885.0001. In addition, any substances used to enhance
virulence should be tested along with the test substance.
(2) Test system. The microbial pest control agent (MPCA) will be
tested in a complex, realistic microcosm which should be designed in con-
sultation with the Agency. The microcosm should contain members from
all trophic levels found in natural aquatic ecosystems.
(3) Test organisms, (i) Following consultation with the Agency, the
registration applicant shall choose a combination of the following species
that reflects the species diversity of the target ecosystem:
(A) A typical bottom-feeding fish (e.g. catfish or carp).
(B) A cold-water fish, a warm-water fish, or a marine fish (e.g. brook
trout, rainbow trout, bass, bluegill, northern pike, walleye, or sheepshead
minnow).
(C) Mollusks (e.g. oyster or freshwater clams).
(D) Crustaceans (e.g. Daphnia spp., shrimp, or crayfish).
(E) Nymphs (e.g. mayfly).
(c) Reporting and evaluation of data. In addition to the information
required by OPPTS 885.0001, specific data reporting and evaluation re-
quirements will be established on a case-by-case basis following consulta-
tion with the Agency.
(d) Tier progression. If pathogenic effects are observed, simulated
and actual field testing may be required and, additional testing may be
required.
(e) References. The following contain useful background information
for developing acceptable protocols.
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(1) Johnson, B.T. and R.A. Schoettger. A biological model for esti-
mating the uptake, transfer, and degradation of xenobiotics in an aquatic
food chain. FEDERAL REGISTER 40(123):26906-26909 (June 25, 1975).
(2) Macek, K.J. et al. Bioconcentration of C14-pesticides exposure.
Pp. 119-142 in Structure-activity correlations in studies of toxicity and
bioconcentration with aquatic organisms. G.D. Veith and D.E.
Konasevich, eds. Proceedings of a Symposium, Burlington, Ontario, March
11-13, 1975. Sponsored by Standing Committees on Scientific Basis for
Water Control Criteria of the International Joint Commission's Research
Advisory Board (1975).
(3) Schimmel, S.C. et al. Acute toxicity to and bioconcentration of
endosulfan by estuarine animals. Pp. 241-252 in Aquatic Toxicology and
Hazard Evaluation. F.L. Mayer and J.L. Hamelink, eds. STP #634, Amer-
ican Society for Testing and Materials, Philadelphia, PA.
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