United States Prevention, Pesticides EPA712-C-96-320
Environmental Protection and Toxic Substances February 1996
Agency (7101)
&EPA Microbial Pesticide
Test Guidelines
OPPTS 885.3400
Hypersensitivity
ncidents
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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 885.3400 Hypersensitivity incidents.
(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 the OPP guideline 152A-15.
(b) Reporting. (1) The reporting requirements for these incidents
should be the same as those for conventional chemical pesticide incident
reports as specified in the Pesticide Incident Report form (EPA Form
Number 8550-5, OMB Form number 158-R0008). The following informa-
tion should be provided, if available:
(i) A description of the ingredients (including the microbial pest con-
trol agent (MPCA)) to which affected individuals were exposed.
(ii) The frequency and duration of exposure to the material, and routes
of exposure.
(iii) The time, date, and location of exposure to the material.
(iv) The situation or circumstances under which exposure to the mate-
rial occurred.
(v) Any clinical observations.
(2) The data should be submitted to one of the following addresses:
(i) Via the U.S. Postal Service: Document Processing Desk, Office
of Pesticide Programs (7504C), Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460.
(ii) Via personal or courier delivery: Office of Pesticide Programs,
Document Processing Desk, Rm. 266A, Crystal Mall 2, 1921 Jefferson
Davis Highway, Arlington, VA 22202.
(c) Tier progression. If any incidents of hypersensitivity of humans
or domestic animals are observed during the production or testing of the
technical grade of the active ingredient, the manufacturing-use product,
or the end-use product, additional testing may be required. The specific
requirements will depend on the nature of the observations and will be
determined after consultation with the Agency.
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