United States Prevention, Pesticides EPA712-C-96-299
Environmental Protection and Toxic Substances February 1996
Agency (7101)
&EPA Microbial Pesticide
Test Guidelines
OPPTS 885.2000
Background for Residue
Analysis of Microbial
Pest Control Agents
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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 885.2000 Background for residue analysis of microbial pest
control agents.
(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 153A-l.
(b) Requirements. A petition for a tolerance or for an exemption
from the requirement of a tolerance must be submitted as specified in 40
CFR 158.740 in connection with each application for registration of a mi-
crobial pest control agent (MPCA) where usage may result in residues
in or on food for humans or feed for domestic animals used for human
food. This petition must contain data satisfying the requirements of 40
CFR 158.740 which are detailed in OPPTS 885, Group B (Residue Test
Guidelines) unless specifically exempted from the requirements.
(c) Purpose. Residue chemistry data are designed to provide the in-
formation necessary to determine the site, nature, and magnitude of resi-
dues in or on food or feed. This information includes plant metabolism
data, residue data, analytical methodology, and, when indicated, animal
metabolism data and animal feeding studies to determine the carry over
of residues into meat, milk, poultry, and eggs.
(d) Authority. Pesticides including MPCAs, intended for use on food
or feed crops, or where usage may reasonably be expected to result (di-
rectly or indirectly) in residues in food or feed, will not be registered un-
less a tolerance, or an exemption from the requirement of a tolerance,
has been established by the Agency, as provided for under sections 406,
408, or 409 of the Federal Food, Drug, and Cosmetic Act ((FFDCA) 21
U.S.C. 346, 346a, and 348). The procedural regulations for filing petitions
for a tolerance or an exemption are included in 40 CFR 180.7.
(e) Approach. The use of an MPCA on food, feed, or raw agricultural
commodities requires that a tolerance, or an exemption from the require-
ment for a tolerance, be established by the Agency. In considering exemp-
tions from the requirement for tolerances, the Agency recognizes that
MPCAs do not necessarily pose the same potential hazards as conventional
chemical pesticides. In fact, certain characteristics of many of these agents
suggest that they may pose relatively less hazard. These characteristics
are listed below:
(1) The efficacy of the agent often depends upon its ability to rep-
licate in the target pest, which is not likely to remain on the crop after
harvest.
(2) The living form of the agent in most instances will usually not
replicate in the absence of the specific target pest (e.g. insect host).
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(3) Certain environmental conditions such as sunlight, rainfall, winds,
humidity, and temperature often greatly reduce the viability of the agent;
therefore, the residues of living organisms are apt to be small or relatively
insignificant shortly after application.
(4) Data supporting currently registered MPCAs indicate that they
would not likely pose a hazard to humans or other mammals.
(5) In many instances where and when a microorganism is used as
an MPCA, the microorganism is already normally present in the environ-
ment and has demonstrated no adverse effects.
(6) Residues of microorganisms used as MPCAs that are capable of
replication on food or feed—a very remote possibility—may be rendered
nonviable or be removed by the usual processing of such foods and feeds
(i.e., washing, drying, heat sterilization, and additions of sugar, salt, and
other preservatives).
(f) Tier progression. The Agency evaluates residue data for MPCAs
used on food, feed, or raw agricultural commodities only if toxic or other
harmful properties were observed in the maximum hazard toxicology tests
(Tier I) prescribed in toxicology test guidelines OPPTS 885.3050 through
885.3650 of this series. If Tier I toxicology tests indicate no toxic or other
harmful properties, then no residue data (with the general exception of
a monitoring method) would be indicated and thus a recommendation for
an exemption from the requirements of a tolerance can be made.
(g) General residue data requirements for MPCAs—(1) When re-
quired. Residue data are required by 40 CFR 158.740 to be included in
a petition for a tolerance or for an exemption from the requirement of
a tolerance, in connection with each application for registration of a manu-
facturing-use product or end-use product composed of or containing an
MPCA, when the following conditions are met:
(i) When the product is intended for use on food or feed crops.
(ii) When use of the product is expected to result in residues in or
on food or feed.
(iii) When results of Tier I toxicology studies conducted in accord-
ance with OPPTS 885.3050 through 885.3500 indicate that there may be
significant human health concerns.
(iv) Residue data may not be required and an exemption from the
requirement of a tolerance may be recommended for products intended
for use on food feed crops or for uses expected to result in residues in
or on food or feed, when the toxicology data developed from Tier I testing,
in accordance with toxicology test guidelines OPPTS 885.3050 through
885.3650 of this series, indicate that there are no significant human health
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concerns. The exception to this is that a monitoring method will be re-
quired for each registered MFC A, even if exempt from tolerance.
(2) Procedures, standards, and reporting. In addition to the provi-
sions set forth in OPPTS 885.0001 that are applicable, the following guid-
ance is provided for conducting, developing, and reporting the residue data
that the Agency requires to support a petition for a tolerance or for an
exemption fom the requirement of a tolerance. In general, the guidance
in OPPTS series 860, particularly in terms of rationale and approach, is
applicable to MPCAs under this subdivision. Unless addressed below, all
parts of OPPTS series 860 as written are to be considered applicable to
this series OPPTS 885; the term "pesticide" is assumed to include
MPCAs. Discussion with appropriate Agency scientists may be helpful be-
fore steps are taken to develop residue data of the nature outlined in this
series.
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