United States Prevention, Pesticides EPA712-C-96-265
Environmental Protection and Toxic Substances February 1996
Agency (7101)
&EPA Occupational and
Residential Exposure
Test Guidelines
OPPTS 875.1600
Application exposure
monitoring data
reporting
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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 875.1600 Application exposure monitoring data reporting.
(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.) and the Toxic Substances Control
Act (TSCA) (15 U.S.C. 2601).
(2) Background. The source material used in developing this har-
monized OPPTS test guideline is OPP guideline 236. This guideline should
be used with OPPTS 875.1000.
(b) Report format. If, in the registrant's opinion, a better format
would result in a more efficient review by the Agency, it may be used.
However, the information described herein must be included.
(1) Title page. The title page should conform with existing Agency
requirements.
(2) Table of contents. The table of contents should indicate the overall
organization of the report and list the page numbers for the different sec-
tions. Tables, figures, and appendices should be listed separately. (Section
tabs would be of help to the Agency in its review.)
(3) Introduction and summary, (i) This section should open with a
description of the purpose of the study and what requirement(s) it is in-
tended to satisfy. Background and historical information relative to the
study should be placed in this section.
(ii) The introduction and summary section should also contain an
overall summary of the study and mention, at a minimum, the following
points:
(A) The chemical (use the name used throughout the report and indi-
cate the formulation) was applied according to actual practice to the pri-
mary crop.
(B) The application rate in units of active ingredient per unit of area,
volume of spray per unit of area, and total units of active ingredient han-
dled during each work activity.
(C) The number of individuals involved in the study, indicating duties
and clothing worn during each work activity monitored.
(D) Indicate unusual problems (such as spills, unusual weather, or
equipment failure) resulting in necessary deviations from the intended test
protocol. Describe the effects of these deviations in the results of the study.
(E) Provide a name and phone number of a contact person in the
event the reviewer has technical questions about the study.
(4) Materials and methods, (i) This section should be in narrative
form, and should contain (in the following order) all details with regard
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to the materials, equipment, experimental design, site description, and pro-
cedures used in conducting the study. The registrant is encouraged to in-
clude drawings (or preferably photographs) of the test site equipment, and
the workers that show the placement of monitoring devices.
(ii) In this section, the following should be included:
(A) Chemical. The name of the active ingredient, CAS number, for-
mulation and percent or concentration of active ingredient and impurities,
EPA registration number, lot number, type of container, and chemical trade
name.
(B) Site. A description of the test site indicating the location, crop.
row spacing, and acres treated for outdoor applications and location, room
size, size of surface treated, ventilation during and after application, and
the air exchange for indoor applications.
(C) Test method. For all applications, a description of the application
rate, spray tank capacity, type of carrier and other additives, final mix
concentration, total pounds of active ingredient applied or mixed, and the
mixing procedures.
(7) For outdoor applications a detailed description of the application
and mixing/loading equipment including nozzle type, height from the
ground and the top of the crop, nozzle pressure, ground speed, boom
length, and cab description shall also be provided when applicable.
(2) For indoor applications a detailed description of the application
equipment, including type of spray nozzle shall be provided.
A description of the subjects used in the study. This shall include
work function, clothing worn (including protective clothing), placement
of all monitoring devices on the subjects, and the duration of the monitored
work function.
(4) A detailed description of the monitoring devices. The description
shall specify the material and brand of the devices used for passive dosim-
etry including total area and the area of the surface exposed to the test
chemical. The description of any air sampling devices shall include brand,
air flow rate, and the type of trapping device used, including the composi-
tion of the material in the collection media.
(5) A description of the laboratory studies conducted prior to initiating
the field studies. This shall include a description of the methodology used
to determine test chemical, stability on the collection media, the efficiency
of extraction, ad stability of the extracts.
(6) A description of the handling of samples from the time they were
taken in the field through analysis with special attention to the conditions
under which the samples were stored. In addition, the handling of storage
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stability samples to be used in determining if the pesticide residues are
stable under storage conditions shall be described.
(7) A description of the required field stability, field fortification, en-
vironmental conditions to which the fortified media was exposed, and a
description of the handling of the samples from field collection to labora-
tory analysis.
Elaboration on the difficulties or special problems that arose dur-
ing the study that necessitated deviation from the intended test protocol
and on the effects the deviations had on the results. This is intended to
include such circumstances as equipment failure and repair with may affect
the exposure monitoring.
(5) Analytical method, (i) The methods used in the study for each
test (i.e. efficiency of extraction, field fortification) are to be described
fully and include method validation data, recovery and method sensitivity
data, stability date, sample chromatograms, and sample calculations. Prepa-
ration and handling of the samples throughout the method should be de-
scribed in detail.
(ii) Identify the instrumentation, equipment, reagents used, and the
operating conditions of the instruments. If the extraction/clean-up proce-
dure is complex, a flow diagram should be submitted. Extraction effi-
ciencies, recoveries, precision, and limit of detection need to be reported
along with the technique used to determine these parameters for each
method.
(6) Results. This section should contain the scientific results of the
study and must be interpretive. Narrative and tables describing all calcula-
tions should be presented. The results shall be reported as described in
OPPTS 875.1000, under paragraphs (h)(6) and (i)(6). A sample calculation
for each separate mathematical manipulation must be provided.
(7) Discussion and conclusions. Because the ultimate determination
of the exposure produced by the use of a pesticide rests with the Agency,
these sections are optional.
(8) Quality assurance. Name (including signature and date) of the
person(s) responsible for the major quality control (QC) duties, should be
included. Also included should be the procedures undertaken by the reg-
istrant/laboratory to validate the report. This may be a list of all audits
and reviews performed that includes the study activity, the date activities
were performed, and the individual(s) involved. Any deficiencies and sub-
sequent corrective action taken should be described.
(9) Location of raw data and final report. The name and address
of the facility in which the raw data and final report are reposed must
be reported.
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(10) Signature page. This page shall contain the dated signatures of
all professionals and scientists involved with or responsible for the study.
(11) Tables and figures. Tables and figures are to be numbered using
Arabic numerals rather than Roman numerals or letters.
(12) References. References must be presented in a standard and con-
sistent format.
(13) Appendix(es). The Appendix(es) should contain:
(i) Copies of all relevant communications.
(ii) A copy of the Agency-approved study protocol and all subsequent
amendments to the protocol.
(iii) To facilitate exposure data reporting and entry into the computer-
ized data base, as well as to facilitate data entry for the registrants, data
entry diskettes and a Data Entry Diskette User's Guide are available at
no charge by calling the Agency contractor for Pesticide Handler Exposure
Database (PHED), Versar, Inc., at 1-800-2-VERSAR.
(iv) Sample chromatograms, diagrams, photographs, or other pictorial
material.
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