ASTM E1429-91(2000)
(Guide)Standard Guide for Assessing the Health Hazard of Pesticides to Applicators and Others with Potential Exposure
Standard Guide for Assessing the Health Hazard of Pesticides to Applicators and Others with Potential Exposure
SCOPE
1.1 This guide covers a stepwise process for using information concerning biological, chemical, physical, and toxicological properties of a pesticide or other chemical(s), or of a formulation to identify adverse effects that may occur to pesticide applicators or others with potential exposure.
1.2 The health hazard assessment process is complex and requires decisions at a number of points; thus, the validity of the assessment depends on the soundness of those decisions, as well as the soundness of the information used. All decisions should be based on carefully documented analyses so that an appropriate assessment can be completed, at the least cost, which is consistent with scientific validity.
1.3 This guide assumes that the reader is knowledgeable in animal toxicology and related pertinent areas, and relies heavily on the judgment of the evaluator, particularly in the area of chronic hazards.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
General Information
Relations
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E 1429 – 91 (Reapproved 2000)
Standard Guide for
Assessing the Health Hazard of Pesticides to Applicators
and Others with Potential Exposure
This standard is issued under the fixed designation E 1429; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope 3.1.2 hazard identification—the process of determining
whether exposure to an agent can cause an increase in the
1.1 This guide covers a stepwise process for using informa-
incidence of a particular adverse health effect and whether the
tion concerning biological, chemical, physical, and toxicologi-
adverse health effect is likely to occur in humans.
cal properties of a pesticide or other chemical(s), or of a
3.1.3 human exposure concentration (HEC)—the concen-
formulation to identify adverse effects that may occur to
tration in the human environment based on application rate or
pesticide applicators or others with potential exposure.
distribution, persistence in the environment, the chemical form
1.2 The health hazard assessment process is complex and
of the material, and location of the pesticide or formulation in
requires decisions at a number of points; thus, the validity of
the air, on surfaces, in vegetation, or in soil.
the assessment depends on the soundness of those decisions, as
3.1.4 maximum safe concentration for humans (MSCH)—a
well as the soundness of the information used. All decisions
prediction of the highest concentration of a material that would
should be based on carefully documented analyses so that an
have no unacceptable adverse effect on humans based on
appropriate assessment can be completed, at the least cost,
toxicity testing in animals, clinical studies, and field experi-
which is consistent with scientific validity.
ence.
1.3 This guide assumes that the reader is knowledgeable in
animal toxicology and related pertinent areas, and relies
4. Summary of Guide
heavily on the judgment of the evaluator, particularly in the
4.1 This guide describes a stepwise process for assessing the
area of chronic hazards.
risk of a pesticide, chemical, or formulation to applicators and
1.4 This standard does not purport to address all of the
other individuals susceptible to exposure of pesticides by
safety concerns, if any, associated with its use. It is the
considering the relationship between the material’s measured
responsibility of the user of this standard to establish appro-
or estimated human exposure concentration(s) and the adverse
priate safety and health practices and determine the applica-
effects likely to result. Unavailable necessary information
bility of regulatory limitations prior to use.
concerning human exposure concentrations and adverse effects
2. Referenced Documents is obtained through a stepwise program that starts with
inexpensive information and progresses to expensive informa-
2.1 ASTM Standards:
2 tion if necessary. At the end of each iteration, the estimated or
E 609 Terminology Relating to Pesticides
measured human exposure concentration(s) is compared with
E 943 Terminology Relating to Biological Effects and En-
2 information on possible adverse effects to determine the
vironmental Fate
adequacy of the available data for assessing the health hazard.
2.2 OSHA Standard:
3 If it is not possible to conclude that the health hazard is either
29 CFR 1910.1200 Hazard Communication Standard
minimal or potentially excessive, the available data are judged
3. Terminology inadequate to characterize the health hazard. If desired, appro-
priate additional information is identified and obtained, so that
3.1 Definitions of Terms Specific to This Standard:
the health hazard can be reassessed. The process is repeated
3.1.1 health hazard assessment—the identification and
until the health hazard is characterized adequately.
evaluation of the adverse effects likely to result from specified
release(s) of a material. The estimate is only semi-quantitative.
5. Significance and Use
5.1 Concern over the toxic effects observed in tests on
This guide is under the jurisdiction of ASTM Committee E35 on Pesticides and animals has demonstrated the need to assess hazards of many
is the direct responsibility of Subcommittee E35.26 on Safety to Man.
new, and some presently used, materials. The process described
Current edition approved July 15, 1991. Published September 1991.
2 herein will help producers, regulatory agencies, and others to
Annual Book of ASTM Standards, Vol 11.05.
Available from Superintendent of Documents, U.S. Government Printing
Office, Washington, DC 20402.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E 1429
compare alternative materials efficiently and adequately, com- development of structure-activity correlations, which may then
pletely assess a final candidate material, or reassess the health allow estimates of the toxicity of more complex mixtures.
hazard of a material already in use. The process is not intended
6.1.5 Efficacy data, particularly the nature of the target
for pesticide registration; this guide provides techniques for organism(s) and biological effects on this organism(s), may
health hazard assessment.
provide some information on the toxicity of the material.
5.2 Sequential assessment and feedback allow appropriate 6.1.6 Material Safety Data Sheet (MSDS). Obtain or pre-
judgments concerning the efficient use of resources, thereby
pare a MSDS (such as OSHA Form 174) for each material or
minimizing unnecessary testing and focusing effort on the formulation under evaluation; this information should comply
information most pertinent to each material. For different
with OSHA Standard 29 CFR 1910.1200. A revised MSDS
materials and situations, hazard assessment will appropriately should be prepared when a change in the composition of the
be based on substantially different amounts and kinds of
material/product occurs which changes any of the information
biological, chemical, physical, and toxicological data. on the MSDS, or when the investigator becomes aware of any
5.3 Assessment of the health hazard of a material should
significant information regarding the health hazards of a
never be considered complete for all time. Reassessment chemical or ways in which to protect against the health
should be considered if new uses are discovered, the nature of
hazards.
the exposure changes, or new information on biological,
6.2 Initial Estimates of Human Exposure Concentrations
chemical, physical, or toxicological properties becomes avail-
(HEC)—Based on the available information on recommended
able.
usage, chemical and physical properties, and analogy with
5.4 Periodic review will help ensure that new information
other pesticides for which data are available, an initial estimate
receives prompt and appropriate attention.
should be made of the concentrations likely to be found on
5.5 If a pesticide is transformed substantially into another
various surfaces and in the air. Information on persons who
chemical entity in the environment, the hazard of the trans-
will be exposed (age and weight), the duration and frequency
formed material(s) may need to be assessed.
of exposures, and the potential for drift during application, and
possible misuses (both intentionally and unintentionally) are
6. Phase I—Use of Low-Cost Information
needed. From these data, human exposure by skin contact,
6.1 Collection of Available Data—The initial step in assess- ingestion, and inhalation are estimated.
ment of the hazard of a material is to assemble all of the
6.3 Hazard Identification—Based on chemical structure,
available pertinent information concerning the following:
information on similar materials, efficacy, and available data on
6.1.1 Recommended use, frequency of application, amounts
toxicity to animals, an initial assessment should be made of
of release, types of application, expected dispersion, and
whether the material is biologically inactive or presents special
potential for accidental release.
concerns. In some cases, enough data on the toxicity of the
6.1.2 Composition, structure, and chemical reactions of the
material may be available to allow a good estimate of the
test material, with emphasis on those chemical properties likely
concentrations likely to affect human beings adversely.
to affect the testing procedures, HECs, and biological ef-
6.4 If the material(s) is subject to regulatory review by the
4,5,6
fects. Complete chemical characterization of the test ma-
U.S. Environmental Protection Agency or other federal or state
terial is important, but it is often difficult to obtain. Many
agencies, the requirements of those regulations must be evalu-
industrial chemicals contain a mixture of isomers, homologs,
ated (see Appendix X2).
or polymer chains of various lengths, as well as impurities or
6.5 Phase I Health Hazard Assessment— By using infor-
by-products. The manufacturer(s) of the chemical(s) of interest
mation on the HECs and biological effects, the health hazard
should supply this information.
should be assessed as either minimal, potentially excessive, or
6.1.3 Physical properties, with particular emphasis on vola-
uncertain.
tility, evaporation rate, surface tension, dispersibility, sorption,
6.5.1 Minimal Health Hazard—The health hazard to pesti-
and solubility.
cide users and others can usually be judged minimal if one or
6.1.4 Toxicity of the pesticide or similar materials to mam-
more of the following conditions exists:
mals and target organisms. If toxicity data on the material(s) of
6.5.1.1 Use and distribution patterns are such that signifi-
interest or similar materials are not available in the literature
cant exposure to humans is very unlikely.
(see Appendix X1), some acute and subchronic testing of the
6.5.1.2 Existing evidence indicates that the material and its
test material is necessary. Sources for definitions and some test
degradation products are toxicologically inactive to humans.
methods of acute animal toxicity are cited in Appendix X2. In
6.5.1.3 Toxicity is known for the material or materials of
some cases, it is highly desirable to compare the toxicity of the
similar structure to the test material, and exposure information
technical grade material with that of the purified active
indicates that the exposure for humans is likely to be without
ingredient. Use of reagent-grade materials can simplify the
an appreciable potential for deleterious effects. The data should
include the results of acute, subchronic and, if available,
chronic testing.
Condensed Chemical Dictionary, Van Nostrand Reinhold Co., New York, NY
(use latest edition).
The Merck Index: An Encyclopedia of Chemicals and Drugs, Merck and
Company, Rahway, NJ (use latest edition).
6 7
Handbook of Chemistry and Physics, Chemical Rubber Company, Cleveland, Hallenbeck, W. H. and Cunningham, K. M., Quantitative Risk Assessment and
OH (use latest edition). Occupational Health, Louis Publishers, Inc., Chelsea, MI, 1986.
E 1429
6.5.2 Potentially Excessive Health Hazard—The determina- 7.5.3 Uncertain Health Hazard—The health hazard should
tion of a potentially excessive health hazard is usually appro- be judged uncertain if the following are true:
priate if the HECs exceed the estimated MSCH. If there is 7.5.3.1 The MSCH from acute and subchronic testing is
continuing interest in the material, Phase II must be considered. only several-fold above the HECs.
7.5.3.2 Experience with similar materials is limited or
6.5.3 Uncertain Health Hazard—For most new materials,
the available information will not be adequate to allow the mixed, so that a definitive hazard assessment is lacking.
7.5.3.3 Human safety evaluations show unacceptable bio-
conclusion of a minimal or potentially excessive health hazard.
Thus, the health hazard will have to be judged uncertain. If logical activity.
7.5.3.4 If the health hazard is judged uncertain and there is
there is continuing interest in the material, Phase II must be
considered. a continuing interest in the material, Phase III is necessary.
8. Phase III—Use of High-Cost Information
7. Phase II—Use of Medium-Cost Information
8.1 Because of the substantial increase in time, effort, and
7.1 Whereas Phase I involves the collection and analysis of
money required for tests considered in Phase III, it is particu-
already available data, Phase II will require at least some
larly important in this phase that the health hazard assessment
medium-cost efforts to obtain new information on HECs and
program be tailored to the individual material in order to obtain
toxicity. An initial review of Phase I should indicate the most
the most useful information in the least expensive, scientifi-
cost-effective starting point.
cally sound manner.
7.2 Improved Estimates of Human Exposure
8.2 Refined Estimates of Human Exposure
Concentrations—The HECs used in Phase I may have been
Concentrations—Unless it has already been conducted, a
obtained with only minimal information on release, and little or
thorough modelling effort of the fate of the material should be
no information on biological, chemical, and physical properties
performed using all available data. It is especially important to
that determine environmental fate. In Phase II, appropriate tests
predict peak concentrations, concentrating mechanisms, and
should be undertaken to obtain important data on biological,
persistence. If the material of concern is already in use, field
chemical, and physical properties which are not already avail-
monitoring should be used to validate the model. Potential
able. If degradation is substantial, degradation products and
application misuses or accidents should be considered.
their properties should be considered. Assumptions and data
8.3 Chronic Toxicity Testing—Biological tests for mutage-
used to derive the HECs should be examined carefully to
nicity, carcinogenicity, neurotoxicity, reproduction, teratoge-
determine the confidence that should be placed in them. If the
nicity, and inhalation should be conducted.
material is already in use, some environmental monitoring is
8.3.1 If the results of acute or subchronic toxicity tests
appropriate; in addition, some field experience and work-place
present an unusual pattern or show large differences in sensi-
exposure data, if available, should be evaluated.
tivity between species, chronic testing should probably include
7.3 Toxicity Testing—Unless appropriate data are already
more than one species. The spe
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.