ASTM E1429-91(1996)
(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.
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Designation: E 1429 – 91 (Reapproved 1996)
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 incidence of a particular adverse health effect and whether the
adverse health effect is likely to occur in humans.
1.1 This guide covers a stepwise process for using informa-
3.1.3 human exposure concentration (HEC)—the concen-
tion concerning biological, chemical, physical, and toxicologi-
tration in the human environment based on application rate or
cal properties of a pesticide or other chemical(s), or of a
distribution, persistence in the environment, the chemical form
formulation to identify adverse effects that may occur to
of the material, and location of the pesticide or formulation in
pesticide applicators or others with potential exposure.
the air, on surfaces, in vegetation, or in soil.
1.2 The health hazard assessment process is complex and
3.1.4 maximum safe concentration for humans (MSCH)—a
requires decisions at a number of points; thus, the validity of
prediction of the highest concentration of a material that would
the assessment depends on the soundness of those decisions, as
have no unacceptable adverse effect on humans based on
well as the soundness of the information used. All decisions
toxicity testing in animals, clinical studies, and field experi-
should be based on carefully documented analyses so that an
ence.
appropriate assessment can be completed, at the least cost,
which is consistent with scientific validity.
4. Summary of Guide
1.3 This guide assumes that the reader is knowledgeable in
4.1 This guide describes a stepwise process for assessing the
animal toxicology and related pertinent areas, and relies
risk of a pesticide, chemical, or formulation to applicators and
heavily on the judgment of the evaluator, particularly in the
other individuals susceptible to exposure of pesticides by
area of chronic hazards.
considering the relationship between the material’s measured
1.4 This standard does not purport to address all of the
or estimated human exposure concentration(s) and the adverse
safety concerns, if any, associated with its use. It is the
effects likely to result. Unavailable necessary information
responsibility of the user of this standard to establish appro-
concerning human exposure concentrations and adverse effects
priate safety and health practices and determine the applica-
is obtained through a stepwise program that starts with
bility of regulatory limitations prior to use.
inexpensive information and progresses to expensive informa-
2. Referenced Documents tion if necessary. At the end of each iteration, the estimated or
measured human exposure concentration(s) is compared with
2.1 ASTM Standards:
2 information on possible adverse effects to determine the
E 609 Definition of Terms Relating to Pesticides
adequacy of the available data for assessing the health hazard.
E 943 Terminology Relating to Biological Effects and En-
If it is not possible to conclude that the health hazard is either
vironmental Fate
minimal or potentially excessive, the available data are judged
2.2 OSHA Standard:
inadequate to characterize the health hazard. If desired, appro-
29 CFR 1910.1200 Hazard Communication Standard
priate additional information is identified and obtained, so that
3. Terminology the health hazard can be reassessed. The process is repeated
until the health hazard is characterized adequately.
3.1 Definitions of Terms Specific to This Standard:
3.1.1 health hazard assessment—the identification and
5. Significance and Use
evaluation of the adverse effects likely to result from specified
5.1 Concern over the toxic effects observed in tests on
release(s) of a material. The estimate is only semi-quantitative.
animals has demonstrated the need to assess hazards of many
3.1.2 hazard identification—the process of determining
new, and some presently used, materials. The process described
whether exposure to an agent can cause an increase in the
herein will help producers, regulatory agencies, and others to
compare alternative materials efficiently and adequately, com-
This guide is under the jurisdiction of ASTM Committee E-35 on Pesticides
pletely assess a final candidate material, or reassess the health
and is the direct responsibility of Subcommittee E35.26 on Safety to Man.
hazard of a material already in use. The process is not intended
Current edition approved July 15, 1991. Published September 1991.
Annual Book of ASTM Standards, Vol 11.05.
for pesticide registration; this guide provides techniques for
Available from Superintendent of Documents, U.S. Government Printing
health hazard assessment.
Office, Washington, DC 20402.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
E 1429
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.
6.3 Hazard Identification—Based on chemical structure,
ment of the hazard of a material is to assemble all of the
available pertinent information concerning the following: information on similar materials, efficacy, and available data on
toxicity to animals, an initial assessment should be made of
6.1.1 Recommended use, frequency of application, amounts
of release, types of application, expected dispersion, and whether the material is biologically inactive or presents special
concerns. In some cases, enough data on the toxicity of the
potential for accidental release.
6.1.2 Composition, structure, and chemical reactions of the material may be available to allow a good estimate of the
concentrations likely to affect human beings adversely.
test material, with emphasis on those chemical properties likely
4,
to affect the testing procedures, HECs, and biological effects. 6.4 If the material(s) is subject to regulatory review by the
,
5 6
U.S. Environmental Protection Agency or other federal or state
Complete chemical characterization of the test material is
important, but it is often difficult to obtain. Many industrial agencies, the requirements of those regulations must be evalu-
chemicals contain a mixture of isomers, homologs, or polymer ated (see Appendix X2).
chains of various lengths, as well as impurities or by-products. 6.5 Phase I Health Hazard Assessment—By using informa-
The manufacturer(s) of the chemical(s) of interest should tion on the HECs and biological effects, the health hazard
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-
cant exposure to humans is very unlikely.
interest or similar materials are not available in the literature
(see Appendix X1), some acute and subchronic testing of the 6.5.1.2 Existing evidence indicates that the material and its
degradation products are toxicologically inactive to humans.
test material is necessary. Sources for definitions and some test
methods of acute animal toxicity are cited in Appendix X2. In 6.5.1.3 Toxicity is known for the material or materials of
similar structure to the test material, and exposure information
some cases, it is highly desirable to compare the toxicity of the
technical grade material with that of the purified active indicates that the exposure for humans is likely to be without
an appreciable potential for deleterious effects. The data should
ingredient. Use of reagent-grade materials can simplify the
development of structure-activity correlations, which may then include the results of acute, subchronic and, if available,
chronic testing.
allow estimates of the toxicity of more complex mixtures.
6.1.5 Efficacy data, particularly the nature of the target 6.5.2 Potentially Excessive Health Hazard—The determina-
tion of a potentially excessive health hazard is usually appro-
organism(s) and biological effects on this organism(s), may
provide some information on the toxicity of the material. priate if the HECs exceed the estimated MSCH. If there is
continuing interest in the material, Phase II must be considered.
6.5.3 Uncertain Health Hazard—For most new materials,
Condensed Chemical Dictionary, Van Nostrand Reinhold Co., New York, NY
the available information will not be adequate to allow the
(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
conclusion of a minimal or potentially excessive health hazard. 7.5.3.2 Experience with similar materials is limited or
Thus, the health hazard will have to be judged uncertain. If mixed, so that a definitive hazard assessment is lacking.
there is continuing interest in the material, Phase II must be
7.5.3.3 Human safety evaluations show unacceptable bio-
considered. logical activity.
7.5.3.4 If the health hazard is judged uncertain and there is
7. Phase II—Use of Medium-Cost Information
a continuing interest in the material, Phase III is necessary.
7.1 Whereas Phase I involves the collection and analysis of
already available data, Phase II will require at least some
8. Phase III—Use of High-Cost Information
medium-cost efforts to obtain new information on HECs and
8.1 Because of the substantial increase in time, effort, and
toxicity. An initial review of Phase I should indicate the most
money required for tests considered in Phase III, it is particu-
cost-effective starting point.
larly important in this phase that the health hazard assessment
7.2 Improved Estimates of Human Exposure
program be tailored to the individual material in order to obtain
Concentrations—The HECs used in Phase I may have been
the most useful information in the least expensive, scientifi-
obtained with only minimal information on release, and little or
cally sound manner.
no information on biological, chemical, and physical properties
8.2 Refined Estimates of Human Exposure
that determine environmental fate. In Phase II, appropriate tests
Concentrations—Unless it has already been conducted, a
should be undertaken to obtain important data on biological,
thorough modelling effort of the fate of the material should be
chemical, and physical properties which are not already avail-
performed using all available data. It is especially important to
able. If degradation is substantial, degradation products and
predict peak concentrations, concentrating mechanisms, and
their properties should be considered. Assumptions and data
persistence. If the material of concern is already in use, field
used to derive the HECs should be examined carefully to
monitoring should be used to validate the model. Potential
determine the confidence that should be placed in them. If the
application misuses or accidents should be considered.
material is already in use, some environmental monitoring is
8.3 Chronic Toxicity Testing—Biological tests for mutage-
appropriate; in addition, some field experience and work-place
nicity, carcinogenicity, neurotoxicity, reproduction, teratoge-
exposure data, if available, should be evaluated.
nicity, and inhalation should be conducted.
7.3 Toxicity Testing—Unless appropriate data are already
8.3.1 If the results of acute or subchronic toxicity tests
available, acute and subchronic toxicity tests will normally be
present an unusual pattern or show large differences in sensi-
necessary to evaluate ingestion, skin penetration and irritation,
tivity between species, chronic testing should probably include
eye irritation, and inhalation potential. Initial toxicity results on
more than one species. The species us
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