ASTM E1429-91(2004)
(Guide)Standard Guide for Assessing the Health Hazard of Pesticides to Applicators and Others with Potential Exposure (Withdrawn 2010)
Standard Guide for Assessing the Health Hazard of Pesticides to Applicators and Others with Potential Exposure (Withdrawn 2010)
SIGNIFICANCE AND USE
Concern over the toxic effects observed in tests on animals has demonstrated the need to assess hazards of many new, and some presently used, materials. The process described herein will help producers, regulatory agencies, and others to compare alternative materials efficiently and adequately, completely assess a final candidate material, or reassess the health hazard of a material already in use. The process is not intended for pesticide registration; this guide provides techniques for health hazard assessment.
Sequential assessment and feedback allow appropriate judgments concerning the efficient use of resources, thereby minimizing unnecessary testing and focusing effort on the information most pertinent to each material. For different materials and situations, hazard assessment will appropriately be based on substantially different amounts and kinds of biological, chemical, physical, and toxicological data.
Assessment of the health hazard of a material should never be considered complete for all time. Reassessment should be considered if new uses are discovered, the nature of the exposure changes, or new information on biological, chemical, physical, or toxicological properties becomes available.
Periodic review will help ensure that new information receives prompt and appropriate attention.
If a pesticide is transformed substantially into another chemical entity in the environment, the hazard of the transformed material(s) may need to be assessed.
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.
WITHDRAWN RATIONALE
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.
Formerly under the jurisdiction of Committee E35 on Pesticides and Alternative Control Agents, this guide was withdrawn in October 2010 due to inactivity and a lack of interest.
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:E1429–91(Reapproved 2004)
Standard Guide for
Assessing the Health Hazard of Pesticides to Applicators
and Others with Potential Exposure
This standard is issued under the fixed designation E1429; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope 3. Terminology
1.1 This guide covers a stepwise process for using informa- 3.1 Definitions of Terms Specific to This Standard:
tion concerning biological, chemical, physical, and toxicologi- 3.1.1 hazard identification—the process of determining
cal properties of a pesticide or other chemical(s), or of a whether exposure to an agent can cause an increase in the
formulation to identify adverse effects that may occur to incidence of a particular adverse health effect and whether the
pesticide applicators or others with potential exposure. adverse health effect is likely to occur in humans.
1.2 The health hazard assessment process is complex and 3.1.2 health hazard assessment—the identification and
requires decisions at a number of points; thus, the validity of evaluation of the adverse effects likely to result from specified
the assessment depends on the soundness of those decisions, as release(s) of a material.The estimate is only semi-quantitative.
well as the soundness of the information used. All decisions 3.1.3 human exposure concentration (HEC)—the concen-
should be based on carefully documented analyses so that an tration in the human environment based on application rate or
appropriate assessment can be completed, at the least cost, distribution, persistence in the environment, the chemical form
which is consistent with scientific validity. of the material, and location of the pesticide or formulation in
1.3 This guide assumes that the reader is knowledgeable in the air, on surfaces, in vegetation, or in soil.
animal toxicology and related pertinent areas, and relies 3.1.4 maximum safe concentration for humans (MSCH)—a
heavily on the judgment of the evaluator, particularly in the prediction of the highest concentration of a material that would
area of chronic hazards. have no unacceptable adverse effect on humans based on
1.4 This standard does not purport to address all of the toxicity testing in animals, clinical studies, and field experi-
safety concerns, if any, associated with its use. It is the ence.
responsibility of the user of this standard to establish appro- 3.2 For additional references to terms used in this guide, see
priate safety and health practices and determine the applica- Terminology E609 and E943.
bility of regulatory limitations prior to use.
4. Summary of Guide
2. Referenced Documents
4.1 Thisguidedescribesastepwiseprocessforassessingthe
2.1 ASTM Standards: risk of a pesticide, chemical, or formulation to applicators and
E609 Terminology Relating to Pesticides other individuals susceptible to exposure of pesticides by
E943 Terminology Relating to Biological Effects and Envi- considering the relationship between the material’s measured
ronmental Fate or estimated human exposure concentration(s) and the adverse
2.2 OSHA Standard: effects likely to result. Unavailable necessary information
29 CFR 1910.1200 Hazard Communication Standard concerning human exposure concentrations and adverse effects
is obtained through a stepwise program that starts with
inexpensive information and progresses to expensive informa-
This guide is under the jurisdiction ofASTM Committee E35 on Pesticides and
tion if necessary.At the end of each iteration, the estimated or
Alternative ControlAgents and is the direct responsibility of Subcommittee E35.26
measured human exposure concentration(s) is compared with
on Safety to Man.
Current edition approved Oct. 1, 2004. Published October 2004. Originally
information on possible adverse effects to determine the
approved in 1991. Last previous edition approved in 2000 as E1429 – 91 (2000).
adequacy of the available data for assessing the health hazard.
DOI: 10.1520/E1429-91R04.
If it is not possible to conclude that the health hazard is either
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM minimal or potentially excessive, the available data are judged
Standards volume information, refer to the standard’s Document Summary page on
inadequate to characterize the health hazard. If desired, appro-
the ASTM website.
priate additional information is identified and obtained, so that
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.
E1429–91 (2004)
the health hazard can be reassessed. The process is repeated 6.1.4 Toxicity of the pesticide or similar materials to mam-
until the health hazard is characterized adequately. mals and target organisms. If toxicity data on the material(s) of
interest or similar materials are not available in the literature
5. Significance and Use (see Appendix X1), some acute and subchronic testing of the
test material is necessary. Sources for definitions and some test
5.1 Concern over the toxic effects observed in tests on
methods of acute animal toxicity are cited inAppendix X2.In
animals has demonstrated the need to assess hazards of many
some cases, it is highly desirable to compare the toxicity of the
new,andsomepresentlyused,materials.Theprocessdescribed
technical grade material with that of the purified active
herein will help producers, regulatory agencies, and others to
ingredient. Use of reagent-grade materials can simplify the
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:
informationonsimilarmaterials,efficacy,andavailabledataon
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
testmaterial,withemphasisonthosechemicalpropertieslikely
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 ProtectionAgency 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 informa-
by-products.The manufacturer(s) of the chemical(s) of interest
tion 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
more of the following conditions exists:
6.5.1.1 Use and distribution patterns are such that signifi-
Condensed Chemical Dictionary, Van Nostrand Reinhold Co., New York, NY
cant exposure to humans is very unlikely.
(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 RiskAssessment and
OH (use latest edition). Occupational Health, Louis Publishers, Inc., Chelsea, MI, 1986.
E1429–91 (2004)
6.5.1.2 Existing evidence indicates that the material and its 7.5.2 Potentially Excessive Health Hazard—A judgment of
degradation products are toxicologically inactive to humans. potentially excessive health hazard is appropriate if acute and
subchronic toxicity levels occur at concentrations near or
6.5.1.3 Toxicity is known for the material or materials of
similar structure to the test material, and exposure information below the HECs. If the health hazard is judged potentially
excessive and there is continuing interest in the material, Phase
indicates that the exposure for humans is likely to be without
anappreciablepotentialfordeleteriouseffects.Thedatashould III is necessary.
7.5.3 Uncertain Health Hazard—The health hazard should
include the results of acute, subchronic and, if available,
chronic testing. be judged uncertain if the following are true:
7.5.3.1 The MSCH from acute and subchronic testing is
6.5.2 Potentially Excessive Health Hazard—Thedetermina-
only several-fold above the HECs.
tion of a potentially excessive health hazard is usually appro-
7.5.3.2 Experience with similar materials is limited or
priate if the HECs exceed the estimated MSCH. If there is
mixed, so that a definitive hazard assessment is lacking.
continuinginterestinthematerial,PhaseIImustbeconsidered.
7.5.3.3 Human safety evaluations show unacceptable bio-
6.5.3 Uncertain Health Hazard—For most new materials,
logical activity.
the available information will not be adequate to allow the
7.5.3.4 If the health hazard is judged uncertain and there is
conclusion of a minimal or potentially excessive health hazard.
a continuing interest in the material, Phase III is necessary.
Thus, the health hazard will have to be judged uncertain. If
there is continuing interest in the material, Phase II must be
8. Phase III—Use of High-Cost Information
considered.
8.1 Because of the substantial increase in time, effort, and
money required for tests considered in Phase III, it is particu-
7. Phase II—Use of Medium-Cost Information
larly important in this phase that the health hazard assessment
7.1 Whereas Phase I involves the collection and analysis of
programbetailoredtotheindividualmaterialinordertoobtain
already available data, Phase II will require at least some
the most useful information in the least expensive, scientifi-
medium-cost efforts to obtain new information on HECs and
cally sound manner.
toxicity. An initial review of Phase I should indicate the most
8.2 Refined Estimates of Human Exposure
cost-effective starting point.
Concentrations—Unless it has already been conducted, a
7.2 Improved Estimates of Human Exposure
thorough modelling effort of the fate of the material should be
Concentrations—The HECs used in Phase I may have been
performed using all available data. It is especially important to
obtainedwithonlyminimalinformationonrelease,andlittleor
predict peak concentrations, concentrating mechanisms, and
noinformationonbiological,chemical,andphysicalproperties
persistence. If the material of concern is already in use, field
thatdetermineenvironmentalfate.InPhaseII,appropriatetests
monitoring should be used to validate the model. Potential
should be undertaken to obtain important data on biological,
application misuses or accidents should be considered.
chemical, and physical properties which are not already avail-
8.3 Chronic Toxicity Testing—Biological tests for mutage-
able. If degradation is substantial, degradation products and
nicity, carcinogenicity, neurotoxicity, reproduction, teratog
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.