ASTM E3155-19
(Guide)Standard Guide for Assessing Mammal Health at Chemically Contaminated Terrestrial Sites Using Rodent Sperm Analysis
Standard Guide for Assessing Mammal Health at Chemically Contaminated Terrestrial Sites Using Rodent Sperm Analysis
SIGNIFICANCE AND USE
5.1 The RSA method provides risk and resource managers with an enhanced understanding of the ecological health concerns at the sites they oversee because unlike conventional terrestrial ERAs, actual site mammals are the ones evaluated. Additionally, the HQs of desktop efforts report only on the contaminant exposure route of ingestion, and can only evaluate chemicals singly, whereas RSA findings reflect all three exposure routes as well as the combined effects of multiple chemicals on a highly valued endpoint. Critically, the RSA method incorporates site history considerations that necessarily influence the phenomenon of biological response. If reproductive impacts at contaminated sites were ever to be elicited, such would be apparent today because evaluated sites have, at a minimum, continuously exposed their ecological receptors to chemicals for multiple decades during which time tens and often more than one hundred generations have passed (5).
5.2 Application of the subject guide familiarizes remedial decision-makers and risk managers with two concepts. First, rather than attempting to predict health effects arising in site receptors, there may be more value in documenting demonstrated health effects, should such exist in actual site-exposed mammalian receptors. Second, the possibility exists that site receptors never experienced stress or impact over the years since a site first became contaminated.
5.3 Application of the subject guide can allow for substantial cost savings. Often, the outcomes of HQ-based assessments are summarily relied upon to conduct ongoing studies, monitor sites, or implement site cleanups, all of which may be unnecessary. Where RSA applications should demonstrate that maximally site-exposed mammalian receptors (as defined in section 4.1) are not experiencing compromise with regard to the sensitive endpoint of reproductive success, it can become apparent that soil remediation efforts on behalf of mammals are not needed.
5.4 The des...
SCOPE
1.1 This guide describes the procedures for obtaining and interpreting data associated with a direct health status assessment for mammalian receptors at chemically contaminated terrestrial sites where ERA work is either scheduled or ongoing, and irrespective of the number and type of chemicals that may be present. Through reviewing sperm features, the RSA method reports on the reproductive health of male rodents in their natural environmental settings, with these animals serving as surrogates for other (and larger) site mammals (4).
1.2 These procedures are applicable at any terrestrial property that supports small mammals (for example, mice, voles, rats, squirrels) and has contaminated soil. Importantly, chemicals of concern in site soils need not be spermatoxins. Additionally, the RSA method considers that any combination of chemicals or other site stressors might collectively act to compromise reproduction, held to be a sensitive toxicological endpoint for mammals. The anticipated primary application of the method will be at historically contaminated sites (such as Superfund sites). The procedures describe tasks conducted in the field and in a laboratory. For the latter, tasks may be conducted either in an on-site mobile laboratory, or in a more conventional laboratory setting. For certain tasks, a make-shift work space may be suitable as well (see 7.3).
1.3 Initial determinations of compromised or non-compromised reproduction in resident male small rodents are made through a cautious comparative review of sperm parameters. Briefly, for the rodents of a given species collected at both a contaminated site and a habitat-matched (non-contaminated) reference location, arithmetic means are first computed for each of the three sperm parameters of count, motility, and morphology. If one or more of the parameter means of the contaminated site rodents reflect an unfavorable shift (that is, count or motility is less than ...
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Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E3155 − 19
Standard Guide for
Assessing Mammal Health at Chemically Contaminated
1
Terrestrial Sites Using Rodent Sperm Analysis
This standard is issued under the fixed designation E3155; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Contaminated terrestrial properties provide opportunities for determining whether or not toxico-
logical responses of concern have arisen in ecological receptors contacting them. The guide,
employing direct health status assessment of rodents captured at contaminated sites, can furnish
information to support such determinations, thereby providing a greater degree of realism in health
assessmentsforresidentmammalsthanthatofferedingenericdesktopassessments.Thisguide’sdirect
health status assessment design involves only wild-type animals in their natural state, with this
arrangement circumventing a commonplace species extrapolation element, one that introduces a
considerable degree of uncertainty in ecological risk assessments (ERAs). Of note, the guide is not
itself a terrestrial ERA method, but rather an additional tool to inform such efforts. In the area of
notatingsignificanteffects,theguide’sbiologicalthresholds-for-effectreplacearbitrarilyornegotiated
differences, or both in response that are only assumed to be biologically meaningful (for example, a
2
20% decrement in a measure), and that typically are not confirmed in field studies (1). Due to the
availability of the thresholds-for-effect, the guide allows for bright-line determinations to be made,
creating an opportunity to supply a high level of conservatism to outcomes (see 9.4). Importantly,
Rodent Sperm Analysis (RSA) is distinctly different from others in concept and practice because it
aims to make yes/no determinations (that is, that reproductive impact has occurred or that it has not)
as opposed to generating estimates of the likelihood of certain toxicological outcomes arising in the
future. RSAprovides a useful line of evidence for ERA, wherein mammal reproduction is a common
endpoint, and it may simplify remedial decision-making for contaminated terrestrial sites.
This guide, notably removed from testing with laboratory-reared, commercially available, and
chemicallynaiveorganismsthataresubjectedtobriefchemicalexposuresincontrolledenvironments,
is predicated on a fundamental underlying premise consistent with the field condition considered (2,
3). It is recognized that sufficient time has elapsed at contaminated sites for toxicological effects of
concern to have been elicited. Given that typical sites are minimally 30 years old by the time they
submit to ERA (2-8), the described standard understands that if critical effects (here, reproductive
impacts) have not appeared over such a time course, they are unlikely to ever occur. Addressing
mammals, one of only two tetrapod classes evaluated in ERA(ClassAves is the other), the guide has
three unique features that set it apart from conventional ecological assessment tasks. First, the
proceduredirectlyassesseshealthbyevaluatingtheactualanimalsthatinhabitcontaminatedsites.(Of
note,commontoRSAandthedesktop-basedriskcharacterizationsofmanyconventionalERAs,isthe
defining of overall mammal health through the key biological function of reproduction.) Second, the
procedure considers the three chemical uptake routes of ingestion, inhalation, and dermal contact,
whereas conventional ERAs only report hazards for the first of these. The procedure’s third unique
feature is its ability to evaluate the effects of chemical mixtures, whereas the conventional hazard
quotient (HQ)-reliant ERAprocess can only review chemicals singly. The procedure is supported by
the existence of established sperm-based barometers of reproductive capability/success for the rodent
grouping. In contradistinction, for most other current biological measures that can be collected in the
laboratoryorfield(forexample,anenzymelevel,sizeofaninternalorgan),itisnotknownhowmuch
of a contaminated site-mediated sublethal change signifies health compromise (3, 9).
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E3155 − 19
1. Scope example, with respective home ranges of 400+ and 640 acres
for the red fox and white-tailed deer (10-14), these species
1.1 This guide describes the procedures for obtaining and
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