4.1 Contaminated sites subject to remediation are growing in complexity and associated remediation costs, presenting a challenge for managers of contaminated sites. The need to properly monitor, evaluate, and report remediation processes (including physical, chemical, and biological) characterizing site conditions and contaminant mass and attenuation is critical for the evaluation and selection of effective remediation strategies. Assessment and characterization of biological processes associated with contaminant attenuation is supported and improved by the accurate and consistent use of molecular biological tools (MBTs) including data acquisition, interpretation, and reporting.4.2 The development of this guide through ASTM International is designed to meet the needs of managers of contaminated sites within the United States and elsewhere. The variety of available MBTs and the complexity with which they are currently being applied are not addressed in existing ASTM International Standards. The principal users of this guide should be industry project managers, regulators, consultants, analytical laboratories, and community stakeholders.1.1 This guide provides a framework for the application of molecular biological tools (MBTs) to assess and characterize in-situ biological processes to improve contaminated soil and groundwater management. While the focus of this guide is on in-situ biological processes, some concepts of how to apply MBTs can also be applied to ex-situ bioremediation approaches (for example, biopiles, bioreactors) to support design, operation, and troubleshooting. The intent of this guide is to develop a consistent way in which MBTs are applied at contaminated sites, not to develop expertise. Technical experts need to be engaged whenscoping, planning, executing, and interpreting data for MBTs. Lastly, there is a brief description of isotopic techniques within section 5.2; however, the scope and focus of this guide is the use of nucleic acid-based MBTs to assess biological processes at contaminated sites.1.2 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.3 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.
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1.1 The requirements in this document are for part manufacturers using additive manufacturing techniques and are independent of the used material and manufacturing method.1.2 This document specifies criteria for AM relevant processes as well as quality-relevant characteristics and factors along the additive system operations and defines activities and sequences within an additive manufacturing production site.1.3 This document is applicable to the additive manufacturing technologies defined in ISO/ASTM 52900 and defines quality assurance measures along the manufacturing process.1.4 Environment, health and safety aspects are not covered comprehensively in this document. The corresponding content is addressed in the equipment manufacturer guidelines and ISO/ASTM 52931, ISO 27548,2 ISO/ASTM 52933, and ISO/ASTM 52938-1.31.5 This document provides requirements that are additional to those provided by a quality management system (such as, ISO 9001, ISO/TS 22163, ISO 19443, EN 9100, ISO 13485, IATF 16949). Additionally, this document can be used to establish quality management system relevant content that is specific to AM-technology.1.6 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.
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4.1 Intended Use: 4.1.1 This guide may be used by various parties involved in sediment corrective action programs, including regulatory agencies, project sponsors, environmental consultants, toxicologists, risk assessors, site remediation professionals, environmental contractors, and other stakeholders.4.2 Importance of the CSM: 4.2.1 The CSM should be continuously updated and refined to describe the physical properties, chemical composition and occurrence, biologic features, and environmental conditions of the sediment corrective action project (Guide E1689).4.3 Reference Material: 4.3.1 This guide should be used in conjunction with other ASTM guides listed in 2.1 (especially Guides E3344 and E3382); this guide should also be used in conjunction with the material in the References at the end of this guide (including 1). Utilizing these reference materials will direct the user in developing representative background concentrations for a sediment site.4.4 Flexible Site-Specific Implementation: 4.4.1 This guide provides a systematic, but flexible, framework to accommodate variations in approaches by regulatory agencies and by the user based on project objectives, site complexity, unique site features, regulatory requirements, newly developed guidance, newly published scientific research, changes in regulatory criteria, advances in scientific knowledge and technical capability, and unforeseen circumstances.4.5 Regulatory Frameworks: 4.5.1 This guide is intended to be applicable to a broad range of local, state, tribal, federal, or international jurisdictions, each with its own unique regulatory framework. As such, this guide does not provide a detailed discussion of the requirements or guidance associated with any of these regulatory frameworks, nor is it intended to supplant applicable regulations and guidance. The user of this guide will need to be aware of the regulatory requirements and guidance in the jurisdiction where the work is being performed.4.6 Systematic Project Planning and Scoping Process: 4.6.1 When applying this guide, the user should undertake a systematic project planning and scoping process to collect information to assist in making site-specific, user-defined decisions for a particular project, including assembling an experienced team of project professionals. These practitioners should have the appropriate expertise to scope, plan, and execute a sediment data acquisition and analysis program. This team may include, but is not limited to, project sponsors, environmental consultants, toxicologists, site remediation professionals, analytical chemists, geochemists, and statisticians.4.7 Use of Representative Background to Set a Boundary: 4.7.1 Representative background concentrations for sediments can be used to delineate a sediment corrective action, establishing the boundary of the sediment corrective action area by distinguishing site-related impacts from representative background concentrations. This application requires the development of a BTV for the representative background data set.4.8 Use of Representative Background to Establish Cleanup Levels: 4.8.1 Representative background concentrations for sediments can be used to establish cleanup levels for use in sediment corrective actions. In cases where risk-based sediment cleanup levels are below representative background concentrations, background concentrations are typically used as the cleanup level (4). This ensures that the cleanup levels are sustainable. Any recontamination from ongoing sources will eventually result in surface sediment concentrations greater than the risk-based cleanup level, but the surface sediment should still meet a cleanup level based on representative background concentrations, even following recontamination.4.9 Use of Representative Background in Risk Assessments: 4.9.1 Representative background concentrations can be used in the risk assessment process (including human and ecological risk assessments) to understand risks posed by background levels of contaminants to human health and the environment, and the incremental risks posed by site-related releases or activities (or both) that result in sediment concentrations that exceed representative background concentrations. Conversely, they can be used to estimate the risk reduction for various contaminants, if sediment is remediated from existing COC concentrations to lower values (that is, representative background concentrations).4.10 Use of Representative Background in Post-Remedy Monitoring Programs: 4.10.1 Post-remedy monitoring programs can also use representative background sediment concentrations either as a corrective action target or to understand how post-remedy concentrations compare to the sources not attributable to current or historical site releases or activities. Typically, source control actions taken to ensure that site-related releases are controlled and will not re-contaminate the post-corrective action sediments must be developed based on an understanding of ongoing contributions from representative background. Ongoing sources unrelated to current or historical site-related releases or activities (that may or may not be subject to source control actions) must be considered in this evaluation.4.11 Other Considerations: 4.11.1 This guide does not cover all components of a program to develop representative sediment background concentrations.4.11.2 The overarching process to develop representative background concentrations (including CSM considerations) is not covered in detail in this guide but is discussed in more depth in Guide E3382.4.11.3 The selection of a background reference area(s) for the sediment site is not covered in detail in this guide but is extensively described in Guide E3344.4.11.4 Sediment sampling and laboratory analyses are not covered in this guide. Guides E3163 and E3164 contain extensive information concerning sediment sampling and laboratory analyses.4.11.5 Data quality objectives are not covered in this guide. Data quality objectives are described in (5).4.11.6 Background study design considerations are not covered in this guide but are described in other references, including Guides E3163 and E3164, as well as (6, 7).4.11.7 Geospatial analysis considerations are not thoroughly discussed in this guidance but are discussed in more depth relative to environmental evaluations in (8), which focuses on quality assurance concerns relative to geospatial analyses.4.11.8 In this guide, only the concentrations of COCs are considered to be in scope. Residual background radioactivity is out of scope.4.12 Structure and Components of This Guide: 4.12.1 The user of this guide should review the overall structure and components of this guide before proceeding with use, including:Section 1 Section 2 Referenced DocumentsSection 3 TerminologySection 4 Section 5 Overview of Representative Background Concentration Development ProcessSection 6 Development of Candidate Background Data SetsSection 7 Evaluation of Candidate Background Data Sets to Obtain Representative Background Data SetsSection 8 Data VisualizationSection 9 Evaluation of High Nondetect Data PointsSection 10 Evaluation of Outlying Data PointsSection 11 Forensic Chemistry Evaluation of Organic ContaminantsSection 12 Geochemical Evaluation of MetalsSection 13 Methodology Application to Develop a Representative Background Data Set from a Candidate Background Data SetSection 14 Development of Representative Background ConcentrationsSection 15 Comparison of Sediment Site and Representative Background Data Sets Using Statistical Two-Sample TestingSection 16 KeywordsAppendix X1 Organic and Inorganic Chemistry OverviewAppendix X2 Illustrative Case Studies from One Example Sediment SiteAppendix X3 Summaries for Outlier Testing and Two-Sample Statistical TestingReferences 1.1 This guide describes data visualization, statistical, forensic chemistry and geochemical methodologies (including case studies) used in the evaluation of candidate background data sets; this evaluation leads to the development of representative background data sets for the sediment site. Statistical methodologies can then be applied to the representative background data sets to develop background threshold values (BTVs) that are measures of the upper limit of representative sediment background concentrations for the sediment site. In addition, representative background data sets and sediment site data sets can be compared using two-sample statistical tests to determine if there are statistically significant differences (at a specified confidence level) between the two data sets (such as, the median or mean values of the two data sets are significantly different).1.1.1 This guide is intended to inform, complement, and support, but not supersede the guidelines established by local, state, tribal, federal, or international agencies.1.2 Technically defensible representative sediment background concentrations are critical for several purposes (1).2 These include sediment site delineation, establishing remedial goals and cleanup levels, remedy selection, assessment of risks posed by representative background concentrations, and establishing appropriate post-remedial monitoring plans.1.3 The overarching framework for the development of representative sediment background concentrations at sediment sites is presented in Guide E3382. Guide E3240 provides a general discussion of how conceptual site model (CSM) development fits into the risk-based corrective action framework for contaminated sediment sites, while Guide E3382 provides a detailed discussion of the elements of a sediment site CSM that need to be considered when developing representative sediment background concentrations. Guide E3344 describes how to select an appropriate background reference area(s) from which to collect sediment samples for laboratory analysis. Guide E3164 describes the sampling methodologies to obtain sediment samples in the field (whether from the sediment site or background reference area[s]), while Guide E3163 discusses appropriate laboratory methodologies for the chemical analysis of potential contaminants of concern (PCOCs) in the sediment samples. Relevant content contained in Guides E3344 and E3382 is summarized herein, but the individual guides should be consulted for more detailed coverage of these topics.1.4 This guide focuses on the approach for the development of representative sediment background concentrations used for remedial actions performed under various regulatory programs, including the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). Although many of the references cited in this guide are CERCLA oriented, the guide is applicable to remedial actions performed under local, state, tribal, federal, and international cleanup programs. However, the guide does not describe requirements for each jurisdiction. The requirements for the regulatory entity under which the cleanup is being performed should be reviewed to confirm compliance.1.5 This guide is designed to apply to contaminated sediment sites where sediment data have been collected and are readily available. Additionally, this guide assumes that risk assessments have been performed, so that the contaminants of concern (COCs) that exceed risk-based thresholds have been identified.1.5.1 Furthermore, this guide presumes that the identified risk-based thresholds are low enough to pose corrective action implementation challenges, or the site is subject to recontamination from uncontrolled ongoing anthropogenic or natural sources, or both. In all cases, representative sediment background concentrations will be useful for determining the extent of corrective remedial actions (when used as remedial goals or cleanup levels), evaluating risks posed by representative background concentrations, and establishing appropriate post-remedial monitoring plans.1.6 Units—The values stated in SI or CGS units are to be regarded as standard. No other units of measurement are included in this standard.1.7 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.8 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.
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4.1 Intended Use—This guide may be used by various parties involved in sediment corrective action programs, including regulatory agencies, project sponsors, environmental consultants, toxicologists, risk assessors, site remediation professionals, environmental contractors, and other stakeholders.4.2 Importance of the CSM—The CSM should be continuously updated and refined to describe the physical properties, chemical composition and occurrence, biologic features, and environmental conditions of the sediment corrective action project (Guide E1689).4.3 Reference Material—This guide should be used in conjunction with other ASTM guides listed in 2.1 (especially Guides E3242 and E3382); this guide should also be used in conjunction with the material in the References at the end of this guide (including 3). Utilizing these reference materials will direct the user in developing representative sediment background concentrations.4.4 Flexible Site-Specific Implementation—This guide provides a systematic but flexible framework to accommodate variations in approaches by regulatory agencies and by the user based on project objectives, site complexity, unique site features, regulatory requirements, newly developed guidance, newly published scientific research, changes in regulatory criteria, advances in scientific knowledge and technical capability, and unforeseen circumstances.4.5 Regulatory Frameworks—This guide is intended to be applicable at a broad range of local, state, tribal, federal (such as CERCLA), or international jurisdictions, each with its own unique regulatory framework. As such, this guide does not provide a detailed discussion of the requirements or guidance associated with any of these regulatory frameworks, nor is it intended to supplant applicable regulations and guidance. The user of this guide will need to be aware of the regulatory requirements and guidance in the jurisdiction where the work is being performed.4.6 Systematic Project Planning and Scoping Process—When applying this guide, the user should undertake a systematic project planning and scoping process to collect information to assist in making site-specific, user-defined decisions for a particular project, including assembling an experienced team of project professionals (that is, experienced practitioners familiar with current sediment site characterization and remediation techniques, as well as geochemistry and statistics). These practitioners should have the appropriate expertise to scope, plan, and execute a sediment data acquisition and analysis program. This team may include, but is not limited to, project sponsors, environmental consultants, toxicologists, site remediation professionals, analytical chemists, geochemists, and statisticians.4.6.1 Depending on the regulatory requirements in a jurisdiction, the choice of background reference areas may need to consider critical habitats and ecological receptors.4.6.2 In this guide, sediment (3.1.11) is defined as material being found at the bottom of a water body. Upland soils of sedimentary origin are excluded from consideration as sediment in this guide.4.7 Other Considerations—This guide does not cover all components of a program to develop representative sediment background concentrations.4.7.1 Sediment sampling and laboratory analyses are not covered in this guide. Guides E3163 and E3164 contain extensive information concerning sediment sampling and laboratory analyses.4.7.2 Data quality objectives are not covered in this guide. Data quality objectives are described in (4).4.7.3 Background study design considerations are not covered in this guide but are described in other references, including Guides E3163 and E3164, as well as (5).4.7.4 The use of data evaluation methodologies to obtain representative background data sets from candidate background data sets is not covered in detail in this guide but is discussed in more depth in Guide E3242.4.7.4.1 Identification and removal of high nondetect values from candidate background data sets are discussed in detail in Guide E3242.4.7.4.2 Identification and removal of outliers from candidate background data sets are discussed in detail in Practice E178, as well as Guide E3242.4.7.4.3 Geochemical methodologies used in evaluating candidate background data sets to obtain representative background data sets are discussed in detail in Guide E3242; their applications during background reference area selection are discussed in this guide.4.7.4.4 Chemical forensics methodologies used in evaluating candidate background data sets to obtain representative background data sets are discussed in detail in Guide E3242; their applications during background reference area selection are discussed in this guide.4.7.5 The use of statistical methods to develop BTVs from representative background data sets and to compare such data sets (or the developed BTVs) to the sediment site data sets are discussed in detail in Guide E3242.4.7.6 Geospatial analysis considerations are not thoroughly discussed in this guidance but are discussed in more depth relative to environmental evaluations in (6), which focuses on quality assurance concerns relative to geospatial analyses.4.7.7 In this guide, only the concentrations of PCOCs are considered to be in scope. Residual background radioactivity is out of scope.4.8 Structure and Components of this Guide—The user of this guide should review the overall structure and components of this guide before proceeding with use, including:Section 1 Section 2 Referenced DocumentsSection 3 TerminologySection 4 Section 5 Overview of Representative Background Concentrations and Calculation ProcessSection 6 Background Reference Area Selection CriteriaSection 7 KeywordsAppendix X1 Case StudyReferences 1.1 This guide focuses on the selection of sediment background reference areas from aquatic environments for the purpose of developing representative sediment background concentrations. These concentrations are typically used in contaminated sediment corrective actions performed under various regulatory programs, including the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). Although many of the references cited in this guide are CERCLA-oriented, the guide is applicable to remedial actions performed under local, state, tribal, federal, and international cleanup programs. However, this guide does not describe the requirements for each jurisdiction.1.1.1 The sediment background reference areas chosen using this guide will need to be approved by the regulatory agency having jurisdiction (or they should take no exception to the areas chosen), especially if the representative background sediment concentrations will potentially be used to develop sediment remedial criteria.1.2 This guide provides a framework to select appropriate sediment background reference areas for the collection of sediment data in the development of representative sediment background concentrations. It is intended to inform, complement, and support, but not supersede, local, state, tribal, federal, or international guidelines.1.2.1 This guide is designed to apply to contaminated sediment sites where sediment data have been collected and are readily available. Additionally, it assumes that risk assessments have been performed, so that the potential contaminants of concern (PCOCs) that exceed risk-based thresholds have been identified. This guide can be applied at multiple points within the project life cycle (such as site assessment and remedial design).1.2.2 Furthermore, this guide presumes that the identified risk-based thresholds are low enough to pose corrective action implementation challenges or that the sediment site is subject to recontamination from ongoing anthropogenic or natural sources (or both) that are not controlled. In either case, representative sediment background concentrations are useful for determining the extent of corrective remedial actions (when used as remedial goals), evaluating risks posed by representative background concentrations, and establishing appropriate post-remedial monitoring plans.1.2.3 A case study for selecting a background reference area using a tiered decision analysis approach is presented in Appendix X1. It compares various characteristics of a hypothetical sediment site associated with a former upland manufactured gas plant (MGP) facility to three candidate background reference areas and identifies the background reference area that best satisfies the decision analysis objectives.1.3 Methodologies used to develop representative background concentrations at contaminated sediment sites are not discussed in this guide—refer to Guide E3242 for a discussion of these methodologies.1.4 Related ASTM Standards—This guide is related to Guide E3382, which provides the overarching framework for the development of representative background concentrations at contaminated sediment sites, including Conceptual Site Model (CSM) considerations. This guide is also related to Guide E3242, which provides a detailed framework for developing representative sediment background concentrations, including statistical and geochemical considerations as well as background threshold values. This guide is also related to Guide E3164, which addresses corrective action monitoring before, during, and after sediment remediation activities, as well as Guide E3163, which concerns sediment sampling and analytical techniques used during sediment corrective action projects. Guide D4823, which concerns sediment core sampling, is also related to this guide.1.4.1 Specifically, this guide is intended to be used under the overarching framework of Guide E3382, in conjunction with the detailed framework to develop representative background values outlined in Guide E3242, to help ensure appropriate background reference areas are chosen for use in representative background concentration development.1.5 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this guide.1.6 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.7 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.
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4.1 The ESC Process—This practice describes a process for characterizing hazardous waste contaminated sites8, that provides cost-effective, timely, high-quality information derived primarily from judgement-based sampling and measurements by an integrated, multidisciplinary project team during a limited number of field mobilizations. (See Appendix X1 for additional background on the ESC process, its distinction from traditional site characterization, and its relationship to other approaches to site characterization and Appendix X5 and X6 for illustrative examples of the ESC process.)4.2 Determining Appropriateness of ESC—The ESC process should be initiated when an ESC client, regulatory authority, and stakeholders determine that contaminants at a site present a potential threat to human health or the environment and the ESC process will identify vadose zone, groundwater, and other contaminant migration pathways in a timely and cost-effective manner, especially when decisions concerning remedial or other action must be made as rapidly as possible. Situations where the process may be applicable are as follows:4.2.1 ESA—Sites where environmental site assessments (ESAs) conducted by using Practice E1527, Practice E1528, and Guide E1903 identify levels of contamination requiring further, more intensive characterization of the geologic and hydrologic system of contaminant migration pathways. Section X1.5.3 discusses the relationship between ESAs and the ESC process.4.2.2 Petroleum Release Sites—Large petroleum release sites, such as refineries. The user should review both this practice and Guide E1912 to evaluate whether the ESC or ASC process is more appropriate for such sites.4.2.3 Subsurface Radioactivity—Sites or facilities with subsurface contamination by radioactivity.4.2.4 Other Subsurface Contamination—Other sites or facilities where contaminant migration in the vadose zone and groundwater is a matter of concern and heterogeneity of the vadose zone and groundwater system or potential complex behavior of contaminants requires use of the ESC process.4.3 Defining Objectives and Data Quality Requirements—The ESC process requires project objectives and data quality requirements that will provide the ESC client, regulatory authority, and stakeholders with the necessary information to analyze risk or apply regulatory standards-based cleanup in order to choose a course of action. Once these have been defined, the ESC process relies on the expert judgement of the core technical team, operating within the framework of an approved dynamic work plan, as the primary means for selecting the type and location of measurements and samples throughout the ESC process. An ESC project focuses on collecting only the information required to meet the project objectives and ceases characterization as soon as the objectives are met.NOTE 4: This practice uses the term “data quality requirements” to refer to the level of data accuracy and precision needed to meet the intended use for the data. The U.S. EPA Data Quality Objectives (DQO) process is one way to accomplish this. The ESC process applies the concept of quality control and data quality requirements to geologic and hydrologic data as well as chemical data, but within a general framework of judgement-based rather than statistical sampling methods. Section X1.4.4 discusses the DQO process in more detail along with the role of judgement-based and statistically based sampling methods in the ESC process. Practice D5792 provides guidance on development of DQOs for generation of environmental data related to waste management.4.4 Use of ESC Process for Risk Analysis and Remedial Action: 4.4.1 Characterizing Contaminant Migration Pathways—Normally an ESC project will characterize the contaminant migration pathways (and sources if not already known) before any detailed risk analysis involving exposure to environmental receptors is performed, because environmental receptors are not known until the migration pathways are known. Risk analysis expertise will normally be required as an input into defining project objectives and data quality requirements (see 4.3); such expertise is involved as appropriate during field data collection phases of an ESC project. Identification of contaminant sources and environmental receptors for risk analysis is straightforward at most sites and does not, per se, require the ESC process. The ESC process focuses on characterizing vadose zone and groundwater contaminant migration pathways and determining the distribution, concentration, and fate of contaminants along these migration pathways, because these factors are more difficult to identify than sources and environmental receptors.4.4.2 Considering Remedial Action and Alternatives—The ESC process is designed to avoid a presumption that remedial action is required (that is, an engineered solution rather than no further action or ongoing monitoring). In any ESC project, remediation engineering expertise is incorporated into the process at the earliest point at which a need for remedial action is identified. (See 13.3.) Guide D5745 provides guidance for developing and implementing short-term measures or early actions for site remediation.4.5 Flexibility Within ESC—Modification of procedures described in this practice may be appropriate if required to satisfy project objectives or regulatory requirements, or for other reasons. The ESC process is flexible enough to accommodate a variety of different technical approaches to obtaining environmental data. However, for an investigation to qualify as an ESC project, as formalized by ASTM, modifications should not eliminate any of the essential features of the ESC process listed in Table 1. Alternative site characterization approaches that use some, but not all, of the essential elements described in Table 1 may be appropriate for a site, but these approaches would not qualify as an ESC project as defined in this practice.NOTE 5: Users may prefer to use or develop alternative terminology for different aspects of the ESC process, depending on the regulatory context in which it is applied. However, precise or approximate equivalencies to steps or functions in the ESC process should be clearly identified.4.6 Use of ESC in Conjunction with Other Methods—This practice can be used in conjunction with Guide D5730 for identification of potentially applicable ASTM standards and major non-ASTM guidance. In karst and fractured rock hydrogeologic settings, this practice can be used in conjunction with Guide D5717.1.1 Applicability of the ESC Process—This practice covers a process for expedited site characterization (ESC) of hazardous waste contaminated sites2 to identify vadose zone, groundwater and other relevant contaminant migration pathways and determine the distribution, concentration, and fate of contaminants for the purpose of providing an ESC client, regulatory authority, and stakeholders with the necessary information to choose a course of action.3 Generally, the process is applicable to larger-scale projects or contaminated sites where the ESC process can be reasonably expected to reduce the time and cost of site characterization compared to alternative approaches. The ESC process has been applied successfully at a variety of sites (see Table X1.1). It typically achieves significant cost and schedule savings compared to traditional site characterization (see X1.2 and X1.3),4 although it should be recognized that in-depth site characterization of hazardous waste contaminated sites may require a more elaborate process than ESC.1.2 Features of the ESC Process—The ESC process operates within the framework of existing regulatory programs. It focuses on collecting only the information required to meet characterization objectives and on ensuring that characterization ceases as soon as the objectives are met. Central to the ESC process is the use of judgement-based sampling and measurement to characterize vadose zone and groundwater contamination in a limited number of field mobilizations by an integrated multidisciplinary team, led by a technical leader and operating within the framework of a dynamic work plan that gives him or her the flexibility of responsibility to select the type and location of measurements needed to optimize data collection activities. Table 1 identifies other essential features of the ESC process, and Fig. 1 presents a flow diagram for the entire ESC process.FIG. 1 Overview of the Expedited Site Characterization Process1.3 Investigation Methods—The process described in this practice is based on good scientific practice but is not tied to any particular regulatory program, site investigation method or technique, chemical analysis method, statistical analysis method, risk analysis method, or computer modeling code. Appropriate investigation techniques in an ESC project are highly site specific and are selected and modified based upon the professional judgement of the core technical team (in particular the technical team leader). Whenever feasible, noninvasive and minimally invasive methods are used, as discussed in Appendix X2. Appropriate chemical analysis methods are equally site specific. Analyses may be conducted in the field or laboratory, depending on data quality requirements, required turnaround time, and costs.1.4 Sites Generally Not Appropriate for the ESC Process—Generally, the ESC process is not applicable to: small petroleum release sites, real estate property transactions that require no more than a Phase I ESA, sites where contamination is limited to the near surface or there is no basis for suspecting that contaminant movement through the vadose zone and groundwater is a matter of concern, sites where the cost of remedial action is likely to be less than the cost of site characterization, or sites where existing statutes or regulations prohibit the use of essential features of the ESC process.51.5 Other Potentially Applicable ASTM Standards for Site Characterization—Guide E1912 addresses accelerated site characterization (ASC) for petroleum release sites, and Guide E1739 addresses use of the risk-based corrective action (RBCA) process at petroleum release sites. Section X1.5.1 describes the ASC process, and X1.5.2 discusses the relationship between ESC and the RBCA process. Practices E1527 and E1528 and Guide E1903 address real estate property transactions, and X1.5.3 discusses the relationship between the ESC process and investigations for real estate property transactions. Classification D5746 addresses environmental conditions of property area types for Department of Defense installations, and Practice D6008 provides guidance on conducting environmental baseline surveys to determine certain elements of the environmental condition of federal real property.1.6 The values stated in both inch-pound and SI units are to be regarded separately as the standard. The values given in parentheses are for information only.1.7 All references in this standard to the “engineer” must be understood as referring to a qualified professional (such as an engineer, soil scientist or geologist) who has the appropriate experience and, if required by local regulations, certification.1.8 This practice offers an organized collection of information or a series of options and does not recommend a specific course of action. This document cannot replace education or experience and should be used in conjunction with professional judgment. Not all aspects of this practice may be applicable in all circumstances. This ASTM standard is not intended to represent or replace the standard of care by which the adequacy of a given professional service must be judged, nor should this document be applied without consideration of a project's many unique aspects. The word “Standard” in the title of this document means only that the document has been approved through the ASTM consensus process.1.9 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.10 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.
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5.1 This test method is useful in quality and cost control during manufacture. Both appearance and performance of pile yarn floor coverings can be affected by the number of binding sites per length and width.5.2 This test method is considered satisfactory for acceptance testing of commercial shipments because current estimates of between-laboratory precision are acceptable and the method is used extensively in the trade for acceptance testing.5.2.1 If there are differences of practical significance between reported test results for two laboratories (or more), comparative tests should be performed to determine if there is statistical bias between them using competent statistical assistance. As a minimum, use test samples for such comparative tests that are as homogeneous as possible, drawn form the same lot of material as the samples that resulted in the disparate results during initial testing, and that are randomly assigned in equal numbers to each laboratory for testing. The test results from the laboratories should be compared using a statistical test for unpaired data at a probability level chosen prior to the testing series. If a bias is found either its cause must be found and corrected, or future test results for that material must be adjusted in consideration of the know bias.1.1 This test method describes the measurement of the number of binding sites per unit length or width of machine-made, woven, knitted, and tufted pile yarn floor covering both before and after adhesive backing application.1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.1.3 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.4 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.
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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 described RSA method can typically be applied at that point in the ERA process where HQs for one or more mammalian species are found to be greater than 1.0, as in the process’s Step 2 (Screening-Level Exposure Estimate and Risk Calculation; where ecological threats are evaluated in a general, as opposed to a specific fashion). Alternatively and particularly at sites that are not governed as rigidly as, for example, Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA; aka Superfund-type) sites, the guide can be applied once it is established that a site has a chemical contamination footprint of interest (that is, that soil concentrations are high enough to potentially be harmful to mammalian site receptors). In light of the propensity for preliminary and refined HQs to suggest mammals are ingesting unhealthful doses of site contaminants, in turn commonly leading to advancing to the field for a verification effort, the application of RSA as a first evaluative effort is intended to be a time- and cost-saving effort.5.5 The significance of this guide is the method design that reflects an understanding of certain unavoidable ERA process constraints, specifically in the areas of field mammal collection and subsequent tissue analysis. First, the RSA method recognizes that small rodents are the only mammals that can be routinely culled from the field (that is, to be removed and not returned), and further, that this reality is unlikely to ever change. Efforts to regularly harvest larger mammals (for example, fox) may be challenged by local governing agencies and animal care institutions. Additionally, acquiring a sufficiency of larger mammals is time-consuming and labor-intensive, owing to relatively miniscule animal densities. Further, many larger mammals (for example, long-tailed weasel, badger) are not found in all habitats or in all states. In contrast, small rodents occur in virtually every habitat, are relatively easy to collect, and are numerous enough to allow for defensible comparisons between or among sites. In selecting the maximally exposed small rodent to work with (that is, an animal confined to contaminated surroundings throughout its life due to a home range that is almost always of one acre or less), the RSA method features a common basis of comparison (and certainly wherever it should be applied in the United States).5.6 RSA theory understands that, generally at contaminated terrestrial sites, there is worry that receptors-of-concern might be reproductively compromised. The focus on reproduction as the dominant toxicological endpoint of concern (6, 7), recognizes that much method development for reproductive effects in rodents (in support of human health) has occurred (9, 17). That reproduction bears this status is evident in the hierarchy of preferred toxicity reference values (TRVs) that ecological risk assessors often select in support of HQ computation. Additional recognition is given to the reality that standardized means for effectively assessing other endpoints of interest in field-collected organisms, such as neurotoxicity or behavior, do not exist. Where established sperm parameter benchmark exceedances are not observed in contaminated site rodents, such can constitute a significant line of evidence in support of a determination that reproduction is proceeding adequately. The RSA method recognizes that impairments to other biological functions (for example, behavior, nerve impulse transmission) of contaminated-site rodents may be occurring despite reproduction proceeding normally (2, 3). Where such is the case, the method’s supporting theory understands that other endpoints being reached do not necessarily pose a concern for they have not impeded the ability of maximally exposed rodents to survive to the age of reproduction, find mates, and produce viable young (2, 18).5.7 This guide recognizes that an analagous reproductive assessment approach for female rodents, is not available at the present time. Importantly, an absent reproductive assessment approach for females does not constitute a shortcoming of the subject guide. Relevant U.S. EPA guidance, for example, supports evaluating one sex of a species where drug and chemical regulation is concerned, and drawing conclusions based on such information (19). In this context several noteworthy points follow. First, over 98 % of all mammalian toxicity studies considered in crafting the U.S. EPA’s Soil Screening Levels (SSLs) for ERA (for some 17 inorganic and 4 organic chemical species) are of the single-sex type, with 35 % of the studies being male-only (20). Additionally, for 37 % of the universe of chemicals with SSLs, the number of male-only toxicity studies exceeds the number of female-only toxicity studies. Finally, a significant percentage of the most commonly applied toxicological benchmarks for wildlife (21) derive from single-sex studies. Critically, with its focus on directly assessing reproduction in male rodents, RSA is notably far less destructive than would be a method involving the culling of female rodents from the field, given that the latter are the ones that bear the young.5.8 This guide recognizes the value in employing the wild rodent in field-based mammalian receptor assessment. Aside from the reality that rodents may constitute the only mammals that can regularly be culled from sites (discussed above), there are key advantages that accrue to working with these animals. Small rodents occur in nearly all terrestrial habitats, allowing the guide to be broadly applicable in a geographical sense. A second advantage is that the small rodent with perhaps no exception, will likely be the maximally-exposed mammal in terrestrial settings, this again, in terms of having direct contact with contaminated soils. This follows from rodents being non-migratory in nature, having extremely limited home ranges that effectively contain them at contaminated sites, and their spending nearly all of their time directly contacting the ground (that is, contaminated soils; 2, 4, 18).5.9 In providing a useful line of evidence in support of ERAs for mammals, this guide employs a straightforward extrapolation approach (2, 18), one that is isomorphic to that applied in conventional HQ-based assessments. If site rodents, that have more constant and intimate contact with affected site soils than that of any other site mammal, are not found to have compromised reproduction, larger and wider-ranging mammals, with their considerably lesser degrees of site (that is, contaminated soil) contact, should also be free of reproductive compromise. An appreciation for this extrapolation scheme derives from a review of the principal extrapolation scheme of conventionally-applied desktop-based ERAs. There, a laboratory-based mouse or rat study is routinely used to determine if another mammal (for example, deer, fox, rabbit) is ingesting an unhealthful quantity of a given chemical. With the conventional ERA scheme, there are numerous differences to acknowledge, and even at the level of the rodent. Thus the test animal and the wild form inhabiting the site of interest that is to be assessed, do not match in terms of species, rearing, environment/habitat, or feeding design, and these differences weaken conclusions that can be drawn. In contrast, the subject standard in its initial extrapolation, compares sperm measures, each a proven barometer of reproductive success (22-25), in populations of conspecifics living less than a kilometer apart, with one population inhabiting a soil-contaminated area, and the other a contaminant-free one. The RSA method recognizes that small rodents of contaminated sites are integrators of potentially imposing environmental stressors that extend beyond chemicals that may be present in soil and diet items, to include such things as physical habitat disturbances (for example, noise or land vibration). RSA understands that conventional ecological assessments necessarily strive to know of small rodent reproductive capability, as this grouping is held to be a keystone ecosystem element. Where reproductive compromise is not observed in an RSA outcome, there is demonstration that a site’s exhaustive list of site stressors, in the actual arrays in which they occur, are not impinging on what is generally held to be the most important toxicological endpoint.5.10 One limitation of this guide is that the biologically-significant thresholds-for- (reproductive)-effect that are applied, are laboratory-derived. A second limitation of this guide is that shrews generally cannot submit to the RSA method, owing to their exceedingly high metabolism that interferes with their being live-trapped in the field. In the rare case where the only rodents present at a contaminated site of concern should be shrews, the RSA method can probably not be successfully applied. If for any reason a given contaminated site does not offer a small rodent population altogether, or if there is not at least one common small rodent species occurring at both the site of interest and a suitable habitat-matched reference location, or an appropriate reference location cannot be found (see 8.1), the method is not applicable. RSA is intended only to identify if site mammals are reproductively compromised. The method does not concern itself with identifying the chemical(s) or physical site stressors responsible for observed sperm parameter threshold-for-effect exceedances, or the determination of cleanup levels, and such are not method limitations. The situation is analogous to standardized whole effluent toxicity tests conducted with various aquatic test species (for example, Fundulus sp.). There, the objective is only to ascertain if the degree of wastewater treatment is adequate to support the aquatic life inhabiting a receiving waterbody’s mixing zone. (Standard whole effluent toxicity testing is not designed in the main, to identify the constituent or constituents in effluent that may be responsible for unacceptable test outcomes.)5.11 This guide is consistent with ERA guidance and guidelines (26, 27), where advancing to the field for an environmentally relevant assessment of the health of site receptors (so-called ‘field verification’) is a recognized formal step. In understanding that sufficient time has elapsed at contaminated sites for reproductive compromise to be evident (if that endpoint was ever to be triggered), this guide is designed to document such demonstrated compromise. Critically, RSA is not a risk assessment method that aims to forecast or predict health effects arising in mammals with ongoing contaminant exposures. The guide then is related to, but distinctly different from other ASTM standards that bear on the toxicological effects prediction aspect of ERA (Guides E1527-13, E1689, E1848-96, E2081, E2205-02, E2616, and E2790). The guide is also consistent with guidelines for reproductive toxicity risk assessment as per the U.S. EPA (19). Specifically, assessing the reproductive health of only one sex of a species is deemed adequate for an overall species assessment (17). In one key area however, this guide is quite unlike conventional ERAs that are largely restricted to the level of desktop analysis. Whereas conventional assessments rely on either statistically-significant differences in outcome, or on a commonly negotiated difference in biological response (for example, 20 %) when drawing conclusions, this guide primarily avails itself to the utility of a series of established biologically-significant thresholds alluded to previously (22-25). Further, a statistical comparison need only be applied for one of two possible RSA outcomes (see 9.3.1 and 9.4).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 that of reference location animals; the percentage of abnormally-shaped sperm is greater relative to reference location animals), the percent decrease or increase in each mean is compared to the relevant established sperm parameter benchmark, each in the form of that degree of shift in an unfavorable direction that signifies lesser reproductive success (2) (see 9.3).1.4 Advanced determinations of compromised or non-compromised reproduction in larger site-contacting mammals, the true focus of the RSA method and this guide, are made through an applied spatial movements-based extrapolation scheme. Where established sperm parameter benchmark exceedances are not observed in contaminated-site rodents, other mammals contacting a site are also assumed to have non-compromised reproduction. This follows from the latter all having notably lesser degrees of site exposure due to home ranges that are vastly larger than those of rodents. By way of example, with respective home ranges of 400+ and 640 acres for the red fox and white-tailed deer (10-14), these species would spend minimal amounts of their time (for example, 5 %) at prototypical contaminated sites that cover areas of 25 acres or less (15, 16). Where one or more sperm parameter benchmarks are exceeded in contaminated-site rodents (certainly indicating that the rodents are reproductively compromised), other site mammals may also be reproductively compromised. The greater the disparity between the home ranges of the target species (that is, the site rodent) and any of the other mammals known to contact the contaminated site in question, the less likely it will be that the latter are reproductively compromised. The RSA method employs the same toxicological extrapolation principles as that used for mammals in conventional desktop-based ERAs. In those ERAs, stressor-mediated responses of rodents (of a laboratory-based study) assist with the interpretation of health effects for an expanded list of mammals that cannot conveniently be evaluated directly for health status (for example, fox, skunk, raccoon, deer, coyote, etc.).1.5 This guide is arranged as follows: Section 1Referenced Documents 2Terminology 3Summary of Guide 4 5Safety Precautions 6Apparatus 7Procedure 8Reporting 9Keywords 101.6 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.7 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.
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4.1 The SDN determined by this method represents an average over the interval from the beginning of brake application to the rest position. It may be a reasonable estimate of the SDN during one or more portions of the specified traffic incident if the test conditions and the incident conditions are sufficiently similar. Since this standard determines an average SDN from the initial speed to rest, care should be exercised in any application of the test results to a portion of the incident that does not end with the specified traffic incident vehicle at rest.4.2 The uncertainty of the SDN determined by this method can be evaluated by procedures shown in this method. The relationship between the SDN of this test method and the SDN of a specified traffic incident is beyond the scope of this method. The similarity between test and specified traffic incident SDNs depends on the similarity of vehicles, vehicle ballast conditions, vehicle weight transfer during braking, vehicle tires, pavement surface, pavement surface contamination, and vehicle speed during a particular phase of the incident sequence.4.3 The SDN determined by this method does not necessarily agree or correlate directly with other methods of skid resistance measurements, such as Test Method E274/E274M. This test method is suitable for those situations where adequate similarity can be shown.4.4 When it is known that a particular wheel brake was not functional during the incident, the method provides for only the desired wheels to be braked on the test vehicle to duplicate the specified traffic incident vehicle.1.1 This test method covers determination of an average stopping distance number (SDN) under the conditions that this method was executed. The experimental conditions are generally intended to be similar to those of a specified traffic incident. The data from this method is not comparable to measured distances of a specified traffic incident vehicle that cannot be shown to have continuous, full application of its braking system.1.2 This test method determines the SDN from the measured stopping distance and initial speed when the wheels on specified axles are braked in the same manner as the specified traffic incident vehicle. The evaluation vehicle’s braking system is required to duplicate the specified incident vehicle for both type (conventional, partial ABS, or full ABS) and functionality (all brakes functional or not).1.3 The method documents the test conditions as a basis for evaluating their similarity to conditions of a specified traffic incident.1.4 The values stated in either inch-pound units or SI units are to be regarded separately as standard. Within the test, the SI units are shown in brackets. The values stated in each system are not exact equivalents; therefore, each system must be used independently of the other. Combining values from the two systems may result in nonconformance with the specification.1.5 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.6 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.
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