A Class Approach to Hazard Assessment of Organohalogen Flame Retardants (2019) / Chapter Skim
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2 Hazard Assessment Scoping Plan
2 Hazard Assessment Scoping Plan
Pages 9-21
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From page 9... ...
Chapter 3 provides examples or case in the 1980s, toxic equivalency factors for dioxin-like studies that illustrate the committee's general strategy for chemicals were developed on the basis of relative pononpolymeric, additive organohalogen flame retardants tency, and this allowed assessment of these chemicals as (OFRs) .1 a class (Van den Berg et al.
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Expand Yes Subclass, or Reclassify End Point A End Point B End Point C Hazard Assessment Search Literature to Identify All Relevant Data Extract Data Discordant Evaluate and Integrate Data Data "Potentially Hazardous" "Not Hazardous" Perform Analyses, Generate New Data, Reclassify, or Risk Assessment Make Policy for Subclass Decision FIGURE 2-1 Scoping plan to conduct a hazard assessment for the Consumer Product Safety Commission (CPSC) by using a class approach.
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Both approaches have rationales Evaluation of the general approaches to forming based on common functional groups (such as aldehyde, chemical classes at various regulatory agencies and nonepoxide, ester, or specific metal ion) , a common mecha- regulatory consortia reveals that there has been a grownism, common constituents or chemical classes or similar ing understanding of the advantages and potential pitfalls carbon range numbers (frequently related to substances of of defining chemical hazard and risk in a class context.
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Ultimately, the agency then focused on the category of small linear and committee's approach embraces the class concept, and it recommends a method to evaluate the hazard posed by 2 As noted in Chapter 1, NAM studies encompass computational OFR subclasses created on the basis of a combination modeling, in vitro assays in human and animal cells and tissues, of structural characteristics, physicochemical properties, and toxicity testing using alternative animal species, such as zebra- and biology. The committee concludes that it is scientififish and nematodes.
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The evitrate the entire purpose of a class approach to hazard as- dence table or map can also help to identify data gaps that sessment. The committee therefore recommends defining might need to be addressed before a class-level hazard aschemical classes or subclasses as broadly as is feasible for sessment is conducted.
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The class approach prologic, and NAM studies -- that will be considered in the posed here would use the breadth of modern experimental analysis. The analysis plan should clearly identify the type and computational modeling methods to facilitate hazard of review, such as a systematic review (IOM 2011)
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For this scenario, the commitferences in experimental design or models or was associ- tee identified the following options: ated with test-chemical purity, dosing regimen, or timing of dosing or observations. A final step in the process is • Option 2-1: Generate toxicity data for the subclass.
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For example, animal toxicity data, including pharmacokinetic data, might be collected on only a small subset of chemicals of the larger subclass. As noted, identification of the chemicals to be studied in greater detail can be informed by the results of NAM studies.
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Use The committee has proposed a class approach to that value in the risk characterization of all subclass hazard assessment that represents a reinterpretation and members. Note that, absent data on multiple chemiaugmentation of the traditional hazard assessment of indi- cals, it might not be certain that the ones on which vidual chemicals.
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Considering the cumulative risk Exposure Assessment associated with multiple subclasses could also pro vide a basis for determinations related to the entire Several aspects of exposure assessment might need class. to be addressed to integrate the class approach into risk assessment.
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The only pos As discussed above, the committee encourages the sible practical approach for a set of chemicals as large as use of NAM studies to fill data gaps. The costs, resourc- the OFRs is a class approach.
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:e0148900. minated flame retardants (BFRs)
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2018. Review of Report and Approach to Evalu- Van den Berg, M., L
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