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3.10.1 Exposure‐Related Information Required
ОглавлениеExamples of EPA data requirements involving exposure information are: (i) the number of workers “reasonably likely to be exposed” to the chemical at the manufacturing site; (ii) the physical form(s) in which the chemical substance is sent off‐site; (iii) the percentage of total reported production volume associated with each physical form; and (iv) the maximum concentration of the chemical substance at the time it leaves the submitter's manufacturing site or, if the chemical substance is site‐limited, the maximum concentration at the time it is reacted on‐site to produce a different chemical substance; (v) whether the use is consumer or commercial; (vi) if the chemical is used in products intended for children. “Reasonably likely to be exposed” means an exposure to a chemical substance which, under foreseeable conditions of manufacture, processing, distribution in commerce, or use of the chemical, is more likely to occur than to not occur. Covered exposures include exposures through any route of entry, but exclude “accidental” or “theoretical” exposures.
The CDR requirements increase the need to have certain exposure information pertinent to chemical substances in the workplace and in commerce, or during use. Producers will need more detailed information about workplace exposures and producers making more than 300 000 pounds per year per chemical substance will need specific processing and use information as required under the rule. EPA states that its three primary reasons for seeking such information are to tailor a chemical substance's reporting requirements more closely to match EPA's information needs; to obtain new and updated information relating to potential exposures to a subset of chemical substances listed on the TSCA Inventory; and to improve the utility of the information reported. The agency has stated that receipt of this exposure information will “enable EPA to more selectively conduct initial risk screening on a subset of the chemical substances with its purview.” These data will, along with other EPA initiatives to collect hazard data, including the High Production Volume (HPV) Challenge Program and Voluntary Children's Chemical Evaluation Program (VCCEP), allow EPA to prioritize its TSCA Section 4 rulemaking and enforceable consent agreement initiatives. This verbiage emphasizes the increasing need for exposure information and the involvement of IH in this regulatory process.