All TSCA Risk Evaluations - Draft & Final

Project ID

3585

Category

OPPT REs

Added on

June 1, 2021, 9:51 a.m.

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Technical Report

Abstract  This document presents the scope of the risk evaluation to be conducted for n-methylpyrrolidone. If a hazard, exposure, condition of use or potentially exposed or susceptible subpopulation has not been discussed, EPA, at this point in time, is not intending to include it in the scope of the risk evaluation. As per the rulemaking, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (TSCA), with respect to conditions of use in conducting a risk evaluation under TSCA, EPA will first identify “circumstances” that constitute “conditions of use” for each chemical. While EPA interprets this as largely a factual determination—i.e., EPA is to determine whether a chemical substance is actually involved in one or more of the activities listed in the definition—the determination will inevitably involve the exercise of some discretion.

Technical Report

Abstract  This document presents the scope of the risk evaluation to be conducted for TCE. If a hazard, exposure, condition of use or potentially exposed or susceptible subpopulation has not been discussed, EPA, at this point in time, is not intending to include it in the scope of the risk evaluation. As per the rulemaking, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (TSCA), with respect to conditions of use in conducting a risk evaluation under TSCA, EPA will first identify “circumstances” that constitute “conditions of use” for each chemical. While EPA interprets this as largely a factual determination—i.e., EPA is to determine whether a chemical substance is actually involved in one or more of the activities listed in the definition—the determination will inevitably involve the exercise of some discretion.

Technical Report

Abstract  This Risk Evaluation for Asbestos, Part 1: Chrysotile Asbestos (hereafter referred to as “Part 1” or “Part 1 of the risk evaluation”) for imported, processed and distributed uses of chrysotile asbestos was performed in accordance with the Frank R. Lautenberg Chemical Safety for the 21st Century Act and is being issued following public comment and peer review. The Frank R. Lautenberg Chemical Safety for the 21st Century Act amended the Toxic Substances Control Act (TSCA), the Nation’s primary chemicals management law, in June 2016. Under the amended statute, EPA is required, under TSCA Section 6(b), to conduct risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, under the conditions of use, without consideration of costs or other non-risk factors, including an unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant to the Risk Evaluation. Also, as required by TSCA Section 6(b), EPA established, by rule, a process to conduct these Risk Evaluations, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (82 FR 33726) (Risk Evaluation Rule). Part 1 of the risk evaluation is in conformance with TSCA Section 6(b) and the Risk Evaluation Rule and is to be used to inform risk management decisions. In accordance with TSCA Section 6(b), if EPA finds unreasonable risk from a chemical substance under its conditions of use in any final Risk Evaluation, the Agency will propose actions to address those risks within the timeframe required by TSCA. However, any proposed or final determination that a chemical substance presents unreasonable risk under TSCA Section 6(b) is not the same as a finding that a chemical substance is “imminently hazardous” under TSCA Section 7. The conclusions, findings, and determinations in Part 1 are for the purpose of identifying whether the chemical substance presents unreasonable risk under the conditions of use, in accordance with TSCA section 6, and are not intended to represent any findings under TSCA section 7.

Technical Report

Abstract  This draft risk evaluation for perchloroethylene was performed in accordance with the Frank R. Lautenberg Chemical Safety for the 21st Century Act and is being disseminated for public comment and peer review. The Frank R. Lautenberg Chemical Safety for the 21st Century Act amended the Toxic Substances Control Act (TSCA), the Nation’s primary chemicals management law, in June 2016. As per EPA’s final rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (82 FR 33726), EPA is taking comment on this draft, and will also obtain peer review on this draft risk evaluation for PCE. All conclusions, findings, and determinations in this document are preliminary and subject to comment. The final risk evaluation may change in response to public comments received on the draft risk evaluation and/or in response to peer review, which itself may be informed by public comments. The preliminary conclusions, findings, and determinations in this draft risk evaluation are for the purpose of identifying whether the chemical substance presents unreasonable risk of injury to health or the environment under the conditions of use, including unreasonable risk to a potentially exposed or susceptible subpopulation (PESS) in accordance with TSCA section 6, and are not intended to represent any findings under TSCA section 7. PCE is subject to federal and state regulations and reporting requirements. PCE has been a reportable Toxics Release Inventory (TRI) chemical under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) since 1987. It is designated a Hazardous Air Pollutant (HAP) under the Clean Air Act (CAA), and is a hazardous substance under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA). It is subject to National Primary Drinking Water Regulations (NPDWR) under the Safe Drinking Water Act (SDWA) and designated as a toxic pollutant under the Clean Water Act (CWA) and as such is subject to effluent limitations. PCE is currently manufactured, processed, distributed, used, and disposed of as part of industrial, commercial, and consumer conditions of use. PCE has a wide-range of uses, including production of fluorinated compounds, and as a solvent in dry cleaning and vapor degreasing. A variety of consumer and commercial products use PCE such as adhesives (arts and crafts, as well as light repairs), aerosol degreasing, brake cleaners, aerosol lubricants, sealants, stone polish, stainless steel polish and other wipe cleaners (cleaners used for wiping surfaces). EPA evaluated the following categories of conditions of use: manufacturing; processing; distribution in commerce, industrial, commercial and consumer uses and disposal. The yearly aggregate production volume ranged from 388 to 324 million pounds between 2012 and 2015.

Technical Report

Abstract  This draft risk evaluation for 1-Bromopropane (1-BP) was performed under the auspices of the Frank R. Lautenberg Chemical Safety for the 21st Century Act and disseminated for public comment and peer review. The Frank R. Lautenberg Chemical Safety for the 21st Century Act amended the Toxic Substances Control Act, the Nation’s primary chemicals management law, on June 22, 2016. As per EPA’s final rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (82 FR 33726), EPA is taking comment on, and will also obtain peer review on, this draft risk evaluation for 1-BP. All conclusions, findings, and determinations in this document are subject to comment.

Technical Report

Abstract  This document presents the scope of the risk evaluation to be conducted for 1-BP. If a hazard, exposure, condition of use or potentially exposed or susceptible subpopulation has not been discussed, EPA, at this point in time, is not intending to include it in the scope of the risk evaluation. As per the rulemaking, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (TSCA), with respect to conditions of use in conducting a risk evaluation under TSCA, EPA will first identify “circumstances” that constitute “conditions of use” for each chemical. While EPA interprets this as largely a factual determination—i.e., EPA is to determine whether a chemical substance is actually involved in one or more of the activities listed in the definition—the determination will inevitably involve the exercise of some discretion.

Technical Report

Abstract  This problem formulation document refines the conditions of use, exposures and hazards presented in the scope of the risk evaluation for 1-BP and presents refined conceptual models and analysis plans that describe how EPA expects to evaluate risk for 1-BP.

Technical Report

Abstract  This problem formulation document refines the conditions of use, exposures and hazards presented in the scope of the risk evaluation for HBCD and presents refined conceptual models and analysis plans that describe how EPA expects to analyze the risk associated with the conditions of use of HBCD.

Technical Report

Abstract  This draft risk evaluation for methylene chloride was performed in accordance with the Frank R. Lautenberg Chemical Safety for the 21st Century Act and is being disseminated for public comment and peer review. The Frank R. Lautenberg Chemical Safety for the 21st Century Act amended the Toxic Substances Control Act (TSCA), the Nation’s primary chemicals management law, in June 2016. As per EPA’s final rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (82 FR 33726), EPA is taking comment on this draft, and will also obtain peer review on this draft risk evaluation for methylene chloride. All conclusions, findings, and determinations in this document are preliminary and subject to comment. The final risk evaluation may change in response to public comments received on the draft risk evaluation and/or in response to peer review, which itself may be informed by public comments. The preliminary conclusions, findings, and determinations in this draft risk evaluation are for the purpose of identifying whether the chemical substance presents unreasonable risk or no unreasonable risk under the conditions of use, in accordance with TSCA section 6, and are not intended to represent any findings under TSCA section 7.

Technical Report

Abstract  On May 23rd EPA received a manufacturer requested risk evaluation for diisononyl phthalate (DINP; CAS RN 28553-12-0 & 68515-48-0). This substance is represented by two CAS RNs (28553-12-0 & 68515-48-0) that reflect differences in how the chemical is manufactured. This document provides publicly available information as of the date of this document on the manufacturing (including importing), processing, distribution in commerce, use, and disposal of DINP and is used to inform decisions regarding conditions of use. The document does not reflect information received directly from other sources such as manufacturers, processors, etc., which has further informed the conditions of use in the draft Scope Document. As such, the uses described in this document may differ from the conditions of use in the draft Scope Document. DINP is a phthalate used as a plasticizer, pigment, and fragrance in consumer and commercial products as well as numerous manufacturing applications (EPA 2017a, 2017b). DINP is a general purpose plasticizer for PVC in many applications and has replaced use of DEHP as a plasticizer in many applications except for medical supplies (Ullmann's 2017, 2007). Table 1-1 includes basic information about DINP.

Technical Report

Abstract  This document presents the scope of the risk evaluation to be conducted for di-isobutyl phthalate under the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The Frank R. Lautenberg Chemical Safety for the 21st Century Act amended TSCA on June 22, 2016. The new law includes statutory requirements and deadlines for actions related to conducting risk evaluations of existing chemicals.

Technical Report

Abstract  This document presents the scope of the risk evaluation to be conducted for di-isononyl phthalate under the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The Frank R. Lautenberg Chemical Safety for the 21st Century Act amended TSCA on June 22, 2016. The new law includes statutory requirements and deadlines for actions related to conducting risk evaluations of existing chemicals.

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