TSCA Existing Chemical Risk Evaluation and Management; Generic ICR for Interviews and Focus Groups (EPA ICR No. 2584.01 and OMB Control No. 2070-NEW) and TSCA Existing Chemical Risk Evaluation and Management; Generic ICR for Surveys (EPA ICR No. 2585.01 and OMB Control No. 2070-NEW)
ICR SUPPORTING STATEMENT ATTACHMENT A
Public Comments on Proposed ICR and EPA Responses to Public Comments
Seven comments were submitted during the comment period for the August 2019 Federal Register Notice and during consultation. The comment period ended on October 4 2019.
EPA Responses to Comments from an Anonymous Commenter and the Household and Commercial Products Association (HCPA)
Comment 1: The Anonymous commenter and the HCPA support the EPA’s Generic ICR and have no further comment.
Response 1: No response necessary.
EPA Responses to Comments from the American Chemistry Council (ACC)
Comment 1: ACC requests that EPA indicate how collected information will be made publicly available. More specifically, ACC requests that if EPA plans to make notes, transcripts, and videos widely available, that EPA should provide a way for companies to remove identifying information from content generated during these informal activities to the extent possible. ACC also wants to make sure that TSCA CBI protections are applied to information collected under these generic ICRs.
Response 1: Respondents may claim as confidential information provided in an interview, focus group, or survey. EPA generally treats this information as obtained under TSCA, such that confidentiality claims are subject to the provisions of TSCA Section 14. EPA will disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures in TSCA section 14 and the regulations at 40 CFR part 2, under which EPA will provide advance notice and an opportunity to object prior to public disclosure.
EPA intends to generate public versions of the information submitted. These versions will not contain information claimed as confidential by the respondents. EPA may use information claimed as confidential in averages, ranges, aggregates, or in other ways that properly mask specific information claimed as confidential and/or a trade secret. If EPA receives a Freedom of Information Act request for the information, the Agency will determine whether the information is entitled to confidential treatment in accordance with TSCA Section 14 and procedures at 40CFR part 2, as applicable. EPA will request that companies create sanitized versions of anything they submit in writing. EPA will also ask during an interview or focus group whether any information provided is confidential.
EPA Responses to Comments from the Chemical Users Coalition (CUC)
Comment 1: CUC encourages EPA to consult widely with stakeholders, including a wide variety of commercial enterprises as well as with technical experts and knowledgeable members of the general public.
Response 1: EPA concurs with this comment.
Comment 2: CUC recommends that the information collection activities undertaken should be documented in the record of any related rulemakings to ensure transparency in a manner that also takes into account TSCA’s protections for confidential business information and considerations for an individual’s privacy.
Response 2: EPA concurs with this comment. Also see EPA’s response to comments above from ACC.
EPA Responses to Comments from the Aerospace Industries Association (AIA)
Comment 1: AIA believes that to ensure appropriate regulatory actions are taken in line with the requirements of TSCA, the EPA should, as part of the risk evaluation process, detail how the information obtained from these ICRs has been used to determine the level of risk associated with a particular condition of use for a chemical substance.
Response 1: EPA concurs with this comment.
Comment 2: AIA stated that if a risk evaluation for a chemical substance determines that an unreasonable risk exists, when considering subsequent regulatory action, EPA should also be required to demonstrate that such action is consistent with any identified unreasonable risks and is necessary to protect against them. AIA believes that a risk management rule from the EPA that sets out how the agency will address and manage unreasonable risks would, alongside the information covered in these ICRs, enable more effective chemical regulation and increased transparency for all stakeholders.
Response 2: EPA will promulgate any necessary risk management rules under TSCA section 6(a) consistent with all requirements for such rules set forth in TSCA section 6.
EPA Responses to Comments from Earthjustice
Comment 1: EPA should use its authorities under Sections 4, 8, and 11 of TSCA to gather all “reasonably available information” about the known and reasonably foreseen hazards and exposures from all conditions of use, with a special emphasis on potentially exposed or susceptible subpopulations.
Response 1: As noted in the ICR Supporting Statement, this voluntary information collection would be carried out in conjunction with other TSCA authorities under sections 4, 8, and 11, as appropriate. EPA has not indicated it would rely solely on voluntary requests for information. EPA considers the exercise of its information gathering authorities on a case-by-case basis, in view of statutory deadlines and the value the additional information would likely have in reducing uncertainty in its fit-for-purpose evaluations.
Comment 2: EPA should apply Technical Guidance of EJ2020 to risk populations, reaching out to potentially impacted minority populations, low-income populations, and tribes/indigenous people. EPA should also conduct outreach to impacted communities and workers.
Response 2: EPA concurs with this comment.
EPA Responses to Comments from the Environmental Defense Fund
Comment 1: EPA has provided no sound reasoning for relying solely on voluntary requests for information, and doing so may result in limited, biased, inaccurate, or incomplete information on the chemicals.
Response 1: As noted in the ICR Supporting Statement, this voluntary information collection would be carried out in conjunction with other TSCA authorities under sections 4, 8, and 11, as appropriate. EPA has not indicated it would rely solely on voluntary requests for information. EPA considers the exercise of its information gathering authorities on a case-by-case basis, in view of statutory deadlines and the value the additional information would likely have in reducing uncertainty in its fit-for-purpose evaluations.
Comment 2: For voluntary submissions, EPA should take additional steps to ensure completeness and accuracy and to vet information based on underlying data. EPA should request that submitters always provide full studies, as well as underlying data whenever reasonably available or obtainable. EPA should also seek input directly from workers for manufacturers and processors, providing them an easy method to submit information on workplace practices and conditions independently from management.
Response 2: EPA concurs with this comment.
Comment 3: EPA should take measures to ensure that its process will in fact accurately assess the full range of existing processes, relying on independent data where possible.
Response 3: EPA concurs with this comment.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Monroe, Albert |
| File Modified | 0000-00-00 |
| File Created | 2021-01-22 |