TSCA Existing Chemical Risk Evaluation and Management; Generic ICR for Interviews and Focus Groups
New collection (Request for a new OMB Control Number)
No
Regular
Approved with change
02/28/2022
07/24/2020
Upon resubmission, the program must use the standard 18 question Supporting Statement format.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
02/28/2025
36 Months From Approved
850
0
0
950
0
0
0
0
0
The Environmental Protection Agency (EPA or the Agency) intends to initiate a new voluntary information collection for chemical industry research involving focus groups, one-on-one interviews, and other structured discussions to provide more comprehensive and accurate information to inform the risk evaluation and risk management of existing chemicals as required under section 6 of the Toxic Substances Control Act (TSCA). In 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA), which updated TSCA, was signed into law. Under TSCA, EPA must prioritize chemical substances for risk evaluation; conduct risk evaluations to determine whether chemical substances present unreasonable risk; and manage any unreasonable risks found to be presented, all under strict statutory deadlines. Many of these chemicals may have multiple conditions of use that fall under EPAâs authority under TSCA. Under TSCA, for each chemical substance evaluated, EPA must evaluate hazards and exposures. The purpose of this ICR is to help fill data gaps for EPAâs risk evaluations and risk management of existing chemicals under section 6 of TSCA. In accordance with TSCA section 26, EPA must make TSCA section 6 risk evaluation and risk management decisions consistent with the best available science and based on the weight of the scientific evidence. To carry out its statutory obligations, EPA needs sufficient information about chemicals undergoing risk evaluation and risk management, including information related to the chemicalsâ conditions of use, hazards, exposures, potentially exposed or susceptible sub-populations, health and environmental effects, benefits, reasonably ascertainable economic consequences, alternatives, and other information. The collection of such information is subject to TSCAâs strict statutory time frames (set forth in section 6). Therefore, EPA is seeking approval for a generic information collection request (ICR) to conduct interviews and focus groups of chemical users, processors, distributors, manufacturers (including importers), and recyclers, chemical waste handlers, consumers of chemical-containing products, employees who may be exposed to the chemical evaluated, state and local regulators, non-governmental organizations, industry experts, and knowledgeable members of the public (including potentially exposed or susceptible sub-populations) related to information collection for TSCA chemical risk evaluation and risk management.
As appropriate, under this ICR EPA would collect data in several ways, such as interviews and focus groups. This research would consist of open-ended structured discussions or interviews with individuals or small groups of individuals, and therefore can provide in-depth information. These information collection efforts are intended to supplement other reasonably available information on chemicals in commerce and will provide support for the Agencyâs policy and regulatory activities regarding existing chemicals under TSCA section 6. Data collected under this generic clearance may be used in several ways during the risk evaluation and risk management processes, including establishing generic scenarios, developing models of various conditions of use of chemicals evaluated under TSCA or their alternatives, pretesting survey questions, and providing important context for publicly available information already available to EPA. By learning more about the conditions of use, hazards, exposures, potentially exposed or susceptible sub-populations, health and environmental effects, benefits, reasonably ascertainable economic consequences, alternatives, and other information for chemicals being evaluated or regulated, EPA would be able to more precisely and effectively carry out its risk evaluation and risk management obligations under TSCA.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
2584ss01_Part B__REV.docx