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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View Generic ICR - OIRA Conclusion
OMB Control No:
2070-0219
ICR Reference No:
202007-2070-002
Status:
Active
Previous ICR Reference No:
202004-2070-001
Agency/Subagency:
EPA/OCSPP
Agency Tracking No:
2584.02
Title:
TSCA Existing Chemical Risk Evaluation and Management; Generic ICR for Interviews and Focus Groups
Type of Information Collection:
New collection (Request for a new OMB Control Number)
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
02/28/2022
Retrieve Notice of Action (NOA)
Date Received in OIRA:
07/24/2020
Terms of Clearance:
Upon resubmission, the program must use the standard 18 question Supporting Statement format.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
02/28/2025
36 Months From Approved
Responses
850
0
0
Time Burden (Hours)
950
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
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 EPA’s 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 EPA’s 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 chemicals’ 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 TSCA’s 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 Agency’s 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.
Authorizing Statute(s):
US Code:
15 USC 2601 et seq.
Name of Law: Toxic Substances Control Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
84 FR 38029
08/05/2019
30-day Notice:
Federal Register Citation:
Citation Date:
85 FR 34434
06/04/2020
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
0
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
850
0
0
850
0
0
Annual Time Burden (Hours)
950
0
0
950
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
This is a new collection of information.
Annual Cost to Federal Government:
$93,264
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Angela Hofmann 202 260-2922 hofmann.angela@epamail.epa.gov
Common Form ICR:
No
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
07/24/2020
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