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
07/24/2020
Requested
Previously Approved
36 Months From Approved
2,142
0
710
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
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.
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_PartB_2020-07-08.docx