Justification

2

Request for a Non-Substantive Change

to an Existing Approved Information Collection

(EPA ICR No. 1884.14; OMB Control No. 2070-0162; Chemical Data Reporting under the Toxic Substances Control Act (TSCA section 8(a))

I. Introduction

Why is EPA Requesting a Non-Substantive Change?

The existing, approved ICR, entitled “Chemical Data Reporting under the Toxic Substances Control Act (TSCA section 8(a))” does not include a comprehensive guidance document on Chemical Data Reporting (CDR) rule requirements related to its applicable petition processes. One of these petition processes is for full exemption of byproducts that are recycled within site-limited, physically enclosed systems (40 CFR 711.10(d)(1) new with April 2020’s CDR Revisions rulemaking). The other is for partial exemption of chemicals for which the CDR processing and use information is of "low current interest" to the Agency (40 CFR 711.6(b)(2) available since 2003’s IUR Amendments rulemaking).

Under TSCA as amended by the Lautenberg Act in 2016, EPA is charged with protecting human health and the environment from potential chemical risks. EPA’s Office of Pollution and Toxics (OPPT) carries out its responsibilities by, among other things, prioritizing chemicals for evaluation, conducting risk evaluations and, where necessary, taking risk management actions under TSCA, as well as by making non-confidential information publicly available in order to promote informed decision-making and transparency. CDR data help the Agency to identify, assess, and control potential risks to human health and the environment posed by commercial chemical substances. TSCA section 8(a) authorizes the Administrator to promulgate rules to provide for the maintenance and collection of records from manufacturers (including importers) and processors of commercial chemical substances. Sections 8(a)(1) and (2) of TSCA also authorize the Agency to collect information on the chemical substance manufacturing (including importing) industry. EPA possesses broad discretion in determining the information to be reported under TSCA section 8(a).

Through the CDR regulation¹, EPA collects basic exposure-related manufacturing, processing, and use information used by the Agency and others in a wide range of activities. The CDR data collection is on a four-year reporting cycle and mainly contains information drawn from the principal reporting year but also contains some information, by year, from the previous three years. The information collected enables EPA to better understand and interpret the state of U.S. chemical manufacturing, processing, and use, and further enhances EPA’s ability to identify, evaluate, and manage potential chemical risks.

II. Description of Non-Substantive Changes

What Information Collection Request (ICR) is EPA changing?

ICR Title:	Chemical Data Reporting under the Toxic Substances Control Act (TSCA section 8(a))
ICR Numbers:	EPA ICR No.1884.14; OMB Control No. 2070-0162

What is the current status of this ICR?

This ICR is currently approved through April 30, 2022.

What are the changes that EPA is making to this collection of information?

EPA is not making changes to this collection of information. The purpose of this action is to attach guidance to the ICR and make it available to the public. This is a new guidance document, but it includes primarily a collection of language that has been pulled or adapted from proposed or final CDR/IUR rules, associated response to comments, past petitions, and existing CDR guidance/webpages.

Did EPA consult with stakeholders about this approach?

Guidance particular to the new petition process was requested by OMB during interagency review of the CDR Revisions rule, and by some commenters during the associated public comment period. To assist potential petitioners in understanding the types of information that a petition should include to assist EPA in determining if certain types of manufacturing processes and associated byproduct substances meet the criteria of this exemption, EPA agreed to make guidance available (for the petition process associated with the new exemption for byproducts that are recycled or otherwise used within site-limited, physically enclosed systems (40 CFR 711.10(d)(1))), similar to the information already available on the CDR website for the existing CDR petition process (40 CFR 711.6(b)(2)). Given that the new byproduct exemption petition process was somewhat modeled after the existing partial exemption petition process, EPA decided to have the guidance cover both types of CDR-specific petition.

Will this change impact the annual ICR burden estimate?

This change will not increase the annual ICR burden estimate. It is not mandatory for stakeholders to review the guidance. This action will not change the scope or content of submissions, nor would it prescribe a format.

What is the expected non-paperwork impact of this change?

The Agency expects that review of the guidance document will take up to one hour.

How does the guidance document help EPA properly perform Agency functions necessary to comply with legal requirements and achieve program objectives?

This guidance was designed to elucidate the process and requirements of CDR-specific petitions and is consistent with existing regulations and guidance. This guidance identifies and clarifies examples of the types of information submitters can provide to the agency in support of petitions for full or partial exemption from reporting to CDR. This guidance is expected to make the requirements and process of submitting a CDR-specific petition more comprehensible and, as a result, make the evaluation of submitted petitions by EPA less onerous (helping both parties to better meet regulatory deadlines associated with petition submission and response).

1 The original IUR rule was codified at 40 CFR part 710. In its August 2011 amendments, EPA moved the CDR rule to 40 CFR part 711.

2