Request for a Non-Substantive Change
to an Existing Approved Information Collection
I. Introduction
Why is EPA Requesting a Non-Substantive Change?
EPA is requesting a non-substantive change in order to implement changes to the e-PMN electronic reporting tool and related instructions. The action is intended to further streamline and reduce the administrative costs and burdens of TSCA section 5 notifications for both industry and EPA. However, EPA is not modifying the information collection requirements or adjusting Agency paperwork burden estimates.
II. Description of Non-Substantive Changes
What Information Collection Request (ICR) is EPA changing?
ICR Title: |
TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals |
ICR Numbers: |
EPA ICR No. 1188.12; OMB Control No. 2070-00381 |
What is the current status of this ICR?
This ICR is currently approved through July 31, 2016.
What are the changes that EPA is making to this collection of information?
Respondents who must submit a significant new use notice to EPA, in compliance with a Significant New Use Rule, are already required to sign and submit them electronically. The January 2010 e-PMN final rule2 directs respondents prepare their Significant New Use Notice (SNUN) filings using a thick client version of the e-PMN software (i.e., the software is installed on their computers) before submitting them to EPA electronically through EPA’s Central Data Exchange (CDX). Following promulgation of that rule, EPA announced online, web-based (thin client) electronic reporting workflows for TSCA Chemical Data Reporting, TSCA section 4 test data submissions, TSCA section 8(a) preliminary assessment information rules, TSCA section 8(d) health and safety data reporting rules, and mandatory notifications of substantial risk under TSCA section 8(e) along with related, voluntary “For Your Information” submissions.
EPA is implementing a thin client version of the e-PMN software and will require its use by respondents instead of the thick-client version. The thin client e-PMN software will reside as a module within Chemical Information Submission System (CISS) in CDX. The thin client version of the e-PMN software will eliminate certain firewall and file submission size limitations, as well as reduce the potential for invalid submissions through built-in validation procedures. In addition, EPA is offering an XML schema to submitters who choose to work on their submissions offline rather than online, which allows them to later upload their information to the thin client version of the e-PMN software for submission using CDX.
EPA expects that most TSCA section 5 submitters are already registered in CDX. Those users do not need to re-register with CDX, nor will they need to re-verify their identities. In order to use the Thin Client Version of the e-PMN software required under this direct final rule, users who have previously registered with CDX under the TSCA workflow to submit TSCA section 5 submissions, or other CDX workflows will only need to add the “Submission for Chemical Safety and Pesticide Program (CSPP)” CDX workflow to their user profiles. New TSCA section 5 filers would also be able to take advantage of a more streamlined CDX registration process that also allows many respondents to use an online LexisNexis identity-proofing tool instead of submitting does not involve the submission of signed forms to EPA.
EPA has prepared a comprehensive user guide for CISS users (Attachment 2) that addresses CDX registration and electronic signatures, general submission preparation and completion, and submission status tracking notifications. This user guide will available at http://www.epa.gov/oppt/chemtest/ereporting. EPA has also prepared separate, role-specific user guides for the e-PMN software module in CISS (i.e., the Thin Client Version) (Attachments 3-8), which will be available at http://epa.gov/oppt/newchems/epmn/epmn-index.htm.
Does this change require a rulemaking?
Yes. The existing TSCA section 5 electronic reporting regulations at 40 CFR Parts 7203, 7214, 7235 and 7256 establish standards and requirements for use of EPA’s Central Data Exchange (CDX) to electronically submit SNUNs, other TSCA section 5 notices, and support documents to the Agency, and requires users to obtain the thick client version of the software . EPA is issuing a direct final rule to amend the premanufacture notification regulations to mandate the use of the thin-client version of the e-PMN reporting software instead of the thick-client version.
Did EPA consult with stakeholders about this electronic reporting approach?
Yes. The EPA conducted several webinars for industry to explain the new e-PMN software. The agency also gave a presentation on the new software on February 25, 2013 at the Global Chemicals Conference in Baltimore, MD. Comments received in response to the webinars and public presentation strongly supported the agency’s effort to move to the Thin Client Version of the e-PMN software.
In addition, the EPA has established a 180-day time frame between the publication date and effective date of this direct final rule to allow companies time to prepare to submit TSCA section notices to the agency through CDX using the e-PMN module in CISS. During this time, the EPA will offer testing and training opportunities for the electronic reporting tool and schedule webinars for stakeholders to further gain experience with its use. The EPA also plans to hold further training and outreach sessions at which industry representatives and others who will submit materials under TSCA may express remaining questions and concerns regarding operation of the reporting tool.
Will this change impact the annual ICR burden estimate?
No. The changes do not affect the estimated annual burden. Although EPA is implementing a new reporting tool, the respondent activities are the same.
List of Attachments
Attachment 1: |
TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting; Revisions to Notification Regulations; Direct Final Rule [RIN 2070-AJ98] |
Attachment 2: |
CDX Chemical Safety and Pesticide Programs (CSPP) Registration User Guide |
Attachment 3: |
Section 5 Notices and Supports User Guide – Primary Authorized Official |
Attachment 4: |
Section 5 Notices and Supports User Guide – Primary Agent/Consultant |
Attachment 5: |
Section 5 Notices and Supports User Guide – Primary Support |
Attachment 6: |
Section 5 Notices and Supports User Guide – Secondary Authorized Official |
Attachment 7: |
Section 5 Notices and Supports User Guide – Secondary Agent/Consultant |
Attachment 8: |
Section 5 Notices and Supports User Guide – Secondary Support |
2 75 FR 773, January 6, 2010. See: http://www.gpo.gov/fdsys/pkg/FR-2010-01-06/pdf/E9-31004.pdf
Page
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | Request for a Non-Substantive Change to an Existing Approved Information Collection |
| Author | Peter Smith |
| File Modified | 0000-00-00 |
| File Created | 2021-01-24 |