Request for a Non-Substantive Change

This non-substantive change request reallocates individual paperwork activities, or information collections (ICs), from a rule-related ICR to an existing approved ICR. This change request also effectuates the burden changes described in the rule-related ICR and summarized herein. The changes described in this request are non-substantive because OMB has already approved them in the rule-related ICR package under OMB Control No. 2070-0173. As explained in both the final rule preamble and the rule-related ICR, the incremental changes to the baseline paperwork activities and their related burden, as well as the analysis of the program change burden, would ultimately be incorporated into an ICR that is approved under OMB Control No. 2070-0038. After doing so, EPA would then discontinue the rule-related ICR.

EPA submitted a single, rule-related ICR to OMB to address the new paperwork activities (i.e., information collections, or ICs) related to implementation of the final rule’s electronic reporting requirements. The new ICs apply equally to the existing information collection programs approved under OMB Control Nos. 2070-0012 and 2070-0038. The ICR approved under OMB Control No. 2070-0038 (and the subject of this change request) addresses the paperwork activities associated with Significant New Use Rules (SNURs) issued by EPA’s Existing Chemicals Program under section 5 of the Toxic Substances Control Act. The other ICR, approved under OMB Control No. 2070-0012, addresses the paperwork activities associated with EPA’s New Chemicals Program under section 5 of TSCA. EPA determined it was more efficient to address the rule’s paperwork requirements as they apply to both information collection programs in a single ICR, and to then update the existing approved ICRs after OMB approved the rule-related ICR.

II. Background

Overview of the Final Rule and Rule-Related ICR

On January 6, 2010, EPA promulgated a final rule entitled, “TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting; Revisions to Notification Regulations” (75 FR 773). The final rule amends the Toxic Substances Control Act (TSCA) section 5 reporting regulations at subpart D of 40 CFR parts 700, 720, 721, 723, and 725. The amendments establish electronic reporting regulations for certain notification requirements under TSCA section 5, including Premanufacture and Significant New Use Notifications (PMNs and SNUNs). The final rule streamlines and reduces the administrative costs and burdens of TSCA section 5 notifications for both industry and EPA by phasing in the requirement that respondents submit certain TSCA section 5 notices and support documents to EPA electronically using the Agency’s Central Data Exchange (CDX). The rule also established requirements regarding the use of CDX, including user registration, authorization, and electronic signature. EPA also now requires that respondents include a payment identification number on the PMN form to enable EPA to link user fee payments with specific submissions. The payment identification number may be a check number, a wire transfer number, or a pay.gov transaction number. Lastly, EPA no longer requires that designated Agents sign the PMN form. The effective date of the final rule is April 6, 2010.

OMB approved the rule-related ICR on March 29, 2010 under OMB Control No. 2070-0173. The rule-related ICR addresses the paperwork activities associated with the amended reporting and recordkeeping requirements and the incremental program change burdens, specifically:

Rule familiarization,
Registering with EPA’s electronic reporting portal (the Central Data Exchange, or CDX),
Obtaining a CDX electronic signature (including authentication of identity and verifying authorization of the CDX registrant to submit on behalf of the company), and,
Setting up a Pay.gov account (not required by the rule) if respondents wished to make payments for the existing TSCA fees electronically.

Did OMB Review the Rule Under Executive Order (EO) 12866?

No. OMB determined that the rule was not a significant regulatory action under the EO. However, EPA did submit the rule-related ICR to OMB for review at both the proposed and final rule stages as required under the Paperwork Reduction Act and OMB’s implementing regulations at 5 CFR 1320.11. EPA’s ICR submission at the proposed rule stage was accompanied by the draft notice of proposed rulemaking; at the final rule stage, the ICR submission was accompanied by the draft final rule.

III. 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. 1188.09; OMB Control No. 2070-0038

What is the current status of this ICR?

This ICR is currently approved through November 30, 2012. The ICR currently identifies the information collections (ICs), responses per IC and burden subtotal per IC shown in Table 1. The total annual burden approved for this ICR is 1,423 hours, with an estimated 20 responses per year.

Table 1. Currently Approved ICs under EPA ICR No. 1188.09

TITLE	RESPONSES	TIME (HOURS)
TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals / chemical verification	5	34
TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals / submitting SNUNs	10	1,189
TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals / customer notification	5	200

What are the changes that EPA is making to this ICR?

EPA is making three distinct changes to the ICR. First, EPA is transferring certain information collection activities and related burden recently approved under OMB Control No. 2070-0173 (identified in Table 2 of this request) to this ICR (i.e., OMB Control No. 2070-0038) Second, EPA is adjusting the baseline unit burden for submitting SNUNs. The unit burden is presented as a range in the ICR, and EPA used the high-end estimate for the annual burden analysis. To ensure consistency in burden estimates for the submission of SNUNs between the Existing Chemicals and New Chemicals programs, EPA will now use the mid-range estimate (as was done for the New Chemicals program ICR). Last, EPA is effectuating program change burden reductions related to the clerical level efficiencies of electronic submission. Each of these changes was analyzed and described in the documents, “Economic Analysis of the Amendments to TSCA Section 5 Premanufacture and Significant New Use Notification Requirements Final Rule,” as well as the “Impact Analysis of the Final e-PMN Rule on Paperwork Burdens Approved under Existing EPA ICRs,” (identified as Appendix 1 of the rule-related ICR), and is summarized here.

Burden Increases/Decreases – Adjustments

Transfer of New e-PMN Activities and Burden from Rule-Related ICR

Roughly three of the 10 New Chemicals program respondents (about one-third of respondents) will implement the rule provisions each year during the two-year phase-in, which will result in an increase of 10 annual burden hours on respondents (see Table 2). This increase is associated with the time required to complete company-level paperwork activities related to the final e-PMN rule requirements, i.e., CDX Registration, CDX Electronic Signature, E-Payment (Pay.gov ID), and Rule Familiarization. The activities and the burden increase were considered in the e-PMN final rule ICR and approved as a program change increase under OMB Control No. 2070-0173. The transfer of these activities and the related burden to OMB Control No 2070-0038 does not in itself add any “new” burden – the change is merely an adjustment that reflects the transfer of activities and burden from one ICR to another.

Changes to the Baseline Unit Burden

EPA is harmonizing the baseline unit burden estimates for reporting and recordkeeping related to the submission of both new and existing chemical SNUNs. EPA used mid-range burden estimates of 105 hours for reporting and two hours for recordkeeping per response for new chemical SNUNs under OMB Control No. 2070-0012, and high-end burden estimates of 113.25 hours for reporting and 5.67 hours per response for recordkeeping for existing chemical SNUNs under OMB Control No. 2070-0038. EPA is adjusting the baseline burden estimates for OMB Control No. 2070-0038 by adopting the mid-range estimates for existing chemical SNUNs. The reporting burden adjustment results in a decrease of 82 annual hours and the recordkeeping burden adjustment results in a decrease of 37 annual hours, for a total baseline burden adjustment decrease of 119 annual hours, as indicated in Table 3.

Table 2. New, Rule-Related ICs and Burden Approved under OMB Control No. 2070-0173

New ICs Transferred from Rule-Related ICR	No. of Respondents	Responses Per Year	Burden Per Response	Annual Burden
CDX Registration	10	3	0.9	2
CDX Electronic Signature	10	3	1.8	5
E-Payment (Pay.gov ID)	10	3	0.1	1
Rule Familiarization (Annualized)	10	3	0.8	2
Additional Respondent Burden – Program Change				10

Table 3. Existing Chemical SNUN Baseline Reporting & Recordkeeping Burden Adjustments

Existing Chemicals SNUN Submission IC	Number of SNUNs/Year	Current Baseline	Adjusted Baseline	Change per SNUN	Total Change
Existing Chemicals SNUN Submission IC	Number of SNUNs/Year	Hours/SNUN	Hours/SNUN	Hours/SNUN	Hours/Year
Reporting	10	113.25	105	-8.25	-82
Recordkeeping	10	5.67	2	-3.67	-37
IC Total	10	118.92	107	-11.92	-119

Net Impact of Adjustments

Given the adjustment decrease of 119 hours to the baseline reporting and recordkeeping burden for existing chemical SNUNs, and the transfer of paperwork activities and the related 10 hours of burden from the rule-related ICR, EPA estimates a net adjustment decrease of 109 annual burden hours.

Burden Decreases – Program Changes

As discussed in the final rule preamble and supporting documents, the primary benefit of electronic reporting of SNUNs to EPA’s Existing Chemicals Program through CDX is burden reduction. When the Agency prepared the economic analysis and rule-related ICR (EPA No. 2327.02; OMB Control No. 2070-0173), EPA analyzed the impact that adoption of electronic reporting would have on baseline respondent burden. This analysis was presented in Appendix 1 of the rule-related ICR and is summarized in Table 5 of this change request.

The e-PMN final rule added two new data fields to the PMN form: (1) a field for entering the User Fee Payment Identification Number, and (2) a field for entering an optional email address of the principals listed on the Submitter Identification section of the PMN form. Based on reporting burden estimates developed for similar data elements on another EPA-required reporting form, the User Fee Payment Identification Number will increase burden on technical staff by 10 minutes per notice and the email address data field will increase technical burden by one minute per notice.^¹ This modest increase in reporting burden is offset by the overall burden savings related to electronic reporting. In addition, EPA removed the “Agent Signature Block” from the PMN form. The burden change associated with the removal of this field is negligible because fewer than five percent of submissions have a completed “Agent Signature Block” and, therefore, it was not factored into the rule-related burden analysis.

As indicated in Table 4, implementation of electronic reporting saves existing chemical SNUN submitters approximately 13 hours per response. There is no reduction of burden at the management and technical levels of respondent activities because the reporting software does not significantly alter their response actions. The burden savings associated with electronic reporting using the e-PMN software are realized at the clerical/administrative level. The deployment and adoption of the e-PMN software results in a reporting burden reduction of about 128 hours annually over baseline estimates.

Table 4. Reporting and Recordkeeping Burden Hour Program Changes (Per Response)

Existing Chemicals

SNUN Submission IC

Adjusted Baseline Response Burden

Response Burden

after e-PMN rule

Program

Change

Reporting

105

92.2

-12.8

Recordkeeping

-1

The recordkeeping burden for respondents submitting SNUNs to the Existing Chemicals Program through CDX is also decreased. Specifically, recordkeeping burden is reduced by half (from two hours to one hour) due to the efficiencies in creating and storing SNUNs electronically; one technical and one clerical staff member both save 30 minutes on recordkeeping. The deployment and adoption of the e-PMN software results in a recordkeeping burden reduction of about 10 hours annually over baseline estimates.

Table 5. Existing Chemical SNUN Reporting & Recordkeeping Burden Program Changes

Existing Chemicals SNUN Submission IC	Annual Responses	Baseline (Adjusted)		Program Changes		New Estimates
Existing Chemicals SNUN Submission IC	Annual Responses	Burden Per Response	Annual Burden	Burden Per Response	Annual Burden	Burden Per Response	Annual Burden
Reporting	10	105	1050	-12.8	-128	92.2	922
Recordkeeping	10	2	20	-1	-10	1	10
Total	10	107	1070	-13.8	-138	93.2	932

Net Impact of Program Changes

Given the adjustment to the baseline reporting and recordkeeping burden for SNUNs and the transfer of paperwork activities and burden from the rule-related ICR, EPA estimates a net annual burden decrease of 109 hours (an adjustment).

Bottom Line Changes in Burden

The adjustments to Agency estimates as well as program changes resulting from implementation of the e-PMN final rule combine for a net burden reduction of 247 hours under OMB Control No. 2070-0038. This represents a total burden reduction of approximately 17 percent over the currently approved ICR (program change reduction of approximately 10 percent and adjustment-related reduction of approximately 7 percent). Table 6 shows the bottom line net changes to the annual burden hours currently approved under EPA ICR No. 1188.09 (OMB Control No. 2070-0038). Table 7 shows the updated list of ICs, and the corresponding number of responses and burden hours as requested under this non-substantive change request.

Table 6. Bottom Line Burden Changes

Activity Summary	Burden Hour Change
Reporting – baseline adjustment	-82
Recordkeeping – baseline adjustment	-37
Transfer of ICs and Burden from OMB Control Number 2070-0173	10
Reporting – program changes	-128
Recordkeeping – program changes	-10
Total Burden Change	-247

Table 7. Updated ICs for OMB Control No. 2070-0012

TITLE	RESPONSES	TIME (HOURS)
TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals / chemical verification	5	34
TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals / submitting SNUNs	10	932
TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals / customer notification	5	200
CDX Registration	3	2
CDX Electronic Signature	3	5
Establishment of a Pay.gov account	3	1
e-PMN Rule Familiarization	3	2

1 Based on engineering estimates for reporting e-mail address for TRI Reporting. Memo entitled, “TRI Reporting Burden Estimates,” from Hilary Eustace, David Cooper and Susan Day, Abt Associates, to Paul Borst, US EPA. July, 2004.

File Type	application/msword
File Title	Request for a Non-Substantive Change to an Existing Approved Information Collection
Author	Peter Smith
Last Modified By	Peter Smith
File Modified	2010-04-13
File Created	2010-04-07