Page 1 of 4 

## Request for a Non **- Substantive Change**  **to an Existing Approved Information Collection**  **I. Introduction** 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. 1188.11 ; OMB Control No. 2070

- 00 38 What is the Current Status o f this ICR ? This ICR is currently

approved through 7/31/2016 . 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 736 , with an estimated 98 respo nses per year. **Table 1. Currently Approved ICs under EPA ICR No. 1188.11**  **Information Collection**  **No. of**

**Respondents No. of** 

**Responses / Respondent**  **Responses**

**Subtotal Annual** 

**Burden Hours per Response**  **Annual**

**Burden Hours per Activity**  **Per Firm Activities** Rule f amiliarization 4.24 1 4.24 0.83 **3.52** CDX registration activities

 CDX registration 4.24 1 4.24 0.92 **3.89**

 ESA 4.24 1 4.24 1.75 **7.42**

 Pay.gov a ccount 4.24 1 4.24 0.13 **0.57** Preparation, submission, and recordkeeping for SNUN 4.24 1.65 7 92.2 **645 Per SNUR Activities**  Chemical verification 5 1 5 1.17 **5.85** Notifying customers (p er SNUR) 35 2 70 1 **70.00 Totals**  61.20 1.33 9 8.96 98.00 **736.25**Page 2 of 4

Wh y is EPA Requesting a Non

-Substantive Change? EPA is taking direct final action to amend the Toxic Substance Control Act (TSCA) section 5 electronic reporting regulations at 40 CFR Parts 700, 720, 721, 723 and 725. These electronic reporting regulations establish standards and requirements for use of EPA’s Central Data Exchange (CDX) to electronically submit Significant New Use Notices ( SNUNs ), other TSCA section 5 notices, and suppo rt documents to the Agency

. The direct final action provides the user community with new methods for accessing the e

PMN software, new procedures for completing the e

- PMN form, and changes to the CDX registration process . The action is intended to further streamline and reduce the administrative costs and burdens of TSCA section 5 notifications for both industry and EPA. 

### II. **Overview** EPA is amending the reporting procedures for the submission of SNUNs and other TSCA section 5 notices and support documents to the Agency by mandating the use of an updated version of the e

- PMN reporting software , the “Thin Client Version” (i .e., a cloud

-based software system). Submitters must register and submit information electronicall y using the Agency ’ s Central Data Exchange ( CDX)

. EPA receives significant new use notices under TSCA section 5(a)(2) Section 5 of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2604, authorizes EPA to determine that a use of a chemical substance is a “significant new use.” E PA must make this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2). Onc e EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a notice to EPA at least 90 days before they manufacture, import or process the substance for that use

. Regulations implementing significant new uses appear at 40 CFR part 721. TSCA section 5 notices, such as SNUNs, and support documents , are submitted electronicall y to the Agency via CDX. Once EPA receives a SNUN , EPA may take regulatory

action under TSCA sections 5(e), 5(f), 6 or 7 to control the activities for which it has received a SNUN. If EPA does not take action, TSCA section 5(g) requires EPA to explain in the Federal Register its reasons for not taking action. Persons who intend to export a substance identified in a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b)

. The regulations that interpret TSCA section 12(b) appear at 40 CFR part 707. Does this change require a rulemaking? Yes . EPA is issuing a direct final rule to amend the premanufacture notification regulations to mandate the use of an updated version of the e

- PMN reporting software

. 

### III. **Description of Non -**  **S ubstantive Changes**  What are the changes that EPA is making to this ICR? EPA is moving from a Thick Client software s ys tem to a “cloud

– based ,” or Thin Client software s ystem. While EPA expects that this change in the software system will reduce the burden to all submitters of TSCA section 5 notice s , this burden reduction is expected to be minimal and has not been quantified for this ICR change request.Page 3 of 4

**A .**  **Program Change: e**  **- PMN Reporting Software Update**  In January

2010, EPA issued a final rule requiring the use of e

- PMN reporting software for the submission of Premanufacture Notices (PMNs) and other TSCA section 5 notices and support documents to the Agency using the Internet through EPA’ s Central Data Ex change (CDX). The new version of the e

- PMN sof tware will operate as a “cloud,” or Thin Client, software s ys tem rather than as a downloadable, or Thick Client, software s ys tem. EPA expects that both the Agency and TSCA section 5 submitters will experience burden reductions as a result of the software update. The Thin Client Version will eliminate certain firewall and file submission size limitations, as well as reduce the potential for invalid submissions through built

- in validation procedures. The Thin Client Version will also allow users to work offline using an Extensible Markup Language (XML) schema , which , in turn, allows them to later upload their information to the Thin Client Version and will make information readily accessible to registrants of the submitting company and their designated support persons. While EPA expects that this change will reduce the burden to all submitters of any TSCA section 5 notice, this burden reduction is expected to be minimal and has not been quantified for this ICR chang e request. 

### IV. Bottom Line Burden Changes EPA does not expect a change in annual net burden as a result of the program change to the TSCA section 5 Significant New Use Notification regulations . N ew burden associated with rule familiarization is estimated to remain at approximately 736 hours annually

. These summary level changes are highlighted in Table 5 , while Table 6 demonstrates the updated list of ICs associated with this collection and the related annual burden estimates. **Table 2**  **. Bottom**  **L i**  **ne B**  **urden C**  **hange s**  **Activity Summary Burden Hour Change**  **Adjustments Program Changes**  e - PMN Reporting Software Update 0 0 **Total Burden Change 0** Page 4 of 4

**Table 3**  **. Updated ICs for OMB Control No.**  **2070 -**  **00 38**  **Information Collection**  **No. of**

**Respondents No. of** 

**Responses / Respondent**  **Responses**

**Subtotal Annual** 

**Burden Hours per Response**  **Annual**

**Burden Hours per Activity**  **Per Firm Activities** Rule f amiliarization 4.24 1 4.24 0.83 **3.52** CDX registration activities

 CDX registration 4.24 1 4.24 0.92 **3.89**

 ESA 4.24 1 4.24 1.75 **7.42**

 Pay.gov a ccount 4.24 1 4.24 0.13 **0.57** Preparation, submission, and recordkeeping for SNUN 4.24 1.65 7 92.2 **645 Per SNUR Activities**  Chemical verification 5 1 5 1.17 **5.85** Notifying customers (p er SNUR) 35 2 70 1 **70.00 Totals**  61.20 1.33 9 8.96 98.00 **736.25**