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## Request for a Non **- Substantive Change**  **to an Existing Approved Information Collection**  **I. Introduction** What Information Collection Request (ICR) is EPA changing ? **ICR Title:** Premanufacture Review Reporting and Exemption Requirements for

New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances **ICR Numbers:** EPA ICR No. 0574.15 ; OMB Control No. 2070

- 00 12 What is the Current Status o f this ICR ? This ICR is currently

approved through 12/31/2015 . 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 117,162 hours, with an estimated 2,126 responses per year. **Table 1. Currently Approved ICs under EPA ICR No.**  **0574.15 Title**  **Average Reporting Hours**  **per Response Hours for** 

**Recordkeeping Responses**  **Total Tim**  **e (Hours)**
PMN 92.2 1 720 67,104 SNUN 92.2 1 8 746 MCAN 288.2 1 3 868 TME 86.2 1 8 698 LVE/LoREX 92.2 1 419 39,051 TERA 507.2 1 2 1,016 Tier I and II 110.2 1 3 334 Polymer 2 4 175 1,050 Research and Development 2.5 0.5 200 600 Instant Photographic Film Articles 0.5 0.25 1 1 Bona Fide 20 2 116 2,552 5(e) Test 151 17.5 12 2,022 Non

- Testing 5(e) Burden 25 25 16 800 NOC 0.6 0.125 443 321 **TOTAL 2,126**  **117,162** 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 premanufacture notices (PMNs), other TSCA section 5 notices, and support 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, changes to the CDX registrationPage 2 of 5

process, and adds the requirement to submit “bona fide intents to manufacture” electronically . The action is intended to further streamline and reduce the administrative costs and burdens of TSCA section 5 notifications for both industry and EPA. EPA is requiring electronic reporting for those submitting Notice s of Bona Fide Intent to Manufacture or Import (bona fides) in the existing, approved ICR (EPA ICR No. 0574.15 ; OMB Contro l No. 2070

- 00 12 ). This request for a non

- substantive change identifies changes to the existing, approved IC R related to EPA’s implementation of an electronic reporting option under the Government Paperwork Elimination Act for TSCA section 5. The changes include the form and format of the collection, identification of new paperwork activities (i.e., information collections, or ICs), as well as baseline adjustments and anal ys is of program changes related to the electronic reporting option

. 

### II. **Overview** EPA is amending the reporting procedures for the submission of Premanufacture Notices (PMNs) 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 V ersion” (i.e., a cloud

-based software system). EPA is also requiring electronic reporting for those submitting a bona fide notice under TSCA section 5

. Submitters must register and submit information electronically using the Agency ’ s Central Data Exchange ( CDX)

. EPA receives bona fide notice submissions under TSCA section 5 Under TSCA section 5 ( 15.U.S.C. 2604 ), any person who manufacturers or imports new chemical substances must submit to the Administrator of EPA a premanufacture notice (PMN) of intent to manufacture or import a new chemical substance at least 90 days before manufacture or import begins. Pursuant to 40 CFR 720.25, a person intending to manufacture or import a chemical substance not publicly listed on the TSCA Inventory of existing chemicals may submit a Bona Fide Intent to Manufacture or Import Notice to determine whether the substance is listed in the confidential inventory

. 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 , as well as require the use of electronic reporting of TSCA section 5 Notices of Bona Fide Intent to Manufacture or Import (bona fides). 

### III. **Description of Non -**  **S ubstantive Changes**  What are the changes that EPA is making to this ICR? EPA is making two distinct changes that affect the burden reported in the ICR. First, EPA is adjusting the baseline burden associated with this ICR by adding an IC to cover CDX registration activities for new TSCA section 5 submitters

. S econdly, EPA is effectuating program change burden reducti ons related to the clerical level efficiencies resulting from electronic submission of bona fide notices

. In addition , EPA is moving from a Thick Client software s ys tem to a “cloud

– based ,” or Thin Client software s ys tem. While EPA expects that this change in the software s ys tem 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 5

**A .**  **Baseline Adjustments to Existing ICs** Changes to the Total Burden for CDX Registration Activities As part of EPA’s electronic reporting requirements, submitters of TSCA section 5 Notices are required to register and submit information electronically with EPA’s Central Data Exchange (CDX) s ys tem. EPA estimates that companies submitting section 5 Notices for the first time would incur a one

- time burden to complete CDX registration activities, obtain a CDX electronic signature, and set up a Pay .gov ID account. The total burden associated with CDX registration is approximately 2.80 hours per company. EPA assumes each company will register five employees, resulting in a per

- employee burden of 0. 6 6 hours. This per

- employee burden includes 0.18 hours for CDX registration, 0.35 hours for submitting and then verifyingelectronic signature agreemen**t** s , and 0. 1 3 hours for setting up a Pay .gov account. In fiscal ye ar 201 3 , a total of 392 new registrants , 303 TSCA

- Authorized Officials (AO) and 89 TSCA

- Support Registrants (SR) , were approved via CDX for all T SCA section 5 activities, resulting in a total annual burden of 258.72 hours (Table 2 ). EPA estimates that about 1 0 percent of new CDX registrations will be a result of employee turnover, based on data provided in the Cross

- Median Electronic Reporting Rule (CROMERR) IC R (EPA, 2011). Therefore, approximately 30 new Authorized Of ficials and 9 new Support Registrants will replace previously

registered CDX users each year. The burden associat ed with new CDX registration activities is the same regardless of whether the registrant is new or replacing an existing emplo ye e. As a result, burden is not estimated separately for each type of registration

. **Table 2**  **. Baseline Adjustments**  **Associated wit h New CDX Registration Activities** 

**Title CDX** 

**Registration Burden**  **(Hours) CDX E**  ****

**Signature Burden**  **(Hours) E**  ****

**Payment (Pay.gov**  **ID account)**  **(Hours) Total Burden** 

**for CDX Registration**  **Activities ,**  **(Hours) Annual** 

**Number of New CDX**  **Registrants Total Annual** 

**Burden for**  **CDX Registration**  **(Hours) Currently**  **Approved** 0 0 0 0 0 0 **Updated Estimate**  0.18 0.35 0. 1 3 0. 6 6 392 258.72 **Change 0.18**  **0.35 0.**  **1 3**  **0. 6**  **6 392**  **258.72 B.**  **Rule Familiarization** The rule will require TSCA Section 5 submitters and their staff to become familiar with the requirements for electronic reporting. Rule familiarization is estimated to require 0.55 hours of technical labor and 0.27 hours of managerial labor, as described in the Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule (EPA, 2009a), which measures the costs of mandatory electronic reporting of TSCA section 5 notices.Page 4 of 5

**Table 3**  **. Rule Familiarization Burden for**  **TSCA S ection 5**  **Submitters**
**Title Rule** 

**Familiarization Burden**  **(Hours) Annual** 

**Number of TSCA Section**  **5 Submitters Total Annual** 

**Burden for Rule**  **Familiarization Currently**  **Approved** 0 0 0 **Updated Estimate**  0.82 336 275.52 **Change 0.82**  **336 275.52**  **C .**  **Electronic Reporting Results in Program Change Burden Reductions** Electronic reporting is expected to reduce a respondent’s burden b y five hours per bona fide, due to the reduction or elimination of clerical/administrative time, and a reduction in recordkeeping costs , both of which are associated with the new electronic reporting requirement

. This program change is estimate d to reduce the total annual burden associated with bona fide submission s by about 580 hours ; from 2,552 hours to 1,972 hours (see Table 4 ). **Table 4**  **. Program C**  **hanges to Existing ICs Resulting from Electronic Reporting**  **of Bona Fides**
**Title Responses**  **Average Reporting**  **Hours per Response**  **Total**

**Burden for Reporting**  **Hours for**

**Recordkeeping Total Burden**  **for Recordkeeping**  **Total Burden**

**for Reporting and**  **Recordkeeping Currently**  **Approved** 116 20 2,320 2 232 2,552 **Updated Estimate**  116 16 1,856 1 116 1,972 **Change 0**  **- 4**  **- 464**  **- 1**  **- 116**  **- 580**  **D. 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). A 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 change request. 

### IV. Bottom Line Burden Changes EPA expects a net burden decrease of 46 hours per year, from 117,162 hours annuall y to 117, 116 hours, as a result of both adjustment and program changes to the TSCA section 5 Premanufacture and Significant New Use Notification regulations

. The burden is expected to decrease b y 304 hours as result of program change s requiring the electronic submission of bona fide notices and rule familiarizationPage 5 of 5

associate d with the new electronic reporting requirements. The burden is expected to increase by a total of 259 hours resulting from the adjustment made to the anal ys is in order to account for CDX registration activities

. 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 5**  **. Bottom L**  **ine B**  **urden C**  **hange s** 

**Table 6**  **. Updated ICs for OMB Control No. 2070**  **- 0012**  **Title Average**  **Reporting Hours per Response**  **Hours for**

**Recordkeeping Responses**  **Total Time (Hours)**
PMN 92.2 1 720 67,104 SNUN 92.2 1 8 746 MCAN 288.2 1 3 868 TME 86.2 1 8 698 LVE/LoREX 92.2 1 419 39,051 TERA 507.2 1 2 1,016 Tier I and II 110.2 1 3 334 Polymer 2 4 175 1,050 Research and Development 2.5 0.5 200 600 Instant Photographic Film Articles 0.5 0.25 1 1 Bona Fide 16 1 116 1,972 5(e) Test 151 17.5 12 2,022 Non

- Testing 5(e) Burden 25 25 16 800 NOC 0.6 0.125 443 321 **TOTAL FOR SECTION 5**  **SUBMISSIONS 2,126**  **116,582** CDX Registration Activities CDX E

- Signature Burden 0.35 0 392 137 CDX Registration Burden 0.18 0 392 71 Pay.gov ID 0.03 0 392 51 **TOTAL FOR CDX REGISTRATION ACTIVITIES**  **259** Rule Familiarization Rule Familiarization Burden 0.82 0 336 **276 TOTAL FOR ALL ACTIVITIES**  **117,11 6**  **Activity Summary Burden Hour Change**  **Adjustments Program Changes**  CDX Registration for New TSCA S ection 5 Submissions 259 Rule Familiarization 276 Section 5 Bona Fide Notices

- 580 **Total Burden Change -**  **46**