## Economic **An aly** **sis of the**  **TSCA Section 5**  **Premanufacture and Significant New**  **Use Notification Electronic**  **Reporting; Re**  **vi sions to**  **Notification Regulations** 

RIN 2070 -AJ98

November 17, 2014

-- Does not contain TSCA CBI
–

**Economic and Policy**

**A naly** **sis Branch** Economics, Exposure and Technology Division Office of Pollution, Prevention, and Toxics U.S. Environmental Protection Agency

1200 Pennsylvania Avenue Wa shington, DC 20460**Contents ▌**  **pg. i** 



### Economic A **naly sis of the Premanufacture Notification Electr** **onic Reporting Modified Final Rule**  **Contributors** The EPA analyst responsible for this report is Stephanie Suazo of the Economic and Policy Analysis Branch; Economics, Exposure and Technology Division; Office of Pollution Prevention and Toxics. Analytical and draft preparation support was provided by Abt Associates Inc. under EPA Contract No. EP
-W
- 08
- 010.**Contents ▌**  **pg. ii**  

### Executive Summary This economic analysis estimates the net burden and cost savings associated with the final rule to amend the premanufacture notificati on regulation to facilitate the introduction and use of electronic reporting of Toxic Substances Control Act (TSCA) section 5 Notices of Bona Fide Intent to Manufacture or Import (bona fides)
. This action is intended to streamline and reduce the administrative costs and burden of the notifications for both industry and EPA. In addition, the rule would amend the TSCA section 5 Premanufacture and Significant New Use Notification regulations by mandating the use of an updated version of the e
-PMN reporting sof tware. In January 2010, EPA issued a final rule requiring the use of the 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 Exchange (CDX). The new version of the e
PMN software described in this EA will operate as a “cloud” , or T hin C lient, software system rather than as a downloadable , or T hick C lient, software system. This updated version of the software has a number of benefits including , but not limited to , the elimination of certain firewall and file submission size limitations that exist with the current version of the software. There are two components of this action that are specific to bona fide submiss ions: 1. Making the e
- PMN software available for bona fide submissions, and 2. Requiring use of the software for bona fide submissions as is now required for most TSCA section 5 notices and related documents including: PMNs (40 CFR part 720), Significant New U se Notices (SNUNs) (40 CFR part 721), Test Market Exemption Applications (TMEAs) (40 CFR part 720), Low Volume Exemption notices (LVEs) (40 CFR 723.50), Low Exposure/Low Release Exemption (LoRex) notices (40 CFR 723.50), biotechnology notices for genetical ly modified microorganisms (40 CFR part 725), Notices of Commencement of Manufacture or Import (NOCs) (40 CFR 720.102), and other support documents (e.g., correspondence, requests for suspensions of the notice review period, and test data). Making the so ftware available to industry is expected to result in cost savings for both industry and EPA. However, this rule, which includes a new requirement for electronic submission of bona fide notices, may result in some increase in cost to some industry users as they make the transition to the new method of submission. As a result of making the software available to Industry users, EPA believes that submitters of bona fide notices will experience burden and cost savings because the time required to enter, review , and edit their notices using the e
-PMN software and transmit their submissions to EPA electronically will be less than that for the existing paper
-based process. In this economic analysis, estimated burden and cost savings are presented in comparison to the burden and costs that will be incurred if industry were to continue submitting notices via paper, as was outlined in the previous Information Collection Request (ICR) for TSCA section 5 Premanufacture and Significant New Use Notifications
. Once the rule (which includes the new requirement for electronic submission of bona fide notices) is fully implemented, EPA estimates a net burden savings to industry of 180 hours and a net cost of approximately $ 4 ,000 in the first year. In subsequent years, EPA estimates an annual net burden savings to industry of 4 89 hours and annual net cost savings of approximately $ 1 7 , 0 0 0 . The Agency**Contents ▌**  **pg. iii** 

is projected to experience an annual net burden savings of 40 hours and annual net cost savings of $3,000 for these same submission s once the rule is fully implemented. Requiring the use of the e
- PMN software for submission of Notices of Bona Fide Intent to Manufacture or Import eliminates the option of submitting paper. To the extent that any firm currently submits bona fides on pap er, they are expected to incur transactions costs in order to meet these mandatory submission requirements. This may require some industry users to revise their internal processes or recordkeeping systems, invest in new hardware, or other adjustments , in order to submit their bona fides electronically. At this time, EPA is unable to estimate what these costs might be. However, any firm which has submitted section 5 notifications since April 2012, or which intends to submit any other TSCA section 5 notification types to EPA in the future, must use the e
- PMN software in accordance with existing regulations for those submissions. The total annual burden to society (industry plus EPA) from the e
-PMN software is expected to decrease by 57 hours in the first year and 529 hours in subsequent years . The total cost to society is expected to increase by $ 1 , 00 0 in year one and decrease by $ 20 , 000 in future years . These cost savings may be diminished by any transactions costs that firms compelled to switch to the new software system might face for submission of Notices of Bona Fide Intent to Manufacture or Import. EP A assumes that the transition from the Thick Client Version to the Thin Client Version will have a negligible impact on industry or Agency burden or costs , and, therefore, the cost savings associated with the transfer from the Thick Client Version to the Thin Client Version are only described qualitatively in this report.**Contents ▌**  **pg. iv**  

### Table of Contents **1. Introduction**  **................................ ................................**  **................................ .............................**  **1 -**  **6 2.**  **Industry Burdens and Costs ................................**  **................................ ................................**  **... 2**  **- 8**  2.1 Scope of the Modified e
-PMN Rule
................................ ................................ ............... 2
- 8 2.2 Wage Rates
................................ ................................ ................................ ..................... 2
- 8 2.3 Firm Level Compliance Costs
................................ ................................ ........................ 2
- 9 2.3.1 Rule Familiarization
................................ ................................ ......................... 2
- 9 2.3.2 CDX Registration, CDX Electronic Signature, and Pay.gov Account Setup
. 2
- 10 2.4 Bona Fide Submission Costs Savings
................................ ................................ ............. 12 2.4.1 Baseline Industry Burden for Completing a Bona Fide Intent to Manufacture or Import Notice
................................ ................................ ................................ ................... 12 2.4.2 Burden Reductions from the e
- PMN Rule Amendment
................................ .... 14 2.5 Industry Burden
................................ ................................ ................................ ............... 15 2.5.1 Total Annual Cost from Rule Familiarization
................................ ................... 15 2.5.2 Total Annual Savings from Electronic Bona Fide Submissions
........................ 16 2.5.3 Total Annual Cost from New CDX Registrations
................................ ............. 16 2.5.4 Total Change in Industry Burden
................................ ................................ ...... 17 2.5.5 Efficiencies from the Thin Client Software
................................ ....................... 18 **3. Agency Burdens and Costs**  **................................ ................................**  **................................ ......**  **20** 3.1 Labor Rates for EPA Staff
................................ ................................ ............................... 20 3.2 Changes in Agency Burdens and Cost Associated with the Final e
-PMN Rule
.............. 21 **4. Benefits of the Final e**  **- PMN Modifications Rule**  **................................ ................................**  **... 22**  4.1 Industry Benefits
................................ ................................ ................................ ............. 22 4.1.1 Electronic Reporting of Bona Fide Notifications
................................ .............. 22 4.1.2 Updated e
-PMN Software
................................ ................................ .................. 23 4.2 Agency Benefits
................................ ................................ ................................ .............. 23 4.2.1 Electronic Reporting of Bona Fide Notifications
................................ .............. 23 4.2.2 Updated e
-PMN Software
................................ ................................ .................. 23**Contents ▌**  **pg. v** 

**5. Additional Analyses**  **................................ ................................**  **................................ .................**  **24** 5.1 Regulatory Flexibility Act (RFA)
................................ ................................ .................... 24 5.2 Unfunded Mandates Reform Act (UMRA)
................................ ................................ ..... 24 5.3 Paperwork Reduction Act (PRA)
................................ ................................ .................... 24 5.4 Executive Order 13132, Federalism
................................ ................................ ................ 25 5.5 Executive Order 12898, Environmental Justice
................................ .............................. 26 5.6 Executive Order 13045, Protection of Children
................................ .............................. 26 5.7 Executive Order 13175, Tribal Governments
................................ ................................ .. 26 5.8 Executive Order 13211, Energy Supply, Distribution, or Use
................................ ........ 26 5.9 Executive Order 13563, Improving Regulation and Regulatory Review
........................ 26 **6. REFERENCES**  **................................ ................................**  **................................ .........................**  **28 pg.**  **6**



## 1. **Introduction** This economic analysis estimates the net burden and cost savings associated with the final rule to amend the premanufacture notification regulations to require the use of electronic reporting of TSCA section 5 Notices of Bona Fide Intent to Manufacture or Import (bona fides). This action is intended to streamline and reduce the administrative costs and burden of TSCA section 5 notifications for both industry and EPA. The rule would also amend the Toxic Substances Control Act (TSCA) section 5 Premanufacture and Significant New Use Notification regulations by mandating the use of an updated version of the e
PMN reporting software. 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 Exchange (CDX). This new version of the e
- PMN software will operate as a “cloud”, or Thin Client , software system rather than as a downloadable, or Thick Client , software system. The Thin Client Version of the e
-PMN software has many advantages over the previous Thick Client Version. EPA developed the Thin Client Version to provide a more efficient way of accessing the e
PMN software and completing the e
-PMN form, including additional built
- in validation procedures. The Thin Client Version of the software was also designed to enable more efficient data transmittal, including increasing the size of files that can be submitted to EPA. By moving from the Thick Client Version of the e
-PMN software to the Thin Client Version, the Agency has eliminated the roadblocks associated with firewalls that were previously encountered by some u sers by allowing submitters to work directly online within the Thin Client Version or, if they choose, to work offline using an Extensible Markup Language (XML) schema which allows them to later upload their information to the Thin Client Version. In completing the PMN form, submitters will find that sharing files within the Thin Client Version makes the information readily accessible to registrants of the submitting company and their designated support persons. A final benefit of using the Thin Client Version is that the most updated version of the e
-PMN software will be available whenever the submitter log s into the Chemical Information Submission System ( CISS )
. This rule also amends existing regulations for notifying EPA of any new manufacturing site of a chemical substance for which an exemption was granted by EPA under 40 CFR 723.50. As required under 40 CFR 723.50(j)(6)(ii), a manufacturer (including importer) must notify EPA of any new manufacturing site of a chemical substance for which an exemption was granted by EPA under 40 CFR 723.50. Under the existing regulation, companies may use the Notice of Commencement (NOC) to report manufacturing site changes to EPA. However, the electronic version of the NOC in the e
PMN software cannot accommodate notificati ons of manufacturing site changes. Therefore, this direct final rule requires that such notifications be submitted electronically to EPA via CDX as a “support document” to the original notification. This report presents EPA OPPT ’s analysis of potential changes to industry and government burden and costs that will result from this final rule to (1) require the electronic submission of bona fide notices and (2) modify the electronic reporting system for all TSCA section 5 notices. Section 2 of this report discusses activities to be undertaken by industry to comply with the final rule, presents estimated chang es to industry costs and burden compared to the baseline of t he current paper system,**pg. 7** 

and calculates the total industry costs and burden. Section 3 focuses on changes to the Agency’s burden and cost to administer the TSCA sec tion 5 notice s program as a result of implementing the final rule. Section 4 consists of a description of the qualitative benefits of the rule. Section 5 presents an analysis of other impacts as required by various statutes and executive orders.**pg. 8** 



## 2. **Industry**

**Burdens and Costs 2.1**  

### Scope of the Modified e **- PMN Rule**  T he 2010 e -PMN rule (40 CFR Parts 700, 720, 721, 723, and 725 ) required the maj ority of TSCA section 5 notices to be submitted electronically via CDX
. The current rule modification now also requires the electronic submission of bona fide notices. Consequently , the methodology and results presented in this economic analysis characterize the changes in reporting burden specific only to bona fide notices, which EPA will now have the capability to receive electronically, rather than via the existing, paper
-based process . EPA assume s that both the transition from the Thick Client Version to the Thin Client Version of the e
- PMN software , 

### as well as the changes to the procedures for notifying EPA of any new manufacturing site of a chemical substance for which an exemption was granted b y EPA under 40 CFR 723.50 , will have negligible impact on industry or Agency burden and costs , and , therefore , the cost savings associated with these changes are only described qualitatively in this report . 

### 2.2 **Wage Rates** The rule involves activities that may require efforts by employees in the following three labor classifications: managerial, technical, and clerical. Costs for each activity are calculated by estimating the labor hours required in each labor category and m ultiplying that burden by the wage rate for each labor category. This section presents the estimated wage rate in each labor category. Loaded wage rates for managerial, technical, and clerical personnel are derived by combining data on wages and fringe benefits with estimates of overhead rates, following the methodology described in Wage Rates for Economic Analysis of the Toxics Release Inventory Program (EPA, 2002 a). Wage data for each labor category in December 201 3 are provided by the Employer Costs for Employee Compensation (ECEC) Supplemental Tables available on the BLS website (BLS, 201 4 a). The loaded wage rate is $ 77.82 for managerial labor; $ 64.55 for technical labor; and $ 30.35 for clerical labor. Table 1 pre sents the basic data used to calculate the loaded wage rates for all three categories of labor.**pg. 9** 

**Table 1**  **: Loaded Industry Wage Rates, December 201 3** 
**Labor Category**  **Da ta Sources**  **Date Wage**  **( 201**  **3 $)**  **Fringe**

**Benefit (**  **201 3**  **$) Fringes** 

**as % wage**  **Over -**  **head**

**% wage 2**  **Fringe +**

**overhead factor**  **Loaded**

**Wages 1**  **( 201**  **3 $)**  **(a) (b)**  **(c) =(b)/(a) (d)**  **(e)=(c)+(d)+1 (f)=(a) x (e)** 
**Managerial** BLS ECEC,

Private Manufacturing industries, “M gt, Business, and Financial” 3 Dec
1 3 $46.25 $23.7 1 51.26% 17% 1.68 $77.82

**Professional/ Technical**  BLS ECEC,

Private Manufacturing industries, “Professional and related“ 3 Dec
1 3 $38.16 $19.90 52.15% 17% 1.69 $64.55

**Clerical** BLS ECEC,

Private Manufacturing industries, “Office and Administrative Support” 3 Dec
1 3 $18.05 $9.23 51.14% 17% 1.68 $30.35

**Notes:** 1 Wage data are rounded to the closest pennies in this table; however, in calculations using these numbers for this report, unrounded values were used. 2 An overhead rate of 17% was used based on assumptions in Wage Rates for Economic Analyses of the Toxics Release Inventory Program (EPA, 2002 a), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002 b ). 3 Employer Costs for Employee Compensation Supplementary Tables December 201 3 , U.S. Bureau of Labor Statistics, March 1 2 , 201 4 (BLS, 201 4 a) 

### 2.3 **Firm Level Compliance Costs**  **2.3.1 Rule Familiarization**  The rule will require bona fide 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 Prema nufacture Notification Electronic Reporting Final Rule (EPA, 2009 a), which measures the costs of mandatory electronic reporting of TSCA section 5 notices. As shown in Table 2 , the total labor cost associated with rule familiarization is $ 56.51
.**pg. 10** 

**Table 2**  **: Rule Familiarization Burden and Cost for Bona Fide**  **Submitters Reporting**  **Activity Clerical Labor** 

**(at $ 30.35**  **/hour) Technical Labor (at**  **$ 64.55**  **/hour) Managerial Labor** 

**(at $ 77.82**  **/hour) Total Labor Cost**  **( 2013**  **$) Burden**  **Cost Burden**  **Cost Burden**  **Cost Burden**  **Cost** Rule Familiarization 0 $0.00 0.55 $35.50 0.27 $ 21.01 0.82 $ 56.51 **Note:** Costs may not equal labor wage rate times burden hours as shown, due to rounding. Unrounded estimates were used during the actual cost calculations. **Source:** See; EPA, 2009 a . **2.3.2 CDX Registration, CDX Electronic Signature, and Pay.gov A** **ccount Setup** If a firm has not completed a previous TSCA section 5 notice that required electronic submission under the 2010 e -PMN Rule ( 40 CFR Parts 700, 720, 721, 723, and 725 ) ( including Premanufacture Notices ( PMNs), SNUNs, Test Market Exemption (TME) applications, Low Volume Exemption (LVE) notices, Low Exp osure/Low Release (LoREX) exemption notices, Biotechnology Notices for genetically modified microorganisms, Notices of Commencement of Manufacture or Import (NOCs), and support documents to section 5 notices ), then the submitter must register their company and key users with the CDX reporting tool, deliver a CDX electronic signature to EPA, and establish and use a Pay.gov E
-payment account. 1 These activities are only required of first
-time submitters of any section 5 notice
. EPA receives an average of 116 bona fide submissions each year. In the first year of the rule, EPA conservatively assumes all bona fide submitters to be new registrants. After the first year, the number of new bona fides submitters is expected to be 50% of the numb er of annual submissions. Therefore, 116 new submitters will register in the first year and 58 will register for each of the subsequent years
. These activities are estimated to require the following burden activities , based on the estimates presented in th e Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule (EPA, 2009 a):
 CDX registration: EPA estimates that companies will spend approximately 0.18 hours per employee to register with CDX (EPA, 2009 a)
 CDX electronic signature: EPA estimates that companies will spend 0.25 hours preparing, submitting, and filing an electronic signature agreement (Authentication of Identity) form to EPA per employee. In addition, EPA estimates that a manager will spend an additional 0.50 hours acc essing, preparing, and submitting verification forms (Verification of Authorization) for all authorized submitters to EPA. The total burden incurred by companies submitting and then verifying electronic signature agreements is 1.75 hours. Note that this bu rden does not include any additional time required to contact EPA’s CDX help desk to notify a change of submitter status, should one occur (EPA, 2009 a)
. Filing the electronic signature agreement may be done either through mail or electronically. EPA believes the cost of electronic filing to be negligible, and the cost of a paper filing via the US Postal Service to be $2. 60 per company (including five $0.46 stamps and five $0.06 business envelope s)
. The average mailing cost per employee is $0.56 (USPS, 2013 )
.

1 Although the rule does not require submitters to establish and use a Pay .gov account, the burden estimates in this analysis are conservative insofar as to include the use of Pay.gov as a required activity.**pg. 11** 

 Payment via Pay.gov account: EPA estimates that each manager will spend approximately 0.13 hours setting up a Pay.gov ID account, logging into the system, finding the appropriate form, and filling it out. This burden does not include the time required to click ‘submit’ on the form and wait for payment processing (EPA, 2009 a)
. **Table 3**  **: CDX Registration, CDX Electronic Signature, and Pay.gov Account Setup Burden and Cost for First** **- Time Submitters** 

**Registration Activity Technical**  **Labor (** $64.55 per hour) **Managerial Labor** $77.82 per hour) **Burden (Per Employee)**  **Cost**

**(Per Employee) Burden** 

**(Per Employee) Cost** 

**(Per Employee)** CDX Registration 0.18 $11.83 0.18 $14.27 CDX Electronic Signature 0.25 $16.14 0.75 $58.37 Mailing Cost 0.00 $0.52 0.00 $0.52 E
- Payment (Pay.gov ID) 0.00 $0.00 0.13 $10.37 **Total 0.43**  **$28.49 1.07**  **$83.52 Note:**  Costs may not equal labor wage rate times burden hours as shown, due to rounding. Unrounded estimates were used during the actual cost calculations. **Source:** See; EPA, 2009a**pg. 12** 



### 2.4 **Bona Fide Submission Costs**  **Savings 2.4.1**  **Baseline Industry**  **Burden for Completing a Bona Fide I ntent to Manufacture or Import**  **Notice** Under TSCA section 8(b) , EPA is required to compile and publish a current list of each chemical substance that is manufactured or processed in the United States; this list is called the TSCA Inventory. EPA considers substances listed on the TSCA Inventory to be “ existing ” chemicals in U.S. commerce, and substances not on the TSCA Inventory are considered “new” chemicals. If a substance is determined to be a “new” chemical substance for TSCA purposes, it is subject to TSCA section 5 Premanufacture Notice requirements. If an intended manufacturer or importer of a chemical substance is unsure of the TSCA Inventory status of the chemical (e.g., cannot find that substance on one of the public sources of non
- confidential TSCA Inventory data), the company or representative can obtain a written determination from EPA if it can demonstrate a “bona fide intent.” It can do this by submitting a B ona Fide Intent to Manufacture or Import Notice
. The actions that submitters must take to complete a bona fide notice as well as the estimate baseline burden for each action are listed below. All burden estimates are taken from Regulatory Impact Analysis o f Amendments to Regulations for TSCA Section 5 Premanufacture Notifications (EPA, 1994).

 **Provide S**  **pecific C**  **hemical I**  **dentification D**  **ata :**  This includes the Chemical Abstracts Index (CAS RN) name as well as information about the substances ’ manufacture or importation. EPA estimates this will take approximately 2 hours of technical time (EPA, 1994).

 **Provide a Signed Statement:** This statement certifies that the submitter intends to manufacture or import that chemical substance for commercial purposes. EPA estimates this will take approximately 2 to 3 hours of managerial time (EPA, 1994).

 **Provide a Description of Research and Development**  **Activities or a Description of**  **Foreign Use (Importers Only) :**  The submitter must provide a brief description of the research and development (R&D) activities conducted to date related to the substance, including the year in which the person first started to conduct R&D activity on the substance, and the general types of research and development activities conducted thus far (e.g., synthesis, substance isolation/purification, formulating, product development, process development, end
-use application, toxicity testing, etc.). The person must also indicate whether any pilot plant or production
- scale plant evaluations have been conducted involving the manufacture or processing of the substance. If an importer is unable to provide any information on R&D activities they must provide information on how long the substance has been in commercial use outside of the United States, the name of a country in which it has been commercially used, whether the importer believes that the substance has already been used commercially, in any country, for the same purpose or application that the importer is intending. Providing this information is expected to take to take 3 hours of technical time and 1 hour of managerial time (EPA, 1994).

 **Provide a Use, Infrared Spectroscopy, and Estimated Dat**  **e of PMN Submission :**  The submitter must provide a detailed description of the intended use of the substance, an infrared spectrum of the substance, and information on the manufacturing, import, or processing facility location
. The submitter must also provi de the estimated month and year in which they**pg. 13**  intend to submit a PMN if EPA informs the submitter that the substance is not on the TSCA Inventory . EPA estimates that completing these tasks will take approximately 1 hour of technical time and 1 hour of managerial time (EPA, 1994).

 **Provide a Manufacturing Process**  **Description :**  Domestic manufacturers must provide a description of the most probable manufacturing process. Importers must provide information on how they intend to process or use the substance for a commercial purpose
. Providing this information is expected to take between 5 and 6 hours of technical time (EPA, 1994).

 **Possibly Submit a Letter of Support:**  This may be necessary if some information is withheld from the bona fides submitter. In some cases, a potential manufacturer may be intending to use reactants whose specific chemical identities are held confidential by their suppliers. In certain other cases, a potential importer may be intending to bring into the United States a substance whose identity is known only to its foreign manufacturer. In these cases, a letter of support from the domestic or foreign manufacturer of the confidential substances can be provided directly to EPA and should include specific chemical identity information. For the pur

poses of this analysis, the burden to the submitter for requesting this letter be sent to EPA is assumed to be included in the burden for providing chemical identity. The Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufa cture Notifications (EPA, 1994) also states that between 3 and 4 hours of clerical time will be needed to support the activities listed above
. EPA also estimates that there will be two hours of recordkeeping associated with each paper bona fide submission (EPA, 2011) and mailing cost s associated with filing the submission (EPA, 2009 a) ; n either of these costs is accounted for in the 1994 RIA. EPA assumes that regulated companies will incur mailing costs for export notifications delivered to EPA. Notification s are assumed to be shipped via the U.S. Postal Service (USPS) as first
- class registered mail with a return receipt (USPS, 201 3 ). The estimated per
- shipment and annual mailing costs incurred by individual submitters are detailed in Table 4
. **Table 4**  **: Derivation of Total Mailing Cost Postal**  **S ervice**  **Cost** Registered mail, regular, with $0 declared value $ 11.20 Return receipt, requested at time of mailing (receive by mail) $2. 5 5 Postage, regular First Class, up to 1 ounce $0. 46 **Cost per export notice -**  **Subtotal $**  **14.21 Source:**  USPS, 201 3
. Table 5 provides the baseline burden and cost for a single bona fide submission , based on the activities listed above . While the 1994 EA provides burden ranges, this analysis uses the mid
-point burden estimates in the cost calculations. As shown in Table 5 , the baseline burden of a single bona fide submission is approximately 21.5 hours , with a cos t of $ 1, 308
.**pg. 14** 

**Table 5**  **: Baseline Burden for Paper**  **Bona Fide I ntent to Manufacture or Import Notice**  **s Labor**  **Category Hourly** 

**Burden Range For**  **Submission 1**  **Midpoint**

**Hourly Burden For Submission**  **Hourly Burden for**  **Recordkeeping 2**  **Total**

**Hourly Burden**  **Wage s** 

**( 201**  **3 $)**  **Total Cost**  **Managerial** 4
- 5 4.5 4.5 $ 77.82 $ 350 **Technical** 11
- 12 11.5 1 12.5 $64.55 $807 **Clerical** 3
- 4 3.5 1 4.5 $30.35 $137 **Mailing Cost** **3** $14.21 **Total 18**  **- 21**  **19.5 2**  **21.5 $1,**  **308 Source**  **s :**  1 EPA, 1994 2 EPA, 2011 3 USPS, 2013 **2.4.2 Burden Reductions from the**  **e -**  **PM N Rule**  **Am endment**  EPA expects that bona fide submitters will experience burden savings because the time required to enter, review, and edit their notices using the e
-PMN software and transmit their submissions to EPA electronically will be lower compared to the existing pro cess of submitting a written notice to EPA. Anticipated burden reduction is likely to include:
 Filling out a form for a chemical similar to one previously submitted will be faster with the e
PMN as the facility will already have an electronic copy of the e arlier form to edit rather than having to fill out a new form.
 Preparation and submission of attachments will be streamlined in the e
-PMN, because those attachments that the submitter already has in electronic format can simply be attached, rather than the submitter sending paper copies with sequentially numbered pages. Burden will still be incurred to prepare a PDF file and submit attachments that are in paper format. Sanitized versions of attachments will still need to be prepared.
 All relevant staff within the submitting company will be able to access the e
- PMN form easily and directly input their information. The e
- PMN form will also facilitate easier internal review prior to submission.
 The number of forms that need to be resubmitted because they are de clared incomplete or invalid by EPA should be greatly reduced because the e
-PMN form cannot be printed or submitted via CDX if any fields are incomplete.
 The cutting and pasting function in the e
-PMN form will allow submitters to copy information within and across forms, reducing the time previously required to retype information.
 All routine correspondence with the Agency, including submission of supporting documents, will be via CDX once the rule is fully implemented. This automation will save time and de livery costs, and will reduce delays in EPA’s review of incoming notices
.**pg. 15** 

In order to estimate the burden and cost savings to all submitters, EPA assumed that the burden savings associated with electronic reporting and submission via CDX are due to the red uction or elimination of clerical/administrative time , and a reduction in recordkeeping costs (EPA, 2009 a) . As mentioned above, although a majority of submitters already use an electronic format to prepare notices, EPA does not consider this in burden and cost savings estimates because it is not required under the current rule, nor are there OMB
- approved estimates of burden from electronic preparation of a paper notice. Form
- level burden savings include those activities that are associated with each e
-PMN submission once all registration, signature, and account set
-up activities at the company level have been completed. Baseline form burden and cost includes form completi on, recordkeeping, and postage. As a result of the modified final e
-PMN rule, submitters will experience a reduction in form
- level burden due to the efficiencies and reduced time associated with using e
- PMN software to fill out bona fide notices and using CDX to submit these notices. EPA expects that electronic submission will remove all clerical burden associated with submitting a bona fide ( 3 .5 hours ) , and all postage costs associated with mailing the notice ( $ 14.21 ) (EPA, 2009 a). Although recordkeeping requirements under the current rule have not been changed , EPA assumes that the final rule will reduce recordkeeping burden by half because of the efficiencies in creating and storing bona fide notices and supporting documents electronically. 2 For bona fide notices, baseline recordkeeping burden is estimated to be two hours. For each of these notices, one hour of recordkeeping burden will be saved (30 minutes for one technical staff member and 30 minutes for one clerical staff member). Table 6 presents the burden for one electronic bona fide submission. The burden per submission is now approximately 17 hours and $1, 1 40
. **Table 6**  **: Burden for Electronic**  **Bona Fide I ntent to Manufacture or Import Notice**  **s Labor**  **Category Hourly** 

**Burden Range For**  **Submission 1**  **Midpoint**

**Hourly Burden For**  **Submission Hourly Burden** 

**for Recordkeeping**  **1 Total** 

**Hourly Burden**  **Wage s** 

**( 201**  **3 $)**  **Total Cost Managerial**  4
- 5 4.5 0 **4.5** $ 77.82 $3 50 **Technical** 11
- 12 11.5 .5 **12** $64.55 $775 **Clerical** 0 0 .5 **0.5** $30.35 $15.18 **Mailing Cost -**  **- -**  **-** $0 $0 **Total 15**  **- 17**  **16 1**  **17** - **$1, 140**  **Source s**  **:** 1 EPA, 2009a 

### 2.5 **Industry Burden**  **2.5.1 Total A**  **nnual Cost from Rule Familiarization** EPA expects that all TSCA Section 5 submitters will need to become familiar with the new electronic reporting requirements generated by the final rule. Following the approach outlined in The Economic

2 Based on EP A’s best professional judgment.**pg. 16** 

Analysis of the Premanufacure Notification Electronic Reporting Rule (EPA, 2009a), EPA calculated the annual number firms completing TSCA Section 5 submissions and assumes all of these firms will undergo rule familiarization in the first year of the rule. Between FY 2011 and FY 2013, an average of 336 firms submitted TSCA Section 5 notices each year , and the total industry burden for rule familiarization is calculated to be 275 hours and $18, 966 for all 336 firms in the first year of the analysis
. **Table 7**  **: Industry Burden for Rule Fam**  **iliarization (First Year Only)**  **Hourly Burden**  **per Firm**  **Total Cost**

**per Firm**  **Total**

**Number of Firms**  **Total**

**Hourly Burden**  **Total Cost Baseline**  0.82 $56.51 **0 0**  **$0 Am**  **ended Rule**  0.82 $56.51 **336 275**  **$18,966 Burden Change**  **(Baseline -**  **Am ended**  **Rule) 0**  **$0 336**  **275 $18,966** 
**2.5.2 Total A**  **nnual Savings from Electronic Bona Fide Submissions** Table 8 presents the burden reduction for a single bona fide submission and the total expected annual industry savings , after accounting for CDX registration costs for new TSCA s ection 5 submitters
. Submitters are expected to save approximately 4.5 hours and $ 168 per bona fide submission. EPA receives approximately 116 bona fides per year, for an industry savings of 522 hours and $ 19, 475
. **Table 8**  **: Industry Burden Reduction for Submitting Electronic**  **Bona Fide I ntent to**  **Manufacture or Import Notice s** 

**Hourly Burden per**  **Subm ission**  **Hourly Burden**

**for Recordkeeping**  **per Submission Total** 

**Hourly Burden**  **per Subm** **ission Total Cost** 

**per Subm** **ission Total** 

**Number of Subm** **issions Total** 

**Hourly Burden**  **Total Cost**
**Baseline** 19.5 2 21.5 **$1,308** 116 **2,494 $151,711**  **Am ended**  **Rule** 16 1 17 **$1,140** 116 **1,972 $134,512**  **Burden Change (Baseline**  **- Am**  **ended Rule) -**  **3.5 -**  **1 -**  **4.5 -**  **$168 -**  **522 -**  **$19,475**
**2.5.3 Total A**  **nnual Cost from New CDX Registrations**  In addition to the cost saving generated from electronic submission, new submitters of TSCA section 5 notices will incur costs associated with rule familiarization , CDX Registration, CDX Electronic Signature, and Pay.gov Account Setup
. EPA c onservatively estimates that in the first year of the rule, all 116 bona fide submitters will be new registrants. In the subsequent years of the rule, EPA estimates approximately 50 percent of all bona fide submitters will be first
-time registrants with CDX as a result o f the rule, resulting in 58 staff members registering with CDX. Using the percentages of technical and managerial registrants presented in Section 2.3.2 , EPA estimates that 80% of the registrant s will be technical staff ( 93 employees in the first year , 46 employees in subsequent years )**pg. 17** 

and 20 % will be managerial staff ( 23 employees in the first year, 12 employees in subsequent years )
. The industry will incur an additional burden of 65 hours and $4, 497 in the first year and 33 hours and $ 2 , 276 in the years after the first as a result of CDX registration for bona fide submissions. **Table 9**  **: Industry Burden for New CDX Registrations Resulting from Requiring Electronic**  **Bona Fide I ntent to Manufacture or Import Notice**  **s Technical**  **Labor Burden**  **per Em** **ployee Technical** 

**Labor Cost per**  **Em ployee**  **Total**

**Number of Technical**  **Registrants Managerial** 

**Labor Burden per**  **Em ployee**  **Managerial**

**Labor Cost per**  **Em ployee**  **Total**

**Number of Managerial**  **Registrants Total** 

**Burden Total Cost**  **(a) (b)**  **(c) (d)**  **(e) (f)**  **(g)=(a)*(c)** **+ (d)*(f)** **(h)=(b)*(c)**

**+ (e)*(f)** **First Year Baseline**  0 $64.55 0 0 $77.82 0 **0 $0.00**  **Am ended Rule**  0.43 $64.55 93 1.07 $77.82 23 **64.6 $4,497**  **Burden Change (Baseline**  **- Am**  **ended Rule) 0.43**  **- 93**  **1.07 -**  **23 64.6**  **$4,497 Subsequent Years**  **Baseline** 0 $64.55 0 0 $0.00 0 **0 $0.00**  **Am ended Rule**  0.43 $64.55 46 1.07 $77.82 12 **32.62 $2,276**  **Burden Change (Baseline**  **- Am**  **ended Rule) 0.43**  **- 46**  **1.07 -**  **12 32.62**  **$2,276**

**2.5.4 Total Change in Industry Burden**  Overall , in the first year , industry is expected to save approximately 182 hours but expend $ 3, 988 as a result of electronic submission, after accounting for new CDX registration costs. In the first year, costs are expected to increase as a result of the costs associated with rule familiarization for all section 5 submitters. However, in subsequent years , industry is expected to save 489 hours and $ 17, 199 annually as a result of the final rule
.**pg. 18** 

**Table 10**  **: Total Industry Burden for Electronic Submission of Bona Fide Notices and New CDX**  **Registration Industry Burden**  **for Rule Familiarization**  **1 Industry Cost**  **for Rule Familiarization**  **1 Industry** 

**Burden for Electronic**  **Subm ission**  **2 Industry** 

**Cost for Electronic**  **Subm ission**  **2 Industry** 

**Burden for CDX**  **Registration 3**  **Industry**

**Cost for CDX**  **Registration 3**  **Total**

**Hourly Burden**  **Total**

**Cost (a)**  **(b) (c)**  **(d) (e)**  **(f) (g)=(a)+**  **(c)+ (e) (h** **)=(b)+**

**(d)+ (f) First Years**  **Baseline** 0 0 2,494 $151,711 0 $0.00 **2,494 $151,711**  **Am ended**  **Rule** 275 $18,302 1,972 $132,236 65 $4,497 **2,312 $155,699**  **Burden Change**  **(Baseline -**  **Am ended**  **Rule) 275**  **$18,302 -**  **522 -**  **$19,475 65**  **$4,497 -**  **182 $3,988**  **Subsequent Years Baseline**  0 0 2,494 $151,711 0 $0.00 **2,494 $151,711**  **Am ended**  **Rule** 0 $0 1,972 $132,236 33 $2,276 **2,005 $134,512**  **Burden Change**  **(Baseline -**  **Am ended**  **Rule) 0**  **$0 -**  **522 -**  **$19,475 33**  **$2,276 -**  **489 -**  **$17,199 Sources:**  1 Table 7 2 Table 8 3 Table 9 **2.5.5 Efficiencies from the Thin Client Software** 

EPA expects that bona fide notice submitters will experience burden savings because the time required to enter, review, and edit their notices us ing the e
-PMN software and transmit their submissions to EPA via the Thin Client Version of the submission software will be reduced compared to the existing process of submitting a written notice to EPA. Submitters of other TSCA section 5 notic es will also experience burden reductions resulting from the transition from the Thick Client Version to the Thin Client Version of the software :
 The Thin Client Version will provide a more efficient way of accessing the e
- PMN software and completing the e
- PMN form , including additional built
- in validation procedures, reducing the potential for invalid submissions.
 The Thin Client Version of the software is designed to enable more efficient data transmittal, including increasing the size of files that can be submitted to EPA.
 The Thin Client Version eliminates the roadblocks associated with firewalls that were previously encountered by some users of the Thick Client Version and allows users to work offline using an Extensible Markup Language (XML) schema which all ows them to later upload their information to the Thin Client Version.**pg. 19** 

 Submitters will find that sharing files within the Thin Client Version makes the information readily accessible to registrants of the submitting company and their designated support persons.**pg. 20** 



## 3. **A gency**  **B urdens**  **and C**  **osts 3.1**  **Labor Rates for EPA Staff**  Agency labor costs are calculated based on annual Federal salaries for the Washington
- Baltimore area published by the Office of Personnel Management effective January 201 3 (OPM, 201 3 ). EPA assume s that, on average, a federal GS
- 13, Step 5 full
-time equivalent (FTE) will conduct its collection and administrative activities under this final rule. 3 The average salary for a GS
- 13 , Step 5 employee was $100,904 in 201 3 , without fringe benefits and overh ead costs. In order to derive the fully loaded salary, EPA multiplied the annual salary by an assumed loading factor of 1.6 to reflect federal fringe benefits and overhead (EPA, 2009 b ) , which results in a fully loaded annual salary of $161,446 (see Table 11 ). Dividing the fully loaded annual salary by 2,080 hours (i.e., the number of hours in a work year) yields an hourly FTE wage rate of $77.62. Fully loaded costs for Agency labor are shown in Table 11
. **Table 11**  **: Derivation of Loaded A gency**  **Wage Rates Labor**  **Category Data**  **Source for Wage**

**Inform ation**  **Date Wage**  **Fringe Benefit**  **Fringes**

**as % wage**  **Overhead**

**as % wage**  **Fringe +**

**overhead factor**  **Loaded**

**Wages** (a) (b) (c)=(b)/(a) (d) (e)=(c)+(d)+1 (f)=(a)*(e)
EPA staff FTE Annual Federal staff cost:

OPM Washington
Baltimore
-Northern Virginia, DC
- MD
- PA
- VA
WV, area, GS
- 13 Step 5 pay rates, with 60% overheads a
. Jan

201 3 $100,904 (annual)

-- [Included

in 60% overhead] 60% b 1.60 $161,446 (annual) $48.51 (hourly) $77.62 (hourly)
**Notes** : a The Agency salary is the unloaded federal GS
- 13 Step 5 salary ($100,904 for 201 3 ),from the OPM salary table for the Washington
- Baltimore
-Northern Virginia Locality Pay Area (OPM, 201 3 ). Hourly rates are based on annual salary divided by 2,080 hours. b The 60% fringes
- and
- overhead rate is from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs) (EPA, 2009b )
.

3 The GS
- 13 S tep 5 is consistent with ICR No. 0574.1 5 ( EP A, 20 11 ), which covers bona fides
.**pg. 21** 



### 3.2 **Changes in A gency** **Burden and Cost A**  **ssociated with the Final e -**  **PMN Rule**  The conversion to an electro nic reporting system , as well as the adoption of the Thin Client Version of the software to facilitate form submission and processing , is expected to create long
-term burden reductions and efficiencies for EPA. For example, when data is submitted electroni cally, the time required for EPA staff to review and process the information will be reduced because manual data entry or processing will be eliminated. The use of CDX will enable EPA to notify the submitter that the Agency has received the submission and will lead to higher quality data being available more quickly to EPA. EPA also expects to realize burden savings attributable to the eventual elimination of its current systems of processing bona fide notices. These savings will stem from eliminating manual data entry of bona fides and related support documents, reducing resources dedicated to quality assurance/quality control (AQ/AC) of the current paper
-based system, and either greatly reducing or eliminating operating and maintenance costs for the existing system. Baseline Agency burden associated with bona fide notices, 2 hours per notice, is taken from the most recent version of the Information Collection Request for Premanufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances (EPA, 2011)
. The Agency extramural cost of $91.74 for contract support was taken from the Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications and inflated to 2013 dollars using the Bureau of Labor Statistics (BLS) Employment Cost Index (ECI) for Private industry, Professional and Related Labor ( BLS, 2014b ). Potential Agency burden savings associated with the modified final e
- PMN rule are characterized based on information in the CDX Business Case Analysis regarding the estimated monetary benefit from using CDX. For this analysis, EPA assumes an average annual savings of 17 percent, based on the assumptions used in EPA, 2009 a , for a total post compliance burden of 1.66 hours per notice. As a result of electronic bona fide submissions the Agency expects to save approximately 39 hours and $3,100 annually. **Table 12**  **: Agency Burden Reductions for Electronic Submissions of Bona Fide I**  **ntent to Manufacture or Import Notices** 

**Hourly Burden per**  **Subm ission**  **Hourly**

**Agency Wage Rate**  **Agency**

**Extram ural**  **Cost Total Cost** 

**per Subm** **ission Total** 

**Number of Subm** **issions Total** 

**Hourly Burden**  **Total**

**Cost Baseline**  2 .00 $77.62 $93.53 $249 116 232 $28,857 **Am ended**  1.66 $77.62 $93.53 $222 116 193 $25,795 **Cost Savings 0.34**  **$26.39 39.44**  **$3,061 pg.**  **22**



## 4. **B enefits**  **of the**  **F inal**  **e -**  **PM N**  **Mo difications**  **Rule** As mentioned in the other sections of this Economic Analysis, the final reporting system is intended to streamline and reduce the administrative costs and burden associated with TSCA section 5 reporting for both industry and EPA. EPA expects the rule to result in improved efficiencies within the New Chemicals Program and an enhanced ability to carry out broader government efforts to move to modern, electronic methods of information gathering. Under the modification to the final e
-PMN rule, (1) submitters of bona fide notices will be required to submit these notices to the Agency electronically ; and (2) the EPA will be moving to a new version of the e
- PMN software that operate s as a “cloud” , or Thin Client Version of the software system rather than as a downloadable , or Thick Client , software sys tem. CDX is a point of entry or web services node for the electronic submission of environmental data to the Agency. CDX works with EPA program offices such as the New Chemicals Program that are seeking to identify ways to better manage incoming data, and with stakeholders such as bona fide notice submitters looking for ways to reduce time and money spent to meet EPA reporting requirements. This section discusses the benefits expected to result from electronic reporting via a thin
- client system and from the electronic submission of bona fides for both industry and the Agency. 

### 4.1 **Industry**

**Benefits 4.1.1**  **Electronic Reporting of Bona Fide Notifications**  As a result of the modification to the e
- PMN rule, EPA expects bona fide notice submitters to experience burden savings because the time required to enter, review, edit, and transmit their submissions to EP A will be reduced. The e
-PMN software includes numerous helpful features for completing and submitting bona fides. A validation mechanism will alert users when a require d field on the form is either missing information or contains certain kinds of incorrect information. Further, maintaining electronic files is also expected to be less burdensome than hardcopy files. Additional benefits to companies using the bona fide notice software include:
 Filling out a form for a chemical similar to one previously submitted will be faster with the electronic submission of bona fide notices as the facility will already have an electronic copy of the earlier form to edit rather than having to fill out a new form.  Preparation and submission of attachments will be streamlined because those attachments that are already in electronic format can simply be attached rather than submitting hard copies with sequentially numbered pages. Burden will still be incurred to prepare a PDF file and submit attachments that are in paper format. Sanitized versions of attachments will still need to be prepared.  All relevant staff within the submitting company will be able to easily access the electronic bona f

ide notice form and directly input their information. The electronic form will also facilitate easier internal review prior to submission.  The electronic bona fide notice form will allow submitters to attach chemical structure diagrams using EPA
- approved s oftware.  The cutting and pasting function in the electronic bona fide notice software will allow submitters to copy information within and across forms, cutting down on time previously required to retype information.**pg. 23** 

EPA expects that this automation will s ave industry time and postage, because routine correspondence with the Agency, including submission of supporting documents, will be via CDX
. By streamlining the bona fide reporting process, the use of CDX will eliminate the need for submitters to print, photocopy, and mail paper notices. The system will provide immediate electronic confirmation that EPA received the submitter’s information. **4.1.2 Updated e**  **- PM**  **N Software** The new Thin Client Version of the electronic submission software, a module within the Chemical Information Submission System (CISS) , will benefit industry submitters. CISS was developed by EPA as a web
-based reporting tool for use in submitting data for all sections of TSCA electronically to the Agency. CISS provides user
- friendly navigatio n, works with CDX to secure online communication, creates a completed Portable Document Format (PDF) file for review prior to submission, and enables data, reports, and other information to be submitted easily as PDF attachments, or by other electronic standards, such as XML. The Thin Client system will eliminate certain firewall and file submission size limitations that exist with the current version of the software. The Thin Client Version provides a more efficient way of accessing the e
- PMN software, com pleting the e
- PMN form, and submitting data. It will allow submitters to work directly onl ine or, if they choose, to work offline using an Extensible Markup Language (XML) schema which allows them to later upload their information to the Thin Client Version. In completing the PMN form, submitters will find that sharing files within the Thin Client Version makes the information readily accessible to registrants of the submitting company and their designated support persons. A final benefit of using the Thin Client Version is that the most updated version of the e
- PMN software will be available whenever the submitter log s into CISS. 

### 4.2 **Ag ency**  **Benefits 4.2.1**  **Electronic Reporting of Bona Fide Notifications**  EPA expects that the conversion to an electronic reporting system will create long
- term burden reduction and efficiencies for the Agency. The need to process paper forms will be eliminated and quality assurance/quality control (QA/QC) and O&M costs for the existing system will be reduced. The electronic bona fide notic e software will also improve data quality because it will facilitate data correction and validation by highlighting fields with omitted or inconsistent data prior to submission. **4.2.2 Updated e**  **- PM**  **N Software** The new Thin Client Version of the electronic submission software, a module within the Chemical Information Submission System (CISS), will also benefit the Agency
. Itwill reduce error associated with Agency data entry. It will ensure that all bona fide submissions contain the necessary information to process the notice. The cloud based system will also give EPA the ability to provide widespread automatic software updates to all CDX users ; this will ensure that updates and bug fixes will be universal and that all users will have the same software version.**pg. 24** 



## 5. **A d**  **ditional A**  **nal ys**  **es** This section presents the additional analysis required under various statutes and Executive Orders. 

### 5.1 **Regulatory**

**Flexibility A ct (RFA** **)** Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq. , the Agency hereby certifies that this rule will not have a significant adverse economic impact on a substantial number of small entities, due to the burden
-reducing nature of this rule, which will benefit all submitters regardless of the size of the entity. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of today's rule on small entities, small entity is defined as: (1) a small business as defined by the Small Business Administration’s (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, c ounty, town, school district or special district with a population of less than 50,000; and ( 3) a small organization that is any not - for
-pro fit enterprise which is independently owned and operated and is not dominant in its field. In determining whether a rule has a significant adverse economic impact on a substantial number of small entities, an agency may certify that a rule will not have a significant adverse economic impact on a substantial number of small entities if the rule relieves regulatory burden, or otherwise has a positive economic effect on all of the small entities subject to the rule. This rule is expected to red uce existing regulatory burden. 

### 5.2 **Unfunded Mandates Reform A ct (UMRA** **)** Based on EPA ’ s experience with past bona fides , State, local, and tribal governments have not been affected by this reporting requirement, and EPA does not have any reason to believe that any State, local, or tribal government will be affected by this rulemaking. As such, EPA has determined that this re gulatory action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the re quirements of sections 202 , 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104
-4). 

### 5.3 **Paperwork Reduction A ct (PRA** **)** The information collection requirements contained in this direct final rule have been submitted for approval to the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq
. The PRA was enacted to minimize the paperwork burden for individuals; businesses; State, local and tribal governments; and other entities resulting from the collection of information by or for the federal government. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB c ontrol numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9. OMB has already approved the underlying information collection requirements described in this direct final rule under OMB control numbers 2070
- 0012 and 2070
- 0038 (EPA In formation C ollection Request (ICR) No. 0574.15, Premanufacture Review Reporting and Exemption Requirements for New**pg. 25** 

Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances ; and, EPA ICR No. 1188.11, TSCA Section 5(a)(2) Significant N ew Use Rules for Existing Chemicals ) , respectively
. EPA has submitted a request for additional approval to OMB under PRA because the direct final rule alters the required form and format of the existing, approved collections of information
. This rule
-related ICR addresses the incremental paperwork activities related to submitting TSCA S ection 5 information to EPA electronically , b y effectuating program change burden reductions related to the clerical level efficiencies resulting from electronic submission o f bona fide notices. In addition, EPA is also adding an information collection to cover CDX registration activities for new TSCA section 5 submitters and EPA is moving from a Thick Client software system to a “cloud

– based,” or Thin Client, software system. While EPA expects that the change in the software system will reduce the burden to all submitters of TSCA section 5 notices, this burden reduction is expected to be minimal and has not been quantified for this ICR change request
. The information collection requirements described in the final rule are not enforceable until OMB approves them. The ICR document for this final rule provides a detailed presentation of the estimated burden and costs for three years of the rule
-related program
. Burden is defined at 5 CFR 1320.3(b). In the first year of the rule, the total burden to industry is expected to decrease 182 hours and the total cost is expected to increase by $3,988, for a total burden of 2,312 hours and $155,699. 

### This includes an average per firm burden of 0. 82 hours for rule familiarization for 336 TSCA Section 5 submitters (Sectio n 2.5.1 ), a per- submission burden of 17.0 hours for electronic reporting of 116 bona fide submissions (Sectio n 2.5.2 ), a per-registrant burden 0.43 hours for 93 new technical labor CDX registrations, and a
-per registrant burden of 1.07 hours for 23 new managerial CDX registrants (Sectio n 2.5.3 ) . In all subsequent years of the rule the total industry burden is expected to decrease by 485 hours and $17,199. 

### This includes a per submission burden of 17.0 hours for electronic reporting of 116 bona fide submissions (Sectio n 2.5.2 ), a per-registrant burden 0.43 hours for 46 new technical labor CDX registrations, and a per
-registrant 1.07 hours for 12 new managerial CDX registrants (Sectio n 2.5.3 )
. The information col lected under the existing ICR will be modified by changing the form in which the submitter completes and submits the required information to EPA. As such, responses to the collection of information covered by these ICRs are still mandatory but, with the final rule, respondents will be required to use the e
-PMN software to complete bona fide notices. Respondents will be required to use the Thin Client Version of the e
- PMN software to generate, complete, and, ultimately, submit the form
. However, use of the current Thick Client Software will be allowed until the effective date of this rule
. 

### 5.4 **Executive Order 13132**  **, Federalism** Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” Policies that have federalism implications are defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government” (64 FR 43255, August 10, 1999).**pg. 26** 

The final rule establishes reporting and recordkeeping requirements that apply to manufacturers (including importers) and processors of certain chemicals. EPA has no information to indicate that any state or local government manufactures or processes the chemical substances covered by this action. 

### 5.5 **Executive Order 12898**  **, Environmental Justice** Executive Order 12898, “Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations” (59 FR 7629, February 16, 1994), establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low
- income populations in the United States. The information collected under this final rule, if finalized, will assist EPA and others in determining the potential hazards and risks associated with various chemicals manufactured and used at high production volumes. Although not directly impacting environmental justice
-related concerns, this information will enable the Agency to better protect human health and the environment, including in low
- income and minority communities. 

### 5.6 **Executive Order 13045, Protection of Children**  Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), requires EPA to identify and assess environmental health and safety risks that may disproportionately affect children. This type of analysis is required for rules that will have an impact of $100 million or more only. The impact of this SNUR will be less than $100 million and therefore no analysis of such impacts on children is required. 

### 5.7 **Executive Order 13175**  **, Tribal Governments** Executive Order 13175 is Consultation and Coordination with Indian Tribal Governments (59 FR 22951, November 6, 2000). This rule does not have Tribal implications because EPA has no information to indicate that any tribal government manufactures or processes the chemical substances covered by this action. 

### 5.8 **Executive Order 13211, Energy Supply, Distribution, or Use**  This rule is not sub

ject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use. 

### 5.9 **Executive O**  **rder 13563, Improving Regulation and Regulatory Rev**  **iew** Executive Order 13563, Improving Regulation and Regulatory Review (76 FR 3821, January 21, 2011), requires EPA to base regulations on the best available science, allow for public participation and the open exchange of ideas, promote predictability and reduce uncertainty, identify and use the best, most innovative, and le ast burdensome tools for achieving regulatory ends, consider both the**pg. 27** 

costs and benefits qualitatively and quantitatively and ensure regulations are accessible, consistent, written in plain language, and easy to understand. The final rule establishes rep orting and recordkeeping requirements that apply to manufacturers (including importers) and processors of certain chemicals. Consistent with EO 13563, this document qualitatively and quantitatively describes both the costs and benefits of the final rule as well as the underlying data used in the analyses. EPA chose the best available data to analyze the costs and benefits described in this document and the best analytic approaches given the available data and other constraints.**pg. 28** 



## 6. **REFERENCES** 40 CFR Parts 700, 720, 721, 723, and 725. TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting; Revisions to Notification Regulations. January 6, 2010 http://www.epa.gov/opptintr/newchems/epmn/epmn
- frnotice.pdf BLS, 201 4a . Employer Costs f or Employee Compensation Summary, Private industry workers, Goods
-producing industries, white
- collar occupations, Table 11. U.S. Department of Labor, Bureau of Labor Statistics. Washington, DC. December 201 3
. BLS, 201 4b . Bureau of Labor Statistics. Employment Cost Index

– Total Compensation: Professional and Related Private Industry, Not Seasonally Adjusted. (Series ID: CIU2010000120000I (B)), extracted August 2014 . http:/data.bls.gov/cgi
-bin/srgate. (BLS 201 4b ) EPA, 1 99 4. Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications September 1994. EPA, 2002 a . Wage Rates for Economic Analysis of the Toxics Release Inventory Program. U.S.EPA, Office of Pollution Prevention and T oxics, Economic and Policy Analysis Branch. Washington, DC. June 10, 2002. EPA, 2002b . Revised Economic Analysis for the Amended Inventory Update Rule: Final Report. U.S.EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. W ashington, DC. August 2002. EPA, 2009 a . The Economic Analysis of the Premanufacure Notification Electronic Reporting Rule July 29, 2009. EPA, 2009b. U.S. EPA, Office of Environmental Information, Collection Strategies Division, ICR Handbook EPA’s Guide to Writing Information Collection Requests under the Paperwork Reduction Act of 199. Revised 10/2009. EPA, 2011. Information Collection Request for Premanufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances EPA ICR No: 0574.15 OMB Control No.: 2070
- 0012 . November 2011. OPM, 2013 . U.S. Office of Personnel Management. Salary Table 2013
- DCB (Washington

– Baltimore
-Northern Virginia, DC
-MD
-VA
-WV
-PA). 2007. U.S. Pos tal Service (USPS) , 201 3
. 2013 USPS Postage Rate Increase Guide <

### http://www.stamps.com/whitepapers/2013
-usps - postage - rate - increase
- guide.pdf >. Accessed August 2014
.