Economic Analysis 

of the TSCA

Section 5 

Premanufacture 

and Significant New

Use Notification 

Electronic 

Reporting; 

Revisions to 

Notification 

Regulations

RIN 2070-AJ98

November 17, 2014

-- Does not contain TSCA CBI –

Economic and Policy Analysis Branch

Economics, Exposure and Technology Division

Office of Pollution, Prevention, and Toxics

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue

Washington, DC 20460

Contents ▌pg. i

Economic Analysis of the Premanufacture Notification Electronic 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 notification 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 software. 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 ePMN software described in this EA will operate as a “cloud”, or Thin Client, software system rather 

than as a downloadable, or Thick Client, 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 submissions: 

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 Use 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 genetically 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 software 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 489 hours and annual net cost savings of approximately $17,000. 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 submissions 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 paper, 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 $1,000 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. 

EPA 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 ePMN 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 ePMN 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 users 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 logs 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 ePMN software cannot accommodate notifications 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 changes to industry costs and burden compared to the baseline of the 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 section 5 notices 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

The 2010 e-PMN rule (40 CFR Parts 700, 720, 721, 723, and 725) required the majority 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 assumes 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 by 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 multiplying 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, 2002a). Wage 

data for each labor category in December 2013 are provided by the Employer Costs for Employee 

Compensation (ECEC) Supplemental Tables available on the BLS website (BLS, 2014a). The loaded 

wage rate is $77.82 for managerial labor; $64.55 for technical labor; and $30.35 for clerical labor. 

Table 1 presents 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 2013

Labor 

Category Data Sources Date

Wage

(2013$)

Fringe 

Benefit

(2013$)

Fringes 

as % 

wage

Over-head 

% wage2

Fringe + 

overhead 

factor

Loaded 

Wages1

(2013$)

(a) (b) (c) =(b)/(a) (d) (e)=(c)+(d)+1 (f)=(a) x (e)

Managerial

BLS ECEC, 

Private 

Manufacturing 

industries,

“Mgt, Business, 

and Financial”3

Dec13

$46.25 $23.71 51.26% 17% 1.68 $77.82 

Professional/

Technical

BLS ECEC, 

Private 

Manufacturing 

industries, 

“Professional 

and related“3

Dec13

$38.16 $19.90 52.15% 17% 1.69 $64.55 

Clerical

BLS ECEC, 

Private 

Manufacturing 

industries, 

“Office and 

Administrative 

Support” 3

Dec13

$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, 2002a), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final 

Report (EPA, 2002b).

3 Employer Costs for Employee Compensation Supplementary Tables December 2013, U.S. Bureau of Labor Statistics, 

March 12, 2014 (BLS, 2014a)

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 Premanufacture Notification 

Electronic Reporting Final Rule (EPA, 2009a), 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, 2009a.

2.3.2 CDX Registration, CDX Electronic Signature, and Pay.gov Account 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 Exposure/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 number 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 the Economic Analysis of the Premanufacture Notification Electronic 

Reporting Final Rule (EPA, 2009a):

 CDX registration: EPA estimates that companies will spend approximately 0.18 hours per 

employee to register with CDX (EPA, 2009a)

 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 accessing, 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 burden 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, 2009a).

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 envelopes). 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, 2009a).

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 Intent 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 Bona 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 of Amendments to 

Regulations for TSCA Section 5 Premanufacture Notifications (EPA, 1994).

 Provide Specific Chemical Identification Data: This includes the Chemical Abstracts Index 

(CASRN) 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 Date 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 provide 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 purposes 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 Premanufacture 

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 costs associated with filing 

the submission (EPA, 2009a); neither 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. 

Notifications are assumed to be shipped via the U.S. Postal Service (USPS) as first-class registered 

mail with a return receipt (USPS, 2013). 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 Service Cost

Registered mail, regular, with $0 declared value $11.20

Return receipt, requested at time of mailing (receive by mail) $2.55

Postage, regular First Class, up to 1 ounce $0.46

Cost per export notice - Subtotal $14.21

Source: USPS, 2013.

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 cost of $1,308.
pg. 14

Table 5: Baseline Burden for Paper Bona Fide Intent to Manufacture or Import Notices

Labor 

Category

Hourly 

Burden 

Range For 

Submission1

Midpoint 

Hourly Burden 

For Submission

Hourly Burden 

for 

Recordkeeping2

Total 

Hourly 

Burden

Wages 

(2013$) 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 

Cost3 $14.21 

Total 18 - 21 19.5 2 21.5 $1,308

Sources:

1EPA, 1994

2EPA, 2011

3USPS, 2013

2.4.2 Burden Reductions from the e-PMN Rule Amendment

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 process 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 ePMN 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 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 declared 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 

delivery 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 reduction or 

elimination of clerical/administrative time, and a reduction in recordkeeping costs (EPA, 2009a). 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 completion, 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, 2009a). 

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.2For 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 $1,140.

Table 6: Burden for Electronic Bona Fide Intent to Manufacture or Import Notices

Labor 

Category

Hourly 

Burden 

Range For 

Submission1

Midpoint 

Hourly Burden 

For 

Submission

Hourly Burden 

for 

Recordkeeping1

Total 

Hourly 

Burden

Wages 

(2013$) Total Cost

Managerial 4 - 5 4.5 0 4.5 $77.82 $350

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

Sources:

1EPA, 2009a

2.5 Industry Burden 

2.5.1 Total Annual 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 EPA’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 Familiarization (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

Amended Rule 0.82 $56.51 336 275 $18,966

Burden Change

(Baseline - Amended 

Rule)

0 $0 336 275 $18,966

2.5.2 Total Annual 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 section 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 Intent to 

Manufacture or Import Notices

Hourly 

Burden per 

Submission

Hourly Burden 

for 

Recordkeeping 

per Submission

Total 

Hourly 

Burden per 

Submission

Total Cost

per 

Submission

Total 

Number of

Submissions

Total 

Hourly 

Burden

Total Cost

Baseline 19.5 2 21.5 $1,308 116 2,494 $151,711

Amended Rule 16 1 17 $1,140 116 1,972 $134,512

Burden Change 

(Baseline -

Amended Rule)

-3.5 -1 -4.5 -$168 -522 -$19,475

2.5.3 Total Annual 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 conservatively 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 of 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 

registrants 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 Intent to Manufacture or Import Notices

Technical 

Labor 

Burden 

per 

Employee

Technical 

Labor 

Cost per 

Employee

Total 

Number of 

Technical 

Registrants

Managerial 

Labor 

Burden per 

Employee

Managerial 

Labor Cost 

per 

Employee

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 

Amended Rule 0.43 $64.55 93 1.07 $77.82 23 64.6 $4,497 

Burden Change 

(Baseline -

Amended 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 

Amended Rule 0.43 $64.55 46 1.07 $77.82 12 32.62 $2,276 

Burden Change 

(Baseline -

Amended 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 

Familiarization1

Industry Cost 

for Rule 

Familiarization1

Industry 

Burden for 

Electronic 

Submission2

Industry 

Cost for 

Electronic 

Submission2

Industry 

Burden for 

CDX 

Registration3

Industry 

Cost for 

CDX 

Registration3

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

Amended 

Rule 275 $18,302 1,972 $132,236 65 $4,497 2,312 $155,699

Burden 

Change 

(Baseline -

Amended 

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

Amended 

Rule 0 $0 1,972 $132,236 33 $2,276 2,005 $134,512

Burden 

Change 

(Baseline -

Amended 

Rule)

0 $0 -522 -$19,475 33 $2,276 -489 -$17,199

Sources:

1Table 7

2Table 8

3Table 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 using 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 

notices 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 allows 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. Agency Burdens and Costs

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 2013 (OPM, 2013). EPA 

assumes 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 2013, without fringe benefits and overhead 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, 2009b), 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 Agency Wage Rates

Labor 

Category

Data Source for Wage 

Information 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 WashingtonBaltimore-Northern 

Virginia, DC-MD-PA-VAWV, area, GS-13 Step 5 

pay rates, with 60% 

overheads a.

Jan 

2013

$100,904

(annual)

--

[Included 

in 60% 

overhead]

60% b1.60

$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 2013),from the OPM salary table for the 

Washington-Baltimore-Northern Virginia Locality Pay Area (OPM, 2013). 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 Step 5 is consistent with ICR No. 0574.15 (EPA, 2011), which covers bona fides. 
pg. 21

3.2 Changes in Agency Burden and Cost Associated with the Final e-PMN 

Rule 

The conversion to an electronic 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 electronically, 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, 2009a, 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 Intent to 

Manufacture or Import Notices

Hourly 

Burden per 

Submission

Hourly 

Agency Wage 

Rate

Agency 

Extramural 

Cost

Total Cost 

per 

Submission

Total 

Number of 

Submissions

Total 

Hourly 

Burden

Total 

Cost

Baseline 2.00 $77.62 $93.53 $249 116 232 $28,857 

Amended 1.66 $77.62 $93.53 $222 116 193 $25,795 

Cost Savings 0.34 $26.39 39.44 $3,061 
pg. 22

4. Benefits of the Final e-PMN Modifications 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 operates

as a “cloud”, or Thin Client Version of the software system rather than as a downloadable, or Thick 

Client, software system. 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 EPA 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 required 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 fide 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 software.

 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 save 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-PMN 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 navigation, 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, completing 

the e-PMN form, and submitting data. It will allow submitters to work directly online 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 logs into CISS. 

4.2 Agency 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 notice 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-PMN 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. It will 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. Additional Analyses

This section presents the additional analysis required under various statutes and Executive Orders.

5.1 Regulatory Flexibility Act (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, county, town, school 

district or special district with a population of less than 50,000; and (3) a small organization that is 

any not-for-profit 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 reduce 

existing regulatory burden. 

5.2 Unfunded Mandates Reform Act (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 

regulatory action does not impose any enforceable duty, contain any unfunded mandate, or otherwise 

have any effect on small governments subject to the requirements of sections 202, 203, 204, or 205 of 

the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

5.3 Paperwork Reduction Act (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 control 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 Information Collection 

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 New 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 Section 5 information to EPA electronically, by effectuating program change 

burden reductions related to the clerical level efficiencies resulting from electronic submission of 

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 

(Section 2.5.1), a per-submission burden of 17.0 hours for electronic reporting of 116 bona fide 

submissions (Section 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 

(Section 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 (Section 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 

(Section 2.5.3).

The information collected 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 subject 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 Order 13563, Improving Regulation and Regulatory Review

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 least 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 reporting 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, 2014a. Employer Costs for 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 2013.

BLS, 2014b. 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 2014b)

EPA, 1994. 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 Toxics, 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. 

Washington, DC. August 2002.

EPA, 2009a. 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. Postal Service (USPS), 2013. 2013 USPS Postage Rate Increase Guide 

<http://www.stamps.com/whitepapers/2013-usps-postage-rate-increase-guide.pdf>. 

Accessed August 2014.