ECONOMIC ANALYSIS 

OF THE 

PREMANUFACTURE NOTIFICATION 

ELECTRONIC REPORTING FINAL RULE 

--- DOES NOT CONTAIN TSCA CBI --- 

Prepared by: 

Wendy Hoffman 

Economic and Policy Analysis Branch 

Economics, Exposure and Technology Division 

Office of Pollution Prevention and Toxics 

Office of Prevention, Pesticides and Toxic Substances 

U.S. ENVIRONMENTAL PROTECTION AGENCY 

1200 PENNSYLVANIA AVENUE, NW 

WASHINGTON, D.C. 20460 

July 13, 2009 
CONTRIBUTORS

The EPA analyst responsible for this report is Wendy Hoffman 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. of Cambridge, Massachusetts under EPA Contract No. EP-W-08-

010. 
 i

ABSTRACT 

This economic analysis estimates the net burden and cost savings associated with 

the final rule to amend the premanufacture notification regulations to facilitate the 

introduction and use of an electronic reporting system. This action is intended to 

streamline and reduce the administrative costs and burdens of the TSCA section 

notifications for both industry and EPA by establishing standards and requirements for 

the use of EPA’s Central Data Exchange (CDX) to electronically submit Premanufacture 

Notices (PMNs) and other TSCA section 5 notices and support documents to the Agency. 

EPA is also amending the TSCA section 5 User Fee regulations to add a new User Fee 

Payment Identity Number field to the PMN form, which will enable the Agency to match 

more easily a particular user fee with its notice submission. 

The Agency is phasing-in CDX reporting over a two-year period after the 

effective date of the final rule. During the phase-in period, submitters will have the option 

of submitting notices via paper, optical disc, or CDX. EPA projects that 33 percent of 

first-year submissions and 66 percent of all second-year submissions will be made via 

CDX. In the third year after the effective date of the final rule, submission of section 5 

notices via CDX will be mandatory. Regardless of the delivery method, EPA is requiring 

that all submissions be generated using the “e-PMN” software. 

As a result of the final rule, EPA believes that section 5 notice submitters 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 via CDX 

will be reduced compared to 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).1

 When the rule is fully 

implemented, EPA estimates annual net burden savings to industry of 16,187 hours and 

annual net cost savings of $458,000 for all TSCA section 5 notice submissions. EPA is 

projected to experience an annual net burden savings of 13,563 hours and annual net cost 

savings of $1 million for all TSCA section 5 notice submissions once the rule is fully 

implemented. 

 

1 Burden and cost savings are made in comparison to an adjusted version of the estimated burden and costs 

presented in the previously published ICR (EPA ICR No. 0574.14). This adjusted version accounts for an update 

in the number of yearly submissions and the cost of shipping submissions to EPA. 
 ii

TABLE OF CONTENTS 

 Page

ABSTRACT.....................................................................................................................i 

1.0 INTRODUCTION ..............................................................................................1 

2.0 INDUSTRY BURDENS AND COSTS...............................................................4 

2.1 Scope of the Final e-PMN Rule...................................................................4 

2.2 Activities Affected by the Final e-PMN rule................................................4 

2.3 Methodology.................................................................................................5 

2.3.1 Estimating the Universe of Affected Entities and Forms ..............8 

2.4 Per Company Burden and Cost.....................................................................9 

2.4.1 Company-Level Burden.................................................................10 

2.4.2 Company-Level Cost .....................................................................11 

2.5 Per Form Burden and Cost Savings...............................................................15 

2.5.1 Form-Level Burden Savings..........................................................15 

2.5.2 Form-Level Cost Savings ..............................................................17 

2.6 Phase-In of Final e-PMN Rule......................................................................19 

2.7 Summary of Impacts......................................................................................21 

3.0 AGENCY BURDENS AND COSTS ..................................................................27 

3.1 Changes in Agency Burdens and Cost Associated with the Final 

e-PMN Rule .........................................................................................................27 

4.0 BENEFITS OF THE FINAL e-PMN RULE.......................................................31 

4.1 Industry Benefits............................................................................................31 

4.1.1 Electronic Reporting ......................................................................31 

4.1.2 CDX......................................... .........................................31 

4.2 Agency Benefits............................................................................................33 

4.2.1 Electronic Reporting ......................................................................33 

4.2.2 CDX ...............................................................................................33 

5.0 ADDITIONAL ANALYSES...............................................................................34 

5.1 Executive Order 12866 ...............................................................................34 

5.2 Regulatory Flexibility Act (RFA)...............................................................34 

5.3 Unfunded Mandates Reform Act (UMRA) ................................................35 

5.4 Paperwork Reduction Act (PRA)................................................................35 

5.5 Executive Order 13132 ...............................................................................36

5.6 Executive Order 12898 ...............................................................................36 

5.7 Executive Order 13045 ...............................................................................37 

5.8 Executive Order 13175 ...............................................................................37 

5.9 Executive Order 13211 ...............................................................................37 

5.10 National Technology Transfer and Advancement Act ...............................37 
 iii

6. 0 REFERENCES ....................................................................................................38 

APPENDIX A Industry Burdens and Costs by Type of Notice...............................38 

Table A-1 Form Level Burden, SNUN Forms Only........................................................40 

Table A-2 Form Level Cost, SNUN Forms Only ...........................................................40 

Table A-3 Form Level Burden, MCAN Forms Only .....................................................41 

Table A-4 Form Level Cost, MCAN Forms Only ..........................................................41 

Table A-5 Form Level Burden, TMEA Forms Only ......................................................42 

Table A-6 Form Level Cost, TMEA Forms Only ...........................................................42 

Table A-7 Form Level Burden, LVE/LOREX Forms Only ...........................................43 

Table A-8 Form Level Cost, LVE/LOREX Forms Only ................................................43 

Table A-9 Form Level Burden, NOC Forms Only .........................................................44 

Table A-10 Form Level Cost, NOC Forms Only ...........................................................44 

Table A-11 Form Level Burden, TERA Forms Only .....................................................45 

Table A-12 Form Level Cost, TERA Forms Only .........................................................45 

Table A-13 Form Level Burden, TIER I / II Forms Only ..............................................46 

Table A-14 Form Level Cost, TIER I / II Forms Only ...................................................46 

Table A-15 Form Level Burden, 5(e) Test Forms Only .................................................47 

Table A-16 Form Level Cost, 5(e) Test Forms Only ......................................................47 

LIST OF TABLES 

Table 1 Final e-PMN Phase-In Schedule for Notices, NOCs, and Support Documents 

Submitted After Effective Date of Final Rule ...................................................3 

Table 2 Universe of Affected Entities and Forms Based on Average Submissions between 

2003 and 2007....................................................................................................9 

Table 3 Loaded Hourly Wage Rates by Labor Category 2007........................................11 

Table 4 Company Level Burden, PMN Forms Only .......................................................13 

Table 5 Company Level Cost, PMN Forms Only............................................................13 

Table 6 Company Level Burden, All Forms....................................................................14 

Table 7 Company Level Cost, All Forms .......................................................................14 

Table 8 Weighted Average Postage Rates.......................................................................17 

Table 9 Form Level Burden, PMN Forms Only..............................................................18 

Table 10 Form Level Cost, PMN Forms Only ................................................................18 

Table 11 One-time Burden, Subject to Phase-In .............................................................20 

Table 12 One-time Burden, Not Subject to Phase-In ......................................................20 

Table 13 Recurring Burden Savings, Subject to Phase-In...............................................20 

Table 14 Recurring Burden Savings, Not Subject to Phase-In........................................21 

Table 15 Burden Savings for PMN Submissions, by Year..............................................22 

Table 16 Cost Savings for PMN Submissions, by Year ..................................................22 

Table 17 Burden Savings for All Section 5 Notices, by Year .........................................23 

Table 18 Cost Savings for All Section 5 Notices, by Year..............................................23 

Table 19 Average Burden Savings per Company Due to the e-PMN Rule 

(All Section 5 Notices).........................................................................................24 

Table 20 Average Burden Savings per Company Due to the e-PMN Rule 
 iv

(All Section 5 Notices).........................................................................................24 

Table 21 Average Burden Savings per Company Due to the e-PMN Rule 

(PMNs only).........................................................................................................25 

Table 22 Average Cost Savings per Company Due to the e-PMN Rule 

(PMNs Only)........................................................................................................25 

Table 23 Average Burden Savings per Form Due to the e-PMN Rule (All Section 5 

Notices)................................................................................................................26 

Table 24 Average Cost Savings per Form Due to the e-PMN Rule (All Section 5 

Notices)................................................................................................................26 

Table 25 Estimated Agency Burden Savings Due to the e-PMN Rule ...........................29 

Table 26 Estimated Agency Cost Savings Due to the e-PMN Rule................................30 
 1

1.0 INTRODUCTION 

This report presents the U.S. Environmental Protection Agency (EPA), Office of 

Pollution Prevention and Toxics’ (OPPT) analysis of the potential changes to industry 

and Agency burdens and costs as a result of a final rule to amend the premanufacture 

notification regulations to facilitate the introduction and use of a new electronic reporting 

system. This new reporting system is intended to streamline and reduce the 

administrative costs and burdens of the TSCA section 5 new chemicals program for both 

industry and EPA. EPA is also amending the TSCA section 5 User Fee regulations to 

add a new User Fee Payment Identity Number field to the PMN form, which will enable 

the Agency to match more easily a particular user fee with its notice submission. A 

second new information element on the amended PMN form will be optional and consist 

simply of the e-mail addresses for the principals listed on the Submitter Identification 

section of the PMN form. 

EPA has developed software which industry will be required to use to submit 

section 5(e) premanufacture notifications electronically through EPA’s secured webbased system, the Central Data Exchange (CDX). This requirement will mean that for 

the first time, manufacturers and importers of TSCA new chemical substances will be 

able to use the Internet to submit Premanufacture Notices (PMNs) and other TSCA 

section 5 notices and support documents to the Agency, while maintaining protection of 

confidential business information. The software, called e-PMN and which will be 

available free of charge by download from EPA’s New Chemicals Program website or by 

request on CD, will replace the existing PMN form. 

Currently, TSCA section 5 notices must be sent to EPA on paper through the U.S. 

mail or delivered by courier. Submitters are able to generate certain TSCA section 5 

notices electronically using the PMN form available at the EPA New Chemicals Program 

website (https://cdx.epa.gov/ssl/pmn/download.asp). The form uses Adobe Acrobat 

software, which allows submitters to complete and save the form electronically and then 

print out and mail it to EPA as hard copy. This Adobe Acrobat software must be 

purchased, although only if the user wishes to save the form. Approximately 35 percent 

of TSCA section 5 notices are currently generated using this software. Most of the 

remaining submissions are generated using other Agency-approved software that has 

been developed by industry trade groups or individual notice submitters. A very small 

percentage of submitters choose to fill out the PMN form by hand or typewriter, using a 

version of the form downloaded from EPA’s TSCA New Chemicals Program website 

(See http://www.epa.gov/opptintr/newchems/pubs/pmnpart1.pdf and 

http://www.epa.gov/opptintr/newchems/pubs/pmnpart2.pdf). 

 The e-PMN software and electronic submission via CDX will change the way that 

companies interact with the Agency regarding TSCA section 5 submissions. EPA 

believes that use of the e-PMN software and CDX will reduce the reporting burden on 

industry by reducing both the cost and the time required to review, edit, and transmit data 

to the Agency. Companies will be required to register with EPA to use CDX for data 

transmission. In turn, the Agency will be able to communicate back electronically with 
 2

submitters, which should be more efficient than using the U.S. mail. The e-PMN 

software’s validation mechanism should help industry users submit fewer incomplete 

notices, which ultimately will save EPA and industry processing resources and reduce 

transaction times. 

The Agency will also benefit in other ways from receiving electronic submissions. 

Among numerous other benefits, data systems that currently are populated manually will 

be populated electronically, reducing the potential for error that exists when data are 

entered by hand. 

CDX will support the submission of the following section 5 notices: 

Premanufacture Notices (PMNs) (40 CFR 720), Significant New Use Notices (SNUNs) 

(40 CFR 721), Test Market Exemption Applications (TMEAs) (40 CFR 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 (MCAN)(40 CFR 725), Notices of Commencement of 

Manufacture or Import (NOCs) (40 CFR 720.102) and other support documents (e.g., 

correspondence, amendments and test data). 

In this rule, the Agency is introducing CDX reporting in two phases over a twoyear period to allow submitters to gain experience and develop confidence in using the ePMN software and the submission delivery system. During the first year following the 

effective date of the final rule, the Agency will allow submissions on paper, optical disc 

(CDs, DVDs), and via CDX. Regardless of the delivery method, EPA will require that 

all submissions be generated using the new e-PMN computer software. One year after 

the final rule’s effective date, paper submissions will no longer be accepted for any new 

notices and support documents (including NOCs). Two years after the final rule’s 

effective date, optical disc-based submissions (e.g., CDs, DVDs) for all new notices and 

support documents will no longer be accepted. In the third year after the final rule’s 

effective date, all submitters will be required to submit electronically via CDX using the 

e-PMN software. The Agency is using this phased approach because it will allow 

submitters to gain experience in using the e-PMN software and the submission delivery 

system (See Table 1). EPA projects that by the first year of the final rule 33 percent of 

notices will be submitted via CDX, 66 percent by the second year, and 100 percent by the 

third year, at which time CDX submission will be required of all subjected notices. 
 3

Table 1 

 e-PMN Phase-In Schedule for Applicable Notices* 

Submission 

Method 

Before 

effective 

date of Final 

Rule 

First year after 

effective date of 

Final Rule 

Second year 

after effective 

date of Final 

Rule 

Third year after 

effective date of the 

Final Rule, and 

thereafter 

Paper Existing PMN 

form 

Optional 

Scanner-friendly 

paper form, 

generated and 

finalized using ePMN software 

Invalid Invalid 

Optical Disc 

(CD, DVD) 

Not 

applicable 

Optional 

Electronic 

submission 

generated and 

finalized using ePMN software 

Optional 

Electronic 

submission 

generated and 

finalized using ePMN software 

Invalid 

CDX/Internet Not 

applicable

Optional Optional Mandatory 

* For list of applicable notices, see section 2.1. Notice of Commencement (NOC) and support documents 

whose original notices were submitted on paper before the new system is implemented will still need to be 

mailed as hard copy. 

This report presents EPA’s (OPPT) analysis of potential changes to industry and 

government burdens and costs that will result from this final rule to change the reporting 

system for TSCA section 5 notices. Section 2 discusses activities to be undertaken by 

industry to comply with the final rule, presents estimated changes to industry costs and 

burdens compared to the baseline of the current paper system, and calculates the total 

industry costs and burden. Section 3 focuses on changes to the Agency’s burden and cost 

to administer the section 5 notice 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.
 4

2.0 INDUSTRY BURDENS AND COSTS 

2.1 Scope of the Final e-PMN Rule 

In addition to PMNs, other types of section 5 notices will be affected similarly by 

the final e-PMN rule. The methodology and results presented in this economic analysis 

characterize the changes in reporting burden specific to the following set of section 5 

notices for which EPA will have the capability to receive electronic submissions: 

• Premanufacture Notice (PMN) 

• Significant New Use Notice (SNUN) 

• Microbial Commercial Activity Notice (MCAN) 

• Test Marketing Exemption (TME) 

• Low Volume Exemption (LVE) 

• Low Exposure Low Release Exemption (LoREX) 

• TSCA Experimental Release Application (TERA) 

• Tier I Exemption/Tier II Exemption 

• 5(e) Test 

• Notice of Commencement (NOC) 

Several types of section 5 notices currently have no required or official forms. Those 

notices include LVE modifications, LoREX modifications, TME applications (TMEAs), 

and Biotechnology notices for genetically modified microorganisms. The final rule 

explains to submitters how they can use the e-PMN software to submit these notices. 

The following types of notices are excluded from the analysis because submitters 

will not have the option of submitting them through CDX and, therefore, they are not 

affected by the rule: Non-5(e) Testing, Notice of Bona Fide Intent to Manufacture, 

prenotice communications, and TSCA Inventory Corrections. In addition, R&D 

exemptions do not require any communication with the Agency and because the Instant 

Photographic Film Articles exemption has not been used in recent years, both are 

excluded from the analysis. The Agency has not developed electronic reporting 

capability for these TSCA section 5-related notices and support documents at this time 

because of the variability and infrequent nature of these types of submissions. 

 This section presents results for PMNs and for all section 5 notices (including 

PMNs), separately. 

 2.2 Activities Affected by the Final e-PMN Rule 

As a result of the final e-PMN rule, EPA expects that PMN and other section 5 

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 CDX, will be reduced compared to the existing process. Anticipated burden 

reduction is likely to include: 
 5

• 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 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. 

• Burden associated with submitting multiple copies will be reduced. Currently 

submitters must file one original, two copies, and one sanitized version. With the ePMN, only electronic versions of the CBI and sanitized forms are required. 

• Preparation of sanitized forms will be automated when the submitter brackets CBI 

data in the form. 

• 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. 

• Preparing consolidated PMNs, which can include as many as six chemicals, will no 

longer necessitate retyping of required (but duplicate) information. 

• The e-PMN form will allow submitters to attach chemical structure diagrams using 

EPA-approved software. 

• The “profiler” feature of the e-PMN will allow a submitting company to enter 

company identification information once and then access it for future submissions, 

thus eliminating the time to retype this information. 

• 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 reduce delays in EPA’s review. 

Submitters will also incur a small additional reporting burden from the two new 

data fields being added to the e-PMN form (User Fee Payment Identification Number and 

optional email address). In addition, submitters will incur a one-time reporting burden to 

facilitate reporting via CDX. This burden, however, should be minimized by the fact that 

it is only expected to be incurred the first time a company submits a section 5 

notice/PMN. 

 2.3 Methodology 

Currently, the OMB-approved estimates of burden for reporting PMN and section 

5 notices (published in EPA ICR No. 0574.14 and referred as the ‘baseline burden’ in this 

analysis) reflect the time required to fill out by hand, review, and mail in a paper version 

of a notice. In the rulemaking context, the appropriate baseline burden and cost should 
 6

reflect the currently approved OMB burden estimates. Therefore, although submitters are 

currently using electronic methods to generate their reports, the correct baseline to use in 

this analysis must reflect paper submission. 

The ideal way to estimate potential change in reporting burden would be to 

compare PMN/section 5 notice submitters’ experience with e-PMN and CDX to their 

experience with the current paper method. However, to date, PMN/section 5 notice 

submitters have had no experience with the e-PMN software or use of CDX to submit 

their PMNs. Therefore, EPA considered the pros and cons of a number of options for 

estimating the change in submission burden, including: 

1) Conduct a survey of nine or fewer IUR reporters who use CDX to submit nonTSCA section 5 reports and apply their time savings, in percentage terms, to the 

administrative time expended by section 5 notice/PMN submitters. 

a. Pros – This option is based on actual experience with CDX. 

b. Cons – This option is not based on section 5 notice/PMN submitter 

experience with the e-PMN software or CDX. 

2) Fill out paper PMN and e-PMN forms and compare the time spent doing each to 

estimate a potential percentage of time saved. 

a. Pros – This option is based on actual experience with both forms. 

b. Cons – This option is a simulated, not an actual industry experience, and 

does not address CDX activities. 

3) Conduct a survey of nine or fewer section 5 notice/PMN submitters regarding 

their potential time saving associated with the e-PMN software and CDX, 

compared to the current process. 

a. Pros – This option would entail interviewing submitters that actually fill 

out section 5 notices/PMNs. 

b. Cons – These submitters have no direct experience with the e-PMN 

software or CDX on which to judge burden changes; the great majority of 

current submitters use an electronic form, which is not comparable to the 

baseline handwritten form. 

4) Undertake a combination of #2 and #3: Generate an estimate of the change in 

burden and then test it with PMN submitters through a survey of nine or fewer 

PMN submitters. 

a. Pros – This option starts with an actual estimate and asks for feedback. 

b. Cons – Industry has no actual experience with the e-PMN software or 

CDX. 

5) Assume the difference in paper format and e-PMN is clerical/administrative time. 

Use the existing OMB-approved reporting burden estimates and eliminate clerical 

burden as an estimate of time savings. 

a. Pros – This option relies on existing OMB-approved burden estimates. 

b. Cons – This assumes that all, and only, clerical time is saved. 

Initially, EPA considered Option #4 to be the method most likely to generate 

realistic estimates. Using actual PMN data, EPA prepared a mock PMN submission by 

filling out a paper form by hand. The e-PMN prototype was then filled out using the 
 7

same PMN data. EPA did not attempt to simulate attaching documents to the form, to 

create a sanitized version of the form, nor to create a consolidated PMN. An additional 

limitation of this approach is that filling out only one form does not allow for the 

estimation of potential savings associated with filling out subsequent forms. 

EPA’s initial findings from this effort suggested that, in comparison to the paper 

form, the electronic version could require the same or more time to complete. EPA 

believes it is likely, however, that there are other potential important savings (as noted 

above, and in Section 4) that are difficult to quantify. 

Because no measurable time savings were observed from the paper-to-electronic 

comparison stated above, EPA considered developing and administering a survey to 

estimates potential burden changes between formats. However, only one percent or 

fewer of current PMN notices are completed entirely by hand. Furthermore, EPA 

estimates that approximately 85 percent of PMNs are currently completed using some 

electronic format (EPA’s Adobe Acrobat form, industry-designed electronic forms), even 

though all notices must be sent to the Agency on paper.2

 As a result, EPA decided that a 

survey would be unlikely to yield useful information on the difference between paper 

submission and e-PMN submission. A survey would be useful, however, following a 

pilot of e-PMN and CDX, to evaluate burden savings associated with the use of the 

electronic form and submissions via CDX. 

EPA therefore undertook an alternate approach, #5, to estimate the burden and 

cost savings to all submitters from changing to an e-PMN form and submission via CDX. 

Specifically, EPA took the previously published baseline burden, approved by OMB, and 

assumed that the burden savings associated with electronic reporting and submission via 

CDX were due to the reduction or elimination of clerical/administrative time. The 

baseline time estimate for clerical burden (12 percent of total burden) was assumed to 

approximate the amount of clerical/administrative time involved in filling out and 

submitting the paper form. A time savings of 12 percent, equal to 13 hours, due to 

switching to the e-PMN will result. This estimate of potential form completion and 

submission savings is in line with estimated savings between electronic and paper 

submissions estimated in the Cross-Media Electronic Reporting Rule 

(CROMERR) Cost Benefit Analysis of 10 percent.3

 

In addition, CROMERR was used to develop estimates of burden from CDX 

registration and electronic signature agreements. Estimated form completion burden 

resulting from the inclusion of two new data fields on the e-PMN form was based on 

engineering estimates of burden for TRI reporting. 

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 

 

2

 The approximately 15 percent remaining PMNs are filled in either using a typewriter or some combination of 

typewritten and handwritten forms, with the handwritten portion usually very small. 

3

 EPA, 2004. Cross-Media Electronic Reporting Rule (CROMERR) Cost Benefit Analysis. November 17, 2004. 

p. 62. 
 8

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. Likewise, EPA does 

not consider the burden and costs associated of submission via optical disc during the 

phase-in of the final rule because this form of submission will not be required by 

industry. Moreover, EPA expects only a very small number of submissions via optical 

disc prior to full phase in of the rule. 

The following sections outline, in further detail, the approach EPA used to 

estimate changes in industry reporting burden due to the final e-PMN rule for all section 

5 notice types outlined above. Burden and cost savings are presented in comparison to 

the burden and costs that would be incurred if industry were to continue submitting 

notices via paper (i.e., baseline conditions). It should be noted that in this analysis, the 

estimates of burden and cost savings are calculated in comparison to an adjusted version 

of the estimated baseline burden and costs presented in the previously published ICR 

(EPA ICR No. 0574.14). The adjusted version of baseline estimates accounts for an 

update in the number of yearly submissions and the cost of shipping submissions to EPA. 

The analysis was completed for two universes: all section 5 notices and PMNs only. 

2.3.1 Estimating the Universe of Affected Entities and Forms 

Burden from the final e-PMN rule is calculated at both a per-company and perform level. Companies may submit multiple section 5 notices in any given year. In this 

analysis, the number of companies submitting PMN/section 5 notices on a yearly basis is 

estimated by averaging the number of unique companies submitting notices during the 

years 2003 through 2007. That number was 295. The number of companies was then 

increased by 10 to account for the 10 additional companies the Agency anticipates will 

submit SNUNs each year in response to SNURs promulgated under the existing 

chemicals program. Similarly, EPA based the number of PMN/section 5 notices it 

expects to be submitted on the average number of PMN/section 5 notices submitted for 

the years 2003 through 2007. The number of expected notices, however, is adjusted 

downward because an EPA analysis of the submissions received during 2003 through 

2007 revealed that about 15 percent of submitted PMN forms were invalid because of 

errors related to chemical ID, missing signatures, and other problems. Because EPA 

expects the e-PMN software to drastically reduce the number of invalid submissions in 

the future, the average number of submissions over the 2003 to 2007 time period is 

reduced by 15 percent to reflect only the valid number of forms that EPA expects to 

receive (see Table 2). 

In this analysis, EPA assumes that both the number of companies and the number 

of forms submitted remain static for all years including the phase-in period and years 

subsequent to the phase-in. Concurrently, EPA assumes that a mixture of first-year and 

subsequent-year filers comprise the static number of submissions. EPA estimates the 

percent of first time e-PMN filers on a yearly basis to be 25 percent. This percentage was 

derived by counting the number of new PMN filers in 2007 (e.g., filers who did not 

submit in any year prior from 2003 through 2006) and dividing by all submitters in 2007. 

For the sake of analytical simplicity, the mixture of newly incoming companies is 
 9

assumed to begin after year three in this analysis, at which time all submissions will be 

via CDX. This assumption does not affect estimated burden for years 1, 2, and 3 in a 

significant way because the number of first-year submissions is overshadowed by the 

number of companies submitting via CDX for the first time during the phase-in period. 

Table 2 

Universe of Affected Entities and Forms (on an annual basis) 

Based on Average Submissions between 2003 and 2007 

Number of Companies 305 

Number of Companies (PMNs ONLY) 200 

Average Number of Notices per 

Company 5.3 

Average Number of PMNs per Company 3.6 

Number of PMNs 720 

Number of SNUNs 18 

Number of MCANs 3 

Number of TMEAs 8 

Number of LVE/LOREXs 419 

Number of TERAs 2 

Number of Tier I / IIs 3 

Number of 5e Tests 12 

Number of NOCs 443 

% of Companies that are New in 

Subsequent Years 25% 

2.4 Per Company Burden and Cost 

Company-level burden includes those activities that facilitate submission of an ePMN: rule familiarization, CDX registration, CDX electronic signature, and setting up a 

Pay.gov account4

. All activities performed at the company-level occur only once during 

the first year that an activity is undertaken. For example, EPA assumes that rule 

familiarization will be incurred by all companies during the first year following rule 

promulgation, regardless of whether the e-PMN is submitted via paper, optical disc, or 

CDX. In addition, companies that submit section 5 notices for the first time in 

subsequent years will incur rule familiarization burden the first year they submit a section 

5 notice. Those companies that submit e-PMNs again in subsequent years will not incur a 

subsequent rule familiarization burden. All other company-level activities, while they are 

incurred only once, will be subject to the phase-in provision of the final e-PMN rule. (See 

section 2.6, Phase-in of the Final Rule). 

2.4.1 Company-Level Burden 

EPA estimates that management, technical, and clerical staff at companies 

submitting section 5 notices will incur the following burden under the final rule: 

 

4

 While the final rule does not require submitters to establish and use a pay.gov account to pay PMN and related 

fees, the economic analysis is being conservative and is including the use of Pay.gov as a required activity. 
 10

CDX registration – Based on the CROMERR Cost Benefit Analysis, EPA 

assumes that companies will spend 11 minutes per employee to register with CDX (EPA, 

2004) Furthermore, EPA assumes that an average of four technical staff members and 

one manager will need to register for each company, totaling 55 minutes of burden per 

company. 

CDX electronic signature (labor) – Based on the CROMERR Cost Benefit 

Analysis, EPA assumes that companies will spend 15 minutes preparing, submitting, and 

filing an electronic signature agreement (Authentication of Identity) form to EPA per 

employee (EPA, 2004). This burden will apply to one manager and four technical staff 

members per company will incur this burden, totaling 75 minutes of burden per company. 

In addition, EPA uses its best professional judgment to estimate that a manager will 

spend an additional 30 minutes 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 

105 minutes. It should be noted that the burden associated with CDX Electronic 

Signatures does not include costs associated with contacting EPA’s CDX help desk to 

notify a change of submitter status, should one occur. 

CDX electronic signature (non-labor costs) –Non-labor costs include a $0.41 

stamp and a $0.02 standard business envelope for each of 5 signature agreements. The 

total non-labor cost for electronic signature agreements equals $2.15.

Payment via Pay.gov account – Based on best professional judgment, EPA 

assumes that one manager per company will spend 8 minutes setting up a Pay.gov ID 

account, logging into the system, finding the e-PMN form, and filling it out. This time 

estimate does not include the time required to click ‘submit’ for an e-PMN form and wait 

for payment processing.5

Rule Familiarization – Management and technical staff will spend time 

familiarizing themselves with the new requirements for electronic submission of their 

company’s section 5 notices. Using its best professional judgment, based on the time 

required to read and comprehend supporting e-PMN regulatory documentation, EPA 

estimates that one manager will spend 33 minutes and one technical staff member will 

spend 16 minutes per company on rule familiarization. 

 2.4.2 Company-Level Cost 

EPA determined the per-company costs by multiplying the unit burden hour 

estimates by fully loaded hourly rates for the appropriate categories of labor conducting 

 

5 EPA’s time estimate is based on best professional judgment of completing a TSCA User Fee form on the 

pay.gov website.
 11

these activities.6 Loaded hourly rates are the product of wages, benefits, and overhead. 

Hourly wage rates are divided into three categories: managerial, technical, and clerical. 

Average wage and salary data for these categories are obtained from the Employer Costs 

for Employee Compensation (ECEC) report from the Bureau of Labor Statistics (BLS) 

for all goods-producing, private industries. The additional cost of benefits, such as paid 

leave and insurance, is also derived from information provided in the ECEC report. 

Loading factors for benefits are calculated separately for managerial, technical, and 

clerical labor by dividing the benefits percentage of total compensation by the wage 

percentage of total compensation. Based on information provided by the chemical 

industry and chemical industry trade associations, EPA applied an additional loading 

factor of 17 percent for general overhead.7 This loading factor is added to the benefits 

loading factor, then applied to the base wage. The new wage rates are calculated using 

current data on salaries and benefits for these three labor categories. The fully loaded 

2007 hourly wage rates are shown in Table 3 

Table 3 

Loaded Hourly Wage Rates by Labor Category 2007 

Labor 

Category 

Occupational 

Type 

Average 

Hourly 

Wage 

Benefit 

(% 

wages) 

Overhead 

(% wages) 

Loaded 

Hourly 

Rate 

Managerial 

Management, 

business, and 

financial $36.44 44.1% 17% $58.71 

Technical 

Professional 

and related $32.52 40.9% 17% $51.35 

Clerical 

Office and 

administrative 

support $15.78 44.9% 17% $25.54 

Source: BLS. Employer costs per hour worked for employee compensation and costs 

as a percent of total compensation: Private industry workers, by occupational group 

and full-time and part-time status, December 2007. Table 11. 

http://www.bls.gov/news.release/ecec.t11.htm 

For each labor category, per company cost is estimated by: 

1) Multiplying the amount of time staff from each labor category spends on an 

activity by the loaded hourly wage rate for each labor category; 

2) Multiplying the labor cost derived in step one by the number of employees 

who incur this burden; 

3) Adding any non-labor costs associated with the activity. 

 

6

 Employer Costs for Employee Compensation, Private industry workers, Goods-producing industries, whitecollar occupations, as published by the U.S. Department of Labor, Bureau of Labor Statistics. Table 11 of the 

Employer Costs for Employee Compensation Summary, December 2007. 7 An overhead rate of 17% was used based on assumptions in Wage Rates for Economic Analyses of the Toxics 

Release Inventory Program (EPA, 2002), and the Revised Economic Analysis for the Amended Inventory Update 

Rule: Final Report (EPA, 2002a). 
 12

EPA multiplied per company burden and cost by the number of submitters to 

obtain total company-level burden and cost for any form type. For company burden and 

costs specific to PMNs, see Tables 4 and 5. For company burden and cost associated 

with all section 5 notices, see Table 6 and 7. 
. 13

Table 4 

Company-Level Burden, PMN Forms Only 

* Includes management, technical, and clerical labor. ** Percent of universe that has completed activity by this year. 

Table 5 

Company-Level Cost, PMN Forms Only 

* Includes management, technical, and clerical labor. ** Percent of universe that has completed activity by this year. 

All Labor Categories Unit Burden* Phase-In Rate** Company-Lev

Activity 

Non-Labor 

($) 

Burden 

(Hours) 

Employees 

Incurring 

Burden 

OneTime 

Burden 

% 

Year 1 

% 

Year 2 

% 

Year 3 

% 

Subsequent 

Years Year 1 Year 2 

CDX Registration $ - 0.4 5 Y 33% 67% 100% 100% 61 61 CDX Electronic Signature $ 2.15 1.0 5 Y 33% 67% 100% 100% 117 117 E-Payment (Pay.gov ID) $ - 0.1 1 Y 33% 67% 100% 100% 9 9 Rule Familiarization $ - 0.8 2 Y 100% 100% 100% 100% 163 - 

All Labor Categories Unit Burden* Phase-In Rate** Compan

Activity 

Non-Labor 

$) 

Burden 

(Hours) 

Employees 

Incurring 

Burden 

OneTime 

Burden 

% 

Year 1 

% 

Year 2 

% 

Year 3 

% 

Subsequent 

Years Year 1 Year 2 

CDX Registration $ - 0.4 5 Y 33% 67% 100% 100% $ 3,228 $ 3,228 CDX Electronic Signature $ 2.15 1.0 5 Y 33% 67% 100% 100% $ 6,502 $ 6,502 E-Payment  (Pay.gov ID) $ - 0.1 1 Y 33% 67% 100% 100% $ 522 $ 522 Rule Familiarization $ - 0.8 2 Y 100% 100% 100% 100% $ 8,780 $ - 
. 14

Table 6 

Company-Level Burden, All Forms 

* Includes management, technical, and clerical labor. ** Percent of universe that has completed activity by this year. 

Table 7 

Company-Level Cost, All Forms 

* Includes management, technical, and clerical labor. ** Percent of universe that has completed activity by this year. 

All Labor Categories Unit Burden* Phase-In Rate** Company-Le

Activity 

Non-Labor 

($) 

Burden 

(Hours) 

Employees 

Incurring 

Burden 

OneTime 

Burden 

% 

Year 1 

% 

Year 2 

% 

Year 3 

% 

Subsequent 

Years Year 1 Year 2 

CDX Registration $ - 0.4 5 Y 33% 67% 100% 100% 93 93 CDX Electronic Signature $ 2.15 1.0 5 Y 33% 67% 100% 100% 178 178 E-Payment (Pay.gov ID) $ - 0.1 1 Y 33% 67% 100% 100% 14 14 Rule Familiarization $ - 0.8 2 Y 100% 100% 100% 100% 249 

All Labor Categories Unit Burden* Phase-In Rate** Compa

Activity 

Non-Labor 

($) 

Burden 

(Hours) 

Employees 

Incurring 

Burden 

OneTime 

Burden 

% 

Year 1 

% 

Year 2 

% 

Year 3 

% 

Subsequent 

Years Year 1 Year 2 

CDX Registration $ - 0.4 5 Y 33% 67% 100% 100% $ 4,923 $ 4,923 CDX Electronic Signature $ 2.15 1.0 5 Y 33% 67% 100% 100% $ 9,916 $ 9,916 E-Payment (Pay.gov ID) $ - 0.1 1 Y 33% 67% 100% 100% $ 796 $ 796 Rule Familiarization $ - 0.8 2 Y 100% 100% 100% 100% $ 13,389 $ - 
 15

2.5 Per Form Burden and Cost Savings 

Form-level burden savings include those activities that are associated with each ePMN submission once all registration, signature, and account set-up activities at the 

company level have been completed. Baseline form burden includes form completion, 

recordkeeping, and postage. As a result of the 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 section 5 notices and using CDX to 

submit these notices. EPA expects that all form-level burden savings will be realized each 

time a section 5 notice is submitted. Recordkeeping and postage savings are subject to 

the phase-in provision of the final e-PMN rule. Because all notices must be generated 

using e-PMN software beginning in the first year following rule promulgation, form 

completion burden saving will be realized by all submitters immediately. 

2.5.1 Form-Level Burden and Burden Savings 

Baseline form completion and recordkeeping burden estimates are 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.

8

 EPA estimates form 

completion and recordkeeping burden changes outlined below in comparison to these 

baseline burdens. EPA estimates that management, technical, and clerical staff at 

companies submitting section 5 notices will realize the following burden changes: 

Form Completion (Burden) - The final rule adds two new data fields to the ePMN form that do not exist on the current paper version of the form: (1) a field for 

entering the User Fee Payment Identification Number, and (2) a field for entering an 

optional email address of the principals listed on the Submitter Identification section of 

the PMN form. These two data fields will increase the burden incurred by technical staff 

members submitting PMN/section 5 notices. Based on reporting burden estimates 

developed for similar data elements on another EPA required reporting form, EPA 

estimates that the User Fee Payment Identification Number will increase burden by 10 

minutes per notice and that the email address data field will increase technical burden by 

one minute per notice.9

 

Form Completion (Burden Savings) – As described above, in this analysis, the 

form completion burden savings associated with electronic reporting using the e-PMN 

software are approximated by the elimination of clerical/administrative time. Therefore, 

under the final rule, EPA assumes that submitters will save the baseline time estimated 

for clerical burden (12 percent of total burden) or 13 hours. In addition, EPA is removing 

the “Agent Signature Block” from the PMN form, which will constitute a burden 

reduction. This burden savings is not included in this analysis, however, because EPA’s 

 

8

 EPA ICR No. 0574.14 OMB Control No. 2070-0014. 

9

 Based on engineering estimates for reporting e-mail address for TRI Reporting. Memo entitled, “TRI 

Reporting Burden Estimates,” from Hilary Eustace, David Cooper and Susan Day, Abt Associates, to Paul Borst, 

US EPA. July, 2004. 
 16

review of submitted notices has shown that fewer than five percent of submissions have a 

completed “Agent Signature Block,” and as such, expected burden savings are 

insignificant. 

Form Completion (Net Burden Change) - The net form completion burden change 

due to the final e-PMN rule is a reduction of 12 hours and 49 minutes per notice. This 

net burden reduction is attributable to the decreased clerical time for form completion and 

increased technical time of filling out the two new data fields mentioned above. 

 Recordkeeping – Although recordkeeping requirements under the current rule are 

not expected to change, EPA assumes that the final rule will reduce recordkeeping burden 

by half because of the efficiencies in creating and storing section 5 notices and supporting 

documents electronically.10 For most section 5 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). For section 5(e) Test notices, baseline recordkeeping burden is estimated 

to be 35 hours due to the need to copy and file relevant records including those related to: 

manufacturing, importing, or processing volumes; shipment amounts and customer 

information; labels (documentation of labeling procedures and copies of labels); MSDS; 

and compliance with any additional restrictions on use, disposal, and discharge 

limitations. Therefore, for each section 5(e) Test notice, 17.5 hours of recordkeeping 

burden will be saved (8.75 hours for one technical staff member and 8.75 hours for one 

clerical staff member). For Notices of Commencement (NOC), baseline recordkeeping 

burden is estimated to be 15 minutes. Therefore, for each NOC, 7.5 minutes of 

recordkeeping burden will be saved (3.75 minutes for one technical staff member and 

3.75 minutes for one clerical staff member). 

Postage – Non-labor postage costs are based on the assumptions that a typical 

submission is 100 pages in length, weighs 1.0 lbs., and is shipped from Kansas City, MO 

to Washington D.C. Kansas City MO was selected as the standard location because it is 

located in the geographic center of the country. Non-labor costs for each type of 

submission are estimated as a weighted average of the different types of delivery services 

used by section 5 Notice submitters in FY2007 for each form type (See Table 8). 

Delivery options include overnight mail services such as FedEx, UPS, DHL, USPS 

Express Mail, U.S. Postal Service, and local Washington D.C. courier delivery. 

 

 

10 Based on EPA’s best professional judgment. 
 17

Table 8 

Weighted Average Postage Rates by Submission Type 

COUNTS OF SUBMISSION FY2007 

Mail 

Service

Postage 

Rate

LOREX/ 

LVE/LVM MCANS NOC PMN SNUN TERA TMEA 

Courier $ 15.00 370 6 193 766 24 0 13

DHL $ 42.55 33 0 20 29 0 0 1

USPS 

(Express) $ 22.65 5 0 18 14 0 0 0

FedEx $ 39.13 261 4 176 442 3 1 19

UPS $ 39.13 46 0 50 76 0 0 0

USPS $ 4.80 20 1 42 34 0 0 1

Weighted 

Average 

Postage 

Rate $ 26.09 $ 22.85 $ 26.45 $ 24.59 $ 17.68 $ 39.13 $ 28.99 

Note: Information on mail delivery type was not available for Tier I/II and 5(e) Test Notices. Therefore, 

PMN postage rates calculated for PMNs were assumed for these two Notice types. 

Courier service includes walk-ins, hand delivery and messenger service to the Confidential Business 

Information Center. 

Source: US EPA, OPPT, 2008. www.ups.com, www.fedex.com, www.usps.com, www.dhl.com. 

2.5.2 Form-Level Cost Savings 

For each labor category, cost savings are estimated by multiplying unit burden 

savings for an activity by the average number of section 5 notices/PMNs submitted on a 

yearly basis. Per form burden savings are estimated by: 

1) Multiplying the amount of time staff from each labor category saves on an 

activity by the loaded hourly wage rate for each labor category (see derivation 

of wage rates above); 

2) Multiplying the labor savings derived in step one by the number of employees 

who experience this burden savings; 

3) Adding any non-labor cost savings associated with the activity. 

EPA multiplied per form burden and cost savings by the number of forms submitted to 

obtain the total form-level burden and cost savings for any form type. For form-level 

burden and cost savings specific to PMNs, see Tables 9 and 10. For form-level burden 

and cost savings associated with each of the other forms separately, see Appendix A.
18

Table 9 

Form-Level Burden, PMN Forms Only 

* Includes management, technical, and clerical labor. ** Percent of universe that has completed activity by this year. 

Table 10 

Form -Level Cost, PMN Forms Only 

* Includes management, technical, and clerical labor ** Percent of universe that has completed activity by this year.

All Labor Categories Unit Burden* Phase-In Rate** Form-Level 

Activity 

Non-Labor 

 ($) 

Burden 

(Hours) 

Employees 

Incurring 

Burden 

OneTime 

Burden 

% 

Year 1 

% 

Year 2 

% 

Year 3 

% 

Subsequent 

Years Year 1 Year 2 

Form Completion $ - -12.8 2 N 100% 100% 100% 100% (9,234) (9,234) Recordkeeping $ - -1.0 2 N 33% 67% 100% 100% (240) (480) Postage $ (24.59) 0.0 1 N 33% 67% 100% 100% - - 

All Labor Categories Unit Burden* Phase-In Rate** Form-

Activity 

Non-Labor 

($) 

Burden 

(Hours) 

Employees 

Incurring 

Burden 

OneTime 

Burden 

% 

Year 1 

% 

Year 2 

% 

Year 3 

% 

Subsequent 

Years Year 1 Year 2 

Form Completion $ - -12.8 2 N 100% 100% 100% 100% $ (232,425) $ (232,425Recordkeeping $ - -1.0 2 N 33% 67% 100% 100% $ (9,233) $ (18,465Postage $ (24.59) 0.0 1 N 33% 67% 100% 100% $ (5,907) $ (11,813
 19

2.6 Phase-in of Final e-PMN Rule 

The Agency is introducing CDX reporting in two phases over a two-year period. 

During the first year following the effective date of the final rule, the Agency will allow 

submissions via CDX, optical disc (i.e., CD or DVD), and paper. Regardless of the 

delivery method, EPA will require that all notices be generated using the e-PMN 

computer software. One year after the final rule’s effective date, paper submissions will 

no longer be accepted for any new notices and support documents (including NOCs). 

Two years after the final rule’s effective date, optical disc-based submissions for all new 

notices and support documents will no longer be accepted. In the third year after the final 

rule’s effective date, all submitters will be required to submit electronically via CDX 

using the e-PMN software. The Agency is following this phased approach because it will 

allow submitters to gain experience in using the e-PMN software and the submission 

delivery system. 

In generating estimates of burden changes due to the final rule, EPA projects that 

33 percent of first year submissions and 66 percent of all second year submissions will be 

made via CDX. All submissions must be made via CDX by the third year and beyond. 

The actual rates of adoption of CDX in years one and two of the rule could be higher or 

lower than EPA’s projections. However, lacking any data on which to base other 

projections, EPA is assuming an even rate of adoption over the two-year phase-in period. 

In addition, while submission via optical disc will be permitted in years one and two, it 

will not be required by the final rule, nor does EPA expect that many notices will be 

submitted in this format. Hence, EPA does not consider submission via optical disc in its 

phase-in assumptions. The actual burden incurred by submitters will depend on the 

phase-in rate of the final rule as well as the nature of the burden (i.e., one-time burden or 

recurring burden). Burden estimates fall in to one of the following categories: 

One-time burden, subject to phase-in: 

One-time burden that is subject to the phase-in provision is specific to companylevel activities such as CDX registration, CDX electronic signature, and setting up a 

pay.gov account. Because these burdens will be incurred only once, each burden-year 

accounts for only the net burden incurred for that year. For example, although all 

companies are expected to submit via CDX by the third year, burden estimates must be 

adjusted to account for those companies that have already incurred the burden in the first 

or second year. Specific calculations are shown in Table 11. 
 20

Table 11 

One-time Burden, Subject to Phase-In 

Year of Burden Method of Estimation 

First Year Multiply the company-level burden estimate by 33% 

Second Year Multiply the company-level burden estimate by 66%, and subtract the 

burden incurred by companies during the first year 

Third Year Multiply the company-level burden estimate by 100%, and subtract the 

burden incurred by companies during the first and second years 

Subsequent Years Multiply the company-level burden estimate by the projected % of 

companies that will be new in subsequent years 

One-time burden, not subject to phase-in: 

One-time burden that is not subject to the phase-in provision is specific to rule 

familiarization only, which is a company-level activity. EPA is projecting that this 

burden will be incurred by all companies filling out PMNs/section 5 notices, regardless of 

the method of submission used during the phase-in period. There are no estimated second 

and third year burdens for rule familiarization because the universe of companies 

submitting notices remains static during the phase-in period for this analysis. In 

subsequent years, companies that will be submitting notices for the first time will incur 

the rule familiarization burden. Specific calculations are shown in Table 12. 

Table 12 

One-time Burden, Not Subject to Phase-In 

Year of Burden Method of Estimation 

First Year Multiply the company-level burden estimate by 100% 

Second Year Multiply the company-level burden estimate by 100% and subtract the 

burden incurred by companies during the first year 

Third Year Multiply the company-level burden estimate by 100% and subtract the 

burden incurred by companies during the first and second years 

Subsequent Years Multiply the company-level burden estimate by the projected % of 

companies that will be new in subsequent years 

Recurring burden savings, subject to phase-in: 

Recurring burden savings subject to the phase-in provision are specific to formlevel activities such as recordkeeping and postage requirements. These burden savings 

are associated with all PMN/section 5 notices submitted via CDX, regardless of the year. 

Specific calculations are shown in Table 13. 

Table 13 

Recurring Burden Savings, Subject to Phase-In 

Year of Burden Method of Estimation 

First Year Multiply the company-level burden estimate by 33% 

Second Year Multiply the company-level burden estimate by 66% 

Third Year Multiply the company-level burden estimate by 100% 

Subsequent Years Multiply the company-level burden estimate by 100% 
 21

Recurring burden savings, not subject to phase-in: 

Recurring burden savings that are not subject to the phase-in provision are 

specific to form completion only. These burden savings are associated with all 

PMN/section 5 notices, regardless of their method of submission, for all years because 

submitters will be required to use the e-PMN software starting in Year 1. Specific 

calculations are shown in Table 14. 

Table 14 

Recurring Burden Savings, Not Subject to phase-in 

Year of Burden Method of Estimation 

First Year Multiply the company-level burden estimate by 100% 

Second Year Multiply the company-level burden estimate by 100% 

Third Year Multiply the company-level burden estimate by 100% 

Subsequent Years Multiply the company-level burden estimate by 100% 

2.7 Summary of Impacts 

The estimated changes in industry burden and cost due to the final e-PMN rule are 

presented in Tables 15 through 24. Total industry burden savings are presented for PMN 

submissions alone in Table 15; associated costs are shown in Table 16. Total industry 

burden for all section 5 notices combined are shown in Table 17 and associated costs are 

presented in Table 18. The tables show both company-level burden and costs changes at 

the company level, e.g., CDX-related costs, and at the form-level, e.g., e-PMN softwarerelated changes, and the total industry burden and cost changes from the company- and 

form-level changes combined. While the activities related to CDX are estimated to 

impose additional burden and cost, those increases are offset by the burden and cost 

savings industry is expected to incur as a result of using the e-PMN software. 

For example, Table 15 shows that while total company-level burden is estimated 

to increase by 350 hours in year one of the rule for PMN notices only, that increase is 

offset by savings at the form-level, resulting in an estimated total industry net savings of 

9,124 hours. Beyond the third year of the rule, net industry savings for PMN notices only 

are estimated to be 9,774 hours. Associated cost savings are shown in Table 16 for PMN 

notices only. In the first year of the rule, total industry costs savings are estimated at 

approximately $229,000 in the first year of the rule, and approximately $268,000 beyond 

the third year of the rule. Similarly, for all notices, Table 17 shows an estimated total 

industry net burden saving of 14,972 hours in the first year, and 16,187 hours in 

subsequent years beyond the third year of the rule. For all notices combined, Table 18 

shows an estimated total industry savings of approximately $458,000 in years three and 

beyond. 

Average burden and cost savings per company due to the final rule are presented 

for all notices combined, and for PMN notices only in Tables 19 through 22. Results are 
 22

presented on a per-form basis for all notices combined in Tables 23 and 24. For example, 

Table 19 shows an estimated average net burden savings of 50.4 hours per-company for 

all notices in the first year and in subsequent years of the rule. Associated cost savings at 

the per-company level shown in Table 20 are estimated to be approximately $1,400 for 

all years of the rule for all notices. For PMNs only, Table 21 shows estimated average 

burden savings of 46.2 hours per-company in the first year and in subsequent years of the 

rule. On a per-form basis, Table 22 shows estimated average savings of approximately 

$1,200 for PMNs only for all years of the rule. For all notices combined, Table 23 shows 

estimated average burden savings of approximately 9.5 hours per form for all years of the 

rule, and Table 24 shows estimated average cost savings of approximately $260 per form 

for all years of the rule, for all notices combined. 

 

Table 15 

Burden Savings for PMN Submissions, by Year 

Total Company-Level Burden (hours) 

Year 1 Year 2 Year 3 

Subsequent 

Years 

350 187 187 181 

Total Form-Level Burden Savings (hours) 

Year 1 Year 2 Year 3 

Subsequent 

Years 

(9,474) (9,714) (9,954) (9,954) 

Total Industry Burden Savings by Year (hours) 

Year 1 Year 2 Year 3 

Subsequent 

Years 

(9,124) (9,528) (9,768) (9,774) 

 

Table 16 

Cost Savings for PMN Submissions, by Year 

Total Company-Level Cost 

Year 1 Year 2 Year 3 

Subsequent 

Years 

$ 19,032 $ 10,252 $ 10,252 $ 9,884 

Total Form-Level Cost Savings 

Year 1 Year 2 Year 3 

Subsequent 

Years 

$ (247,564) $ (262,703) $ (277,842) $ (277,842) 

Total Industry Cost Savings by Year 

Year 1 Year 2 Year 3 

Subsequent 

Years 

$ (228,532) $ (252,451) $ (267,590) $ (267,958) 
 23

Table 17 

Burden Savings for All Section 5 Notices, by Year 

Total Company-Level Burden (hours) 

Year 1 Year 2 Year 3 

Subsequent 

Years 

534 285 285 276 

Total Form-Level Burden Savings (hours) 

Year 1 Year 2 Year 3 

Subsequent 

Years 

(15,506) (15,984) (16,463) (16,463) 

Total Industry Burden Savings by Year (hours) 

Year 1 Year 2 Year 3 

Subsequent 

Years 

(14,972) (15,700) (16,178) (16,187) 

Table 18 

Cost Savings for All Section 5 Notices, by Year 

Total Company-Level Cost 

Year 1 Year 2 Year 3 

Subsequent 

Years 

$ 29,023 $ 15,634 $ 15,634 $ 15,073 

Total Form-Level Cost Savings 

Year 1 Year 2 Year 3 

Subsequent 

Years 

$ (408,295) $ (440,498) $ (472,701) $ (472,701) 

Total Industry Cost Savings by Year 

Year 1 Year 2 Year 3 

Subsequent 

Years 

$ (379,271) $ (424,863) $ (457,066) $ (457,628) 
 24

Table 19 

Average Burden Savings per Company 

Due to the e-PMN Rule (All Section 5 Notices) 

Average Company Burden (hours) 

Year 1 Year 2 Year 3 

Subsequent 

Years 

3.6 2.8 2.8 3.6 

Average Form Burden Savings per Company (hours) 

Year 1 Year 2 Year 3 

Subsequent 

Years 

(54.0) (54.0) (54.0) (54.0) 

Average Combined Company Burden Savings by Year (hours) 

Year 1 Year 2 Year 3 

Subsequent 

Years 

(50.4) (51.2) (51.2) (50.4) 

Table 20 

 Average Cost Savings per Company 

Due to the e-PMN Rule (All Section 5 Notices) 

Average Company Costs 

Year 1 Year 2 Year 3 Subsequent 

Years 

$ 198 $ 154 $ 154 $ 198 

Average Form Savings per Company 

Year 1 Year 2 Year 3 

Subsequent 

Years 

$ (1,550) $ (1,550) $ (1,550) $ (1,550) 

Average Combined Company Savings by Year 

Year 1 Year 2 Year 3 

Subsequent 

Years 

$ (1,352) $ (1,396) $ (1,396) $ (1,352) 
 25

Table 21 

Average Burden Savings per Company 

Due to the e-PMN Rule (PMNs Only) 

Average Company Burden (hours) 

Year 1 Year 2 Year 3 

Subsequent 

Years 

3.6 2.8 2.8 3.6 

Average Form Burden Savings per Company (hours) 

Year 1 Year 2 Year 3 

Subsequent 

 Years 

(49.8) (49.8) (49.8) (49.8) 

Average Combined Company Burden Savings by Year (hours) 

Year 1 Year 2 Year 3 

Subsequent 

Years 

(46.2) (47.0) (47.0) (46.2) 

Table 22 

Average Cost Savings per Company 

Due to the e-PMN Rule (PMNs Only) 

Average Company Cost 

Year 1 Year 2 Year 3 

Subsequent 

Years 

 $ 198 $ 154 $ 154 $ 198 

Average Form Cost Savings per Company 

Year 1 Year 2 Year 3 

Subsequent 

Years 

 $ (1,389) $ (1,389) $ (1,389) $ (1,389) 

Average Combined Company Cost Savings by Year 

Year 1 Year 2 Year 3 

Subsequent 

Years 

 $ (1,192) $ (1,235) $ (1,235) $ (1,192) 
 26

Table 23 

 Average Burden Savings per Form Due 

to the e-PMN Rule (All Section 5 Notices) 

Average Company Burden per Form (hours) 

Year 1 Year 2 Year 3 

Subsequent 

Years 

0.7 0.5 0.5 0.7 

Average Burden Savings per Form (hours) 

Year 1 Year 2 Year 3 

Subsequent 

Years 

(10.1) (10.1) (10.1) (10.1) 

Average Combined Form Burden Savings by Year (hours) 

Year 1 Year 2 Year 3 

Subsequent 

Years 

(9.4) (9.6) (9.6) (9.4) 

Table 24 

 Average Cost Savings per Form Due 

To the e-PMN Rule (All Section 5 Notices) 

Average Company Cost per Form 

Year 1 Year 2 Year 3 

Subsequent 

Years 

$ 37 $ 29 $ 29 $ 37 

Average Cost Savings per Form 

Year 1 Year 2 Year 3 

Subsequent 

Years 

$ (290) $ (290) $ (290) $ (290) 

Average Combined Form Cost Savings by Year 

Year 1 Year 2 Year 3 

Subsequent 

Years 

$ (253) $ (262) $ (262) $ (253) 
 27

3.0 AGENCY BURDENS AND COSTS 

3.1 Changes in Agency Burden Associated with the Final e-PMN Rule 

The conversion to an electronic reporting system as well as the adoption of CDX 

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 e-PMN 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. 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. For example, EPA 

typically keys or scans in the data from paper submissions. That duplicative step can 

cause errors. Consequently, EPA must now perform quality assurance checks on 

extracted and scanned information. 

Because companies will register with EPA to submit their data electronically via 

CDX, the Agency in turn will be able to communicate electronically with submitters via 

CDX. Some examples of routine communications from EPA that could occur through 

CDX include the Acknowledgment Letter (acknowledging receipt of a notice), and the 

Incomplete Letter (stating why a notice has been declared incomplete). These 

communications are typically sent through the mail. Electronic communication should 

provide significant time and resource savings for both parties. 

Because the current TSCA section 5 program is based entirely on paper 

submissions, the Agency first will need to convert to an electronic reporting system. 

Based on conversion costs developed in the Cross-Media Electronic Reporting Rule 

(CROMERR) Cost Benefit Analysis, EPA estimates incurring a one-time cost of $200,000 

to convert the New Chemicals section 5 notice program to an electronic system.11 

Following the methodology in the CROMERR Cost Benefit Analysis, EPA is distributing 

this cost over the first two years following promulgation of the rule. 

In addition to the cost of converting to an electronic reporting system, EPA will 

incur additional annual costs associated with the operation and maintenance (O&M) of 

CDX for the e-PMN data flow. According to A Business Case Analysis of EPA’s Central 

Data Exchange, these costs are not currently incurred by the Program Offices; however, 

in future years the Program Offices are expected to cover these costs.12 EPA developed 

an estimate of CDX O&M costs attributable to the e-PMN program by apportioning the 

overall CDX maintenance cost estimated in the CROMERR Cost Benefit Analysis to 

individual systems. This approach yields an estimate of $57,353 annual maintenance cost 

per data flow system (i.e., program). Although the e-PMN data flow is smaller than the 

data flows included in the CROMERR analysis, the CROMERR analysis does not 

 

11 US EPA, 2004. Cross-Media Electronic Reporting Rule (CROMERR) Cost Benefit Analysis, Final. November 

17, 2004. p. 19. 

12 US EPA, 2007. A Business Case Analysis of EPA’s Central Data Exchange. March 2007. p. 5. 
 28

include costs associated with operations and, therefore, the $57,353 might be considered 

a lower bound estimate of total O&M. 

The Agency will also incur costs associated with providing technical assistance to 

submitters, including conducting a beta or pilot test of the final submission process, 

conducting approximately three trainings sessions around the country to demonstrate the 

e-PMN software, operating a telephone hotline, and other outreach activities. Although 

not quantified at this time, these activities are likely to require both labor and extramural 

resources. 

EPA also expects to realize burden savings attributable to the eventual elimination 

of its current systems of processing paper section 5 notices once the e-PMN form and 

CDX system are fully implemented. These savings will stem from eliminating manual 

data entry of section 5 notices and related support documents, reducing resources 

dedicated to quality assurance/quality control (QA/QC) 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 section 5 notices 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.

13 Potential Agency burden 

savings associated with the final e-PMN rule are characterized based on information in 

the CDX Business Case Analysis regarding the estimated monetary benefit from using 

CDX. Of the six Program Data Flows studied in the CDX Business Case Analysis, 

monetary benefits from using CDX as compared to a paper submission baseline were 

quantified for two flows: TRI (Toxic Release Inventory) and e-NOI (electronic Notice of 

Intent under the National Pollution Discharge Elimination System). Benefits ranged from 

11 percent savings (e-NOI) to 22 percent savings (TRI) compared to the cost of the 

baseline process. For this analysis, EPA assumes an average annual savings of 16.5 

percent which applies to the three areas mentioned above. However, because EPA is 

phasing in electronic reporting via CDX over a two-year period, Agency savings will also 

be phased-in. As noted in Section 1.1 above, EPA assumes that one-third of PMNs will 

be submitted via CDX in the first year, two-thirds of PMNs will be submitted via CDX in 

the second year, and all PMNs will be submitted via CDX by the third year. The overall 

change in Agency burden is presented in Table 25 and the overall change in Agency cost 

is presented in Table 26.

 

13 EPA ICR No. 0574.14 OMB Control No. 2070-0014. 
29

Table 25 

Estimated Agency Burden Savings due to the Final e-PMN Rule 

Baseline Agency Burden Savings Compared to Ba

Type of Notice 

Average 

Annual 

Number of 

Responses 

Agency 

Labor 

Hours 

Total 

Agency 

Hours 

Percent 

Annual 

Savings 

Burden 

Hour 

Savings 

Year 1 

Burden 

Hour 

Savings 

Year 2 

Burde

Hou

Savin

Year 

PMN 720 64 46,109 17% 2,536 5,072 7,6SNUN 18 64 1,130 17% 62 124 1MCAN 3 1,067 3,628 17% 200 399 5Exemptions:  TME 8 109 834 17% 46 92 1 LVE/LoREX 419 22 9,219 17% 507 1,014 1,5 TERA 2 1,476 2,509 17% 138 276 4 Tier I and II 3 187 477 17% 26 52  R&D 200 0 - - -  Instant photographic film articles 0 0 - - Bona Fide 116 2 232 - - 5(e) Test 12 1,500 17,850 17% 982 1,964 2,9Non-Testing 5(e) Burden 16 65 1,040 - NOCs 443 1 443 17% 24 49 Correction Requests 9 21 189 - - Total 1,968 83,660 Total Burden Hour Savings 4,521 9,042 13,5
30

Table 26 

Estimated Agency Cost Savings due to the Final e-PMN Rule 

Type of Notice 

Total Agency Baseline 

Costs, Based on 

Updated Universe of 

Notices 

Percent 

Annual 

Savings Savings Year 1 Savings Year 2 Savings 

PMN $3,935,207 17% $216,436 $432,873 $SNUN $95,403 17% $ 5,247 $10,494 $ MCAN $251,116 17% $13,811 $27,623 Exemptions:  TME $57,719 17% $3,175 $6,349  LVE/LoREX $946,364 17% $52,050 $104,100 $ TERA $173,687 17% $9,553 $19,106 $  Tier I and II $33,008 17% $1,815 $3,631  R&D - - -  Instant photographic film articles - - - Bona Fide $25,765 - - 5(e) Test $1,235,577 17% $67,957 $135,913 $Non-Testing 5(e) Burden $71,989 - - NOCs $30,654 17% $1,686 $3,372 Correction Requests $38,994 - - Total $6,895,483 Total Savings $ 371,730 $ 743,461 $ 1,1Cost to Develop Automated Collection $ 100,000 $ 100,000 Total O&M Cost $ 57,353 $ 57,353 $ Net Savings $ 214,377 $ 586,108 $ 1,0
 -31-

4.0 BENEFITS OF THE FINAL e-PMN RULE 

As mentioned in other sections of this Economic Analysis, the final reporting 

system is intended to streamline and reduce the administrative costs and burden of the 

TSCA section 5 New Chemicals Program 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 final rule, submitters of section 5 notices 

will be required to submit these notices to the Agency via the Central Data Exchange 

(CDX) starting the third year after the rule is promulgated. Submission via CDX will be 

optional during the first two years of the rule. 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 section 5 notice 

submitters looking for ways to reduce time and money spent to meet EPA reporting 

requirements. In this section, the benefits expected to result from electronic reporting 

and from the use of CDX for both industry and the Agency are discussed. 

4.1 Industry Benefits 

4.1.1 Electronic Reporting 

As a result of the e-PMN rule, EPA expects section 5 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 PMN, and other section 5 notice preparation. A validation mechanism 

will alert users when a required field on the form is either missing information or 

contains certain kinds of incorrect information. For example, if “use” information is 

claimed CBI, then the e-PMN software will indicate that the form is not complete unless 

the submitter has provided both specific use information on the CBI version of the form, 

and generic use information on the sanitized non-CBI version of the form. The e-PMN 

software includes header pages for biotechnology notices (i.e., Microbial Commercial 

Activity Notices (MCANs), TSCA Experimental Release Applications (TERAs), Test 

Marketing Exemption Applications (TMEAs), and Tier I or Tier II Exemption requests), 

support documents, and attachments – any document not submitted on the PMN form 

itself – that identify submitters and the nature of their communications. In addition, these 

header pages allow the software to identify and store any data correctly in the Agency’s 

databases, when submitted by paper or CD during the two-year CDX phase-in period. 

Further, the convenience of an automated electronic form is expected to reduce 

the time required to read and become familiar with the form. The e-PMN software also 

allows for the creation of a sanitized version of the form containing CBI by simply 

bracketing the CBI information in the form. This feature will decrease the effort to create 

a sanitized version manually and reduce the likelihood of sanitization errors. Maintaining 

electronic files may is also expected to be less burdensome than hardcopy files. 
 -32-

 Additional benefits to companies using the e-PMN software 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 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. 

• Submission of multiple copies will be eliminated. Currently submitters must file one 

original, two copies, and one sanitized version. With the e-PMN, only electronic 

versions of the CBI and sanitized forms are required. 

• All relevant staff within the submitting company will be able to easily access the ePMN form and directly input their information. The e-PMN form will also facilitate 

easier internal review prior to submission. 

• Preparing consolidated PMNs will no longer necessitate retyping of required (but 

duplicate) information. 

• The e-PMN form will allow submitters to attach chemical structure diagrams using 

EPA-approved software. 

• The “profiler” feature of the e-PMN software will allow a submitting company to 

enter company identification information once and then access it for future 

submissions, thus eliminating the time to retype this information. 

• The number of forms that need to be resubmitted because they are declared 

incomplete or invalid by EPA will be greatly reduced because the e-PMN form 

cannot be printed in finalized form, or submitted via CDX if any fields are 

incomplete. 

• The cutting and pasting function in the e-PMN software will allow submitters to copy 

information within and across forms, cutting down on time previously required to 

retype information. 

4.1.2 CDX 

Once the e-PMN rule is fully implemented, routine correspondence with the 

Agency, including submission of supporting documents, will be via CDX. EPA expects 

that this automation will save industry time and postage. By streamlining the section 5 

notice 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. In addition, the built-in data edit and data 

quality checks will ensure that the electronic form was filled out correctly. Additional 

benefits that section 5 submitters will realize using CDX include: 

• Improved security and transmission of confidential business information (CBI) 

through registration and authentication; 

• Option to participate in an online payment system such as Pay.gov; and, 
 -33-

• Availability of a hotline that provides assistance to users in the initial 

establishment of their account, program usage guidelines, and error 

troubleshooting. 

4.2 Agency Benefits 

4.2.1 Electronic Reporting 

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. As an example, EPA currently keys in the data from 

section 5 notices, manually. That duplicative step can cause errors which may lead to 

confusion and delays if EPA acts on information inconsistent with what the submitter 

actually reported on their PMN. The e-PMN 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 CDX 

By using CDX, OPPT will be able to implement electronic reporting more 

quickly, economically, and easily than they could if they designed a system themselves. 

Use of CDX will enable EPA to notify the submitter that the Agency has received their 

submission and will lead to higher quality data being available more quickly to EPA. 

Because companies will be registered with EPA to submit their data electronically to the 

Agency via CDX, the Agency in turn will be able to communicate electronically with 

submitters via CDX. Some examples of routine communications from EPA that could go 

through CDX include the Acknowledgment Letter (acknowledging receipt of a notice), 

and the Incomplete Letter (stating why a notice has been declared incomplete). Usually, 

these communications are sent through the mail. An electronic means of communication 

should provide significant time and resource savings for both parties. Additional benefits 

to the Agency from using CDX include:

• Elimination of redundant costs for maintaining hardware, software, and human 

resources to manage electronic reporting for the New Chemicals Program; 

• Faster, lower-cost implementation of the Section 5 data flow; 

• A decrease in the time required to make information internally accessible; and 

• Reduction in record management costs by eliminating redundant record keeping. 

Finally, the Government Paperwork Elimination Act (GPEA, Pub. L. 105-277; 44 

USC 3504) requires that, when practicable, federal organizations use electronic forms, 

electronic filings, and electronic signatures to conduct official business with the public. 

EPA’s Cross-Media Electronic Reporting Regulation (CROMERR) (October 13, 2005; 

70 FR 59848; FRL-7977-1; 44 CFR 3) provides that any requirement in Title 40 of the 

Code of Federal Regulations to submit a report directly to EPA can be satisfied with an 

electronic submission that meets certain conditions once the Agency publishes a notice 
 -34-

that electronic document submission is available for that requirement. See Unit II.F. for 

more information on electronic signatures. In light of GPEA and CROMERR, EPA is 

promulgating these amendments to enable, and eventually require, manufacturers, 

importers, and processors of TSCA chemical substances to use the Internet, through 

EPA’s Central Data Exchange (CDX), to submit TSCA section 5 notices to the Agency. 

5.0 ADDITIONAL ANALYSES 

This section presents the additional analysis required under various statutes and 

Executive Orders. 

5.1 Executive Order 12866

Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 

51735, October 4, 1993), the Office of Management and Budget (OMB) determined that 

this final rule is a “significant regulatory action” under section 3(f) of the Executive 

Order because this action does raise novel legal or policy issues. Accordingly, EPA 

submitted the proposed rulemaking to OMB for review under Executive Order 12866 and 

any changes made in response to OMB comments have been documented in the public 

docket for this rulemaking as required by section 6(a)(3)(E) of the Executive Order. As 

such, this action is not subject to review under this Executive Order. 

5.2 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, when promulgated as finalized, 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. 

The factual basis for the Agency's certification under the RFA is presented in the small 
 -35-

entity impact analysis prepared as part of the Economic Analysis for this final rule (Ref. 

2), and is briefly summarized in Unit IV. 

5.3 Unfunded Mandates Reform Act (UMRA) 

Based on EPA's experience with past PMNs, 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 affect 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). 

5.4 Paperwork Reduction Act (PRA) 

 The information collection requirements contained in this 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 Information Collection 

Request (ICR) document prepared by EPA has been assigned EPA ICR number 2327.01 

(OMN Control No. 2070-0173), a copy of which has also been placed in the docket for 

the final rule. This rule-related Information Collection Request (ICR) addresses the 

incremental paperwork activities related to submitting Section 5 information to EPA 

electronically and describes the changes that will ultimately be incorporated into the ICRs 

that are currently approved under OMB Control No. 2070-0012 and 2070-0038 (EPA 

ICR No. 0574, Premanufacture Review Reporting and Exemption Requirements for New 

Chemical Substances and Significant New Use Reporting Requirements for Chemical 

Substances; and, EPA ICR No. 1188, TSCA Section 5(a)(2) Significant New Use Rules 

for Existing Chemicals, respectively). 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. 

 The amended information collection activities contained in this final rule are 

designed to assist the Agency in meeting its responsibility under TSCA to receive, 

process, and review premanufacture and significant new use notices in a timely manner 

and further the proper performance of the functions of the Agency. Information 

collection for review of premanufacture and significant new use notifications is 

authorized by TSCA section 5 and confidentially of submitted information is protected 

under TSCA section 14. 

 The information collected under the two existing ICRs will be modified with 

only the addition of two new data elements: 1) a User Fee Payment Identity Number; and 

2) the submitter’s email address(es), which will be optional. In addition, one data 

element will be removed: 1) “Agent Signature Block.” The other revision to the 

information collection activities already approved by OMB is the change affecting how 

the submitter completes and submits the required form to EPA. As such, responses to the 
 -36-

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 the form. The 

methods for submitting the completed form to EPA will change over a two-year period 

following the effective date of the rule to allow for the new required submission through 

CDX to be fully implemented. 

 Burden is defined at 5 CFR 1320.3(b). 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. The aggregate burden varies by year during the first three years of 

the rule because of the phase-in schedule of the final requirements. The incremental, rulerelated burden and cost to chemical manufacturers, importers, and processors who will 

submit notices to the Agency for review are summarized here. The projected total burden 

to industry is 363 hours per year for the first 3 years of the rule. This includes an 

estimated average burden per response of 0.9 hours for CDX registration, 1.8 hours for 

requesting a CDX electronic signature, 0.1 hour for establishing a Pay.gov account for 

electronic fee payments, and 0.8 hour for rule familiarization. 

Once the final rule is implemented, EPA anticipates that the average annual total 

burden to industry for the submission of TSCA section 5 notices will be 117,399 hours 

per year for the first three years of the rule. This includes an estimated average burden 

per response of 59.7 hours, 1,968 responses per year (for all notices combined), and 305 

total respondents each year. The projected average annual cost per year to industry is $32 

million, which reflects an average annual savings of $5.7 million over the three-year ICR 

period as a result of both the e-PMN rule and a lower total number of notices that the 

Agency is expecting to receive during the three-year ICR period. See Appendix 1 of the 

ICR for a complete year-by-year analysis of the final rule’s aggregate impact on the 

estimated paperwork burdens and costs on the New and Existing Chemicals Programs, as 

addressed in EPA ICR No. 0574.13 (OMB Control No. 2070-0012) and EPA ICR No. 

1188.08 (OMB Control No. 2070-0038). 

5.5 Executive Order 13132 

Under Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 

1999), EPA has determined that this final rule does not have ‘‘federalism implications’’ 

because it will not 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, as specified in the Executive 

Order. This final rule establishes electronic notification requirements that apply to 

manufacturers (including importers) and processors of certain chemicals. This rule does 

not apply directly to States and localities and will not affect State and local governments. 

Thus, Executive Order 13132 does not apply to this final rule. 

5.6 Executive Order 12898 

This final rule will not have an adverse impact on the environmental and health 
 -37-

conditions in low-income and minority communities. Therefore, under Executive Order 

12898, entitled Federal Actions to Address Environmental Justice in Minority 

Populations and Low-Income Populations (59 FR 7629, February 16, 1994), the Agency 

does not need to consider environmental justice-related issues. 

5.7 Executive Order 13045 

This final rule does not require special consideration pursuant to the terms of 

Executive Order 13045, entitled Protection of Children from Environmental Health Risks 

and Safety Risks (62 FR 19885, April 23, 1997), because it is not likely to have an annual 

effect on the economy of $100 million or more, nor does it establish an environmental 

standard, or otherwise have a disproportionate effect on children. 

5.8 Executive Order 13175 

Under Executive Order 13175, entitled Consultation and Coordination with 

Indian Tribal Governments (65 FR 67249, November 6, 2000), EPA has determined that 

this final rule does not have tribal implications because it will not have substantial direct 

effects on tribal governments, on the relationship between the Federal Government and 

the Indian tribes, or on the distribution of power and responsibilities between the Federal 

Government and Indian tribes, as specified in the Order. EPA has no information to 

indicate that any tribal government manufactures or imports the chemical substances 

covered by this action. Thus, Executive Order 13175 does not apply to this final rule. 

5.9 Executive Order 13211 

This final 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 final rule does not have any significant adverse effect on the 

supply, distribution, or use of energy. 

5.10 National Technology Transfer and Advancement Act

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 

(NTTAA), 15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its 

regulatory activities unless to do so would be inconsistent with applicable law or 

impractical. Voluntary consensus standards are technical standards (e.g., materials 

specifications, test methods, sampling procedures, etc.) that are developed or adopted by 

voluntary consensus standards bodies. This final rule does not impose any technical 

standards that will require EPA to consider any voluntary consensus standards. 
 -38-

6.0 REFERENCES 

Abt Associates, Inc., 2004. Memo: TRI Reporting Burden Estimates from Hilary Eustace, 

David Cooper and Susan Day, Abt Associates, to Paul Borst. US EPA. July 16, 

2004. 

BLS, 2007. 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 

2007. 

BLS, 2007a. Producer Price Index for the Chemical Manufacturing Industry. Series Id 

PCU325. Create Customized Tables” link at 

http://www.bls.gov/ppi/home.htm#data. Washington, DC. December 2007. 

EPA, 2002. 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, 2002a. 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, 2003. Burden Cost Analysis Supporting the Information Collection Request 

Renewal for TSCA Section 5 Premanufacture Notifications. U.S.EPA, Office of 

Pollution Prevention and Toxics, Economic and Policy Analysis Branch. 

Washington, DC. OMB Control No. 2070-0014. August 15, 2003. 

EPA, 2004. Cross-Media Electronic Reporting Rule (CROMERR) Cost Benefit Analysis. 

Final. Washington, DC. November 17, 2004. 

EPA, 2007. Business Case Analysis of EPA’s Central Data Exchange. U.S. EPA, Office 

of Environmental Information. Washington, DC. March 2007. 

OPM, 2007. U.S. Office of Personnel Management. Salary Table 2007-DCB 

(Washington – Baltimore-Northern Virginia, DC-MD-VA-WV-PA). 2007. 
 -39-

APPENDIX A 

INDUSTRY BURDENS AND COSTS BY TYPE OF NOTICE
 -40-

Table A-1 

Form Level Burden, SNUN Forms Only 

* Includes management, technical, and clerical labor. ** Percent of universe that has completed activity by this year. 

Table A-2 

Form Level Cost, SNUN Forms Only 

* Includes management, technical, and clerical labor. ** Percent of universe that has completed activity by this year. 

All Labor Categories Unit Burden* Phase-In Rate** Form-Level 

Activity 

Non-Labor 

($) 

Burden 

(Hours) 

Employees 

Incurring 

Burden 

OneTime 

Burden 

% 

Year 1 

% 

Year 2 

% 

Year 3 

% 

Subsequent 

Years Year 1 Year 2 

Form Completion $ - -12.8 2 N 100% 100% 100% 100% (226) (226) Recordkeeping $ - -1.0 2 N 33% 67% 100% 100% (6) (12) Postage $ (17.68) 0.0 1 N 33% 67% 100% 100% - - 

All Labor Categories Unit Burden* Phase-In Rate** Form-L

Activity 

Non-Labor 

($) 

Burden 

(Hours) 

Employees 

Incurring 

Burden 

OneTime 

Burden 

% 

Year 1 

% 

Year 2 

% 

Year 3 

% 

Subsequent 

Years Year 1 Year 2 

Form Completion $ - -12.8 2 N 100% 100% 100% 100% $ (5,694) $ (5,694) Recordkeeping $ - -1.0 2 N 33% 67% 100% 100% $ (226) $ (452) Postage $ (17.68) 0.0 1 N 33% 67% 100% 100% $ (104) $ (208) 
 -41-

Table A-3 

Form Level Burden, MCAN Forms Only 

* Includes management, technical, and clerical labor. ** Percent of universe that has completed activity by this year. 

Table A-4 

Form Level Cost, MCAN Forms Only 

All Labor Categories Unit Burden* Phase-In Rate** Form-

Activity 

Non-Labor 

($) 

Burden 

(Hours) 

Employees 

Incurring 

Burden 

OneTime 

Burden 

% 

Year 1 

% 

Year 2 

% 

Year 3 

% 

Subsequent 

Years Year 1 Year 2 

Form Completion $ - -13.8 2 N 100% 100% 100% 100% $ (1,184) $ (1,184) Recordkeeping $ - -1.0 2 N 33% 67% 100% 100% $ (44) $ (87) Postage $ (22.85) 0.0 1 N 33% 67% 100% 100% $ (26) $ (52) 

* Includes management, technical, and clerical labor. ** Percent of universe that has completed activity by this year. 

All Labor Categories Unit Burden* Phase-In Rate** Form-Level 

Activity 

Non-Labor 

($) 

Burden 

(Hours) 

Employees 

Incurring 

Burden 

OneTime 

Burden 

% 

Year 1 

% 

Year 2 

% 

Year 3 

% 

Subsequent 

Years Year 1 Year 2 

Form Completion $ - -13.8 2 N 100% 100% 100% 100% (47) (47) Recordkeeping $ - -1.0 2 N 33% 67% 100% 100% (1) (2) Postage $ (22.85) 0.0 1 N 33% 67% 100% 100% - - 
 -42-

Table A-5 

Form Level Burden, TMEA Forms Only 

* Includes management, technical, and clerical labor. ** Percent of universe that has completed activity by this year. 

Table A-6 

Form Level Cost, TMEA Forms Only 

* Includes management, technical, and clerical labor. ** Percent of universe that has completed activity by this year. 

All Labor Categories Unit Burden* Phase-In Rate** Form-Level 

Activity 

Non-Labor 

($) 

Burden 

(Hours) 

Employees 

Incurring 

Burden 

OneTime 

Burden 

% 

Year 1 

% 

Year 2 

% 

Year 3 

% 

Subsequent 

Years Year 1 Year 2 

Form Completion $ - -11.8 2 N 100% 100% 100% 100% (90) (90) Recordkeeping $ - -1.0 2 N 33% 67% 100% 100% (3) (5) Postage $ (28.99) 0.0 1 N 33% 67% 100% 100% - - 

All Labor Categories Unit Burden* Phase-In Rate** Form-

Activity 

Non-Labor 

($) 

Burden 

(Hours) 

Employees 

Incurring 

Burden 

OneTime 

Burden 

% 

Year 1 

% 

Year 2 

% 

Year 3 

% 

Subsequent 

Years Year 1 Year 2 

Form Completion $ - -11.8 2 N 100% 100% 100% 100% $ (2,273) $ (2,273) Recordkeeping $ - -1.0 2 N 33% 67% 100% 100% $ (98) $ (196) Postage $ (28.99) 0.0 1 N 33% 67% 100% 100% $ (74) $ (148) 
 -43-

Table A-7 

Form Level Burden, LVE/LOREX Forms Only 

* Includes management, technical, and clerical labor. ** Percent of universe that has completed activity by this year. 

Table A-8 

Form Level Cost, LVE/LOREX Forms Only 

* Includes management, technical, and clerical labor. ** Percent of universe that has completed activity by this year. 

All Labor Categories Unit Burden* Phase-In Rate** Form-Leve

Activity 

Non-Labor 

($) 

Burden 

(Hours) 

Employees 

Incurring 

Burden 

OneTime 

Burden 

% 

Year 1 

% 

Year 2 

% 

Year 3 

% 

Subsequent 

Years Year 1 Year 2 

Form Completion $ - -12.8 2 N 100% 100% 100% 100% (5,371) (5,371) Recordkeeping $ - -1.0 2 N 33% 67% 100% 100% (140) (279) Postage $ (26.09) 0.0 1 N 33% 67% 100% 100% - - 

All Labor Categories Unit Burden* Phase-In Rate** Form-

Activity 

Non-Labor 

($) 

Burden 

(Hours) 

Employees 

Incurring 

Burden 

OneTime 

Burden 

% 

Year 1 

% 

Year 2 

% Year 

3 

% 

Subsequent 

Years Year 1 Year 2 

Form Completion $ - -12.8 2 N 100% 100% 100% 100% $ (135,188) $ (135,18Recordkeeping $ - -1.0 2 N 33% 67% 100% 100% $ (5,370) $ (10,74Postage $ (26.09) 0.0 1 N 33% 67% 100% 100% $ (3,644) $ (7,28
 -44-

Table A-9 

Form Level Burden, NOC Forms Only 

* Includes management, technical, and clerical labor. ** Percent of universe that has completed activity by this year. 

Table A-10 

Form Level Cost, NOC Forms Only 

* Includes management, technical, and clerical labor. ** Percent of universe that has completed activity by this year. 

All Labor Categories Unit Burden* Phase-In Rate** Form-Level 

Activity 

Non-Labor 

($) 

Burden 

(Hours) 

Employees 

Incurring 

Burden 

OneTime 

Burden 

% 

Year 1 

% 

Year 2 

% 

Year 3 

% 

Subsequent 

Years Year 1 Year 2 

Form Completion $ - 0.1 2 N 100% 100% 100% 100% 26 26 Recordkeeping $ - -0.1 2 N 33% 67% 100% 100% (18) (37) Postage $ (26.45) 0.0 1 N 33% 67% 100% 100% - - 

All Labor Categories Unit Burden* Phase-In Rate** Form-

Activity 

Non-Labor 

($) 

Burden 

(Hours) 

Employees 

Incurring 

Burden 

OneTime 

Burden 

% 

Year 1 

% 

Year 2 

% 

Year 3 

% 

Subsequent 

Years Year 1 Year 2 

Form Completion $ - 0.1 2 N 100% 100% 100% 100% $ 2,755 $ 2,75Recordkeeping $ - -0.1 2 N 33% 67% 100% 100% $ (709) $ (1,419Postage $ (26.45) 0.0 1 N 33% 67% 100% 100% $ (3,904) $ (7,809
 -45-

Table A-11 

Form Level Burden, TERA Forms Only 

* Includes management, technical, and clerical labor. ** Percent of universe that has completed activity by this year. 

Table A-12 

Form Level Cost, TERA Forms Only 

* Includes management, technical, and clerical labor. ** Percent of universe that has completed activity by this year. 

All Labor Categories Unit Burden* Phase-In Rate** Form-Level 

Activity 

Non-Labor 

($) 

Burden 

(Hours) 

Employees 

Incurring 

Burden 

OneTime 

Burden 

% 

Year 1 

% 

Year 2 

% 

Year 3 

% 

Subsequent 

Years Year 1 Year 2 

Form Completion $ - -13.8 2 N 100% 100% 100% 100% (23) (23) Recordkeeping $ - -1.0 2 N 33% 67% 100% 100% (1) (1) Postage $ (39.13) 0.0 1 N 33% 67% 100% 100% - - 

All Labor Categories Unit Burden* Phase-In Rate** Form-

Activity 

Non-Labor 

($) 

Burden 

(Hours) 

Employees 

Incurring 

Burden 

OneTime 

Burden 

% 

Year 1 

% 

Year 2 

% 

Year 3 

% 

Subsequent 

Years Year 1 Year 2 

Form Completion $ - -13.8 2 N 100% 100% 100% 100% $ (592) $ (592) Recordkeeping $ - -1.0 2 N 33% 67% 100% 100% $ (22) $ (44) Postage $ (39.13) 0.0 1 N 33% 67% 100% 100% $ (22) $ (44) 
 -46-

Table A-13 

Form Level Burden, TIER I / II Forms Only 

* Includes management, technical, and clerical labor. ** Percent of universe that has completed activity by this year. 

Table A-14 

Form Level Cost, TIER I / II Forms Only 

* Includes management, technical, and clerical labor. ** Percent of universe that has completed activity by this year. 

All Labor Categories Unit Burden* Phase-In Rate** Form-Level 

Activity 

Non-Labor 

($) 

Burden 

(Hours) 

Employees 

Incurring 

Burden 

OneTime 

Burden 

% 

Year 1 

% 

Year 2 

% 

Year 3 

% 

Subsequent 

Years Year 1 Year 2 

Form Completion $ - -3.8 2 N 100% 100% 100% 100% (10) (10) Recordkeeping $ - -1.0 2 N 33% 67% 100% 100% (1) (2) Postage $ (24.59) 0.0 1 N 33% 67% 100% 100% - - 

All Labor Categories Unit Burden* Phase-In Rate** Form-

Activity 

Non-Labor 

($) 

Burden 

(Hours) 

Employees 

Incurring 

Burden 

OneTime 

Burden 

% 

Year 1 

% 

Year 2 

% 

Year 3 

% 

Subsequent 

Years Year 1 Year 2 

Form Completion $ - -3.8 2 N 100% 100% 100% 100% $ (237) $ (237) Recordkeeping $ - -1.0 2 N 33% 67% 100% 100% $ (33) $ (65) Postage $ (24.59) 0.0 1 N 33% 67% 100% 100% $ (21) $ (42) 
 -47-

Table A-15 

Form Level Burden, 5(e) Test Forms Only 

* Includes management, technical, and clerical labor. ** Percent of universe that has completed activity by this year. 

Table A-16 

Form Level Cost, 5(e) Test Forms Only 

* Includes management, technical, and clerical labor. ** Percent of universe that has completed activity by this year.

All Labor Categories Unit Burden* Phase-In Rate** Form-Level 

Activity 

Non-Labor 

($) 

Burden 

(Hours) 

Employees 

Incurring 

Burden 

OneTime 

Burden 

% 

Year 1 

% 

Year 2 

% 

Year 3 

% 

Subsequent 

Years Year 1 Year 2 

Form Completion $ - -4.3 2 N 100% 100% 100% 100% (51) (51) Recordkeeping $ - -17.5 2 N 33% 67% 100% 100% (69) (139) Postage $ (24.59) 0.0 1 N 33% 67% 100% 100% - - 

All Labor Categories Unit Burden* Phase-In Rate** Form-

Activity 

Non-Labor 

($) 

Burden 

(Hours) 

Employees 

Incurring 

Burden 

OneTime 

Burden 

% 

Year 1 

% 

Year 2 

% 

Year 3 

% 

Subsequent 

Years Year 1 Year 2 

Form Completion $ - -4.3 2 N 100% 100% 100% 100% $ (1,256) $ (1,256Recordkeeping $ - -17.5 2 N 33% 67% 100% 100% $ (2,669) $ (5,337Postage $ (24.59) 0.0 1 N 33% 67% 100% 100% $ (98) $ (195