### 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, 2009CONTRIBUTORS

The EPA analyst responsible for this report is Wendy Hoffman of the Economic and Policy Analysis Branch; Economics, E xposure and Technology Division; Office of Pollution Prevention and Toxics. Analytical an d draft preparation support was provided by Abt Associates, Inc. of Cambridge, Mass achusetts 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 co sts and burdens of the TSCA section notifications for both industry and EPA by es tablishing standards and requirements for the use of EPA’s Central Data Exchange (C DX) to electronically submit Premanufacture Notices (PMNs) and other TSCA section 5 not ices and support documents to the Agency. EPA is also amending the TSCA section 5 Us er Fee regulations to add a new User Fee Payment Identity Number field to the PMN fo rm, which will enable the Agency to match more easily a particular user fee with its notice submission.

The Agency is phasing-in CDX reporti ng 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 a ll second-year submissions will be made via CDX. In the third year after the effective date of the fina l rule, submission of section 5 notices via CDX will be mandatory. Regard less 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 en ter, 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 pape r-based process. In this economic analysis, estimated burden and cost savings are presen ted in comparison to the burden and costs that will be incurred if industry were to c ontinue 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 burd en savings to industry of 16,187 hours and annual net cost savings of $458,000 for all TS CA section 5 notice submissions. EPA is projected to experience an annual net burde n 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 ...............................37iii 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 Burde n, 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 a nd 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 Burde n, 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 Ruleiv (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 Du e 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................................301 1.0 INTRODUCTION

This report presents the U.S. Environmen tal Protection Agency (EPA), Office of Pollution Prevention and Toxics’ (OPPT) analys is 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 f acilitate 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 al so 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 particul ar 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 prin cipals listed on the Submitter Identification

section of the PMN form.

EPA has developed software which industr y 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 Prem anufacture Notices (PMNs) and other TSCA section 5 notices and support documents to the Agency, while maintaining protection of

confidential business information. The so ftware, 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 av ailable 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 ar e currently generate d 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 EP A’s TSCA New Chemicals Program website (See http://www.epa.gov/opptintr/n ewchems/pubs/pmnpart1.pdf and http://www.epa.gov/opptintr/n ewchems/pubs/pmnpart2.pdf).

The e-PMN software and electronic subm ission via CDX will change the way that companies interact with the Agency rega rding 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 with2 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 a nd 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, reduc ing 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 720.10 2) 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 sy stem. 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 NOC s). Two years after the final rule’s effective date, optical disc-based submissi ons (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 require d to submit electronically via CDX using the e-PMN software. The Agency is using th is 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 fina l 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 wi ll 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 andfinalized using ePMN software Invalid Invalid

Optical Disc (CD, DVD) Not applicable Optional

Electronic

submission generated andfinalized using ePMN software Optional

Electronic

submission generated andfinalized 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 fr om 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, pres ents estimated changes to industry costs and burdens compared to the baseline of the cu rrent 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 re quired 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 secti on 5 notices will be affected similarly by the final e-PMN rule. The methodology and resu lts presented in this economic analysis characterize the changes in re porting burden specific to the following set of section 5 notices for which EPA will have the capab ility 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 Rel ease 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 offi cial forms. Those

notices include LVE modificat ions, LoREX modifications, TM E applications (TMEAs), and Biotechnology notices for genetically modi fied 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, No tice of Bona Fide Intent to Manufacture, prenotice communications, and TSCA Inve ntory 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, EP A expects that PMN and other section 5 notice submitters will experience burden savi ngs 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 c opy 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 pr epare 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 copi es, and one sanitized version. With the ePMN, only electronic versions of the CBI and sanitized forms are required.

• Preparation of sanitized forms will be au tomated 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 informa tion. 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 a nd 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, reduci ng 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 additio nal 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, how ever, 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 should6 reflect the currently approved OMB burden estim ates. Therefore, although submitters are currently using electronic methods to generate their reports, the correct baseline to use in this analysis must re flect paper submission.

The ideal way to estimate potential cha nge in reporting burden would be to compare PMN/section 5 notice submitters’ ex perience with e-PMN and CDX to their experience with the cu rrent 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 tim e 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 act ual 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 inte rviewing 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: Gene rate 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 ac tual estimate and asks for feedback.

b. Cons – Industry has no actual experi ence 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 bu rden estimates and eliminate clerical burden as an estimate of time savings.

a. Pros – This option relies on exis ting 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 da ta, EPA prepared a mock PMN submission by filling out a paper form by hand. The e-PMN prototype was then filled out using the7 same PMN data. EPA did not attempt to simu late 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 filli ng 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 s uggested that, in comparison to the paper form, the electronic version could require th e same or more time to complete. EPA believes it is likely, however, that there are other potential importa nt 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 de veloping and administering a survey to estimates potential burden changes between formats. However, only one percent or fewer of current PMN notices are comple ted 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 burde n savings associated with the use of the

electronic form and submissions via CDX.

EPA therefore undertook an alternate appr oach, #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 publishe d baseline burden, approved by OMB, and assumed that the burden savings associated with electronic repor ting and submission via

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

baseline time estimate for cl erical burden (12 percent of total burden) was assumed to approximate the amount of clerical/adminis trative 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 es timate of potential form completion and submission savings is in line with estimat ed 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 de velop estimates of burden from CDX registration and electronic signature agreements. Estimated form completion burden resulting from the inclusion of two new da ta 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 cons ider 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 (C ROMERR) 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 prepara tion 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 fo rm of submission will not be required by industry. Moreover, EPA expects only a very small number of submissions via optical disc prior to full pha se 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 co st 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 pr esented 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 sec tion 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 th e submissions received during 2003 through 2007 revealed that about 15 pe rcent of submitted PMN forms were invalid because of errors related to chemical ID, missing signa tures, 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 submi ssions over the 2003 to 2007 time period is reduced by 15 percent to reflect only the va lid 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, th e mixture of newly incoming companies is9 assumed to begin after year th ree 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 activitie s that facilitate submission of an ePMN: rule familiarization, CDX registration, CDX electronic signature, and setting up a Pay.gov account 4 . All activities performed at the co mpany-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 compan ies during the first year following rule promulgation, regardless of whether the e-PMN is submitted via paper, optical disc, or CDX. In addition, companie s that submit section 5 notices for the first time in subsequent years will incur rule familiarization burden the fi rst 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 ot her 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, techni cal, 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 av erage 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 signatur e 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 th e 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 signatu re (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 prof essional judgment, EPA assumes that one manager per company w ill spend 8 minutes setting up a Pay.gov ID account, logging into the system, finding th e 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 suppor ting e-PMN regulatory documentation, EPA estimates that one manager will spend 33 mi nutes 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 cost s by multiplying the unit burden hour estimates by fully loaded hourly rates for th e appropriate categorie s 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: manageri al, technical, and clerical. Average wage and salary data for these cate gories 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 a dditional 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 associa tions, 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 wa ge. The new wage rates are calculated using

current data on salaries and be nefits 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 fr om 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 associ ated 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 fo r 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..13Table 4Company-Level Burden, PMN Forms Only* Includes management, technical, and clerical labor.** Percent of universe that has completed activity by this year.Table 5Company-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-Level Burden (hours)*ActivityNon-Labor($)Burden(Hours)EmployeesIncurringBurdenOneTimeBurden%Year 1%Year 2%Year 3%SubsequentYearsYear 1Year 2Year 3SubsequentYearsCDX Registration $ - 0.45 Y 33% 67% 100% 100% 61 61 6146CDX ElectronicSignature$ 2.15 1.05 Y 33% 67% 100% 100% 117 117 117 88E-Payment(Pay.gov ID)$ - 0.11 Y 33% 67% 100% 100% 9 9 9 7Rule Familiarization $ - 0.82 Y 100% 100% 100% 100% 163 - -41All Labor Categories Unit Burden*Phase-In Rate**Company-Level Cost*ActivityNon-Labor$)Burden(Hours)EmployeesIncurringBurdenOneTimeBurden%Year 1%Year 2%Year 3%SubsequentYearsYear 1Year 2Year 3SubsequentYearsCDX Registration $ - 0.45 Y 33% 67% 100% 100% $ 3,228 $ 3,228 $ 3,228 $2,421CDX ElectronicSignature$ 2.15 1.05 Y 33% 67% 100% 100% $ 6,502 $ 6,502 $ 6,502 $ 4,877E-Payment(Pay.gov ID)$ - 0.11 Y 33% 67% 100% 100% $ 522 $ 522 $ 522 $ 391Rule Familiarization $ - 0.82 Y 100% 100% 100% 100% $ 8,780 $ - $ - $2,195.14Table 6Company-Level Burden, All Forms* Includes management, technical, and clerical labor.** Percent of universe that has completed activity by this year.Table 7Company-Level Cost, All Forms* Includes management, technical, and clerical labor.** Percent of universe that has completed activity by this year.All Labor Categories Unit Burden*Phase-In Rate**Company-Level Burden (hours)*ActivityNon-Labor($)Burden(Hours)EmployeesIncurringBurdenOneTimeBurden%Year 1%Year 2%Year 3%SubsequentYearsYear 1 Year 2Year 3SubsequentYearsCDX Registration$ - 0.45 Y 33% 67% 100% 100% 93 93 9370CDX ElectronicSignature$ 2.15 1.05 Y 33% 67% 100% 100% 178 178 178 133E-Payment(Pay.gov ID)$ - 0.11 Y 33% 67% 100% 100% 14 14 1410Rule Familiarization $ - 0.82 Y 100% 100% 100% 100% 249 - -62All Labor Categories Unit Burden*Phase-In Rate**Company-Level Cost*ActivityNon-Labor($)Burden(Hours)EmployeesIncurringBurdenOneTimeBurden%Year 1%Year 2%Year 3%SubsequentYearsYear 1 Year 2Year 3SubsequentYearsCDX Registration$ - 0.45 Y 33% 67% 100% 100% $ 4,923 $ 4,923 $ 4,923 $3,692CDX ElectronicSignature$ 2.15 1.05 Y 33% 67% 100% 100% $ 9,916 $ 9,916 $ 9,916 $ 7,437E-Payment(Pay.gov ID)$ - 0.11 Y 33% 67% 100% 100% $ 796 $ 796 $ 796 $597Rule Familiarization $ - 0.82 Y 100% 100% 100% 100% $ 13,389 $ - $ -$ 3,34715 2.5 Per Form Burden and Cost Savings

Form-level burden savings include those act ivities that are associated with each ePMN submission once all registration, signatu re, and account set-up activities at the company level have been completed. Base line 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-l evel burden savings will be realized each

time a section 5 notice is submitted. Recordk eeping 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 firs t year following rule promulgation, form completion burden saving will be rea lized by all submitters immediately.

2.5.1 Form-Level Burden and Burden Savings

Baseline form completion and recordkeepi ng burden estimates are taken from the

most recent version of the Information Collection Request for Premanufacture Review Reporting and Exemption Requirements for Ne w Chemical Substances and Significant New Use Reporting Requiremen ts for Chemical Substances

. 8 EPA estimates form completion and recordkeeping burden changes outlined below in comparison to these baseline burdens. EPA estimates that manage ment, technical, and clerical staff at companies submitting section 5 notices will realize the following burden changes:

Form Completion (Burden)

- The final rule adds two ne w data fields to the ePMN form that do not exist on the current pa per version of the form: (1) a field for entering the User Fee Payment Identificati on Number, and (2) a field for entering an optional email address of the principals list ed on the Submitter Identification section of

the PMN form. These two data fields will incr ease 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 repor ting 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 burde n) 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 include d 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 fewe r 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 attributab le 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 requiremen ts under the current rule are not expected to change, EPA a ssumes that the final rule will reduce recordkeeping burden by half because of the efficiencies in crea ting and storing section 5 notices and supporting documents electronically. 10 For most section 5 notices, ba seline 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 st aff member and 30 minutes for one clerical staff member). For section 5(e) Test notic es, baseline recordkeeping burden is estimated to be 35 hours due to the need to copy and f ile relevant records incl uding those related to: manufacturing, importing, or processing vol umes; shipment amounts and customer information; labels (documentation of labeli ng procedures and copies of labels); MSDS; and compliance with any additional restrict ions 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 t echnical staff member and 8.75 hours for one clerical staff member). For Notices of Co mmencement (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 minut es for one technical staff member and

3.75 minutes for one cler ical staff member).

Postage – Non-labor postage costs are based on the assumptions that a typical submission is 100 pages in length, weighs 1.0 lb s., and is shipped from Kansas City, MO to Washington D.C. Kansas City MO was sel ected as the standard location because it is located in the geographic center of the c ountry. 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 FY 2007 for each form type (See Table 8). Delivery options include overnight mail se rvices such as FedEx, UPS, DHL, USPS Express Mail, U.S. Postal Service, an d 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 availa ble for Tier I/II and 5(e) Test Notices. Therefore, PMN postage rates calculated for PMNs we re assumed for these two Notice types. Courier service includes walk-ins, hand delivery an d 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 numb er of section 5 notices/PMNs submitted on a yearly basis. Per form burden savings are estimated by:

1) Multiplying the amount of time staff fr om 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 bur den and cost savings for any form type. For form-level burden and cost savings specifi c 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.18Table 9Form-Level Burden, PMN Forms Only* Includes management, technical, and clerical labor.** Percent of universe that has completed activity by this year.Table 10Form -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 Burden (hours) *ActivityNon-Labor($)Burden(Hours)EmployeesIncurringBurdenOneTimeBurden%Year 1%Year 2%Year 3%SubsequentYearsYear 1Year 2Year 3SubsequentYearsForm Completion $ - -12.82 N 100% 100% 100%100% (9,234) (9,234) (9,234)(9,234)Recordkeeping $ - -1.02 N 33% 67% 100%100% (240) (480) (720)(720)Postage$ (24.59) 0.01 N 33% 67% 100%100% - - --All Labor Categories Unit Burden*Phase-In Rate**Form-Level Cost*ActivityNon-Labor($)Burden(Hours)EmployeesIncurringBurdenOneTimeBurden%Year 1%Year 2%Year 3%SubsequentYearsYear 1Year 2Year 3SubsequentYearsForm Completion $ - -12.82 N 100% 100% 100%100% $ (232,425) $ (232,425) $ (232,425) $ (232,425)Recordkeeping $ - -1.02 N 33% 67% 100%100% $ (9,233) $ (18,465) $ (27,698) $ (27,698)Postage$ (24.59) 0.01 N 33% 67% 100%100% $ (5,907) $ (11,813) $ (17,720) $ (17,720)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 w ill 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 fo llowing 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 th e 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 signatur e, 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 th e burden in the first or second year. Specific calcu lations 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 duri ng the first and second years Subsequent Years Multiply t he 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 th e phase-in provision is specific to rule familiarization only, which is a company-leve l activity. EPA is projecting that this burden will be incurred by all companies filling out PMNs/sec tion 5 notices, regardless of the method of submission used during the pha se-in period. There ar e 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 s ubmitting notices for the first time will incur the rule familiarization burden. Specifi c 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 duri ng the first and second years Subsequent Years Multiply t he 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 com pany-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-PM N 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 com pany-level burden estimate by 100%

2.7 Summary of Impacts

The estimated changes in industry burden a nd cost due to the final e-PMN rule are presented in Tables 15 through 24. Total i ndustry burden savings are presented for PMN submissions alone in Table 15; associated co sts 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 tota l industry burden and cost changes from the company- and form-level changes combined. While the ac tivities related to CDX are estimated to impose additional burden and cost, those incr eases 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 show n 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 al l 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 thir d 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 compa ny due to the final rule are presented for all notices combined, and for PMN notices only in Tables 19 through 22. Results are22 presented on a per-form basis for all notices co mbined 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. Fo r PMNs only, Table 21 shows estimated average burden savings of 46.2 hours per-company in the fi rst 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 approxima tely 9.5 hours per form for all years of the rule, and Table 24 shows estimated average co st 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 Y ear 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 reporti ng system as well as the adoption of CDX to facilitate form submission and processi ng 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 inconsiste nt 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 EP A 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 (ack nowledging receipt of a notice), and the Incomplete Letter (stating why a notice has been declared incomplete). These communications are typically sent through the mail. Elect ronic communication should provide significant time and res ource 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 w ith the operation and ma intenance (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 incu rred 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 attributab le 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). Alt hough the e-PMN data flow is smaller than the

data flows included in the CROMERR an alysis, 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, th e $57,353 might be considered

a lower bound estimate of total O&M.

The Agency will also incur costs associat ed with providing technical assistance to submitters, including conducting a beta or pilot test of the final submission process, conducting approximately three trainings sess ions around the country to demonstrate the e-PMN software, operating a telephone hotline, and other outreach act ivities. Although not quantified at this time, th ese activities are likely to requi re 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 sa vings will stem from eliminating manual data entry of section 5 notices and re lated support documents, reducing resources dedicated to quality assura nce/quality control (QA/QC) of the current paper-based system, and either greatly reducing or elim inating operating and maintenance costs for the existing system.

Baseline Agency burden associated with se ction 5 notices is ta ken from the most

recent version of the Information Collection Request for Premanufacture Review Reporting and Exemption Requirements for Ne w Chemical Substances and Significant New Use Reporting Requiremen ts 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 Da ta Flows studied in the CDX Business Case Analysis

, monetary benefits from using CDX as comp ared to a paper submission baseline were quantified for two flows: TRI (Toxic Release In ventory) and e-NOI (e lectronic Notice of Intent under the National Pollution Discharge El imination System). Benefits ranged from 11 percent savings (e-NOI) to 22 percent savi ngs (TRI) compared to the cost of the baseline process. For this analysis, EP A 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 subm itted via CDX by the third year. The overall change in Agency burden is presented in Tabl e 25 and the overall change in Agency cost is presented in Table 26.

13 EPA ICR No. 0574.14 OMB Control No. 2070-0014.29Table 25Estimated Agency Burden Savings due to the Final e-PMN RuleBaseline Agency BurdenSavings Compared to Baseline BurdenType of NoticeAverageAnnualNumber ofResponsesAgencyLaborHoursTotalAgencyHoursPercentAnnualSavingsBurdenHourSavingsYear 1BurdenHourSavingsYear 2BurdenHourSavingsYear 3BurdenHour SavingsSubsequentYearsPMN720 64 46,109 17% 2,536 5,072 7,608 7,608SNUN18 64 1,130 17% 62 124 186186MCAN3 1,067 3,628 17% 200 399 599 599Exemptions:TME8 109 834 17% 46 92 138 138LVE/LoREX419 22 9,219 17% 507 1,014 1,521 1,521TERA2 1,476 2,509 17% 138 276 414 414Tier I and II3 187 477 17% 26 52 79 79R&D200 0 - - - - -Instant photographic film articles0 0 - - - -Bona Fide116 2 232 - - - -5(e) Test12 1,500 17,850 17% 982 1,964 2,945 2,945Non-Testing 5(e) Burden16 65 1,040- - -NOCs443 1 443 17% 24 49 73 73Correction Requests9 21 189 - - - -Total1,96883,660Total Burden HourSavings4,5219,04213,56313,56330Table 26Estimated Agency Cost Savings due to the Final e-PMN RuleType of NoticeTotal Agency BaselineCosts, Based onUpdated Universe ofNoticesPercentAnnualSavingsSavings Year 1Savings Year 2Savings Year 3SavingsSubsequentYearsPMN$3,935,207 17%$216,436 $432,873 $649,309 $649,309SNUN$95,403 17% $ 5,247 $10,494 $ 15,741 $15,741MCAN$251,116 17% $13,811 $27,623 $41,434 $41,434Exemptions:TME$57,719 17% $3,175 $6,349 $ 9,524 $9,524LVE/LoREX$946,364 17% $52,050 $104,100 $156,150 $156,150TERA$173,687 17% $9,553 $19,106 $ 28,658 $28,658Tier I and II$33,008 17% $1,815 $3,631 $5,446 $5,446R&D- - - - -Instant photographic film articles-- - - -Bona Fide$25,765 - - - -5(e) Test$1,235,577 17% $67,957 $135,913 $203,870 $203,870Non-Testing 5(e) Burden$71,989- - - -NOCs$30,654 17% $1,686 $3,372 $5,058 $5,058CorrectionRequests$38,994 - - - -Total$6,895,483Total Savings$ 371,730$ 743,461 $ 1,115,191 $ 1,115,191Cost to Develop Automated Collection$ 100,000$ 100,000-$ -Total O&M Cost$ 57,353$ 57,353$ 57,353 $ 57,353Net Savings$ 214,377$ 586,108 $ 1,057,838 $ 1,057,838-31- 4.0 BENEFITS OF THE FINAL e-PMN RULE

As mentioned in other sec tions of this Economic Anal ysis, the final reporting system is intended to streamline and reduce the administrative costs and burden of the TSCA section 5 New Chemicals Program fo r 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 year s of the rule. CDX is a point of entry or web services

node for the electronic submissi on of environmental data to the Agency. CDX works with EPA program offices such as the New Chemi cals Program that are seeking to identify ways to better manage incoming data, and w ith 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 indu stry 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 re quired 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 secti on 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 informa tion. For example, if “use” information is claimed CBI, then the e-PMN soft ware 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 biotechnol ogy notices (i.e., Mi crobial Commercial Activity Notices (MCANs), TSCA Experiment al Release Applications (TERAs), Test Marketing Exemption Applications (TMEAs), a nd 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 a nd store any data correc tly 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 vers ion 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 lik elihood 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 c opy 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 fo rmat 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 ve rsion. With the e-PMN, only electronic versions of the CBI and sanitized forms are required.

• All relevant staff within the submitting co mpany will be able to easily access the ePMN form and directly input their informa tion. The e-PMN form will also facilitate easier internal review prior to submission.

• Preparing consolidated PMNs will no longe r necessitate retypi ng 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 informati on 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-PM N software will allow submitters to copy information within and across forms, cutt ing 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 sa ve 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 prov ide 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, pr ogram usage guidelines, and error troubleshooting.

4.2 Agency Benefits

4.2.1 Electronic Reporting

EPA expects that the conversion to an el ectronic reporting system will create long

term burden reduction and efficiencies for th e Agency. The need to process paper forms will be eliminated and quality assurance/qua lity 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 s ubmitter 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 EP A 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 r outine communications from EPA that could go through CDX include the Acknowledgment Lett er (acknowledging recei pt of a notice), and the Incomplete Letter (stating why a notice has been declared incomplete). Usually, these communications are sent through the ma il. 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 main taining hardware, software, and human resources to manage electronic report ing 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 Elim ination Act (GPEA, Pub. L. 105-277; 44 USC 3504) requires that, when practicable, fe deral organizations use electronic forms, electronic filings, and electronic signatures to conduct offici al business with the public. EPA’s Cross-Media Electronic Reporti ng Regulation (CROMERR) (October 13, 2005; 70 FR 59848; FRL-7977-1; 44 CFR 3) provides that any requir ement 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 c onditions once the Agency publishes a notice-34- that electronic document submission is availabl e 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 subm it TSCA section 5 notices to the Agency.

5.0 ADDITIONAL ANALYSES

This section presents the additional anal ysis required under va rious statutes and

Executive Orders.

5.1 Executive Order 12866

Under Executive Or der 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 “signi ficant regulatory action” under se ction 3(f) of the Executive

Order because this action does raise novel le gal 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 commen ts have been documented in the public docket for this rulemaking as required by secti on 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 Regulat ory 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 econom ic impact on a substantial nu mber 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) regulati ons at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, c ounty, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently ow ned 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 agen cy may certify that a rule will not have a significant adverse economic impact on a substa ntial 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 certificati on under the RFA is presented in the small-35- entity impact analysis prepared as part of th e 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 th is reporting requirement, and EPA does not have any reason to believe that any State, lo cal, 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 ma ndate, or otherwise have any affect on small governments subject to the requireme nts 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 co ntained 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 EP A 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 Informa tion Collection Request (ICR) addresses the incremental paperwork activities related to submitting Section 5 information to EPA electronically and describes the changes that w ill 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 Ne w 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 collect ion of information unl ess 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 activit ies contained in this final rule are designed to assist the Agency in meeting its responsibility under TSCA to receive, process, and review premanufacture and signifi cant new use notices in a timely manner and further the proper performance of the functions of the Agency. Information collection for review of pr emanufacture 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 Signa ture Block.” The other revision to the information collection activities already a pproved 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 I CRs 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 estima ted burden and costs for three years of the rule-related program. The aggr egate burden varies by year du ring the first three years of the rule because of the phase-i n schedule of the fina l requirements. The incremental, rulerelated burden and cost to chemical manufact urers, 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 firs t 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 an ticipates that the average annual total burden to industry for the submission of TS CA 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 sa vings 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 th e 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 Or der 13132, entitled “ Federalism ” (64 FR 43255, August 10, 1999), EPA has determined that this final rule does not have ‘‘fed eralism implications’’

because it will not have substantial direct effects on the States, on the relationship between the national government and the Stat es, or on the distribution of power and responsibilities among the various levels of government, as specifi ed in the Executive

Order. This final rule establishes electr onic notification requirements that apply to manufacturers (including importers) and proce ssors of certain chemicals. This rule does not apply directly to States and localities and will not aff ect 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 comm unities. 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 envir onmental 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 di sproportionate effect on children.

5.8 Executive Order 13175

Under Executive Or der 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 tr ibal implications because it wi ll not have substantial direct effects on tribal governments, on the relati onship between the Federal Government and the Indian tribes, or on the distribution of power and res ponsibilities between the Federal Government and Indian tribes, as specifie d in the Order. EPA has no information to indicate that any trib al government manufactures or imports the chemical substances covered by this action. Thus, Executive Orde r 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 Nati onal 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 standard s are technical stan dards (e.g., materials specifications, test methods, sampling procedures , etc.) that are devel oped or adopted by voluntary consensus standards bodies. This final rule does not impose any technical standards that will require EPA to cons ider 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 Chemic al 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 Invento ry Update Rule: Final Report . U.S.EPA, Office of Pollution Pr evention and Toxics, Economic and Policy Analysis Branch. Washington, DC. August 2002.

EPA, 2003. Burden Cost Analysis Supporting th e Information Collection Request Renewal for TSCA Section 5 Premanufacture Notifications . U.S.EPA, Office of Pollution Prevention and Toxics, Econo mic 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 COST S BY TYPE OF NOTICE-40-Table A-1Form Level Burden, SNUN Forms Only* Includes management, technical, and clerical labor.** Percent of universe that has completed activity by this year.Table A-2Form 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 Burden (hours)*ActivityNon-Labor($)Burden(Hours)EmployeesIncurringBurdenOneTimeBurden%Year 1%Year 2%Year 3%SubsequentYearsYear 1Year 2Year 3SubsequentYearsForm Completion $ - -12.82 N 100% 100% 100%100% (226) (226) (226)(226)Recordkeeping$ - -1.02 N 33% 67% 100%100% (6) (12) (18)(18)Postage$ (17.68) 0.01 N 33% 67% 100%100% - - --All Labor Categories Unit Burden*Phase-In Rate**Form-Level Cost*ActivityNon-Labor($)Burden(Hours)EmployeesIncurringBurdenOneTimeBurden%Year 1%Year 2%Year 3%SubsequentYearsYear 1Year 2Year 3SubsequentYearsForm Completion $ - -12.82 N 100% 100% 100% 100% $ (5,694) $ (5,694) $ (5,694) $(5,694)Recordkeeping$ - -1.02 N 33% 67% 100% 100% $ (226) $ (452) $ (679) $(679)Postage$ (17.68) 0.01 N 33% 67% 100% 100% $ (104) $ (208) $ (312) $ (312)-41-Table A-3Form Level Burden, MCAN Forms Only* Includes management, technical, and clerical labor.** Percent of universe that has completed activity by this year.Table A-4Form Level Cost, MCAN Forms OnlyAll Labor Categories Unit Burden*Phase-In Rate**Form-Level Cost*ActivityNon-Labor($)Burden(Hours)EmployeesIncurringBurdenOneTimeBurden%Year 1%Year 2%Year 3%SubsequentYearsYear 1Year 2Year 3SubsequentYearsForm Completion $ - -13.82 N 100% 100% 100%100% $ (1,184) $ (1,184) $ (1,184) $ (1,184)Recordkeeping$ - -1.02 N 33% 67% 100%100% $ (44) $ (87) $ (131) $(131)Postage$ (22.85) 0.01 N 33% 67% 100%100% $ (26) $ (52) $ (78) $ (78)* 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 Burden (hours)*ActivityNon-Labor($)Burden(Hours)EmployeesIncurringBurdenOneTimeBurden%Year 1%Year 2%Year 3%SubsequentYearsYear 1Year 2Year 3SubsequentYearsForm Completion $ - -13.82 N 100% 100% 100%100% (47) (47) (47) (47)Recordkeeping$ - -1.02 N 33% 67% 100%100% (1) (2) (3)(3)Postage$ (22.85) 0.01 N 33% 67% 100%100% - - ---42-Table A-5Form Level Burden, TMEA Forms Only* Includes management, technical, and clerical labor.** Percent of universe that has completed activity by this year.Table A-6Form 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 Burden (hours)*ActivityNon-Labor($)Burden(Hours)EmployeesIncurringBurdenOneTimeBurden%Year 1%Year 2%Year 3%SubsequentYearsYear 1Year 2Year 3SubsequentYearsForm Completion $ - -11.82 N 100% 100% 100%100% (90) (90) (90) (90)Recordkeeping$ - -1.02 N 33% 67% 100%100% (3) (5) (8)(8)Postage$ (28.99) 0.01 N 33% 67% 100%100% - - --All Labor Categories Unit Burden*Phase-In Rate**Form-Level Cost*ActivityNon-Labor($)Burden(Hours)EmployeesIncurringBurdenOneTimeBurden%Year 1%Year 2%Year 3%SubsequentYearsYear 1Year 2Year 3SubsequentYearsForm Completion $ - -11.82 N 100% 100% 100%100% $ (2,273) $ (2,273) $ (2,273) $ (2,273)Recordkeeping$ - -1.02 N 33% 67% 100%100% $ (98) $ (196) $ (294) $(294)Postage$ (28.99) 0.01 N 33% 67% 100%100% $ (74) $ (148) $ (222) $ (222)-43-Table A-7Form Level Burden, LVE/LOREX Forms Only* Includes management, technical, and clerical labor.** Percent of universe that has completed activity by this year.Table A-8Form 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-Level Burden (hours)*ActivityNon-Labor($)Burden(Hours)EmployeesIncurringBurdenOneTimeBurden%Year 1%Year 2%Year 3%SubsequentYearsYear 1Year 2Year 3SubsequentYearsForm Completion $ - -12.82 N 100% 100% 100%100% (5,371) (5,371) (5,371)(5,371)Recordkeeping $ - -1.02 N 33% 67% 100%100% (140) (279) (419)(419)Postage$ (26.09) 0.01 N 33% 67% 100%100% - - --All Labor Categories Unit Burden*Phase-In Rate**Form-Level Cost*ActivityNon-Labor($)Burden(Hours)EmployeesIncurringBurdenOneTimeBurden%Year 1%Year 2% Year3%SubsequentYearsYear 1Year 2Year 3SubsequentYearsForm Completion $ - -12.82 N 100% 100% 100%100% $ (135,188) $ (135,188) $ (135,188) $ (135,188)Recordkeeping $ --1.02 N 33% 67% 100%100% $ (5,370) $ (10,740) $ (16,110) $ (16,110)Postage$ (26.09)0.01 N 33% 67% 100%100% $ (3,644) $ (7,289) $ (10,933) $ (10,933)-44-Table A-9Form Level Burden, NOC Forms Only* Includes management, technical, and clerical labor.** Percent of universe that has completed activity by this year.Table A-10Form 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 Burden (hours)*ActivityNon-Labor($)Burden(Hours)EmployeesIncurringBurdenOneTimeBurden%Year 1%Year 2%Year 3%SubsequentYearsYear 1Year 2Year 3SubsequentYearsForm Completion $ - 0.12 N 100% 100% 100%100% 26 26 2626Recordkeeping$ - -0.12 N 33% 67% 100%100% (18) (37) (55)(55)Postage$ (26.45) 0.01 N 33% 67% 100%100% - - --All Labor Categories Unit Burden*Phase-In Rate**Form-Level Cost*ActivityNon-Labor($)Burden(Hours)EmployeesIncurringBurdenOneTimeBurden%Year 1%Year 2%Year 3%SubsequentYearsYear 1Year 2Year 3SubsequentYearsForm Completion $ - 0.12 N 100% 100% 100%100% $2,755 $ 2,755 $ 2,755 $2,755Recordkeeping$ - -0.12 N 33% 67% 100%100% $ (709) $ (1,419) $ (2,128) $(2,128)Postage$ (26.45) 0.01 N 33% 67% 100%100% $ (3,904) $ (7,809) $ (11,713) $ (11,713)-45-Table A-11Form Level Burden, TERA Forms Only* Includes management, technical, and clerical labor.** Percent of universe that has completed activity by this year.Table A-12Form 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 Burden (hours)*ActivityNon-Labor($)Burden(Hours)EmployeesIncurringBurdenOneTimeBurden%Year 1%Year 2%Year 3%SubsequentYearsYear 1Year 2Year 3SubsequentYearsForm Completion $ - -13.82 N 100% 100% 100%100% (23) (23) (23) (23)Recordkeeping$ - -1.02 N 33% 67% 100%100% (1) (1) (2)(2)Postage$ (39.13) 0.01 N 33% 67% 100%100% - - --All Labor Categories Unit Burden*Phase-In Rate**Form-Level Cost*ActivityNon-Labor($)Burden(Hours)EmployeesIncurringBurdenOneTimeBurden%Year 1%Year 2%Year 3%SubsequentYearsYear 1Year 2Year 3SubsequentYearsForm Completion $ - -13.82 N 100% 100% 100%100% $ (592) $ (592) $ (592) $(592)Recordkeeping$ - -1.02 N 33% 67% 100%100% $ (22) $ (44) $ (65) $(65)Postage$ (39.13) 0.01 N 33% 67% 100%100% $ (22) $ (44) $ (67) $ (67)-46-Table A-13Form 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-14Form 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 Burden (hours)*ActivityNon-Labor($)Burden(Hours)EmployeesIncurringBurdenOneTimeBurden%Year 1%Year 2%Year 3%SubsequentYearsYear 1Year 2Year 3SubsequentYearsForm Completion $ - -3.82 N 100% 100% 100%100% (10) (10) (10) (10)Recordkeeping$ - -1.02 N 33% 67% 100%100% (1) (2) (3)(3)Postage$ (24.59) 0.01 N 33% 67% 100%100% - - --All Labor Categories Unit Burden*Phase-In Rate**Form-Level Cost*ActivityNon-Labor($)Burden(Hours)EmployeesIncurringBurdenOneTimeBurden%Year 1%Year 2%Year 3%SubsequentYearsYear 1Year 2Year 3SubsequentYearsForm Completion $ - -3.82 N 100% 100% 100%100% $ (237) $ (237) $ (237) $(237)Recordkeeping$ - -1.02 N 33% 67% 100%100% $ (33) $ (65) $ (98) $(98)Postage$ (24.59) 0.01 N 33% 67% 100%100% $ (21) $ (42) $ (63) $ (63)-47-Table A-15Form 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-16Form 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 Burden (hours)*ActivityNon-Labor($)Burden(Hours)EmployeesIncurringBurdenOneTimeBurden%Year 1%Year 2%Year 3%SubsequentYearsYear 1Year 2Year 3SubsequentYearsForm Completion $ - -4.32 N 100% 100% 100%100% (51) (51) (51) (51)Recordkeeping$ - -17.52 N 33% 67% 100%100% (69) (139) (208)(208)Postage$ (24.59) 0.01 N 33% 67% 100%100% - - --All Labor Categories Unit Burden*Phase-In Rate**Form-Level Cost*ActivityNon-Labor($)Burden(Hours)EmployeesIncurringBurdenOneTimeBurden%Year 1%Year 2%Year 3%SubsequentYearsYear 1Year 2Year 3SubsequentYearsForm Completion $ - -4.32 N 100% 100% 100%100% $ (1,256) $ (1,256) $ (1,256) $(1,256)Recordkeeping$ - -17.52 N 33% 67% 100%100% $ (2,669) $ (5,337) $ (8,006) $(8,006)Postage$ (24.59) 0.01 N 33% 67% 100%100% $ (98) $ (195) $ (293) $ (293)