OMB Control Number 2070-0173; EPA ICR Number 2327.02

New Information Collection Activities for Electronic Submissions under TSCA Section 5

Appendix 1

Impact Analysis of the Final TSCA Section 5 Premanufacture and Significant New Use 

Notification Electronic Reporting Rule [RIN 2070-AJ41] on Paperwork Burdens Approved 

under Existing EPA ICRs
i

TABLE OF CONTENTS

1.0 Introduction....................................................................................................................... 1

1.1 Terminology................................................................................................................... 1

1.1.1 Company-level Burden......................................................................................... 1

1.1.2 Form-level Burden................................................................................................ 1

1.2 Assumptions................................................................................................................... 2

1.2.1 Respondents........................................................................................................... 2

1.2.2 Number and Types of TSCA Section 5 Notices Submitted Under New 

Chemicals Program .............................................................................................................. 2

1.2.3 Number and Types of Significant New Use Notices Submitted Under Existing 

Chemicals Program .............................................................................................................. 3

2.0 Impacts of e-PMN Final Rule on New Chemicals Program Burdens (OMB Control 

No. 2070-0012)............................................................................................................................... 4

2.1 Adjustments to the Baseline Number of Responses................................................... 4

2.1.1 Impact of Adjusted Baseline Number of Responses on Reporting Burden..... 4

2.1.2 Impact of Adjusted Baseline Number of Responses on Recordkeeping 

Burden ................................................................................................................................. 4

2.1.3 Summary Burden Impact of Baseline Response Adjustments......................... 5

2.2 Reporting Burden Program Changes ......................................................................... 6

2.2.1 New Company-Level Reporting Burdens........................................................... 6

2.2.2 Reductions in Form-Level Reporting Burden for New Chemicals 

Submissions ........................................................................................................................... 6

2.3 New Chemicals Recordkeeping Burden Program Changes.................................... 10

2.3.1 Reductions in Form-Level Recordkeeping Burden for New Chemicals 

Submissions ......................................................................................................................... 11

2.4 Summary Burden Impact of Rule-Related Program Changes............................... 16

2.5 Net Burden Decrease - New Chemicals Program .................................................... 16

3.0 Impacts of e-PMN Final Rule on Existing Chemicals Program Burdens (OMB 

Control No. 2070-0038)............................................................................................................... 16

3.1 Adjustments to the Baseline Reporting and Recordkeeping Estimates for Existing 

Chemical SNUNs..................................................................................................................... 16

3.1.1 Impact of Adjusted Baseline Reporting and Recordkeeping Estimates........ 17

3.2 Reporting Burden Program Changes ....................................................................... 19

3.2.1 New Company-Level Reporting Burdens......................................................... 19

3.2.2 Reductions in Form-Level Reporting Burden for Existing Chemical SNUN 

Submissions ......................................................................................................................... 19

3.3 Existing Chemicals Recordkeeping Burden Program Changes............................. 22

3.4 Summary Burden Impact of Rule-Related Program Changes............................... 23

3.5 Net Burden Decrease - Existing Chemicals Program.............................................. 23

4.0 Summary of Net Changes to Annual Paperwork Burden Estimates......................... 24

4.1 Adjustments................................................................................................................. 24

4.1.1 Fewer New Chemicals Responses...................................................................... 24

4.1.2 Harmonized SNUN Reporting and Recordkeeping Burden Estimates......... 24

4.2. Program Changes........................................................................................................ 25

4.2.1 Modest Rule Implementation Burden............................................................... 25

4.2.2 Resulting Burden Reduction.............................................................................. 25

4.3 Net Changes................................................................................................................. 25
1

1.0 Introduction

This appendix analyzes the expected impact of the final TSCA Section 5 Premanufacture 

and Significant New Use Notification Electronic Reporting Rule [RIN 2070-AJ41] on the 

paperwork burden associated with the following existing approved ICRs:

 Pre-Manufacture Review Reporting and Exemption Requirements for New 

Chemical Substances and Significant New Use Reporting Requirements for 

Chemical Substances (OMB Control No. 2070-0012)

 TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals (OMB 

Control No. 2070-0038).

The two ICRs have some similar information collection components; this appendix describes 

certain baseline adjustments made for consistency between burden estimates. In addition, this 

appendix also describes the program change-related burden increases and reductions that are the 

expected outcome of implementing the e-PMN rule.

1.1 Terminology

1.1.1 Company-level Burden

Company-level burden includes those activities that facilitate submission of an e-PMN: 

CDX registration, CDX electronic signature (i.e., authentication of identity and verification of 

authorization), setting up a Pay.gov account, and rule familiarization. All activities performed at 

the company-level occur only once during the first year that an activity is undertaken. Rule 

familiarization, for example, will be incurred by all companies during the first year following 

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

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

subsequent years will incur rule familiarization burden the first year they submit a section 5 

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

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

incurred only once, will be incurred in the year in which the company adopts electronic reporting 

via CDX.

1.1.2 Form-level Burden

Form-level burden includes form completion, recordkeeping, and postage. As a result of 

the e-PMN rule, submitters will experience a reduction in form-level burden due to the 

efficiencies and reduced time associated with using the new e-PMN software to fill out section 5 

notices and using CDX to submit these notices. All form-level burden savings are expected to be 

realized each time a section 5 notice is submitted. Recordkeeping and postage savings will be 

realized in years when electronic reporting via CDX is used. However, because all notices must 

be generated using the new e-PMN software beginning in the first year following rule 

promulgation, form completion burden saving will be realized by all submitters immediately.
1.2 Assumptions

1.2.1 Respondents

This information collection affects companies that manufacture, process or import 

chemical substances. These companies are typically found in NAICS major groups 325 

(Chemical Manufacture) and 324 (Petroleum and Coal Products). EPA estimates that there are 

305 respondent companies that will submit TSCA section 5 notices to EPA. The Agency

estimates 295 respondents under the New Chemicals Program and an additional 10 respondents 

under the Existing Chemicals Program.

Burden and cost calculations are based on the assumption that EPA will receive an annual 

average of 2,135 TSCA section 5 notices under the New Chemicals program and 10 TSCA 

significant new use notices (SNUNs) under Existing Chemicals program. The estimated number 

of notices that will be submitted under the New Chemicals program is derived by averaging the 

number of notices received in years 2003 through 2007 for each of the submission types listed in 

the paragraph above, adjusting these averages by 15 percent to reflect only valid submissions and 

then summing these averages (See Table 1).

Table 1

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 - New Chemicals 8

Number of SNUNs - Existing Chemicals 10

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%

1.2.2 Number and Types of TSCA Section 5 Notices Submitted Under New 

Chemicals Program

The number of notices that EPA expects to be submitted each year is typically estimated 

by averaging the number of each type of submission received over the past three years according 

to data provided in the OPPT New Chemicals Annual Report (EPA, 2006) and adjusting it by 15 

percent to reflect only valid submissions. However, for this ICR, the numbers of notices were 
averaged for the past five years (2003 through 2007) to provide a longer term picture of section 5 

activity as part of the economic analysis for the e-PMN rule (EPA, 2009.) This change in 

method of determining the average annual number of responses has resulted in baseline burden 

adjustments, as described in section 2 of this appendix, for which EPA has accounted prior to 

analyzing the impact of the final rule on the overall reporting and recordkeeping burden

Prior to the 1995 amendments to the PMN rule, 70 to 80 percent of all TSCA section 5 

notices were full PMN submissions. From 1995 through 2003, the increase in exemptions did 

not significantly change this distribution. However, since 2003, full PMN submissions 

accounted on average for approximately 60 percent of all TSCA section 5 submissions. EPA 

expects few persons to submit significant new use notices (SNUNs). The number of SNUNs 

submitted is a function of the number of chemicals regulated under Significant New Use Rules 

(SNURs), which are relatively few. Based on the average number of SNUNs received annually

during the last five years, the Agency expects to receive approximately eight SNUNs annually.

The amendments also placed stricter control on bona fide notices, which are intended to 

establish bona fide intent on the part of the submitter to manufacture or import a chemical 

substance. These controls were established in response to the steadily increasing number of bona 

fide notices submitted to EPA. The amendments have caused a significant reduction in bona fide 

submissions. Historical EPA data suggests that EPA should expect 116 bona fide notices to be 

submitted annually.

On average, EPA expects LVE and LoREX exemptions to account for approximately 419 

notices annually. TMEs are expected to average eight applications per year, or less than one 

percent of all TSCA section 5 notices. NOCs are expected to account for 443 notices annually, 

while correction requests are expected to account for nine notices annually, or less than one

percent of all TSCA section 5 notices (EPA, 2006, and EPA, 2009).

The various exemptions available to submitters since the 1995 PMN amendments have 

reduced significantly the need for consent order development and post-notice data review. 

Historical EPA data indicate that such consent orders and post-notice data reviews will account 

for roughly two percent of the total TSCA section 5 notices. Based on historical data, EPA 

estimates 28 cases will be subject to TSCA section 5(e) consent order restrictions burden, with 

12 cases requiring test data, and 16 non-testing TSCA section 5(e) cases. Testing is usually

contracted out to a laboratory, thus the burden associated with testing requirements represents the 

time that personnel from the submitting firm will spend overseeing the testing, assumed to be 25 

percent of the lab burden.

1.2.3 Number and Types of Significant New Use Notices Submitted Under 

Existing Chemicals Program

As explained in EPA ICR No. 1188.09 (OMB Control No. 2070-0038), EPA estimates 

that it will receive 10 SNUNs per year under TSCA Section 5(a)(2) during the three-year period 

covered by this ICR (see Table 2).
Table 2

Anticipated Number of SNURs and SNUNs

Under The Existing Chemicals Program

Year

Anticipated Number of 

SNURs

Anticipated Number of 

SNUNS

First Year 5 10

Second Year 5 10

Third Year 5 10

Three Year Totals 15 30

2.0 Impacts of e-PMN Final Rule on New Chemicals Program Burdens (OMB Control 

No. 2070-0012)

2.1 Adjustments to the Baseline Number of Responses

As mentioned in section 1.2.2 of this appendix, EPA utilized a somewhat different 

approach to project the number of new chemicals respondents and responses for this burden 

analysis than was used for the same projection in the ICR currently approved under OMB 

Control No. 2070-0012. For this analysis, EPA considered the average number of responses 

submitted annually over a 5-year period and adjusted the annual average by 15 percent to count 

only valid submissions. Previously, EPA had traditionally based its projections on the number of 

responses submitted in each of the previous 3 years. This change in calculation led EPA to 

estimate that 203 fewer net responses would be submitted annually across all types of activities 

covered under this ICR. The reduction in the number of baseline responses will impact the 

baseline annual burden estimate of 148,803 hours (143,450 reporting hours + 4,633 

recordkeeping hours) currently approved under EPA ICR No. 0574.13.

2.1.1 Impact of Adjusted Baseline Number of Responses on Reporting 

Burden

With a projected 203 fewer annual responses, EPA estimates a net reporting burden 

decrease of 14,289 hours (an adjustment) over the current reporting burden baseline projections 

for each activity in the ICR currently approved under OMB Control No. 2070-0012. A break out 

of the projected change in number of responses by type of submission, as well as the resulting 

change in reporting burden, is provided in Table 3.

2.1.2 Impact of Adjusted Baseline Number of Responses on Recordkeeping 

Burden

Similarly, EPA estimates a net recordkeeping burden decrease of 345 hours (an 

adjustment) over the current recordkeeping burden baseline projections for each activity in the 
ICR currently approved under OMB Control No. 2070-0012 as a result of a projected 203 fewer 

annual responses. A break out of the projected change in number of responses by type of 

submission, as well as the resulting change in recordkeeping burden, is provided in Table 4.

Table 3

New Chemicals Baseline Reporting Burden Adjustments by IC

EXISTING

Information Collection

Adjustments - Reporting

Change in Number of 

Annual Responses

Burden Hours 

per Response

Burden Hours 

per Year

Premanufacture Notification -85 105 -8,925

PMN-related Significant New Use Notices 1 105 105

Microbial Commercial Activity Notices (MCANs) 0 302 0

Test Marketing Exemptions 3 98 294

Low Volume and Low Release/Low Exposure (LVE/LoREX) Exemptions -51 105 -5,355

TSCA Experimental Release Applications (TERAs) 0 521 0

Tier I/Tier II Exemptions 1 114 114

Bona Fide Intent Notifications (Bona Fides) -17 20 -340

Test Data Submissions under Section 5(e) Consent Orders -1 155 -155

Notice of Commencement -54 0.5 -27

BASELINE REPORTING BURDEN ADJUSTMENTS - SUBTOTAL -14,289

Table 4

New Chemicals Baseline Recordkeeping Burden Adjustments by IC

EXISTING

Information Collection

Adjustments - Recordkeeping

Change in Number of 

Annual Responses

Burden hours 

per response

Burden hours 

per year

Premanufacture Notification -85 2 -170

PMN-related Significant New Use Notices 1 2 2

Microbial Commercial Activity Notices (MCANs) 0 2 0

Test Marketing Exemptions 3 2 6

Low Volume and Low Release/Low Exposure (LVE/LoREX) Exemptions -51 2 -102

TSCA Experimental Release Applications (TERAs) 0 2 0

Tier I/Tier II Exemptions 1 2 2

Bona Fide Intent Notifications (Bona Fides) -17 2 -34

Test Data Submissions under Section 5(e) Consent Orders -1 35 -35

Notice of Commencement -54 0.25 -14

BASELINE RECORDKEEPING BURDEN ADJUSTMENTS - SUBTOTAL -345

2.1.3 Summary Burden Impact of Baseline Response Adjustments

The overall impact of the adjusted baseline number of responses is a net reduction of 

14,634 annual burden hours. With these adjustments, the baseline reporting and recordkeeping 

burden is reduced to 133,449 hours (129,161 hours and the baseline recordkeeping burden is 

reduced to 4,288 hours).
Table 5

Total New Chemicals Baseline Burden Adjustments

Baseline Reporting Burden Adjustments – Subtotal -14,289

Baseline Recordkeeping Burden Adjustments - Subtotal -345

Total Baseline Burden Adjustments -14,634

2.2 Reporting Burden Program Changes

Upon implementation of the final rule, the average annual new chemicals reporting 

burden is estimated to be approximately 114,670 hours. As discussed in section 1 of this 

appendix, respondents will incur new, company-level reporting burdens while realizing formlevel reporting burden savings. Company-level reporting burden includes those activities that 

facilitate submission of an e-PMN: CDX registration, CDX electronic signature (i.e., 

authentication of identity and verification of authorization), setting up a Pay.gov account, and 

rule familiarization. Form-level burden includes completion and submission of TSCA section 5 

notices.

2.2.1 New Company-Level Reporting Burdens

EPA estimates that the e-PMN rule will impose an average program change increase of 

353 annual burden hours on respondents and is associated with the time required to complete 

company-level paperwork activities related to the final e-PMN rule requirements, i.e., CDX 

Registration, CDX electronic signature, E-Payment (Pay.gov ID), and Rule Familiarization. 

These activities and related burdens are explained in full in the supporting statement for EPA 

ICR No. 2327.07 (OMB Control No. 2070-0173). They are also included in the burden analysis 

presented in Tables 7 through 9. As indicated in Table 7, company-level burdens are higher in 

the first year due to initial rule familiarization burdens which are not incurred in subsequent 

years.

2.2.2 Reductions in Form-Level Reporting Burden for New Chemicals 

Submissions

The baseline reporting burden hours for each type of notice were estimated in PreManufacture Review Reporting and Exemption Requirements for New Chemical Substances and 

Significant New Use Reporting Requirements for Chemical Substances (EPA ICR No. 0574.13; 

OMB Control No. 2070-0012). However, respondent adoption of electronic preparation and 

submission under the e-PMN rule will affect the existing reporting burden hour estimates for 

each type of covered notice1. The adoption of electronic preparation and submission through 

CDX using the e-PMN software to prepare and submit TSCA section 5 notices will bring about 

burden savings by creating administrative efficiencies and time savings. The reporting burden 

savings relative to specific notice types are indicated in Table 6. The net impacts of these 

 

1 EPA is not accepting the electronic submission of certain types of documents and notices that are customarily part 

of the new chemicals program. In those cases, there are no program change reductions to form-level reporting or 

recordkeeping burden.
changes, coupled with the new rule related burdens described in section 2.2.1 of this appendix, 

are demonstrated in Tables 7 through 9. 

Table 6

Anticipated New Chemicals Program Reporting Burden Savings Under the e-PMN Rule

Type of New Chemicals 

Program Notice

Current Estimated 

Response Burden Hours

Estimated Response Burden 

Hours after e-PMN rule

Burden Hours Saved

Per Response

Full PMN 105 92.2 12.8

New Chemical SNUN 105 92.2 12.8

LVE 105 92.2 12.8

LoREX 105 92.2 12.8

MCAN 302 288.2 13.8

TME 98 86.2 11.8

TERA 521 507.2 13.8

Tier I 114 110.2 3.8

Tier II 114 110.2 3.8

5(e) Test submissions 155 150.7 4.3

NOC 0.5 0.6 (0.1)

Because the final e-PMN rule phases-in the use of CDX over the three-year period, the 

number of companies and forms using CDX will vary across the phase-in period. Therefore, 

burden hours are presented separately for each year of the phase-in period. Prior to the e-PMN

rule, only form-level burden was estimated for section 5 notices. Due to new activities that will 

occur at the company-level once electronic reporting via CDX is available, burden is broken out 

at the company and form level in the rule-related ICR.

Tables 7, 8 and 9 present the respondent reporting burden associated with this 

information collection during the first 3 years of rule implementation. The form-level during 

each of these years is estimated to total 114,317 hours. This burden estimate is calculated by 

multiplying the hours of reporting burden by the number of each type of notice that EPA expects 

to receive and summing across the notice types. Note that burden is adjusted to reflect the 

savings associated with the e-PMN rule in each year of the phase-in period, and also reflects 

adjustments to the baseline number of TSCA section 5 notices expected to be submitted to the 

new chemicals program. Because all notices must be generated using the new e-PMN software 

beginning in the first year following rule promulgation, however, form completion burden saving 

will be realized by all submitters immediately. After accounting for the baseline adjustments 

described in section 2.1.1 of this appendix, the estimated 114,317 annual hours of form-level 

reporting burden reflects a 14,844 hour net program change reduction.
Table 7

Revised New Chemicals Program Reporting Burden Under the e-PMN Rule, Year 1

Type of Notice

Avg. Annual 

Companies/Responses1

Current Average 

Reporting Hours 

per 

Company/Response

Revised Average 

Reporting Hours 

per 

Company/Response

Revised Total 

Reporting 

Hours

COMPANY BURDEN

CDX Registration 98 0 0.9 90

CDX Electronic Signature 98 0 1.8 172

E-Payment (Pay.gov ID) 98 0 0.1 13

Rule Familiarization 295 0 0.8 236

Total (Company) 589 511

FORM BURDEN

PMN 720 105 92.2 66,384

SNUN 8 105 92.2 738

MCAN 3 302 288.2 865

Exemptions:

 TME 8 98 86.2 690

 LVE/LoREX 419 105 92.2 38,632

 TERA 2 521 507.2 1,014

 Tier I and II 3 114 110.2 331

Polymer 175 2 2 350

 R&D 200 2.5 2.5 500

 Instant photographic 1 0.5 0.5 1

Bona Fide 116 20 20 2,320

5(e) Test 12 155 150.7 1,808

Non-Testing 5(e) Burden 16 25 25 400

NOC 443 0.5 0.6 266

Correction Request29 2 2 18

Total (Form) 2,135 114,317

Total (Combined Company and 

Form) 114,828

1Average Annual Responses computed as the average of the number of notices filed annually from 2003 through 2007 based on OPPT, 2008, 

then adjusted by 15% to reflect only valid submissions. For section 5 notices not subject to the e-PMN rule (R&D, Bona Fide, 5(e) NonTesting, Instant Photographic and Correction Requests), the average annual number of responses is assumed to equal the number presented in 

Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting 

Requirements for Chemical Substances (EPA ICR No. 0574.13; OMB Control No. 2070-0012).

2 TSCA Inventory Correction Requests are covered under another ICR entitled, Correction of Misreported Chemical Substances on the Toxic 

Substances Control Act Chemical Substances Inventory (EPA ICR No. 1741.05; OMB Control No. 2070-0145) and are included in this 

analysis only to provide a full assessment of related program burdens. Such correction requests are typically submitted after EPA has 

processed an NOC and added the related chemical to the TSCA Inventory.
Table 8

Revised New Chemicals Program Reporting Burden Under the e-PMN Rule, Year 2

Type of Notice

Avg. Annual 

Companies/Responses1

Current Average 

Reporting Hours 

per 

Company/Response

Revised Average 

Reporting Hours 

per 

Company/Response

Revised Total 

Reporting 

Hours

COMPANY BURDEN

CDX Registration 98 0 0.9 90

CDX Electronic Signature 98 0 1.8 172

E-Payment (Pay.gov ID) 98 0 0.1 13

Rule Familiarization 0 0 0.8 0

Total (Company) 294 275

FORM BURDEN

PMN 720 105 92.2 66,384

SNUN 8 105 92.2 738

MCAN 3 302 288.2 865

Exemptions:

 TME 8 98 86.2 690

 LVE/LoREX 419 105 92.2 38,632

 TERA 2 521 507.2 1,014

 Tier I and II 3 114 110.2 331

Polymer 175 2 2 350

 R&D 200 2.5 2.5 500

 Instant photographic 1 0.5 0.5 1

Bona Fide 116 20 20 2,320

5(e) Test 12 155 150.7 1,808

Non-Testing 5(e) Burden 16 25 25 400

NOC 443 0.5 0.6 266

Correction Request 9 2 2 18

Total (Form) 2,135 114,317

Total (Combined Company and 

Form)

114,592

1Average Annual Responses computed as the average of the number of notices filed annually from 2003 through 2007 based on OPPT, 2008, 

then adjusted by 15% to reflect only valid submissions. For section 5 notices not subject to the e-PMN rule (R&D, Bona Fide, 5(e) NonTesting, Instant Photographic and Correction Requests), the average annual number of responses is assumed to equal the number presented in

Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting 

Requirements for Chemical Substances (EPA ICR No. 0574.13; OMB Control No. 2070-0012).

2 TSCA Inventory Correction Requests are covered under another ICR entitled, Correction of Misreported Chemical Substances on the Toxic 

Substances Control Act Chemical Substances Inventory (EPA ICR No. 1741.05; OMB Control No. 2070-0145) and are included in this 

analysis only to provide a full assessment of related program burdens. Such correction requests are typically submitted after EPA has 

processed an NOC and added the related chemical to the TSCA Inventory.
Table 9

Revised New Chemicals Program Reporting Burden Under the e-PMN Rule, Year 3

Type of Notice

Avg. Annual 

Companies/Responses1

Current Average 

Reporting Hours 

per 

Company/Response

Revised Average 

Reporting Hours 

per 

Company/Response

Revised Total 

Reporting 

Hours

COMPANY BURDEN

CDX Registration 98 0 0.9 90

CDX Electronic Signature 98 0 1.8 172

E-Payment (Pay.gov ID) 98 0 0.1 13

Rule Familiarization 0 0 0.8 0

Total (Company) 294 275

FORM BURDEN

PMN 720 105 92.2 66,384

SNUN 8 105 92.2 738

MCAN 3 302 288.2 865

Exemptions:

 TME 8 98 86.2 690

 LVE/LoREX 419 105 92.2 38,632

 TERA 2 521 507.2 1,014

 Tier I and II 3 114 110.2 331

 R&D 200 2.5 2.5 500

Polymer 175 2 2 350

 Instant photographic 1 0.5 0.5 1

Bona Fide 116 20 20 2,320

5(e) Test 12 155 150.7 1,808

Non-Testing 5(e) Burden 16 25 25 400

NOC 443 0.5 0.6 266

Correction Request 9 2 2 18

Total (Form) 2,135 114,317

Total (Combined Company and 

Form)

114,592

1Average Annual Responses computed as the average of the number of notices filed annually from 2003 through 2007 based on OPPT, 2008, 

then adjusted by 15% to reflect only valid submissions. For section 5 notices not subject to the e-PMN rule (R&D, Bona Fide, 5(e) NonTesting, Instant Photographic and Correction Requests), the average annual number of responses is assumed to equal the number presented in

Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting 

Requirements for Chemical Substances (EPA ICR No. 0574.13; OMB Control No. 2070-0012).

2 TSCA Inventory Correction Requests are covered under another ICR entitled, Correction of Misreported Chemical Substances on the Toxic 

Substances Control Act Chemical Substances Inventory (EPA ICR No. 1741.05; OMB Control No. 2070-0145) and are included in this 

analysis only to provide a full assessment of related program burdens. Such correction requests are typically submitted after EPA has 

processed an NOC and added the related chemical to the TSCA Inventory.

2.3 New Chemicals Recordkeeping Burden Program Changes

Respondents will not incur any company-level recordkeeping burdens. Rather, they will 

realize form-level recordkeeping burden savings related to electronically submitted TSCA 

section 5 notices. However, while respondents will realize immediate reporting burden savings 

since all respondents will be required to use the e-PMN software to prepare their submissions, 

not all respondents will realize immediate recordkeeping burden savings. As described in 
section 1.1.2 of this appendix, recordkeeping and postage savings will be realized in years when 

electronic reporting via CDX is used. Reductions in recordkeeping burden are contingent upon 

adoption of electronic submission via CDX. Once a respondent electronically submits 

information in an initial TSCA section 5 submission, the burden for maintaining or updating 

these records is minimal. EPA expects that 33 percent of respondents to submit TSCA section 5 

notices electronically via CDX in the first year, 67 percent will do so by the second year, and 100

percent will do so by the third year (when all respondents are required to submit electronically). 

Thus, the average annual new chemicals recordkeeping burden over the first 3 years of the rule is 

approximately 3,339 hours (and 2,863 hours annually each year thereafter).

2.3.1 Reductions in Form-Level Recordkeeping Burden for New Chemicals 

Submissions

The estimated 2 hours for each SNUN recordkeeping reflects is an aggregate annualized 

recordkeeping burden is an assumption based on the recordkeeping burden associated with 

essential technical requirements, such as records that demonstrate that the first commercial batch 

of chemical manufactured for commercial purposes under the exemption met certain eligibility

criteria. EPA assumes that recordkeeping burden will be reduced by half due to the efficiencies 

in electronically creating and storing those TSCA section 5 notices and supporting documents

that are covered by the final rule. For most TSCA section 5 notices covered by the rule, baseline 

recordkeeping burden is estimated to be two hours. 

The recordkeeping burden savings relative to specific notice types are indicated in Table 

10. For these notices, one technical and one clerical staff member will each save 30 minutes on 

recordkeeping. For section 5(e) test notices, baseline recordkeeping burden is estimated to be 35 

hours because of the need to copy and file relevant records. This includes records related to: 

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

labels (documentation of labeling procedures and copies of labels); MSDS; and compliance with 

any additional restrictions on use, disposal, and discharge limitations. Therefore, for section 5(e) 

test notices, EPA estimates that one technical and one clerical staff member will each save 8.8 

hours on recordkeeping. For Notices of Commencement (NOC), baseline recordkeeping burden 

is estimated to be 15 minutes. Therefore, for NOCs, one technical and one clerical staff member 

will each save four minutes on recordkeeping.

As shown in Tables 11, 12, and 13, the total respondent recordkeeping burden associated 

with this information collection is estimated to equal 3,814 hours in the first year following the 

effective date of the e-PMN rule, 3,341 hours in the second year, and 2,863 hours in the third 

year following the effective date of the final rule. This burden estimate is calculated by 

multiplying the estimated recordkeeping burden associated with each type of submission (as 

estimated in EPA 1994) by the estimated number of submissions for each notice and then 

summing across notice types. Note that recordkeeping burden is adjusted by the savings 

associated with electronic reporting via CDX in each year of the phase-in period, and also 

reflects adjustments to the baseline number of TSCA section 5 notices expected to be submitted 

to the new chemicals program
Table 10

Anticipated New & Existing Chemicals Program Recordkeeping Burden Hour Savings Under the e-PMN Rule

Type of TSCA Section 5 Notice (New 

and Existing Chemicals Programs)

Current Estimated 

Recordkeeping Burden 

Per Response

Estimated Recordkeeping 

per Burden Response after 

Rule Implementation

Burden Saved

Per Response

Full PMN 2.00 1.00 1.00

SNUN12.00 1.00 1.00

LVE 2.00 1.00 1.00

LoREX 2.00 1.00 1.00

MCAN 2.00 1.00 1.00

TME 2.00 1.00 1.00

TERA 2.00 1.00 1.00

Tier I 2.00 1.00 1.00

Tier II 2.00 1.00 1.00

5(e) Test submissions 35.0 17.5 17.5

NOC 0.25 0.125 0.125

1The “current” recordkeeping burden for Existing Chemical SNUNs has been adjusted from the estimate of 5.67 hours 

calculated in TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals (EPA ICR No 1188.09; OMB 

Control No. 2070-0038), to 2 hours here, to be consistent with Pre-Manufacture Review Reporting and Exemption 

Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances

(EPA ICR No. 0574.13; OMB Control No. 2070-0012) and the Economic Analysis for the final e-PMN rule.

Once a respondent submits information in an initial TSCA section 5 submission, the 

burden for maintaining or updating these records is minimal. The Agency had assumed an 

aggregate annualized recordkeeping burden of two hours for each PMN, SNUN, MCAN, or 

exemption submission, or biotech submission. This was based on the recordkeeping burden 

associated with essential technical requirements, such as records that demonstrate that the first 

commercial batch of chemical manufactured for commercial purposes under the exemption met 

certain eligibility criteria. The recordkeeping burden for 5(e) testing and non-testing 5(e) burden 

were 35 and 25 hours, respectively (EPA, 1994). The Agency expects that promulgation of the 

e-PMN rule and the submission of fewer TSCA section 5 notices will reduce the recordkeeping 

burden from the current total of 4,633 hours to 2,863 hours by the third year.

The average recordkeeping burden of the first 3 years of the rule is 3,339 annual hours.

After accounting for the baseline recordkeeping burden adjustments described in section 2.1.2 of 

this appendix, this figure reflects an average annual 949 hour net program change reduction over 

the first 3 years of the rule (474 hours in the first year, 947 hours in the second year, and 1,425 in 

the third year and all subsequent years).
13

Table 11

Revised New Chemicals Program Respondent Recordkeeping Burden Under the e-PMN Rule, Year 1

Type of Notice

Average 

Annual 

Responses via 

non-CDX1

Average 

Annual 

Responses via 

CDX1

Current 

Average 

Recordkeeping 

Hours per 

non-CDX 

Response

Revised 

Average 

Recordkeeping 

Hours per 

CDX Response

Total 

Recordkeeping 

Hours for nonCDX

Total 

Recordkeeping 

Hours for 

CDX

Total 

Recordkeeping 

Hours for all 

Responses

PMN 480 240 2 1 960 240 1,200

SNUN 5 3 2 1 10 3 13

MCAN 2 1 2 1 4 1 5

Exemptions:

 TME 5 3 2 1 10 3 13

 LVE/LoREX 279 140 2 1 558 140 698

 TERA 1 1 2 1 2 1 3

 Tier I / II 2 1 2 1 4 1 5

 R&D 200 0 0.5 0.5 100 0 100

 Polymer 175 0 4 4 700 0 700

 Instant 

photographic 1 0 0.25 0.25 1 0 1

Bona Fide 116 0 2 2 232 0 232

5(e) Test 8 4 35 17.5 280 70 350

Non-Testing 5(e) 

Burden 16 0 25 25 400 0 400

NOC 295 148 0.25 0.125 74 18 92

Correction 

Request 9 0 0.25 0.25 2 0 2

Total 1,594 541 3,337 477 3,814

1Average Annual Responses computed as the average of the number of notices filed annually from 2003 through 2007 based on OPPT, 2008, then adjusted by 

15% to reflect only valid submissions. The CDX responses and non-CDX responses are determined by the % of responses that will utilize CDX for a given year: 

33% for the first year, 67% for the second year, and 100% for the third year. For section 5 notices not subject to the e-PMN rule (R&D, Bona Fide, Non-Testing 

5(e), Instant Photographic and Correction Requests), the average annual number of responses is assumed to equal the number presented in Pre-Manufacture Review 

Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances (EPA ICR No. 

0574.13; OMB Control No. 2070-0012).

2 TSCA Inventory Correction Requests are covered under another ICR entitled, Correction of Misreported Chemical Substances on the Toxic Substances Control 

Act Chemical Substances Inventory (EPA ICR No. 1741.05; OMB Control No. 2070-0145) and are included in this analysis only to provide a full assessment of 

related program burdens. Such correction requests are typically submitted after EPA has processed an NOC and added the related chemical to the TSCA 

Inventory.
Table 12

Revised New Chemicals Program Respondent Recordkeeping Burden Under the e-PMN Rule, Year 2

Type of Notice

Average 

Annual 

Responses via 

non-CDX1

Average 

Annual 

Responses via 

CDX1

Current

Average 

Recordkeeping 

Hours per 

non-CDX 

Response

Revised 

Average 

Recordkeeping 

Hours per 

CDX Response

Total 

Recordkeeping 

Hours for nonCDX

Total 

Recordkeeping 

Hours for 

CDX

Total 

Recordkeeping 

Hours for all 

Responses

PMN 240 480 2 1 480 480 960

SNUN 3 5 2 1 6 5 11

MCAN 1 2 2 1 2 2 4

Exemptions:

 TME 3 5 2 1 6 5 11

 LVE/LoREX 140 279 2 1 280 279 559

 TERA 1 1 2 1 2 1 3

 Tier I / II 1 2 2 1 2 2 4

 R&D 200 0 0.5 0.5 100 0 100

 Polymer 175 0 4 4 700 0 700

 Instant

photographic 1 0 0.25 0.25 1 0 1

Bona Fide 116 0 2 2 232 0 232

5(e) Test 4 8 35 17.5 140 140 280

Non-Testing 

5(e) Burden 16 0 25 25 400 0 400

NOC 148 295 0.25 0.125 37 37 74

Correction 

Request 9 0 0.25 0.25 2 0 2

Total 1,058 1,077 2,390 951 3,341

1Average Annual Responses computed as the average of the number of notices filed annually from 2003 through 2007 based on OPPT, 2008, then adjusted by 

15% to reflect only valid submissions. The CDX responses and non-CDX responses are determined by the % of responses that will utilize CDX for a given year: 

33% for the first year, 67% for the second year, and 100% for the third year. For section 5 notices not subject to the e-PMN rule (R&D, Bona Fide, Non-Testing 

5(e), Instant Photographic and Correction Requests), the average annual number of responses is assumed to equal the number presented in the Pre-Manufacture 

Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances (EPA 

ICR No. 0574.13; OMB Control No. 2070-0012).

2 TSCA Inventory Correction Requests are covered under another ICR entitled, Correction of Misreported Chemical Substances on the Toxic Substances Control 

Act Chemical Substances Inventory (EPA ICR No. 1741.05; OMB Control No. 2070-0145) and are included in this analysis only to provide a full assessment of 

related program burdens. Such correction requests are typically submitted after EPA has processed an NOC and added the related chemical to the TSCA 

Inventory.
Table 13

Revised New Chemicals Program Respondent Recordkeeping Burden Under the e-PMN Rule, Year 3

Type of Notice

Average 

Annual 

Responses via 

non-CDX1

Average 

Annual 

Responses via 

CDX1

Current 

Average 

Recordkeeping 

Hours per 

non-CDX 

Response

Revised 

Average 

Recordkeeping 

Hours per 

CDX Response

Total 

Recordkeeping 

Hours for nonCDX

Total 

Recordkeeping 

Hours for 

CDX

Total 

Recordkeeping 

Hours for all 

Responses

PMN 0 720 2 1 0 720 720

SNUN 0 8 2 1 0 8 8

MCAN 0 3 2 1 0 3 3

Exemptions:

 TME 0 8 2 1 0 8 8

 LVE/LoREX 0 419 2 1 0 419 419

 TERA 0 2 2 1 0 2 2

 Tier I / II 0 3 2 1 0 3 3

 R&D 200 0 0.5 0.5 100 0 100

 Polymer 175 0 4 4 700 0 700

 Instant 

photographic 1 0 0.25 0.25 1 0 1

Bona Fide 116 0 2 2 232 0 232

5(e) Test 0 12 35 17.5 0 210 210

Non-Testing 

5(e) Burden 16 0 25 25 400 0 400

NOC 0 443 0.25 0.125 0 55 55

Correction 

Request 9 0 0.25 0.25 2 0 2

Total 517 1,618 1,435 1,428 2,863

1Average Annual Responses computed as the average of the number of notices filed annually from 2003 through 2007 based on OPPT, 2008, then adjusted by 

15% to reflect only valid submissions. The CDX responses and non-CDX responses are determined by the % of responses that will utilize CDX for a given year: 

33% for the first year, 67% for the second year, and 100% for the third year. For section 5 notices not subject to the e-PMN rule (R&D, Bona Fide, Non-Testing 

5(e), Instant Photographic and Correction Requests), the average annual number of responses is assumed to equal the number presented in Pre-Manufacture 

Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances (EPA 

ICR No. 0574.13; OMB Control No. 2070-0012).

2 TSCA Inventory Correction Requests are covered under another ICR entitled, Correction of Misreported Chemical Substances on the Toxic Substances Control 

Act Chemical Substances Inventory (EPA ICR No. 1741.05; OMB Control No. 2070-0145) and are included in this analysis only to provide a full assessment of 

related program burdens. Such correction requests are typically submitted after EPA has processed an NOC and added the related chemical to the TSCA 

Inventory.
2.4 Summary Burden Impact of Rule-Related Program Changes

The overall impact of the rule-related program changes is a net reduction of annual 

burden hours.

Table 14

Total New Chemicals Burden Program Changes (Years 1 through 3)

Company-level Reporting Burden Program Changes – Subtotal 353

Form-level Reporting Burden Program Changes – Subtotal -14,844

Recordkeeping Burden Program Changes – Subtotal -947

Total Burden Program Changes -15,438

2.5 Net Burden Decrease - New Chemicals Program

EPA expects an average net burden decrease of 30,410 hours annually (14,634 hour net 

adjustment decrease and 15,438 hour net program change reduction) over the 148,803 total 

annual hours presently approved under EPA ICR No 0574.13 (OMB Control No. 2070-0012), 

based on the changes described in sections 2.1 through 2.3 of this appendix.

Table 15

New Chemicals Program Average Annual Burden Changes (Adjustments and Program Changes)

Form-level Reporting Burden Adjustments -14,289 hours

Form-level Reporting Burden Program Changes -14,844 hours

Company-level Reporting Burden Program Changes +353 hours

Recordkeeping Burden Adjustments -345 hours

Recordkeeping Burden Program Changes -947 hours

Total Burden Changes -30,410 hours

3.0 Impacts of e-PMN Final Rule on Existing Chemicals Program Burdens (OMB 

Control No. 2070-0038)

3.1 Adjustments to the Baseline Reporting and Recordkeeping Estimates for 

Existing Chemical SNUNs

The baseline reporting and recordkeeping burden for the currently approved ICR entitled

TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals (EPA ICR No. 1188.09; 

OMB Control No. 2070-0038) is 1,423 annual hours. Of the 1,423 annual burden hours 

approved under that ICR, EPA estimated that the annual reporting and recordkeeping burden 

related to the submission of existing chemical SNUNs is 1,189 hours (about 1,132 reporting 

hours and 57 recordkeeping hours).

In calculating the SNUN-related burden subtotal for that ICR, EPA estimated that the 

SNUN-related reporting burden ranges between 94.25 and 113.25 hours per response, as shown 

in Table 16. In keeping with the conservative assumptions already employed, EPA used the high 

end of the range of reporting burden hours (i.e., 113.25 hours) in subsequent cost and overall 
annual burden hour calculations. EPA then assumed that SNUN-related recordkeeping requires 

about 5 percent of the time spent on reporting, or 5.67 hours per SNUN.

Respondents submitting a SNUN, whether for a new or an existing chemical, use the 

same form to submit the information to EPA. As estimated in the currently approved ICR 

entitled Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical 

Substances and Significant New Use Reporting Requirements for Chemical Substances (EPA 

ICR No. 0574.13; OMB Control No. 2070-0012), and as analyzed throughout section 2 of this 

appendix and in the economic analysis for the final rule, the reporting burden for a new chemical 

SNUN is 105 hours and the recordkeeping burden for a new chemical SNUN is 2 hours. The 

estimated 105 hours for a new chemical SNUN submission is the approximate mid-point 

estimate of the range presented in Table 16. The estimated 2 hours for each SNUN 

recordkeeping reflects is an aggregate annualized recordkeeping burden is an assumption based 

on the recordkeeping burden associated with essential technical requirements, such as records 

that demonstrate that the first commercial batch of chemical manufactured for commercial 

purposes under the exemption met certain eligibility criteria.

EPA is adjusting the estimated reporting and recordkeeping burden for an existing 

chemical SNUN from 113.25 hours to 105 hours and 5.67 hours to 2 hours, respectively, to 

ensure consistency with SNUN-related estimates presented in EPA ICR No. 0574.13 and in the 

economic analysis for the final rule.

3.1.1 Impact of Adjusted Baseline Reporting and Recordkeeping Estimates

As explained in section 3.1 of this appendix, to make this analysis consistent with that 

presented in EPA ICR No. 0574.13 for SNUN submission and recordkeeping, the baseline 

reporting burden for submitting an existing chemical SNUN is adjusted to the estimated midpoint of 105 hours, rather than the upper-bound estimate of 113.25 hours of reporting burden 

presented in EPA ICR No. 1188.09. This reporting burden adjustment results in a decrease of 82 

annual hours. The recordkeeping burden for SNUN submission activities is also adjusted, from 

5.67 hours per response to 2 hours per response. This recordkeeping adjustment results in a 

decrease of 37 annual hours. Thus, these baseline adjustments result in a burden decrease of 119 

annual hours, from 1,189 annual hours to 1,070 annual hours (1,050 reporting hours and 20 

recordkeeping hours.
Table 16

Current Unit Reporting Burden Estimates Associated 

With Filing an Existing Chemical SNUN, By Labor Category

Activity

Secretarial 

Hours

Technical 

Hours

Managerial 

Hours

Total Hours

General information/ instructions 2 - 2.5 1.5 - 2 3 - 4 6.5 - 8.5

Chemical identity 1.5 - 2 3 - 6 1 5.5 – 9

Trade name ID .25 .25

Byproducts/impurities 

identification 1 1

Production & marketing

data 1.5 2 - 3 3.5 - 4.5

Production volume 1 1

Category of use 3 3

Hazard information 3 - 4 3 – 4

Human exposure and 

environmental release 2.5 - 3.5 6 - 7 8.5-10.5

Site information 14 - 16 14 – 16

Occupational exposure 13 - 14 13 – 14

Environmental release/ disposal

9 - 10 9 – 10

Sites controlled by others 2 10 - 12 2 - 2.5 14 - 16.5

List of attachments 2 6 - 8 1 - 1.5 9 - 11.5

Certification .5 .5

Data submissions .5 1.5 - 2 .5 2.5 – 3

Totals 12 - 14

66.25 -

79.25 16 - 20

94.25 -

113.25

Source: EPA, 1994.
Table 17

Existing Chemicals Baseline Reporting and Recordkeeping Burden Adjustments

Existing Chemical SNUN 

Response Activity

Number of 

SNUNs/Year

Current Baseline Adjusted Baseline Change per SNUN Total Change

Hours/SNUN Hours/SNUN Hours/SNUN Hours/Year

Reporting 10 113.25 105 -8.25 -82

Recordkeeping 10 5.67 2 -3.67 -37

Total 10 118.92 107 -11.92 -119

3.2 Reporting Burden Program Changes

Upon implementation of the final rule, the average annual existing chemicals reporting 

burden is estimated to be approximately 934 hours. As discussed in section 1 of this appendix, 

respondents will incur new, company-level reporting burdens while realizing form-level 

reporting burden savings. Company-level reporting burden includes those activities that 

facilitate submission of an e-PMN: CDX registration, CDX electronic signature (i.e., 

authentication of identity and verification of authorization), setting up a Pay.gov account, and 

rule familiarization. Form-level reporting burden includes completion and submission of 

Existing Chemical SNUNs.

EPA projects that one-third of first year submissions and two-thirds 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 assumes an even rate of adoption over the two-year phase-in period.

3.2.1 New Company-Level Reporting Burdens

EPA estimates that the e-PMN rule will impose an average program change increase of 

12 annual burden hours on respondents and is associated with the time required to complete 

company-level paperwork activities related to the final e-PMN rule requirements, i.e., CDX 

Registration, CDX electronic signature, E-Payment (Pay.gov ID)2, and Rule Familiarization. 

These activities and related burdens are explained in full in the supporting statement for EPA 

ICR No. 2327.07 (OMB Control No. 2070-0173). The activities are also included in the burden 

analysis presented in Tables 18 through 20. As indicated in Table 18 company-level burdens are 

higher in the first year due to initial rule familiarization burdens that not incurred in subsequent 

years.

3.2.2 Reductions in Form-Level Reporting Burden for Existing Chemical 

SNUN Submissions

In addition to the baseline adjustments described in section 3.1 of this appendix,

respondent adoption of electronic preparation and submission under the e-PMN rule will further 

 

2 Use of Pay.gov to remit the SNUN submission fee is not be mandatory under the final e-PMN rule, but EPA 

assumes conservatively in the Economic Analysis for the final e-PMN rule that SNUN submitters will send the fee 

via a Pay.gov account.
affect the reporting burden estimates for existing chemical SNUNs. The adoption of electronic 

preparation and submission through CDX using the e-PMN software to prepare and submit 

existing chemical SNUNs will bring about burden savings by creating administrative efficiencies 

and time savings. Specifically, EPA estimates that the reporting burden will be reduced from 

105 hours per submission to 92.2 hours per submission, saving 12.8 hours per response. The net 

impacts of these changes, coupled with the new rule related burdens described in section 3.2.1 of 

this appendix, are demonstrated in Tables 18 through 20. 

Because the final e-PMN rule phases-in the use of CDX over the three-year period, the 

number of companies and forms using CDX will vary across the phase-in period. Therefore, 

burden hours are presented separately for each year of the phase-in period. Prior to the e-PMN

rule, only form-level burden was estimated for existing chemical SNUNs. Due to new activities 

that will occur at the company-level once electronic reporting via CDX is available, burden is 

broken out at the company and form level in the rule-related ICR. EPA is assuming an even rate 

of adoption over the two-year phase-in period. For existing chemical SNUNs, this means that 

EPA is assuming that companies will incur the burden associated with CDX registration, 

completing the Electronic Signature Agreements, and setting up a Pay.gov account to submit the 

TSCA fee, at the rate of 3.3 (10/3) additional companies in each of year of the ICR’s approval. 

At that point, all SNUN submissions will be made via CDX.

Tables 18, 19 and 20 present the respondent reporting burden associated with this 

information collection during the first 3 years of rule implementation. The form-level during 

each of these years is estimated to total 922 hours. This burden estimate is calculated by 

multiplying the hours of reporting burden by the number of existing chemical SNUNs that EPA 

expects to receive. Note that burden is adjusted to reflect the savings associated with the e-PMN

rule in each year of the phase-in period, and also reflects adjustments to the existing chemical 

SNUN baseline reporting burden for consistency purposes. Because all existing chemical 

SNUNs must be generated using the new e-PMN software beginning in the first year following 

rule promulgation, however, form completion burden saving will be realized by all submitters 

immediately. After accounting for the baseline adjustments described in section 3.1.1 of this 

appendix, the estimated 922 annual hours of form-level reporting burden reflects a 128 hour 

program change reduction.
Table 18

Revised Existing Chemical SNUN Reporting Burden Under the e-PMN Rule, Year 1

Type of Notice

Avg. Annual 

Additional 

Companies/Responses1

Current Average 

Reporting Hours 

per 

Company/Response

Revised Average 

Reporting Hours 

per 

Company/Response

Revised Total 

Reporting 

Hours

COMPANY BURDEN

CDX Registration 3.3 0 0.9 2.97

CDX Electronic Signature 3.3 0 1.8 5.94

E-Payment (Pay.gov ID) 3.3 0 0.1 0.33

Rule Familiarization 10 0 0.8 8

Total (Company) 17.2

FORM BURDEN

SNUN 10 105 92.2 922

Total (Combined Company and 

Form) 939

1 The CDX responses and non-CDX responses are determined by the number of additional companies/responses that will 

utilize CDX for a given year: About one-third of the companies each year- (10/3) ~ 3.3 companies.

Table 19

Revised Existing Chemical SNUN Reporting Burden Under the e-PMN Rule, Year 2

Type of Notice

Avg. Annual 

Additional 

Companies/Responses1

Current Average 

Reporting Hours 

per 

Company/Response

Revised Average 

Reporting Hours 

per 

Company/Response

Revised Total 

Reporting 

Hours

COMPANY BURDEN

CDX Registration 3.3 0 0.9 2.97

CDX Electronic Signature 3.3 0 1.8 5.94

E-Payment (Pay.gov ID) 3.3 0 0.1 0.33

Rule Familiarization 0 0 0.8 0.0

Total (Company) 9.2

FORM BURDEN

SNUN 10 105 92.2 922

Total (Combined Company and 

Form) 931.2

1 The CDX responses and non-CDX responses are determined by the number of additional companies/responses that will 

utilize CDX for a given year: About one-third of the companies each year- (10/3) ~ 3.3 companies.
Table 20

Revised Existing Chemical SNUN Reporting Burden Under the e-PMN Rule, Year 3

Type of Notice

Avg. Annual 

Additional 

Companies/Responses1

Current Average 

Reporting Hours 

per 

Company/Response

Revised Average 

Reporting Hours 

per 

Company/Response

Revised Total 

Reporting 

Hours

COMPANY BURDEN

CDX Registration 3.3 0 0.9 2.97

CDX Electronic Signature 3.3 0 1.8 5.94

E-Payment (Pay.gov ID) 3.3 0 0.1 0.33

Rule Familiarization 0 0 0.8 0.0

Total (Company) 9.2

FORM BURDEN

SNUN 10 105 92.2 922

Total (Combined Company and 

Form) 931.2

1 The CDX responses and non-CDX responses are determined by the number of additional companies/responses that will 

utilize CDX for a given year: About one-third of the companies each year- (10/3) ~ 3.3 companies.

3.3 Existing Chemicals Recordkeeping Burden Program Changes

Respondents will not incur any company-level recordkeeping burdens. Rather, they will 

realize form-level recordkeeping burden savings related to electronically submitted existing 

chemical SNUNs. Upon the rule’s effective date, all respondents will be required to use the ePMN software to prepare their submissions and therefore will realize immediate reporting 

burden savings. However, not all respondents will realize immediate recordkeeping burden 

savings. As described in section 1.1.2 of this appendix, recordkeeping and postage savings will 

be realized in years when electronic reporting via CDX is used. Reductions in recordkeeping 

burden are contingent upon adoption of electronic submission via CDX. Once a respondent 

electronically submits an existing chemical SNUN, the burden for maintaining or updating 

related records is minimal. EPA expects that 33 percent of respondents to submit existing 

chemical SNUNs electronically via CDX in the first year, 67 percent will do so by the second 

year, and 100 percent will do so by the third year (when all respondents are required to submit 

electronically).

As discussed in section 3.1.1 of this appendix, the existing chemicals SNUN-related 

recordkeeping burden was adjusted from 5.67 hours per SNUN to 2 hours per SNUN ensure 

consistency with burden estimates for new chemical SNUNs. EPA expects that respondents 

submitting existing chemical SNUNs will experience the same reporting and recordkeeping 

burden savings as respondents submitting new chemical SNUNs (i.e., one technical and one 

clerical staff member are estimated to each save 30 minutes on recordkeeping, for a total 

recordkeeping burden of one hour, as CDX is adopted). EPA therefore assumes that 

recordkeeping burden will be reduced by half (from 2 hours to 1 hour) due to the efficiencies in 

creating and storing SNUNs and supporting documents electronically. 
Table 21 shows that in the first year of the ICR approval period, when EPA assumes 

three companies will submit SNUNs via CDX, the total recordkeeping burden is estimated to be 

17 hours. By year three, when all 10 existing chemical SNUNs expected each year will be 

submitted via CDX, the total record keeping drops to 10 hours. The total three-year 

recordkeeping burden is estimated to be 40 hours, or an annual average of slightly more than 13 

hours. 

Table 21

Revised Respondent Recordkeeping Burden For Existing Chemical SNUNs Under the e-PMN Rule, Years 1 through 3

Year

Average 

Annual 

Responses 

via nonCDX

Average 

Annual 

Responses 

via CDX

Current 

Average 

Recordkeeping 

Hours per 

non-CDX 

Response

Revised 

Average 

Recordkeeping 

Hours per 

CDX Response

Total 

Recordkeeping 

Hours for nonCDX

Total 

Recordkeeping 

Hours for 

CDX

Total 

Recordkeeping 

Hours for all 

Responses

Year 1 6.7 3.3 2 1 13.3 3.3 16.7

Year 2 3.3 6.7 2 1 6.7 6.7 13.3

Year 3 0 10 2 1 0 10 10

TOTAL 40.0

Thus, the average annual SNUN-related recordkeeping burden over the first 3 years of 

the rule is approximately 13 hours (and 10 hours annually each year thereafter).

3.4 Summary Burden Impact of Rule-Related Program Changes

The overall impact of the rule-related program changes is a net reduction of annual 

burden hours.

Table 22

Average Annual Existing Chemicals Burden Program Changes (Years 1 through 3)

Company-level Reporting Burden Program Changes – Subtotal 12

Form-level Reporting Burden Program Changes – Subtotal -128

Recordkeeping Burden Program Changes – Subtotal -13

Total Burden Program Changes -129

3.5 Net Burden Decrease - Existing Chemicals Program

EPA expects an average net burden decrease of 248 hours annually (119 hour adjustment 

decrease and 129 hour net program change reduction) over the 1,423 total annual hours presently 

approved under EPA ICR No 1188.09 (OMB Control No. 2070-0038), based on the changes 

described in sections 3.2 through 3.3.

Table 23

Existing Chemicals Program Average Annual Burden Changes (Adjustments and Program Changes)

Form-level Reporting Burden Adjustments -82 hours

Form-level Reporting Burden Program Changes -128 hours

Company-level Reporting Burden Program Changes +12 hours

Recordkeeping Burden Adjustments -37 hours

Recordkeeping Burden Program Changes -13 hours

Total Burden Changes -248 hours
4.0 Summary of Net Changes to Annual Paperwork Burden Estimates

4.1 Adjustments

Adjustments to baseline estimates for both of the ICRs addressed in this appendix are 

responsible for notable changes in EPA’s overall annual burden estimates. The baseline 

adjustments to EPA ICR Nos. 0574.13 and 1188.09 are responsible for a combined reduction of 

14,753 burden hours. This section of this appendix summarizes those adjustments.

4.1.1 Fewer New Chemicals Responses

EPA estimated the annual number of new chemicals-related submissions over a 5-year 

average and the adjusted that annual average by 15 percent to count only valid submissions. In 

previous ICR renewals, EPA would have based its projection, in part, on the average number of 

annual responses submitted in the previous 3 years. This change led EPA to estimate that 203

fewer net responses would be submitted annually across all types of activities covered under this 

ICR. The result of this change is an estimated net decrease of 14,634 reporting and 

recordkeeping hours. This adjustment is addressed in section 2.1 of this appendix.

4.1.2 Harmonized SNUN Reporting and Recordkeeping Burden Estimates

Respondents submitting a SNUN, whether for a new or an existing chemical, use the 

same form to submit the information to EPA. However, EPA had utilized different points in the 

same estimated burden range when developing separate reporting burden associated with SNUNs 

for ICR Nos. 0574.13 and 1188.09. The reporting burden estimate presented in ICR No. 0574.13

reflected the approximate mid-point of the estimated burden range (105 hours), while the 

reporting burden estimate presented in ICR No. 1188.09 reflected the high-end of the same 

estimated burden range (about 113 hours). To ensure consistent analysis, EPA harmonized the 

SNUN reporting burden estimates for both new and existing chemical SNUNs by utilizing the 

mid-point of the range (105 hours). The application of this harmonized estimate to EPA ICR No. 

1188.09 results in an adjustment decrease of about 82 annual reporting burden hours.

Similarly, EPA had utilized different SNUN-related recordkeeping estimates when 

developing the annual burden estimates for ICR Nos. 0574.13 and 1188.09 (2 hours and 5.67 

hours, respectively, per SNUN). Again, to ensure consistent analysis, EPA harmonized the 

SNUN-related recordkeeping burden estimates for both new and existing chemical SNUNs by

adopting the SNUN-related recordkeeping estimate of 2 hours per SNUN as presented in ICR 

No. 0574.13. As explained in sections 2.3.1 and 3.1 of this appendix, the estimated 2 hours for 

each SNUN recordkeeping reflects an aggregate annualized recordkeeping burden and is an 

assumption based on the recordkeeping burden associated with essential technical requirements, 

such as records that demonstrate that the first commercial batch of chemical manufactured for 

commercial purposes under the exemption met certain eligibility criteria. The application of this 

harmonized estimate to EPA ICR No. 1188.09 results in an additional adjustment decrease of 

about 37 annual recordkeeping burden hours.
4.2. Program Changes

The net impact of the e-PMN rule is an estimated 15,567 hour administrative-level 

program change burden reduction on TSCA section 5 respondents. This section of this appendix 

summarizes those program changes.

4.2.1 Modest Rule Implementation Burden

EPA estimates that the e-PMN rule will impose an average program change increase of 

365 annual burden hours on both new and existing chemical respondents submitting TSCA 

section 5 notices (353 hours + 12 hours, respectively). This estimate reflects modest start-up 

burden associated with CDX registration, obtaining a CDX electronic signature, optional EPayment (establishing a Pay.gov ID), and Rule Familiarization. Each of these activities will 

facilitate electronic preparation and submission of TSCA section 5 notices to EPA, which in turn 

will bring about burden reduction for respondents. Company-level rule-implementation burdens 

are higher in the first year due to initial rule familiarization burdens which are not incurred in 

subsequent years.

4.2.2 Resulting Burden Reduction

The 365 annual burden hours of new, company-level burden is offset by a program 

change reduction of 14,972 annual form-level reporting burden hours on both new and existing 

chemical respondents submitting TSCA section 5 notices (14,844 hours + 128 hours, 

respectively). These form-level burden reductions will be realized immediately because the 

reductions are attributed primarily to the electronic preparation of TSCA section 5 notices. In 

addition, new and existing chemical respondents will realize a program change reduction of an 

average 960 annual burden hours (947 hours + 13 hours, respectively) over the first 3 years.

4.3 Net Changes

EPA projects that the combined burden adjustments and program changes result in a net 

burden reduction of 30,320 annual hours. Adjustments combine for a net decrease of 14,753

annual burden hours for both new and existing chemical respondents. Program changes combine 

for a net decrease of 15,567 annual burden for both and existing chemical respondents.