Document ID: EPA-HQ-OPPT-2008-0296-0011
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-01-06T05:00Z

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

TABLE OF CONTENTS

  TOC \o "1-3" \h \z \u    HYPERLINK \l "_Toc248572583"  1.0
Introduction	  PAGEREF _Toc248572583 \h  1  

  HYPERLINK \l "_Toc248572584"  1.1	Terminology	  PAGEREF _Toc248572584
\h  1  

  HYPERLINK \l "_Toc248572585"  1.1.1	Company-level Burden	  PAGEREF
_Toc248572585 \h  1  

  HYPERLINK \l "_Toc248572586"  1.1.2	Form-level Burden	  PAGEREF
_Toc248572586 \h  1  

  HYPERLINK \l "_Toc248572587"  1.2	Assumptions	  PAGEREF _Toc248572587
\h  2  

  HYPERLINK \l "_Toc248572588"  1.2.1	Respondents	  PAGEREF
_Toc248572588 \h  2  

  HYPERLINK \l "_Toc248572589"  1.2.2	Number and Types of TSCA Section 5
Notices Submitted Under New Chemicals Program	  PAGEREF _Toc248572589 \h
 2  

  HYPERLINK \l "_Toc248572590"  1.2.3	Number and Types of Significant
New Use Notices Submitted Under Existing Chemicals Program	  PAGEREF
_Toc248572590 \h  3  

  HYPERLINK \l "_Toc248572591"  2.0	Impacts of e-PMN Final Rule on New
Chemicals Program Burdens (OMB Control No. 2070-0012)	  PAGEREF
_Toc248572591 \h  4  

  HYPERLINK \l "_Toc248572592"  2.1	Adjustments to the Baseline Number
of Responses	  PAGEREF _Toc248572592 \h  4  

  HYPERLINK \l "_Toc248572593"  2.1.1	Impact of Adjusted Baseline Number
of Responses on Reporting Burden	  PAGEREF _Toc248572593 \h  4  

  HYPERLINK \l "_Toc248572594"  2.1.2	Impact of Adjusted Baseline Number
of Responses on Recordkeeping Burden		  PAGEREF _Toc248572594 \h  4  

  HYPERLINK \l "_Toc248572595"  2.1.3	Summary Burden Impact of Baseline
Response Adjustments	  PAGEREF _Toc248572595 \h  5  

  HYPERLINK \l "_Toc248572596"  2.2	Reporting Burden Program Changes	 
PAGEREF _Toc248572596 \h  6  

  HYPERLINK \l "_Toc248572597"  2.2.1	New Company-Level Reporting
Burdens	  PAGEREF _Toc248572597 \h  6  

  HYPERLINK \l "_Toc248572598"  2.2.2	Reductions in Form-Level Reporting
Burden for New Chemicals Submissions	  PAGEREF _Toc248572598 \h  6  

  HYPERLINK \l "_Toc248572599"  2.3	New Chemicals Recordkeeping Burden
Program Changes	  PAGEREF _Toc248572599 \h  10  

  HYPERLINK \l "_Toc248572600"  2.3.1	Reductions in Form-Level
Recordkeeping Burden for New Chemicals Submissions	  PAGEREF
_Toc248572600 \h  11  

  HYPERLINK \l "_Toc248572601"  2.4	Summary Burden Impact of
Rule-Related Program Changes	  PAGEREF _Toc248572601 \h  16  

  HYPERLINK \l "_Toc248572602"  2.5	Net Burden Decrease - New Chemicals
Program	  PAGEREF _Toc248572602 \h  16  

  HYPERLINK \l "_Toc248572603"  3.0	Impacts of e-PMN Final Rule on
Existing Chemicals Program Burdens (OMB Control No. 2070-0038)	  PAGEREF
_Toc248572603 \h  16  

  HYPERLINK \l "_Toc248572604"  3.1	Adjustments to the Baseline
Reporting and Recordkeeping Estimates for Existing Chemical SNUNs	 
PAGEREF _Toc248572604 \h  16  

  HYPERLINK \l "_Toc248572605"  3.1.1	Impact of Adjusted Baseline
Reporting and Recordkeeping Estimates	  PAGEREF _Toc248572605 \h  17  

  HYPERLINK \l "_Toc248572606"  3.2	Reporting Burden Program Changes	 
PAGEREF _Toc248572606 \h  19  

  HYPERLINK \l "_Toc248572607"  3.2.1	New Company-Level Reporting
Burdens	  PAGEREF _Toc248572607 \h  19  

  HYPERLINK \l "_Toc248572608"  3.2.2	Reductions in Form-Level Reporting
Burden for Existing Chemical SNUN Submissions	  PAGEREF _Toc248572608 \h
 19  

  HYPERLINK \l "_Toc248572609"  3.3	Existing Chemicals Recordkeeping
Burden Program Changes	  PAGEREF _Toc248572609 \h  22  

  HYPERLINK \l "_Toc248572610"  3.4	Summary Burden Impact of
Rule-Related Program Changes	  PAGEREF _Toc248572610 \h  23  

  HYPERLINK \l "_Toc248572611"  3.5	Net Burden Decrease - Existing
Chemicals Program	  PAGEREF _Toc248572611 \h  23  

  HYPERLINK \l "_Toc248572612"  4.0	Summary of Net Changes to Annual
Paperwork Burden Estimates	  PAGEREF _Toc248572612 \h  24  

  HYPERLINK \l "_Toc248572613"  4.1	Adjustments	  PAGEREF _Toc248572613
\h  24  

  HYPERLINK \l "_Toc248572614"  4.1.1	Fewer New Chemicals Responses	 
PAGEREF _Toc248572614 \h  24  

  HYPERLINK \l "_Toc248572615"  4.1.2	Harmonized SNUN Reporting and
Recordkeeping Burden Estimates	  PAGEREF _Toc248572615 \h  24  

  HYPERLINK \l "_Toc248572616"  4.2.	Program Changes	  PAGEREF
_Toc248572616 \h  25  

  HYPERLINK \l "_Toc248572617"  4.2.1	Modest Rule Implementation Burden	
 PAGEREF _Toc248572617 \h  25  

  HYPERLINK \l "_Toc248572618"  4.2.2	Resulting Burden Reduction	 
PAGEREF _Toc248572618 \h  25  

  HYPERLINK \l "_Toc248572619"  4.3	Net Changes	  PAGEREF _Toc248572619
\h  25  

 1.0	Introduction  TC "1.0	Introduction" \f C \l "1"  

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  TC "1.1	Terminology" \f C \l "2"  

1.1.1	Company-level Burden  TC "1.1.1	Company-level Burden" \f C \l "3" 

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  TC "1.1.2	Form-level Burden" \f C \l "3"  

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  TC "1.2	Assumptions" \f C \l "2"  

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  TC "1.2.2	Number and Types of TSCA Section 5 Notices
Submitted Under New Chemicals Program" \f C \l "3"  

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  TC "1.2.3	Number and Types of Significant
New Use Notices Submitted Under Existing Chemicals Program" \f C \l "3" 

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)  TC "2.0	Impacts of e-PMN Final Rule on New
Chemicals Program Burdens (OMB Control No. 2070-0012)" \f C \l "1"   
TOC \o "1-3" \u  

 

2.1	Adjustments to the Baseline Number of Responses  TC "2.1	Adjustments
to the Baseline Number of Responses" \f C \l "2"  

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  TC "2.1.1	Impact of Adjusted Baseline Number of Responses on
Reporting Burden" \f C \l "3"  

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  TC "2.1.2	Impact of Adjusted Baseline Number of Responses on
Recordkeeping Burden" \f C \l "3"  

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	  =SUM(ABOVE)  -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	  =SUM(ABOVE)  -345

2.1.3	Summary Burden Impact of Baseline Response Adjustments  TC "2.1.3
Summary Burden Impact of Baseline Response Adjustments" \f C \l "3"  

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	  =SUM(ABOVE) 
-14,289 

Baseline Recordkeeping Burden Adjustments - Subtotal	  =SUM(ABOVE)  -345

Total Baseline Burden Adjustments	  =SUM(ABOVE)  -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 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 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 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). 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 notice.  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 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)	   =SUM(ABOVE)  589 	 

  =SUM(ABOVE)  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 Request2	9	2	2	18

Total (Form)	  =SUM(ABOVE)  2,135 	 	 	  =SUM(ABOVE)  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) Non-Testing,
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)	   =SUM(ABOVE)  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)	  =SUM(ABOVE)  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) Non-Testing,
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)	   =SUM(ABOVE)  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)	  =SUM(ABOVE)  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) Non-Testing,
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

SNUN1	2.00	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).

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 non-CDX	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	  =SUM(ABOVE)  1,594 	  =SUM(ABOVE)  541 

	  =SUM(ABOVE)  3,337 	477	  =SUM(ABOVE)  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 non-CDX	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	  =SUM(ABOVE)  1,058 	  =SUM(ABOVE)  1,077 

	  =SUM(ABOVE)  2,390 	  =SUM(ABOVE)  951 	  =SUM(ABOVE)  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 non-CDX	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	  =SUM(ABOVE)  517 	  =SUM(ABOVE)  1,618 

	  =SUM(ABOVE)  1,435 	1,428	  =SUM(ABOVE)  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	  =SUM(ABOVE)  -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	  =SUM(ABOVE)     =SUM(ABOVE)  -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
mid-point 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	  =SUM(ABOVE)  118.92 	  =SUM(ABOVE)  107 	  =SUM(ABOVE) 
-11.92 	  =SUM(ABOVE)  -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), 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 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
e-PMN 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 non-CDX 	Average Annual Responses via
CDX 	Current Average Recordkeeping Hours per non-CDX Response	Revised
Average Recordkeeping Hours per CDX Response	Total Recordkeeping Hours
for non-CDX	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	  =SUM(ABOVE)  -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	  =SUM(ABOVE)     =SUM(ABOVE)  -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
E-Payment (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.

 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.

 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.

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