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Request for a Non-Substantive Change 

to an Existing Approved Information Collection

I. Introduction

What Information Collection Request (ICR) is EPA changing?

ICR Title: Premanufacture Review Reporting and Exemption Requirements for 

New Chemical Substances and Significant New Use Reporting 

Requirements for Chemical Substances

ICR Numbers: EPA ICR No. 0574.15; OMB Control No. 2070-0012

What is the Current Status of this ICR?

This ICR is currently approved through 12/31/2015. The ICR currently identifies the information 

collections (ICs), responses per IC and burden subtotal per IC shown in Table 1. The total annual burden 

approved for this ICR is 117,162 hours, with an estimated 2,126 responses per year.

Table 1. Currently Approved ICs under EPA ICR No. 0574.15

Title

Average 

Reporting Hours 

per Response

Hours for 

Recordkeeping Responses Total Time (Hours)

PMN 92.2 1 720 67,104

SNUN 92.2 1 8 746

MCAN 288.2 1 3 868

TME 86.2 1 8 698

LVE/LoREX 92.2 1 419 39,051

TERA 507.2 1 2 1,016

Tier I and II 110.2 1 3 334

Polymer 2 4 175 1,050

Research and Development 2.5 0.5 200 600

Instant Photographic Film Articles 0.5 0.25 1 1

Bona Fide 20 2 116 2,552

5(e) Test 151 17.5 12 2,022

Non-Testing 5(e) Burden 25 25 16 800

NOC 0.6 0.125 443 321

TOTAL 2,126 117,162

Why is EPA Requesting a Non-Substantive Change?

EPA is taking direct final action to amend the Toxic Substance Control Act (TSCA) section 5 electronic 

reporting regulations at 40 CFR Parts 700, 720, 721, 723 and 725. These electronic reporting regulations 

establish standards and requirements for use of EPA’s Central Data Exchange (CDX) to electronically

submit premanufacture notices (PMNs), other TSCA section 5 notices, and support documents to the 

Agency. The direct final action provides the user community with new methods for accessing the ePMN software, new procedures for completing the e-PMN form, changes to the CDX registration 
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process, and adds the requirement to submit “bona fide intents to manufacture” electronically. The

action is intended to further streamline and reduce the administrative costs and burdens of TSCA section 

5 notifications for both industry and EPA.

EPA is requiring electronic reporting for those submitting Notices of Bona Fide Intent to Manufacture or 

Import (bona fides) in the existing, approved ICR (EPA ICR No. 0574.15; OMB Control No. 2070-

0012). This request for a non-substantive change identifies changes to the existing, approved ICR related 

to EPA’s implementation of an electronic reporting option under the Government Paperwork 

Elimination Act for TSCA section 5. The changes include the form and format of the collection, 

identification of new paperwork activities (i.e., information collections, or ICs), as well as baseline 

adjustments and analysis of program changes related to the electronic reporting option.

II. Overview

EPA is amending the reporting procedures for the submission of Premanufacture Notices (PMNs) and 

other TSCA section 5 notices and support documents to the Agency by mandating the use of an updated 

version of the e-PMN reporting software, the “Thin Client Version” (i.e., a cloud-based software 

system). EPA is also requiring electronic reporting for those submitting a bona fide notice under TSCA 

section 5. Submitters must register and submit information electronically using the Agency’s Central 

Data Exchange (CDX).

EPA receives bona fide notice submissions under TSCA section 5

Under TSCA section 5 (15.U.S.C. 2604), any person who manufacturers or imports new chemical 

substances must submit to the Administrator of EPA a premanufacture notice (PMN) of intent to 

manufacture or import a new chemical substance at least 90 days before manufacture or import begins. 

Pursuant to 40 CFR 720.25, a person intending to manufacture or import a chemical substance not 

publicly listed on the TSCA Inventory of existing chemicals may submit a Bona Fide Intent to 

Manufacture or Import Notice to determine whether the substance is listed in the confidential inventory. 

Does this change require a rulemaking?

Yes. EPA is issuing a direct final rule to amend the premanufacture notification regulations to mandate 

the use of an updated version of the e-PMN reporting software, as well as require the use of electronic 

reporting of TSCA section 5 Notices of Bona Fide Intent to Manufacture or Import (bona fides).

III. Description of Non-Substantive Changes

What are the changes that EPA is making to this ICR?

EPA is making two distinct changes that affect the burden reported in the ICR. First, EPA is adjusting 

the baseline burden associated with this ICR by adding an IC to cover CDX registration activities for 

new TSCA section 5 submitters. Secondly, EPA is effectuating program change burden reductions 

related to the clerical level efficiencies resulting from electronic submission of bona fide notices.

In addition, EPA is moving from a Thick Client software system to a “cloud–based,” or Thin Client

software system. While EPA expects that this change in the software system will reduce the burden to 

all submitters of TSCA section 5 notices, this burden reduction is expected to be minimal and has not 

been quantified for this ICR change request. 
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A. Baseline Adjustments to Existing ICs

Changes to the Total Burden for CDX Registration Activities 

As part of EPA’s electronic reporting requirements, submitters of TSCA section 5 Notices are required 

to register and submit information electronically with EPA’s Central Data Exchange (CDX) system. 

EPA estimates that companies submitting section 5 Notices for the first time would incur a one-time 

burden to complete CDX registration activities, obtain a CDX electronic signature, and set up a Pay.gov 

ID account. The total burden associated with CDX registration is approximately 2.80 hours per 

company. EPA assumes each company will register five employees, resulting in a per-employee burden 

of 0.66 hours. This per-employee burden includes 0.18 hours for CDX registration, 0.35 hours for 

submitting and then verifying electronic signature agreements, and 0.13 hours for setting up a Pay.gov 

account. In fiscal year 2013, a total of 392 new registrants, 303 TSCA-Authorized Officials (AO) and 89

TSCA-Support Registrants (SR), were approved via CDX for all TSCA section 5 activities, resulting in 

a total annual burden of 258.72 hours (Table 2).

EPA estimates that about 10 percent of new CDX registrations will be a result of employee turnover, 

based on data provided in the Cross-Median Electronic Reporting Rule (CROMERR) ICR (EPA, 2011).

Therefore, approximately 30 new Authorized Officials and 9 new Support Registrants will replace 

previously registered CDX users each year. The burden associated with new CDX registration activities 

is the same regardless of whether the registrant is new or replacing an existing employee. As a result, 

burden is not estimated separately for each type of registration. 

Table 2. Baseline Adjustments Associated with New CDX Registration Activities

Title

CDX 

Registration 

Burden

(Hours)

CDX ESignature 

Burden 

(Hours)

EPayment 

(Pay.gov 

ID 

account)

(Hours)

Total Burden 

for CDX 

Registration 

Activities, 

(Hours)

Annual 

Number of 

New CDX 

Registrants

Total Annual 

Burden for 

CDX 

Registration

(Hours)

Currently 

Approved 0 0 0 0 0 0

Updated 

Estimate 0.18 0.35 0.13 0.66 392 258.72

Change 0.18 0.35 0.13 0.66 392 258.72

B. Rule Familiarization

The rule will require TSCA Section 5 submitters and their staff to become familiar with the 

requirements for electronic reporting. Rule familiarization is estimated to require 0.55 hours of technical 

labor and 0.27 hours of managerial labor, as described in the Economic Analysis of the Premanufacture 

Notification Electronic Reporting Final Rule (EPA, 2009a), which measures the costs of mandatory 

electronic reporting of TSCA section 5 notices.
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Table 3. Rule Familiarization Burden for TSCA Section 5 Submitters

Title

Rule 

Familiarization 

Burden

(Hours)

Annual 

Number of 

TSCA Section

5 Submitters

Total Annual 

Burden for 

Rule 

Familiarization 

Currently 

Approved 0 0 0

Updated 

Estimate 0.82 336 275.52

Change 0.82 336 275.52

C. Electronic Reporting Results in Program Change Burden Reductions

Electronic reporting is expected to reduce a respondent’s burden by five hours per bona fide, due to the 

reduction or elimination of clerical/administrative time, and a reduction in recordkeeping costs, both of 

which are associated with the new electronic reporting requirement. This program change is estimated to 

reduce the total annual burden associated with bona fide submissions by about 580 hours; from 2,552 

hours to 1,972 hours (see Table 4). 

Table 4. Program Changes to Existing ICs Resulting from Electronic Reporting of Bona Fides

Title Responses

Average 

Reporting 

Hours per 

Response

Total 

Burden for 

Reporting

Hours for 

Recordkeeping

Total Burden 

for 

Recordkeeping

Total Burden 

for Reporting 

and 

Recordkeeping

Currently 

Approved 116 20 2,320 2 232 2,552

Updated 

Estimate 116 16 1,856 1 116 1,972

Change 0 -4 -464 -1 -116 -580

D. e-PMN Reporting Software Update

In January 2010, EPA issued a final rule requiring the use of e-PMN reporting software for the 

submission of Premanufacture Notices (PMNs) and other TSCA section 5 notices and support 

documents to the Agency using the Internet through EPA’s Central Data Exchange (CDX). A new 

version of the e-PMN software will operate as a “cloud,” or Thin Client, software system rather than as a 

downloadable, or Thick Client, software system. EPA expects that both the Agency and TSCA section 5

submitters will experience burden reductions as a result of the software update. The Thin Client Version 

will eliminate certain firewall and file submission size limitations, as well as reduce the potential for 

invalid submissions through built-in validation procedures. The Thin Client Version will also allow 

users to work offline using an Extensible Markup Language (XML) schema, which, in turn, allows them 

to later upload their information to the Thin Client Version and will make information readily accessible 

to registrants of the submitting company and their designated support persons. While EPA expects that 

this change will reduce the burden to all submitters of any TSCA section 5 notice, this burden reduction 

is expected to be minimal and has not been quantified for this ICR change request.

IV. Bottom Line Burden Changes

EPA expects a net burden decrease of 46 hours per year, from 117,162 hours annually to 117,116 hours,

as a result of both adjustment and program changes to the TSCA section 5 Premanufacture and 

Significant New Use Notification regulations. The burden is expected to decrease by 304 hours as result 

of program changes requiring the electronic submission of bona fide notices and rule familiarization 
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associated with the new electronic reporting requirements. The burden is expected to increase by a total 

of 259 hours resulting from the adjustment made to the analysis in order to account for CDX registration 

activities. These summary level changes are highlighted in Table 5, while Table 6 demonstrates the 

updated list of ICs associated with this collection and the related annual burden estimates.

Table 5. Bottom Line Burden Changes

Table 6. Updated ICs for OMB Control No. 2070-0012

Title

Average 

Reporting Hours 

per Response

Hours for 

Recordkeeping Responses Total Time (Hours)

PMN 92.2 1 720 67,104

SNUN 92.2 1 8 746

MCAN 288.2 1 3 868

TME 86.2 1 8 698

LVE/LoREX 92.2 1 419 39,051

TERA 507.2 1 2 1,016

Tier I and II 110.2 1 3 334

Polymer 2 4 175 1,050

Research and Development 2.5 0.5 200 600

Instant Photographic Film Articles 0.5 0.25 1 1

Bona Fide 16 1 116 1,972

5(e) Test 151 17.5 12 2,022

Non-Testing 5(e) Burden 25 25 16 800

NOC 0.6 0.125 443 321

TOTAL FOR SECTION 5 

SUBMISSIONS 2,126 116,582

CDX Registration Activities

CDX E-Signature Burden 0.35 0 392 137

CDX Registration Burden 0.18 0 392 71

Pay.gov ID 0.03 0 392 51

TOTAL FOR CDX 

REGISTRATION ACTIVITIES 259

Rule Familiarization

Rule Familiarization Burden 0.82 0 336 276

TOTAL FOR ALL ACTIVITIES 117,116

Activity Summary

Burden Hour Change

Adjustments Program Changes

CDX Registration for New TSCA Section 5 Submissions 259

Rule Familiarization 276

Section 5 Bona Fide Notices -580

Total Burden Change -46