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Supporting Statement for a Request for OMB Review under

the Paperwork Reduction Act

1. IDENTIFICATION OF THE INFORMATION COLLECTION

1(a) Title and Number of the Information Collection

Title: New Information Collection Activities for Electronic Submissions

under TSCA Section 5

EPA ICR No.: 2327.02 OMB Control No.: 2070-0173

1(b) Short Characterization

The Government Paperwork Elimination Act (GPEA, Pub. L. 105-277) requires that,

when practicable, federal organizations use electronic forms, electronic filings, and electronic 

signatures to conduct official business with the public. EPA’s Cross-Media Electronic Reporting 

Regulation (CROMERR) (October 13, 2005; 70 FR 59848; FRL-7977-1) provides that any

requirement in Title 40 of the Code of Federal Regulations to submit a report directly to EPA can 

be satisfied with an electronic submission that meets certain conditions once the Agency

publishes a notice that electronic document submission is available for that requirement

In light of GPEA and CROMERR, EPA developed a final rule entitled, “TSCA Section 5 

Premanufacture and Significant New Use Notification Electronic Reporting; Revisions to 

Notification Regulations” (RIN 2070-AJ41) to amend the Toxic Substances Control Act (TSCA) 

section 5 Notification regulations and related provisions to phase-out paper-based submissions 

and facilitate the introduction and use of a new electronic reporting mechanism. This action will

enable, and eventually require, manufacturers, importers, and processors of TSCA chemical 

substances to use the Internet, through EPA’s Central Data Exchange (CDX), to submit TSCA 

section 5 notices to the Agency. These include Premanufacture Notices (PMNs) (40 CFR 720, 

Attachment 3), Significant New Use Notices (SNUNs) (40 CFR 721, Attachment 4), Test Market 

Exemption Applications (TMEAs) (40 CFR 720), Low Volume Exemption notices (LVEs) (40 

CFR 723.50), Low Exposure/Low Release Exemption (LoRex) notices (40 CFR 723.50) (see 

Attachment 5), Biotechnology notices for genetically modified microorganisms (40 CFR 725, 

Attachment 6), Notices of Commencement of Manufacture or Import (NOCs) (40 CFR 720.102) 

and other support documents (e.g., correspondence, amendments and test data).

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

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

CDX, optical disc, and paper. Regardless of the delivery method, EPA will require that all 

submissions be generated with new “e-PMN” computer software. Paper submissions will no 

longer be accepted for any new notices and support documents (including NOCs) beyond the 

first year after the final rule’s effective date. Disc-based submissions (e.g., CDs and data DVDs) 

for all new notices and support documents will no longer be accepted beyond the second year 

after the final rule’s effective date. After this, all submitters will be required to submit 

electronically via CDX using the e-PMN software. The Agency is incorporating this phased 
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approach because it will allow submitters to gain experience in using the e-PMN software and 

the submission delivery system. Note that the final CDX and e-PMN software amendments to 

the PMN notification requirements in 40 CFR 720 will apply to the SNUN requirements in 40 

CFR 721.25(a). EPA is also amending the TSCA section 5 User Fee regulations at 40 CFR 

700.45 to add a new User Fee Payment Identity Number field to the PMN form. This will enable 

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

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

paperwork activities related to submitting section 5 information to EPA electronically and 

describes the changes that will ultimately be incorporated into the ICRs that currently approved 

under OMB Control No. 2070-0012 and 2070-0038 (EPA ICR No. 0574, Premanufacture 

Review Reporting and Exemption Requirements for New Chemical Substances and Significant 

New Use Reporting Requirements for Chemical Substances; and, EPA ICR No. 1188, TSCA 

Section 5(a)(2) Significant New Use Rules for Existing Chemicals, respectively).

At this time, the Agency does not have electronic reporting capability for all TSCA 

section 5-related notices and support documents. Examples are the Notice of Bona Fide Intent to 

Manufacture (“bona fide”), prenotice communications, and TSCA Inventory Correction 

Requests. EPA may consider offering electronic reporting of these and other submissions in the 

future.

2. NEED FOR AND USE OF THE COLLECTION

2(a) Need/Authority for the Collection

Section 5(a)(1)(A) of TSCA requires persons to notify EPA at least 90 days before they

manufacture or import a new chemical substance for commercial purposes. Section 3(9) of 

TSCA defines a “new chemical substance” as any substance that is not on the Inventory of 

Chemical Substances compiled by EPA under section 8(b) of TSCA. Section 5(a)(2) of TSCA 

authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA 

must make this determination by rule after considering all relevant factors, including those listed 

in TSCA section 5(a)(2). Once EPA determines that a use of a chemical substance is a significant 

new use, TSCA section 5(a)(1)(B) requires persons to submit a notice to EPA at least 90 days 

before they manufacture, import, or process the chemical substance for that use.

2(b) Practical Utility/Users of the Data

e-PMN Software

The phase-out of paper-based submissions in favor of CDX reporting, including use of 

the e-PMN reporting software, for TSCA section 5 notices and support documents, is in concert 

with broader government efforts to move to modern, electronic methods of information 

gathering. The required use of CDX for submission of TSCA section 5 notices and support 

documents will be consistent with the Government Paperwork Elimination Act (GPEA, Pub. L. 

105-277), which requires that, when practicable, federal organizations use electronic forms, 

electronic filings, and electronic signatures to conduct official business with the public.
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The e-PMN software and electronic submission via CDX will change the way that 

companies interact with the Agency regarding many TSCA section 5 submissions. Companies 

will be registered with EPA to submit their data electronically to the Agency via CDX and the 

Agency in turn will be able to communicate back electronically with submitters. This promotes 

efficiency in communications and cost savings in submissions and correspondence. PMN 

reporting software allows for more efficient data transmittal, and the software’s validation 

mechanism should help industry users submit fewer incomplete notices, which ultimately will

save EPA and industry processing resources and reduce transaction times. EPA believes the 

adoption of electronic communications will reduce the reporting burden on industry by reducing

both the cost and the time required to review, edit and transmit data to the Agency. 

All information sent via CDX will be transmitted securely to protect CBI. Furthermore, 

if anything in the submission has been claimed CBI, a sanitized copy of the notice must be 

provided by the submitter. The new e-PMN software will facilitate the creation of this sanitized 

non-CBI version, eliminating the need for the submitter to do this manually. It also will allow 

submitters to share a draft notice within their company during the creation of a notice and to save 

a copy of the final file for future use. A “Profiler,” available in the software, will also allow for 

certain information to be kept on file by the submitter to avoid re-entering the same information 

into a new form. 

The Agency will also benefit from receiving electronic submissions. Data systems that 

currently are populated manually will now be populated electronically, reducing the potential for 

human error that exists when data are entered by hand. Agency personnel will also be able to 

communicate more efficiently with submitters electronically, compared to using U.S. mail.

User Fee Payment Identity Number

As required by 40 CFR part 700 (Attachment 2), respondents must pay a fee when they

submit PMNs, MCANs, certain PMN exemption application notices, and SNUNs to the Agency. 

The amended PMN form will include a new User Fee Payment Identity Number field to enable 

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

User Fee Payment Identity Number will be required and may be a check number, a wire transfer 

number, or a “Pay.gov” transaction number used to transmit the user fee.

E-mail address for Principal Contacts

The second new information element on the amended PMN form is optional and consists

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

the PMN form. This information will help facilitate electronic communications with the proper 

point of contact from the submitting entity.
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3. NON-DUPLICATION, CONSULTATIONS AND OTHER COLLECTION 

CRITERIA

3(a) Non-Duplication

EPA is the only Federal Agency that collects information on significant new uses of 

chemical substances. A notification of an intent to engage in a significant new use serves two 

functions: as a notice, and as a document that contains information about a chemical substance 

and potential exposures to that substance. The notification element is unique to SNURs and 

therefore not obtainable elsewhere. The chemical information aspect will also contain unique 

information. Only the person who intends to commence a significant new use of a chemical 

substance will know the potential for human and environmental exposures to that substance, the 

quantity intended to be produced, imported, or processed, and the manner in which the person 

will engage in the significant new use.

A person submitting a significant new use notice is not required to develop test data, 

except where a test rule under TSCA section 4 has been promulgated for the chemical substance 

or mixture subject to the SNUR. However, the person must submit data that are known to or 

reasonably ascertainable by that person. For published data the submitter need only provide a 

literature citation (40 CFR 720.50(d)(3)(ii)). For existing chemicals that are related to the 

chemical substance that is the subject of the SNUR (e.g., impurities, byproducts), neither the 

published data nor a literature citation need be submitted. Also, notices need not include 

information previously submitted to EPA (unless the previously submitted information was 

claimed confidential, in which case it must be resubmitted).

3(b) Public Notice Required Prior to ICR Submission to OMB

The Notice of Proposed Rulemaking (December 22, 2008; 73 FR 78261) served as the public 

notice for this ICR. EPA specifically sought comments on the following:

 Whether the proposed 2-year phase-in period following promulgation of the final rule, 

during which time paper and/or optical disc submissions would be accepted, is reasonable 

or necessary to allow sufficient time to transition to the new Internet-based method, and 

 Did industry have information that could further inform EPA’s estimate regarding 

burden. For example, EPA asked whether submitters intended on submitting notices via 

CDX as soon as it becomes available, or if not, when during the 2-year phase-in period 

would they expect to begin using CDX? 

The public comments overwhelmingly supported the 2-year phase-in period following 

promulgation of the final rule. Commenters agreed that the 2-year phase-in period is reasonable 

and necessary to allow sufficient time for transition to the new electronic reporting method.

Although EPA did not receive any comments directly related to its burden estimate, EPA did 

receive positive feedback on the proposed electronic submittal system. Commenters strongly 

supported the Agency’s effort to move to electronic methods of information gathering. 

Commenters agreed with the Agency’s statements that this change will allow for more effective 

and efficient reviews of section 5 notices and that the changes will improve communication with 
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submitters. One commenter appreciated aspects of the e-PMN software such as the ability of the 

e-PMN software to check for completeness of a PMN submission and create non-CBI versions of 

notices. Another commenter was pleased to see the addition of the new User Fee Payment 

Identity Number field to track payments. EPA retained the 2-year phase-in period for electronic 

submissions which is supported by the comments received. Since EPA did not receive any 

comments directly related to its burden estimate, no changes were made.

3(c) Consultations

In addition to the public notice and comment period, OMB regulations, 5 CFR 

1320.8(d)(1), require agencies to consult with potential ICR respondents and data users about 

specific aspects of an ICR before the agency submits the ICR to OMB for review and approval. 

In accordance with this regulation, EPA will solicit consultation feedback from nine potential 

ICR respondents and data users with respect to this final rule ICR.

3(d) Effects of Less Frequent Collection

The frequency of the submission of information under TSCA section 5 is not under the 

Agency’s control. Manufacturers of new chemical substances typically submit a PMN, SNUN, 

or MCAN at least 90 days prior to anticipated manufacturing or distribution of the substance for 

non-exempt commercial use. Submission of information thus is on an as-needed, on-occasion 

basis, initiated by respondents. Subsequent reporting will only be required if EPA determined 

that a specific use of a substance constituted a significant new use. Less frequent collection will

mean respondents not being required to submit data at all, which may present a violation of 

TSCA.

3(e) General Guidelines

This collection of information is consistent with all OMB guidelines under 5 CFR 1320.6 

except with respect to the maintenance of records by respondents for more than three years. 

EPA believes a five-year recordkeeping requirement is needed to carry out an effective program. 

The five-year recordkeeping requirement is consistent with the five-year statute of limitations 

under 28 U.S.C. 2462 held applicable to all EPA enforcement actions, including administrative 

proceedings under TSCA. 3M Company v. Carol Browner and EPA, 17F.3d (DC Cir.1994). In 

addition, a five-year retention period comports with certain recordkeeping requirements imposed 

by the Occupational Safety and Health Administration and helps to keep these requirements 

consistent with one another, thereby avoiding different reporting obligations. Therefore, the 

Agency requires respondents to retain records for more than three years.

3(f) Confidentiality

The Agency’s policies allow public involvement while preserving confidentiality. TSCA 

section 14(a) prohibits, except in limited circumstances, the disclosure of trade secret 

information. TSCA section 14(b) allows disclosure of health and safety studies, including 

underlying data, unless these studies disclose confidential process or mixture information. Under 

40 CFR 720.85 and 720.87(see also 40 CFR Part 2), when the specific chemical identity or use 

data are claimed confidential, the Agency requires the submitter to provide generic descriptions 
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for inclusion in Federal Register notices and the public file. Additionally, the submitter must 

provide a “sanitized” copy of all health and environmental effects data, with confidential 

information deleted, for placement in the public docket. Within the Agency, only personnel with 

the required clearance may handle CBI.

Based on its experience, EPA expects that most information included in TSCA section 5 

notices will be CBI. EPA has developed an elaborate system to prevent unauthorized disclosure 

of CBI. This system includes procedures for logging material in and out of the Confidential 

Business Information Center (CBIC) at EPA headquarters and procedures for photocopying and 

transmitting CBI. These procedures apply to CBI submitted by manufacturers as well as CBI 

generated by EPA staff in the course of their review. Access to CBI is restricted to persons who 

need the information for their work. No one is allowed access to CBI without first undergoing 

instruction on procedures for handling CBI. Special procedures also restrict access to 

computerized CBI. These security measures apply to CBI submitted by manufacturers as well as 

CBI generated by EPA staff in the course of their review. A wrongful disclosure of CBI may

result in either a fine or imprisonment. These procedures are detailed in the current “TSCA CBI 

Protection Manual”. EPA believes these procedures protect confidential information while 

providing the public with as much information as possible.

Any information being sent via CDX will be transmitted using secure technologies to 

protect CBI. The e-PMN software will encrypt PMN submissions using a Federal Information 

Processing Standards (FIPS) compliant encryption module. The encryption module employs a 

public key algorithm which converts readable text into encrypted text. This public key is 

downloaded from CDX to the e-PMN software, and the corresponding private key is sent to 

EPA’s New Chemical System (NCS). The encryption remains while your submission is 

transmitted via CDX to NCS. Your file can be decrypted only with the NCS's private key when it 

has reached its final destination. The NCS is the only party that possesses the private key, which 

converts the encrypted text back into readable text.

The same thing can occur for all correspondence going back to the submitter, including 

the electronic Copy of Record. The NCS and e-PMN software are also provided with a set of 

public and private keys, so that correspondence containing any potential confidential business 

information will remain encrypted during transmission via CDX and can be opened only by the 

submitter within the e-PMN software.

3(g) Sensitive Questions

This section is not applicable. The information requested is not sensitive in nature.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a) Respondent NAICS Codes

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).
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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%

4(b) Information Requested

(i) Data items, including record keeping requirements

With the exceptions of the new e-PMN software and the minor revisions to the PMN 

form that will be incorporated into that software, that is, the required User Fee Payment Identity

Number, optional E-mail address for Principal Contacts, and software-generated format for 

Biotech notices (EPA Form 6300-07, TSCA Biotechnology Notice for Online Submissions), the 

data items presently approved under OMB Control Numbers 2070-0012 and 2070-0038 are 

otherwise unchanged. In addition to these data items, respondents will also be required to 

register with CDX and complete the electronic signature agreement by completing

(ii) Respondent Activities

Register with EPA’s CDX and Complete Electronic Signature Agreement

To register in CDX, the CDX registrant (also referred to as “Electronic Signature Holder”

or “Public/Private Key Holder”) downloads two forms: the Electronic Signature Agreement and 

the Verification of Company Authorizing Official form. Registration enables CDX to perform 

two important functions: Authentication of identity and verification of authorization. Within the 

“Electronic Signature Agreement” form, the Authorized Official (AO) agrees to certain CDX 

security conditions. On the “Verification of Company Authorizing Official” form, the AO 

designates himself/herself as the AO and attests to the completeness and accuracy of the 

submitted information. 

There is a third form generated by CDX that the AO needs to fill out if the AO wants to 

authorize other persons to submit support documents on his or her behalf, including a paid 

employee of the company, an outside consultant for the company, or an authorized representative 
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agent for the company. This form is entitled, “Authorization and Verification for Section 5 

Notice Support Submitter by Company Authorizing Official.” On this form, the AO designates 

various persons to submit support documents on his or her behalf, and attests to the completeness 

and accuracy of the submitted information. Persons designated by the AO to submit on his or 

her behalf must also sign this form along with the Electronic Signature Agreement form, in order 

to be “linked” to the AO by EPA; and therefore, be able to submit support documents via CDX 

on the AO’s behalf.

When these forms are received, EPA activates the submitter's registration in CDX and 

sends him or her an e-mail notification. 

Use the e-PMN Software to Prepare TSCA Section 5 Notices

In all cases, respondents will use the e-PMN software to:

 generate the submission materials for TSCA section 5 notices, including forms (i.e., the 

PMN form (EPA Form 7710-25), the NOC (EPA Form 7710-56) and the TSCA 

Biotechnology Notice for Online Submissions (EPA Form 6300-07)) as well as 

submission materials that do not require a standardized form or format; and,

 populate the submission materials with the relevant information

There are no required or official forms for certain TSCA section 5 notices, such as LVE

modifications, LoRex Exemption modifications, and TMEAs. For biotechnology notices, no 

EPA-approved forms exist. To allow for electronic and paper submission of these notices using 

the e-PMN software, the Agency is finalizing the rule as follows:

(1) For exemption modifications, submitters will use the e-PMN form by checking the 

“modification” box on page 1, filling in contact information on page 3, and 

including the previous exemption number and chemical identity information. A 

submitter may send a cover letter with the new revisions to the original exemption 

notice or the pertinent pages of the e-PMN form. 

(2) For a TMEA, the submitter will check the “TMEA” box on page 1 of the e-PMN

form, and either fill out the form or attach a cover letter for the body of the 

submission containing the information required by 40 CFR 720.38.

(3) Biotechnology notices will have their own menu option. Instead of selecting 

“Premanufacture Notice,” a submitter will select “Biotech,” which will prompt the 

software to present the submitter a header page with choices of biotech notices, and 

space to fill in contact information. The e-PMN software will populate this 

information in a new form entitled, “TSCA Biotechnology Notice for Online 

Submissions” (EPA Form 6300-07). The additional information will be submitted 

as an attachment(s).
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Notice Type Use of e-PMN Software

PMN Form 7710-25 generated and finalized by e-PMN software.

Low Volume 

Exemption (LVE)

Form 7710-25 generated and finalized by e-PMN software.

Test Market Exemption 

Application (TMEA)

e-PMN software to generate finalized submission either using 

7710-25 or cover letter and attached information.

NOC e-PMN software to generate finalized submission using Form 

7710-56.

Biotechnology

Notices

e-PMN software to generate finalized “header” sheet (EPA 

Form 6300-07, TSCA Biotechnology Notice for Online 

Submissions) with contact data, add attachment with notice 

information, include signature page.

Modifications to 

Previous Notices

Form 7710-25 generated and finalized by e-PMN software. 

Fill in pages 1, 2, and 3 of the Form, plus either applicable 

pages of Form, cover letter, or attachment.

Support

Documents

e-PMN software to generate finalized “header” sheet 

identifying reason for submission and contact data.

Finalize and Submit

A respondent’s activities to finalize and a submit TSCA section 5 notices will depend on 

the chosen submission method. The e-PMN software will require users to complete a finalization 

process before preparing the information for submission to EPA. During the finalization step, 

the e-PMN software checks that all legally required information is included and provides 

warnings for certain kinds of missing, incomplete or incorrect data. 

Paper

After the e-PMN finalization step is complete, respondents will print submission 

materials using the e-PMN software, sign them as required, and deliver the submission to EPA 

via US Mail or courier.

Optical disc

After the e-PMN finalization step is complete, respondents will prepare the data 

generated by the e-PMN software in XML for transfer to an optical disc. With limited exception, 

discs will be submitted with an original signed hard copy of page 2 (Certification page) and a 

hard copy of page 3 (a copy of page 3 is needed for contact information in the event that the disc

is not readable). A disc-based TMEA submission will only need to be accompanied by a hard 

copy of the completed page 3. For biotechnology notices, a signed hard copy of a biotech 

certification will need to accompany the disc. Discs will need to be delivered only by courier 

service to avoid damage to the disk from the Agency’s mail screening equipment.
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Using e-PMN Software to Submit Electronically to EPA via CDX 

After the e-PMN finalization step is complete, the e-PMN software will prompt 

respondents to log-in to CDX. Respondents will the simply transmit the information to EPA 

online by clicking on the e-PMN software’s “send” button.

5. THE INFORMATION COLLECTED - AGENCY ACTIVITIES, COLLECTION 

METHODOLOGY, AND INFORMATION MANAGEMENT

5(a) Agency Activities

The Agency activities described in ICRs that currently approved under OMB Control No. 2070-

0012 and 2070-0038 remain unchanged, except as described below:

 convert to an electronic reporting system

 scan paper-based section 5 submissions to create electronic data for inclusion in Agency

data systems

 transfer data submitted on optical disc to Agency data systems

 acknowledge receipt of submissions and notify respondents of any submission 

deficiencies

 provide technical assistance to respondents

5(b) Collection Methodology and Management

For the past few years, submitters have been able to generate TSCA section 5 notices 

using an electronic version of the PMN form (EPA Form 7710-25) available at the EPA New 

Chemicals Program website (https://cdx.epa.gov/ssl/pmn/download.asp). The form, which used 

Adobe Acrobat software, only allows submitters to complete and save the form electronically, 

and then print out and mail it to EPA as hard copy. Each company must purchase Adobe 

Acrobat software to fill out the form. For those who wish to fill out the PMN form by hand or 

typewriter, a PDF version of the form is available from EPA’s New Chemical website 

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

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

 The e-PMN software will be available as a free internet download. The Agency will also 

make available free optical discs containing the software. The data being transmitted 

electronically via CDX will be encrypted to protect CBI. The software will work with Windows, 

Macs, Linux, and UNIX-based computers, using XML for more efficient data transmittal to 

Agency data systems that once was performed manually.

Once CDX is implemented as a mechanism for submission of section 5 notices and the ePMN requirements are in place, respondents submitting new section 5 notices such as PMNs, 

NOCs, SNUNs, and related support documents such as correspondence, amendments and test 

data initially will have the option to use e-PMN software to submit by paper, optical disc, or via 

CDX. Each of these submissions must be generated using the e-PMN software and need to 

undergo a “finalization” step in the generation of the documents. After a two-year phase-in 

period, all submissions will be required to be submitted electronically via CDX.
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However, NOCs and support documents that are submitted to the Agency for review after

implementation of CDX-based submissions, but that are related to section 5 notices that were

submitted to the Agency for review before implementation of CDX-based submissions, will still 

be required to be submitted on paper. The Agency is taking this position because although the 

section 5 notices received after implementation of the new system will be entered into a newly 

created database, section 5 notices submitted before promulgation of this rule will only exist in 

the “legacy” database, i.e., the database used prior to promulgation of this rule. This will 

similarly be the case for SNUNs and related support documents. Support documents that are 

submitted to the Agency for review after implementation of CDX-based submissions but that are 

related to SNUNs that were submitted to the Agency for review before implementation of CDXbased submissions will also still have to be submitted by paper. The Agency will prefer to allow 

everything to be submitted electronically; however, at this time the Agency does not have the 

resources to enter placeholders for old files in the new system to accommodate support 

documents and NOCs that will ultimately be submitted to the Agency for section 5 notices and 

SNUNs submitted prior to the effective date of this rule.

An electronic signature will be required for TSCA section 5 notices submitted to the 

Agency via CDX. Electronic signatures are granted as part of the CDX user-registration process. 

However, since the Agency has no system for collecting official signatures for forms submitted 

on an optical disc, such as a CD, original signatures will have to accompany the disc and any 

paper forms submitted during the phase-in period.

The electronic submission software will change the way that companies now interact with 

the Agency with many of its submissions. EPA believes this change to electronic 

communications potentially reduces the reporting burden on industry because it will reduce both 

the cost and the time required to enter, review, edit and transmit data to the Agency. The 

electronic submission software will also improve data quality because it will facilitate data 

correction and validation by highlighting fields with omitted data prior to submission. The 

protection of encrypted TSCA CBI data and the generation of an electronic Copy of Record that 

is returned to the submitter are other critical advantages of submitting data electronically through 

CDX.

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

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

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

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

Incomplete Letter (stating why a submission has been declared incomplete). Usually, these 

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

significant time and resource savings for both parties.

The Agency is introducing the electronic submission software in two phases. The first 

year, the Agency will allow the submission of information for notices and support documents via 

CDX, optical disc, and using paper forms generated with the e-PMN software. All paper 

submissions will be eliminated after the first year for all new section 5 notices and support 

documents whose parent notices were submitted after the new system was implemented. Disc

submissions generated using the e-PMN software will be eliminated at the end of the second year 
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for all new section 5 notices and support documents whose original notices were submitted after 

the new system was implemented. After the second year, only electronic submissions via CDX 

will be allowed for new section 5 notices and support documents whose related notices were 

submitted after the new system was implemented. Support documents whose parent notices

were submitted before the new system was implemented will still need to be mailed as hard copy

to the Agency. The Agency considers two years sufficient time for submitters to have gained 

experience using the e-PMN software and confidence in the CDX delivery system.

The Adobe electronic form now in use for filling out the PMN form uses a “header” page 

at the beginning of the PMN form. The “header” page asks for certain information for the 

purpose of adding or spawning additional pages requested by the submitter. This page is not part 

of the SNUN that is presently submitted to the Agency. In the new e-PMN software, there are 

header pages for support documents, and attachments that identify submitters and the nature of 

their communications. These header pages allow the software to identify and store data correctly

in the Agency’s databases when submitted by paper.

Submitters will be required to use the e-PMN software to generate section 5 notices and 

support documents regardless of whether they are submitted via CDX or delivered on a disc, or 

submitted on paper. A notice may be submitted on paper; however, for the notice to be declared 

complete, the entire PMN form must be generated and “finalized” using the software. Copying 

another form will not suffice. Disc submissions must be accompanied by an original, signed, 

hard copy of page 2 of the new e-PMN form (the Certification page), and page 3, (contact 

information in case the submitted disc is unreadable). All e-PMN software users, regardless of 

how a document will be submitted, need to undergo a “finalization” step in generating a 

document.

During the “finalization” step, the e-PMN software checks that all legally required 

information is included, provides warnings where necessary, and saves data in a read-only 

format acceptable to the Agency. Section 5 notices whose data have not undergone the 

“finalization” step will be declared incomplete. This step is necessary to allow for an accurate 

and efficient transfer of data from an optical disc or a paper-based form to the EPA data systems. 

The word, “finalized”, will be in the file name and the name will end with “_tsca”. The 

“finalized” file (folder) will contain the CBI and non-CBI data in XML format that are noneditable. The CBI and non-CBI attachments will also be in this folder in their native format. 

Attachments must be submitted in one of EPA’s approved formats for the Agency to be able to 

open the files.

The biggest difference between the old and new methods of data entry on the e-PMN 

form is the user interface. Data now will be entered through a series of pages or screens on the 

computer as opposed to being entered on the form itself. Most screens will represent a page of 

the printed e-PMN form. For those submitters who would like to see how their data looks on the 

e-PMN form once filled out, the new software will allow the submitter to navigate between the 

e-PMN form and a PDF version. The PDF or printed version will have the look of the original or 

current paper PMN form; however, submitters should not submit the PDF to the Agency because 

the submission will be in the wrong format and thus declared incomplete. Only the “finalized” 

read-only XML file folder will be accepted by the Agency. 
December 15, 2009

Page 13 of 28

The questions and pagination on the new e-PMN form will be the same as on the old 

PMN form, except that fields on the print form have been expanded to make more room for 

submitter information, which will result in the total number of pages being greater. Fields on the 

new print form have been realigned to make the form easier to scan. Once the old PMN form is 

phased out, submitters will no longer be able to use that form, and section 5 notices using the old 

form will be considered incomplete.

Other changes to the e-PMN form will be the addition of a new required field on page 1 

of the e-PMN form, a User Fee Payment Identity Number, to enable the Agency to more easily

match a particular user fee with a particular notice submission. For example, the User Fee 

Payment Identity Number may be a check number, a wire transfer transaction number, or a 

“pay.gov” transaction number used to transmit the user fee. This information is presently in the 

submitter’s possession. Also, EPA will request optional e-mail addresses for the principals listed 

on the Submitter Identification section of the e-PMN form. 

The e-PMN software will include many useful features for section 5 notice preparers. 

One feature is a built-in validation mechanism which will alert users that information, required 

by regulation, is missing or potentially incorrect. This should help reduce the number of 

incomplete section 5 notices, saving submitter and EPA processing resources and time. Also, 

similar to the existing PDF PMN form, the new e-PMN software will allow for the creation of a 

sanitized non-CBI version from the complete section 5 notices submission containing CBI. It 

also will allow submitters to share a draft notice within their company during the creation of a 

section 5 notice and to save a copy of the final file for future reference. The software will allow 

the submitter to create a profile with his/her contact information, which will save the submitter 

time in reentering that information on subsequent notices.

In addition to support provided with the e-PMN software, OPPT has set up a TSCA 

Hotline to aid persons subject to this information collection that provides information regarding 

TSCA section 5(a)(2) reporting as well as other regulatory information. When Hotline staff is

unable to answer questions regarding TSCA section 5(a)(2), the questions are referred to the 

OPPT Chemical Control Division (CCD) staff for resolution

5(c) Small Entity Flexibility

The reporting and recordkeeping requirements associated with TSCA section 5 are 

applicable to all affected entities, regardless of the size of the firm. However, OPPT has taken a 

number of steps intended to minimize the burden placed on small businesses. TSCA section 

26(d) established the TSCA Assistance Office, now known as the Environmental Assistance 

Division (EAD), to provide technical and other non-financial assistance to manufacturers, 

importers and processors of chemical substances and mixtures. This office has established a tollfree hotline to assist small businesses complying with TSCA rules. It provides material such as 

copies of Federal Register notices, advisories, and other information on request, performs on-site 

field visits and consultations, and has hired a contractor to assist small businesses, free of charge, 

in complying with TSCA requirements. In addition, “small business concerns” submit a reduced 

fee of $100 (rather than $2,500) for each TSCA section 5 notice submitted pursuant to the user 

fee regulation at 40 CFR 700.45(a)(1).
December 15, 2009

Page 14 of 28

5(d) Collection Schedule

Whenever any person intends to engage in a significant new use of a chemical substance, 

they are required to submit a notice of their intentions to EPA not less than 90 days before 

beginning to manufacture, import or process the substance for the intended use.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION

This section presents incremental burden and costs estimates associated with the final

electronic submission requirements for TSCA section 5 Notices. EPA estimates that the final

rule will impact 305 respondents – 295 New Chemicals program respondents and 10 Existing 

Chemical program respondents. Although respondents will experience some incremental burden 

increases as a result of the e-PMN rule, EPA expects that section 5 notice submitters will 

experience overall burden and cost savings associated with electronic form completion and 

submission via CDX.

This ICR Supporting Statement analyzes only the incremental paperwork burdens and 

costs that will be imposed by the final rule related to rule familiarization, CDX registration, CDX 

electronic signature, setting up a Pay.gov account. In addition, this Supporting Statement 

assesses the unit-level (as opposed to aggregate) changes in burden for each type of TSCA 

section 5 notice that will result from implementation of the final rule. Appendix 1 provides a 

complete year-by-year analysis of the final rule’s aggregate impact on the estimated paperwork 

burdens and costs on the New and Existing Chemicals Programs, as addressed in 

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) and TSCA Section 5(a)(2) Significant New Use Rules for 

Existing Chemicals (EPA ICR No 1188.08; OMB Control No. 2070-0038).

6(a) Estimating Respondent Burden

6(a)(i) New Rule-related Burdens

EPA expects that respondents will incur minimal additional burdens and costs in carrying 

out the additional paperwork activities that will be imposed by the rule. This includes the burden 

associated with activities that facilitate submission of an e-PMN: CDX registration, CDX 

electronic signature, setting up a Pay.gov account, and rule familiarization. These activities 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, respondents 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 respondents that submit e-PMNs again in subsequent years do not incur a 

subsequent rule familiarization burden. However for the sake of this ICR analysis, EPA 

annualized the expected 1st-year rule familiarization responses. The other activities (CDX 

registration, CDX electronic signature, setting up a Pay.gov account), while they are incurred 
December 15, 2009

Page 15 of 28

only once, will be incurred in the year in which the respondents adopt electronic reporting via 

CDX.

Activity Brief Assessment of Burden Burden Estimate 

per Respondent

CDX registration Based on the CROMERR Cost Benefit Analysis, EPA assumes that 

companies will spend 11 minutes per employee to register with CDX 

(EPA, 2004). Furthermore, EPA assumes that an average of four 

technical staff members and one manager will need to register for each 

company (5 employees/firm)

55 minutes 

(0.9 hours)

CDX electronic 

signature (labor)

1

Authentication of Identity: Based on the CROMERR Cost Benefit 

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

submitting, and filing an electronic signature agreement form to EPA per 

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

technical staff members per company (5 employees/firm) for a subtotal 

of 75 minutes.

Verification of Authorization: One manager will spend an additional 30 

minutes accessing, preparing, and submitting verification forms for all 

authorized submitters to EPA

105 minutes

(1.8 hours)

E-payment via 

Pay.gov account2

Although establishment of a Pay.gov account will be optional, for the 

purposes of this ICR, companies are assumed to set up an account by 

which to make section 5 notice-related payments. One manager per 

company will establish a Pay.gov ID account, log into the system, and 

fill out an e-PMN payment form.

8 minutes

(0.1 hours)

Rule 

Familiarization

Management and technical staff will spend time familiarizing themselves 

with the new requirements for electronically submitting their section 5 

notices via CDX. EPA estimates that one manager will spend 33 minutes 

and one technical staff member will spend 16 minutes per company on 

rule familiarization.

49 minutes

(0.8 hours)

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

 Also, EPA modified certain data elements of the PMN form. The first modification is the 

removal of the ‘Agent Signature Block’ data field from the PMN form. EPA does not estimate 

the burden savings from removing the ‘Agent Signature Block’ because a review of previously

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

“Agent Signature Block,” and expected burden savings are insignificant. In addition, EPA is 

adding two new data fields: (1) User Fee Payment Identification Number, and (2) optional email 

address of principals listed in the Submitters Identification section. EPA anticipates that the new 

fields will increase technical burden by 10 minutes and one minute, respectively.

3

 

1 The burden associated with CDX Electronic Signatures does not include costs associated with contacting EPA’s 

CDX helpdesk to notify a change of submitter status, should one occur.

2 EPA’s time estimate is based on best professional judgment of completing a TSCA User Fee form on the pay.gov 

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

payment processing.

3 Based on Engineering Estimates of reporting e-mail address for TRI Reporting. Memo entitled TRI Reporting 
December 15, 2009

Page 16 of 28

6(a)(i)(A) Rule-related Burden – New Chemicals Program (2070-0012)

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

353 annual burden hours on respondents, and that roughly 98 of the 295 new chemicals program 

respondents (about one-third of respondents) will implement the rule provisions each year during 

the two-year phase-in. This program change increase 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. 

Table 1

Annual New Chemicals Program Reporting Burden Under the e-PMN Rule

Type of Notice

Avg. Annual 

Responses1

Hrs. per 

Response

Total 

Reporting Hrs.

CDX Registration 98 0.9 90

CDX Electronic Signature 98 1.8 172

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

Rule Familiarization (Annualized) 98 0.8 78

Total 353

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 the previous ICR

6(a)(i)(B) Rule-related Burden – Existing Chemicals Program (2070-0038)

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

10 annual burden hours on respondents, and that roughly three of the 10 existing chemicals 

program respondents (about one-third of respondents) will implement the rule provisions each 

year during the two-year phase-in. This program change increase 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. 

 

Burden Estimates from Hilary Eustace, David Cooper and Susan Day, Abt Associates, to Paul Borst, US EPA.., 

July, 2004.
December 15, 2009

Page 17 of 28

Table 2

Annual Existing Chemicals Program Reporting Burden Under the e-PMN Rule

Type of Notice

Avg. Annual 

Responses1

Hrs. per 

Response

Total 

Reporting Hrs.

CDX Registration 3 0.9 2.7

CDX Electronic Signature 3 1.8 5.4

E-Payment (Pay.gov ID) 3 0.1 0.3

Rule Familiarization (Annualized) 3 0.8 2.4

Total 10.8

1 EPA assumes that about one third of the respondents will adopt CDX submissions each year- (10/3) ~ 

3 responses.

6(a)(ii) Anticipated Burden Reductions Resulting from the Rule

EPA expects that section 5 notice submitters will experience overall burden and cost 

savings associated with completing TSCA section 5 notices electronically via the e-PMN

software and submitting those notices electronically via CDX. Specifically, EPA expects burden 

reduction for activities related to form completion, recordkeeping, and postage upon 

implementation of the e-PMN rule. Respondents are expected to experience these burden 

reductions 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. Respondents are 

expected to realize burden savings each time a section 5 notice is submitted. Recordkeeping and 

postage savings will be realized in years when electronic reporting via CDX is used. The final 

rule requires that all notices be generated using the new e-PMN software beginning in the first 

year following rule promulgation; however, form completion burden savings will be realized by

all submitters immediately. Although respondents will be able to submit TSCA section 5 notices

to EPA on optical discs during the first 2 years of rule implementation, EPA does not project any

burden savings for this type of submission vehicle. Rather, EPA assumes that the overall amount 

of time and money invested in the preparation and submission of notices via optical disc will be 

similar to that required for paper-based submissions.

Firms that are subject to a New or Existing Chemical SNUR may respond to the SNUR in 

one of a few ways. The manners which firms may response are addressed in TSCA Section 

5(a)(2) Significant New Use Rules for Existing Chemicals (EPA ICR No 1188.08; OMB Control 

No. 2070-0038) and 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). This rule-related ICR analyzes the 

incremental difference in reporting burden that will be brought about by the e-PMN final rule 

when firms respond to a SNUR by submitting a SNUN via CDX and does not consider the 

burdens of other SNUR response options because they are unaffected by the final rule.

6(a)(ii)(A) Expected Recordkeeping Burden Reductions

EPA expects that recordkeeping burden for TSCA section 5 respondents will decrease 

due to the e-PMN rule. Specifically, EPA assumes that recordkeeping burden will be reduced by 

half due to the efficiencies in creating and storing electronically section 5 notices and supporting 

documents. For most section 5 notices, baseline recordkeeping burden is estimated to be two 
December 15, 2009

Page 18 of 28

hours. 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.

Table 3

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 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 1188.08; 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.

EPA expects no recordkeeping burden reductions or increases for the following:

 R&D exemption: Potential users of this exemption incur burdens related third 

party notification and recordkeeping. Users of this exemption do not need to 

submit information to EPA and, therefore, they will not need to register with CDX 

and will not be affected by the e-PMN rule. Reductions in recordkeeping burden 

are linked with the respondents’ use of the e-PMN software to prepare and submit 

information electronically, and subsequent utilization of electronic storage of 

records related to the submission.

 Instant photographic film articles exemption notices: Submissions of instant 

photographic film articles exemption notices are very infrequent. EPA has not 

received any such notifications in many years and does not expect to receive any 

such notices during the course of the next several years. Therefore, EPA does not 

expect that any associated burden will be imposed upon respondents.
December 15, 2009

Page 19 of 28

 Non-Testing 5(e) submissions: Respondents will not be permitted to make this 

type of submission via CDX under the e-PMN rule. Reductions in recordkeeping 

burden are linked with the respondents’ use of the e-PMN software to prepare and 

submit information electronically, and subsequent utilization of electronic storage 

of records related to the submission.

 Bona Fides: Respondents will not be permitted to make this type of submission 

via CDX under the e-PMN rule. Reductions in recordkeeping burden are linked 

with the respondents’ use of the e-PMN software to prepare and submit 

information electronically, and subsequent utilization of electronic storage of 

records related to the submission.

 Correction requests: Respondents will not be permitted to make this type of 

submission via CDX under the e-PMN rule. Reductions in recordkeeping burden 

are linked with the respondents’ use of the e-PMN software to prepare and submit 

information electronically, and subsequent utilization of electronic storage of 

records related to the submission.

6(a)(ii)(B) Expected Reporting Burden Reductions

6(a)(ii)(B)(1) New Chemicals Program Burden (2070-0012)

The unit burdens for the various types of notices traditionally submitted on paper to EPA 

under the New Chemicals program are estimated in the ICR entitled Premanufacture Review 

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

Reporting Requirements for Chemical Substances, approved under OMB Control No. 2070-

0012. EPA expects that the electronic submission option will reduce burden associated with 

reporting for PMN, New Chemical SNUN, LVE, LoREX, MCAN, TME, TERA, Tier I and II 

Exemptions, 5(e) Test, and slightly increase burden associated with NOC submissions.4The 

burden estimates for each of these submission types includes the time spent reading and 

becoming familiar with the form, gathering the required information and preparing the report, 

producing sanitized responses for items claimed as CBI, and maintaining a file of the submission 

(EPA, 1994).

The convenience of an automated electronic form may reduce the time required to read 

and become familiar with the form. The e-PMN software will also enable the submitter to create 

a sanitized version of the form containing CBI, decreasing the effort to do this manually. 

Maintaining electronic files may also be less burdensome than hardcopy files. In addition, 

burden reduction may result from eliminating or reducing some of the activities associated with 

paper submission, such as printing, photocopying, and mailing paper notices. Furthermore, 

electronic data submission will reduce the time required for EPA staff to review the information, 

because there will be no need for manual data entry or processing.

 

4 Reporting burden for NOCs is expected to increase slightly because the very small amount of clerical burden that is 

reduced is offset by the increase of 11 minutes in reporting time due to two new data fields on the e-PMN form. The 

total increase in reporting burden for NOCs is less than 0.1 hours.
December 15, 2009

Page 20 of 28

Table 4

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

Type of New Chemicals 

Program Notice

Current Estimated 

Response Burden 

Estimated Response Burden 

after e-PMN rule

Burden Saved

Per Response

Full PMN 105 hrs. (EPA, 1994) 92.2 hrs. 12.8 hrs.

New Chemical SNUN 105 (EPA, 1994) 92.2 12.8

LVE 105 (EPA, 1994) 92.2 12.8

LoREX 105 (EPA, 1994) 92.2 12.8

MCAN 302 (EPA, 1994) 288.2 13.8

TME 98 (EPA, 1994) 86.2 11.8

TERA 521 (EPA, 1997) 507.2 13.8

Tier I 114 (EPA, 1997) 110.2 3.8

Tier II 114 (EPA, 1997) 110.2 3.8

5(e) Test submissions 155 150.7 4.3

NOC 0.5 0.6 (0.1)

EPA expects no reporting burden reductions or increases for the following:

 R&D exemption: Potential users of this exemption incur burdens related 3rdparty notification and recordkeeping. Users of this exemption do not need to 

submit information to EPA and, therefore, they will not need to register with CDX 

and will not be affected by the e-PMN rule.

 Instant photographic film articles exemption notices: Submissions of instant 

photographic film articles exemption notices are very infrequent. EPA has not 

received any such notifications in many years and does not expect to receive any 

such notices during the course of the next several years. Therefore, EPA does not 

expect that any associated burden will be imposed upon respondents.

 Non-Testing 5(e) submissions: Respondents will not be permitted to make this 

type of submission via CDX under the e-PMN rule. 

 Bona Fides: Respondents will not be permitted to make this type of submission 

via CDX under the e-PMN rule.

 Correction requests: Respondents will not be permitted to make this type of 

submission via CDX under the e-PMN rule. 

6(a)(ii)(B)(2) Existing Chemicals Program Burden (2070-0038)

As a result of the e-PMN rule, existing chemical SNUN respondents will experience a 

reduction in reporting burden due to the efficiencies and reduced time associated with using the 

e-PMN software to complete a SNUN, and using CDX to submit the notice. Reporting burden 

savings are expected to be realized each time a SNUN is submitted. The final rule requires that 

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

promulgation. Consequently, form completion burden savings will be realized by all SNUN 

submitters immediately.
December 15, 2009

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Table 5

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

Type of Existing

Chemicals Program Notice

Current Estimated 

Response Burden 

Estimated Response 

Burden after e-PMN rule

Burden Saved

Per Response

Existing Chemical SNUN 105 92.2 12.8

1The reporting burden for Existing Chemical SNUNs has been adjusted from the estimate of 113.25 hours calculated 

in TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals (EPA ICR No 1188.08; OMB Control 

No. 2070-0038), to 105 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.

6(b) Estimating Respondent Cost

The average annual respondent labor costs associated with the paperwork activities 

described in this rule-related ICR (i.e., CDX registration, CDX electronic signature, setting up a 

Pay.gov account, and rule familiarization) are estimated to be $19,998. As indicated in Tables 6 

and 7, this estimate is composed of the following costs: $19,404 for New Chemicals program 

respondents and $594 for Existing Chemicals program respondents. The wage rates indicated in 

these tables were derived as described in section 6(b)(1) of this supporting statement.

Table 6

Average Annual New Chemicals Program Respondent Cost Calculation 

Activity / Notice

Avg. 

Annual # 

of 

Companies 

/ 

Responses

Total Burden and Wage Rate

by Labor Category Total 

Avg. 

Costs Per 

Company 

/ Notice

Total 

Company / 

Notice Cost

($) 

Managerial Technical Clerical

Hrs

Wage

($) Hrs

Wage

($) Hrs

Wage

($)

CDX Registration 98 0.2 58.71 0.7 51.35 0 25.54 48 4,704

CDX Electronic Signature 98 0.8 58.71 1.0 51.35 0 25.54 98 9,604

E-Payment (Pay.Gov ID) 98 0.1 58.71 0.0 51.35 0 25.54 8 784

Rule Familiarization (Annualized) 98 0.3 58.71 0.6 51.35 0 25.54 44 4,312

Total 19,404

Table 7

Average Annual Existing Chemicals Program Respondent Cost Calculation 

Activity / Notice

Avg. 

Annual # 

of 

Companies 

/ 

Responses

Total Burden and Wage Rate

by Labor Category Total 

Avg. 

Costs Per 

Company 

/ Notice

Total 

Company / 

Notice Cost

($) 

Managerial Technical Clerical

Hrs

Wage

($) Hrs

Wage

($) Hrs

Wage

($)

CDX Registration 3 0.2 58.71 0.7 51.35 0 25.54 48 144

CDX Electronic Signature 3 0.8 58.71 1.0 51.35 0 25.54 98 294

E-Payment (Pay.Gov ID) 3 0.1 58.71 0.0 51.35 0 25.54 8 24

Rule Familiarization (Annualized) 3 0.3 58.71 0.6 51.35 0 25.54 44 132

Total 594
December 15, 2009

Page 22 of 28

6(b)(i) Derivation of Wage Rates

To determine the per-company and per-form costs, the unit burden hour estimates are 

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

activities.5Loaded hourly rates are the product of wages, benefits, and overhead. Hourly wage 

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

salary data for these categories are obtained from the Employer Costs for Employee 

Compensation (ECEC) report from the Bureau of Labor Statistics (BLS) for all goods-producing, 

private industries. The additional cost of benefits, such as paid leave and insurance, is also 

derived from information provided in the ECEC report. 

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

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

of total compensation. Based on information provided by the chemical industry and chemical 

industry trade associations, an additional loading factor of 17 percent is applied for general 

overhead. This approach is used for consistency with Office of Pollution Prevention and Toxics 

economic analyses for two major rulemakings: Wage Rates for Economic Analyses of the Toxics 

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

Inventory Update Rule: Final Report (EPA, 2002a). This loading factor is added to the benefits 

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

data on salaries and benefits for these three labor categories. The fully loaded 2007 hourly wage 

rates are shown in Table 8. Details on the calculation of the wage rates can be found in 

Attachment 11. 

Table 8

Loaded Hourly Wage Rates by Labor Category 2007

Labor 

Category

Occupational 

Type

Average 

Hourly 

Wage

Benefit (% 

wages)

Overhead

(% wages)

Loaded 

Hourly 

Rate

Managerial

Management, 

business, and 

financial $36.44 44.1% 17% $58.71 

Technical

Professional and 

related $32.52 40.9% 17% $51.35 

Clerical

Office and 

administrative 

support $15.78 44.9% 17% $25.54 

Source: BLS, 2007. Employer costs per hour worked for employee compensation and costs as a 

percent of total compensation: Private industry workers, by occupational group and full-time and 

part-time status, December 2007. Table 11. http://www.bls.gov/news.release/ecec.t11.htm

6(c) Estimating Agency Burden and Cost

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

facilitate form submission and processing are expected to create long term burden reductions and 

 

5 Employer Costs for Employee Compensation, Private industry workers, Goods-producing industries, white-collar 

occupations, as published by the U.S. Department of Labor, Bureau of Labor Statistics. Table 11 of the Employer 

Costs for Employee Compensation Summary, December 2007. 
December 15, 2009

Page 23 of 28

efficiencies for EPA. Because the current e-PMN program is based entirely on paper 

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

estimates incurring a one time cost of $200,000 spread out over the first two years to convert the 

New Chemicals section 5 notice program to an electronic system.6In addition, annual costs will 

be associated with the operation and maintenance (O&M) of CDX for the e-PMN data flow. 

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

apportioning the overall CDX maintenance cost estimated in the CROMERR Cost Benefit 

Analysis, Final (EPA, 2004) to individual programs. This approach yields an estimate of 

$57,353 per year per program. Note that although the e-PMN data flow will be smaller than the 

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

associated with operations and, therefore, the $57,353 might be considered a lower bound 

estimate of total O&M. 

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

5 notice submitters. This technical assistance will include conducting a beta or pilot test of the 

new submission process with approximately 50 submitters and conducting approximately three 

training sessions around the country to demonstrate the tool and other outreach, including a 

hotline. Although EPA is not able to quantify the costs at this time, these Agency activities are 

likely to require both labor and extramural resources. 

Agency burden savings are expected due to the elimination of the need to process paper 

forms, reduced quality assurance/quality control (QA/QC) and O&M costs for the existing 

system. Potential Agency burden savings associated with the e-PMN rule are characterized 

based on information in the Business Case Analysis of EPA’s Central Data Exchange (EPA, 

2007) regarding the estimated monetary benefit from using CDX. Of the six Program Data 

Flows studied in the CDX Business Case Analysis, monetary benefits from using CDX as 

compared to a paper submission baseline were quantified for two flows: TRI (Toxic Release 

Inventory) and e-NOI (electronic Notice of Intent under the National Pollution Discharge 

Elimination System). Benefits ranged from 11 percent savings (e-NOI) to 22 percent savings 

(TRI) compared to the cost of the baseline process. For this analysis, an average savings of 16.5 

percent savings annually was assumed. However, because EPA is phasing-in electronic reporting 

via CDX over a two-year period, Agency savings will not be fully realized until the end of the 

two-year phase-in period. 

6(d) Bottom Line Burden Hours and Cost

Table 9. Total Annual Bottom Line Burden and Costs / Master Table

Collection Activity Annual Burden Hours Annual Costs

Annual Respondent Burden and Costs

Additional New Chemicals Program Burden 

Under the e-PMN Rule (Table 1)

353 $19,404

Additional Existing Chemicals Program 

Burden Under the e-PMN Rule (Table 2)

10 $594

Respondent Total 363 $19,998.00

 

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

2004.pg 19. Following the methodology in the CROMERR Cost Benefit Analysis, this cost is distributed over the 

first two years following promulgation of the rule.
December 15, 2009

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6(e) Reason for Changes in Burden

Not applicable. This request describes new paperwork activities related to the 

implementation of the final e-PMN rulemaking. These activities include CDX registration, CDX 

electronic signature, setting up a Pay.gov account for online fee payments, and rule 

familiarization. New Chemicals program respondents will incur an annual average of 353 

additional hours of rule implementation burden, and Existing Chemicals program respondents an 

annual average of 10 additional hours. The estimated total annual rule-related burden is 363 

hours. This increase is a program change.

EPA expects that this increase will be offset by substantial burden reductions brought on 

by efficiencies related to electronic reporting upon implementation of the final rule. These 

expected reductions are summarized in section 6(b) and described in detail in Appendix 1.

6(f) Burden Statement

The estimated annual respondent burden for this rule-related collection is 363 hours and 

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

for requesting a CDX electronic signature, 0.1 hours for establishing an account for electronic 

fee payments, and 0.8 hours for rule familiarization. According to the Paperwork Reduction Act, 

“burden” means the total time, effort, or financial resources expended by persons to generate, 

maintain, retain, or disclose or provide information to or for a Federal agency. For this 

collection it includes the time needed to review instructions; develop, acquire, install and utilize 

technology and systems for the purposes of collecting, validating, and verifying information, 

processing and maintaining information, and disclosing and providing information; adjust the 

existing ways to comply with any previously applicable instructions and requirements; train 

personnel to be able to respond to a collection of information; search data sources; complete and 

review the collection of information; and transmit or otherwise disclose the information. An 

agency may not conduct or sponsor, and a person is not required to respond to, a collection of 

information unless it displays a currently valid OMB control number. The OMB control number 

for this information collection appears above. The OMB control numbers for EPA’s regulations 

in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9 and 

included on the related collection instrument or form, if applicable.

The Agency has established a public docket for the final rule under Docket ID No. EPAHQ-OPPT-2008-0296, which is available for online viewing at www.regulations.gov, or in 

person viewing at the Pollution Prevention and Toxics Docket in the EPA Docket Center 

(EPA/DC). The EPA/DC Public Reading Room is located in the EPA West Building, Room 

3334, 1301 Constitution Ave., NW.,Washington, DC. The EPA/DC Public Reading Room is 

open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The 

telephone number for the EPA/DC Public Reading Room is (202) 566-1744, and the telephone 

number for the Pollution Prevention and Toxics Docket is (202) 566-0280. You may submit 

comments regarding the Agency's need for this information, the accuracy of the provided burden 

estimates and any suggested methods for minimizing respondent burden, including the use of 

automated collection techniques.
December 15, 2009

Page 25 of 28

Submit your comments, referencing Docket ID No. EPA-HQ-OPPT-2008-0296 and 

OMB Control No. 2070-NEW, to (1) EPA online using www.regulations.gov (our preferred 

method), or by mail to: Document Control Office (DCO), Office of Pollution Prevention and 

Toxics (OPPT), Environmental Protection Agency, Mail Code: 7407T, 1200 Pennsylvania Ave., 

NW, Washington, D.C. 20460, and (2) OMB by mail to: Office of Information and Regulatory

Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th 

Street, NW, Washington, DC 20503.
December 15, 2009

Page 26 of 28

 REFERENCES 

BLS, 2007. Employer Costs for Employee Compensation Summary, Private industry workers, 

Goods-producing industries, white-collar occupations, Table 11. U.S. Department of 

Labor, Bureau of Labor Statistics. Washington, DC. December 2007.

BLS, 2007a. Producer Price Index for the Chemical Manufacturing Industry. Series Id 

PCU325. Create Customized Tables” link at http://www.bls.gov/ppi/home.htm#data

Washington, DC. December 2007. 

EPA, 1984. AReview of Agency SNUR Costs.@ Memorandum to Susan Hazen, Office of Toxic 

Substances, from Michael Shapiro. Washington, DC. November 16, 1984.

EPA, 1985. Response times and Labor Costs Final Data Element List Comprehensive 

Assessment Information Rule. Washington, DC. April 30, 1985. pp. 94-106.

EPA, 1992. Instructions for Preparing Information Collection Requests (ICRs). U.S.EPA ,

Office of Policy, Planning, and Evaluation. Washington, DC. June 1, 1992.

EPA, 1994. Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 

Premanufacture Notifications. U.S.EPA, Office of Pollution Prevention and Toxics,

Regulatory Impacts Branch. Washington, DC. September 9, 1994. 

EPA, 1999. Economic Analysis of Expedited Significant New Use Rules for 41 Chemical

Substances and Background Support Document for Economic Analysis of Significant 

New Use Rules. U.S.EPA, Office of Pollution Prevention and Toxics, Economic and 

Policy Analysis Branch. Washington, DC. July 20, 1999.

EPA, 2002. Wage Rates for Economic Analysis of the Toxics Release Inventory Program. 

U.S.EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis 

Branch. Washington, DC. June 10, 2002.

EPA, 2002a. Revised Economic Analysis for the Amended Inventory Update Rule: Final Report. 

U.S.EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis 

Branch. Washington, DC. August 2002.

EPA, 2003. Burden Cost Analysis Supporting the Information Collection Request Renewal for 

TSCA Section 5 Premanufacture Notifications. U.S.EPA, Office of Pollution Prevention 

and Toxics, Economic and Policy Analysis Branch. Washington, DC. August 15, 2003.

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

Washington, DC. November 17, 2004.

EPA, 2007. Business Case Analysis of EPA’s Central Data Exchange. U.S. EPA, Office of 

Environmental Information. Washington, DC. March 2007.
December 15, 2009

Page 27 of 28

EPA, 2009. Economic Analysis of the Premanufacturing Notification Electronic Reporting Final

Rule. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy

Analysis Branch. Washington, DC. July 13, 2009.

EPA, 2009. Economic Analysis of the Amendment to the Polymer Exemption Rule 

to Exclude Certain Perfluorinated Polymers. Office of Pollution Prevention and Toxics, 

Economic and Policy Analysis Branch. Washington, DC. July 17, 2009.

OPM, 2007. U.S. Office of Personnel Management. Salary Table 2007-DCB (Washington –

Baltimore-Northern Virginia, DC-MD-VA-WV-PA). 2007.
December 15, 2009

Page 28 of 28

LIST OF APPENDICES

Appendices and attachments to the supporting statement are available in the public docket 

established for the final rule under docket identification number EPA-HQ-OPPT-2008-0296. 

They are available for online viewing at www.regulations.gov or otherwise accessed as described 

in section 6(f) of the supporting statement.

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

ATTACHMENTS TO THE SUPPORTING STATEMENT

Attachment 1: 15 U.S.C. 2604 – Section 5 of the Toxic Substances Control Act. Also 

available at online at the US House of Representatives’ US Code website

Attachment 2: 40 CFR Part 700 –General. Also available online at the National 

Archives and Records Administration’s Electronic CFR Website

Attachment 3: 40 CFR Part 720 – Premanufacture Notification. Also available online 

at the National Archives and Records Administration’s Electronic CFR 

Website

Attachment 4: 40 CFR Part 721 – Significant New Uses Of Chemical Substances. Also 

available online at the National Archives and Records Administration’s 

Electronic CFR Website

Attachment 5: 40 CFR Part 723 - Premanufacture Notification Exemptions. Also 

available online at the National Archives and Records Administration’s 

Electronic CFR Website

Attachment 6: 40 CFR Part 725 – Reporting Requirements And Review Processes 

For Microorganisms. Also available online at the National Archives and 

Records Administration’s Electronic CFR Website

Attachment 7: EPA Form 7710-25 – Premanufacture Notice. Also available online at 

http://epa.gov/oppt/newchems/pubs/pmnforms.htm

Attachment 8: EPA Form 7710-56 – Notice of Commencement of Manufacture or 

Import. Also available online at 

http://epa.gov/oppt/newchems/pubs/pmnforms.htm

Attachment 9: EPA Form 6300-07 – EPA Biotech Form. Generated only when 

preparing a biotech notice using e-PMN software.

Attachment 10: Screenshots of e-PMN Software Tool

Attachment 11: Derivation of Industry Wage Rates and Agency Costs