Document ID: EPA-HQ-OPPT-2008-0296-0010
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-01-06T05:00Z

Supporting Statement for a Request for OMB Review under

the Paperwork Reduction Act

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 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.

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.

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.

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 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 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).

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 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,   SEQ CHAPTER \h \r 1 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: 

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. 

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.

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). 



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.

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 ( 
HYPERLINK "http://www.epa.gov/opptintr/newchems/pubs/pmnpart1.pdf" 
http://www.epa.gov/opptintr/newchems/pubs/pmnpart1.pdf  and   HYPERLINK
"http://www.epa.gov/opptintr/newchems/pubs/pmnpart2.pdf" 
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 e-PMN 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. 

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 CDX-based 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 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 non-editable.  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. 

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 toll-free
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).

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 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)	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 account	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.

		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	 

  =SUM(ABOVE)  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. 



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	 

  =SUM(ABOVE)  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 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

SNUN1	2.00	1.00	1.00

LVE	2.00	1.00	1.00

LoREX	2.00	1.00	1.00

MCAN	2.00	1.00	1.00

TME	2.00	1.00	1.00

TERA	2.00	1.00	1.00

Tier I	2.00	1.00	1.00

Tier II	2.00	1.00	1.00

5(e) Test submissions	35.0	17.5	17.5

NOC	0.25	0.125	0.125

1The 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.

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.
 The 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.



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
3rd-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.

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.

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

	  =SUM(ABOVE)  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

	  =SUM(ABOVE)  594 

	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. Loaded
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 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.  In 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   SEQ CHAPTER \h \r 1 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	  =SUM(ABOVE)  $19,998.00 

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. EPA-HQ-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.

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.

                                                                    
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  
HYPERLINK "http://www.bls.gov/ppi/home.htm#data" 
http://www.bls.gov/ppi/home.htm#data  Washington, DC.  December 2007.  

EPA, 1984.  (Review 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.   SEQ CHAPTER \h \r 1 Burden Cost Analysis Supporting the
Information Collection Request Renewal for TSCA Section 5 Premanufacture
Notifications.   SEQ CHAPTER \h \r 1  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. 

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.

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   HYPERLINK "http://www.regulations.gov_" 
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’  HYPERLINK
"http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t13t16+21
52+0++%28%29%20%20AND%20%28%2815%29%20ADJ%20USC%29%3ACITE%20AND%20%28USC
%20w%2F10%20%282604%29%29%3ACITE%20%20%20%20%20%20%20%20%20" US Code
website 

Attachment 2:	40 CFR Part 700 –General. Also available online at the
National Archives and Records Administration’s  HYPERLINK
"http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=1cbb423ae22d6c
a5e6da818be3004c98&rgn=div5&view=text&node=40:30.0.1.1.1&idno=40"
Electronic CFR Website 

Attachment 3:	40 CFR Part 720 – Premanufacture Notification. Also
available online at the National Archives and Records Administration’s
  HYPERLINK
"http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=1cbb423ae22d6c
a5e6da818be3004c98&rgn=div5&view=text&node=40:30.0.1.1.9&idno=40" 
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  HYPERLINK
"http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=1cbb423ae22d6c
a5e6da818be3004c98&rgn=div5&view=text&node=40:30.0.1.1.10&idno=40"
Electronic CFR Website 

Attachment 5:	40 CFR Part 723 - Premanufacture Notification Exemptions.
Also available online at the National Archives and Records
Administration’s  HYPERLINK
"http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=1cbb423ae22d6c
a5e6da818be3004c98&rgn=div5&view=text&node=40:30.0.1.1.11&idno=40"
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  HYPERLINK
"http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=5afa024d40ea93
4ec5fabe8982d90e8e&rgn=div5&view=text&node=40:30.0.1.1.12&idno=40"
Electronic CFR Website 

Attachment 7:	EPA Form 7710-25 – Premanufacture Notice.  Also
available online at   HYPERLINK
"http://epa.gov/oppt/newchems/pubs/pmnforms.htm" 
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   HYPERLINK
"http://epa.gov/oppt/newchems/pubs/pmnforms.htm" 
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

 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.

 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.

 Based on Engineering Estimates of reporting e-mail address for TRI
Reporting.  Memo entitled TRI Reporting Burden Estimates from Hilary
Eustace, David Cooper and Susan Day, Abt Associates, to Paul Borst, US
EPA.., July, 2004.

 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.

 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. 

 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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