[Federal Register Volume 75, Number 3 (Wednesday, January 6, 2010)]
[Rules and Regulations]
[Pages 773-790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-31004]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 700, 720, 721, 723, and 725

[EPA-HQ-OPPT-2008-0296; FRL-8794-5]
RIN 2070-AJ41


TSCA Section 5 Premanufacture and Significant New Use 
Notification Electronic Reporting; Revisions to Notification 
Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is amending Toxic Substances Control Act (TSCA) section 5 
reporting regulations at 40 CFR parts 700, 720, 721, 723, and 725. The 
amendments establish electronic reporting requirements for TSCA section 
5 submissions. This action is intended to streamline and reduce the 
administrative costs and burdens of TSCA section 5 notifications for 
both industry and EPA by establishing standards and requirements for 
the use of EPA's Central Data Exchange (CDX) to electronically submit 
premanufacture notices (PMNs) and other TSCA section 5 notices and 
support documents to the Agency. EPA is also amending TSCA section 5 
user fee regulations by adding a new User Fee Payment Identity Number 
field to the PMN form, to enable the Agency to match more easily a 
particular user fee with its notice submission. Lastly, EPA is amending 
the PMN form by removing the Agent signature block field, and thus the 
requirement for designated agents to sign the form.

DATES: This final rule is effective April 6, 2010.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPPT-2008-0296. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket 
Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., 
NW., Washington, DC. The EPA/DC Public Reading Room hours of operation 
are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number of the EPA/DC Public Reading Room is 
(202) 566-1744, and the telephone number for the OPPT Docket is (202) 
566-0280. Docket visitors are required to show photographic 
identification, pass through a metal detector, and sign the EPA visitor 
log. All visitor bags are processed through an X-ray machine and 
subject to search. Visitors will be provided an EPA/DC badge that must 
be visible at all times in the building and returned upon departure.

[[Page 774]]


FOR FURTHER INFORMATION CONTACT: For general information contact: Colby 
Lintner, Regulatory Coordinator, Environmental Assistance Division 
(7408M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: [email protected].
    For technical information contact: Greg Schweer, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (202) 564-8469; e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

    You may be affected by this action if you manufacture, import, or 
process chemical substances for commercial purposes that are subject to 
TSCA. Potentially affected entities may include, but are not limited 
to:
     Manufacturers, importers, and processors of chemical 
substances or mixtures (NAICS codes 325 and 324110, e.g., chemical 
manufacturing and processing and petroleum refineries).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in 40 CFR parts 700, 
720, 721, 723, and 725 for TSCA section 5-related obligations. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the technical person listed under FOR 
FURTHER INFORMATION CONTACT.

II. Background

A. What Action is the Agency Taking?

    EPA is issuing these amendments pursuant to TSCA section 5, 15 
U.S.C. 2604. The amendments are to the TSCA Section 5 Premanufacture 
and Significant New Use Notification regulations and related 
provisions. This final rule was proposed in the Federal Register issue 
of December 22, 2008 (Ref. 1). The purpose of the amendments is to 
require use of an electronic reporting mechanism for TSCA section 5 
notices.
    The Government Paperwork Elimination Act (GPEA) (Public Law 105-277 
(44 U.S.C. 3504)) requires Federal agencies to provide for the:
    1. Option of electronic maintenance, submission, or disclosure of 
information, when practicable as a substitute for paper.
    2. Use and acceptance of electronic signatures, when practicable. 
EPA's Cross-Media Electronic Reporting Regulation (CROMERR) (40 CFR 
part 3), published in the Federal Register issue of October 13, 2005 
(Ref. 2) provides that any requirement in title 40 of the CFR 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 (See 
Unit III.F. for more information on electronic signatures.).
    In light of GPEA and CROMERR, EPA is issuing these amendments to 
require manufacturers (including importers) and processors of TSCA 
chemical substances to use the Internet, through EPA's CDX, to submit 
TSCA section 5 notices and related documents to the Agency. These 
include PMNs (40 CFR part 720), Significant New Use Notices (SNUNs) (40 
CFR part 721), Test Market Exemption Applications (TMEAs) (40 CFR part 
720), Low Volume Exemption notices (LVEs) (40 CFR 723.50), Low 
Exposure/Low Release Exemption (LoRex) notices (40 CFR 723.50), 
biotechnology notices for genetically modified microorganisms (40 CFR 
part 725), Notices of Commencement of Manufacture or Import (NOCs) (40 
CFR 720.102), and other support documents (e.g., correspondence, 
requests for suspensions of the notice review period, amendments, and 
test data).
    The Agency is introducing CDX reporting in three phases over a 2-
year period. During the first year following the effective date of this 
final rule, the Agency will allow submissions via CDX, optical disc (CD 
or DVD), and paper. Regardless of the method of submission, EPA will 
require that all submissions be generated using the new electronic-PMN 
(e-PMN) software. One year after the effective date of this final rule, 
paper submissions will no longer be accepted for any new notices and 
support documents (including NOCs), though optical discs may continue 
to be used. Two years after the effective date of this final rule, 
optical discs will no longer be accepted, and all submitters must 
submit the notices and support documents identified in Table 1 of Unit 
III.I. via CDX. The phased approach allows submitters to gain 
experience in using the e-PMN software and the submission delivery 
system.
    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 new field will enable the Agency to more easily match a 
particular user fee with its notice submission. The second new 
information element on the amended PMN form will be optional and 
consist simply of the e-mail address for the Authorized Official (AO) 
submitting the notice listed on the ``Submitter Identification'' 
section on page 3 of the PMN form. EPA is also removing the required 
Agent signature block field on page 2 of the form.

B. What is the Agency's Authority for Taking this Action?

    Section 5(a)(1)(A) of TSCA requires persons to notify EPA at least 
90 days before manufacturing a new chemical substance for commercial 
purposes (under TSCA manufacture includes import). Section 3(9) of TSCA 
defines a ``new chemical substance'' as any substance that is not on 
the TSCA 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 manufacturing or processing the chemical substance for 
that use. GPEA requires Federal agencies to provide for the:
     1. Option of electronic maintenance, submission, or disclosure of 
information, when practicable as a substitute for paper.
    2. Use and acceptance of electronic signatures, when practicable.

C. How are Premanufacture Notices and Other TSCA Section 5 Notices 
Currently Submitted and Processed by the Agency?

    Currently, TSCA section 5 submissions must be sent to EPA on paper 
through the U.S. mail or delivered by courier. Submitters are able to 
use electronic means to generate hard copies for certain TSCA section 5 
notices, using the PMN form available on EPA's TSCA New Chemicals 
Program website (https://cdx.epa.gov/ssl/pmn/download.asp). The form 
can be filled out using the free Adobe Reader, which

[[Page 775]]

allows submitters to complete the form electronically and then print 
out and mail it to EPA as hard copy. The Adobe Reader allows the user 
to complete and print the form, but it does not allow the user to save 
the form. Approximately 35% of TSCA section 5 notices are currently 
generated using this software. Most of the remaining submissions are 
generated using other software that has been developed by industry 
trade groups or individual notice submitters. A very small percentage 
of submitters choose to fill out the PMN form by hand or typewriter, 
using a version of the form downloaded from EPA's TSCA New Chemicals 
Program website (See http://www.epa.gov/opptintr/newchems/pubs/pmnpart1.pdf and http://www.epa.gov/opptintr/newchems/pubs/pmnpart2.pdf.).
    If the submitter marks anything on the PMN form as CBI, then the 
submitter must submit one version of the form containing the CBI and 
another version of the form without CBI. The latter version is referred 
to as the sanitized or non-CBI version and is required for the public 
docket.
    Upon receipt at EPA, paper submissions are assigned a ``mail 
received'' number, which is used to identify the submission until an 
official document control number (DCN) is generated, which does not 
occur until EPA verifies that the notice is complete. Once the mail 
information is captured, the submission is sent for prescreening. 
During prescreening, the submission is checked for completeness using 
criteria listed at 40 CFR 720.65. If the notice does not pass 
prescreening, EPA declares the original notice ``Incomplete'' and 
notifies the submitter that information is missing or incorrect, and 
that the submitter must correct the package and provide a new 
submission to EPA. If a new notice is not submitted, EPA will return 
the user fee.
    After a successful prescreening, EPA generates a DCN and barcode 
for the submission. EPA also generates a DCN and barcode for the non-
CBI version of a CBI submission and places the non-CBI version in the 
public docket. The original CBI submission is then kept in a hard copy 
case file folder in a TSCA CBI storage area for reference. Any 
supporting documents for the CBI submission are also assigned DCNs and 
barcodes, and placed in the hard copy case file folder.

III. Description of Changes for TSCA Section 5 Reporting

     This unit provides a detailed description of EPA's electronic 
reporting software, the changes to the reporting process, the benefits 
of electronic reporting to both industry and EPA, and how EPA is 
phasing-in the electronic reporting.

A. What is CDX?

    EPA's CDX is the point of entry on the Environmental Information 
Exchange Network (Exchange Network) for environmental data submissions 
to the Agency. CDX provides the capability for submitters to access 
their data through the use of web services. CDX enables EPA and 
participating program offices to work with stakeholders-including 
State, tribal, and local governments and regulated industries-to enable 
streamlined electronic submission of data via the Internet. For more 
information about CDX, go to http://www.epa.gov/cdx.

B. What is the e-PMN Software?

    EPA has developed e-PMN software for use in preparing and 
submitting PMNs and other TSCA section 5 notices and support documents 
electronically to the Agency. EPA is providing two different variations 
of the e-PMN software, one with encryption and one without encryption. 
The e-PMN software with encryption, available on EPA's CDX website 
(http://cdx.epa.gov/epa_home.asp), accommodates electronic submission 
through CDX. The e-PMN software without encryption is available through 
EPA's TSCA New Chemicals Program website (http://www.epa.gov/oppt/newchems). Both variations of the e-PMN software are available free of 
charge as Internet downloads. The e-PMN software without encryption 
will also be available on optical discs provided by the Agency upon 
request (See Unit III.H. for more details.).
    The e-PMN software works with Windows, Macs, Linux, and UNIX-based 
computers, using Extensible Markup Language (XML) specifications for 
more efficient data transmittal across the Internet. The e-PMN software 
operates using the Java 6 programming language, which can be downloaded 
free from http://www.java.com, if it is not already installed on your 
computer. The e-PMN software provides user-friendly navigation, works 
with CDX to secure on-line communication, and can create a completed 
Portable Document Format (PDF) file using the PMN form to accommodate 
internal company review prior to submission or for submission to EPA 
during the 2-year period before which CDX submission is required.
    The e-PMN software includes features intended to be helpful for 
preparing PMNs and other notices using the PMN form, such as SNUNs. A 
validation mechanism alerts users when a field on the form, required by 
regulation, is either missing information or contains certain kinds of 
potentially incorrect information. For example, if ``use'' information 
is claimed CBI, then the e-PMN software indicates that the form is not 
complete unless the submitter has provided both specific use 
information on the CBI version of the form and generic use information 
on the non-CBI version of the form. The e-PMN software includes header 
pages for biotechnology notices (i.e., Microbial Commercial Activity 
Notices (MCANs), TSCA Experimental Release Applications (TERAs), TMEAs, 
and Tier I or Tier II Exemption Requests), support documents, and 
attachments--any document not submitted on the PMN form itself--that 
identify submitters and the nature of their communications.
    Guidance documents developed by EPA for TSCA section 8(a) Inventory 
Update Rule (IUR) reporting via CDX are available at http://www.epa.gov/opptintr/iur/pubs/factsheet.pdf and http://www.epa.gov/opptintr/iur/pubs/cdx_qanda.pdf. These documents provide background 
information on reporting via CDX that is relevant and useful for TSCA 
section 5 reporting as well. EPA has developed similar specific 
guidance for TSCA section 5 reporting via CDX, along with the e-PMN 
submission software, available on EPA's TSCA New Chemicals Program 
website (http://www.epa.gov/oppt/newchems).

C. What Are the Benefits of CDX Reporting and Use of the e-PMN 
Software, Compared to the Existing Paper Method?

    The change to phase-out paper-based submissions in favor of CDX 
reporting, including use of the e-PMN reporting software, is in concert 
with broader government efforts to move to modern, electronic methods 
of information gathering. The use of CDX for submission of TSCA section 
5 notices and support documents is consistent with GPEA, that requires 
Federal agencies to provide for the:
     1. Option of electronic maintenance, submission, or disclosure of 
information, when practicable as a substitute for paper.
    2. Use and acceptance of electronic signatures, when practicable.
    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 register with EPA to submit their 
data electronically to the Agency via CDX and the Agency will benefit 
from

[[Page 776]]

receiving electronic submissions. Data systems that once were populated 
manually will now be populated electronically, reducing the potential 
for 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 or courier 
services. PMN electronic 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 (See 
Unit V. for more detail.). It also will allow submitters to share a 
draft notice within the 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.
    Please note that although submitters will be able to communicate to 
EPA via CDX after the effective date of this final rule, the capacity 
will not initially be available for EPA to communicate back to 
submitters via CDX at the time this final rule becomes effective 
(except for e-mails related to CDX registration and copy of record 
notifications). Two examples of routine communications from EPA that 
are planned to be sent via CDX rather than the U.S. mail are the 
``Acknowledgement Letter'' (acknowledging receipt of a notice) and the 
``Incomplete Letter'' (stating why a notice has been declared 
incomplete by EPA). EPA will continue sending these letters by paper 
until approximately 1 year after the effective date of this final rule. 
EPA will issue a document in the Federal Register when EPA has the 
ability to send these letters electronically.
    All information sent by the submitter via CDX will be transmitted 
securely to protect CBI. Furthermore, if anything in the submission has 
been claimed CBI, a non-CBI copy of the notice must be provided by the 
submitter. The new e-PMN software will facilitate the creation of this 
non-CBI version, eliminating the need for the submitter to do this 
manually.

D. What Are the Changes to the Existing PMN Form?

    EPA is amending the PMN form in order to collect two new 
information elements. First, 40 CFR part 700 requires submitters to 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 electronically. The second new 
information element on the amended PMN form will be optional and 
consist simply of the e-mail addresses for the AO or AOs listed on the 
Submitter Identification section on page 3 of the PMN form. The e-mail 
address will enable the Agency to contact the submitter through e-mail, 
facilitating communications related to the submission.
    EPA is also removing the required Agent signature block field on 
page 2 of the PMN form. On the existing PMN form, if a manufacturer/
importer subject to the notice requirements in 40 CFR part 720 
designates an agent to submit the form pursuant to 40 CFR 720.40(e), 
both the manufacturer/importer and the agent must sign the form. EPA is 
removing the requirement that agents sign the PMN form because few 
agents have submitted forms in the past, and the Agent signature block 
is rarely used by the Agency. Eliminating the second signature also 
simplifies development of the e-PMN form. Note that a form submitted by 
an agent will still have to be signed by the manufacturer/importer's AO 
(an electronic signature if submitted via CDX), and the agent's name 
and contact information will still be provided on page 3 of the PMN 
form. The AO remains responsible for false or misleading statements in 
the notice.
    The e-PMN software will allow users to print paper copies for 
internal company use. The printed version of the amended e-PMN form 
will have the same general look of the current paper PMN form, i.e., 
containing the same fields (with the modifications to the form 
discussed in Unit III.D.) and the same pagination. However, fields have 
been expanded to make more room for submitter information, resulting in 
a larger total number of pages, and realigned to make the form easier 
to scan. Persons who choose to submit PMNs on paper during the first 
year after the effective date of this final rule will be required to 
use the new e-PMN software to generate the paper form for each PMN or 
other TSCA section 5 notices they submit. EPA is requiring use of the 
new paper form because the Agency has incorporated into the form many 
scanning efficiencies for the electronic capturing of data that will be 
lost if a blank PMN form is printed, photocopied, and used for another 
submission.

E. How Will PMNs be Submitted via the Internet Using CDX?

    In order to submit TSCA section 5 notices via the Internet, 
submitters will have to register with EPA's CDX and use the e-PMN 
software to prepare a data file for submission through CDX.
    1. Registering with CDX. To register with CDX, the submitter can 
click on the website, http://cdx.epa.gov/epa_home.asp. The submitter 
will be asked to agree to terms and conditions, provide information 
about the submitter and his or her organization, select a user name and 
password, and download, complete, and mail an electronic signature 
agreement to EPA (discussed further in Unit III.F.). The electronic 
signature agreement is needed to identify an authorized person and 
establish a method to electronically sign the submission. Once EPA 
receives the electronic signature agreement, the submitter's user name 
and password will be activated, and only then will the submitter be 
able to send a submission to EPA through CDX. For planning purposes, 
please allow up to 1 week for EPA to process the electronic signature 
agreement and activate the submitter's user name and password.
    EPA has established a 90-day time-frame between the publication 
date and effective date of this final rule. Companies can use this time 
to register with CDX so they are prepared to submit notices to EPA via 
CDX on the effective date of this final rule.
    2. Preparing the submission. All submitters must use the new e-PMN 
software to prepare their submissions of TSCA section 5 notices. EPA is 
providing two different variations of the e-PMN software, one with 
encryption and one without encryption. The e-PMN software with 
encryption, available on EPA's CDX website (http://cdx.epa.gov/epa_home.asp), accommodates electronic submission through CDX. The e-PMN 
software without encryption is available through EPA's TSCA New 
Chemicals Program website (http://www.epa.gov/oppt/newchems). Both 
variations of the e-PMN software are available free of charge as 
Internet downloads. The e-PMN software

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without encryption will also be available on optical discs provided by 
the Agency upon request (See Unit III.H. for more detail.).
    The e-PMN software guides users through the process of creating a 
PMN submission on their computers. Once a user completes the relevant 
data entry, the software will validate the submission by performing 
basic error checks and making sure all the required fields are 
completed, allow the user to create and save the submission for company 
records, and prompt users to choose a submission method.
    3. Completing the submission to EPA. During the 2-year phase-in 
period when paper and/or optical disc submission will still be allowed, 
the software will, as appropriate, also allow the user to choose 
``Print,'' ``Save as a PDF,'' ``Save as an XML file'' for a submission 
on an optical disc, or ``Transmission through CDX.'' While permitted, 
submissions made in paper or using an optical disc will need to be 
mailed or delivered to EPA in the same manner that they are currently. 
When ``Transmission through CDX'' is selected, the user will be asked 
to provide the user name and password that were created during the CDX 
registration process. The software will then encrypt the file and 
submit it via CDX to EPA.

F. What is the Electronic Signature Agreement for the e-PMN?

    In order to submit electronically to EPA via CDX, submitters of all 
TSCA section 5 documents must first register with CDX. One must 
register either as:
    1. An AO of a company who can send all types of TSCA section 5 
documents to EPA via CDX or
    2. Someone authorized by the AO to send TSCA section 5 supporting 
documents to EPA via CDX. Note, however, that AOs are the only persons 
allowed to send TSCA section 5 notices and Letters of Support to EPA 
via CDX.
    There are two ways that joint submissions can be submitted to EPA 
via CDX. The first way is for each joint submitter to fill out his or 
her portion of the submission in separate notice forms. These forms are 
linked to each other within EPA via a common identifying number--a 
``TS'' number (See regulatory text language in 40 CFR 700.45(e)(3).)--
which both companies are required to develop together and put on their 
respective forms. The second way is for one of the joint submitters to 
provide supporting information in a Letter of Support. Both will 
require the AOs of the joint submitting companies to register in order 
to submit to EPA via CDX.
    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 AO agrees to certain CDX security 
conditions. On the ``Verification of Company Authorizing Official'' 
form, the AO designates himself or 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 described in Unit III.F. are received, EPA 
activates the submitter's registration in CDX and sends him or her an 
e-mail notification. Submitters will need to complete and sign these 
forms only once.

G. Will CBI be Protected When Submitting via CDX?

    Yes. EPA will ensure secure transmission of PMN data sent from the 
user's desktop through the Internet via the Transport Layer Security 
(TLS) 1.0 protocol. TLS 1.0 is a widely used approach for securing 
Internet transactions, and is endorsed by the National Institute of 
Standards and Technology (NIST) for protecting data sent over the 
Internet. See NIST Special Publication 800-52, ``Guidelines for the 
Selection and Use of Transport Layer Security (TLS) Implementations,'' 
http://csrc.nist.gov/publications/nistpubs/800-52/SP800-52.pdf.
    In addition, e-PMN software supports EPA's CROMERR requirements, as 
described under 40 CFR part 3, by enabling the submitter to 
electronically sign, encrypt, and submit submissions which EPA 
subsequently provides back to the submitter as an unaltered copy of 
record. This assures the submitter that the Agency has received exactly 
what the submitter sent to EPA. The current version of the e-PMN 
encrypts using Federal Information Processing Standards (FIPS)-
validated RSA BSAFE Crypto-J. EPA may incorporate other encryption 
modules into future versions of e-PMN. Information submitted via CDX is 
processed within EPA by secure systems certified for compliance with 
FIPS.

H. Will EPA Make a Version of the Software Without Encryption Available 
for Users Who Want to Obtain the Software Without Registering via CDX?

    Yes. EPA is providing two different variations of the e-PMN 
software, one with encryption and one without encryption. The e-PMN 
software with encryption, available on EPA's CDX website (http://cdx.epa.gov/epa_home.asp), accommodates electronic submission through 
CDX. This software contains an application program interface that 
allows the submitter to interact with CDX to encrypt the submission 
using FIPS-validated RSA BSAFE Crypto-J. The encryption software is 
subject to restrictions under the Export Administration Act of 1979, 
Public Law 96-72, 93 Stat. 503, as amended. Making this e-PMN software 
with encryption available only through EPA's CDX website will enable 
EPA to restrict and monitor the issuance of this ``Encryption 
Software'' according to export control requirements by requiring CDX 
registration before the controlled software can be downloaded.
    The e-PMN software without encryption, available through EPA's TSCA 
New Chemicals Program website (http://www.epa.gov/oppt/newchems), does 
not contain FIPS-validated RSA BSAFE Crypto-J or the application 
programming interface to enable the submitter to interact with CDX to 
encrypt the submission.
    The e-PMN software, both with and without encryption, produce 
identical e-PMN files; however, only by registering through CDX can the 
e-PMN software with encryption (containing the application program 
interface to encrypt submissions) be downloaded and used for sending 
files to EPA via CDX. Users of the e-PMN software without encryption do 
not have to register with CDX. The e-PMN software without encryption 
can be used to create a paper PMN form for submission during the first 
year after the effective date of this final rule, or to create a PMN 
file that

[[Page 778]]

can be saved to an optical disc and submitted to EPA during the first 2 
years after the effective date of this final rule. The software without 
encryption also allows users to create an e-PMN file that can be 
uploaded to the e-PMN software with encryption, to send to EPA via CDX.
    The variations of the e-PMN software, both with and without 
encryption, are accessible through EPA's TSCA New Chemicals Program 
website (http://www.epa.gov/oppt/newchems). There is a link on EPA's 
TSCA New Chemicals Program website to EPA's CDX website (http://cdx.epa.gov/epa_home.asp), where users can download the e-PMN software 
with encryption after they register with CDX and EPA approves their 
registration. Units III.E. and III.F. describe how to register with CDX 
and the information that is necessary to provide to EPA for approval 
consideration. It will take EPA approximately 1 week to process and 
approve CDX registrations. The e-PMN software without encryption can be 
downloaded directly from EPA's TSCA New Chemicals Program website 
without CDX registration or EPA approval.
    If and when EPA makes changes to the e-PMN software, an automatic 
download of the updated software will be triggered when a submitter 
opens their existing variation of the software (i.e., the with and 
without encryption variations). Submitters will then be required to 
validate their submissions with this new version before submitting to 
EPA. e-PMN software installed from optical discs will not automatically 
be updated with new versions of the software. However, EPA will keep a 
list of all submitters that request optical discs. If major revisions 
to the software are made during the first two years after the effective 
date of the final rule, EPA will notify these submitters of the 
availability of the updated software.

I. Must I Use the e-PMN Software for Any Paper or Optical Disc 
Submissions During the 2-Year Phase-In Period?

    Yes. On the effective date of this final rule, submitters must use 
the e-PMN software to generate TSCA section 5 notices, NOCs, and 
support documents regardless of whether they are submitted via CDX, on 
optical disc, or in paper form (40 CFR part 720.3 defines ``support 
documents'' as materials and information submitted to EPA in support of 
a TSCA section 5 notice, including but not limited to, correspondence, 
amendments, and test data. The term ``support documents'' does not 
include orders under TSCA section 5(e) (either consent orders or orders 
imposed pursuant to TSCA section 5(e)(2)(B))). EPA will not accept 
paper submissions that use either the old version of the paper PMN form 
or the amended form filled in by hand or typewriter. The Agency will 
make available free Internet downloads or, upon request, optical discs 
that contain the version of e-PMN software lacking encryption. All e-
PMN software users, regardless of how a document is submitted, must 
undergo a ``finalization'' step in generating a document. During the 
finalization step, the e-PMN software checks that all required fields 
contain information and provides warnings for certain kinds of missing, 
incomplete, or incorrect data. Notices submitted on paper or optical 
disc containing data which have not undergone finalization will be 
declared ``Incomplete'' by EPA. This step is necessary to allow for an 
accurate and efficient transfer of data from an optical disc or a paper 
form to the EPA data systems, and also enables the generation of a non-
CBI version.
    Anyone submitting the paper form generated using the e-PMN software 
must submit the notice to the Agency via U.S. mail or a courier 
service. The paper form must be hand signed on page 2. If the submitter 
makes any CBI claims, the original submission needs to include both the 
CBI version and a non-CBI version.
    Optical discs must be submitted with an original hand-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 
optical disc is not readable). Optical discs must be delivered only by 
courier service, to avoid damage to the disk from the Agency's mail 
screening equipment.

J. How Will Electronic Submission of TSCA Section 5 Notices that 
Currently Have No Required or Official Forms be Handled by CDX or the 
e-PMN Software?

    Certain TSCA section 5 notices such as LVE modifications, LoREX 
modifications, TMEAs, and biotechnology notices currently have no 
required or official forms. In order to allow for electronic and paper 
submission of these notices using the e-PMN software and CDX, the 
Agency is requiring the following:
    1. For exemption modifications, submitters must 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 submission containing the information required by 40 CFR 
720.38.
    3. Biotechnology notices (Form 6300-07) will have their own menu 
option. Instead of selecting ``Premanufacture Notice,'' a submitter 
will select ``Biotechnology,'' which will prompt the software to 
present a header page to the submitter with choices of biotechnology 
notices, and space to fill in contact information. The information 
required by 40 CFR part 725 must be submitted as an attachment(s).
    The notices listed in Unit III.I.1.-3. must undergo the 
``finalization'' step (See Unit III.H.). An exemption submission on an 
optical disc must be accompanied by a complete signed hard copy of page 
2 and a complete hard copy of page 3 of the e-PMN form for contact 
information in case the optical disc is not readable. The TMEA will 
only need a complete page 3. The optical discs for both types of 
submissions will need to be delivered by courier to the Agency to avoid 
damage to the optical disc from the Agency's mail screening equipment. 
If submitted by paper, the forms must be generated using the e-PMN 
software and sent to the Agency. For biotechnology notices, a signed 
hard copy of a biotechnology certification must accompany the optical 
disc. The printed form must follow the same procedures: Use the e-PMN 
software to generate a finalized ``header'' sheet with contact data, 
add an attachment with notice information, and include a signature 
page.
    The submission process for completing the various notice and 
document types is summarized in Table 1 of this unit. After the 
effective date of this final rule, all of these notices must be 
prepared using the new e-PMN software.

[[Page 779]]



   Table 1.--Process for Preparing TSCA Section 5 Notices and Support
                                Documents
------------------------------------------------------------------------
       TSCA Section 5 Document                      Process
------------------------------------------------------------------------
PMNs and SNUNs                        Form 7710-25 generated and
                                       finalized by e-PMN software.
------------------------------------------------------------------------
LVE                                   Form 7710-25 generated and
                                       finalized by e-PMN software.
------------------------------------------------------------------------
LoREX                                 Form 7710-25 generated and
                                       finalized by e-PMN software.
TMEA                                  e-PMN software to generate
                                       finalized submission either using
                                       Form 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 with
                                       contact data, add attachment with
                                       notice information, include
                                       signature page using Form 6300-
                                       07.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

K. How Will Submission Requirements and Delivery Methods to EPA Vary 
for Submissions via Paper, Optical Disc, or CDX?

    Depending upon how a notice is submitted, the following submission 
requirements and delivery methods must be used:
    1. Paper. Printed, signed, and ``header'' sheets for attachments; 
delivered by U.S. mail or courier. Allowed for the first year.
    2. Optical discs. Data must be saved as XML files rather than as 
PDF files. Optical discs submitted with an original signed hard copy of 
page 2 (Certification page) and a hard copy of page 3. Delivered by 
courier only. Allowed for the first 2 years only.
    3. CDX. Document developed on-line; simply hit ``send button'' to 
deliver to EPA via CDX.

L. Over What Time-Frame Will the Internet-Based CDX Reporting 
Requirement be Phased-In?

    The Agency is introducing electronic reporting in three phases. In 
the first phase, the Agency is allowing the submission of TSCA section 
5 notices and support documents via CDX, on optical disc, and on paper. 
All submissions (whether submitted via CDX, on optical disc, or on 
paper) must be generated using the new e-PMN software.
    In the second phase, occurring 1 year after the effective date of 
this final rule, paper submissions will no longer be accepted for any 
new notices and support documents (including NOCs). In the third phase, 
at the end of the second year after the effective date of this final 
rule, optical disc submissions for all new notices and support 
documents will no longer be accepted. Thereafter, EPA will accept TSCA 
section 5 notices and support documents only through CDX. TSCA section 
5 notices and support documents not submitted in the appropriate manner 
as set forth in 40 CFR parts 720, 721, and 725 will be considered 
invalid by EPA and returned to the submitter.
    Note that NOCs and support documents whose original notices were 
submitted before the effective date of this final rule will still need 
to be mailed as hard copy to the Agency. This is necessary because, 
although the notices received after implementation of the new system 
will be entered into the newly created EPA database, notices submitted 
before the effective date of this final rule will only exist in EPA's 
``legacy'' database, i.e., the database used prior to the effective 
date of this final rule, and so a subsequent support document will not 
be able to be linked up with its parent notice within EPA's new 
database. The phase-in schedule for submissions is displayed in Table 2 
of this unit.

              Table 2.--e-PMN Phase-In Schedule for TSCA Section 5 Notices and Support Documents\1\
----------------------------------------------------------------------------------------------------------------
                                                                                               Third Year After
                                   Before Effective    First Year After    Second Year After   Effective Date of
       Submission  Method         Date of Final Rule   Effective Date of   Effective Date of    the Final Rule,
                                                          Final Rule          Final Rule        and Thereafter
----------------------------------------------------------------------------------------------------------------
Paper                             Existing PMN form   Scanner-friendly    Invalid             Invalid
                                                       paper form,
                                                       generated and
                                                       finalized using e-
                                                       PMN software
----------------------------------------------------------------------------------------------------------------
Optical disc                      Not applicable      Electronic          Electronic          Invalid
                                                       submission          submission
                                                      generated and       generated and
                                                       finalized using e-  finalized using e-
                                                       PMN software with   PMN software with
                                                       hard copies of      hard copies of
                                                       pages 2 and 3.      pages 2 and 3.
----------------------------------------------------------------------------------------------------------------
CDX/Internet                      Not applicable      Available and       Available and       Mandatory
                                                       optional            optional
----------------------------------------------------------------------------------------------------------------
\1\ NOCs and support documents for notices originally submitted on paper before the effective date of this final
  rule must still be mailed as hard copy.


[[Page 780]]

M. Will EPA Offer Any Exceptions to the e-PMN Requirements?

    No. After careful consideration, the Agency has concluded that the 
overall benefits from everyone using the e-PMN software and submission 
through CDX exceed those associated with maintaining a multi-optioned 
reporting approach (Ref. 3). The Agency recognizes that there is the 
potential for costs and burden associated with predictable or 
unanticipated technical difficulties in electronic filing or with 
conversion to an electronic CDX reporting format. However, EPA expects 
that reduced reporting costs to submitters will ultimately exceed the 
transition costs and that any transition difficulties will be mitigated 
by:
    1. The phase-in periods.
    2. EPA's planned outreach and training sessions prior to the 
effective date of this final rule. The Agency has allowed ample time 
between the date of publication and the effective date of this final 
rule for submitters to install and become proficient with the e-PMN 
software.
    3. EPA's technical support following the effective date of this 
final rule.

N. Will All Types of TSCA Section 5 Notices and Communications be 
Submitted via e-PMN Software?

    At this time, the Agency does not have electronic reporting 
capability for all TSCA section 5-related notices (i.e., Bona Fide 
Intent to Manufacture (bona fide) notices and polymer exemption annual 
reports); support documents (i.e., TSCA section 5(e) consent orders or 
orders imposed pursuant to TSCA section 5(e)(2)(B)); and certain 
communications (e.g., pre-notice communications and TSCA Inventory 
Correspondence), due to the variability and infrequent nature of these 
types of submissions. EPA may consider offering electronic reporting of 
these and other submissions in the future.

IV. Response to Comments

    The Agency received comments from three persons on the proposed 
rule. Copies of all comments received are available in the public 
docket for this action. The comments received on the proposed rule did 
not result in EPA making significant changes to the final rule. A 
discussion of the comments germane to the rulemaking and the Agency's 
responses follow:
    1. Comment--i. Response to Two Questions Listed in Unit V. of the 
Proposed Rule. Unit V. of the proposed rule identified two issues on 
which the Agency was specifically requesting public comment. These 
issues were:
     Whether the proposed 2-year phase-in period following the 
effective date 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.
     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 the effective date 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 TSCA 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.
    ii. Response. EPA retained the 2-year phase-in period for 
electronic submissions which is supported by the comments received. EPA 
did not receive any comments directly related to its burden estimate 
and therefore did not revise the estimate.
    2. Comment--i. Dedicated technical assistance. EPA received 
comments regarding the importance of providing robust technical 
assistance both during and after the 2-year transition period. 
Commenters requested that Agency resources be available for quickly 
resolving any software problems. One commenter asked that the technical 
assistance contacts be knowledgeable about both the system software as 
well as the PMN TSCA section 5 process.
    ii. Response. EPA will provide dedicated technical assistance to 
help submitters. For help with CDX registration, submitters can contact 
the CDX Help Desk. Submitters will be able to call the TSCA Hotline for 
help with basic questions on the TSCA section 5 process. For answers to 
more complex questions, the TSCA Hotline will be equipped to refer 
callers to EPA technical staff experienced with the e-PMN software and 
TSCA section 5. Contact information for the TSCA Hotline, CDX Help 
Desk, and relevant EPA staff are available through EPA's TSCA New 
Chemicals Program website (http://www.epa.gov/oppt/newchems). EPA will 
not, however, have a designated hotline staffed with experts who can 
provide both system software assistance on CDX and the e-PMN and 
respond to detailed TSCA section 5 process questions.
    3. Comment--i. Non-routine information and the e-PMN form. One 
commenter asked how EPA would handle non-routine information that the 
submitter may need to report on the electronic form, but for which 
there is no standardized field. The commenter asked that EPA provide 
consistent and informed guidance for handling these situations for 
which a workaround may be needed.
    ii. Response. A submitter who is unable to enter the necessary 
information on the e-PMN form can contact the TSCA Hotline and/or EPA 
technical experts for assistance. EPA will work with submitters on how 
to express non-routine information on the e-PMN form on a case-by-case 
basis. The ``Helpful Hints: Q and A for Use of the e-TSCA/e-PMN 
Submission Software,'' accessible via EPA's TSCA New Chemicals Program 
website (http://www.epa.gov/oppt/newchems), addresses workaround issues 
that EPA has encountered to date. EPA will update the Q and A on a 
regular basis with new issues and solutions to those issues as they 
arise.
    4. Comment--i. Who will be able to use the electronic submission 
process? One commenter requested that EPA clarify whether the e-PMN 
form will be available only to the manufacturer or importer, or whether 
consultants will be able to prepare and submit PMNs and other TSCA 
section 5 submissions on behalf of clients as well.
    ii. Response. Consultants will not be able to submit PMN notices or 
Letters of Support. Only the AO for the client, registered with CDX, 
can submit PMN notices and/or Letters of Support. However, a consultant 
will be able to submit all other support documents on behalf of the 
client as long as the consultant is:
     Registered in CDX.
     Authorized by the AO in CDX to submit documents on the 
client's behalf.

[[Page 781]]

    EPA will be using a two-tiered approach for registration and 
submission of PMNs. The first tier is the company AO, who, for the 
purposes of EPA's CROMERR and this final rule, is the person who 
certifies and signs the notice. The second tier will be comprised of 
persons designated and authorized by the company's AO to submit 
supporting documents.
    The AO has the ability to submit all documents on the company's 
behalf via CDX. During CDX registration, all AOs will be required to 
fill out two forms: The ``Electronic Signature Agreement'' form in 
which the AO agrees to certain CDX security conditions and the 
``Verification of Company Authorizing Official'' form in which the AO 
designates himself or 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. 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 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. Note, that a 
client, or company, can have multiple AO's.
    The approach described in Unit IV.4. was discussed in the preamble 
of the proposed rule. To clarify the different responsibilities of the 
AO and persons designated to submit support documents on the AO's 
behalf, EPA has added regulatory text at 40 CFR 720.40(e)(3)(i) and 
(ii).
    5. Comment--i. Downloading e-PMN software. One commenter had a 
question about downloading the e-PMN software. The commenter was 
concerned that only individuals within a company could download the 
software from the EPA site onto their individual computers, as opposed 
to a single download onto a company network. The commenter expressed 
the opinion that the system should allow for shared software on a 
computer network.
    ii. Response. The e-PMN software is designed to be used either as a 
stand-alone program on an individual's computer or as a shared system 
on a company's LAN. Many users may access the program at the same time. 
Upon request, EPA will also provide the software to a company on 
optical disc.
    6. Comment --i. Barrier for small and foreign businesses. One 
commenter suggested that for smaller companies, especially those 
outside the United States where English is not the primary language, 
the requirements to register on EPA's CDX and to use the electronic 
reporting software could be overly burdensome. They recommended that 
EPA develop an on-line training module to help address this potential 
problem.
    ii. Response. EPA has options to aid small and foreign businesses. 
These companies can utilize the 2-year phase period to familiarize 
themselves with sending documents via CDX, during which time they may 
still submit information on paper or optical disc for the first year, 
and on optical disc for the second year. These companies will also be 
able to call the TSCA Hotline, CDX Help Desk, and EPA technical staff 
for help with basic questions. Note, that 40 CFR 720.22(a)(3) states 
that, ``Only manufacturers that are incorporated, licensed, or doing 
business in the United States may submit a notice.'' Foreign entities 
not meeting the requirement of 40 CFR 720.22(a)(3), however, may submit 
Letters of Support (See also response to comment 7. in this unit.).
    7. Comment --i. Capability for collaborative efforts with third 
parties. Many companies, particularly smaller businesses, use third 
parties, such as consultants or law firms, in the preparation of TSCA 
section 5 notices. As such, one commenter suggested that the e-PMN 
process should be capable of allowing collaborative efforts with these 
parties and should be as ``user-friendly'' as possible. The commenter 
was concerned that the process could increase burden for smaller 
companies by requiring the company to cut and paste input from the 
third party into the company's final electronic submission.
    ii. Response. EPA believes the new e-PMN form is as ``user-
friendly'' for collaborating with third parties as the current form. To 
work with a third party, the notice preparer will create the draft e-
PMN file. This file is essentially a folder, i.e., one unit made up of 
many documents. The preparer may send the file (which includes the 
attachments as a part of the file structure) to the third party 
electronically, via e-mail, or they can save the file onto an optical 
disc for mailing. This is similar to the current way of doing business 
using the electronic Adobe PMN. There is, however, no process in place 
to use CDX to exchange files between e-PMN users, i.e., the preparer 
and a third party. CDX is only for exchange of information between a 
submitter and EPA.
    8. Comment --i. Linkage with computer models. One commenter 
recommended that the program have the ability to link the output of the 
Sustainable Future's computer modeling and other EPA modeling directly 
into the e-PMN form.
    ii. Response. The xml schema for the e-PMN is available for anyone 
to use to create a program to download data from other models or 
databases into the e-PMN form. Upon installation of the e-PMN software 
a program folder called ``eTSCA'' is created. Within the eTSCA program 
folder is another folder called ``user.'' The schema is available in 
the eTSCA/user folder, entitled ``eTSCA--v1.0.xsd.''
    9. Comment --i. Unique circumstances that may not easily fit within 
electronic reporting requirements. One commenter noted that there are 
unique circumstances that may not easily fit within electronic 
reporting requirements. An example given by the commenter was in 
regards to submitters that work with companies who file Letters of 
Support for a PMN, where the information provided by the supporting 
company is not revealed to the PMN submitter. Under current business 
practices, the company providing the Letter of Support discloses the 
trade secret information that is necessary to complete the PMN directly 
to the Agency. The commenter expressed concern that if those companies 
have difficulty with the requirement to register for CDX, and need to 
gain expertise with the software only to submit what may be a few data 
points, it could impede or block the PMN completion process.
    ii. Response. EPA will remain attentive to these unique 
circumstances and work to develop workable processes. EPA will consider 
providing additional outreach tailored to answer the questions and meet 
of the needs of unique submitter groups. For assistance with CDX, 
submitters can call the CDX Help Desk. For e-PMN or TSCA section 5 
process questions, submitters can call either the TSCA Hotline or the 
appropriate EPA technical experts.

V. Estimated Economic Impact

    The Agency's evaluation of the economic impact of this final rule 
is present in a document entitled ``Economic Analysis of the Amendments 
to TSCA Section 5 Premanufacture and Significant New Use Notification 
Requirements Final Rule'' (Ref. 3), a copy of which is available in the 
docket and is briefly summarized in this unit. EPA estimates

[[Page 782]]

that the electronic submission of TSCA section 5 notices and support 
documents will reduce the burden and cost currently associated with the 
paper-based reporting of TSCA section 5 notices and support documents. 
The burden estimation of 95 to 114 hours to complete the currently 
existing paper PMN form includes the time spent reading and becoming 
familiar with the form, gathering the required information and 
preparing the report, producing non-CBI responses for items claimed as 
CBI, and maintaining a file of the submission (Ref. 4).
    In its economic analysis for the final rule (Ref. 3), EPA estimated 
cost and burden savings at the industry level, at the individual 
company level, and on a per-form basis. Estimates presented in this 
unit are for all TSCA section 5 notices; estimates for PMNs separately 
can be found in the economic analysis.
    At the industry level for all TSCA section 5 notices, EPA estimates 
a net total burden decrease of 14,972 hours in the first year of the 
final rule, 15,700 hours in the second year of the final rule, and 
16,178 hours in the third year of the final rule. Industry savings are 
estimated at 16,187 hours per year for subsequent years of the final 
rule. At the company level for all TSCA section 5 notices, EPA 
estimates an average net total burden decrease of 50.4 hours in the 
first year of the final rule, 51.2 hours in the second and third years 
of the final rule, and 50.4 hours per year for subsequent years of the 
final rule.
    At the industry level for all TSCA section 5 notices, EPA estimates 
a net cost savings of $379,271 in the first year of the final rule, 
$424,863 in the second year of the final rule, and $457,066 in the 
third year of the final rule. Industry savings are estimated at 
$457,628 per year for subsequent years of the final rule. When taking 
into account the lower total number of TSCA section 5 notices expected 
during this 3-year Information Collection Request (ICR) period in 
addition to savings attributable to the final rule, the average annual 
reduction in industry costs is $5.7 million. At the company level for 
all TSCA section 5 notices, EPA estimates an average cost savings of 
$1,352 in the first year of the final rule, $1,396 in the second and 
third years of the final rule, and $1,352 in subsequent years of the 
final rule.
    EPA estimates that the Agency also will experience a reduction in 
both burden and cost to administer the TSCA section 5 premanufacture 
notification program as a result of the final rule. Specifically, EPA 
expects to experience a net burden reduction of 4,521 hours in the 
first year of the final rule, a reduction of 9,042 hours in the second 
year of the final rule, and a reduction of 13,563 hours in the third 
and subsequent years of the final rule. The Agency expects to 
experience a net savings of $214,377 in the first year of the final 
rule, a net savings of $586,108 in the second year of the final rule, 
and a net savings of $1,057,838 in the third and subsequent years of 
the final rule.
    EPA recognizes that information and feedback received during the 2-
year phase-in period, along with experience gained during this phase-in 
period, can be used to further improve the use of the new Internet-
based reporting mechanism. This information will also inform the 
Agency's estimates, which will be reflected in the ICR, which EPA must 
complete every 3 years under the Paperwork Reduction Act (PRA), 44 
U.S.C. 3501 et seq.

VI. References

    The following is a listing of the documents referenced in this 
preamble that have been placed in the public docket for this final rule 
under docket ID number EPA-HQ-OPPT-2008-0296, which is available for 
inspection as specified under ADDRESSES.
    1. EPA. TSCA Section 5 Premanufacture and Significant New Use 
Notification Electronic Reporting; Revisions to Notification 
Regulations; Proposed Rule. Federal Register (73 FR 78261, December 22, 
2008) (FRL-8395-8). Available on-line at: http://www.gpoacess.gov/fr/index.html.
    2. EPA. Cross-Media Electronic Reporting; Final Rule. Federal 
Register (70 FR 59847, October 13, 2005) (FRL-7977-1). Available on-
line at: http://www.gpoacess.gov/fr/index.html.
    3. EPA. Economic and Policy Analysis Branch, Office of Pollution 
Prevention and Toxics (OPPT). Economic Analysis of the Amendments to 
TSCA Section 5 Premanufacture and Significant New Use Notification 
Requirements Final Rule. July 13, 2009.
    4. EPA. Regulatory Impacts Branch, OPPT. Regulatory Impact Analysis 
of Amendments to Regulations for TSCA Section 5 Premanufacture 
Notifications. September 9, 1994.
    5. EPA. Supporting Statement for a Request for OMB Review Under The 
Paperwork Reduction Act. Information Collection Request (ICR): New 
Information Collection Activities Related to Electronic Submission of 
Certain TSCA Section 5 Notices EPA ICR No. 2327.02. OMB Control No. 
2070-0173.

VII. Statutory and Executive Order Reviews

A. Executive Order 12866

    This action is not a ``significant regulatory action'' under the 
terms of Executive Order 12866, entitled Regulatory Planning and Review 
(58 FR 51735, October 4, 1993) and is therefore not subject to review 
under the Executive Order.

B. Paperwork Reduction Act

    The information collection requirements contained in this final 
rule have been submitted for OMB approval under the Paperwork Reduction 
Act (PRA), 44 U.S.C. 3501 et seq. The ICR document prepared by EPA, 
identified under EPA ICR No. 2327.02 and OMB control number 2070-0173, 
is available in the docket for the final rule (Ref. 5). The information 
collection requirements described in the final rule are not enforceable 
until OMB approves them.
    This rule-related ICR covers amendments to existing reporting and 
recordkeeping programs that are approved under OMB control numbers 
2070-0012 and 2070-0038. The final rule amends these existing 
information collections in two ways. First, respondents will be 
required to use the e-PMN software to generate TSCA section 5 notices 
and support documents. After a 2-year phase-in period following the 
effective date of this final rule, respondents will be required use the 
e-PMN software to submit this information to EPA electronically via the 
Agency's CDX. Second, respondents will be required to provide a new 
data element, a User Fee Payment Identity Number, when preparing and 
submitting TSCA section 5 notices and support documents.
    The information collection activities contained in this final rule 
are designed to assist the Agency in meeting its responsibility under 
TSCA to receive, process, and review TSCA section 5 notices and support 
documents in a timely manner and further the proper performance of the 
functions of the Agency. Information collection for review of PMNs and 
all other TSCA section 5 notices and support documents is authorized by 
TSCA section 5 and confidentiality of submitted information is 
protected under TSCA section 14.
    Responses to the collection of information are mandatory. 
Respondents will be required to use the e-PMN software to generate, 
complete, and, ultimately, submit the form. The methods for submitting 
the completed form to EPA will change over a 2-year period following 
the effective date of

[[Page 783]]

this final rule to allow for the new required submission through CDX to 
be fully implemented. In the third year after the effective date of 
this final rule, all TSCA section 5 notices and support documents must 
be submitted to EPA electronically via CDX using the e-PMN software.
    The ICR document for this final rule provides a detailed 
presentation of the estimated burden and costs for 3 years of the 
program. The aggregate burden varies by year during the first 3 years 
of the final rule because of the phase-in schedule of the requirements. 
The rule-related burden and cost to chemical manufacturers, importers, 
and processors who would submit notices to the Agency for review is 
summarized here. The projected total burden to industry is 363 hours 
per year for the first 3 years of the final rule. This 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 final rule familiarization. Burden is defined at 5 CFR 
1320.3(b).
    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 numbers for EPA's 
regulations in 40 CFR are listed in 40 CFR part 9. After approval of 
this rule-related ICR by OMB, the Agency will amend the existing ICRs 
(OMB control numbers 2070-0012 and 2070-0038) to reflect the new 
information collection activities and resulting changes in burden. Upon 
OMB's approval of the amendments to the existing, approved ICRs, EPA 
will discontinue the ICR approved under OMB control number 2070-0173.

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 
5 U.S.C. 601 et seq., the Agency hereby certifies that this final rule 
will not have a significant adverse economic impact on a substantial 
number of small entities, due to the burden-reducing nature of this 
action which will benefit all submitters regardless of the size of the 
entity.
    Small entities include small businesses, small organizations, and 
small governmental jurisdictions. For purposes of assessing the impacts 
of this action on small entities, small entity is defined as:
    1. A small business as defined by the Small Business 
Administration's (SBA) regulations at 13 CFR 121.201.
    2. A small governmental jurisdiction that is a government of a 
city, county, town, school district, or special district with a 
population of less than 50,000.
    3. A small organization that is any not-for-profit enterprise which 
is independently owned and operated and is not dominant in its field.
    In determining whether a rule has a significant adverse economic 
impact on a substantial number of small entities, among other reasons, 
an agency may certify that a rule will not have a significant adverse 
economic impact on a substantial number of small entities if the rule 
relieves regulatory burden or otherwise has a positive economic effect 
on all of the small entities subject to the rule. This final rule is 
expected to reduce the existing regulatory burden. The factual basis 
for the Agency's certification under the RFA is presented in the small 
entity impact analysis prepared as part of the Economic Analysis for 
this final rule (Ref. 3), and is briefly summarized in Unit IV.

D. Unfunded Mandates Reform Act

    Based on EPA's experience with past PMNs and SNUNs, State, local, 
and tribal governments have not been affected by these reporting 
requirements, and EPA does not have any reason to believe that any 
State, local, or tribal government will be affected by this final rule. 
As such, EPA has determined that this regulatory action does not impose 
any enforceable duty, contain any unfunded mandate, or otherwise have 
any affect on small governments subject to the requirements of sections 
202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Public Law 104-4).

E. Executive Order 13132

    Under Executive Order 13132, entitled Federalism (64 FR 43255, 
August 10, 1999), EPA has determined that this final rule does not have 
``federalism implications'' because it will not have substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in the Executive Order. This final rule will establish electronic 
notification requirements that apply to manufacturers (including 
importers) and processors of certain chemical substances. This final 
rule will not apply directly to States and localities and will not 
affect State and local governments. Thus, Executive Order 13132 does 
not apply to this final rule.

F. Executive Order 13175

    Under Executive Order 13175, entitled Consultation and Coordination 
with Indian Tribal Governments (65 FR 67249, November 9, 2000), EPA has 
determined that this final rule does not have tribal implications 
because it will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and the 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in the 
Executive Order. EPA has no information to indicate that any tribal 
government manufactures or imports the chemical substances covered by 
this action. Thus, Executive Order 13175 does not apply to this final 
rule.

G. Executive Order 13045

    This final rule will not require special consideration pursuant to 
the terms of Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997), because it is not likely to have an annual effect on the 
economy of $100 million or more, nor does it establish an environmental 
standard, or otherwise have a disproportionate effect on children.

H. Executive Order 13211

    This final rule is not subject to Executive Order 13211, entitled 
Actions Concerning Regulations that Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001), because this final 
rule does not have any significant adverse effect on the supply, 
distribution, or use of energy.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA) (15 U.S.C. 272 note) directs EPA to use voluntary 
consensus standards in its regulatory activities unless to do so would 
be inconsistent with applicable law or impractical. Voluntary consensus 
standards are technical standards (e.g., materials specifications, test 
methods, sampling procedures, etc.) that are developed or adopted by 
voluntary consensus standards bodies. This final rule will not impose 
any technical standards that will require EPA to consider any voluntary 
consensus standards.

J. Executive Order 12898

    This final rule will not have an adverse impact on the 
environmental

[[Page 784]]

and health conditions in low-income and minority communities. 
Therefore, under Executive Order 12898, entitled Federal Actions to 
Address Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994), the Agency does not need 
to consider environmental justice-related issues.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of the rule in the Federal Register. 
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Parts 700, 720, 721, 723, and 725

    Environmental protection, Chemicals, Electronic reporting, 
Hazardous substances, Reporting and recordkeeping requirements.


    Dated: December 22, 2009.
Stephen A. Owens,
Assistant Administrator, Office of Prevention, Pesticides and Toxic 
Substances.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 700--[AMENDED]

0
1. The authority citation for part 700 is revised to read as follows:

    Authority: 15 U.S.C 2625 and 2665, 44 U.S.C. 3504.


0
2. Section 700.45 is amended by revising paragraphs (e)(1) through 
(e)(3); (e)(4)(i), (ii), and (iv); and (e)(5)(i), (ii), and (iv) to 
read as follows:


Sec.  700.45  Fee payments.

* * * * *
    (e) * * *
    (1) Each remittance under this section shall be in United States 
currency and shall be paid by money order, bank draft, wire transfer, 
Pay.gov service provided through the Department of the Treasury, or 
check drawn to the order of the Environmental Protection Agency.
    (2) Each paper remittance shall be sent to the Environmental 
Protection Agency, Washington Finance Center, Toxic Substances Control 
Act User Fees, P.O. Box 979073, St. Louis, MO 63197-9000.
    (3) Persons who submit a TSCA section 5 notice shall place an 
identifying number and a payment identity number on the front page of 
each TSCA section 5 notice submitted. The identifying number must 
include the letters ``TS'' followed by a combination of 6 numbers 
(letters may be substituted for some numbers). The payment identity 
number may be a check number, a wire transfer number, or a ``Pay.gov'' 
transaction number used to transmit the user fee. The same TS number 
and the submitter's name must appear on the corresponding fee 
remittance under this section. If a remittance applies to more than one 
TSCA section 5 notice, the person shall include the name of the 
submitter and a new TS number for each TSCA section 5 notice to which 
the remittance applies, and the amount of the remittance that applies 
to each notice. Any remittance not having the identifying name and 
numbers described in this paragraph will be returned to the remitter.
    (4)(i) Each person who remits the fee identified in paragraph 
(b)(1) of this section for a PMN, consolidated PMN, intermediate PMN, 
or significant new use notice shall insert a check mark for the 
statement, ``The company named in part 1, section A is a small business 
concern under 40 CFR 700.43 and has remitted a fee of $100 in 
accordance with 40 CFR 700.45(b).'' under ``CERTIFICATION'' on page 2 
of the Premanufacture Notice for New Chemical Substances (EPA Form 
7710-25).
    (ii) Each person who remits the fee identified in paragraph (b)(1) 
of this section for an exemption application under TSCA section 5(h)(2) 
shall insert a check mark for the statement, ``The company named in 
part 1, section A is a small business concern under 40 CFR 700.43 and 
has remitted a fee of $100 in accordance with 40 CFR 700.45(b).'' in 
the exemption application.
* * * * *
    (iv) Each person who remits the fee identified in paragraph (b)(1) 
of this section for a MCAN for a microorganism shall insert a check 
mark for the statement, ``The company named in part 1, section A is a 
small business concern under 40 CFR 700.43 and has remitted a fee of 
$100 in accordance with 40 CFR 700.45(b).'' in the certification 
required in Sec.  725.25(b) of this chapter.
    (5)(i) Each person who remits a fee identified in paragraph (b)(2) 
of this section for a PMN, consolidated PMN, intermediate PMN, or 
significant new use notice shall insert a check mark for the statement, 
``The company named in part 1, section A has remitted the fee specified 
in 40 CFR 700.45(b).'' under ``CERTIFICATION'' on page 2 of the 
Premanufacture Notice for New Chemical Substances (EPA Form 7710-25).
    (ii) Each person who remits a fee identified in paragraph (b)(2) of 
this section for an exemption application under TSCA section 5(h)(2) 
shall insert a check mark for the statement, ``The company named in 
part 1, section A has remitted the fee specified in 40 CFR 700.45(b).'' 
in the exemption application.
* * * * *
    (iv) Each person who remits the fee identified in paragraph (b)(1) 
of this section for a MCAN for a microorganism shall insert a check 
mark for the statement, ``The company named in part 1, section A is a 
small business concern under 40 CFR 700.43 and has remitted a fee of 
$100 in accordance with 40 CFR 700.45(b).'' in the certification 
required in Sec.  725.25(b) of this chapter.
* * * * *

PART 720--[AMENDED]

0
3. The authority citation for part 720 continues to read as follows:

    Authority: 15 U.S.C 2604, 2607, and 2613.


0
4. Section 720.3 is amended by adding paragraphs (ii), (jj), (kk), and 
(ll) to to read as follows:


Sec.  720.3  Definitions.

* * * * *
    (ii) Central Data Exchange or CDX means EPA's centralized 
electronic document receiving system, or its successors.
    (jj) e-PMN software means electronic-PMN software created by EPA 
for use in preparing and submitting Premanufacture Notices (PMNs) and 
other TSCA section 5 notices and support documents electronically to 
the Agency.
    (kk) Optical disc means compact disc (CD) or digital video disc 
(DVD).
    (ll) Support documents means materials and information submitted to 
EPA in support of a TSCA section 5 notice, including but not limited 
to, correspondence, amendments, and test data. The term ``support 
documents'' does not include orders under TSCA section 5(e) (either 
consent orders or orders imposed pursuant to TSCA section 5(e)(2)(B)).

0
5. Section 720.40 is amended by revising paragraphs (a)(2), (c), 
(d)(2), and (e) to read as follows:


Sec.  720.40  General.

    (a) * * *

[[Page 785]]

    (2) All notices must be submitted on EPA Form 7710-25. Notices, and 
any support documents related to these notices, may only be submitted 
in a manner set forth in this paragraph.
    (i) Paper-based submissions. Notices, and any support documents 
related to these notices, may be submitted on paper on or before April 
6, 2011. All paper-based notices must be generated using e-PMN 
reporting software and be completed through the finalization step of 
the software, and e-PMN software must be used to print EPA Form 7710-25 
for submission to EPA. Paper notices, and any support documents related 
to such notices, must be submitted either via U.S. mail to the Document 
Control Office (DCO) (7407M), Office of Pollution Prevention and 
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001 or submitted via courier to the Environmental 
Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 
1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
    (A) Support documents for notices that are submitted before April 
6, 2010 must be submitted on paper either via U.S. mail to the Document 
Control Office (DCO) (7407M), Office of Pollution Prevention and 
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001 or submitted via courier to the Environmental 
Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 
1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
    (B) [Reserved]
    (ii) Submissions on optical disc--(A) Notices may be submitted as 
electronic files on optical disc on or before April 6, 2012. All 
notices submitted as electronic files on optical disc must be generated 
using e-PMN reporting software and be completed through the 
finalization step of the software. Optical discs containing electronic 
notices must be submitted by courier to the Environmental Protection 
Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 
Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
    (B) Persons submitting on optical disc must also complete and 
submit on paper the Certification and Submitter Identification sections 
of EPA Form 7710-25.
    (iii) Submissions via CDX. Notices and any related support 
documents may be submitted electronically to EPA via CDX. Prior to 
submission to EPA via CDX, such notices must be generated and completed 
on EPA Form 7710-25 using e-PMN reporting software. To obtain a version 
of e-PMN software that contains an encryption module you must register 
with CDX. A version without encryption may be downloaded without 
registering with CDX.
    (iv) You can obtain the e-PMN software as follows:
    (A) Website. Go to EPA's TSCA New Chemicals Program website at 
http://www.epa.gov/oppt/newchems and follow the appropriate links.
    (B) Telephone. Call the EPA CDX Help Desk at 1-888-890-1995.
    (C) E-mail. [email protected].
* * * * *
    (c) Where to submit a notice or support documents. For submitting 
notices or support documents via CDX, use the e-PMN software. Paper 
notices or support documents must be submitted either via U.S. mail to 
the Document Control Office (DCO) (7407M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via 
courier to the Environmental Protection Agency, OPPT Document Control 
Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, 
Washington, DC 20004. Optical discs containing electronic notices or 
support documents must be submitted by courier to the Environmental 
Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 
1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004. Persons 
submitting on optical disc must also complete and submit on paper the 
Certification and Submitter Identification sections of EPA Form 7710-
25.
    (d) * * *
    (2) If information is claimed as confidential pursuant to Sec.  
720.80, a person who submits a notice to EPA in the manner set forth in 
Sec.  720.40(a)(2)(i), (ii), or (iii) must also provide EPA with a 
sanitized copy.
    (e) Agency or joint submissions--(1) A manufacturer or importer may 
designate an agent to assist in submitting the notice. If so, only the 
manufacturer or importer, and not the agent, signs the certification on 
the form.
    (2) A manufacturer or importer may authorize another person, (e.g., 
a supplier or a toll manufacturer) to report some of the information 
required in the notice to EPA on its behalf. The manufacturer or 
importer should indicate in a cover letter accompanying the notice 
which information will be supplied by another person and must identify 
that other person as a joint submitter where indicated on their notice 
form. The other person supplying information (i.e., the joint 
submitter) may submit the information to EPA using either the notice 
form or a Letter of Support, except that if the joint submitter is not 
incorporated, licensed, or doing business in the United States, the 
joint submitter must submit the information to EPA in a Letter of 
Support only, not in a notice form. The joint submitter must indicate 
in the notice or Letter of Support the identity of the manufacturer or 
importer. Any person who submits a notice form or Letter of Support for 
a joint submission must sign and certify the notice form or Letter of 
Support.
    (3) Only the Authorized Official (AO) of a company can submit all 
TSCA section 5 documents.
    (i) The AO can authorize other persons to submit only support 
documents on their behalf.
    (ii) To authorize a support registrant to submit support documents, 
both the AO and support registrant must sign the ``Authorization and 
Verification for Section 5 Notice Support Submitter by Company 
Authorizing Official'' available from the CDX website at http://cdx.epa.gov/epa_home.asp.
* * * * *

0
6. Section 720.65 is amended by revising the section heading and 
paragraphs (a) and (c)(1)(iv) and adding paragraph (c)(x) to read as 
follows:


Sec.  720.65  Acknowledgement of receipt of a notice; errors in the 
notice; incomplete submissions; and false and misleading statements.

    (a) Notification to the submitter. EPA will acknowledge receipt of 
each notice by sending a letter via CDX or U.S. mail to the submitter 
that identifies the premanufacture notice number assigned to the new 
chemical substance and date on which the review period begins. The 
review period will begin on the date the notice is received by the 
Office of Pollution Prevention and Toxics Document Control Officer. The 
acknowledgment does not constitute a finding by EPA that the notice, as 
submitted, is in compliance with this part.
* * * * *
    (c) * * *
    (1) * * *
    (iv) The submitter does not submit the notice in the manner set 
forth in Sec.  720.40(a)(2).
* * * * *
    (x) The submitter does not include an identifying number and a 
payment identity number as required by 40 CFR 700.45(e)(3).
* * * * *

[[Page 786]]


0
7. Section 720.75 is amended by revising paragraphs (b)(2) and (e)(1) 
and adding paragraphs (b)(3) and (b)(4) to read as follows:


Sec.  720.75  Notice review period.

* * * * *
    (b) * * *
    (2) A request for suspension may only be submitted in a manner set 
forth in this paragraph. The request for suspension also may be made 
orally, including by telephone, to the submitter's EPA contact for that 
notice, subject to paragraph (b)(3) of this section.
    (i) Older notices. Requests for suspension for premanufacture 
notices submitted before April 6, 2010 must be submitted on paper 
either via U.S. mail to the Document Control Office (DCO) (7407M), 
Office of Pollution Prevention and Toxics, Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or 
submitted via courier to the Environmental Protection Agency, OPPT 
Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., 
NW., Rm. 6428, Washington, DC 20004.
    (ii) Newer notices. For notices submitted on or after April 6, 
2010, EPA will accept requests for suspension only if submitted in 
accordance with this paragraph:
    (A) Requests for suspension may be submitted on paper on or before 
April 6, 2011. All paper-based requests for suspension must be 
generated using e-PMN reporting software and be completed through the 
finalization step of the software, and e-PMN software must be used to 
print the request for suspension for submission to EPA. Paper requests 
for suspension must be submitted either via U.S. mail to the Document 
Control Office (DCO) (7407M), Office of Pollution Prevention and 
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001 or submitted via courier to the Environmental 
Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 
1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
    (B) Requests for suspension may be submitted as electronic files on 
optical disc on or before April 6, 2012. All requests for suspension 
submitted as electronic files on optical disc generated using e-PMN 
reporting software and be completed through the finalization step of 
the software, and e-PMN software must be used to print the request for 
suspension for submission to EPA. Paper requests for suspension must be 
submitted either via U.S. mail to the Document Control Office (DCO) 
(7407M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001 or submitted via courier to the Environmental Protection Agency, 
OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution 
Ave., NW., Rm. 6428, Washington, DC 20004.
    (C) Requests for suspension may be submitted electronically to EPA 
via CDX. Such requests must be generated and completed using e-PMN 
reporting software. See Sec.  720.40(a)(2)(iv) for information on how 
to obtain e-PMN software.
    (3) An oral request for suspension may be granted by EPA for a 
maximum of 15 days only. Requests for a longer suspension must only be 
submitted in the manner set forth in this paragraph.
    (4) If the submitter has not made a previous oral request, the 
running of the notice review period is suspended as of the date of 
receipt of the written paper request, electronic request on optical 
disc, or CDX submission by EPA.
* * * * *
    (e) * * *
    (1) A submitter may withdraw a notice during the notice review 
period by submitting a statement of withdrawal in a manner set forth in 
this paragraph. The withdrawal is effective upon receipt of the written 
paper request, electronic request on optical disc, or CDX submission by 
EPA.
    (i) Older notices. Statements of withdrawal for premanufacture 
notices submitted before April 6, 2010 must be submitted on paper 
either via U.S. mail to the Document Control Office (DCO) (7407M), 
Office of Pollution Prevention and Toxics, Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or 
submitted via courier to the Environmental Protection Agency, OPPT 
Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., 
NW., Rm. 6428, Washington, DC 20004.
    (ii) Newer notices. For notices submitted on or after April 6, 
2010, EPA will accept statements of withdrawal only if submitted in 
accordance with this paragraph:
    (A) Statements of withdrawal may be submitted on paper on or before 
April 6, 2011. All paper-based statements of withdrawal must be 
generated using e-PMN reporting software and be completed through the 
finalization step of the software, and e-PMN software must be used to 
print the statement of withdrawal for submission to EPA. Paper 
statements of withdrawal must be submitted either via U.S. mail to the 
Document Control Office (DCO) (7407M), Office of Pollution Prevention 
and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW., Washington, DC 20460-0001 or submitted via courier to the 
Environmental Protection Agency, OPPT Document Control Office (DCO), 
EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 
20004.
    (B) Statements of withdrawal may be submitted as electronic files 
on optical disc on or before April 6, 2012. All statements of 
withdrawal submitted as electronic files on optical disc must be 
generated using e-PMN reporting software and be completed through the 
finalization step of the software. Optical discs containing electronic 
statements of withdrawal must be submitted by courier to the 
Environmental Protection Agency, OPPT Document Control Office (DCO), 
EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 
20004.
    (C) Statements of withdrawal may be submitted electronically to EPA 
via CDX. Prior to submission to EPA via CDX, such statements of 
withdrawal must be generated and completed using e-PMN reporting 
software. See Sec.  720.40(a)(2)(iv) for information on how to obtain 
e-PMN software.
* * * * *

0
8. Section 720.80 is amended by revising paragraph (b)(2)(i) to read as 
follows:


Sec.  720.80  General provisions.

* * * * *
    (b) * * *
    (2) * * *
    (i) The notice and attachments must be complete. The submitter must 
designate that information which is claimed as confidential in the 
manner prescribed on the notice form, via EPA's e-PMN software. See 
Sec.  720.40(a)(2)(iv) for information on how to obtain e-PMN software.
* * * * *

0
9. Section 720.102 is amended by revising paragraphs (c)(1) 
introductory text and (d) to read as follows:


Sec.  720.102  Notice of commencement of manufacture or import.

* * * * *
    (c) * * *
    (1) The notice must be submitted on EPA Form 7710-56, which is 
available as part of EPA's e-PMN software. See Sec.  720.40(a)(2)(iv) 
for information on how to obtain e-PMN software. The form must be 
signed and dated by an Authorized Official (AO). All information 
specified on the form must be provided. The notice must contain the 
following information:
* * * * *

[[Page 787]]

    (d) Where to submit. All notices of commencement must be submitted 
to EPA on EPA Form 7710-56. Notices may only be submitted in a manner 
set forth in this paragraph.
    (1) Older notices. Notices of commencement for premanufacture 
notices submitted before April 6, 2010 must be submitted on paper 
either via U.S. mail to the Document Control Office (DCO) (7407M), 
Office of Pollution Prevention and Toxics, Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or 
submitted via courier to the Environmental Protection Agency, OPPT 
Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., 
NW., Rm. 6428, Washington, DC 20004.
    (2) Newer notices. For premanufacture notices submitted on or after 
April 6, 2010, EPA will accept notices of commencement only if 
submitted in accordance with this paragraph:
    (i) Notices of commencement may be submitted on paper on or before 
April 6, 2011. All paper-based notices of commencement must be 
generated using e-PMN reporting software and be completed through the 
finalization step of the software, and e-PMN software must be used to 
print the notice of commencement for submission to EPA. Paper notices 
of commencement must be submitted either via U.S. mail to the Document 
Control Office (DCO) (7407M), Office of Pollution Prevention and 
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001 or submitted via courier to the Environmental 
Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 
1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
    (ii) Notices of commencement may be submitted as electronic files 
on optical disc on or before April 6, 2012. All notices of commencement 
submitted as electronic files on optical disc must be generated using 
e-PMN reporting software and be completed through the finalization step 
of the software. Optical discs containing electronic notices of 
commencement must be submitted by courier to the Environmental 
Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 
1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
    (iii) Notices of commencement may be submitted electronically to 
EPA via CDX on or after April 6, 2010. After April 6, 2012 all notices 
of commencement must be submitted electronically to EPA via CDX. Prior 
to submission to EPA via CDX, such notices of commencement must be 
generated and completed using e-PMN reporting software. See Sec.  
720.40(a)(2)(iv) for information on how to obtain e-PMN software.

PART 721--[AMENDED]

0
10. The authority citation for part 721 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).


0
11. Section 721.25 is amended by revising paragraph (c) to read as 
follows:


Sec.  721.25  Notice requirements and procedures.

* * * * *
    (c) EPA will process the notice in accordance with the procedures 
of part 720 of this chapter, except to the extent they are inconsistent 
with this part.
* * * * *

0
12. Section 721.30 is amended by revising paragraph (b) introductory 
text to read as follows:


Sec.  721.30  EPA approval of alternative control measures.

* * * * *
    (b) Persons submitting a request for a determination of equivalency 
to EPA under this part, unless allowed by 40 CFR 720.40(a)(2)(i), (ii), 
or (iii), must submit the request to EPA via EPA's Central Data 
Exchange (CDX) using EPA-provided e-PMN software in the manner set 
forth in 40 CFR 720.40(a)(2). See 40 CFR 720.40(a)(2)(iv) for 
information on how to obtain e-PMN software. Support documents related 
to these requests must be submitted in the manner set forth in 40 CFR 
720.40(a)(2)(i), (ii), or (iii). If submitted by paper, requests must 
be submitted either via U.S. mail to the Document Control Office (DCO) 
(7407M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; ATTN: SNUR Equivalency Determination or submitted via courier to 
the Environmental Protection Agency, OPPT Document Control Office 
(DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, 
Washington, DC 20004; ATTN: SNUR Equivalency Determination. Optical 
discs containing electronic requests must be submitted by courier to 
the Environmental Protection Agency, OPPT Document Control Office 
(DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, 
Washington, DC 20004; ATTN: SNUR Equivalency Determination. A request 
for a determination of equivalency must contain:
* * * * *

PART 723--[AMENDED]

0
13. The authority citation for part 723 continues to read as follows:

    Authority: 15 U.S.C. 2604.


0
14. Section 723.50 is amended by revising paragraph (e)(1) to read as 
follows:


Sec.  723.50  Chemical substances manufactured in quantities of 10,000 
kilograms or less per year, and chemical substances with low 
environmental releases and human exposures.

* * * * *
    (e) * * *
    (1) A manufacturer applying for an exemption under either paragraph 
(c)(1) or (c)(2) of this section must submit an exemption notice to the 
EPA at least 30 days before manufacture of the new chemical substance 
begins. Unless allowed as described by Sec.  723.50(e)(1)(i), 
(e)(1)(ii), or (e)(1)(iii), exemption notices and modifications must be 
submitted to EPA on EPA Form No. 7710-25 via EPA's Central Data 
Exchange (CDX) using EPA-provided e-PMN reporting software in the 
manner set forth in this paragraph. Support documents related to these 
notices must also be submitted to EPA via CDX using e-PMN software in 
the manner set forth in this paragraph. See 40 CFR 720.40(a)(2)(iv) for 
information on how to obtain e-PMN software.
    (i) Paper-based submissions--(A) Such notices, and any support 
documents related to these notices, submitted before April 6, 2010 must 
be submitted on paper either via U.S. mail to the Document Control 
Office (DCO) (7407M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001 or submitted via courier to the Environmental 
Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 
1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
    (B) All other notices and related support documents may be 
submitted on paper on or before April 6, 2011. All paper-based notices 
must be generated using e-PMN reporting software and be completed 
through the finalization step of the software, and e-PMN software must 
be used to print EPA Form 7710-25 for submission to EPA. Paper notices 
must be submitted either via U.S. mail to the Document Control Office 
(DCO) (7407M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001 or submitted via courier to the Environmental Protection Agency,

[[Page 788]]

OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution 
Ave., NW., Rm. 6428, Washington, DC 20004.
    (ii) Submissions on optical disc--(A) Notices may be submitted as 
electronic files on optical disc on or before April 6, 2012. Notices 
submitted as electronic files on optical disc must be generated using 
e-PMN reporting software and be completed through the finalization step 
of the software. Optical discs containing electronic notices must be 
submitted by courier to the Environmental Protection Agency, OPPT 
Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., 
NW., Rm. 6428, Washington, DC 20004.
    (B) Persons submitting on optical disc must still complete and 
submit on paper the Certification and Submitter Identification sections 
of EPA Form 7710-25 accompanying the optical disc.
    (iii) Submissions via CDX--(A) On or after April 6, 2010, notices, 
and any related support documents, may be submitted electronically to 
EPA via CDX. Prior to submission to EPA via CDX, notices must be 
generated and completed on EPA Form 7710-25 using e-PMN reporting 
software.
    (B) On or after April 6, 2012, all notices must be generated and 
completed on EPA Form 7710-25 using e-PMN reporting software and 
submitted electronically, along with any support documents related to 
these notices, to EPA via CDX.
    (iv) Support documents for notices that are submitted before April 
6, 2010 must be submitted on paper either via U.S. mail to the Document 
Control Office (DCO) (7407M), Office of Pollution Prevention and 
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001 or submitted via courier to the Environmental 
Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 
1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
* * * * *

PART 725--[AMENDED]

0
15. The authority citation for part 725 continues to read as follows:

    Authority: 15 U.S.C 2604, 2607, 2613, and 2625.


0
16. Section 725.25 is amended by revising paragraphs (c), (e)(1), and 
(e)(2) to read as follows:


Sec.  725.25  General administrative requirements.

* * * * *
    (c) Where to submit information under this part. MCANs and 
exemption requests, and any support documents related to these 
submissions, may only be submitted in a manner set forth in this 
paragraph.
    (1) Paper-based submissions. MCANs and exemption requests, and any 
support documents related to these submissions, may be submitted on 
paper on or before April 6, 2011. All paper-based submissions must be 
generated using e-PMN reporting software and be completed through the 
finalization step of the software, and e-PMN software must be used to 
print the biotechnology notice submission to be sent to EPA. Paper 
notices must be submitted either via U.S. mail to the Document Control 
Office (DCO) (7407M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001 or submitted via courier to the Environmental 
Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 
1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
    (2) Submissions on optical disc--(i) MCANs and exemption requests 
may be submitted as electronic files on optical disc on or before April 
6, 2012. MCANs and exemption requests submitted as electronic files on 
optical disc must be generated using e-PMN reporting software and be 
completed through the finalization step of the software. Optical discs 
containing electronic notices must be submitted by courier to the 
Environmental Protection Agency, OPPT Document Control Office (DCO), 
EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 
20004.
    (ii) Persons submitting on optical disc must still prepare, sign, 
and submit on paper, the Certification statement in 40 CFR 725.25(b) 
along with submitter identification and contact information.
    (iii) Support documents for MCANs or exemption requests that are 
submitted before April 6, 2010 must be submitted on paper either via 
U.S. mail to the Document Control Office (DCO) (7407M), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via 
courier to the Environmental Protection Agency, OPPT Document Control 
Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, 
Washington, DC 20004.
    (3) Submissions via CDX. MCANs and exemption requests, and any 
related support documents, may be submitted electronically to EPA via 
CDX. Prior to submission to EPA via CDX, notices must be generated and 
completed on EPA Form 6300-07 using e-PMN reporting software.
* * * * *
    (e) * * *
    (1) A manufacturer or importer may designate an agent to assist in 
submitting the MCAN. If so, only the manufacturer or importer, and not 
the agent, signs the certification on the form.
    (2) A manufacturer or importer may authorize another person, (e.g., 
a supplier or a toll manufacturer) to report some of the information 
required in the MCAN to EPA on its behalf. The manufacturer or importer 
should indicate in a cover letter accompanying the MCAN which 
information will be supplied by another person and identify that other 
person as a joint submitter where indicated in their MCAN. The other 
person supplying information (i.e., the joint submitter) may submit the 
information to EPA either in the MCAN or a Letter of Support, except 
that if the joint submitter is not incorporated, licensed, or doing 
business in the United States, the joint submitter must submit the 
information to EPA in a Letter of Support only, rather than the MCAN. 
The joint submitter must indicate in the MCAN or Letter of Support the 
identity of the manufacturer or importer. Any person who submits the 
MCAN or Letter of Support for a joint submission must sign and certify 
the MCAN or Letter of Support.
* * * * *

0
17. Section 725.29 is amended by revising paragraph (a) to read as 
follows:


Sec.  725.29  EPA acknowledgement of receipt of submission.

    (a) EPA will acknowledge receipt of each submission by sending a 
letter via CDX or U.S. mail to the submitter that identifies the number 
assigned to each MCAN or exemption request and the date on which the 
review period begins. The review period will begin on the date the MCAN 
or exemption request is received by the Office of Pollution Prevention 
and Toxics Document Control Officer.
* * * * *

0
18. Section 725.33 is amended by adding paragraphs (a)(10) and (a)(11) 
to read as follows:


Sec.  725.33  Incomplete submissions.

    (a) * * *
    (10) The submitter does not include an identifying number and a 
payment identity number as required by Sec.  700.45(e)(3) of this 
chapter.

[[Page 789]]

    (11) The submitter does not submit the notice in the manner set 
forth in Sec.  725.25(c).
* * * * *

0
19. Section 725.36 is amended by revising paragraph (a) to read as 
follows:


Sec.  725.36  New information.

    (a) During the review period, if a submitter possesses, controls, 
or knows of new information that materially adds to, changes, or 
otherwise makes significantly more complete the information included in 
the MCAN or exemption request, the submitter must send that information 
within 10 days of receiving the new information, but no later than 5 
days before the end of the review period. The new information must be 
sent in the same manner the original notice or exemption was sent, as 
described in Sec.  725.25(c)(1), (c)(2), and (c)(3).
* * * * *

0
20. Section 725.54 is amended by revising paragraph (b) and adding 
paragraphs (c) and (d) to read as follows:


Sec.  725.54  Suspension of the review period.

* * * * *
    (b) A request for suspension may only be submitted in a manner set 
forth in this paragraph. The request for suspension also may be made 
orally, including by telephone, to the submitter's EPA contact for that 
notice, subject to paragraph (c) of this section.
    (1) Older notices. Requests for suspension for notices submitted 
before April 6, 2010 must be submitted on paper either via U.S. mail to 
the Document Control Office (DCO) (7407M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via 
courier to the Environmental Protection Agency, OPPT Document Control 
Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, 
Washington, DC 20004.
    (2) Newer notices. For notices submitted on or after April 6, 2010, 
EPA will accept requests for suspension only if submitted in accordance 
with this paragraph:
    (i) Requests for suspension may be submitted on paper on or before 
April 6, 2011. All paper-based requests for suspension must be 
generated using e-PMN reporting software and be completed through the 
finalization step of the software, and e-PMN software must be used to 
print the request for suspension for submission to EPA. Paper requests 
for suspension must be submitted either via U.S. mail to the Document 
Control Office (DCO) (7407M), Office of Pollution Prevention and 
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001 or submitted via courier to the Environmental 
Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 
1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
    (ii) Requests for suspension may be submitted as electronic files 
on optical disc on or before April 6, 2012. All requests for suspension 
submitted as electronic files on optical disc generated using e-PMN 
reporting software and be completed through the finalization step of 
the software, and e-PMN software must be used to print the request for 
suspension for submission to EPA. Paper requests for suspension must be 
submitted either via U.S. mail to the Document Control Office (DCO) 
(7407M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001 or submitted via courier to the Environmental Protection Agency, 
OPPT Document Control Office (DCO), EPA East Bldg., 1201 Constitution 
Ave., NW., Rm. 6428, Washington, DC 20004.
    (iii) Requests for suspension may be submitted electronically to 
EPA via CDX. Such requests must be generated and completed using e-PMN 
reporting software. See 40 CFR 720.40(a)(2)(iv) for information on how 
to obtain e-PMN software.
    (c) An oral request for suspension may be granted by EPA for a 
maximum of 15 days only. Requests for longer suspension must only be 
submitted in the manner set forth in this paragraph.
    (d) If the submitter has not made a previous oral request, the 
running of the notice review period is suspended as of the date of 
receipt of the written paper request, electronic request on optical 
disc, or CDX submission by EPA.

0
21. Section 725.60 is amended by revising paragraph (a) to read as 
follows:


Sec.  725.60  Withdrawal of submission by the submitter.

    (a) A submitter may withdraw a notice during the notice review 
period by submitting a statement of withdrawal in a manner set forth in 
this paragraph. The withdrawal is effective upon receipt of the written 
paper request, electronic request on optical disc, or CDX submission by 
EPA.
    (1) Older notices. Statements of withdrawal for notices submitted 
before April 6, 2010 must be submitted on paper either via U.S. mail to 
the Document Control Office (DCO) (7407M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via 
courier to the Environmental Protection Agency, OPPT Document Control 
Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, 
Washington, DC 20004.
    (2) Newer notices. For notices submitted on or after April 6, 2010, 
EPA will accept statements of withdrawal only if submitted in 
accordance with this paragraph:
    (i) Statements of withdrawal may be submitted on paper on or before 
April 6, 2011. All paper-based statements of withdrawal must be 
generated using e-PMN reporting software and be completed through the 
finalization step of the software, and e-PMN software must be used to 
print the statement of withdrawal for submission to EPA. Paper 
statements of withdrawal must be submitted either via U.S. mail to the 
Document Control Office (DCO) (7407M), Office of Pollution Prevention 
and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW., Washington, DC 20460-0001 or submitted via courier to the 
Environmental Protection Agency, OPPT Document Control Office (DCO), 
EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, Washington, DC 
20004.
    (ii) Statements of withdrawal be submitted as electronic files on 
optical disc on or before April 6, 2012. All statements of withdrawal 
submitted as electronic files on optical disc must be generated using 
e-PMN reporting software and be completed through the finalization step 
of the software. Optical discs containing electronic statements of 
withdrawal must be submitted by courier to the Environmental Protection 
Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 
Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
    (iii) Statements of withdrawal may be submitted electronically to 
EPA via CDX. Prior to submission to EPA via CDX, such statements of 
withdrawal must be generated and completed using e-PMN reporting 
software. See 40 CFR 720.40(a)(2)(iv) for information on how to obtain 
e-PMN software.
* * * * *

0
22. Section 725.67 is amended by revising paragraph (a)(1) to read as 
follows:


Sec.  725.67  Applications to exempt new microorganisms from this part.

    (a) * * *
    (1) Any manufacturer or importer of a new microorganism may 
request, under TSCA section 5(h)(4), an exemption, in whole or in part, 
from this part by

[[Page 790]]

sending a Letter of Application in the manner set forth in Sec.  
725.25(c).
* * * * *

0
23. Section 725.190 is amended by revising paragraph (d) to read as 
follows:


Sec.  725.190  Notice of commencement of manufacture or import.

* * * * *
    (d) Where to submit. All notices of commencement must be submitted 
to EPA in a manner set forth in this paragraph.
    (1) Older notices. Notices of commencement for a MCAN submitted 
before April 6, 2010 must be submitted on paper either via U.S. mail to 
the Document Control Office (DCO) (7407M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001 or submitted via 
courier to the Environmental Protection Agency, OPPT Document Control 
Office (DCO), EPA East Bldg., 1201 Constitution Ave., NW., Rm. 6428, 
Washington, DC 20004.
    (2) Newer notices. For MCANs submitted on or after April 6, 2010, 
EPA will accept notices of commencement only if submitted in accordance 
with this paragraph:
    (i) Notices of commencement may be submitted on paper on or before 
April 6, 2011. All paper-based notices of commencement must be 
generated using e-PMN reporting software and be completed through the 
finalization step of the software, and e-PMN software must be used to 
print the statement of withdrawal for submission to EPA. Paper notices 
of commencement must be submitted either via U.S. mail to the Document 
Control Office (DCO) (7407M), Office of Pollution Prevention and 
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001 or submitted via courier to the Environmental 
Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 
1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
    (ii) Notices of commencement may be submitted as electronic files 
on optical disc on or before April 6, 2012. All notices of commencement 
submitted as electronic files on optical disc must be generated using 
e-PMN reporting software and be completed through the finalization step 
of the software. Optical discs containing electronic notices of 
commencement must be submitted by courier to the Environmental 
Protection Agency, OPPT Document Control Office (DCO), EPA East Bldg., 
1201 Constitution Ave., NW., Rm. 6428, Washington, DC 20004.
    (iii) Notices of commencement may be submitted electronically to 
EPA via CDX on or after April 6, 2010. After April 6, 2012 all notices 
of commencement must be submitted electronically to EPA via CDX. Prior 
to submission to EPA via CDX, such notices of commencement must be 
generated and completed using e-PMN reporting software. See 40 CFR 
720.40(a)(2)(iv) for information on how to obtain e-PMN software.

0
24. Section 725.975 is amended by revising paragraph (b) introductory 
text to read as follows:


Sec.  725.975  EPA approval of alternative control measures.

* * * * *
    (b) Persons submitting a request for a determination of equivalency 
to EPA under this part, unless allowed by Sec.  725.25(c) (1), (2), or 
(3), must submit the request to EPA via EPA's Central Data Exchange 
(CDX) using EPA-provided e-PMN software in the manner set forth in 
Sec.  725.25(c). See 40 CFR 720.40(a)(2)(iv) for information on how to 
obtain e-PMN software. Support documents related to these requests must 
also be submitted to EPA via CDX using e-PMN software. If submitted on 
paper, requests must be submitted either via U.S. mail to the Document 
Control Office (DCO) (7407M), Office of Pollution Prevention and 
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; ATTN: SNUR Equivalency Determination or 
submitted via courier to the Environmental Protection Agency, OPPT 
Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., 
NW., Rm. 6428, Washington, DC 20004; ATTN: SNUR Equivalency 
Determination. Optical discs containing electronic requests must be 
submitted by courier to the Environmental Protection Agency, OPPT 
Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., 
NW., Rm. 6428, Washington, DC 20004; ATTN: SNUR Equivalency 
Determination. A request for a determination of equivalency must 
contain:
* * * * *

0
25. Section 725.984 is amended by revising paragraph (b)(1) to read as 
follows:


Sec.  725.984  Modification or revocation of certain notification 
requirements.

* * * * *
    (b) * * *
    (1) Any affected person may request modification or revocation of 
significant new use notification requirements for a microorganism that 
has been added to subpart M of this part using the procedures described 
in Sec.  725.980 by writing to the Director, or a designee, and stating 
the basis for such request. The request must be accompanied by 
information sufficient to support the request. Persons submitting a 
request to EPA under this part, unless allowed by Sec.  725.25(c)(1), 
(c)(2), or (c)(3), must submit the request to EPA via EPA's Central 
Data Exchange (CDX) using EPA-provided e-PMN reporting software in the 
manner set forth in Sec.  725.25(c). See 40 CFR 720.40(a)(2)(iv) for 
information on how to obtain the e-PMN software. Support documents 
related to these requests must also be submitted to EPA via CDX using 
e-PMN software. Paper requests must be submitted either via U.S. mail 
to the Document Control Office (DCO) (7407M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; ATTN: Request to 
Amend SNUR or submitted via courier to the Environmental Protection 
Agency, OPPT Document Control Office (DCO), EPA East Bldg., 1201 
Constitution Ave., NW., Rm. 6428, Washington, DC 20004; ATTN: Request 
to Amend SNUR. Optical discs containing electronic requests must be 
submitted by courier to the Environmental Protection Agency, OPPT 
Document Control Office (DCO), EPA East Bldg., 1201 Constitution Ave., 
NW., Rm. 6428, Washington, DC 20004; ATTN: Request to Amend SNUR.
* * * * *

[FR Doc. E9-31004 Filed 1-5-10; 8:45 am]
BILLING CODE 6560-50-S