[Federal Register Volume 73, Number 246 (Monday, December 22, 2008)]
[Proposed Rules]
[Pages 78261-78276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-30379]


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ENVIRONMENTAL PROTECTION AGENCY

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

[EPA-HQ-OPPT-2008-0296; FRL-8395-8]
RIN 2070-AJ41


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing amendments to the Toxic Substances Control 
Act (TSCA) section 5 Premanufacture and Significant New Use 
Notification regulations to facilitate the introduction and use of 
electronic reporting. 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 proposing to amend the 
TSCA section 5 User Fee regulations to add a new User Fee Payment 
Identity Number field to the PMN form, which would enable the Agency to 
match more easily a particular user fee with its notice submission. 
Lastly, EPA is proposing to remove the Agent signature block field on 
the PMN form, and thus the requirement for designated Agents to sign 
the form.

DATES: Comments must be received on or before February 20, 2009.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2008-0296, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA 
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. 
Attention: Docket ID Number EPA-HQ-OPPT-2008-0296. The DCO is open from 
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the DCO is (202) 564-8930. Such deliveries are 
only accepted during the DCO's normal hours of operation, and special 
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2008-0296. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
http://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses. For additional 
information about EPA's public docket, visit the EPA Docket Center 
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: 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., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, will be publicly available only 
in hard copy. Publicly available docket materials are available 
electronically 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 
Federal 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.

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

[[Page 78262]]

Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 564-8469; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you manufacture, import, or 
process chemicals for commercial purposes. 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.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or e-mail. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

A. What Action is the Agency Taking?

    EPA is proposing amendments to TSCA section 5 Premanufacture and 
Significant New Use Notification regulations and related provisions to 
facilitate the introduction and required use of a new electronic 
reporting mechanism.
    The Government Paperwork Elimination Act (GPEA) (Public Law 105-277 
(44 U.S.C. 3504)) requires that, when practicable, Federal 
organizations use electronic forms, electronic filings, and electronic 
signatures to conduct official business with the public. EPA's Cross-
Media Electronic Reporting Regulation (CROMERR) (40 CFR part 3), 
published in the Federal Register of October 13, 2005 (70 FR 59848) 
(FRL-7977-1) 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 proposing these amendments to 
enable, and eventually require, manufacturers (including importers), 
and processors of TSCA chemical substances to use the Internet, through 
EPA's CDX, to submit TSCA section 5 notices 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 proposing to introduce CDX reporting in two phases 
over a 2-year period. During the first year following the effective 
date of the final rule, the Agency would allow submissions via CDX, 
optical disc, and paper. Regardless of the delivery method, EPA would 
require that all submissions be generated using the new electronic-PMN 
(e-PMN) software. One year after the final rule's effective date, paper 
submissions would no longer be accepted for any new notices and support 
documents (including NOCs). Two years after the final rule's effective 
date, disc-based submissions (e.g., CDs) for all new notices and 
support documents would no longer be accepted. In the third year after 
the final rule's effective date, all submitters would be required to 
submit all notices and support documents identified in Table 1 of Unit 
III.I. electronically via CDX using the e-PMN software. The Agency is 
proposing this phased approach because it would allow submitters to 
gain experience in using the e-PMN software and the submission delivery 
system.
    EPA is also proposing to amend 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 would enable the Agency to match 
more easily a particular user fee with its notice submission. The 
second new information element on the amended PMN form would be 
optional and consist simply of the e-mail address for the authorized 
official submitting the notice listed on the ``Submitter 
Identification'' section on page three of the PMN form. EPA is also 
proposing to remove the required Agent signature block field on page 
two 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 (under TSCA manufacture includes import) a 
new chemical substance for commercial purposes. Section 3(9) of TSCA 
defines a ``new chemical substance'' as any substance that is not on 
the Inventory of

[[Page 78263]]

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 that, when practicable, Federal organizations use electronic 
forms, electronic filings, and electronic signatures to conduct 
official business with the public.

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 
generate certain TSCA section 5 notices electronically using the PMN 
form available at the EPA New Chemicals Program website (https://cdx.epa.gov/ssl/pmn/download.asp). The form uses Adobe Acrobat Reader 
software, which allows submitters to complete the form electronically, 
and then print out and mail it to EPA as hard copy. The software is 
free and allows the user to complete the form and print it, 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 Agency-approved 
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 a version of the form with 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 there is missing or incorrect information, 
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 physical 
case file folder for reference. Any supporting documents for the 
submission are also assigned DCNs and placed in the physical case file 
folders.

III. Description of Proposed Changes for TSCA Section 5 Reporting

    This unit provides a detailed description of EPA's electronic 
reporting software, the proposed changes to the reporting process, the 
benefits of electronic reporting to both industry and EPA, and how EPA 
is proposing to phase-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 new e-PMN software for use in preparing and 
submitting PMNs and other TSCA section 5 notices and support documents 
electronically to the Agency. The e-PMN software would be available as 
a free Internet download from the Agency's website (http://www.epa.gov/oppt/newchems) or on optical discs provided by the Agency upon request. 
The e-PMN software works with Windows, Macs, Linux, and UNIX-based 
computers, using XML (short for ``Extensible Markup Language'') 
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 would provide 
user-friendly navigation, work with CDX to secure on-line 
communication, and create a completed Portable Document Format (PDF) 
file using the PMN form to accommodate internal company review prior to 
submission.
    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 would alert 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 would 
indicate 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 would provide similar specific 
guidance for TSCA section 5 reporting via CDX, along with the e-PMN 
submission software, at the New Chemicals Program homepage (http://www.epa.gov/oppt/newchems) by the effective date of the final rule.

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

    The proposed change to phase-out paper-based submissions in favor 
of CDX reporting, including use of the e-PMN reporting software, for 
TSCA

[[Page 78264]]

section 5 notices and support documents is in concert with broader 
government efforts to move to modern, electronic methods of information 
gathering. The required use of CDX for submission of TSCA section 5 
notices and support documents would be consistent with the GPEA 
requirement that, when practicable, Federal organizations use 
electronic forms, electronic filings, and electronic signatures to 
conduct official business with the public.
    The e-PMN software and electronic submission via CDX would change 
the way that companies interact with the Agency regarding many TSCA 
section 5 submissions. Companies would be registered with EPA to submit 
their data electronically to the Agency via CDX and the Agency in turn 
would benefit from receiving electronic submissions and being able to 
communicate back electronically with submitters. Data systems that once 
were populated manually would now be populated electronically reducing 
the potential for error that exists when data are entered by hand.
    Agency personnel would also be able to communicate more efficiently 
with submitters electronically, compared to using U.S. mail. Two 
examples of routine communications from EPA that would go through CDX 
rather than the U.S. mail are the Acknowledgment Letter (acknowledging 
receipt of a notice), and the Incomplete Letter (stating why a notice 
has been declared incomplete). 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 would save EPA and industry processing resources and 
reduce transaction times. EPA believes the adoption of electronic 
communications would reduce the reporting burden on industry by 
reducing both the cost and the time required to review, edit, and 
transmit data to the Agency. It also would 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, would also allow for certain information to be kept on 
file by the submitter to avoid re-entering the same information into a 
new form.
    All information sent by EPA or the submitter via CDX would 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 would facilitate the 
creation of this non-CBI version, eliminating the need for the 
submitter to do this manually.

D. What are the Proposed Changes to the Existing PMN Form?

    EPA is proposing to amend 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 would 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 would be required and 
may be either 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 would be 
optional and consist simply of the e-mail addresses for the authorized 
officials listed on the Submitter Identification section on page three 
of the PMN form. The e-mail address would enable the Agency to contact 
the submitter through e-mail, facilitating communications related to 
the submission.
    EPA is also proposing to remove the required Agent signature block 
field on page two 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 proposing to remove 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 would still have to be signed by the 
manufacturer/importer's authorized company official, and the Agent's 
name and contact information would still be provided on page three of 
the PMN form. The authorized company official remains responsible for 
false or misleading statements in the notice.
    The e-PMN software would allow users to print paper copies for 
internal company use. The printed version of the amended e-PMN form 
would 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. Under this proposed rule, persons who choose to submit PMNs on 
paper during the first year after the effective date of the final rule 
would be required to use the new e-PMN software to generate the paper 
form for each PMN or other TSCA section 5 notice they submit. EPA is 
proposing this requirement because the Agency has incorporated into the 
form many scanning efficiencies for the electronic capturing of data 
that would be lost if a blank PMN form is printed, photocopied, and 
used for another submission.

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

    The Internet submission of TSCA section 5 notices would require 
submitters to use the e-PMN software to prepare a data file and to 
register with EPA's CDX under ``New Chemicals Submissions.''
    1. Registering with CDX. To register with CDX, the submitter would 
be directed to http://cdx.epa.gov/epa_home.asp. The submitter would be 
asked to agree to Terms and Conditions, provide information about the 
submitter and his/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 would 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 user name and password.
    2. Preparing the submission. All submitters would be required to 
use the new e-PMN software to prepare their submissions of TSCA section 
5 notices. The e-PMN software would be available for free as a download 
from EPA's New Chemicals Program website at http://www.epa.gov/oppt/newchems or mailed on an optical disc upon request. 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 
would 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

[[Page 78265]]

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 would still be 
allowed, the software would, 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 would 
need to be mailed or delivered to EPA in the same manner that they are 
currently. When ``Transmission through CDX'' is selected, the user 
would be asked to provide the user name and password that were created 
during the CDX registration process. The software would then encrypt 
the file and submit it via CDX to EPA's New Chemical System (NCS).

F. What is the Electronic Signatures Agreement?

    In order to submit electronically to EPA via CDX, individuals 
acting on behalf of the submitter must first register with CDX. One 
must register either as:
    1. An authorized official of a company who can send all types of 
TSCA section 5 documents to EPA via CDX, or
    2. Someone authorized by the authorized official to send TSCA 
section 5 supporting documents to EPA via CDX. Note, however, that 
authorized company officials 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 would 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 unique identifying 
number--a ``TS'' number (see proposed 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 would require the authorized company officials 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 by Company Authorizing Official Form. Registration enables 
CDX to perform two important functions: Authentication of identity and 
verification of authorization. For authentication of identity, the 
submitter completes the Electronic Signature Agreement form along with 
a signature and date, has the form notarized, and mails it back to EPA. 
The Verification by Company Authorizing Official Form requires the 
signatures of the authorized company official and anyone he/she 
authorizes to submit support documents for the company. There are 
separate designations for submitter in this form: The submitter is the 
authorized company official or the submitter is one of the following 
persons authorized by the authorized company official--a paid employee 
of the company, an outside consultant for the company, or an authorized 
representative agent for the company. When these forms are received, 
EPA activates the submitter's registration in CDX and sends him or her 
an e-mail notification. Submitters would need to complete and sign 
these forms only once.

G. Would CBI be Protected When Submitting via CDX?

    Yes. EPA would 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 e-PMN encrypts 
using a module based on the 128-bit Advanced Encryption Standard (AES) 
adopted by NIST. AES is implemented as part of the Sun Java Runtime 
Environment (JRE) 5, which is bundled as part of e-PMN installation. 
Details about AES can be found on the NIST website at http://csrc.nist.gov/publications/fips/fips197/fips-197.pdf, and information 
on Sun JRE implementation of AES can be found at http://java.sun.com/developer/technicalArticles/Security/AES/AES_v1.html. As appropriate, 
EPA may incorporate other encryption modules into future versions of e-
PMN (such versions might be developed before or after the final rule is 
to take effect) depending upon availability and suitability.
    Information submitted via CDX is processed within EPA by secure 
systems certified for compliance with Federal Information Processing 
Standards.
    EPA solicits comment on the security of transmission of e-PMN 
information via CDX.

H. Would I be Required to Use the e-PMN Software for Any Paper or 
Optical Disc Submissions During the 2-Year Phase-In Period?

    Yes. Under this proposed rule, submitters would be required to 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. EPA would 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 would make available 
free web downloads or, upon request, optical discs that contain the e-
PMN software. All e-PMN software users, regardless of how a document is 
submitted, would need to 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 
containing data which have not undergone finalization would 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 that was generated using the e-PMN 
software would submit their notices to the Agency via U.S. mail or a 
courier service. The paper form would be signed on page 2. If the 
submitter makes any CBI claims, the original submission would need to 
include both the CBI version and a non-CBI version.
    Optical discs would be submitted with an original signed hard copy 
of page 2 (Certification page) and a hard copy of page 3 (a copy of 
page 3 is needed for contact information in the event that the optical 
disc is not readable). Optical discs would need to be delivered only by 
courier service to avoid damage to the disk from the Agency's mail 
screening equipment.

[[Page 78266]]

I. How Would 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 proposing the following:
    1. For exemption modifications, submitters would 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 would 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 would have their own menu option. Instead 
of selecting ``Premanufacture Notice,'' a submitter would select 
``Biotechnology,'' which would 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 would be submitted as an attachment(s).
    The notices listed in Unit III.I.1. through 3. would need to 
undergo the ``finalization'' step (see Unit III.H.). An exemption 
submission on an optical disc would need to 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 would only need a complete page 3. The optical 
discs for both types of submissions would need to be delivered by 
courier to the Agency to avoid damage to the disk from the Agency's 
mail screening equipment. If submitted by paper, the forms would need 
to be generated using the e-PMN software and sent to the Agency. For 
biotechnology notices, a signed hard copy of a biotechnology 
certification would need to accompany the optical disc. The printed 
form would 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 proposed submission process for completing the various notice 
and document types is summarized in Table 1 of this unit. After the 
effective date of the final rule, all of these notices would be 
prepared using the new e-PMN software.

   Table 1.--Proposed Process for Preparing TSCA Section 5 Notices and
                            Support Documents
------------------------------------------------------------------------
        TSCA Section 5 Documents                 Proposed 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.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

J. How Would Delivery Methods to EPA Vary for Submissions via Paper, 
Optical Disc, or CDX?

    Depending upon how a notice is submitted, the following delivery 
methods would be used:
    1. Paper. Printed, signed, and ``header'' sheets for attachments; 
delivered by 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.

K. Over What Time-Frame Would the Proposed Internet-Based CDX Reporting 
Requirement be Phased-In?

    The Agency is proposing to introduce electronic reporting in three 
phases. In the first phase, the Agency would allow 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) would be required to be generated using the new e-
PMN software.
    In the second phase, occurring 1 year after the effective date of 
the final rule, paper submissions would 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 the final 
rule, optical disc submissions for all new notices and support 
documents would no longer be accepted. Thereafter, EPA would accept 
only TSCA section 5 notices and support documents submitted through 
CDX. TSCA section 5 notices and support documents not submitted in the 
appropriate manner (and, for paper or optical disc submissions, during 
the time allowed for in the phase-in period) as described in this unit 
would be considered invalid by EPA and returned to the submitter. The 
Agency considers the proposed 2-year phase-in period to be enough time 
for submitters to gain experience using the CDX submission method and 
specifically seeks comments on this approach.
    Note that NOCs and support documents whose original notices were 
submitted before the effective date of the final rule would 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 promulgation of this rule will only exist in EPA's ``legacy'' 
database, i.e., the database used prior to promulgation of this rule, 
and so a subsequent support document would not be able to be linked up 
with its parent notice within EPA's new database. The proposed phase-in 
schedule for submissions is displayed in Table 2 of this unit.

[[Page 78267]]



         Table 2.--Proposed 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.       PMN software.
----------------------------------------------------------------------------------------------------------------
CDX/Internet                      Not applicable      Available and       Available and       Mandatory
                                                       optional            optional
----------------------------------------------------------------------------------------------------------------
\1\ NOCs and support documents for notices originally submitted on paper before the new system is implemented
  would still need to be mailed as hard copy.

L. Would EPA Offer Any Exceptions to the Proposed 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. 1). 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 would ultimately exceed the 
transition costs and that any transition difficulties would be 
mitigated by:
    1. The phase-in periods proposed.
    2. EPA's planned outreach and training sessions prior to the 
effective date of the final rule. The Agency will allow ample time 
between the date of publication and the effective date of the final 
rule for submitters to install and become proficient with the e-PMN 
software.
    3. EPA's planned technical support following the final rule's 
effective date.

M. 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 and support 
documents, due to the variability and infrequent nature of certain 
types of submissions. Examples are the Notice of Bona Fide Intent to 
Manufacture (``bona fide'') and prenotice communications. EPA may 
consider offering electronic reporting of these and other submissions 
in the future.

IV. Estimated Economic Impact

    The Agency's estimated economic impact of this proposal is present 
in a document entitled Economic Analysis of the Proposed Amendments to 
TSCA Section 5 Premanufacture and Significant New Use Notification 
Requirements (Ref. 1), a copy of which is available in the docket and 
is briefly summarized in this unit. EPA estimates that the electronic 
submission option would reduce the burden and cost associated with 
reporting for PMNs and other 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. 2).
    In its economic analysis for the proposed rule (Ref. 1), 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 
rule, 15,700 hours in the second year of the rule, and 16,178 hours in 
the third year of the rule. Industry savings are estimated at 16,187 
hours per year for subsequent years of the 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 rule, 51.2 hours 
in the second and third years of the rule, and 50.4 hours per year for 
subsequent years of the 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 rule, $424,863 
in the second year of the rule, and $457,066 in the third year of the 
rule. Industry savings are estimated at $457,628 per year for 
subsequent years of the rule. When taking into account the lower total 
number of notices expected during this 3-year ICR period in addition to 
savings attributable to the 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 rule, $1,396 in the second and third years of the 
rule, and $1,352 in subsequent years of the rule.
    EPA estimates that the Agency also will experience a reduction in 
both burden and cost to administer the TSCA section 5 notice program as 
a result of the proposed rule. Specifically, EPA expects to experience 
a net burden reduction of 4,521 hours in the first year of the rule, a 
reduction of 9,042 hours in the second year of the rule, and a 
reduction of 13,563 hours in the third and subsequent years of the 
rule. The Agency expects to experience a net savings of $214,377 in the 
first year of the rule, a net savings of $586,108 in the second year of 
the rule, and a net savings of $1,057,838 in the third and subsequent 
years of the rule.
    EPA recognizes that information and feedback received during the 2-
year proposed 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 Information 
Collection Request, which EPA must complete every 3 years under the 
Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq.

V. Request for Comment

    The Agency is making the e-PMN software available during the public 
comment period for this proposed rule. This will enable stakeholders to 
use the software on a test basis, which includes the ability to submit 
test notices via

[[Page 78268]]

CDX to EPA. The e-PMN software and guidance for CDX registration and 
submission is available at the Agency's website (http://www.epa.gov/oppt/newchems) or on optical discs provided by the Agency upon request. 
In addition, the following are two topics on which the Agency is 
specifically requesting public comment. EPA encourages all interested 
persons to submit comments on these two topics or other relevant 
topics, as well as on the use of the e-PMN software and submission of 
notices via CDX. This input will assist the Agency in developing a rule 
that successfully addresses information needs while minimizing 
potential reporting burdens associated with the rule. EPA requests that 
commenters making specific recommendations include supporting 
documentation where appropriate, including cost and burden estimates.
    1. Based on the expected efficiency of electronic reporting via the 
Internet, EPA believes that companies would be supportive of the 
proposed rule and would quickly take advantage of the new Internet-
based reporting system, moving away from paper or optical disc 
reporting. EPA specifically seeks comment on whether the proposed 2-
year phase-in period following promulgation of the final rule, during 
which time paper and/or optical disc submissions would be accepted, is 
reasonable or necessary to allow sufficient time to transition to the 
new Internet-based method. Would enabling stakeholders to test the 
system prior to, and technical assistance after, the effective date of 
the final rule be sufficient to prepare industry for the new CDX 
submission method? Should there be no phase-in period, or a period 
shorter than 2 years? Does the proposed phase-in period approach overly 
complicate reporting?
    2. EPA expects that electronic submission would reduce burden 
associated with reporting under TSCA section 5. EPA is seeking 
information that might further inform the Agency's burden estimates. 
Because use of CDX would be optional during the 2-year phase-in period, 
it is uncertain how many submitters would choose to take advantage of 
this submission method during that period. Therefore, estimated costs 
presented by EPA for submitters (reporting burden) and the Agency (time 
required for manual processing of data) may be overestimates of actual 
costs to the extent that submitters are able to use the electronic 
submission tool sooner. For example, do you intend to begin using CDX 
as soon as it is available? If not, when would you expect to begin 
using CDX and why? Are there implementing factors that you expect to 
use in making your decisions that EPA should consider in evaluating the 
Agency's estimates? Are there any factors that would facilitate your 
earlier implementation of CDX? How much time does it take you to fill 
out and submit a notice via CDX, compared to the current paper method?

VI. References

    The public docket for this proposed rule has been established. The 
following is a listing of the documents referenced in this preamble 
that have been placed in the public docket for this proposed rule under 
docket ID number EPA-HQ-OPPT-2008-0296, which is available for 
inspection as specified under ADDRESSES.
    1. EPA. Economic and Policy Analysis Branch, Office of Pollution 
Prevention and Toxics (OPPT). Economic Analysis of the Proposed 
Amendments to TSCA Section 5 Premanufacture and Significant New Use 
Notification Requirements. October 6, 2008.
    2. EPA. Regulatory Impacts Branch, OPPT. Regulatory Impact Analysis 
of Amendments to Regulations for TSCA Section 5 Premanufacture 
Notifications. September 9, 1994.
    3. 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. 2327.01. OMB Control No. 
2070-NEW.

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 proposed 
rule have been submitted for OMB approval under PRA, 44 U.S.C. 3501 et 
seq. The ICR document prepared by EPA, identified under EPA ICR No. 
2327.01 and OMB control number 2070-NEW, is available in the docket for 
the proposed rule (Ref. 3). This ICR will amend the two currently 
approved ICR documents that cover the existing reporting and 
recordkeeping programs that are approved under OMB control number 2070-
0012 and 2070-0038. 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.
    The amended information collection activities contained in this 
proposed rule are designed to assist the Agency in meeting its 
responsibility under TSCA to receive, process, and review PMNs and 
SNUNs in a timely manner and further the proper performance of the 
functions of the Agency. Information collection for review of PMNs and 
SNUNs is authorized by TSCA section 5 and confidentially of submitted 
information is protected under TSCA section 14.
    The information collected under the two existing ICRs, as 
consolidated into the new ICR, would be modified by the addition of two 
new data elements:
    1. A User Fee Payment Identity Number.
    2. The submitter's (authorized official's) e-mail address(es).
    The other revision to the information collection activities already 
approved by OMB, would be the change affecting how the submitter 
completes and submits the required form to EPA. As such, responses to 
the collection of information covered by this ICR would still be 
mandatory, but with the final rule, respondents would be required to 
use the e-PMN software to complete the form. The methods for submitting 
the completed form to EPA would change over a 2-year period following 
the effective date of the rule to allow for the new required submission 
through CDX to be fully implemented.
    Burden is defined at 5 CFR 1320.3(b). The ICR document for this 
proposed 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 rule because of the phase-in 
schedule of the proposed 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 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 rule familiarization.
    Any comments on the Agency's need for this information, the 
accuracy of the provided burden estimates, and any

[[Page 78269]]

suggested methods for minimizing respondent burden, should be directed 
to the docket for this proposed rule, under docket ID number EPA-HQ-
OPPT-2008-0296. You may also submit a copy of your comments on the ICR 
to OMB. See ADDRESSES for submission of comments to EPA. Send comments 
to OMB at the Office of Information and Regulatory Affairs, Office of 
Management and Budget, 725 17\th\ St., NW., Washington, DC 20503, 
Attention: Desk Office for EPA. Since OMB is required to make a 
decision concerning the ICR between 30 and 60 days after December 22, 
2008, a comment to OMB is best assured of having its full effect if OMB 
receives it by January 21, 2009. The final rule will respond to any OMB 
or public comments on the information collection requirements contained 
in this proposal.

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 proposed 
rule, if promulgated as proposed, would 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 document 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, 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 proposed 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 proposed 
rule (Ref. 1), 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 rulemaking. 
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 proposed rule does not 
have ``federalism implications'' because it would 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 proposed rule would establish electronic 
notification requirements that apply to manufacturers (including 
importers) and processors of certain chemicals. This proposed rule 
would not apply directly to States and localities and would not affect 
State and local governments. Thus, Executive Order 13132 does not apply 
to this proposed 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 proposed rule does not have tribal implications 
because it would 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 
proposed rule.

G. Executive Order 13045

    This proposed rule would 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 proposed 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 proposal 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 proposed rule would not 
impose any technical standards that would require EPA to consider any 
voluntary consensus standards.

J. Executive Order 12898

    This proposed rule would not have an adverse impact on the 
environmental 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.

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

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



[[Page 78270]]


    Dated: December 15, 2008.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic 
Substances.
    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 700--[AMENDED]

    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.

    2. By revising Sec.  700.45(e)(1); (e)(2); (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 a unique 
identifying number and a payment identity number on the front page of 
each section 5 notice submitted. The unique 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 
section 5 notice, the person shall include the name of the submitter 
and a new TS number for each 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]

    3. The authority citation for part 720 would continue to read as 
follows:

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

    4. By adding paragraphs (ii), (jj), (kk), and (ll) to Sec.  720.3 
to read as follows:


Sec.  720.3  Definitions.

* * * * *
    (ii) e-PMN software means electronic-PMN software, including 
associated instructions, 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.
    (jj) Central Data Exchange or CDX means EPA's centralized 
electronic document receiving system, or its successors, including 
associated instructions for registering to submit electronic documents.
    (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 
Letters of Support (see Sec.  720.40(e)(2) and Sec.  725.25(e)(2) of 
this chapter), 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)).
    5. By revising Sec.  720.40(a)(2), (c), (d)(2), (e)(1), and (e)(2) 
to read as follows:


Sec.  720.40  General.

    (a) * * *
    (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 until [date 365 
days after effective date of the final rule]. 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 to 
the Document Control Office (DCO) (7407M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
    (A) Support documents for notices that are submitted before 
[effective date of the final rule] must be submitted on paper to the 
Document Control Office (DCO) (7407M), Office of Pollution Prevention 
and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW., Washington, DC 20460-0001.
    (B) [Reserved]

[[Page 78271]]

    (ii) Submissions on optical disc--(A) Notices may be submitted as 
electronic files on optical disc until [date 731 days after effective 
date of the final rule]. 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.
    (iv) You can obtain the e-PMN software and reporting instructions 
and CDX reporting instructions as follows:
    (A) Website. Go to the EPA TSCA New Chemicals Program Internet 
homepage at http://www.epa.gov/oppt/newchems and follow the appropriate 
links.
    (B) By phone or e-mail. Call the EPA CDX Call Center at (866) 411-
4372 (4EPA)
    (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 to the Document Control 
Office (DCO) (7407M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. 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) * * *
    (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 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.
* * * * *
    6. By revising paragraphs (a) and (c)(1)(iv) and adding paragraph 
(c)(x) to Sec.  720.65 to read as follows:


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

    (a) Notification to the submitter. EPA will acknowledge receipt of 
each notice that has been submitted via CDX with a computer response 
via CDX that identifies the premanufacture notice number assigned to 
the new chemical substance and the date on which the review period 
begins. If the notice is submitted on paper or via optical disc, in 
accordance with Sec.  720.40(a)(2)(i) or (ii), EPA will acknowledge 
receipt of the notice by sending the submitter a letter that identifies 
the premanufacture notice number assigned to the new chemical substance 
and the date on which the review period begins. After [date 731 days 
after effective date of the final rule], all acknowledgements will be 
made via CDX. 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 a unique identifying number and 
a payment identity number as required by 40 CFR 700.45(e)(3).
* * * * *
    7. By revising paragraphs (b)(2) and (e)(1) and adding paragraphs 
(b)(3) and (b)(4) to Sec.  720.75 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 [effective date of the final rule] must be 
submitted on paper to the Document Control Office (DCO) (7407M), Office 
of Pollution Prevention and Toxics, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
    (ii) Newer notices. For notices submitted on or after [effective 
date of the final rule], EPA will accept requests for suspension only 
if submitted in accordance with this paragraph:
    (A) Requests for suspension may be submitted on paper until [date 
365 days after effective date of the final rule]. 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 to the Document Control Office (DCO) (7407M), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
    (B) Requests for suspension may be submitted as electronic files on 
optical disc until [date 731 days after effective date of the final 
rule]. 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

[[Page 78272]]

used to print the request for suspension for submission to EPA. Paper 
requests for suspension must be submitted to the Document Control 
Office (DCO) (7407M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001.
    (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 instructions how to 
obtain e-PMN software and reporting instructions, and CDX reporting 
instructions.
    (3) 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.
    (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 [effective date of the final rule] must be 
submitted on paper to the Document Control Office (DCO) (7407M), Office 
of Pollution Prevention and Toxics, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
    (ii) Newer notices. For notices submitted on or after [effective 
date of the final rule], EPA will accept statements of withdrawal only 
if submitted in accordance with this paragraph:
    (A) Statements of withdrawal may be submitted on paper until [date 
365 days after effective date of the final rule]. 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 to the Document Control Office (DCO) (7407M), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
    (B) Statements of withdrawal may be submitted as electronic files 
on optical disc until [date 731 days after effective date of the final 
rule]. 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 instructions how to obtain e-
PMN software and reporting instructions, and CDX reporting 
instructions.
* * * * *
    8. By revising Sec.  720.80(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 how to obtain e-PMN software and CDX 
reporting instructions.
* * * * *
    9. By revising Sec.  720.102(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 instructions how to obtain e-PMN software and reporting 
instructions, and CDX reporting instructions. The form must be signed 
and dated by an authorized official. All information specified on the 
form must be provided. The notice must contain the following 
information:
* * * * *
    (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 [effective date of the final rule] must be 
submitted on paper to the Document Control Office (DCO) (7407M), Office 
of Pollution Prevention and Toxics, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
    (2) Newer notices. For premanufacture notices submitted on or after 
[effective date of the final rule], EPA will accept notices of 
commencement only if submitted in accordance with this paragraph:
    (i) Notices of commencement may be submitted on paper until [date 
365 days after effective date of the final rule]. 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 to the Document Control Office (DCO) (7407M), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
    (ii) Notices of commencement may be submitted as electronic files 
on optical disc until [date 731 days after effective date of the final 
rule]. 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.
    (3) Notices of commencement may 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 instructions how to obtain e-
PMN software and reporting instructions, and CDX reporting 
instructions.

PART 721--[AMENDED]

    10. The authority citation for part 721 would continue to read as 
follows:

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

    11. By revising Sec.  721.25(c) to read as follows:


Sec.  721.25  Notice requirements and procedures.

* * * * *

[[Page 78273]]

    (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.
* * * * *
    12. By revising Sec.  721.30(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 by direct computer-to-computer 
electronic transfer 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)(v) for how to obtain e-PMN software, CDX 
reporting instructions, and other associated documents. 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 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. 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]

    13. The authority citation for part 723 would continue to read as 
follows:

    Authority: 15 U.S.C 2604.

    14. By revising Sec.  723.50(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 by direct computer-to-computer 
electronic transfer 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 Sec.  720.40(a)(2)(iv) of this chapter for how 
to obtain e-PMN software and reporting instructions, and CDX reporting 
instructions.
    (i) Paper-based submissions--(A) Such notices, and any support 
documents related to these notices, submitted before [effective date of 
the final rule] must be submitted on paper to the Document Control 
Office (DCO) (7407M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001.
    (B) All other notices and related support documents may be 
submitted on paper until [date 365 days after effective date of the 
final rule]. 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 to the Document 
Control Office (DCO) (7407M), Office of Pollution Prevention and 
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001.
    (ii) Submissions on optical disc--(A) Notices may be submitted as 
electronic files on optical disc until [date 731 days after effective 
date of the final rule]. 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) As of [effective date of the final 
rule], 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) By [date 731 days after effective date of the final rule], 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 
[effective date of the final rule] must be submitted on paper to the 
Document Control Office (DCO) (7407M), Office of Pollution Prevention 
and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW., Washington, DC 20460-0001.
* * * * *

PART 725--[AMENDED]

    15. The authority citation for part 725 would continue to read as 
follows:

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

    16. By revising Sec.  725.25(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 until [date 365 days after effective date of the final rule]. 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 to 
the Document Control Office (DCO) (7407M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
    (2) Submissions on optical disc--(i) MCANs and exemption requests 
may be submitted as electronic files on optical disc until [date 731 
days after effective date of the final rule]. 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,

[[Page 78274]]

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 [effective date of the final rule] must be submitted 
on paper to the Document Control Office (DCO) (7407M), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
    (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 their 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.
* * * * *
    17. By revising Sec.  725.29(a) to read as follows:


Sec.  725.29  EPA acknowledgement of receipt of submission.

    (a) EPA will acknowledge receipt of each submission via CDX with a 
computer response via CDX that identifies the number assigned to each 
MCAN or exemption request and the date on which the review period 
begins. If the notice or exemption request is submitted on paper or 
optical disc, in accordance with 40 CFR 725.25(c)(1) or (c)(2), EPA 
will acknowledge receipt of the notice by sending the submitter a 
letter that identifies the number assigned to the 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, if submitted via paper or optical disc.
* * * * *
    18. By adding paragraphs (a)(10) and (a)(11) to Sec.  725.33 to 
read as follows:


Sec.  725.33  Incomplete submissions.

    (a) * * *
    (10) The submitter does not include a unique identifying number and 
a payment identity number as required by Sec.  700.45(e)(3) of this 
chapter.
    (11) The submitter does not submit the notice in the manner set 
forth in Sec.  725.25(c).
* * * * *
    19. By revising Sec.  725.36(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).
* * * * *
    20. By revising paragraph (b) and adding paragraphs (c) and (d) to 
Sec.  725.54 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 [effective date of the final rule] must be submitted on paper to 
the Document Control Office (DCO) (7407M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
    (2) Newer notices. For notices submitted on or after [effective 
date of the final rule], EPA will accept requests for suspension only 
if submitted in accordance with this paragraph:
    (i) Requests for suspension may be submitted on paper until [date 
365 days after effective date of the final rule]. 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 to the Document Control Office (DCO) (7407M), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
    (ii) Requests for suspension may be submitted as electronic files 
on optical disc until [date 731 days after effective date of the final 
rule]. 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 to the Document Control 
Office (DCO) (7407M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001.
    (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 Sec.  720.40(a)(2)(iv) of this chapter for 
instructions how to obtain e-PMN software and reporting instructions, 
and CDX reporting instructions.
    (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.
    21. By revising Sec.  725.60(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

[[Page 78275]]

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 [effective date of the final rule] must be submitted on paper to 
the Document Control Office (DCO) (7407M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
    (2) Newer notices. For notices submitted on or after [effective 
date of the final rule], EPA will accept statements of withdrawal only 
if submitted in accordance with this paragraph:
    (i) Statements of withdrawal may be submitted on paper until [date 
365 days after effective date of the final rule]. 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 to the Document Control Office (DCO) (7407M), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
    (ii) Statements of withdrawal be submitted as electronic files on 
optical disc until [date 731 days after effective date of the final 
rule]. 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 Sec.  720.40(a)(2)(iv) of this chapter for instructions 
how to obtain e-PMN software and reporting instructions, and CDX 
reporting instructions.
* * * * *
    22. By revising Sec.  725.67(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 sending a Letter of Application in the manner set 
forth in Sec.  725.25(c).
* * * * *
    23. By revising Sec.  725.190(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 [effective date of the final rule] must be submitted on paper to 
the Document Control Office (DCO) (7407M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
    (2) Newer notices. For MCANs submitted on or after [effective date 
of the final rule], EPA will accept notices of commencement only if 
submitted in accordance with this paragraph:
    (i) Notices of commencement may be submitted on paper until [date 
365 days after effective date of the final rule]. 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 to the Document Control Office (DCO) (7407M), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
    (ii) Notices of commencement be submitted as electronic files on 
optical disc until [date 731 days after effective date of the final 
rule]. 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.
    (3) Notices of commencement may 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.  725.25(c)(4) for instructions how to obtain e-PMN 
software and reporting instructions, and CDX reporting instructions.
    24. By revising Sec.  725.975(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 by direct computer-to-computer 
electronic transfer via EPA's Central Data Exchange (CDX) using EPA-
provided e-PMN software in the manner set forth in Sec.  725.25(c). See 
Sec.  725.25(c)(4) for how to obtain e-PMN software and reporting 
instructions, and CDX reporting instructions. 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 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. 
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:
* * * * *
    25. By revising Sec.  725.984(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 by direct computer-
to-computer electronic transfer via EPA's Central Data

[[Page 78276]]

Exchange (CDX) using EPA-provided e-PMN reporting software in the 
manner set forth in Sec.  725.25(c). See Sec.  725.25(c)(4) for how to 
obtain the e-PMN software, CDX reporting instructions, and other 
associated documents. Support documents related to these requests must 
also be submitted to EPA via CDX using e-PMN software. Paper requests 
must be submitted 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. 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. E8-30379 Filed 12-19-08; 8:45 am]
BILLING CODE 6560-50-S