[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