TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting; Revisions to Notification Regulations, 78261-78276 [E8-30379]
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Federal Register / Vol. 73, No. 246 / Monday, December 22, 2008 / Proposed Rules
List of Subjects in 40 CFR Part 60
Environmental protection,
Administrative practice and procedure,
Air pollution control, Intergovernmental
relations, Reporting and recordkeeping
requirements.
Dated: December 12, 2008.
Stephen L. Johnson,
Administrator.
For the reasons cited in the preamble,
title 40, chapter I, part 60 of the Code
of Federal Regulations is proposed to be
amended as follows:
PART 60—[AMENDED]
1. The authority citation for part 60
continues to read as follows:
Authority: 42 U.S.C. 7401, et seq.
§ 60.100a
[AMENDED]
2. In § 60.100a, paragraph (c) is stayed
from February 24, 2009, until further
notice.
§ 60.101a
[AMENDED]
3. The definition of ‘‘flare’’ in
§ 60.101a is stayed from February 24,
2009, until further notice.
§ 60.102a
[AMENDED]
4. In § 60.102a, paragraph (g) is stayed
from February 24, 2009, until further
notice.
§ 60.107a
[AMENDED]
5. In § 60.107a, paragraphs (d) and (e)
are stayed from February 24, 2009, until
further notice.
[FR Doc. E8–29973 Filed 12–19–08; 8:45 am]
BILLING CODE 6560–50–P
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
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AGENCY: Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
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
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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: https://
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 https://
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 email. 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
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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 https://
www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket
are listed in the docket index available
at https://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
https://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:
TSCA-Hotline@epa.gov.
For technical information contact:
Greg Schweer, Chemical Control
Division (7405M), Office of Pollution
Prevention and Toxics, Environmental
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Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001; telephone number: (202) 564–
8469; e-mail address:
schweer.greg@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
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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
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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
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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
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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 https://
www.epa.gov/opptintr/newchems/pubs/
pmnpart1.pdf and https://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
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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 nonCBI 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 https://
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 (https://www.epa.gov/
oppt/newchems) or on optical discs
provided by the Agency upon request.
The e-PMN software works with
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Windows, Macs, Linux, and UNIXbased computers, using XML (short for
‘‘Extensible Markup Language’’)
specifications for more efficient data
transmittal across the Internet. The ePMN software operates using the Java 6
programming language, which can be
downloaded free from https://
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 online 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 https://www.epa.gov/
opptintr/iur/pubs/factsheet.pdf and
https://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 ePMN submission software, at the New
Chemicals Program homepage (https://
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 ePMN reporting software, for TSCA
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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-
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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
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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 https://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 https://
www.epa.gov/oppt/newchems or mailed
on an optical disc upon request. The ePMN 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
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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
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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, https://
csrc.nist.gov/publications/nistpubs/80052/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 https://
csrc.nist.gov/publications/fips/fips197/
fips-197.pdf, and information on Sun
JRE implementation of AES can be
found at https://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
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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 ePMN 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 ePMN 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.
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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 ePMN 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 ePMN 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
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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.
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?
TABLE 1.—PROPOSED PROCESS FOR
PREPARING TSCA SECTION 5 NOThe Agency is proposing to introduce
TICES AND SUPPORT DOCUMENTS
electronic reporting in three phases. In
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
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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.
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TABLE 2.—PROPOSED E-PMN PHASE-IN SCHEDULE FOR TSCA SECTION 5 NOTICES AND SUPPORT DOCUMENTS1
Submission
Method
Second Year After Effective
Date of Final Rule
Third Year After Effective
Date of the Final Rule, and
Thereafter
Before Effective Date of
Final Rule
First Year After Effective Date
of Final Rule
Paper
Existing PMN form
Scanner-friendly paper form,
generated and finalized
using e-PMN software
Invalid
Invalid
Optical disc
Not applicable
Electronic submission
generated and finalized using
e-PMN software.
Electronic submission
generated and finalized using
e-PMN software.
Invalid
CDX/Internet
Not applicable
Available and optional
Available and optional
Mandatory
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.
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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
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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
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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
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CDX to EPA. The e-PMN software and
guidance for CDX registration and
submission is available at the Agency’s
website (https://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
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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
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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 phasein 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
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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 17th 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.
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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
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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
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Fmt 4702
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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
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.
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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.
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Federal Register / Vol. 73, No. 246 / Monday, December 22, 2008 / Proposed Rules
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 § 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:
§ 700.45
Fee payments.
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*
*
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(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
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Jkt 217001
‘‘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.
*
*
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*
*
(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 § 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 § 725.25(b) of this chapter.
*
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*
*
*
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 § 720.3 to read as follows:
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Sfmt 4702
§ 720.3
Definitions.
*
*
*
*
*
(ii) e-PMN software means electronicPMN 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 § 720.40(e)(2)
and § 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 § 720.40(a)(2), (c),
(d)(2), (e)(1), and (e)(2) to read as
follows:
§ 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]
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Federal Register / Vol. 73, No. 246 / Monday, December 22, 2008 / Proposed Rules
(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 ePMN 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 https://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. epacallcenter@epa.gov.
*
*
*
*
*
(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 § 720.80, a
person who submits a notice to EPA in
the manner set forth in § 720.40(a)(2)(i),
(ii), or (iii) must also provide EPA with
a sanitized copy.
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(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.
*
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*
6. By revising paragraphs (a) and
(c)(1)(iv) and adding paragraph (c)(x) to
§ 720.65 to read as follows:
§ 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 § 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
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78271
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
§ 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 § 720.75 to read as follows:
§ 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
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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 § 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.
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(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
§ 720.40(a)(2)(iv) for instructions how to
obtain e-PMN software and reporting
instructions, and CDX reporting
instructions.
*
*
*
*
*
8. By revising § 720.80(b)(2)(i) to read
as follows:
§ 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 § 720.40(a)(2)(iv)
for how to obtain e-PMN software and
CDX reporting instructions.
*
*
*
*
*
9. By revising § 720.102(c)(1)
introductory text and (d) to read as
follows:
§ 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
§ 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
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Sfmt 4702
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
§ 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 § 721.25(c) to read as
follows:
§ 721.25 Notice requirements and
procedures.
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(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 § 721.30(b)
introductory text to read as follows:
§ 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 ePMN 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 § 723.50(e)(1) to read
as follows:
§ 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.
mstockstill on PROD1PC66 with PROPOSALS
*
*
*
*
*
(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
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16:40 Dec 19, 2008
Jkt 217001
§ 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-tocomputer 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 § 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 ePMN 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
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78273
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 § 725.25(c), (e)(1), and
(e)(2) to read as follows:
§ 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 ePMN 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,
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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 § 725.29(a) to read as
follows:
§ 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
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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 § 725.33 to read as follows:
§ 725.33
Incomplete submissions.
(a) * * *
(10) The submitter does not include a
unique identifying number and a
payment identity number as required by
§ 700.45(e)(3) of this chapter.
(11) The submitter does not submit
the notice in the manner set forth in
§ 725.25(c).
*
*
*
*
*
19. By revising § 725.36(a) to read as
follows:
§ 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 § 725.25(c)(1), (c)(2), and
(c)(3).
*
*
*
*
*
20. By revising paragraph (b) and
adding paragraphs (c) and (d) to
§ 725.54 to read as follows:
§ 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
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Fmt 4702
Sfmt 4702
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 § 720.40(a)(2)(iv) of this
chapter for instructions how to obtain ePMN 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 § 725.60(a) to read as
follows:
§ 725.60 Withdrawal of submission by the
submitter.
(a) A submitter may withdraw a
notice during the notice review period
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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
§ 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 § 725.67(a)(1) to read
as follows:
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Jkt 217001
§ 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 § 725.25(c).
*
*
*
*
*
23. By revising § 725.190(d) to read as
follows:
§ 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
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78275
CDX, such notices of commencement
must be generated and completed using
e-PMN reporting software. See
§ 725.25(c)(4) for instructions how to
obtain e-PMN software and reporting
instructions, and CDX reporting
instructions.
24. By revising § 725.975(b)
introductory text to read as follows:
§ 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
§ 725.25(c) (1), (2), or (3), must submit
the request to EPA by direct computerto-computer electronic transfer via
EPA’s Central Data Exchange (CDX)
using EPA-provided e-PMN software in
the manner set forth in § 725.25(c). See
§ 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 § 725.984(b)(1) to read
as follows:
§ 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 § 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
§ 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
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Exchange (CDX) using EPA-provided ePMN reporting software in the manner
set forth in § 725.25(c). See
§ 725.25(c)(4) for how to obtain the ePMN 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.
*
*
*
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*
[FR Doc. E8–30379 Filed 12–19–08; 8:45 am]
BILLING CODE 6560–50–S
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 300
[Docket No. 0808061071–81575–01]
RIN 0648–AX17
Pacific Halibut Fisheries; Guided Sport
Charter Vessel Fishery for Halibut
mstockstill on PROD1PC66 with PROPOSALS
AGENCY: National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Proposed rule; request for
comments.
SUMMARY: NMFS proposes regulations
that would limit the harvest of Pacific
halibut by guided sport charter vessel
anglers in International Pacific Halibut
Commission Regulatory Area 2C (Area
2C) of Southeast Alaska to one halibut
per day. This proposed regulatory
change is necessary to reduce the
halibut harvest in the charter vessel
sector to approximately the guideline
harvest level for Area 2C. The intended
effect of this action is to manage the
harvest of halibut consistent with an
allocation strategy recommended by the
North Pacific Management Council for
the guided sport charter vessel fishery
and the commercial fishery.
DATES: Comments must be received no
later than January 21, 2009.
ADDRESSES: Send comments to Sue
Salveson, Assistant Regional
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16:40 Dec 19, 2008
Jkt 217001
Administrator, Sustainable Fisheries
Division, Alaska Region, NMFS, Attn:
Ellen Sebastian. You may submit
comments, identified by ‘‘RIN 0648–
AX17’’ by any one of the following
methods:
• Electronic Submissions: Submit all
electronic public comments via the
Federal eRulemaking Portal website at
https://www.regulations.gov.
• Mail: P. O. Box 21668, Juneau, AK
99802.
• Fax: (907) 586–7557.
• Hand delivery to the Federal
Building: 709 West 9th Street, Room
420A, Juneau, AK.
All comments received are a part of
the public record and will be posted to
https://www.regulations.gov without
change. All Personal Identifying
Information (e.g., name, address)
voluntarily submitted by the commenter
may be publicly accessible. Do not
submit Confidential Business
Information or otherwise sensitive or
protected information.
NMFS will accept anonymous
comments (enter N/A in the required
fields if you wish to remain
anonymous). Attachments to electronic
comments must be in Microsoft Word,
Excel, WordPerfect, or Adobe portable
document file (pdf) formats to be
accepted.
Copies of the Environmental
Assessment (EA), Regulatory Impact
Review (RIR), and Initial Regulatory
Flexibility Analysis (IRFA) prepared for
this action may be obtained from NMFS
Alaska Region, P.O. Box 21668, Juneau,
Alaska 99802, Attn: Ellen Sebastian, and
on the NMFS Alaska Region website at
https://alaskafisheries.noaa.gov.
FOR FURTHER INFORMATION CONTACT: Julie
Scheurer, 907–586–7356.
SUPPLEMENTARY INFORMATION: The
International Pacific Halibut
Commission (IPHC) and NMFS manage
fishing for Pacific halibut (Hippoglossus
stenolepis) through regulations
established under the authority of the
Northern Pacific Halibut Act of 1982
(Halibut Act). The IPHC promulgates
regulations governing the halibut fishery
under the Convention between the
United States and Canada for the
Preservation of the Halibut Fishery of
the Northern Pacific Ocean and Bering
Sea (Convention). The IPHC(s
regulations are subject to approval by
the Secretary of State with concurrence
from the Secretary of Commerce
(Secretary). After approval by the
Secretaries of State and Commerce, the
IPHC regulations are published in the
Federal Register as annual management
measures pursuant to 50 CFR 300.62
(March 7, 2008; 73 FR 12280).
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The Halibut Act also provides
regulatory authority to the North Pacific
Fishery Management Council (Council)
and the Secretary. The Council, under
16 U.S.C. 773c(c), may develop
regulations applicable to U.S. nationals
or vessels, which are in addition to, and
not in conflict with regulations adopted
by the IPHC. The regulations developed
by the Council shall only be
implemented with the approval of the
Secretary, and must meet criteria
outlined in section 773c(c), including
consistency with 16 U.S.C. 1853(b)(6).
The Secretary, under 16 U.S.C. 773c(a)
and (b), has the general responsibility to
carry out the Convention and Halibut
Act. According to section 773c(b), ‘‘In
fulfilling [the general responsibility to
carry out the Convention and the
Halibut Act], the Secretary shall, in
consultation with the Secretary of the
department in which the Coast Guard is
operating, adopt such regulations as
may be necessary to carry out the
purposes and objectives of the
Convention and [the Halibut Act].’’ The
Secretary’s authority to take action
under the Halibut Act has been
delegated to NMFS.
NMFS takes this action under section
773c(b) to adopt such regulations as
may be necessary to carry out the
purposes and objectives of the
Convention and the Halibut Act. This
action would implement, among other
measures, a one halibut daily bag limit
on charter vessel anglers in IPHC Area
2C. This bag limit originally was
recommended by the Council in June
2007, implemented by NMFS by final
rule on May 28, 2008, with an effective
date of June 1, 2008 (73 FR 30504). The
May 28, 2008, final rule was enjoined by
the U.S. District Court for the District of
Columbia on June 10, 2008, (see Order
Granting Plaintiffs’ Motion for a
Temporary Restraining Order (TRO),
dated June 11, 2008, and Order Granting
Plaintiffs’ Motion for a Preliminary
Injunction (PI), dated June 19, 2008,
Van Valin, et al. v. Gutierrez, Civil
Action No. 1:08–cv–941). NMFS has
withdrawn the May 28, 2008, final rule
that was challenged in the Van Valin
lawsuit, and now takes action in a
separate rulemaking to implement a one
halibut daily bag limit, giving effect to
the Council’s intent to keep the harvest
of charter vessel anglers to
approximately the established guideline
harvest level (GHL).
In its Order Granting the Plaintiffs’
Motion for a Preliminary Injunction,
dated June 19, 2007, the U.S. District
Court determined that the Plaintiffs had
met the burden for granting a
preliminary injunction, including
demonstrating a likelihood of success
E:\FR\FM\22DEP1.SGM
22DEP1
]]>Agencies
[Federal Register Volume 73, Number 246 (Monday, December 22, 2008)]
[Proposed Rules]
[Pages 78261-78276]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-30379]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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
https://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 https://www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket are listed in the docket index
available at https://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 https://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: TSCA-
Hotline@epa.gov.
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:
schweer.greg@epa.gov.
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 https://
www.epa.gov/opptintr/newchems/pubs/pmnpart1.pdf and https://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 https://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 (https://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 https://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 https://
www.epa.gov/opptintr/iur/pubs/factsheet.pdf and https://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 (https://
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 https://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 https://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,
https://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 https://
csrc.nist.gov/publications/fips/fips197/fips-197.pdf, and information
on Sun JRE implementation of AES can be found at https://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 (https://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 signifi
