[Federal Register Volume 77, Number 74 (Tuesday, April 17, 2012)]
[Proposed Rules]
[Pages 22707-22719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-8937]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 712, 716, 720, 721, 723, 725, 766, 790, and 799
[EPA-HQ-OPPT-2011-0519; FRL-9337-5]
RIN 2070-AJ75
Electronic Reporting Under the Toxic Substances Control Act
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to require electronic reporting for
information that must be submitted under Toxic Substances Control Act
(TSCA) section 4 (pursuant to test rules and enforceable consent
agreements (ECAs)), TSCA section 8(a) Preliminary Assessment
Information Rule (PAIR), and TSCA section 8(d) Health and Safety Data
Reporting rules. Additionally, EPA is proposing amendments to certain
TSCA section 5 reporting regulations that would extend electronic
reporting requirements to Notices of Commencement of Manufacture or
Import (NOCs) and support documents (e.g., correspondence, amendment,
and test data) relating to TSCA section 5 notices submitted to EPA
before April 6, 2010. This proposed rule would require the use of EPA's
Central Data Exchange (CDX) and the Chemical Information Submission
System (CISS) web-based reporting tool for the submission of forms,
reports, and other documents except for TSCA section 5 submissions,
which would use existing e-PMN software. This action is intended to
streamline the reporting process and reduce the administrative costs
associated with information submission and recordkeeping.
DATES: Comments must be received on or before June 18, 2012.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2011-0519, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online 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-2011-0519. 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-
2011-0519. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or email. The
regulations.gov Web site 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 email comment
directly to EPA without going through regulations.gov, your email
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.
Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Katherine Sleasman, Chemical Control Division, Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-7716; email address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture
(including import), process, or distribute in commerce chemical
substances and mixtures. Potentially affected entities may include, but
are not limited to:
Chemicals and Allied Products Manufacturers (NAICS 32411).
Petroleum Refining (NAICS Codes 325 and 32411).
This listing is not intended to be exhaustive, but rather provides
a guide
[[Page 22708]]
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. 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 email. 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?
The Agency is proposing regulations to require electronic reporting
of information submitted under TSCA section 4 (including test rules and
ECAs), TSCA section 8(a) PAIR rule at 40 CFR part 712, and TSCA section
8(d) Health and Safety Data Reporting rules to require use of CISS, a
web-based reporting tool.
The Agency is also proposing to extend TSCA section 5 electronic
reporting requirements to NOCs and support documents (e.g.,
correspondence, amendments, and test data) relating to TSCA section 5
notices submitted to EPA prior to April 6, 2010, the effective date of
the e-PMN final rule (Ref. 1). Currently, follow-up submissions for
TSCA section 5 notices submitted before this date are not subject to
electronic reporting requirements.
The Government Paperwork Elimination Act (GPEA) (44 U.S.C. 3504)
provides 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) (Ref. 2), provides that
any requirement in title 40 of the CFR to submit a report directly to
EPA can be satisfied with an electronic submission that meets certain
conditions once the Agency published a document in the Federal Register
announcing that EPA is prepared to receive certain documents in
electronic form. For more information about CROMERR, go to http://www.epa.gov/cromerr.
This action would require electronic reporting under TSCA section 4
test rules and ECAs, TSCA section 8(a) PAIR, TSCA section 8(d)
regulations, and TSCA section 5-related reporting provisions where
electronic reporting is not already required, taking into consideration
the frequency of reporting under these regulations. EPA is considering
undertaking additional rulemaking regarding requiring electronic
reporting for other TSCA requirements that currently include paper-
reporting obligations. Once this proposed rule becomes effective, EPA
would accept only data, reports, and other information submitted
through CDX. Data, reports, and other information not submitted in the
manner required would be considered invalid by EPA. In addition, the
Agency encourages that voluntary submissions, such as those under
Memoranda of Understandings (MOUs), also be submitted through CDX. The
following regulations would be affected:
1. TSCA section 4 test rules and ECAs. Documents required under
TSCA section 4, include but are not limited to, letters of intent to
conduct testing (40 CFR 790.45), extension requests (40 CFR 790.50),
modification requests (40 CFR 790.55), exemption requests (40 CFR
790.80 and 40 CFR 790.82), hearing requests (40 CFR 790.90), and data
required to be developed under rules at 40 CFR part 799, and documents
and correspondence related to ECAs negotiated pursuant to 40 CFR part
790. Affected sections would include those relating to submission or
modification of a study plan (40 CFR 790.62), and requests to modify
the test schedule for any test required under the consent agreement (40
CFR 790.68). Electronic reporting requirements for TSCA section 4 rules
and ECAs would be added to 40 CFR 766.7, 790.5, and 799.50.
2. TSCA section 5. Additionally, EPA is proposing amendments to
certain TSCA section 5 reporting regulations that would extend
electronic reporting requirements to NOCs and support documents (e.g.,
correspondence, amendment, and test data) relating to TSCA section 5
notices submitted to EPA before April 6, 2010. The e-PMN final rule
(Ref. 1) requires submitters of NOCs and support documents whose
original notices were submitted to EPA prior to April 6, 2010 (``legacy
notices'') to submit those NOCs and support documents to EPA in hard
copy. At the time the final rule was published, EPA believed the hard-
copy submission of these documents was necessary because the Agency
intended to operate two different databases; one for storing TSCA
section 5 notices submitted to EPA after April 6, 2010, and another for
storing legacy notices. EPA originally intended to enter legacy notices
only into EPA's ``legacy database,'' i.e., the database used prior to
April 6, 2010, and so a subsequent NOC or support document would not
have been able to be linked up with its original or ``parent'' legacy
notice if it was entered into EPA's new database.
However, since publication of the e-PMN final rule, EPA's
electronic reporting program has evolved and EPA now has the ability to
house both legacy notices and notices submitted after April 6, 2010, in
the same database. EPA is therefore proposing to amend the regulations
at 40 CFR parts 720, 721, 723, and 725 to require NOCs and support
documents for TSCA section 5 notices originally submitted prior to
April 6, 2010, to be submitted electronically allowing them to be
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stored with their legacy TSCA section 5 notices in the new database.
Within the e-PMN final rule, EPA phased-in electronic reporting of
TSCA section 5 notices and their related NOCs and support documents
over a 2-year period that ends April 6, 2012. Within this proposed
rule, EPA would remove the regulatory text related to the phase-in
because by the time this proposed rule is finalized, EPA expects the
phase-in period will be over and all TSCA section 5 notices, NOCs, and
support documents would be required to be submitted to EPA via CDX.
3. TSCA section 8(a) PAIR. Electronic reporting requirements for
Form 7710-35, Manufacturer's Report--Preliminary Assessment Information
(Manufacturer's Report) would be included in 40 CFR 712.28 and 712.30.
4. TSCA section 8(d). The submission of data, reports, and other
documents are required under the TSCA section 8(d) Health and Safety
Data reporting rule at 40 CFR part 716 and the Dibenzo-para-dioxins/
Dibenzofurans rule at 40 CFR part 766 (specifically 40 CFR 716.30,
716.35, 716.60, and 766.7). Additional affected sections of 40 CFR part
716 would include: The submission of underlying data, preliminary
reports of ongoing studies, additional copies of studies (40 CFR
716.40), requests for extension of time (40 CFR 716.60), and requests
for withdrawal of a chemical substance from a rule (40 CFR 716.105).
B. What is the Agency's authority for taking this action?
The Agency collects information from manufacturers and processors
of chemical substances under TSCA section 4 regulations, TSCA section
8(a) PAIR, and TSCA section 8(d) regulations. Section 4 of TSCA
authorizes EPA to require manufacturers and processors of chemical
substances and mixtures to perform testing to generate data relevant to
a determination whether the manufacture, distribution in commerce,
processing, use, or disposal of such chemical or mixtures presents an
unreasonable risk of injury to health or the environment. Some TSCA
section 4 testing data are required via ECAs. Section 8(a) of TSCA
gives EPA authority to promulgate rules to require that manufacturers
(includes importers) and processors of chemical substances and mixtures
report such data as EPA may reasonably require. One TSCA section 8(a)
reporting rule is the PAIR at 40 CFR part 712. The PAIR requires
chemical manufacturers and importers to complete and submit to EPA a
standardized reporting form with information to help facilitate the
evaluation of the potential adverse human health and environmental
effects from exposure to identified chemical substances, mixtures, or
categories. Under TSCA section 8(d), EPA has the authority to
promulgate rules to require manufacturers (including importers),
processors, and distributors to submit lists and/or copies of ongoing
and completed unpublished health and safety studies.
Section 5(a)(1)(A) of TSCA requires persons to notify EPA at least
90 days before manufacturing a new chemical substance for commercial
purposes (under TSCA manufacture includes import). Section 3(9) of TSCA
defines a ``new chemical substance'' as any chemical substance that is
not on the TSCA Inventory of Chemical Substances compiled by EPA under
TSCA section 8(b). 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 a Significant New Use Rule (SNUR) 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 Significant New Use Notice (SNUN) to EPA at least 90 days
before manufacturing or processing the chemical substance for that use.
C. Is electronic reporting currently required in other EPA TSCA
programs?
Since 2006, under the TSCA section 8(a) Inventory Update Reporting
rule (IUR), manufacturers (including importers) have been able to
submit IUR information electronically to the EPA through CDX (Ref. 3).
EPA is improving upon the 2006 IUR electronic reporting software by
making electronic reporting easier and more accessible to potential
reporters, including non-U.S. companies and those submitters filing
jointly. On August 16, 2011 (Ref. 4), the Agency published the final
Chemical Data Reporting (CDR) rule, amending and renaming the IUR rule
and making electronic reporting mandatory, beginning with the 2012
submission period. In addition, on January 6, 2010, EPA published the
e-PMN final rule, which phased in electronic reporting requirements for
TSCA section 5 notices and other related documents over a 2-year
period. After the 2-year phase-in period ends on April 6, 2012, the
final rule mandates electronic reporting for these documents (Ref. 1).
III. Description of Proposed Changes to Reporting Procedures
This unit provides an overview of EPA's CDX, CISS, and e-PMN
software for NOCs and support documents associated with legacy TSCA
section 5 notices, the proposed changes to the TSCA reporting process,
and the benefits of electronic reporting to both industry and EPA.
A. What is CDX?
CDX is EPA's electronic system for environmental data exchange to
the Agency. CDX also provides the capability for submitters to access
their data through the use of web services. CDX enables EPA to work
with stakeholders, including governments, regulated industries, and the
public to enable streamlined, electronic submission of data via the
Internet. For more information about CDX, go to http://epa.gov/cdx.
B. What is CISS?
EPA developed CISS for use in submitting data for TSCA sections 4,
8(a), and 8(d) electronically to the Agency. The tool is available for
use with Windows, Macs, Linux, and UNIX based computers, using
``Extensible Markup Language'' (XML) specifications for efficient data
transmission across the Internet. CISS, a web-based reporting tool,
provides user-friendly navigation, works with CDX to secure online
communication, creates a completed Portable Document Format (PDF) for
review prior to submission, and enables data, reports, and other
information to be submitted easily as PDF attachments, or by other
electronic standards, such as XML.
C. What is the e-PMN software for TSCA section 5?
EPA developed e-PMN software for use in preparing and submitting
Premanufacture Notices (PMNs) and other TSCA section 5 notices and
support documents electronically to the Agency. For further information
on the software capabilities, please visit the TSCA New Chemicals
Program Web site http://www.epa.gov/oppt/newchems. Also, see the e-PMN
final rule for further guidance (Ref. 1).
D. What are the benefits of CDX reporting and use of CISS and the e-PMN
software?
The effort to eliminate paper-based submissions in favor of CDX
reporting, including use of CISS, is part of broader government efforts
to move to modern, electronic methods of information gathering. CISS
and e-PMN software enable more efficient data transmittal and reduce
errors with the built-in validation procedures. EPA believes the
adoption of electronic reporting reduces the reporting burden for
submitters by
[[Page 22710]]
reducing the cost and time required to review, edit, and transmit data
to the Agency. It also allows submitters to share a draft submission
within their organization, and more easily save a copy for their
records or future use. The resource and time requirements to review and
process data by the Agency will also be reduced and document storage
and retrieval will require fewer resources. EPA expects to benefit from
receiving electronic submissions and communicating back electronically
with submitters. In addition, the use of CDX, CISS, and e-PMN software
ensures the legal dependability of electronic reports so that they meet
the needs of the compliance and enforcement programs. The legal
dependability of electronically submitted documents is enhanced by
valid electronic signatures that can be submitted into evidence,
assurance that electronic documents can be authenticated to provide
evidence of what an individual submitted and/or attested to, and
assurance that electronic signatures resist repudiation by the
signatory (Ref. 5).
E. How would data, reports, and other documents required under TSCA
sections 4, 8(a) PAIR, and 8(d) be submitted via the Internet using
CDX?
This proposed rule would require submitters to register with EPA's
CDX and use CISS to prepare a data file for submission.
1. Registering with CDX. Registration enables CDX to perform two
important functions:
i. Authentication of identity.
ii. Verification of authorization.
To submit electronically to EPA via CDX, individuals must first
register with that system at http://cdx.epa.gov/epa_home.asp.
To register in CDX, the CDX registrant (also referred to as
``Electronic Signature Holder'' or ``Public/Private Key Holder'')
agrees to the Terms and Conditions, provides information about the
submitter and organization, selects a user name and password, and
follows the procedures outlined in the guidance document for CDX
available at http://www.epa.gov/cdr/tools/CDX_Registration_Guide_v0_02.pdf.
Users who have previously registered with CDX for TSCA section 5
submissions, or the Toxic Release Inventory TRI-ME web reporting flow,
will be able to add the ``Submission for Chemical Safety and Pesticide
Program (CSPP)'' CDX flow to their current registration, and use the
CISS web-based reporting tool.
2. Preparing the submission. All submitters would be required to
use CISS to prepare their submissions. CISS guides users through a
``hands-on'' process of creating an electronic submission. Once a user
completes the relevant data fields, attaches appropriate PDF files, or
other file types, such as XML files, and completes metadata
information, the web-based tool validates the submission by performing
a basic error check and makes sure all the required fields and
attachments are provided and complete. Further instructions on
submitting voluntary submissions, such as under MOUs, are available,
and instructions for uploading PDF attachments or other file types,
such as XML, and completing metadata information would be available
through CISS reporting guidance.
3. Completing the submission to EPA. CISS, a web-based reporting
tool, also allows the user to choose ``Print,'' ``Save,'' or ``Transmit
through CDX.'' When ``Transmission through CDX'' is selected, the user
is asked to provide the user name and password that was created during
the CDX registration process. CISS then encrypts the file and submits
it via CDX.
4. Correspondence through CDX. The user will log in to the
application and check the status of their submissions. Upon successful
receipt of the submission by EPA, the status of the submissions will be
flagged as ``Completed.'' The CDX inbox is currently used to notify the
users of any correspondence related to user registration. Information
on accessing the CDX user inbox is provided in the guidance document
for CDX at http://www.epa.gov/cdr/tools/CDX_Registration_Guide_v0_02.pdf.
F. How would TSCA section 5 NOCs and support documents relating to
legacy TSCA section 5 notices be submitted to EPA?
EPA is proposing that NOCs and support documents relating to legacy
TSCA section 5 notices be submitted to EPA using the same process and
timeline as described in 40 CFR 720.40(a)(2), see Unit II.A.3. All NOCs
and support documents would be required to be generated using e-PMN
software and be completed through the finalization step of the
software. See the e-PMN final rule (Ref. 1) for more detailed
information on the process and timeline for submitting NOCs and support
documents.
G. How would CBI be submitted using CISS?
All information sent by the submitter via CDX is transmitted
securely to protect CBI. CISS enables the user to submit CBI in an
electronic format. The reporting tool guides the user through the
process of submitting CBI by prompting the submitter to check a CBI
checkbox if using a form or by submitting a scanned document containing
CBI by bracketing, underlining, or otherwise marking the confidential
information on the document to be submitted prior to scanning.
Documents containing information claimed as CBI would have to be
submitted in an electronic format, in accordance with the recordkeeping
requirements (Ref. 5) and the following regulations:
1. TSCA section 4 test rules and ECAs. Documents required under
TSCA section 4 that may contain information claimed as CBI include
study plans submitted in accordance with test rules (40 CFR 790.50) and
study plans submitted in accordance with an ECA (40 CFR 790.62). CISS
would allow the submitter to indicate if a study plan contains
information claimed as CBI by checking the appropriate box. Then, the
submitter would be prompted to submit the study plan document in an
electronic format. The submitter would need to indicate which
information in the study plan contains information claimed as CBI by
marking the specific information claimed as confidential and
designating it with the words ``confidential business information,''
``trade secret,'' or another appropriate phrase in the document prior
to scanning. Subsequently, if CBI is claimed in either a study plan for
test rules or an ECA, the submitter would be prompted by CISS to
substantiate those claims by answering the substantiating questions
pursuant to 40 CFR 790.7 in a document submitted in an electronic
format.
2. TSCA section 8(a) PAIR. CISS would include areas for indicating
CBI on Form 7710-35, Manufacturer's Report (40 CFR 712.28 and 712.30).
If CBI is indicated on Form 7710-35, the reporting tool would prompt
the submitter to certify that the confidentiality statements are true
by prompting the submitter to select the ``Confidentiality
Certification Statement.''
3. TSCA section 8(d). Documents submitted under TSCA section 8(d)
that contain information claimed as CBI would have to be indicated as
such by using CISS. CISS would allow the submitter to indicate if the
document contains CBI by checking the appropriate box. Then, the
submitter would be prompted to submit the document in an electronic
format. In submitting a document that contains CBI, CISS would prompt
the submitter to submit two copies of the document in an electronic
format. The copy
[[Page 22711]]
containing CBI would need to identify the confidential information by
bracketing or underlining the information and labeling the copy
``confidential,'' ``proprietary,'' or ``trade secret.'' The non-CBI
second copy would need to have all confidential information deleted.
Once CBI is claimed, CISS would prompt the submitter to substantiate
their claims (40 CFR 716.55).
The user guide would also instruct users on how to submit and
substantiate CBI information using CISS.
H. Would CBI be protected when submitting via CDX?
All information sent by the submitter via CDX would be transmitted
securely to protect CBI. Furthermore, if anything in the submission is
claimed as CBI, a non-CBI copy of the submission would have to be
provided by the submitter. The guidance document would instruct users
on how to submit and substantiate CBI information using CISS.
The Agency ensures secure transmission of the data, reports, and
other documents 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) as a means 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.'' Available online at http://csrc.nist.gov/publications/nistpubs/800-52/SP800-52.pdf.
In addition, CISS enables the submitter to electronically sign,
encrypt, and transmit 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. CISS encrypts using a module based on the 256-bit Advanced
Encryption Standard (AES) adopted by NIST. Details about AES can be
found on the NIST Web site at http://csrc.nist.gov/publications/fips/fips197/fips-197.pdf, and EPA may incorporate other encryption modules
into future versions of the tool (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.
I. Would EPA offer any exceptions to the proposed requirements?
The Agency does not expect to offer any exceptions to any final
requirements to submit data, reports, and other documents affected by
this proposed rule electronically. The Agency believes that the overall
benefits of using CISS and e-PMN software, and submission through CDX
exceed those associated with maintaining a paper-based reporting
approach. The proposed electronic reporting requirements are not the
first that would mandate electronic reporting as explained in Unit
II.C. For example, the e-PMN final rule provided for a phased-in
approach using CDX in three phases over a 2-year period. During the
first year following the April 6, 2010 effective date of the final
rule, the Agency allowed submissions via CDX, optical disc (CD or DVD),
and paper. Paper submissions are no longer accepted, and optical discs
will no longer be accepted after April 6, 2012. The phased-in approach
was designed to allow submitters to gain experience using the e-PMN
software and the submission delivery system (Ref. 6).
On August 16, 2011, the Agency published the final rule for the
TSCA Inventory Update Reporting Modifications; Chemical Data Rule (Ref.
4). This final rule requires electronic reporting and does not provide
for a phased-in approach. Previously, in 2006 EPA accepted the 2006 IUR
submissions electronically via CDX, optical discs, and paper-based
methods. However, by allowing submissions to be received through a
variety of mechanisms, the time and resources needed to review and
correct submitter and scanning-related errors took the Agency over 2
years to validate and process for the 2006 IUR. By requiring
submissions to be sent via CDX and the e-CDR web-based reporting tool,
called e-CDRweb, resources and the number of errors should be greatly
reduced.
The Agency recognizes that there is the potential for costs and
burdens associated with predictable or unanticipated technical
difficulties in electronic filing or with conversion to an electronic
format. Since the use of CDX has been in existence for a number of
years and has undergone a number of enhancements, EPA expects the
potential for difficulty to be minimal. However, EPA expects that
reduced reporting costs to submitters would ultimately exceed the
transition costs (see Economic Analysis referenced in Unit IV.).
J. How will the agency provide opportunities for potential users to
become familiar with the reporting tool?
The Agency will offer a webinar open to the public for potential
users to become familiar with CISS before its release following
publication of the final rule. The webinar will be recorded and
available at http://www.epa.gov/oppt/chemtest/ereporting/index.html. An
``Industry Day'' will be scheduled to allow users to become familiar
with CISS in a collaborative setting. Industry Day details will be
announced in the Federal Register. There will also be a week-long
familiarization opportunity to allow users to become accustomed with
CISS on their own and to provide comments to the Agency on its
functionality.
IV. Economic Analysis
The Agency's estimated economic impact of this proposed rule is
presented in a document entitled ``Economic Analysis for the Electronic
Reporting under TSCA Section 4, Section 5 NOCs, Section 8(a) PAIR, and
Section 8(d)'' (Ref. 7) (Economic Analysis), a copy of which is
available in the docket and is briefly summarized in this unit. If a
TSCA section 5 PMN or a SNUN was submitted after the effective date
(April 6, 2010) of the e-PMN final rule it would be subject to the e-
PMN final rule and is required to be submitted electronically online.
However, if a TSCA section 5 PMN or SNUN was submitted prior to the
effective date of the e-PMN final rule (April 2010), it must be printed
and mailed as hard copy to the Agency. This proposed rule would require
all NOC and supporting documents whose original notices were submitted
on paper before the new system was implemented to now be submitted
electronically via the CDX system.
EPA estimated that this proposed rule, if finalized, would result
in cost savings to the affected companies because the time required to
enter, review, edit, and submit their reports using CDX would be
reduced compared to the existing paper-based process.
EPA estimated that this proposed rule would result in total cost to
the industry of approximately $14,061 in year 1 and a cost savings of
$66,834 in each subsequent year. The cost savings in subsequent years
are greater than those in year 1 because of the one-time CDX
registration costs incurred at the initial submission. EPA assumed that
industry would continue to realize cost savings each additional year.
EPA estimates that the Agency also would experience a reduction in
the
[[Page 22712]]
cost to administer submissions of data under TSCA in the long-run. Due
to the one-time development cost of $200,000 for CDX in year 1 and an
annual CDX Operations and Maintenance (O&M) cost of $57,353, EPA would
incur a cost of $197,918 in year 1, after accounting for $59,435 in
savings resulting from the burden reductions associated with electronic
processing of submissions within the Agency. However, in subsequent
years, EPA would only incur the $57,353 annually in O&M costs,
resulting in the Agency savings of $2,082 a year in subsequent years.
In addition to the quantifiable cost savings, EPA believes this
proposed rule would result in other benefits. For example, electronic
reporting would allow for faster review and transmission of submissions
to EPA. For studies containing CBI, electronic reporting would also
improve security during transmission of CBI data to EPA. Additionally,
all information submitted electronically could be linked in a tracking
system, which would facilitate document management efforts. This would
allow companies to manage past and future submissions more easily.
EPA received 9,280 TSCA section 5 supporting documents between
April 1, 2005 and June 22, 2011, with an average of 1,510 supporting
documents each year. EPA assumed that the impact of this proposed rule
on TSCA section 5 supporting documents would be very minimal given that
industry has already undertaken electronic submission of such
supplemental materials.
V. Request for Comment
The Agency is specifically soliciting comments on the following
five topics. EPA encourages all interested persons to submit comments
on these five topics or other relevant topics and submission of data
via CDX. This input will assist the Agency in developing a final rule
that addresses information needs while minimizing reporting burdens
associated with paper-based reporting. EPA requests that comments
include specific recommendations, where appropriate, including cost and
burden estimates.
1. EPA expects that reporting health and safety information
electronically would reduce the burden associated with current paper-
based submission method under TSCA. EPA is seeking information that
might further inform the Agency's burden estimates. Estimated costs
presented by EPA for submitters (reporting burden) and the Agency (time
required for manual processing of data) may overstate actual costs to
the extent that submitters are able to use the electronic submission
tool. EPA invites comment on the relative time and resource burden of
completing CDX registration requirements and making an electronic
submission, versus making a submission via the current paper-based
method.
2. EPA seeks comment on its belief that persons required to report
information under TSCA section 4 or 8(d) rules, or under the TSCA 8(a)
PAIR would benefit from moving from paper based reporting to electronic
because it is less expensive, faster, and easier.
3. CISS enables submitters to send CBI electronically. EPA invites
comments on the submission of CBI information via CDX. The Agency is
requesting submitters use a Portable Document Format (PDF) to send
documents to the Agency. Would this be an acceptable format for
submitters to send CBI to the Agency or is there another format
submitters would prefer?
4. EPA is also considering using CDX to send correspondence
relating to submissions under TSCA sections 4 and 8(d) rules. EPA
invites comments on whether persons required to report under these
sections of TSCA would benefit from receiving electronic correspondence
from EPA via CDX.
5. CISS allows submitters to provide some information to EPA in
fielded formats, such as the chemical identity, while also allowing
submitters to upload files as attachments to a web-based form. EPA
invites comments on the submission of forms, reports, and other
documents in fielded formats. Would it be feasible for submitters to
enter data and information in a fielded format, e.g., the Organisation
for Economic Co-operation and Development (OECD) harmonized template
formats? The OECD harmonized template formats are available online at:
http://www.oecd.org/document/18/0,3746,en_21571361_43392827_44169746_1_1_1_1,00.html.
VI. References
As indicated under ADDRESSES, a docket has been established for
this proposed rule under docket ID number EPA-HQ-OPPT-2011-0519. The
following is a listing of the documents that are specifically
referenced in this action. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical contact listed under FOR FURTHER INFORMATION CONTACT.
1. EPA. TSCA Section 5 Premanufacture and Significant New Use
Notification Electronic Reporting; Revisions to Notification
Regulations; Final Rule. Federal Register (75 FR 773, January 6, 2010)
(FRL-8794-5).
2. EPA. Cross-Media Electronic Reporting; Final Rule. Federal Register
(70 FR 59848, October 13, 2005) (FRL-7977-1).
3. EPA. TSCA Inventory Update Reporting Rule; Electronic Reporting;
Direct Final Rule. Federal Register (71 FR 52494, September 6, 2006)
(FRL-7752-8).
4. EPA. Inventory Update Reporting Modification; Chemical Data
Reporting; Final Rule. Federal Register (76 FR 50816, August 16, 2011)
(FRL-8872-9).
5. Transfer of Records to the National Archives of the United States.
36 CFR part 1235.
6. EPA. Electronic Toxic Control Act (eTSCA)/e-PMN Reporting Tool
User's Guide.
7. EPA. Economic Analysis for Electronic Reporting under TSCA Section
4, Section 5 NOCs, Section 8(a) PAIR, and Section 8(d). February 21,
2012.
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 by the Office of Management and Budget (OMB) under Executive
Orders 12866 and 13563, entitled ``Improving Regulation and Regulatory
Review'' (76 FR 3821, January 21, 2011). EPA has prepared an economic
analysis of this action, which is contained in a document entitled
``Economic Analysis for Electronic Reporting under TSCA Section 4,
Section 5 NOCs, Section 8(a) PAIR, and Section 8(d)'' (Ref. 7). A copy
of the economic analysis is available in the docket for this proposed
rule and is summarized in Unit IV.
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.
2412.01 and OMB control number 2070-NEW, is available in the docket for
the proposed rule. The ICR addresses the incremental changes to the
five currently approved ICR documents that
[[Page 22713]]
cover the existing reporting and recordkeeping programs that are
approved under OMB control numbers 2070-0004, 2070-0012, 2070-0033,
2070-0054, and 2070-0156. 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 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 reports, data, and other information.
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 CISS reporting tool, except for TSCA section 5
submissions, which would require the use of existing e-PMN software.
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 the first year of the program. 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
year of the final rule. This includes an estimated average burden per
response of 0.9 hours for CDX registration, 1.8 hours for requesting a
CDX electronic signature, and 0.8 hours for final rule familiarization.
Any comments on the Agency's need for this information, the
accuracy of the provided burden estimates, and any suggested methods
for minimizing respondent burden, should be submitted to the docket for
this proposed rule, under docket ID number EPA-HQ-OPPT-2011-0519. 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 April 17, 2012, a comment to OMB is
best assured of having its full effect if OMB receives it by May 17,
2012. The final rule will respond to any OMB or public comments on the
information collection requirements contained in this proposed rule.
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.
Small entities include small businesses, small organizations, and
small governmental jurisdictions. For purposes of assessing the impacts
of this proposed rule 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 is presented in the small entity impact analysis prepared
as part of the Economic Analysis for this proposed rule, and is briefly
summarized in Unit IV. EPA analyzed reporting data that identified
individual companies submitting information under TSCA sections 4, 5,
8(a) PAIR, or 8(d) and identified those companies potentially affected
by this proposed rule that qualify for the small business status. EPA
estimated the cost impact ratios for small parent entities potentially
affected by this proposed rule and has determined that the estimated
regulatory costs represent a small impact of less than 1% of their
annual revenue. The estimated ratios range from less than 0.0001% to
0.014%, depending on the NAICS sector and employment size category,
with an average of 0.001%. No small parent entities are expected to
have a cost impact of greater than 1% of annual revenue. Since the
estimated regulatory costs represent a small fraction of a typical
parent entity's revenue (i.e., less than 1%), the impacts of this
proposed rule are likely to be minimal.
D. Unfunded Mandates Reform Act
State, local, and tribal governments have not been affected by the
TSCA sections 4, 5, 8(a) PAIR, and 8(d) reporting requirements, and EPA
does not have any reason to believe that any State, local, or tribal
government would be affected by this proposed rule. Therefore, EPA has
determined that this proposed rule would not impose any enforceable
duty, contain any unfunded mandate, or otherwise have any effect on
small governments subject to the requirements of sections 202, 203,
204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L.
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 would not
have federalism implications because the proposed rule 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 would 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),
[[Page 22714]]
because this action is not an economically significant action as
defined by EO 12866, nor does EPA expect the environmental health or
safety risks addressed by this action to present a disproportionate
risk to 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 is not an economically significant action as
defined by EO 12866, nor would it 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 action is not expected to
impose technical standards, and whether an available and applicable
voluntary consensus standard needs to be evaluated.
J. Executive Order 12898
This proposed rule does not have an adverse impact on the
environmental and health conditions in low-income and minority
communities that require special consideration by the Agency under
Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994). This document proposes
to establish procedures for satisfying existing regulatory requirements
through electronic reporting. It would not affect the level of
protection provided to human health or the environment.
List of Subjects in 40 CFR Parts 712, 716, 720, 721, 723, 725, 766,
790, 799
Environmental protection, Administrative practice and procedure,
Business and industry, Chemicals, Reporting and recordkeeping.
Dated: March 30, 2012.
Louise P. Wise,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 712--[AMENDED]
1. The authority citation for part 712 continues to read as
follows:
Authority: 15 U.S.C. 2607(a).
2. In Sec. 712.3, add new paragraphs (q) and (r) to read as
follows:
Sec. 712.3 Definitions.
* * * * *
(q) Central Data Exchange or CDX means EPA's centralized electronic
document receiving system, or its successors.
(r) Chemical Information Submission System or CISS means EPA's
electronic, web-based reporting tool for the completion and submission
of data, reports, and other information associated with TSCA sections 4
and 8.
3. In Sec. 712.28, revise paragraphs (c) and (d) and add new
paragraph (e) to read as follows:
Sec. 712.28 Form and instructions.
* * * * *
(c) Information to be reported. Persons authorized to report
information under this subpart must include the following information
on Form 7710-35, Manufacturer's Report--Preliminary Assessment
Information (Manufacturer's Report):
(1) A technical certification statement signed and dated by an
authorized person located at the plant site or corporate headquarters
of the respondent company.
(2) A confidentiality statement signed and dated by an authorized
person located at the plant site or corporate headquarters of the
respondent company.
(3) The specific chemical name and Chemical Abstracts Service (CAS)
Registry Number listed in 40 CFR 712.30.
(4) The name, company, address, city, State, ZIP code, and
telephone number of a person who is submitting the form, which may be a
person located at a plant site or corporate headquarters that will
serve as the respondent, and will be able to answer questions about the
information submitted by the company to EPA. A respondent to this
subpart must include the appropriate Dun and Bradstreet Number for each
plant site reported.
(5) The plant site activities, such as the manufacturing of a
chemical substance, including the total quantity of the chemical
substance (in kilograms) imported in bulk during the reporting period.
(6) The total number of workers and total worker-hours in each
process category, which includes enclosed process, controlled release
process, and open process.
(7) The information related to chemical substance processing by
customers, including customers' use in industrial and consumer
products, the market names under which the chemical substance is
manufactured or imported, and the customer's process categories that
are sold to customers for further processing.
(d) Persons must use CISS to complete and submit Form 7710-35,
Manufacturer's Report, (40 CFR part 712, subpart B) and accompanying
letters, via CDX. Submission requires registration with CDX, and must
be made only as set forth in this section.
(e) To access CISS go to https://cdx.epa.gov/ssl/CSPP/PrimaryAuthorizedOfficial/Home.aspx and follow the appropriate links
and for further instructions go to http://www.epa.gov/oppt/chemtest/ereporting/index.html.
4. In Sec. 712.30, revise paragraphs (a)(3)(i), (a)(3)(ii), and
(c)(2) to read as follows:
Sec. 712.30 Chemical lists and reporting periods.
(a) * * *
(3) * * *
(i)(A) The respondent has previously and voluntarily provided EPA
with a Manufacturer's Report on a chemical substance or mixture subject
to subpart B of this part, which contains data for a 1-year period
ending no more than 3 years prior to the effective date described in
paragraph (a)(2) of this section. Respondents meeting this condition
must notify EPA by letter of their desire to have the voluntary
submission used in lieu of a current data submission and must verify
the completeness and current accuracy of the voluntarily submitted
data. Such letters, sent in accordance with the method specified in
Sec. 712.28(d) to EPA, must contain the following language:
I hereby certify that, to the best of my knowledge and belief,
all information entered on this form is complete and accurate. I
agree to permit access to, and the copying of records by, a duly
authorized representative of the EPA Administrator, in accordance
with the Toxic Substances Control Act, to document any information
reported on the form.
(B) Notification letters must be submitted in accordance with the
[[Page 22715]]
method specified in Sec. 712.28(d) prior to the reporting deadline.
(ii) The respondent has previously submitted a Manufacturer's
Report on a chemical substance or mixture subject to subpart B of this
part to the Interagency Testing Committee, but not to EPA, and that
Manufacturer's Report contained data for a 1-year period ending less
than 3 years prior to the effective date described in paragraph (a)(2)
of this section. Respondents meeting this condition must submit a copy
of the Manufacture's Report, in accordance with the method specified in
Sec. 712.28(d) to EPA, and must submit an accompanying letter, also in
accordance with the methods specified in Sec. 712.28(d), notifying EPA
of the respondent's intent that the submission be used in lieu of a
current Manufacturer's Report. The notification letter must verify the
completeness and current accuracy of the voluntarily submitted data.
* * * * *
(c) * * *
(2) You must submit the information using the method specified in
Sec. 712.28(d).
* * * * *
PART 716--[AMENDED]
5. The authority citation for part 716 continues to read as
follows:
Authority: 15 U.S.C. 2607(d).
6. In Sec. 716.3, add the following definitions in alphabetical
order to read as follows:
Sec. 716.3 Definitions.
* * * * *
Central Data Exchange or CDX means EPA's centralized electronic
document receiving system, or its successors.
Chemical Information Submission System or CISS means EPA's
electronic, web-based tool for the completion and submission of data,
reports, and other information.
* * * * *
7. In Sec. 716.30, revise paragraph (c) and add new paragraph (d)
to read as follows:
Sec. 716.30 Submission of copies of studies.
* * * * *
(c) Persons must use CISS to complete and submit all data, reports,
and other information required by 40 CFR part 716, via CDX. Submission
requires registration with CDX, and must be made only as set forth in
this section.
(d) To access CISS go to https://cdx.epa.gov/ssl/CSPP/PrimaryAuthorizedOfficial/Home.aspx and follow the appropriate links
and for further instructions to go http://www.epa.gov/oppt/chemtest/ereporting/index.html.
8. In Sec. 716.35, revise paragraph (c) and add new paragraph (d)
to read as follows:
Sec. 716.35 Submission of lists of studies.
* * * * *
(c) Persons must use CISS to complete and submit all data, reports,
and other information required by 40 CFR part 716, via CDX. Submission
requires registration with CDX, and must be made only as set forth in
this section.
(d) To access CISS go to https://cdx.epa.gov/ssl/CSPP/PrimaryAuthorizedOfficial/Home.aspx and follow the appropriate links
and for further instructions to go http://www.epa.gov/oppt/chemtest/ereporting/index.html.
9. In Sec. 716.40, revise the introductory text of the section to
read as follows:
Sec. 716.40 EPA requests for submission of further information.
EPA may request a person to submit or make available for review the
following information after the initial reporting under Sec. Sec.
716.30 and 716.35. If the requested submissions are not made, EPA may
subpoena them under TSCA section 11, 15 U.S.C. 2610.
* * * * *
10. In Sec. 716.55, revise paragraph (b)(3) to read as follows:
Sec. 716.55 Confidentiality claims.
* * * * *
(b) * * *
(3) Failure to furnish a second copy when information is claimed as
confidential in the first copy will be considered a presumptive waiver
of the claim of confidentiality. EPA will notify the respondent that a
finding of a presumptive waiver of the claim of confidentiality has
been made. The respondent will be given 30 days from the date of his or
her receipt of this notification to submit the required second copy. If
the respondent fails to submit the second copy within the 30 days, EPA
will place the first copy in the public docket.
* * * * *
11. In Sec. 716.60, revise paragraphs (a), (b)(2), (c), and (d),
and add new paragraph (e) to read as follows:
Sec. 716.60 Reporting schedule.
(a) General requirements. Except as provided in Sec. 716.5 and
paragraphs (b) and (c) of this section, submissions under Sec. Sec.
716.30 and 716.35 must be submitted using the electronic method
specified in Sec. Sec. 716.30(c) and 716.35(d), on or before 60 days
after the effective date of the listing of a substance or mixture in
Sec. 716.120 or within 60 days of proposing to manufacture (including
import) or process a listed substance or listed mixture (including as a
known byproduct) if first done after the effective date of the
substance or mixture being listed in Sec. 716.120.
(b) * * *
(2) Submission of copies of completed studies. Persons must submit
studies listed as ongoing or initiated under Sec. 716.35(a)(1) and
(a)(2) within 30 days of completing the study, using the method
specified in Sec. Sec. 716.30(c) and 716.35(c).
(c) Requests for extensions of time. Respondents who cannot meet a
deadline under this section may apply for a reasonable extension of
time. Respondents may request an extension under this section.
Extension requests must be submitted on or before 40 days after the
effective date of the listing of a substance or mixture in Sec.
716.120, using the electronic method specified in Sec. Sec. 716.30(c)
and 716.35(c). EPA's Director of the Office of Pollution Prevention and
Toxics will grant or deny extension requests.
(d) Submission methods. Persons must use CISS to complete and
submit all data, reports, and other information required by 40 CFR part
716, via CDX. Submission requires registration with CDX, and must be
made only as set forth in this section.
(e) To access CISS go to https://cdx.epa.gov/ssl/CSPP/PrimaryAuthorizedOfficial/Home.aspx and follow the appropriate links
and for further instructions to go http://www.epa.gov/oppt/chemtest/ereporting/index.html.
12. In Sec. 716.105, revise paragraph (d) and add new paragraph
(e) to read as follows:
Sec. 716.105 Additions of substances and mixtures to which this
subpart applies.
* * * * *
(d) Persons who wish to submit information that shows why a
substance should be withdrawn must submit their comments by using CISS
to complete and submit all data, reports, and other information
required by 40 CFR part 716, via CDX. Submission requires registration
with CDX, and must be made only as set forth in this section.
(e) To access CISS go to https://cdx.epa.gov/ssl/CSPP/PrimaryAuthorizedOfficial/Home.aspx and follow the appropriate links
and for further instructions to go http://www.epa.gov/oppt/chemtest/ereporting/index.html.
[[Page 22716]]
PART 720--[AMENDED]
13. The authority citation for part 720 continues to read as
follows:
Authority: 15 U.S.C. 2604, 2607, and 2613.
14. In Sec. 720.40:
i. Remove paragraphs (a)(2)(i) and (a)(2)(ii).
ii. Redesignate paragraphs (a)(2)(iii) and (a)(2)(iv) as paragraphs
(a)(2)(i) and (a)(2)(ii).
iii. Revise newly redesignated paragraph (a)(2)(i).
iv. Revise paragraph (c).
The amendments read as follows:
Sec. 720.40 General.
(a) * * *
(2) * * *
(i) Submission via CDX. TSCA section 5 notices and any related
support documents must 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 software. To obtain a version
of e-PMN software that contains an encryption module you must register
with CDX. A version without encryption may be downloaded without
registering with CDX.
* * * * *
(c) Where to submit a notice or support documents. For submitting
notices or support documents via CDX, use the e-PMN software.
* * * * *
15. In Sec. 720.75, revise paragraphs (b)(2) and (e)(1) to read as
follows:
Sec. 720.75 Notice review period.
* * * * *
(b) * * *
(2) A request for suspension may only be submitted in a manner set
forth in this paragraph. The request for suspension also may be made
orally, including by telephone, to the submitter's EPA contact for that
notice, subject to paragraph (b)(3) of this section. Requests for
suspension may be submitted electronically to EPA via CDX. Such
requests must be generated and completed using e-PMN software. See
Sec. 720.40(a)(2)(iv) for information on how to obtain e-PMN software.
* * * * *
(e) Withdrawal of a notice by the submitter. (1)(i) 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 by EPA of the CDX submission.
(ii) Submission of withdrawal notices. EPA will accept statements
of withdrawal only if submitted in accordance with this paragraph.
Statements of withdrawal must be generated, completed, and submitted to
EPA (via CDX) using e-PMN software. See Sec. 720.40(a)(2)(ii) for
information on how to obtain e-PMN software.
* * * * *
16. In Sec. 720.102.
i. Remove paragraph (d)(1).
ii. Designate the introductory text of paragraph (d) as paragraph
(d)(1).
iii. Revise paragraph (d)(2).
The amendments read as follows:
Sec. 720.102 Notice of commencement of manufacture or import.
* * * * *
(d) * * *
(2) Submission of notice of commencement. EPA will accept notices
of commencement only if submitted in accordance with this paragraph.
All notices of commencement must be submitted electronically to EPA via
CDX. Prior to submission to EPA via CDX, such notices of commencement
must be generated and completed using e-PMN software. See Sec.
720.40(a)(2)(ii) for information on how to obtain e-PMN software.
PART 721--[AMENDED]
17. The authority citation for part 721 continues to read as
follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
18. In Sec. 721.30, revise paragraph (b) introductory text to read
as follows:
Sec. 721.30 EPA approval of alternative control measures.
* * * * *
(b) Persons submitting a request for a determination of equivalency
to EPA under this part must submit the request to EPA via CDX using e-
PMN software in the manner set forth in 40 CFR 720.40(a)(2)(i). See 40
CFR 720.40(a)(2)(ii) for information on how to obtain e-PMN software.
Support documents related to these requests must be submitted in the
manner set forth in 40 CFR 720.40(c). A request for a determination of
equivalency must contain:
* * * * *
19. In Sec. 721.185, revise paragraph (b)(1) to read as follows:
Sec. 721.185 Limitation or revocation of certain notification
requirements.
* * * * *
(b) * * *
(1) Any affected person may request modification or revocation of
significant new use notification requirements for a chemical substance
that has been added to subpart E of this part using the procedures
described in Sec. Sec. 721.160 or 721.170 by submitting a request that
is accompanied by information sufficient to support the request.
Persons submitting a request to EPA under this part must submit the
request to EPA using e-PMN software in the manner set forth in 40 CFR
720.40(a)(2)(i). See 40 CFR 720.40(a)(2)(ii) for information on how to
obtain the e-PMN software. Support documents related to these requests
must also be submitted to EPA in the manner set forth in 40 CFR
720.40(c).
* * * * *
PART 723--[AMENDED]
20. The authority citation for part 723 continues to read as
follows:
Authority: 15 U.S.C. 2604.
21. In Sec. 723.50, revise paragraph (e)(1) to read as follows:
Sec. 723.50 Chemical substances manufactured in quantities of 10,000
kilograms or less per year, and chemical substances with low
environmental releases and human exposures.
* * * * *
(e) * * *
(1) A manufacturer applying for an exemption under either paragraph
(c)(1) or (c)(2) of this section must submit an exemption notice to EPA
at least 30 days before manufacture of the new chemical substance
begins. Exemption notices and modifications must be submitted to EPA on
EPA Form No. 7710-25 via CDX using e-PMN software in the manner set
forth in this paragraph. See 40 CFR 720.40(a)(2)(ii) for information on
how to obtain e-PMN software. Notices and any related support
documents, must be generated and completed (via CDX) using e-PMN
software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain
e-PMN software.
* * * * *
PART 725--[AMENDED]
22. The authority citation for part 725 continues to read as
follows:
Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.
23. In Sec. 725.25, revise paragraph (c) to read as follows:
Sec. 725.25 General administrative requirements.
* * * * *
(c) Where to submit information under this part. MCANs and
exemption requests, and any support documents related to these
submissions, may only
[[Page 22717]]
be submitted in a manner set forth in this paragraph. MCANs and
exemption requests, and any related support documents, must be
generated, completed, and submitted to EPA (via CDX) using e-PMN
software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain
e-PMN software.
* * * * *
24. In Sec. 725.54, revise paragraphs (b) and (d) to read as
follows:
Sec. 725.54 Suspension of the review period.
* * * * *
(b)(1) Request for suspension. 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.
(2) Submission of suspension notices. EPA will accept requests for
suspension only if submitted in accordance with this paragraph.
Requests for suspension, must be generated, completed, and submitted to
EPA (via CDX) using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for
information on how to obtain e-PMN software.
* * * * *
(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 CDX submission by EPA.
25. In Sec. 725.60, revise paragraph (a) to read as follows:
Sec. 725.60 Withdrawal of submission by the submitter.
(a)(1) Withdrawal of notice by the submitter. 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 CDX submission by EPA.
(2) Submission of withdrawal notices. EPA will accept statements of
withdrawal only if submitted in accordance with this paragraph.
Statements of withdrawal must be generated, completed, and submitted to
EPA (via CDX) using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for
information on how to obtain e-PMN software.
* * * * *
26. In Sec. 725.190, revise paragraph (d) to read as follows:
Sec. 725.190 Notice of commencement of manufacture or import.
* * * * *
(d) How to submit. All notices of commencement must be generated,
completed, and submitted to EPA (via CDX) using e-PMN software. See 40
CFR 720.40(a)(2)(ii) for information on how to obtain e-PMN software.
27. In Sec. 725.975, revise paragraph (b) introductory text to
read as follows:
Sec. 725.975 EPA approval of alternative control measures.
* * * * *
(b) Persons submitting a request for a determination of equivalency
to EPA under this part must submit the request to EPA (via CDX) using
e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to
obtain e-PMN software. Support documents related to these requests must
also be submitted to EPA via CDX using e-PMN software. A request for a
determination of equivalency must contain:
* * * * *
28. In Sec. 725.984, revise paragraph (b)(1) to read as follows:
Sec. 725.984 Modification or revocation of certain notification
requirements.
* * * * *
(b) * * *
(1) Any affected person may request modification or revocation of
significant new use notification requirements for a microorganism that
has been added to subpart M of this part using the procedures described
in Sec. 725.980. The request must be accompanied by information
sufficient to support the request. Persons submitting a request to EPA
under this part must submit the request to EPA (via CDX) using e-PMN
software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain
e-PMN software. Support documents related to these requests must also
be submitted to EPA via CDX using e-PMN software.
* * * * *
PART 766--[AMENDED]
29. The authority citation for part 766 continues to read as
follows:
Authority: 15 U.S.C. 2603 and 2607.
30. In Sec. 766.3, add the following definitions in alphabetical
order to read as follows:
Sec. 766.3 Definitions.
* * * * *
Central Data Exchange or CDX means EPA's centralized electronic
document receiving system, or its successors.
Chemical Information Submission System or CISS means EPA's
electronic, web-based reporting tool for the completion and submission
of data, reports, and other information.
* * * * *
31. Revise Sec. 766.7 to read as follows:
Sec. 766.7 Submission of information.
(a) All information (including letters of intent, protocols, data,
forms, studies, and allegations) submitted to EPA under this part must
bear the applicable Code of Federal Regulations (CFR) section number
(e.g., Sec. 766.20) and must be submitted using the method specified
in paragraph (b) of this section.
(b) You must use CISS to complete and submit all data, reports, and
other information required under this part.
(c) Submissions must be submitted to EPA via CDX.
(d) To access CISS go to https://cdx.epa.gov/ssl/CSPP/PrimaryAuthorizedOfficial/Home.aspx and follow the appropriate links
and for further instructions go to http://www.epa.gov/oppt/chemtest/ereporting/index.html.
PART 790--[AMENDED]
32. The authority citation for part 790 continues to read as
follows:
Authority: 15 U.S.C. 2603.
33. In Sec. 790.3, add the following definitions in alphabetical
order to read as follows:
Sec. 790.3 Definitions.
* * * * *
Central Data Exchange or CDX means EPA's centralized electronic
document receiving system, or its successors.
* * * * *
Chemical Information Submission System or CISS means EPA's
electronic, web-based tool for the completion and submission of data,
reports, and other information.
* * * * *
34. Revise Sec. 790.5 to read as follows:
Sec. 790.5 Submission of information.
(a) All submissions and correspondence to EPA under this part must
bear the Code of Federal Regulations (CFR) section number of the
subject chemical test rule or, for the consent agreements.
(b) You must use CISS to complete and submit via CDX all data,
reports, other information, and correspondence required by rules
promulgated under TSCA section 4, and for correspondence pertaining to
consent agreements as required under this part. The submissions must be
made only as set forth in this section.
(c) To access CISS go to https://cdx.epa.gov/ssl/CSPP/PrimaryAuthorizedOfficial/Home.aspx and follow the appropriate links
and for further instructions go to http://www.epa.gov/oppt/chemtest/ereporting/index.html.
[[Page 22718]]
35. In Sec. 790.45, revise paragraph (a) to read as follows:
Sec. 790.45 Submission of letter of intent to conduct testing or
exemption application.
(a) No later than 30 days after the effective date of a test rule
described in Sec. 790.40, each person subject to that test rule and
required to comply with the requirements of that test rule as provided
in Sec. 790.42(a) must, for each test required, send his or her notice
of intent to conduct testing, or submit to EPA an application for
exemption from testing by the method specified in Sec. 790.5(b).
* * * * *
36. In Sec. 790.48, revise paragraphs (a)(2), (a)(3), (b)(3),
(b)(4), (b)(5), (c)(2), and (c)(3) to read as follows:
Sec. 790.48 Procedure if no one submits a letter of intent to conduct
testing.
(a) * * *
(2) If no manufacturer subject to the test rule has notified EPA of
its intent to conduct one or more of the required tests within 30 days
after the effective date of the test rule described in Sec. 790.40,
EPA will notify all manufacturers, including those described in Sec.
790.42(a)(4) and (a)(5), through CDX or by publishing a notice of this
fact in the Federal Register specifying the tests for which no letter
of intent has been submitted and will give such manufacturers an
opportunity to take corrective action.
(3) If no manufacturer submits a letter of intent to conduct one or
more of the required tests within 30 days after receipt of EPA's
notification under paragraph (a)(2) of this section, all manufacturers
subject to the test rule will be in violation of the test rule from the
31st day after receipt of the submission or publication of the Federal
Register notice described in paragraph (a)(2) of this section.
(b) * * *
(3) No later than 30 days after the date of publication of the
Federal Register notice described in paragraph (b)(2) of this section,
each person described in Sec. 790.40(a)(4) and (a)(5) and each person
processing the subject chemical as of the effective date of the test
rule described in Sec. 790.40 or by 30 days after the date of
publication of the Federal Register notice described in paragraph
(b)(2) of this section must, for each test specified in the Federal
Register notice, either notify EPA of his or her intent to conduct
testing, or submit to EPA an application for an exemption from testing
requirements for the test. Each such notification to conduct testing or
application for exemption from testing must be submitted to EPA by the
method specified in Sec. 790.5(b).
(4) If no manufacturer or processor of the test chemical has
submitted a letter of intent to conduct one or more of the required
tests within 30 days after the date of publication of the Federal
Register notice described in paragraph (b)(2) of this section, EPA will
notify all manufacturers and processors through CDX or publish a
Federal Register notice of this fact specifying the tests for which no
letter of intent has been submitted. The CDX notification or Federal
Register notice will give the manufacturers and processors an
opportunity to take corrective action.
(5) If no manufacturer or processor submits a letter of intent to
EPA through CDX within 30 days after either receipt of the CDX
notification from EPA under paragraph (b)(4) of this section, all
manufacturers and processors subject to the test rule will be in
violation of the test rule from the 31st day after receipt of such
notification or publication of the Federal Register notice.
(c) * * *
(2) If no processor subject to the test rule has notified EPA
through CDX of its intent to conduct one or more of the required tests
within 30 days after the effective date of the test rule described in
Sec. 790.40, EPA will notify all the processors through CDX or publish
a notice in the Federal Register of this fact, specifying the tests for
which no letter of intent has been submitted and to give the processors
an opportunity to take corrective action.
(3) If no processor submits a letter of intent through CDX to
conduct one or more of the required tests within 30 days after receipt
of the Agency's notification under paragraph (c)(2) of this section,
all processors subject to the test rule will be in violation of the
test rule from the 31st day after receipt of the CDX notification or
publication of the Federal Register notice described in paragraph
(c)(2) of this section.
37. In Sec. 790.50, revise paragraphs (b)(1), (b)(3), and (e) to
read as follows:
Sec. 790.50 Submission of study plans.
* * * * *
(b) * * *
(1) EPA may grant requests for additional time for the development
of study plans on a case-by-case basis. Requests for additional time
for study plan development must be submitted to EPA by the method
specified in Sec. 790.5(b). Any extension request must state why EPA
should grant the extension.
* * * * *
(3) EPA will notify the submitter of EPA's decision to grant or
deny an extension request through CDX.
* * * * *
(e) Amendments to study plans. Test sponsors must submit all
amendments by the method specified in Sec. 790.5(b).
38. In Sec. 790.55, revise paragraphs (a) and (b)(2) to read as
follows:
Sec. 790.55 Modification of test standards or schedules during
conduct of test.
(a) Application. Any test sponsor who wishes to modify the test
schedule for the mandatory testing conditions or requirements (i.e.,
``shall statements'') in the test standard for any test required by a
test rule must submit an application in accordance with this paragraph.
Application for modification must be made by the method specified in
Sec. 790.5(b). Applications must include an appropriate explanation
and rationale for the modification. Where a test sponsor requests EPA
to provide guidance or to clarify a non-mandatory testing requirement
(i.e., ``should statements'') in a test standard, the test sponsor must
submit these requests to EPA by the method format specified in Sec.
790.5(b).
(b) * * *
(2) Where, in EPA's judgment, the requested modification of the
test standard or schedule would not alter the scope of the test or
significantly change the schedule for completing the test, EPA will not
ask for public comment before approving the modification. EPA will
notify the test sponsor of EPA's decision via CDX. EPA will place
copies of each application and EPA approval notification in the docket
for the test rule in question. EPA will publish a notice annually in
the Federal Register indicating the test standards or schedules for
tests required in test rules which have been modified under this
paragraph (b)(2) and describing the nature of the modifications. Until
the Federal Register notice is published, any modification approved by
EPA under paragraph (b)(2) of this section shall apply only to the test
sponsor who applied for the modification under paragraph (a) of this
section.
* * * * *
39. In Sec. 790.62, revise paragraph (c)(4) to read as follows:
Sec. 790.62 Submission of study plans and conduct of testing.
* * * * *
(c) * * *
(4) The test sponsor shall submit any amendments to study plans to
EPA using the method specified in Sec. 790.5(b).
* * * * *
[[Page 22719]]
40. In Sec. 790.68, revise paragraphs (b)(1) and (b)(2)(ii) to
read as follows:
Sec. 790.68 Modification of consent agreements.
* * * * *
(b) * * *
(1) Any test sponsor who wishes to modify the test schedule for any
test required under a consent agreement must submit an application in
accordance with this paragraph. Application for modification must be
made using the method specified in Sec. 790.5(b). Applications must
include an appropriate explanation and rationale for the modification.
EPA will consider only those applications that request modifications to
mandatory testing conditions or requirements (``shall statements'' in
the consent agreement). Where a test sponsor requests EPA to provide
guidance or to clarify a non-mandatory testing requirement (i.e.,
``should statements''), the test sponsor shall submit these requests to
EPA using the method specified in Sec. 790.5(b).
(2) * * *
(ii) Where, in EPA's judgment, the requested modification of a test
standard or schedule would not alter the scope of the test or
significantly change the schedule for completing the test, EPA will not
ask for public comment before approving the modification. EPA will
notify the test sponsor and any other persons who have signed the
consent agreement through CDX of EPA's approval. EPA will place copies
of each application and EPA approval notification in the docket
maintained for the consent agreement in question. EPA will publish a
notice annually in the Federal Register indicating the test standards
or schedules for test required in consent agreements which have been
modified under paragraph (b)(2)(ii) of this section and describing the
nature of the modifications.
* * * * *
41. In Sec. 790.87, revise paragraphs (b)(2)(i), (b)(2)(ii), and
(c) to read as follows:
Sec. 790.87 Approval of exemption applications.
* * * * *
(b) * * *
(2) * * *
(i) If EPA finds an equivalence claim to be in error or
inadequately supported, the applicant will be notified through CDX. The
applicant will be given 15 days to provide clarifying information.
(ii) Exemption applicants will be notified through CDX that
equivalence has been accepted or rejected.
(c)(1) EPA will give exemption applicants final notice that they
have received a conditional exemption through one of the following
ways:
(i) A final Phase II test rule that adopts the study plans in a
two-phase rulemaking.
(ii) A separate Federal Register notice in a single-phase
rulemaking.
(iii) CDX.
(2) All conditional exemptions thus granted are contingent upon the
test sponsors' successful completion of testing according to the
specifications of the test rule.
42. In Sec. 790.88, revise paragraph (b) to read as follows:
Sec. 790.88 Denial of exemption application.
* * * * *
(b) EPA will notify the exemption applicant through CDX or by a
Federal Register notice of EPA's determination that the exemption
application is denied.
43. In Sec. 790.90, revise paragraph (c)(2) to read as follows:
Sec. 790.90 Appeal of denial of exemption application.
* * * * *
(c) * * *
(2) Hearing requests must be submitted using the method specified
in Sec. 790.5(b) and be received by EPA within 30 days of receipt of
the Agency's notification under Sec. 790.88(b). Hearing requests must
provide reasons why a hearing is necessary.
* * * * *
44. In Sec. 790.93, revise paragraphs (b), (c), (d)(2), and (e) to
read as follows:
Sec. 790.93 Termination of conditional exemption.
* * * * *
(b) If EPA determines that one or more of the criteria listed in
paragraph (a) of this section has been met, EPA will notify each holder
of an affected conditional exemption through CDX or a Federal Register
notice of EPA's intent to terminate that conditional exemption.
(c) Within 30 days after receipt of notification under paragraph
(b) of this section that EPA intends to terminate a conditional
exemption, the exemption holder may submit information using the method
specified in Sec. 790.5(b) either to rebut EPA's preliminary decision
or notify EPA of its intent to conduct the required test pursuant to
the test standard established in the test rule. Such a letter of intent
shall contain all of the information required by Sec. 790.45(c).
(d) * * *
(2) Hearing requests must be submitted using the method specified
in Sec. 790.5(b) and must be received by EPA within 30 days after
receipt of the CDX notification or after publication of a notice in the
Federal Register as described in paragraph (b) of this section.
(e) EPA will notify the exemption holder through CDX or by Federal
Register notice of EPA's final decision concerning termination of
conditional exemptions and will give instructions as to what actions
the former exemption holder must take to avoid being found in violation
of the test rule.
45. In Sec. 790.97, revise paragraphs (a) and (c) to read as
follows:
Sec. 790.97 Hearing procedures.
(a) Hearing requests must be submitted using the method specified
in Sec. 790.5(b). Such requests must include the applicant's basis for
appealing EPA's decision.
* * * * *
(c) EPA will notify each applicant of EPA's decision through CDX
within 60 days after the hearing.
PART 799--[AMENDED]
46. The authority citation for part 799 continues to read as
follows:
Authority: 15 U.S.C. 2603, 2611, and 2625.
47. Revise Sec. 799.5 to read as follows:
Sec. 799.5 Submission of information.
(a) Information (e.g., letters, study plans, or reports) submitted
to EPA must be submitted using the method specified in paragraph (b) of
this section. All information submitted under this part must bear the
Code of Federal Regulations (CFR) section number of the subject
chemical test rule (e.g., Sec. 799.1053 for trichlorobenzenes).
(b) You must use CISS to complete and submit all data, reports, and
other information required under this part. Submissions must be
submitted to EPA via CDX.
(c) To access CISS go to https://cdx.epa.gov/ssl/CSPP/PrimaryAuthorizedOfficial/Home.aspx and follow the appropriate links
and for further instructions to go http://www.epa.gov/oppt/chemtest/ereporting/index.html.
[FR Doc. 2012-8937 Filed 4-16-12; 8:45 am]
BILLING CODE 6560-50-P