Document ID: EPA-HQ-OPPT-2013-0385-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2015-07-20T04:00Z

[Federal Register Volume 78, Number 233 (Wednesday, December 4, 2013)]
[Rules and Regulations]
[Pages 72818-72830]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28510]

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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-9394-6]
RIN 2070-AJ75

Electronic Reporting Under the Toxic Substances Control Act

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is amending certain reporting requirements that were 
promulgated under the Toxic Substances Control Act (TSCA) to require 
the use electronic reporting. EPA is requiring the use of electronic 
reporting in order to minimize the paperwork burden associated with the 
underlying regulatory requirements and to minimize the cost to the 
Federal Government of the creation, collection, maintenance, use, 
dissemination, and disposition of information. This action will also 
improve the quality and use of information to strengthen 
decisionmaking, accountability, and openness in government and society, 
as well as provide for the timely dissemination of public information 
and in a manner that promotes the utility of the information to the 
public and makes effective use of information technology.

DATES: This final rule is effective March 4, 2014.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2011-0519 is available at http://www.regulations.gov or at the Office of Pollution Prevention and 
Toxics (OPPT) Docket, Environmental Protection Agency (EPA) Docket 
Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., 
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 
p.m., Monday through Friday, excluding legal holidays. The telephone 
number of the Public Reading Room is (202) 566-1744, and the telephone 
number for the OPPT Docket is (202) 566-0280. Please review the visitor 
instructions and additional information about the docket available at 
http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Katherine Sleasman, Chemical Control Division (7405M), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-7716;

[[Page 72819]]

email address: sleasman.katherine@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. 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 code 
32411).
     Petroleum Refining (NAICS codes 325 and 32411).
    If you have any questions regarding the applicability of this 
action to a particular entity, consult the technical person listed 
under FOR FURTHER INFORMATION CONTACT.

II. Background

A. What action is the agency taking?

    EPA is promulgating amendments to reporting requirements under TSCA 
section 4 (including test rules and Enforceable Consent Agreements 
(ECAs)), TSCA section 5, TSCA section 8(a) Preliminary Analysis 
Information Rule (PAIR) at 40 CFR part 712, and TSCA section 8(d) 
Health and Safety Data Reporting Rules at 40 CFR part 716. EPA 
developed this action in accordance with its final plan for periodic 
retrospective reviews of existing regulations under Executive Order 
13563, entitled ``Improving Regulation and Regulatory Review.'' This 
final rule was proposed in the Federal Register issue of April 17, 2012 
(Ref. 1). The purpose of the amendments is to manage and leverage EPA's 
information resources to reduce information collection burdens on the 
public; increase EPA program efficiency and effectiveness; and improve 
the integrity, quality, and utility of information to all users within 
and outside the Agency, including capabilities for ensuring 
dissemination of public information, public access to Federal 
Government information, and protections for privacy and security.
    This final rule is part of broader government efforts to move to 
modern, electronic methods of information gathering. EPA's Chemical 
Information Submission System (CISS) Web-based reporting tool and e-PMN 
software enable more efficient data transmittal via the Central Data 
Exchange (CDX) and reduces errors with the built-in validation 
procedures. EPA believes the adoption of electronic reporting reduces 
the reporting burden for submitters by reducing the cost and time 
required to review, edit, and transmit data to the Agency. 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. In addition, the final rule ensures the legal dependability 
of electronically submitted documents so that they meet the needs of 
the compliance and enforcement programs. The legal dependability of 
electronically submitted documents is ensured 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.
    The Agency is extending the TSCA section 5 electronic reporting 
requirements to Notice of Commencements (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 TSCA Section 5 Premanufacture and Significant New 
Use Notification Electronic Reporting; Revisions to Notification 
Regulations (Ref. 2). Previously, follow-up submissions for TSCA 
section 5 notices submitted before this date were not subject to 
electronic reporting requirements.
    Effective March 4, 2014, EPA will only accept data, reports, and 
other information subject to these rules when submitted through CDX and 
the CISS tool for the submission of forms, reports, and other 
documents. TSCA section 5 submissions, however, must be submitted 
through CDX using e-PMN software downloaded from EPA's CDX Web site. 
Data, reports, and other information not submitted in the manner 
required will not be considered by EPA to have met the filing 
requirements of those rules. The CISS tool is also available for use in 
making voluntary submissions, such as those under Memoranda of 
Understanding (MOUs), electronically, following the same procedures 
described in this final rule. Submitters should register through CDX 
and submit data, reports, and other documents through the CISS tool. 
The final rule amends the following regulations:
    1. TSCA section 4 test rules and ECAs. Documents required under 
TSCA section 4 include 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), 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 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 an ECA (40 CFR 790.68). Electronic reporting requirements for 
TSCA section 4 rules and ECAs are added to 40 CFR 790.5 and 799.50. In 
addition, anyone who manufactures, imports, or processes a chemical 
substance under 40 CFR part 766, must test that chemical substance 
immediately upon manufacture, import, or processing for the presence of 
halogenated dibenzodioxins/halogenated dibenzofurans (HDDs/HDFs), and 
submit all test data to EPA. A requirement for electronic reporting is 
added to 40 CFR 766.35.
    2. TSCA section 5. EPA is amending certain TSCA section 5 reporting 
requirements that extend electronic reporting requirements to NOCs and 
support documents (e.g., correspondence, amendments, and test data) 
relating to TSCA section 5 notices submitted to EPA before April 6, 
2010. The e-PMN final rule (Ref. 2) required 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 e-PMN 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 electronic 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 
would not have been able to link up a subsequent NOC or support 
document with its original or ``parent'' legacy notice if the 
subsequent document 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 amending 40 CFR parts 720,

[[Page 72820]]

721, 723, and 725 to require NOCs and support documents submitted after 
March 4, 2014 for TSCA section 5 notices originally submitted prior to 
April 6, 2010, to be submitted electronically allowing them to be 
stored with their legacy TSCA section 5 notices in the new database.
    In 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 ended April 6, 2012. In this final rule, EPA is 
removing the phase-in because the phase-in period is over and all TSCA 
section 5 notices, NOCs, and support documents are required to be 
submitted to EPA via CDX.
    3. TSCA section 8(a). Electronic reporting requirements for Form 
7710-35, Manufacturer's Report--Preliminary Assessment Information 
(Manufacturer's Report), are added to 40 CFR 712.28 and 712.30. In 
addition, electronic reporting requirements for Form 7710-51, Dioxins/
Furans Report Form, are added to 40 CFR 766.35.
    4. TSCA section 8(d). Electronic submission of data, reports, and 
other documents are now 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 766.35). Additional affected sections of 40 
CFR part 716 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).
    EPA also requires submission of allegations of significant adverse 
reactions to dibenzo-para-dioxins/dibenzofurans, pursuant to 40 CFR 
part 717. EPA has not received a large number of allegations of 
significant adverse reactions, and therefore is not implementing a 
mechanism for the electronic submission of these allegations of 
significant adverse reactions using the CISS tool at this time. Anyone 
subject to the applicable requirements of 40 CFR part 766 must continue 
to submit to EPA paper copies of allegations of significant adverse 
reactions.

B. What is the agency's authority for taking this action?

    TSCA gives EPA broad authority to regulate the manufacture 
(including import) and processing of chemical substances. The 
underlying requirements promulgated under this broad authority and 
amended by this final rule require manufacturers (including importers) 
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 chemicals or mixtures presents an 
unreasonable risk of injury to health or the environment (TSCA section 
4).
     Report such data as EPA may reasonably require, including 
information that is necessary to facilitate the evaluation of the 
potential adverse human health and environmental effects from exposure 
to identified chemical substances, mixtures, or categories (TSCA 
section 8(a)).
     Submit lists and/or copies of ongoing and completed 
unpublished health and safety studies concerning identified chemical 
substances, mixtures, or categories (TSCA section 8(d)).
     Notify EPA at least 90 days before commencing the 
manufacture of a new chemical substance for commercial purposes (TSCA 
section 5(a)(1)(A)).
     Notify EPA at least 90 days before manufacturing or 
processing the chemical substance for any use of a chemical substance 
that EPA has determined, by rule, to be a ``significant new use'' (TSCA 
section 5(a)(2)).
    In addition, the Paperwork Reduction Act (PRA) requires Federal 
agencies to manage information resources to reduce information 
collection burdens on the public; increase program efficiency and 
effectiveness; and improve the integrity, quality, and utility of 
information to all users within and outside an agency, including 
capabilities for ensuring dissemination of public information, public 
access to Federal Government information, and protections for privacy 
and security (44 U.S.C. 3506). Section 2 of TSCA expresses the intent 
of Congress that EPA carry out TSCA in a reasonable and prudent manner, 
and in consideration of the impacts that any action taken under TSCA 
may have on the environment, the economy, and society (15 U.S.C. 2601). 
Electronic reporting was not available when TSCA was enacted nor when 
several underlying reporting requirements were subsequently promulgated 
by EPA. EPA believes that it is now reasonable and prudent to manage 
and leverage its information resources, including information 
technology (IT), to require the use of electronic reporting in the 
implementation of certain TSCA provisions. Electronic reporting can 
reduce burden and costs for the regulated entities by eliminating the 
costs associated with printing and mailing this information to EPA, 
while at the same time improving EPA's efficiency in reviewing 
submitted information, making decisions and disseminating information 
to the public.

III. Description of Changes to Reporting Procedures

    This unit provides an overview of EPA's CDX, the Chemical Safety 
and Pesticide Program (CSPP), the CISS tool, and the e-PMN software for 
NOCs and support documents associated with legacy TSCA section 5 
notices.

A. What is CDX?

    CDX is EPA's centralized electronic submission receiving system. 
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 the CISS tool for use in submitting data, reports, 
and other information under TSCA electronically to the Agency. In the 
proposed rule CISS was referred to as e-TSCAweb. In this document only 
the term CISS is used. The CISS 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. The CISS 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, and 
protects Confidential Business Information (CBI) as appropriate. Over 
time, there will be updates to CISS tool. The most recent version of 
CISS is available online at http://epa.gov/cdx.

C. What is the e-PMN software for TSCA section 5?

    EPA has 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, visit the TSCA New Chemicals 
Program Web site available online at http://www.epa.gov/oppt/newchems. 
Also, see the e-PMN final rule (Ref. 2) for further guidance.

[[Page 72821]]

D. What are the benefits of CDX reporting and use of the CISS tool and 
the e-PMN software?

    The effort to eliminate paper-based submissions in favor of CDX 
reporting, including use of the CISS tool, is part of broader Federal 
Government efforts to move to modern, electronic methods of information 
gathering. The CISS tool and e-PMN software enable more efficient data 
transmittal and reduces errors with the built-in validation procedures. 
EPA believes the adoption of electronic reporting reduces the reporting 
burden for submitters by 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 and the CISS tool 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 ensured 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. 3).

E. How do I submit data, reports, and other documents required under 
TSCA sections 4, 8(a), and 8(d) using CDX?

    This final rule requires submitters to register with EPA's CDX, 
request access to CSPP, and use the CISS tool to prepare a file for 
submission.
    1. Registering with CDX. Registration enables CDX to authenticate 
each user's identity, and to verify each user's authorization to file 
official submissions to EPA on behalf of a company.
    To submit electronically to EPA via CDX, individuals must first 
register in CDX through EPA's Web page 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, selects a 
program and role, and follows the procedures outlined in the CDX user 
guide available on EPA's Web page 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 Toxics Release Inventory TRI-ME web reporting, are 
able to add CSPP to their current registration, and use the CISS tool.
    2. Communication through CDX. Currently communication through CDX 
between the submitter and EPA is focused on transactional activities, 
meaning the submission of information to EPA and notification from EPA 
that the submission was received. EPA is mandating that all submissions 
of required materials be done through CDX but acknowledges that use of 
certified mail and email for correspondence related to the submissions 
is still necessary since the ability to do so within CDX is not yet 
available. EPA is in the process of enhancing the CDX correspondence 
functionality so the two-way emailing between submitters and EPA is 
offered in a secure environment.
    3. Preparing the submission. All submitters are required to use the 
CISS tool to prepare their submissions. The CISS tool guides users 
through a ``hands-on'' process of creating an electronic submission. 
Once a user completes the relevant data fields, attaches appropriate 
PDF or other file types, such as XML files, and completes metadata 
information, the CISS 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 and instructions 
for uploading PDF attachments or other file types, such as XML, and 
completing metadata information are available through the CISS tool 
user guide.
    4. Completing the submission to EPA. The CISS 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. The CISS tool then encrypts the file and submits it via CDX.

F. How must TSCA section 5 NOCs and support documents relating to 
legacy TSCA section 5 notices be submitted to EPA?

    EPA is requiring that NOCs and support documents relating to legacy 
TSCA section 5 notices be submitted to EPA using the same process as 
described in 40 CFR 720.40(a)(2), see Unit II.A.3. All NOCs and support 
documents are 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. 2) for more detailed information on the process for 
submitting NOCs and support documents.

G. How must CBI be submitted using CISS?

    All information sent by the submitter via CDX is transmitted 
securely to protect CBI. The CISS tool enables the user to submit CBI 
in an electronic format. The CISS tool also guides the user through the 
process of submitting CBI by prompting the submitter to check a CBI box 
if using an electronic form or by submitting a sanitized document 
containing CBI by bracketing, underlining, or otherwise marking the 
confidential information on the document to be submitted prior to 
scanning. The submitter must provide a sanitized non-CBI document and 
CBI document. Documents containing information claimed as CBI must be 
submitted in an electronic format, in accordance with the recordkeeping 
requirements (Ref. 3) 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). The 
CISS tool allows the submitter to indicate whether a study plan 
contains information claimed as CBI by checking the appropriate box. 
The submitter then is prompted to submit the study plan document in an 
electronic format. The submitter must 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 is prompted by the CISS tool 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). The CISS tool includes 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, Manufacturer's Report, the CISS 
tool

[[Page 72822]]

requires the submitter to certify that the confidentially statements 
are true by prompting the submitter to select the ``Confidentiality 
Certification Statement.'' The Dioxins/Furans Report Form (Form 7710-
51) and instructions for downloading the form required under 40 CFR 
part 766 are available online at http://www.epa.gov/oppt/chemtest/ereporting/index.html.
    3. TSCA section 8(d). Documents submitted under TSCA section 8(d) 
that contain information claimed as CBI must be indicated as such by 
using the CISS tool. The CISS tool allows the submitter to indicate if 
the document contains CBI by checking the appropriate box. Then, the 
submitter is prompted to submit the document in an electronic format. 
In submitting a document that contains CBI, the CISS tool prompts the 
submitter to submit two copies of the document in an electronic format. 
The copy containing CBI must identify the confidential information by 
bracketing or underlining the information and labeling the copy 
``confidential,'' ``proprietary,'' or ``trade secret.'' The non-CBI 
second copy needs to have all confidential information deleted. Once 
CBI is claimed, the CISS tool prompts the submitter to substantiate 
their claims (40 CFR 716.55).
    The CISS tool user guide also instructs users on how to submit and 
substantiate CBI information.

H. 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 the CISS tool before its release 
following publication of this final rule. The webinar will be recorded 
and available at http://www.epa.gov/oppt/chemtest/ereporting/index.html. There will also be beta testing to allow submitters to 
become familiar with the CISS tool on their own and to provide comments 
to the Agency on its functionality and performance.

IV. Economic Analysis

    The Agency's estimated economic impact of this final rule is 
presented in a document entitled ``Economic Analysis for the Electronic 
Reporting under Toxic Substance Control Act (TSCA) Final Rule'' 
(Economic Analysis) (Ref. 4) a copy of which is available in the docket 
and is briefly summarized in this unit.
    EPA estimates that this final rule will result in cost savings to 
the affected companies because the time required to enter, review, 
edit, and submit their reports using CDX will be reduced compared to 
the existing paper-based process.
    EPA estimates that this final rule will 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 assumes that 
industry will continue to realize cost savings each additional year.
    EPA estimates that the Agency also will experience a reduction in 
the 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 
will 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. In subsequent 
years, EPA will incur the $57,353 annually in operations and 
maintenance costs, resulting in Agency savings of $2,082 a year in 
subsequent years.
    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 final rule 
relating to the submission of TSCA section 5 supporting documents would 
be very minimal given that industry has already undertaken electronic 
submission of such supplemental materials.

V. Response to Comments

    The Agency received comments from two persons on the proposed rule 
for electronic reporting for TSCA submissions. One was an anonymous 
comment expressing support for electronic reporting and the other 
comment was from an industry trade association. Copies of all comments 
received are available in the docket for this action. The comments 
received on the proposed rule did not result in EPA making significant 
changes to the final rule. A discussion of the comments germane to the 
rulemaking and the Agency's responses follow:
    Comment 1: Phased-in the electronic reporting requirements. One 
commenter stated that EPA must phase-in the electronic reporting 
requirements. The commenter stated that EPA should conduct adequate 
beta testing, and then should accept paper submissions as well as 
electronic ones for at least a 2-year phase-in period. They said that 
it is essential to avoid excessive burden on submitters, as well as to 
avoid placing the regulated community in the position of potential late 
submission or noncompliance related to reporting system obstacles. In 
addition, the commenter asserted that EPA's logs of calls to its 
hotline for the Chemical Data Reporting Rule (CDR) reporting will 
demonstrate objectively the nature and level of problems that users 
have encountered in this electronic reporting system, which was 
mandatory and was not phased-in. They asserted that their member 
companies have spent time working through the new CDR electronic 
reporting system, consulting with EPA's help desk and other staff, and 
otherwise addressing the various issues presented by the mandatory 
electronic reporting under CDR.
    The commenter stated that phasing-in is necessary to allow EPA to 
work with users to ensure that the system is practical, user-friendly, 
and free of errors. Based on the commenter's experience with developing 
CDR submissions, they noted that it is important that persons other 
than an Authorized Official (AO) are able to make submissions as 
appropriate in any electronic system, as they also do with paper 
submissions.
    The commenter strongly urged EPA to continue to allow submissions 
through alternative means for at least a phase-in period. The phase-in 
period should follow a thorough beta-testing period. Furthermore, they 
noted that EPA should consider allowing alternative means of submission 
on a case-by-case basis. It is possible that future rules under TSCA 
sections 4 and 8 will affect entities that have not done prior TSCA 
submissions or even used CDX. They noted that such entities should not 
be forced to use any electronic submission system (particularly in a 
short time frame) unless and until the system is proved to be 
foolproof, efficient, and user-friendly.
    EPA Response: EPA is mandating certain electronic reporting under 
TSCA in this final rule because EPA believes that the benefits of 
filing submissions electronically are substantial, in terms of data 
quality and timeliness of processing and public data availability and 
for records management. The Agency also notes that paper submissions 
contain errors that can be caught with forms associated with electronic 
submissions thus increasing data reliability. Although EPA acknowledges 
the initial burdens incurred with registering submitters in CDX and in 
learning how to use the CISS tool, EPA has received very positive 
feedback from industry submitters for the CDR Rule. Submitters have 
conveyed that the electronic

[[Page 72823]]

reporting tool for that program, eCDRweb, while experiencing some 
initial performance issues, is far superior to previous electronic 
reporting applications used by EPA. EPA believes that, as more TSCA 
submitters register with CDX and gain experience with the CISS tool, 
concerns with using the electronic reporting tool will diminish.
    With regard to IT-related issues that arose during the CDR 
reporting, EPA acknowledges that there were some issues in the 
registration process early in the reporting period, and that CDX 
registrants were unfamiliar with the registration process and how the 
reporting tool worked. EPA responded to issues reported through the CDX 
help desk, the CDR help desk and the TSCA hotline in a timely manner 
with patches to the system. Most of the issues involved delays in CDX 
registration, with the need to reset passwords in the system, and in 
some cases with issues related to using the XML schema provided by EPA.
    The CDX system has been in operation for over 10 years and during 
that time, EPA has continued to improve the registration process so 
that it is more efficient for users. For example, EPA found that 
accepting the Electronic Signature Agreements of CDX registered 
submitters under Toxic Release Inventory for those registering in CDX 
as TSCA submitters significantly reduced the burden associated with the 
CDX registration process. EPA expects eventually to achieve a one-time 
registration process for all Agency submitters, not just for those 
under TSCA, in CDX and is exploring other ways to streamline the CDX 
registration process.
    EPA strongly encourages TSCA submitters to register with CDX in 
advance so that they are in a position to report when the need arises. 
EPA also encourages that multiple submitters in each company register 
as AO with CDX so that an alternate AO will be able to make the 
submission in a timely manner in the event that one of the registered 
AO CDX users is unavailable. It is critical that AO be individuals who 
can make submissions on behalf of their company in order to comply with 
Cross-Media Electronic Reporting Regulation (Ref. 5).
    EPA understands the commenter's interest in beta testing and agrees 
that providing the regulated community with opportunities to learn how 
to use the CISS tool and provide feedback is beneficial. Through these 
opportunities, submitters will gain experience with its functionalities 
and operation, and EPA can make refinements as necessary. In response 
to this comment, EPA has established a 90-day time frame between the 
publication date and effective date of this final rule rather than a 
30- or 60-day time frame, in order to facilitate compliance with the 
final rule's effective date. During the 90 days, EPA will offer 
webinars and training opportunities for submitters to gain experience 
with the reporting tool and CDX. EPA also conducted webinars for TSCA 
section 8(a) on September 18, 2012, and for TSCA section 8(d) on May 
22, 2012, and September 20, 2012. During these webinars, industry 
representatives had the opportunity to familiarize themselves with both 
CDX and CISS and ask questions regarding their functionality. EPA is 
implementing best practices and procedures and adding technologies to 
closely monitor the performance of the CISS tool and accelerate 
resolution of any problems that may arise with the tool. Performance 
status and scheduled updates to the CDX registration process and the 
CISS tool will be made available on the EPA electronic reporting Web 
site available online at http://www.epa.gov/oppt/chemtest/ereporting/index.html. Use of a web-based reporting tool provides assurance that 
upgrades to the system are seamless to the user, minimizing downtime 
and disruptions to the reporting process. EPA is committed to ensuring 
that the gap between incident and response is minimal.
    In light of the substantial disadvantages associated with paper 
submissions, and with the reporting tool improvements and training 
opportunities, EPA does not believe it is necessary to phase-in 
electronic reporting for TSCA sections 4 and 8. As a practical matter, 
electronic reporting requirements covered under this final rule are 
invoked by individual rules that are not promulgated under a set 
schedule and may not have ongoing reporting requirements (e.g., annual 
reporting), so it would be difficult to phase-in electronic reporting 
requirements. Further, the phase-in period in place for TSCA section 5 
notices is completed therefore the regulated community is familiar with 
the ePMN software and an additional phase-in period is not needed. In 
addition, EPA and many regulated entities have gained experience with 
electronic reporting under TSCA and EPA believes that phasing would 
accommodate only a small number of new reporters, while potentially 
confusing those submitters already filing electronically under other 
TSCA requirements. It would also impose burden on EPA to manage both 
paper and electronic systems. EPA believes that by providing additional 
time to register in CDX before this final rule becomes effective, 
continuing to improve registration and help desk functions, and by 
offering training opportunities to industry, both new and experienced 
submitters will be able to successfully report electronically to EPA 
and be aware of the status of submitted data, reports, and other 
documents.
    Comment 2: Information about EPA's plans for offering electronic 
reporting for TSCA sections 8(e) and 12(b). One commenter requested 
that EPA explain its plans for electronic reporting under TSCA section 
8(e) and 12(b), particularly since EPA has been demonstrating its 
software for electronic reporting of TSCA section 8(e) submissions.
    The commenter suggested that EPA establish voluntary electronic 
reporting options for submissions under TSCA section 8(e) and for 
export notifications under TSCA section 12(b). The commenter noted that 
electronic reporting should be voluntary, not mandatory, due to the 
short timeframes for reporting and the ongoing potential for 
submissions to be made by first-time reporters. Also, the commenter 
noted that voluntary electronic reporting would allow companies to use 
any internal systems they may have already developed to accomplish 
export notification, at least until they are able to revise the systems 
to accommodate electronic reporting to EPA.
    EPA Response: EPA will announce the availability of an electronic 
reporting option for use both by those who are required to submit a 
notification of substantial risk under TSCA section 8(e) and by those 
who wish to voluntarily submit related FYI notifications. EPA is also 
considering extending electronic reporting for TSCA section 12(b) 
export notifications but is not announcing the availability of such a 
reporting method at this time.
    Comment 3: Correspondence through CDX. The commenter noted to EPA 
that such correspondence could be useful, depending on its format and 
method of delivery. However, the commenter noted that EPA should not 
rely solely on CDX as the sole means of communication, and requested 
that any material correspondence relating to submissions under TSCA 
sections 4 and 8(d) rules should be transmitted by traditional means 
(e.g., letter and/or email as appropriate) as well as through CDX. 
Finally, it was noted that it is very important that any reporting 
system include a clear mechanism for documented acknowledgement from

[[Page 72824]]

EPA that a submission has been received.
    EPA Response: EPA acknowledges that CDX correspondence with TSCA 
submitters is limited. EPA is considering options to enhance CDX 
correspondence functionalities, including offering the ability to 
conduct two-way emailing between submitters and EPA in a secure 
environment. EPA will continue to allow TSCA submitters to correspond 
with EPA about their electronically reported TSCA submissions through 
email and certified mail after the submission and all related materials 
are electronically reported through CDX. CDX does create and store a 
Copy of Record of the original submission and any amendments made by 
the submitter. This functionality provides records management benefits 
for EPA as well as the regulated community and other stakeholders who 
make TSCA submissions.

VI. References

    As indicated under ADDRESSES, a docket has been established for 
this final 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. Electronic Reporting Under the Toxic Substances Control 
Act; Proposed Rule. Federal Register (77 FR 22707, April 17, 2012) 
(FRL-9337-5).
    2. 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).
    3. Transfer of Records to the National Archives of the United 
States. 36 CFR part 1235.
    4. EPA. Economic Analysis for the Electronic Reporting under 
Toxic Substances Control Act (TSCA) Final Rule. June 17, 2013.
    5. EPA. Cross-Media Electronic Reporting; Final Rule. Federal 
Register (70 FR 59855, October 13, 2005) (FRL-7977-1).

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 for this action, which is 
contained in a document entitled ``Economic Analysis for the Electronic 
Reporting under Toxic Substances Control Act (TSCA) Final Rule'' (Ref. 
4). A copy of the Economic Analysis is available in the docket for this 
final rule and is summarized in Unit IV.

B. Paperwork Reduction Act

    The information collection requirements (ICR) contained in this 
final 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. 2412.02 and OMB Control No. 2070-0183, is available in the docket 
for this final rule. The ICR addresses the incremental changes to the 
four currently approved ICR documents that cover the existing reporting 
and recordkeeping programs that are approved under OMB control numbers 
2070-0004, 2070-0012, 2070-0033, and 2070-0054. 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 final rule are designed to assist the Agency in meeting its 
responsibility under TSCA to receive, process, and review reports, 
data, and other information. Thus, submissions in response to the 
collection of information covered by these ICRs are mandatory and 
respondents are required to use the CISS tool, except for TSCA section 
5 submissions, which require the use of the existing electronic e-PMN 
software.
    Burden is defined at 5 CFR 1320.3(b). The ICR document for this 
final 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 1,228 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.

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 
5 U.S.C. 601 et seq., the Agency hereby certifies that this final rule 
will not have a significant adverse economic impact on a substantial 
number of small entities.
    Small entities include small businesses, small organizations, and 
small governmental jurisdictions. For purposes of assessing the impacts 
of this final 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 final 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 final 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), or 8(d) and identified 
those companies potentially affected by this final rule that qualify 
for the small business status. EPA estimated the cost impact ratios for 
small parent entities potentially affected by this final 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 final rule are likely to be minimal.

[[Page 72825]]

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 
U.S.C. 1531-1538, requires Federal agencies, unless otherwise 
prohibited by law, to assess the effects of their regulatory actions on 
State, local, and tribal governments and the private sector. This final 
rule does not contain a Federal mandate that may result in expenditures 
of $100 million or more for State, local, and tribal governments, in 
the aggregate, or the private sector in any 1 year. EPA estimates that 
this final rule will result in total private sector cost of 
approximately $14,061 in year 1 and a cost savings of $66,834 in each 
subsequent year (Ref. 4). State, local, and tribal governments have not 
been affected by the TSCA sections 4, 5, 8(a), and 8(d) reporting 
requirements, and are not expected to be affected by this final rule. 
Thus, this final rule is not subject to the requirements of UMRA 
sections 202 or 205. This final rule is also not subject to the 
requirements of UMRA section 203 because it contains no regulatory 
requirements that might significantly or uniquely affect small 
governments.

E. Executive Order 13132

    This action does not have a substantial direct effect on States, on 
the relationship between national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled 
``Federalism'' (64 FR 43255, August 10, 1999).

F. Executive Order 13175

    This final rule does not have tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This 
final rule does not significantly nor uniquely affect the communities 
of Indian Tribal governments nor does it involve or impose any 
requirements that affect Indian Tribes. Accordingly, the requirements 
of Executive Order 13175, entitled ``Consultation and Coordination with 
Indian Tribal Governments'' (65 FR 67249, November 9, 2000), do not 
apply to his final rule.

G. Executive Order 13045

    This action is not subject to Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), because this action is not an 
economically significant regulatory action as defined by E.O. 12866, 
and this action does not address environmental health or safety risks 
disproportionately affecting children.

H. Executive Order 13211

    This final rule is not subject to Executive Order 13211, entitled 
``Actions Concerning Regulations that Significantly Affect Energy 
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), because 
this action is not expected to affect energy supply, distribution, or 
use and because this action is not a significant regulatory action 
under E.O. 12866.

I. National Technology Transfer and Advancement Act

    Since this action does not involve any technical standards, section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), 15 U.S.C. 272 note, does not apply to this action.

J. Executive Order 12898

    This final rule does not entail special consideration of 
environmental justice related issues as delineated by Executive Order 
12898, entitled ``Federal Actions to Address Environmental Justice in 
Minority Populations and Low-Income Populations'' (59 FR 7629, February 
16, 1994).

VIII. Congressional Review Act

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

List of Subjects in 40 CFR Parts 712, 716, 720, 721, 723, 725, 766, 
790, and 799

    Environmental protection, Administrative practice and procedure, 
Business and industry, Chemicals, Reporting and recordkeeping 
requirements.

    Dated: November 19, 2013.
James Jones,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.

    Therefore, 40 CFR chapter I is amended as follows:

PART 712--[AMENDED]

0
1. The authority citation for part 712 continues to read as follows:

    Authority: 15 U.S.C. 2607(a).

0
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 
submission receiving system.
    (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, or its successors.

0
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) 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 certification as to the truth and accuracy of the information 
reported 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.

[[Page 72826]]

    (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 the CISS tool to complete and submit Form 
7710-35, Manufacturer's Report, and accompanying letters, via CDX. 
Submission requires registration with CDX, and must be made only as set 
forth in this section.
    (e) To access the CISS tool 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.
0
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 
method specified in Sec.  712.28(d) prior to the reporting deadline.
    (ii)(A) 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. 
Such a letter 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) The submission must be made prior to the reporting deadline.
* * * * *
    (c) * * *
    (2) You must submit the information using the method specified in 
Sec.  712.28(d).
* * * * *

PART 716--[AMENDED]

0
5. The authority citation for part 716 continues to read as follows:

    Authority: 15 U.S.C. 2607(d).

0
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 
submission receiving system.
    Chemical Information Submission System or CISS means EPA's 
electronic, web-based tool for the completion and submission of data, 
reports, and other information, or its successors.
* * * * *
0
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 the CISS tool 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 the CISS tool 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.

0
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 the CISS tool 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 the CISS tool 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.
0
9. 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 by 
certified mail 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 in accordance with the method specified in Sec.  
716.30(d). If the respondent fails to submit the second copy within the 
30 days, EPA will place the first copy in the docket.
* * * * *

0
10. 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(c), 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

[[Page 72827]]

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 (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. 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). The Director of EPA's Office of Pollution Prevention and 
Toxics will grant or deny extension requests.
    (d) Submission methods. Persons must use the CISS tool 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 the CISS tool 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.

0
11. 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 the 
CISS tool 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 the CISS tool 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.

PART 720--[AMENDED]

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

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

0
13. In Sec.  720.40:
0
a. Remove paragraphs (a)(2)(i) and (a)(2)(ii).
0
b. Redesignate paragraphs (a)(2)(iii) and (a)(2)(iv) as paragraphs 
(a)(2)(i) and (a)(2)(ii).
0
c. Revise newly redesignated paragraph (a)(2)(i).
0
d. 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.
* * * * *

0
14. 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)(ii) 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.
* * * * *

0
15. In Sec.  720.102:
0
a. Remove paragraph (d)(1).
0
b. Designate the introductory text of paragraph (d) as paragraph 
(d)(1).
0
c. 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]

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

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

0
17. In Sec.  721.30, revise the introductory text of paragraph (b) 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:
* * * * *
0
18. 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

[[Page 72828]]

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]

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

    Authority: 15 U.S.C. 2604.

0
20. 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]

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

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

0
22. 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 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.
* * * * *

0
23. 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.

0
24. 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.
* * * * *
0
25. 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.

0
26. In Sec.  725.975, revise the introductory text of paragraph (b) 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:
* * * * *
0
27. 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]

0
28. The authority citation for part 766 continues to read as follows:

    Authority: 15 U.S.C. 2603 and 2607.

0
29. 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 
submission receiving system.
    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, or its successors.
* * * * *
0
30. 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

[[Page 72829]]

of Federal Regulations (CFR) section number (e.g., Sec.  766.20).
    (b) You must use the CISS tool to complete and submit all data, 
reports, and other information required under this part except for 
records and reports of allegations of significant adverse reactions, 
which must be submitted in accordance with paragraph (c) of this 
section.
    (1) Submissions must be submitted to EPA via CDX.
    (2) To access the CISS tool 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.
    (c) You must submit records and reports of allegations of 
significant adverse reactions and the accompanying cover letters by one 
of the following methods:
    (1) Mail, preferably certified, to the Document Control Office 
(DCO) (7407M), Office of Pollution Prevention and Toxics (OPPT), 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001, ATTN: Dioxin/Furan report part 766, 
Allegations of significant adverse reactions.
    (2) Hand delivery to OPPT Document Control Office (DCO), EPA East, 
Rm. 6428, 1201 Constitution Ave. NW., Washington, DC, ATTN: Dioxin/
Furan report part 766, Allegations of significant adverse reactions. 
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.

0
31. In Sec.  766.35, revise paragraph (c)(1)(i) to read as follows:

Sec.  766.35  Reporting requirements.

    (c) * * *
    (1) * * *
    (i) A completed form (EPA 7710-51) for that chemical substance. The 
form and instructions are available online at http://www.epa.gov/oppt/chemtest/ereporting/index.html. One form must be submitted for each 
chemical substance for which a positive test result has been submitted.
* * * * *

PART 790--[AMENDED]

0
32. The authority citation for part 790 continues to read as follows:

    Authority: 15 U.S.C. 2603.

0
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 
submission receiving system.
* * * * *
    Chemical Information Submission System or CISS means EPA's 
electronic, web-based tool for the completion and submission of data, 
reports, and other information, or its successors.
* * * * *

0
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 consent agreements.
    (b) You must use the CISS tool 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 the CISS tool 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.
0
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).
* * * * *

0
36. In Sec.  790.48, revise paragraphs (b)(3), (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.

* * * * *
    (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).
* * * * *
    (5) If no manufacturer or processor submits a letter of intent to 
EPA through CDX within 30 days after either receipt of the certified 
letter or publication in the Federal Register notice described in 
(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 the certified letter or publication in the Federal Register.
    (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 by certified mail 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 certified letter or publication of the Federal Register notice 
described in 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 certified letter or publication of the Federal 
Register notice described in paragraph (c)(2) of this section.

0
37. In Sec.  790.50, revise paragraphs (b)(1) 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.
* * * * *

[[Page 72830]]

    (e) Amendments to study plans. Test sponsors must submit all 
amendments by the method specified in Sec.  790.5(b).

0
38. In Sec.  790.55, revise paragraph (a) 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).
* * * * *

0
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).
* * * * *
0
40. In Sec.  790.68, revise paragraph (b)(1) 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).
* * * * *

0
41. In Sec.  790.87, revise paragraph (c) to read as follows:

Sec.  790.87  Approval of exemption applications.

* * * * *
    (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) A letter by certified mail will give exemption applicants 
final notice that they have received a conditional exemption.
    (2) All conditional exemptions thus granted are contingent upon the 
test sponsors' successful completion of testing according to the 
specifications of the test rule.

0
42. 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.
* * * * *

0
43. In Sec.  790.93, revise paragraphs (c) and (d)(2) to read as 
follows:

Sec.  790.93  Termination of conditional exemption.

* * * * *
    (c) Within 30 days after receipt of a letter notification or 
publication of a notice in the Federal Register 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 letter or publication in the Federal Register notice 
described in paragraph (b) of this section.
* * * * *

0
44. In Sec.  790.97, revise paragraph (a) 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.
* * * * *

PART 799--[AMENDED]

0
45. The authority citation for part 799 continues to read as follows:

    Authority: 15 U.S.C. 2603, 2611, and 2625.

0
46. 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 the Central Data Exchange (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. 2013-28510 Filed 12-3-13; 8:45 am]
BILLING CODE 6560-50-P