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[Federal Register Volume 77, Number 74 (Tuesday, April 17, 2012)]
[Proposed Rules]
[Pages 22707-22719]
From the Federal Register Online via the Government Printing 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: 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. 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

[[Page 22709]]

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
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