Electronic Reporting Under the Toxic Substances Control Act, 22707-22719 [2012-8937]
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Federal Register / Vol. 77, No. 74 / Tuesday, April 17, 2012 / Proposed Rules
examines the reasonable alternatives
and assesses their potential
environmental impact. It also identifies
the preferred alternative and how it
affects the proposed rulemaking.
We request your comments on
environmental concerns that you may
have related to the draft EA. This
includes suggesting analyses and
methodologies for use in the EA or
possible sources of data or information
not included in the draft EA. Your
comments will be considered in
preparing the final EA.
This notice is issued under the
authority of 5 U.S.C. 552(a), and 33 CFR
1.05–1, 100.35, and 165.5.
Dated: March 29, 2012.
Cynthia L. Stowe,
Captain, U.S. Coast Guard, Captain of the
Port San Francisco.
[FR Doc. 2012–9070 Filed 4–16–12; 8:45 am]
BILLING CODE 9110–04–P
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
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
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
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SUMMARY:
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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: https://
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 https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through regulations.gov or
email. The regulations.gov 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
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of encryption, and be free of any defects
or viruses.
Docket: All documents in the docket
are listed in the docket index available
at https://www.regulations.gov. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
will be publicly available only in hard
copy. Publicly available docket
materials are available electronically at
https://www.regulations.gov, or, if only
available in hard copy, at the OPPT
Docket. The OPPT Docket is located in
the EPA Docket Center (EPA/DC) at Rm.
3334, EPA West Bldg., 1301
Constitution Ave. NW., Washington,
DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to
4:30 p.m., Monday through Friday,
excluding 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
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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.
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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.
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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 https://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
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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 ePMN final rule, EPA’s electronic
reporting program has evolved and EPA
now has the ability to house both legacy
notices and notices submitted after
April 6, 2010, in the same database. EPA
is therefore proposing to amend the
regulations at 40 CFR parts 720, 721,
723, and 725 to require NOCs and
support documents for TSCA section 5
notices originally submitted prior to
April 6, 2010, to be submitted
electronically allowing them to be
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stored with their legacy TSCA section 5
notices in the new database.
Within the e-PMN final rule, EPA
phased-in electronic reporting of TSCA
section 5 notices and their related NOCs
and support documents over a 2-year
period that ends April 6, 2012. Within
this proposed rule, EPA would remove
the regulatory text related to the phasein because by the time this proposed
rule is finalized, EPA expects the phasein 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
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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 2year 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
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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
https://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
https://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 ePMN 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
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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 https://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 https://
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
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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 https://
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
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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
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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.
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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
https://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 https://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.
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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 paperbased 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 scanningrelated 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 webbased 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.).
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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 https://www.epa.gov/oppt/
chemtest/ereporting/. 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 ePMN 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
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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
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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 webbased 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: https://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.
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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
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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 rulerelated 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.
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.
C. Regulatory Flexibility Act
Pursuant to section 605(b) of the
Regulatory Flexibility Act (RFA), 5
D. Unfunded Mandates Reform Act
State, local, and tribal governments
have not been affected by the TSCA
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22713
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),
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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.
Dated: March 30, 2012.
Louise P. Wise,
Acting Assistant Administrator, Office of
Chemical Safety and Pollution Prevention.
H. Executive Order 13211
PART 712—[AMENDED]
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.
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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.
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Therefore, it is proposed that 40 CFR
chapter I be amended as follows:
1. The authority citation for part 712
continues to read as follows:
Authority: 15 U.S.C. 2607(a).
2. In § 712.3, add new paragraphs (q)
and (r) to read as follows:
§ 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 § 712.28, revise paragraphs (c)
and (d) and add new paragraph (e) to
read as follows:
§ 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
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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 https://
www.epa.gov/oppt/chemtest/ereporting/
index.html.
4. In § 712.30, revise paragraphs
(a)(3)(i), (a)(3)(ii), and (c)(2) to read as
follows:
§ 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 § 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
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method specified in § 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 § 712.28(d) to EPA, and must submit
an accompanying letter, also in
accordance with the methods specified
in § 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
§ 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 § 716.3, add the following
definitions in alphabetical order to read
as follows:
§ 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 § 716.30, revise paragraph (c)
and add new paragraph (d) to read as
follows:
§ 716.30
Submission of copies of studies.
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*
*
*
*
*
(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
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further instructions to go https://
www.epa.gov/oppt/chemtest/ereporting/
index.html.
8. In § 716.35, revise paragraph (c)
and add new paragraph (d) to read as
follows:
§ 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 https://
www.epa.gov/oppt/chemtest/ereporting/
index.html.
9. In § 716.40, revise the introductory
text of the section to read as follows:
§ 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 §§ 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 § 716.55, revise paragraph (b)(3)
to read as follows:
§ 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 § 716.60, revise paragraphs (a),
(b)(2), (c), and (d), and add new
paragraph (e) to read as follows:
§ 716.60
Reporting schedule.
(a) General requirements. Except as
provided in § 716.5 and paragraphs (b)
and (c) of this section, submissions
under §§ 716.30 and 716.35 must be
submitted using the electronic method
specified in §§ 716.30(c) and 716.35(d),
on or before 60 days after the effective
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22715
date of the listing of a substance or
mixture in § 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 § 716.120.
(b) * * *
(2) Submission of copies of completed
studies. Persons must submit studies
listed as ongoing or initiated under
§ 716.35(a)(1) and (a)(2) within 30 days
of completing the study, using the
method specified in §§ 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 § 716.120,
using the electronic method specified in
§§ 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 https://
www.epa.gov/oppt/chemtest/ereporting/
index.html.
12. In § 716.105, revise paragraph (d)
and add new paragraph (e) to read as
follows:
§ 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 https://
www.epa.gov/oppt/chemtest/ereporting/
index.html.
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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 § 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:
§ 720.40
General.
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 § 720.40(a)(2)(ii) for information on
how to obtain e-PMN software.
*
*
*
*
*
16. In § 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:
§ 720.102 Notice of commencement of
manufacture or import.
(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 § 720.75, revise paragraphs
(b)(2) and (e)(1) to read as follows:
*
§ 720.75
§ 721.30 EPA approval of alternative
control measures.
Notice review period.
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*
*
*
*
*
(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 § 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
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*
*
*
*
(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 § 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 § 721.30, revise paragraph (b)
introductory text to read as follows:
*
*
*
*
*
(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 § 721.185, revise paragraph
(b)(1) to read as follows:
chemical substance that has been added
to subpart E of this part using the
procedures described in §§ 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 § 723.50, revise paragraph (e)(1)
to read as follows:
§ 723.50 Chemical substances
manufactured in quantities of 10,000
kilograms or less per year, and chemical
substances with low environmental
releases and human exposures.
*
*
*
*
*
(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 § 725.25, revise paragraph (c) to
read as follows:
§ 721.185 Limitation or revocation of
certain notification requirements.
§ 725.25 General administrative
requirements.
*
*
*
*
*
*
(b) * * *
(1) Any affected person may request
modification or revocation of significant
new use notification requirements for a
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*
*
*
*
(c) Where to submit information
under this part. MCANs and exemption
requests, and any support documents
related to these submissions, may only
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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 § 725.54, revise paragraphs (b)
and (d) to read as follows:
§ 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 ePMN 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 § 725.60, revise paragraph (a) to
read as follows:
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§ 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 § 725.190, revise paragraph (d)
to read as follows:
§ 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
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CDX) using e-PMN software. See 40 CFR
720.40(a)(2)(ii) for information on how
to obtain e-PMN software.
27. In § 725.975, revise paragraph (b)
introductory text to read as follows:
§ 725.975 EPA approval of alternative
control measures.
*
*
*
*
*
(b) Persons submitting a request for a
determination of equivalency to EPA
under this part 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 § 725.984, revise paragraph
(b)(1) to read as follows:
§ 725.984 Modification or revocation of
certain notification requirements.
*
*
*
*
(b) * * *
(1) Any affected person may request
modification or revocation of significant
new use notification requirements for a
microorganism that has been added to
subpart M of this part using the
procedures described in § 725.980. 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.
*
*
*
*
*
§ 766.7
29. The authority citation for part 766
continues to read as follows:
Authority: 15 U.S.C. 2603 and 2607.
30. In § 766.3, add the following
definitions in alphabetical order to read
as follows:
§ 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 § 766.7 to read as follows:
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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., § 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 https://
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.
*
PART 766—[AMENDED]
22717
33. In § 790.3, add the following
definitions in alphabetical order to read
as follows:
§ 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 § 790.5 to read as follows:
§ 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 https://
www.epa.gov/oppt/chemtest/ereporting/
index.html.
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35. In § 790.45, revise paragraph (a) to
read as follows:
§ 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
§ 790.40, each person subject to that test
rule and required to comply with the
requirements of that test rule as
provided in § 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
§ 790.5(b).
*
*
*
*
*
36. In § 790.48, revise paragraphs
(a)(2), (a)(3), (b)(3), (b)(4), (b)(5), (c)(2),
and (c)(3) to read as follows:
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§ 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
§ 790.40, EPA will notify all
manufacturers, including those
described in § 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
§ 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 § 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
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must be submitted to EPA by the
method specified in § 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 § 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 § 790.50, revise paragraphs
(b)(1), (b)(3), and (e) to read as follows:
§ 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
§ 790.5(b). Any extension request must
state why EPA should grant the
extension.
*
*
*
*
*
PO 00000
Frm 00033
Fmt 4702
Sfmt 4702
(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 § 790.5(b).
38. In § 790.55, revise paragraphs (a)
and (b)(2) to read as follows:
§ 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
§ 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
§ 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 § 790.62, revise paragraph (c)(4)
to read as follows:
§ 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 § 790.5(b).
*
*
*
*
*
E:\FR\FM\17APP1.SGM
17APP1
Federal Register / Vol. 77, No. 74 / Tuesday, April 17, 2012 / Proposed Rules
40. In § 790.68, revise paragraphs
(b)(1) and (b)(2)(ii) to read as follows:
§ 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
§ 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 nonmandatory testing requirement (i.e.,
‘‘should statements’’), the test sponsor
shall submit these requests to EPA using
the method specified in § 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 § 790.87, revise paragraphs
(b)(2)(i), (b)(2)(ii), and (c) to read as
follows:
wreier-aviles on DSK5TPTVN1PROD with PROPOSALS
§ 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.
VerDate Mar<15>2010
14:21 Apr 16, 2012
Jkt 226001
(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 § 790.88, revise paragraph (b) to
read as follows:
§ 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 § 790.90, revise paragraph (c)(2)
to read as follows:
§ 790.90 Appeal of denial of exemption
application.
*
*
*
*
*
(c) * * *
(2) Hearing requests must be
submitted using the method specified in
§ 790.5(b) and be received by EPA
within 30 days of receipt of the
Agency’s notification under § 790.88(b).
Hearing requests must provide reasons
why a hearing is necessary.
*
*
*
*
*
44. In § 790.93, revise paragraphs (b),
(c), (d)(2), and (e) to read as follows:
§ 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 § 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.
PO 00000
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Fmt 4702
Sfmt 4702
22719
Such a letter of intent shall contain all
of the information required by
§ 790.45(c).
(d) * * *
(2) Hearing requests must be
submitted using the method specified in
§ 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 § 790.97, revise paragraphs (a)
and (c) to read as follows:
§ 790.97
Hearing procedures.
(a) Hearing requests must be
submitted using the method specified in
§ 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 § 799.5 to read as follows:
§ 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., § 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 https://
www.epa.gov/oppt/chemtest/ereporting/
index.html.
[FR Doc. 2012–8937 Filed 4–16–12; 8:45 am]
BILLING CODE 6560–50–P
E:\FR\FM\17APP1.SGM
17APP1
Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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 https://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or email. The
regulations.gov 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 https://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at https://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
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 https://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 https://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 https://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 https://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 https://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 https://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 https://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 https://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 https://www.epa.gov/oppt/chemtest/ereporting/. 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:
https://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 https://www.epa.gov/oppt/chemtest/ereporting/.
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 https://www.epa.gov/oppt/chemtest/ereporting/.
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 https://www.epa.gov/oppt/chemtest/ereporting/.
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 https://www.epa.gov/oppt/chemtest/ereporting/.
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 https://www.epa.gov/oppt/chemtest/ereporting/.
[[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 https://www.epa.gov/oppt/chemtest/ereporting/.
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 https://www.epa.gov/oppt/chemtest/ereporting/.
[[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 https://www.epa.gov/oppt/chemtest/ereporting/.
[FR Doc. 2012-8937 Filed 4-16-12; 8:45 am]
BILLING CODE 6560-50-P