[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)]
[Rules and Regulations]
[Pages 42739-42747]
[FR Doc No: 2015-17737]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 720, 721, 723, and 725

[EPA-HQ-OPPT-2013-0385; FRL-9927-79]
RIN 2070-AJ98

TSCA Section 5 Premanufacture and Significant New Use
Notification Electronic Reporting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct Final Rule.

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SUMMARY: EPA is taking direct final action to amend the Toxic
Substances Control Act (TSCA) section 5 electronic reporting
regulations. These electronic reporting regulations establish standards
and requirements for use of EPA's Central Data Exchange (CDX) to
electronically submit premanufacture notices (PMNs), other TSCA section
5 notices, and support documents to the Agency. This rule provides the
user community with new methods for accessing the e-PMN software, new
procedures for completing the electronic-PMN (e-PMN) form, changes to
the CDX registration process, adds the requirement to submit ``bona
fide intents to manufacture'' electronically, and changes to the
procedure for notifying EPA of any new manufacturing site of a chemical
substance for which an exemption was granted by EPA. This action is
intended to further streamline and reduce the administrative costs and
burdens of TSCA section 5 notifications for both industry and EPA.

DATES: This direct final rule is effective January 19, 2016 without
further notice, unless EPA receives adverse comment on or before August
19, 2015. If EPA receives adverse comments on this action, EPA will
withdraw the rule before its effective date. EPA will then issue a
proposed rule, providing a 30-day period for public comment.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2013-0385, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     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: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Greg Schweer, Chemical Control Division, Office of Pollution Prevention
and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460-0001; MC 7405M; telephone number: (202) 564-
8469; email address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    You may be affected by this action if you manufacture (which
includes import) or process chemicals for commercial purposes that are
subject to TSCA. The following list of North American Industrial
Classification System (NAICS) codes is not intended to be exhaustive,
but rather provides a guide for readers regarding industries within
which entities are likely to be affected by this action. Potentially
affected entities may include, but are not limited to:
     Manufacturers and processors of chemical substances or
mixtures (NAICS codes 325 and 32411).
    Full descriptions of these NAICS codes and related establishments
are maintained by the U.S. Census Bureau online at https://www.census.gov/eos/www/naics/index.html. Other types of entities not
listed in this unit could also be affected. To determine whether you or
your business may be affected by this action, you should carefully
examine the applicability provisions in 40 CFR parts 700, 720, 721,
723, and 725 for TSCA section 5-related obligations. If you have any
questions regarding the applicability of this action to a particular
entity, consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.

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

    TSCA gives EPA broad authority to regulate the manufacture
(including import) and processing of chemical substances. It is the
expressed intent of Congress that EPA carry out TSCA in a reasonable
and prudent manner, and in consideration of the impacts that any action
taken under TSCA may have on the environment, the economy, and society
(TSCA section 2). The underlying requirements promulgated under this
broad authority and amended by this final rule require manufacturers
(including importers) and processors of chemical substances and
mixtures to:
     Notify EPA at least 90 days before manufacturing a new
chemical substance for commercial purposes (TSCA section 5(a)(1)(A)).
     Notify EPA at least 90 days before manufacturing or
processing the chemical substance for any use of a chemical substance
that EPA has determined to be a ``significant new use'' (TSCA section
5(a)(1)(B)).
    Section 5(h)(4) of TSCA authorizes EPA, upon application and by
rule, to exempt the manufacturer of any new chemical substance from
part or all of the provisions of TSCA section 5.
    In addition, the Paperwork Reduction Act (PRA) requires Federal
agencies to manage information resources to reduce information
collection burdens on the public; increase program efficiency and
effectiveness; and improve the integrity, quality, and utility of
information to all users within and outside an agency, including
capabilities for ensuring dissemination of public information, public
access to Federal Government information, and protections for privacy
and security (44 U.S.C. 3501 et seq.).
    Finally, the Government Paperwork Elimination Act (GPEA) (Pub. L.
105-277 (44 U.S.C. 3504)) instructs Federal agencies to use and accept
from the public, when practicable, electronic forms, electronic
filings, and electronic signatures in the conduct of official business
with the public.

C. What action is the agency taking?

    This direct final rule amends the TSCA Section 5 Premanufacture and
Significant New Use Notification regulations at 40 CFR parts 720, 721,
723 and 725, by mandating the use of an updated version of the e-PMN
reporting software. In the Federal Register of January 2010 (75 FR 773)
(FRL-8794-5), EPA issued a final rule requiring the use of the e-PMN
reporting software for the submission of PMNs and other TSCA section 5
notices and support documents to the Agency using the Internet through
CDX. This new version of the e-PMN software will operate as a ``cloud''
software system (``Thin Client Version'') rather than as a downloadable
software system (``Thick

Client Version''). In addition, the direct final rule extends
electronic reporting requirements to notices of ``bona fide intent to
manufacture'' (bona fides); corrects certain regulatory cross-
references in 40 CFR parts 720 and 721; standardizes the use of
``manufacture'' and similar language in 40 CFR parts 720, 721, and 725;
and specifies electronic reporting procedures for the notification of
new manufacturing sites pursuant to 40 CFR 723.50(j)(6)(ii).

D. Why is the agency taking this action?

    The Agency is taking this action to further facilitate electronic
reporting under TSCA and to streamline and reduce the administrative
costs and burdens of TSCA section 5 notifications for both industry and
EPA. This change will eliminate certain firewall and file submission
size limitations that exist with the current version of the software.
This change will also enable submitters to work directly online within
the Thin Client Version which provides a more efficient way of
accessing the e-PMN software and transmitting data to EPA. In addition,
the extension of the electronic reporting requirements ensures that
submitters are able to use a single method of submission for related
TSCA section 5 notifications.

E. What are the impacts of this action?

    EPA believes that both the transition from the Thick Client Version
to the Thin Client Version of the e-PMN software, as well as the
changes to the procedures for notifying EPA of any new manufacturing
site of a chemical substance for which an exemption was granted by EPA
under 40 CFR 723.50, will streamline and reduce slightly the
administrative costs and burdens associated with TSCA section 5
notifications for both industry and EPA; the only burden expected is
the time it takes a submitter to familiarize themselves with the rule.
EPA believes that submitters of bona fide intents to manufacture will
experience burden and cost savings because the time required to enter,
review, and edit their notices using the e-PMN software and transmit
their submissions to EPA electronically will be less than that for the
existing paper-based process. See also the discussion in Unit IV.

II. Direct Final Rule Procedures

A. Why is EPA using a direct final rule?

    EPA is publishing this rule without a prior proposed rule because
the Agency views this as a noncontroversial action and anticipates no
adverse comment. As addressed in Unit I.A., this action requires the
use of a new version of the e-PMN software that is easier to access,
features enhanced submission security, and eliminates size limitations
on the submitted files. The action also corrects certain outdated
regulatory cross-references, and standardizes terminology across
certain regulatory provisions. If EPA receives adverse comment, the
agency will publish a timely withdrawal in the Federal Register
informing the public that the rule will not take effect. If EPA does
not receive any timely adverse comment, this amendment will become
effective as indicated under DATES without any further action by EPA.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
http://www.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 preparing and submitting
any comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

III. Overview of the CDX, CISS, and the Thin Client Version of the e-
PMN Software

A. What is CDX?

    CDX is EPA's electronic system for environmental data exchange to
the Agency. CDX also provides the capability for submitters to access
their data through the use of web services. CDX enables EPA to work
with stakeholders, including governments, regulated industries, and the
public, to enable streamlined, electronic submission of data via the
Internet. For more information about CDX, go to http://epa.gov/cdx.
TSCA section 5 submissions will be prepared and submitted through
Chemical Information Submission System (CISS) in CDX.

B. What is CISS?

    CISS is a web-based reporting tool developed by EPA for use in
submitting data, reports, and other information under certain sections
of TSCA electronically to the Agency. CISS 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 thin client version of the e-PMN software?

    The thin client version of the e-PMN software is a submission
module within CISS. Following promulgation of the e-PMN final rule in
2010, EPA launched submission modules in CISS for TSCA Chemical Data
Reporting, TSCA section 4 test data submissions, TSCA section 8(a)
preliminary assessment information rules, TSCA section 8(d) health and
safety data reporting rules, and mandatory notifications of substantial
risk under TSCA section 8(e) along with related, voluntary ``For Your
Information'' submissions. EPA has enhanced the e-PMN software in the
thin client version to incorporate several functions already available
to submitters in the other CISS submission modules, including:
    1. Enhanced CDX Registration and Submission Process. When
submitters complete new CDX registration activities, they are prompted
to choose 5 out of 20 offered questions and provide answers to each of
those 5 questions. In order to electronically sign and submit data to
the EPA or to download the Copy of Record in CDX, a user must correctly
answer 1 randomly selected question of the 5 questions chosen by that
user (i.e., a ``20-5-1'' security question) before the transaction can
be completed. When the 20-5-1 security question is answered correctly,
the thin client version of the software then encrypts the information
and transaction is completed.
    2. Optional online Electronic Signature Agreement (ESA) and
identity validation. The thin client version of the e-PMN software
enables electronic submitters who are newly applying for the Authorized
Official (AO) role in CDX to validate their personal identities
electronically via LexisNexis. Those submitters applying for the AO
role who choose to not use LexisNexis, or for whom LexisNexis could not
validate their identities, will need to follow the current, paper-based
e-PMN identity

validation process. In CDX, these submitters will instead select the
``Sign Paper Form'' option. CDX will then instruct the user to print,
sign, and mail the ESA (ESA processing by EPA may take up to 10
business days from the date of receipt). Since support persons are not
able to sign and complete submissions or download the Copy of Record
for a submission, they will be able to register with CDX without
authentication of identity.
    3. AO Role Expansion. The role of the AO has been expanded. Not
only does the AO of the submitting company certify initial notices and
submit all types of section 5 documents to EPA via CDX, the role has
been broadened to allow non-certifying AOs (e.g., technical contacts,
consultants etc.) to conduct all TSCA section 5 business on behalf of
the company except for certifying and submitting initial notices
including joint submissions and letters of support. The role for the
registered support person has also changed. Support persons will have
the ability only to edit information in forms to which they have been
granted access by the AO.
    4. Updated user roles/designations. For joint submissions and/or
letters of support, there are new designations/roles assigned in
registration referred to as ``secondary'' (for both AOs and support
persons). The ``primary'' role designation is for persons who will
create and submit the main PMN and supporting documents. The
``secondary'' role designation is for persons who will create and
submit joint submissions and letters of support.

D. What are the benefits of the thin client version of the e-PMN
software?

    EPA developed the Thin Client Version of the e-PMN software to
provide a more efficient way of accessing the e-PMN software and
completing the e-PMN form. The Thin Client Version of the software was
also designed to enable more efficient data transmittal, including
increasing the size of files that can be submitted to EPA. By moving
from the Thick Client Version of the e-PMN software to the Thin Client
Version, the Agency has eliminated the roadblocks associated with
firewalls that were encountered by some users of the Thick Client
Version by allowing submitters to work directly online within the Thin
Client Version or, if they choose, to work offline using an XML schema
which allows them to later upload their information to the Thin Client
Version. When preparing and completing submissions in the thin client
version, submitters will find that sharing files within the software
makes the information readily accessible to registrants of the
submitting company and their designated support persons. Also, once a
user completes the relevant data fields and attaches appropriate PDF
files or other allowable file types, 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. Finally, the
Thin Client Version assures that submitters will always use the most
up-to-date version of the e-PMN software when initiating, updating,
and/or completing their submissions in CISS.
    In addition, the thin client version improves EPA data management
by altering the process for submitting amendments to a valid notice.
Currently, submitters would electronically submit only the amended
sections of the form. Under the new procedure, companies will revise
the necessary information in the initial notice or a previously
modified version of the notice and an entire updated notice will then
be resubmitted to EPA. This provides EPA with a complete, updated
version of the entire submission in one document.

E. Will CBI be protected when using the thin client version of the e-
PMN software?

    Yes. The application has been designed to support TSCA CBI needs by
providing a secure environment that meets Federal standards. The
application uses Transportation Layer Security with 256-bit digital
encryption, and the data is encrypted at rest using a key that only a
user knows. All data remains encrypted until it is behind several EPA
firewalls and within the EPA CBI LAN, and all encryption algorithms are
compliant with Federal Information Processing Standards. In addition,
users must have valid CDX credentials (user name and password
combination) to access the application, and they choose and provide
answers to 5 of the 20 offered questions in CDX. In order to access the
CDX account and submit data to the EPA or to download the Copy of
Record, a user must correctly answer one of the 5 chosen questions
associated with the CDX account.

F. How do I submit TSCA section 5 notifications and support documents
using CDX and the ``Thin Client Version'' of the e-PMN software?

    EPA has prepared a comprehensive user guide for CISS users that
addresses CDX registration and electronic signatures, general
submission preparation and completion, and submission status tracking
notifications (Ref. 1). This user guide is available through EPA's Web
page at http://www.epa.gov/oppt/chemtest/ereporting. EPA has also
prepared a separate user guide for the e-PMN software module in CISS
(i.e., the Thin Client Version) (Ref. 2) which is available through
EPA's Web page at http://epa.gov/oppt/newchems/epmn/epmn-index.htm.

IV. Description of Changes to Required Reporting Procedures

A. What are the new requirements for ``Bona Fide Intents to
Manufacture''?

    This direct final rule extends the electronic reporting requirement
to submit PMNs, other TSCA section 5 notices, and support documents to
the Agency electronically to include the submissions of bona fides. A
person who intends to manufacture a chemical substance not listed by
specific chemical name in the public portion of the Inventory of
Chemical Substances may ask EPA, through submission of a bona fide
intent to manufacture, whether the substance is included in the
confidential portion of the Inventory and, thus, be able to determine
whether submission of a Premanufacture Notice or Significant New use
Notice in accordance with TSCA section 5(a)(1) is required. Bona fides
were not included within the scope of the January 2010 final rule due
to the variability and frequency of these types of submissions.
However, in that rule, EPA stated that this and other types of
submissions could be considered for electronic reporting in the future.
Bona fides are currently submitted in paper form only according to the
requirements of 40 CFR 720.25, 721.11 and 725.15 which do not prescribe
a format, only required content. This direct final rule requires that
submitter to submit this information electronically using the Thin
Client Version of the e-PMN software.

B. What are the new requirements for notification of new manufacturing
sites?

    As required under 40 CFR 723.50(j)(6)(ii), a manufacturer
(including importer) must notify EPA of any new manufacturing site of a
chemical substance for which an exemption was granted by EPA under 40
CFR 723.50. Under the existing regulation, companies may use, but are
not required to use, the Notice of Commencement (NOC) to report
manufacturing site changes to EPA. Under the existing regulation,
however, if the NOC form is used for this purpose, the manufacturer
must add a statement to the NOC form that the notification is an
amendment to the original

exemption. The electronic version of the NOC in the e-PMN software has
been designed to solely deal with NOCs and will not accommodate
notifications of manufacturing site changes. Therefore, this direct
final rule requires that such notifications of changes in manufacturing
sites be submitted electronically to EPA via CDX as a ``support
document'' to the original notification.

C. How has the required method of submission changed?

    EPA's electronic reporting program has evolved significantly
following the promulgation of the e-PMN final rule in 2010. Following
promulgation of that rule, EPA announced web-based electronic reporting
workflows for TSCA Chemical Data Reporting, TSCA section 4 test data
submissions, TSCA section 8(a) preliminary assessment information
rules, TSCA section 8(d) health and safety data reporting rules, and
mandatory notifications of substantial risk under TSCA section 8(e)
along with related, voluntary ``For Your Information'' submissions.
    Under the current e-PMN rule requirements, TSCA section 5
submitters already must register in CDX and complete an electronic
signature agreement before submitting any information to EPA
electronically via CDX using the e-PMN software. This direct final rule
requires all persons who will be working online on a submission to
register with EPA's CDX and to use the e-PMN module within CISS to
prepare data for submission. EPA expects that most TSCA section 5
submitters are already registered in CDX. Those users do not need to
re-register with CDX, nor will they need to re-verify their identities.
In order to use the Thin Client Version of the e-PMN software required
under this direct final rule, users who have previously registered with
CDX under the TSCA workflow to submit TSCA section 5 submissions, or
other CDX workflows such as the Toxics Release Inventory TRI-ME web
reporting, will only need to add the ``Submission for Chemical Safety
and Pesticide Program (CSPP)'' CDX workflow to their user profiles.

D. Will EPA offer any exceptions to the transition to the thin client
version?

    No. The Agency has concluded that the overall benefits from
everyone using the more efficient Thin Client Version of the e-PMN
software and submission through CDX exceed those associated with
maintaining a multi-optioned reporting approach (Ref. 3). The Agency
recognizes that there is the potential for costs and burden associated
with unpredictable or unanticipated technical difficulties in
electronic filing or with the conversion to the ``Thin Client
Version.'' However, EPA expects that the transition costs and any
transition difficulties will be mitigated by:
    1. EPA's planned outreach and training sessions prior to the
effective date of this direct final rule. EPA believes that the six-
month phase-out period for the Thick Client Version between the date of
publication and the effective date of this direct final rule provides
submitters with ample time to register to use and become proficient
with the Thin Client Version of the e-PMN software. EPA will accept
submissions using the Thin Client Version of the e-PMN software
beginning on September 3, 2015. After January 19, 2016, use of the Thin
Client Version of the e-PMN software becomes mandatory.
    2. EPA's offering of an XML schema to those submitters who choose
to work on their submissions offline rather than online, which allows
them to later upload their information to the Thin Client Version of
the e-PMN software for submission using CDX. The six-month phase-out
period for the period between the date of publication and the effective
date of the final rule should provide these users adequate time to
implement the XML schema on their systems.
    3. EPA's technical support following the effective date of this
final rule.

E. Will all types of TSCA section 5 notices and communications be
submitted via e-PMN software?

    At this time, the Agency lacks electronic reporting capability for
some TSCA section 5-related notices (e.g., polymer exemption annual
reports); certain support documents (i.e., TSCA section 5(e) consent
orders or orders imposed pursuant to TSCA section 5(e)(2)(B)); and
certain communications (e.g., pre-notice communications and TSCA
Inventory correspondence), due to the variability and infrequent nature
of these types of submissions. EPA may consider offering electronic
reporting of these and other submissions in the future.

V. Corrections to 40 CFR Parts 720, 721, 723 and 725

    The direct final rule also corrects certain regulatory cross-
references in 40 CFR parts 720 and 721 and standardizes the use of
``manufacture'' and similar language in 40 CFR parts 720, 721, and 725.
    1. Minor change to definition of ``article'' in 40 CFR 720.3. The
current definition of ``article'' at 40 CFR 720.3(c) incorrectly
references 40 CFR 720.36(g)(5) concerning changes in chemical
composition which have no commercial purpose separate from that of the
article. This rulemaking corrects the cross-reference to 40 CFR
720.30(h)(5).
    2. Removal of the cross-reference to 40 CFR 710.7(e)(2)(v) in 40
CFR 720.25(b)(4) and 40 CFR 721.11(d). The CFR at Sec.  720.25(b)(4)
and Sec.  721.11(d) currently cross-references both 40 CFR
710.7(e)(2)(v) and 40 CFR 720.85(b)(3)(iii). These cross-references
should only be to 40 CFR 720.85(b)(3)(iii); 40 CFR 710.7(e)(2)(v) no
longer exists.
    3. Use of ``manufacture or import'' and similar language in 40 CFR
720.25(b), 40 CFR 721.11 and 40 CFR 725.15. The definition of
``manufacture'' in section 3(7) of TSCA includes both manufacture and
import. However, in many places in TSCA section 5 regulations in parts
720, 721, 725 and elsewhere the terms ``manufacture or import'' or
``manufacture, import or process'' are used. EPA is revising
``manufacture'' and ``manufacturer'' in some of the provisions affected
by this rule to clarify that import is included in manufacture under
TSCA. This is not intended to make any substantive change to the
regulations. As EPA amends other TSCA regulations with similar language
in the future, the Agency intends to make corresponding changes.
    4. Removal of the definition of ``optical disc'' in 40 CFR 720.3.
The January 2010 (75 FR773) final rule phased out the electronic
submission of TSCA section 5 notices to EPA via optical disc as a valid
method of submission as of April 6, 2012. Therefore, the definition
currently presented at 40 CFR 720.3(kk) is obsolete and will be
removed.
    5. Use of CDX to submit written requests for suspension of the
notice review period in 40 CFR 720.75. The January 2010 final rule
phased out paper submissions of TSCA section 5 notices to EPA as of
April 6, 2011, and the electronic submission of TSCA section 5 notices
to EPA via optical disc as a valid method of submission as of April 6,
2012. However, 40 CFR 720.75(b)(4) continues to provide that written
requests for suspension of the notice review period may be submitted to
EPA on paper, on optical disc, or in CDX. This final rule corrects 40
CFR 720.75 to specify that written suspension requests must be
submitted to EPA via CDX.

VI. Estimated Economic Impact

    The Agency's estimated economic impact of this direct final rule is
presented in a document entitled ``Economic Analysis of the TSCA
Section 5 Premanufacture and Significant New Use Notification
Electronic Reporting; Revisions to Notification Regulations'' (Economic
Analysis) (Ref. 3), a copy of which is available in the docket and is
briefly summarized in this unit. In the economic analysis supporting
the January 6, 2010 (75 FR 773) e-PMN final rule, EPA estimated that
the electronic submission of TSCA section 5 notices and support
documents would reduce the burden and cost associated with the paper-
based reporting process of TSCA section 5 notices and support documents
(Ref. 4). This direct final rule amends the existing premanufacture
notification regulation to mandate the use of the Thin Client Version
of the e-PMN reporting software, require use of electronic reporting of
TSCA section 5 bona fides, and amends the procedures for notifying EPA
of any new manufacturing site of a chemical substance for which an
exemption was granted by EPA under 40 CFR 723.50. These amendments are
expected to further streamline and reduce the administrative costs and
burdens associated with TSCA section 5 notifications for both industry
and EPA.
    The Thin Client Version of the e-PMN software will reside as a
module within CISS in CDX. The Thin Client Version will eliminate
certain firewall and file submission size limitations, as well as
reduce the potential for invalid submissions through built-in
validation procedures. Use of the Thin Client Version also assures that
should revisions be made by EPA, submitters will always use the most
up-to-date version of the e-PMN software when initiating, updating,
and/or completing their submission in CISS.
    Making the software available to industry is expected to result in
cost savings for both industry and EPA. However, this direct final
rule, which includes a new requirement for electronic submission of
bona fide notices and changes to the procedures for notifying EPA of
any new manufacturing site of a chemical substance for which an
exemption was granted by EPA under 40 CFR 723.50, may result in some
temporary increase in cost to some industry users as they make the
transition to the new method of submission. As a result of making the
software available, EPA believes that submitters of bona fide notices
will experience burden and cost savings because the time required to
enter, review, and edit their notices using the e-PMN software and
transmit their submissions to EPA electronically will be less than that
for the existing paper-based process. In EPA's economic analysis (Ref.
3), estimated burden and cost savings are presented in comparison to
the burden and costs that will be incurred if industry were to continue
submitting notices via paper, as was outlined in the previous
Information Collection Request (ICR) (Ref. 5). OMB has already approved
the underlying information collection requirements described in this
direct final rule under OMB control numbers 2070-0012 and 2070-0038
(EPA Information Collection Request (ICR) No. 0574.15, Premanufacture
Review Reporting and Exemption Requirements for New Chemical Substances
and Significant New Use Reporting Requirements for Chemical Substances
(Ref. 5) and EPA ICR No. 1188.11, TSCA Section 5(a)(2) Significant New
Use Rules for Existing Chemicals (Ref. 6)), respectively. EPA has
submitted requests for additional approval to OMB under PRA (Refs. 8
and 9) because the direct final rule alters the required form and
format of the existing, approved collections of information.
    Once the rule is fully implemented, EPA estimates a net burden
savings to industry of 180 hours and a net cost of approximately $4,000
in the first year. In subsequent years, EPA estimates an annual net
burden savings to industry of 489 hours and annual net cost savings of
approximately $17,000. The Agency is projected to experience an annual
net burden savings of 40 hours and annual net cost savings of $3,000
for these same submissions once the rule is fully implemented.
    Requiring use of the e-PMN software for submission of bona fides
(40 CFR 720.25, 40 CFR 721.11 and 40 CFR 725.15), suspension requests
(40 CFR 720.75), and changes in manufacturing sites (40 CFR
723.50(j)(6)) eliminates the option of submitting paper. To the extent
that any firms would otherwise submit these notices on paper, these
firms may incur some costs in order to meet these mandatory submission
requirements. For example, some industry users may incur costs related
to adjustments to internal processes or recordkeeping systems, and
investments in compatible information technology. At this time, EPA is
unable to estimate what these costs might be. However, firms have
generally been required to file section 5 notifications electronically
using the e-PMN software since April 2012, and a final rule published
in the Federal Register of December 4, 2013(78 FR 72818) (FRL-9394-6)
requires that any new NOCs for PMNs filed in paper prior to April 2012
be submitted electronically using the e-PMN software (Ref. 7). Firms
expected to submit bona fides, suspension requests, and changes in
manufacturing sites are believed by EPA to primarily be the same firms
that are already complying with the existing regulations. EPA therefore
does not believe that many, if any, firms would incur such costs only
for the electronic submission of bona fides or notifications of
manufacturing site changes for a previously submitted PMN.
    The total annual burden to society (industry plus EPA) from the e-
PMN software is expected to decrease by 57 hours in the first year and
529 hours in subsequent years. The total cost to society is expected to
increase by $1,000 in year one and decrease by $20,000 in future years.
These cost savings may be diminished by any transactions costs that
firms compelled to switch to the new software system might face for
submission of bona fides. EPA believes that both the transition from
the Thick Client Version to the Thin Client Version, as well as the
changes to the procedures for notifying EPA of any new manufacturing
site of a chemical substance for which an exemption was granted by EPA
under 40 CFR 723.50, will have a negligible impact on industry or
Agency burden or costs, and, therefore, the cost savings associated
with these changes are only described qualitatively in the Economic
Analysis (Ref. 3).

VII. References

    The public docket for this final rule has been established. The
following is a listing of the documents referenced in this preamble
that have been placed in the public docket for this final rule under
docket ID number EPA-HQ-OPPT-2013-0385, which is available for
inspection as specified under ADDRESSES.

1. EPA. Central Data Exchange CSPP CDX Registration Guide, December
12, 2011.
2. EPA. Section 5 Notices and Supports Users Guide. December 20,
2013 (available at: http://www.epa.gov/oppt/newchems/epmn/epmn-index.htm).
3. EPA. Economic and Policy Analysis Branch, Office of Pollution
Prevention and Toxics (OPPT). Economic Analysis of the TSCA Section
5 Premanufacture and Significant New Use Notification Electronic
Reporting; Revision to Notification Regulations. November 17, 2014.
4. EPA. Economic and Policy Analysis Branch, Office of Pollution
Prevention and Toxics (OPPT). Economic Analysis of the Amendments to
TSCA Section 5 Premanufacture and Significant New Use

Notification Requirements Final Rule. July 13, 2009.
5. EPA Information Collection Request (ICR) No. 0574.15,
Premanufacture Review Reporting and Exemption Requirements for New
Chemical Substances and Significant New Use Reporting Requirements
for Chemical Substances.
6. EPA ICR No. 1188.12, TSCA Section 5(a)(2) Significant New Use
Rules for Existing Chemicals.
7. EPA. Electronic Reporting Under the Toxic Substances Control Act;
Final Rule. Federal Register (78 FR 72818, December 4, 2013) (FRL-
9394-6).
8. EPA. Supporting Statement for a Request for OMB Review under The
Paperwork Reduction Act. Revision to Premanufacture Review Reporting
and Exemption Requirements for New Chemical Substances and
Significant New Use Reporting Requirements for Chemical Substances
(Direct Final Rule; RIN 2070-AJ98). EPA ICR No. 0574.16. OMB Control
Number 2070-0012.
9. EPA. Supporting Statement for a Request for OMB Review under The
Paperwork Reduction Act. Request for a Non-Substantive Change to an
Existing Approved Information Collection, TSCA Section 5(a)(2)
Significant New Use rules for Existing Chemicals. EPA ICR No.
1188.12; OMB Control Number 2070-0038.

VIII. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action as defined by
Executive Order 12866 (58 FR 51735, October 4, 1993). Accordingly, this
action was not submitted to the Office of Management and Budget (OMB)
for review under Executive Orders 12866 and 13563 (76 FR 3821, January
21, 2011). EPA has prepared an Economic Analysis for this action (Ref.
3), which is available in the docket for this final rule and is
summarized in Unit VI.

B. Paperwork Reduction Act

    The information collection activities in this direct final rule
been submitted for approval to OMB under the PRA (44 U.S.C. 3501 et
seq.) pursuant to the procedures at 5 CFR 1320.5(c)(1) and 1320.10(a).
The underlying requirements are approved under OMB control numbers
2070-0012 and 2070-0038. However, EPA has submitted requests for
additional approval to OMB under PRA because the direct final rule
alters the required form and format of the existing, approved
collections of information.
    The Information Collection Request (ICR) document that EPA prepared
to address the direct final rule requirements related to EPA's New
Chemicals Program has been assigned EPA ICR number 0574.16 (Ref. 8).
This ICR addresses the required use of the Thin Client version of the
e-PMN software system in CDX to complete their TSCA section 5
submissions to EPA's New Chemicals Program instead of a downloadable
Thick Client version of the e-PMN software system. In addition, this
ICR addresses the mandatory electronic submission of bona fide notices
and notifications of new manufacturing sites of chemical substances for
which an exemption was granted by EPA under 723.50.
    As addressed in EPA ICR No. 0574.16, the total burden to industry
is expected to decrease 182 hours and the total cost is expected to
increase by $3,988 in the first year of the rule, for a total burden of
2,312 hours and $155,699. This includes an average per firm burden of
0.82 hours for rule familiarization for 336 TSCA section 5 submitters,
a per-submission burden of 17.0 hours for electronic reporting of 116
bona fide submissions, a per-registrant burden 0.43 hours for 93 new
technical labor CDX registrations, and a-per registrant burden of 1.07
hours for 23 new managerial CDX registrants. In all subsequent years of
the rule the total industry burden is expected to decrease by 485 hours
and $17,199. This includes a per submission burden of 17.0 hours for
electronic reporting of 116 bona fide submissions, a per-registrant
burden 0.43 hours for 46 new technical labor CDX registrations, and a
per-registrant 1.07 hours for 12 new managerial CDX registrants.
    In addition, EPA has been assigned EPA ICR number 1188.12 (Ref. 9)
to the ICR document that addresses the direct final rule requirements
related EPA's Existing Chemicals Program (i.e., the required use of the
Thin Client version of the e-PMN software system in CDX to complete
their TSCA section 5 submissions to EPA's Existing Chemicals Program
instead of a downloadable Thick Client version of the e-PMN software
system). The direct final rule would only require firms who must
already submit significant new use notices for existing chemicals to
use the new electronic reporting tool. EPA, therefore, did not estimate
any rule-related burden changes for this ICR.
    You can find a copy of these ICR documents in the docket for this
direct final rule. 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 must be to the EPA
using the docket identified at the beginning of this direct final rule
by August 19, 2015. You may also send your ICR-related comments to
OMB's Office of Information and Regulatory Affairs via email to
<EMAIL_ADDRESS>Attention: Desk Officer for the EPA.
Since OMB is required to make a decision concerning the ICR between 30
and 60 days after receipt, OMB must receive comments no later than
August 19, 2015.
    Responses to the collection of information are mandatory, pursuant
to EPA's authority under TSCA and PRA (as described in Unit I.C.).
However, the changes to the information collection requirements in this
direct final rule are not enforceable until OMB approves them. An
agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in 40 CFR are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5 U.S.C
Sec.  601 et seq. In making this determination, the impact of concern
is any significant adverse economic impact on small entities, because
the primary purpose of a final regulatory flexibility analysis is to
identify and address regulatory alternatives that ``minimize the
significant economic impact on small entities'' 5 U.S.C. 604. Thus, an
agency may certify that a rule will not have a significant economic
impact on a substantial number of small entities if the rule has no net
burden effect on the small entities subject to the rule.
    As indicated previously, this final rule is expected to reduce the
existing regulatory burden. The factual basis for the Agency's
certification under the RFA is presented in the small entity impact
analysis prepared as part of the Economic Analysis for this final rule
(Ref. 3), and is briefly summarized in Unit IV.

D. Unfunded Mandates Reform Act and Executive Orders 13132 and 13175

    This action will not have substantial direct effects on State,
local, or tribal governments, on the relationship between the Federal
Government and States or Indian Tribes, or on the distribution of power
and responsibilities between the Federal Government and States or
Indian Tribes. As a result, no action is required under Executive Order
13132, entitled ``Federalism'' (64 FR 43255, August 10, 1999), or under
Executive Order 13175,

entitled ``Consultation and Coordination with Indian Tribal
Governments'' (65 FR 67249, November 9, 2000). Nor does it impose any
enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1531-
1538).

E. Executive Orders 13045, 13211, and 12898

    As indicated previously, this action is not a ``significant
regulatory action'' as defined by Executive Order 12866. As a result,
this action is not subject to Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997) and Executive Order 13211
entitled ``Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). In
addition, this action also does not require any special considerations
under Executive Order 12898 entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).

F. National Technology Transfer and Advancement Act (NTTAA)

    Since this action does not involve any technical standards, NTTAA
section 12(d), 15 U.S.C. 272 note, does not apply to this action.

IX. Congressional Review Act

    Pursuant to the CRA, 5 U.S.C. 801 et seq., EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Parts 720, 721, 723, and 725

    Environmental protection, Chemicals, Electronic reporting,
Hazardous substances, Reporting and recordkeeping requirements.

    Dated: July 10, 2015.
Louise P. Wise,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
    Therefore, 40 CFR chapter I is amended as follows:

PART 720--[AMENDED]

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

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

0
2. In Sec.  720.3:
0
a. Revise paragraph (c).
0
b. Remove paragraph (kk).
0
c. Redesignate paragraph (ll) as (kk).
0
d. Revise newly redesignated paragraph (kk).
    The revisions read as follows:

Sec.  [emsp14]720.3  Definitions.

* * * * *
    (c) Article means a manufactured item:
    (1) Which is formed to a specific shape or design during
manufacture;
    (2) Which has end use function(s) dependent in whole or in part
upon its shape or design during end use; and
    (3) Which has either no change of chemical composition during its
end use or only those changes of composition which have no commercial
purpose separate from that of the article and that may occur as
described in Sec.  720.30(h)(5), except that fluids and particles are
not considered articles regardless of shape or design.
* * * * *
    (kk) Support documents means material and information submitted to
EPA in support of a TSCA section 5 notice, including but not limited
to, correspondence, amendments (if notices for these amendments were
submitted prior to January 19, 2016), and test data. The term ``support
documents'' does not include orders under TSCA section 5(e) (either
consent orders or orders imposed pursuant to TSCA section 5(e)(2)(B)).

0
3. In Sec.  720.25, revise paragraphs (b)(1), (b)(2) introductory text,
(b)(2)(i) and (ii), and (b)(4), (5), (6), and (7) to read as follows:

Sec.  720.25  Determining whether a chemical substance is on the
Inventory.

* * * * *
    (b) * * *
    (1) A chemical substance is listed in the public portion of the
Inventory by a specific chemical name (either a Chemical Abstracts (CA)
Index Name or a CA Preferred Name) and a Chemical Abstracts Service
(CAS) Registry Number if its identity is not confidential. If its
identity is confidential, it is listed in the public portion of the
Inventory by a TSCA Accession Number and a generic chemical name that
masks the specific substance identity. The confidential substance is
listed by its specific chemical name only in the confidential portion
of the Inventory, which is not available to the public. A person who
intends to manufacture (including import) a chemical substance not
listed by specific chemical name in the public portion of the Inventory
may ask EPA whether the substance is included in the confidential
Inventory. EPA will answer such an inquiry only if EPA determines that
the person has a bona fide intent to manufacture (including import) the
chemical substance for commercial purposes.
    (2) To establish a bona fide intent to manufacture (including
import) a chemical substance, the person who proposes to manufacture
the substance must submit the request to EPA via CDX. Prior to
submission to EPA via CDX, such bona fide intents to manufacture
(including import) must be generated and completed using e-PMN
software. See Sec.  720.40(a)(2)(ii) for information on how to access
the e-PMN software. A bona fide intent to manufacture (including
import) must contain:
    (i) Except as provided in paragraphs (b)(3)(i) and (ii) of this
section, the specific chemical identity of the substance that the
person intends to manufacture (including import), using the currently
correct CA Index name for the substance and the other correct chemical
identity information in accordance with Sec.  720.45(a) (1), (2), and
(3).
    (ii) A signed statement that the person intends to manufacture
(including import) that chemical substance for commercial purposes.
* * * * *
    (4) EPA will review the information submitted by the proposed
manufacturer (including importer) under this paragraph to determine
whether it has a bona fide intent to manufacture (including import) the
chemical substance. If necessary, EPA will compare this information to
the information requested for the confidential chemical substance under
Sec.  720.85(b)(3)(iii).
    (5) If the proposed manufacturer (including importer) has shown a
bona fide intent to manufacture (including import) the substance, and
has provided sufficient unambiguous chemical identity information so
EPA can make a conclusive determination of the chemical substance's
Inventory status, EPA will search the confidential Inventory and inform
the proposed manufacturer (including importer) whether the chemical
substance is on the confidential Inventory.
    (6) If the chemical substance is found on the confidential
Inventory, EPA will notify the person(s) who originally reported the
chemical substance that another person has demonstrated a bona fide
intent to manufacture (including import) the substance and therefore
was told that the chemical substance is on the Inventory.
    (7) A disclosure of a confidential chemical identity to a person
with a bona fide intent to manufacture

(including import) the particular chemical substance will not be
considered a public disclosure of confidential business information
under section 14 of the Act.
* * * * *

0
4. In Sec.  720.40, revise paragraphs (a)(2)(i), (a)(2)(ii)
introductory text, and (e)(1) and (3) to 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.
    (ii) You can access the e-PMN software as follows:
* * * * *
    (e) Agency or joint submissions--(1) A manufacturer (including
importer) may designate an agent to assist in submitting the notice. If
so, only the manufacturer (including importer), and not the agent,
signs the certification on the form.
    (2) * * *
    (3) Only the Authorized Official (AO) of a submitting company can
certify initial notices and submit all TSCA section 5 documents.
    (i) An AO can authorize other persons to be non-certifying AOs who
may conduct all section 5 business on behalf of the submitting company
except for certifying and submitting initial notices to EPA via CDX.
    (ii) An AO may grant access to a support registrant to edit section
5 documents.
* * * * *

0
5. In Sec.  720.75:
0
a. Revise paragraph (b)(2).
0
b. Remove paragraphs (b)(3) and (4).
0
c. Revise paragraph (e)(2).
    The revisions read as follows:

Sec.  720.75  Notice review period.

* * * * *
    (b) * * *
    (2)(i) Oral requests. A request for a suspension of 15 days or less
may be made orally, including by telephone, to the submitter's EPA
contact for that notice. Any request for a suspension exceeding 15 days
must be submitted in the manner set forth in paragraph (b)(2)(ii) of
this section. The running of the notice review period will be suspended
upon approval of the oral request by the Director or her or his
delegate.
    (ii) Written requests. Requests for suspensions exceeding 15 days
must be submitted electronically to EPA via CDX using e-PMN software.
Requests for suspensions of 15 days or less may also be submitted
electronically to EPA via CDX using e-PMN software. See Sec.
720.40(a)(2)(ii) for information on how to access the e-PMN software.
The running of the notice review period will be suspended upon approval
of the written request by the Director or her or his delegate.
* * * * *
    (e) * * *
    (2) If a manufacturer (including importer) which withdrew a notice
later resubmits a notice for the same chemical substance, a new notice
review period begins.

PART 721--[AMENDED]

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

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

0
7. In Sec.  721.11, revise paragraphs (a), (b) introductory text,
(b)(1), (2), and (3), (d), (e) and (f) to read as follows:

Sec.  721.11  Applicability determination when the specific chemical
identity is confidential.

    (a) A person who intends to manufacture (including import) or
process a chemical substance which is described by a generic chemical
name in subpart E of this part may ask EPA whether the substance is
subject to the requirements of this part. EPA will answer such an
inquiry only if EPA determines that the person has a bona fide intent
to manufacture (including import) or process the chemical substance for
commercial purposes.
    (b) To establish a bona fide intent to manufacture (including
import) or process a chemical substance, the person who proposes to
manufacture (including import) or process the substance must submit the
request to EPA via CDX. Prior to submission to EPA via CDX, such bona
fide intents to manufacture (including import) or process must be
generated and completed using e-PMN software. See 40 CFR
720.40(a)(2)(ii) for information on how to access the e-PMN software. A
bona fide intent to manufacture (including import) or process must
contain:
    (1) The specific chemical identity of the chemical substance that
the person intends to manufacture (including import) or process.
    (2) A signed statement that the person intends to manufacture
(including import) or process the chemical substance for commercial
purposes.
    (3) A description of the research and development activities
conducted to date, and the purpose for which the person will
manufacture (including import) or process the chemical substance.
* * * * *
    (d) EPA will review the information submitted by the manufacturer
(including importer) or processor under paragraph (b) of this section
to determine whether that person has shown a bona fide intent to
manufacture (including import) or process the chemical substance. If
necessary, EPA will compare this information to the information
requested for the confidential chemical substance under Sec.
720.85(b)(3)(iii) of this chapter.
    (e) If the manufacturer (including importer) or processor has shown
a bona fide intent to manufacture (including import) or process the
substance and has provided sufficient unambiguous chemical identity
information to enable EPA to make a conclusive determination as to the
identity of the substance, EPA will inform the manufacturer (including
importer) or processor whether the chemical substance is subject to
this part and, if so, which section in subpart E of this part applies.
    (f) A disclosure to a person with a bona fide intent to manufacture
(including import) or process a particular chemical substance that the
substance is subject to this part will not be considered public
disclosure of confidential business information under section 14 of the
Act.
* * * * *

PART 723--[AMENDED]

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

    Authority:  15 U.S.C. 2604.

0
9. In Sec.  723.50:
0
a. Revise paragraph (j)(6)(ii)(B).
0
b. Remove paragraph (j)(6)(ii)(C).
    The revision reads 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.

* * * * *
    (j) * * *
    (6) * * *
    (ii) * * *
    (B) The notification must be submitted electronically to EPA via
CDX as a support document to the original notification. Prior to
submission to EPA via CDX, such notices must be generated and completed
using the e-PMN software. See 40 CFR 720.40(a)(2)(ii) for

information on how to access the e-PMN software.
* * * * *

PART 725--[AMENDED]

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

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

0
11. In Sec.  725.15, revise paragraphs (a)(2), (b)(2) introductory
text, (b)(2)(ii) and (iii), (d), (e), (f), and (g) to read as follows:

Sec.  725.15  Determining applicability when microorganism identity or
use is confidential or uncertain.

    (a) * * *
    (2) Uncertain microorganism identity. The current state of
scientific knowledge leads to some imprecision in describing a
microorganism. As the state of knowledge increases, EPA will be
developing policies to determine whether one microorganism is
equivalent to another. Persons intending to conduct activities
involving microorganisms may inquire of EPA whether the microorganisms
they intend to manufacture (including import) or process are equivalent
to specific microorganisms described on the Inventory, in Sec.
725.239, or in subpart M of this part.
    (b) * * *
    (2) To establish a bona fide intent to manufacture (including
import) or process a microorganism, the person who proposes to
manufacture (including import) or process the microorganism must submit
the request to EPA via CDX. Prior to submission to EPA via CDX, such
bona fide intents to manufacture (including import) or process must be
generated and completed using e-PMN software. See 40 CFR
720.40(a)(2)(ii) for information on how to access the e-PMN software. A
bona fide intent to manufacture (including import) or process must
contain the following information:
* * * * *
    (ii) A signed statement certifying that the submitter intends to
manufacture (including import) or process the microorganism for
commercial purposes.
    (iii) A description of research and development activities
conducted with the microorganism to date, demonstration of the
submitter's ability to produce or obtain the microorganism from a
foreign manufacturer, and the purpose for which the person will
manufacture (including import) or process the microorganism.
* * * * *
    (d) EPA will review the information submitted by the manufacturer
(including importer) or processor under this paragraph to determine
whether that person has shown a bona fide intent to manufacture
(including import) or process the microorganism. If necessary, EPA will
compare this information to the information requested for the
confidential microorganism under Sec.  725.85(b)(3)(iii).
    (e) In order for EPA to make a conclusive determination of the
microorganism's status, the proposed manufacturer (including importer)
or processor must show a bona fide intent to manufacture (including
import) or process the microorganism and must provide sufficient
information to establish identity unambiguously. After sufficient
information has been provided, EPA will inform the manufacturer
(including importer) or processor whether the microorganism is subject
to this part and if so, which sections of this part apply.
    (f) If the microorganism is found on the confidential version of
the Inventory, in Sec.  725.239 or in subpart M of this part, EPA will
notify the person(s) who originally reported the microorganism that
another person (whose identity will remain confidential, if so
requested) has demonstrated a bona fide intent to manufacture
(including import) or process the microorganism and therefore was told
that the microorganism is on the Inventory, in Sec.  725.239, or in
subpart M of this part.
    (g) A disclosure to a person with a bona fide intent to manufacture
(including import) or process a particular microorganism that the
microorganism is on the Inventory, in Sec.  725.239, or in subpart M of
this part will not be considered a public disclosure of confidential
business information under section 14 of the Act.
* * * * *
[FR Doc. 2015-17737 Filed 7-17-15; 8:45 am]
BILLING CODE 6560-50-P