TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting, 42739-42747 [2015-17737]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)]
[Rules and Regulations]
[Pages 42739-42747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17737]



[[Page 42739]]

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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: https://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 https://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at https://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: Schweer.greg@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. 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/. 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

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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 
https://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 https://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 https://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

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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 https://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 https://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

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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.

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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: https://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

[[Page 42744]]

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 
oria_submissions@omb.eop.gov, 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,

[[Page 42745]]

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

[[Page 42746]]

(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

[[Page 42747]]

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