Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Rules and Regulations 42739 

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. 

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: 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/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 

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42740 Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Rules and Regulations 

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 crossreferences 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 crossreferences, 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 ePMN 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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Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Rules and Regulations 42741 

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 

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42742 Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Rules and Regulations 

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 reregister 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 ePMN 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 § 720.25(b)(4) and § 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 ePMN 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 paperbased 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 

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42744 Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Rules and Regulations 

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 NonSubstantive 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 persubmission 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 rulerelated 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 § 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, 

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Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Rules and Regulations 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] 

■ 1. The authority citation for part 720 

continues to read as follows: 

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

■ 2. In § 720.3: 

■ a. Revise paragraph (c). 

■ b. Remove paragraph (kk). 

■ c. Redesignate paragraph (ll) as (kk). 

■ d. Revise newly redesignated 

paragraph (kk). 

The revisions read as follows: 

§ 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 

§ 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)). 

■ 3. In § 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: 

§ 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 § 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 § 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 

§ 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 

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(including import) the particular 

chemical substance will not be 

considered a public disclosure of 

confidential business information under 

section 14 of the Act. 

* * * * * 

■ 4. In § 720.40, revise paragraphs 

(a)(2)(i), (a)(2)(ii) introductory text, and 

(e)(1) and (3) to read as follows: 

§ 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. 

* * * * * 

■ 5. In § 720.75: 

■ a. Revise paragraph (b)(2). 

■ b. Remove paragraphs (b)(3) and (4). 

■ c. Revise paragraph (e)(2). 

The revisions read as follows: 

§ 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 

§ 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] 

■ 6. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

■ 7. In § 721.11, revise paragraphs (a), 

(b) introductory text, (b)(1), (2), and (3), 

(d), (e) and (f) to read as follows: 

§ 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 

§ 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] 

■ 8. The authority citation for part 723 

continues to read as follows: 

Authority: 15 U.S.C. 2604. 

■ 9. In § 723.50: 

■ a. Revise paragraph (j)(6)(ii)(B). 

■ b. Remove paragraph (j)(6)(ii)(C). 

The revision reads as follows: 

§ 723.50 Chemical substances 

manufactured in quantities of 10,000 

kilograms or less per year, and chemical 

substances with low environmental 

releases and human exposures. 

* * * * * 

(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 

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information on how to access the e-PMN 

software. 

* * * * * 

PART 725—[AMENDED] 

■ 10. The authority citation for part 725 

continues to read as follows: 

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

2625. 

■ 11. In § 725.15, revise paragraphs 

(a)(2), (b)(2) introductory text, (b)(2)(ii) 

and (iii), (d), (e), (f), and (g) to read as 

follows: 

§ 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 § 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 

§ 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 § 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 

§ 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 

§ 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 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 648 

[Docket No. 130822745–5611–02] 

RIN 0648–BD64 

Fisheries of the Northeastern United 

States; Atlantic Surfclam and Ocean 

Quahog Fisheries 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Final rule. 

SUMMARY: This final rule implements an 

information collection program for the 

Atlantic surfclam and ocean quahog 

fisheries. The information collection 

program is intended to obtain more 

detailed information about individuals 

and businesses that hold fishery quota 

allocation in these individual 

transferable quota fisheries. This action 

is necessary to ensure that the MidAtlantic Fishery Management Council 

has the information needed to develop 

a future management action intended to 

establish an excessive share cap in these 

fisheries. 

DATES: Effective January 1, 2016. 

ADDRESSES: Written comments 

regarding the burden-hour estimates or 

other aspects of the collection-ofinformation requirements contained in 

this final rule may be submitted to the 

Greater Atlantic Regional Fisheries 

Office and by email to OIRA_

Submission@omb.eop.gov, or fax to 

(202) 395–7285. 

FOR FURTHER INFORMATION CONTACT: 

Douglas Potts, Fishery Policy Analyst, 

(978) 281–9341. 

SUPPLEMENTARY INFORMATION: 

Background 

Section 402(a)(1) of the MagnusonStevens Fishery Conservation and 

Management Act (Magnuson-Stevens 

Act) authorizes the Secretary of 

Commerce to implement an information 

collection program if a fishery 

management council determines that 

additional information would be 

beneficial for developing, 

implementing, or revising a fishery 

management plan (FMP). The MidAtlantic Fishery Management Council 

formally requested that NMFS 

implement an information collection 

program in the Atlantic surfclam and 

ocean quahog individual transferable 

quota (ITQ) fisheries. The purpose of 

this information collection is to better 

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