72818 Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Rules and Regulations 

ACTION: Notice of deviation from 

drawbridge regulation. 

SUMMARY: The Coast Guard has issued a 

temporary deviation from the regulation 

that governs the U.S. Highway 90 bridge 

across Chef Menteur Pass, mile 2.8, at 

New Orleans, Orleans Parish, Louisiana. 

The deviation is necessary to affect 

repairs and maintenance that is required 

for safe operation of the bridge. This 

deviation allows the bridge to remain 

closed to navigation for 18 consecutive 

days, except that the bridge will open 

twice daily during the middle 14 days 

of the repair period. 

DATES: This deviation is effective 

without actual notice from December 4, 

2013 until December 21, 2013. For the 

purposes of enforcement, actual notice 

will be used from the date the deviation 

was signed, November 18, 2013, until 

December 21, 2013. 

ADDRESSES: The docket for this 

deviation, [USCG–2013–0968] is 

available at http://www.regulations.gov. 

Type the docket number in the 

‘‘SEARCH’’ box and click ‘‘SEARCH.’’ 

Click on Open Docket Folder on the line 

associated with this deviation. You may 

also visit the Docket Management 

Facility in Room W12–140 on the 

ground floor of the Department of 

Transportation West Building, 1200 

New Jersey Avenue SE., Washington, 

DC 20590, between 9 a.m. and 5 p.m., 

Monday through Friday, except Federal 

holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this temporary 

deviation, call or email James 

Wetherington, Bridge Administration 

Branch, Coast Guard, telephone 504– 

671–2128, email 

james.r.wetherington@uscg.mil. If you 

have questions on viewing the docket, 

call Barbara Hairston, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: The 

Louisiana Department of Transportation 

and Development requested a temporary 

deviation from the normal operation of 

the U.S. Highway 90 drawbridge in 

order to remove, repair, and replace 

machinery required to operate the 

drawbridge. This maintenance is 

essential for the continued safe 

operation of the drawbridge. This 

temporary deviation allows the 

drawbridge to remain closed from 7 a.m. 

on Tuesday, December 3, 2013 through 

7 a.m. on Saturday, December 21, 2013. 

During the repair period, the bridge will 

be able to open for the passage of vessels 

twice daily, at 8 a.m. and 4 p.m., 

beginning on Thursday, December 5, 

2013 through Wednesday, December 18, 

2013. 

The bridge has a vertical clearance of 

10 feet above mean high water, 

elevation 3 feet (NGVD 29) in the 

closed-to-navigation position and 

unlimited in the open-to-navigation 

position. 

In accordance with to 33 CFR 

117.436, the draw of the U.S. Highway 

90 Bridge, mile 2.8, shall open on 

signal; except that, from 5:30 a.m. to 

7:30 a.m. Monday through Friday, 

except Federal holidays, the draw need 

open only for the passage of vessels. The 

draw shall open at any time for a vessel 

in distress. 

This deviation is effective from 7 a.m. 

on Tuesday, December 3, 2013 through 

7 a.m. on Saturday December 21, 2013. 

This closure allows for the maintenance 

and repairs to be done safely and 

efficiently. Navigation on the waterway 

consists mainly of commercial 

fishermen and sportsman fishermen. As 

a result of coordination between the 

Coast Guard and the waterway users, it 

has been determined that this closure 

will not have a significant effect on 

these vessels. 

Vessels able to pass through the 

bridge in the closed positions may do so 

at anytime. The bridge will not be able 

to open for emergencies. Rigolets Pass 

can be used as an alternate route for 

vessels unable to pass through the 

bridge in closed positions. The Coast 

Guard will also inform the users of the 

waterways through our Local and 

Broadcast Notices to Mariners of the 

change in operating schedule for the 

bridge so that vessels can arrange their 

transits to minimize any impact caused 

by the temporary deviation. 

In accordance with 33 CFR 117.35(e), 

the drawbridge must return to its regular 

operating schedule immediately at the 

end of the effective period of this 

temporary deviation. This deviation 

from the operating regulations is 

authorized under 33 CFR 117.35. 

Dated: November 18, 2013. 

David M. Frank, 

Bridge Administrator. 

[FR Doc. 2013–29011 Filed 12–3–13; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 712, 716, 720, 721, 723, 

725, 766, 790, and 799 

[EPA–HQ–OPPT–2011–0519; FRL–9394–6] 

RIN 2070–AJ75 

Electronic Reporting Under the Toxic 

Substances Control Act 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is amending certain 

reporting requirements that were 

promulgated under the Toxic 

Substances Control Act (TSCA) to 

require the use electronic reporting. 

EPA is requiring the use of electronic 

reporting in order to minimize the 

paperwork burden associated with the 

underlying regulatory requirements and 

to minimize the cost to the Federal 

Government of the creation, collection, 

maintenance, use, dissemination, and 

disposition of information. This action 

will also improve the quality and use of 

information to strengthen 

decisionmaking, accountability, and 

openness in government and society, as 

well as provide for the timely 

dissemination of public information and 

in a manner that promotes the utility of 

the information to the public and makes 

effective use of information technology. 

DATES: This final rule is effective March 

4, 2014. 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2011–0519 is 

available at http://www.regulations.gov 

or at the Office of Pollution Prevention 

and Toxics (OPPT) Docket, 

Environmental Protection Agency (EPA) 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC. The Public 

Reading Room is open from 8:30 a.m. to 

4:30 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number of the Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Please review the visitor 

instructions and additional information 

about the docket available at http://

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: 

Katherine Sleasman, Chemical Control 

Division (7405M), Office of Pollution 

Prevention and Toxics, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001; 

telephone number: (202) 564–7716; 


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Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Rules and Regulations 72819 

email address: sleasman.katherine@

epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCA-Hotline@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Does this action apply to me? 

You may be potentially affected by 

this action if you manufacture 

(including import), process, or 

distribute in commerce chemical 

substances and mixtures. Potentially 

affected entities may include, but are 

not limited to: 

• Chemicals and Allied Products 

Manufacturers (NAICS code 32411). 

• Petroleum Refining (NAICS codes 

325 and 32411). 

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. 

II. Background 

A. What action is the agency taking? 

EPA is promulgating amendments to 

reporting requirements under TSCA 

section 4 (including test rules and 

Enforceable Consent Agreements 

(ECAs)), TSCA section 5, TSCA section 

8(a) Preliminary Analysis Information 

Rule (PAIR) at 40 CFR part 712, and 

TSCA section 8(d) Health and Safety 

Data Reporting Rules at 40 CFR part 

716. EPA developed this action in 

accordance with its final plan for 

periodic retrospective reviews of 

existing regulations under Executive 

Order 13563, entitled ‘‘Improving 

Regulation and Regulatory Review.’’ 

This final rule was proposed in the 

Federal Register issue of April 17, 2012 

(Ref. 1). The purpose of the amendments 

is to manage and leverage EPA’s 

information resources to reduce 

information collection burdens on the 

public; increase EPA program efficiency 

and effectiveness; and improve the 

integrity, quality, and utility of 

information to all users within and 

outside the Agency, including 

capabilities for ensuring dissemination 

of public information, public access to 

Federal Government information, and 

protections for privacy and security. 

This final rule is part of broader 

government efforts to move to modern, 

electronic methods of information 

gathering. EPA’s Chemical Information 

Submission System (CISS) Web-based 

reporting tool and e-PMN software 

enable more efficient data transmittal 

via the Central Data Exchange (CDX) 

and reduces errors with the built-in 

validation procedures. EPA believes the 

adoption of electronic reporting reduces 

the reporting burden for submitters by 

reducing the cost and time required to 

review, edit, and transmit data to the 

Agency. The resource and time 

requirements to review and process data 

by the Agency will also be reduced and 

document storage and retrieval will 

require fewer resources. In addition, the 

final rule ensures the legal 

dependability of electronically 

submitted documents so that they meet 

the needs of the compliance and 

enforcement programs. The legal 

dependability of electronically 

submitted documents is ensured by 

valid electronic signatures that can be 

submitted into evidence, assurance that 

electronic documents can be 

authenticated to provide evidence of 

what an individual submitted and/or 

attested to, and assurance that electronic 

signatures resist repudiation by the 

signatory. 

The Agency is extending the TSCA 

section 5 electronic reporting 

requirements to Notice of 

Commencements (NOCs) and support 

documents (e.g., correspondence, 

amendments, and test data) relating to 

TSCA section 5 notices submitted to 

EPA prior to April 6, 2010, the effective 

date of the TSCA Section 5 

Premanufacture and Significant New 

Use Notification Electronic Reporting; 

Revisions to Notification Regulations 

(Ref. 2). Previously, follow-up 

submissions for TSCA section 5 notices 

submitted before this date were not 

subject to electronic reporting 

requirements. 

Effective March 4, 2014, EPA will 

only accept data, reports, and other 

information subject to these rules when 

submitted through CDX and the CISS 

tool for the submission of forms, reports, 

and other documents. TSCA section 5 

submissions, however, must be 

submitted through CDX using e-PMN 

software downloaded from EPA’s CDX 

Web site. Data, reports, and other 

information not submitted in the 

manner required will not be considered 

by EPA to have met the filing 

requirements of those rules. The CISS 

tool is also available for use in making 

voluntary submissions, such as those 

under Memoranda of Understanding 

(MOUs), electronically, following the 

same procedures described in this final 

rule. Submitters should register through 

CDX and submit data, reports, and other 

documents through the CISS tool. The 

final rule amends the following 

regulations: 

1. TSCA section 4 test rules and ECAs. 

Documents required under TSCA 

section 4 include letters of intent to 

conduct testing (40 CFR 790.45), 

extension requests (40 CFR 790.50), 

modification requests (40 CFR 790.55), 

exemption requests (40 CFR 790.80 and 

40 CFR 790.82), hearing requests (40 

CFR 790.90), data required to be 

developed under rules at 40 CFR part 

799, and documents and 

correspondence related to ECAs 

negotiated pursuant to 40 CFR part 790. 

Affected sections include those relating 

to submission or modification of a study 

plan (40 CFR 790.62), and requests to 

modify the test schedule for any test 

required under an ECA (40 CFR 790.68). 

Electronic reporting requirements for 

TSCA section 4 rules and ECAs are 

added to 40 CFR 790.5 and 799.50. In 

addition, anyone who manufactures, 

imports, or processes a chemical 

substance under 40 CFR part 766, must 

test that chemical substance 

immediately upon manufacture, import, 

or processing for the presence of 

halogenated dibenzodioxins/

halogenated dibenzofurans (HDDs/

HDFs), and submit all test data to EPA. 

A requirement for electronic reporting is 

added to 40 CFR 766.35. 

2. TSCA section 5. EPA is amending 

certain TSCA section 5 reporting 

requirements that extend electronic 

reporting requirements to NOCs and 

support documents (e.g., 

correspondence, amendments, and test 

data) relating to TSCA section 5 notices 

submitted to EPA before April 6, 2010. 

The e-PMN final rule (Ref. 2) required 

submitters of NOCs and support 

documents whose original notices were 

submitted to EPA prior to April 6, 2010 

(legacy notices) to submit those NOCs 

and support documents to EPA in hard 

copy. At the time the final e-PMN rule 

was published, EPA believed the hard 

copy submission of these documents 

was necessary because the Agency 

intended to operate two different 

databases; one for storing electronic 

TSCA section 5 notices submitted to 

EPA after April 6, 2010, and another for 

storing legacy notices. EPA originally 

intended to enter legacy notices only 

into EPA’s ‘‘legacy database,’’ i.e., the 

database used prior to April 6, 2010, 

and so would not have been able to link 

up a subsequent NOC or support 

document with its original or ‘‘parent’’ 

legacy notice if the subsequent 

document was entered into EPA’s new 

database. 

However, since publication of the ePMN final rule, EPA’s electronic 

reporting program has evolved and EPA 

now has the ability to house both legacy 

notices and notices submitted after 

April 6, 2010, in the same database. EPA 

is therefore amending 40 CFR parts 720, 


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721, 723, and 725 to require NOCs and 

support documents submitted after 

March 4, 2014 for TSCA section 5 

notices originally submitted prior to 

April 6, 2010, to be submitted 

electronically allowing them to be 

stored with their legacy TSCA section 5 

notices in the new database. 

In the e-PMN final rule, EPA phasedin electronic reporting of TSCA section 

5 notices and their related NOCs and 

support documents over a 2-year period 

that ended April 6, 2012. In this final 

rule, EPA is removing the phase-in 

because the phase-in period is over and 

all TSCA section 5 notices, NOCs, and 

support documents are required to be 

submitted to EPA via CDX. 

3. TSCA section 8(a). Electronic 

reporting requirements for Form 7710– 

35, Manufacturer’s Report—Preliminary 

Assessment Information (Manufacturer’s 

Report), are added to 40 CFR 712.28 and 

712.30. In addition, electronic reporting 

requirements for Form 7710–51, 

Dioxins/Furans Report Form, are added 

to 40 CFR 766.35. 

4. TSCA section 8(d). Electronic 

submission of data, reports, and other 

documents are now required under the 

TSCA section 8(d) Health and Safety 

Data Reporting Rule at 40 CFR part 716 

and the Dibenzo-Para-Dioxins/

Dibenzofurans Rule at 40 CFR part 766 

(specifically 40 CFR 716.30, 716.35, 

716.60, and 766.35). Additional affected 

sections of 40 CFR part 716 include the 

submission of underlying data, 

preliminary reports of ongoing studies, 

additional copies of studies (40 CFR 

716.40), requests for extension of time 

(40 CFR 716.60), and requests for 

withdrawal of a chemical substance 

from a rule (40 CFR 716.105). 

EPA also requires submission of 

allegations of significant adverse 

reactions to dibenzo-para-dioxins/

dibenzofurans, pursuant to 40 CFR part 

717. EPA has not received a large 

number of allegations of significant 

adverse reactions, and therefore is not 

implementing a mechanism for the 

electronic submission of these 

allegations of significant adverse 

reactions using the CISS tool at this 

time. Anyone subject to the applicable 

requirements of 40 CFR part 766 must 

continue to submit to EPA paper copies 

of allegations of significant adverse 

reactions. 

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. 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: 

• Perform testing to generate data 

relevant to a determination whether the 

manufacture, distribution in commerce, 

processing, use, or disposal of such 

chemicals or mixtures presents an 

unreasonable risk of injury to health or 

the environment (TSCA section 4). 

• Report such data as EPA may 

reasonably require, including 

information that is necessary to 

facilitate the evaluation of the potential 

adverse human health and 

environmental effects from exposure to 

identified chemical substances, 

mixtures, or categories (TSCA section 

8(a)). 

• Submit lists and/or copies of 

ongoing and completed unpublished 

health and safety studies concerning 

identified chemical substances, 

mixtures, or categories (TSCA section 

8(d)). 

• Notify EPA at least 90 days before 

commencing the manufacture of 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, by rule, to be a ‘‘significant 

new use’’ (TSCA section 5(a)(2)). 

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. 3506). Section 2 

of TSCA expresses the 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 (15 U.S.C. 2601). Electronic 

reporting was not available when TSCA 

was enacted nor when several 

underlying reporting requirements were 

subsequently promulgated by EPA. EPA 

believes that it is now reasonable and 

prudent to manage and leverage its 

information resources, including 

information technology (IT), to require 

the use of electronic reporting in the 

implementation of certain TSCA 

provisions. Electronic reporting can 

reduce burden and costs for the 

regulated entities by eliminating the 

costs associated with printing and 

mailing this information to EPA, while 

at the same time improving EPA’s 

efficiency in reviewing submitted 

information, making decisions and 

disseminating information to the public. 

III. Description of Changes to Reporting 

Procedures 

This unit provides an overview of 

EPA’s CDX, the Chemical Safety and 

Pesticide Program (CSPP), the CISS tool, 

and the e-PMN software for NOCs and 

support documents associated with 

legacy TSCA section 5 notices. 

A. What is CDX? 

CDX is EPA’s centralized electronic 

submission receiving system. CDX also 

provides the capability for submitters to 

access their data through the use of web 

services. CDX enables EPA to work with 

stakeholders, including governments, 

regulated industries, and the public, to 

enable streamlined, electronic 

submission of data via the Internet. For 

more information about CDX, go to 

http://epa.gov/cdx. 

B. What is CISS? 

EPA developed the CISS tool for use 

in submitting data, reports, and other 

information under TSCA electronically 

to the Agency. In the proposed rule 

CISS was referred to as e-TSCAweb. In 

this document only the term CISS is 

used. The CISS tool is available for use 

with Windows, Macs, Linux, and UNIX 

based computers, using ‘‘Extensible 

Markup Language’’ (XML) specifications 

for efficient data transmission across the 

Internet. The CISS tool provides userfriendly 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, and protects 

Confidential Business Information (CBI) 

as appropriate. Over time, there will be 

updates to CISS tool. The most recent 

version of CISS is available online at 

http://epa.gov/cdx. 

C. What is the e-PMN software for TSCA 

section 5? 

EPA has developed e-PMN software 

for use in preparing and submitting 

Premanufacture Notices (PMNs) and 

other TSCA section 5 notices and 

support documents electronically to the 

Agency. For further information on the 

software capabilities, visit the TSCA 

New Chemicals Program Web site 

available online at http://www.epa.gov/ 

oppt/newchems. Also, see the e-PMN 

final rule (Ref. 2) for further guidance. 


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D. What are the benefits of CDX 

reporting and use of the CISS tool and 

the e-PMN software? 

The effort to eliminate paper-based 

submissions in favor of CDX reporting, 

including use of the CISS tool, is part of 

broader Federal Government efforts to 

move to modern, electronic methods of 

information gathering. The CISS tool 

and e-PMN software enable more 

efficient data transmittal and reduces 

errors with the built-in validation 

procedures. EPA believes the adoption 

of electronic reporting reduces the 

reporting burden for submitters by 

reducing the cost and time required to 

review, edit, and transmit data to the 

Agency. It also allows submitters to 

share a draft submission within their 

organization, and more easily save a 

copy for their records or future use. The 

resource and time requirements to 

review and process data by the Agency 

will also be reduced and document 

storage and retrieval will require fewer 

resources. EPA expects to benefit from 

receiving electronic submissions and 

communicating back electronically with 

submitters. In addition, the use of CDX 

and the CISS tool ensures the legal 

dependability of electronic reports so 

that they meet the needs of the 

compliance and enforcement programs. 

The legal dependability of electronically 

submitted documents is ensured by 

valid electronic signatures that can be 

submitted into evidence, assurance that 

electronic documents can be 

authenticated to provide evidence of 

what an individual submitted and/or 

attested to, and assurance that electronic 

signatures resist repudiation by the 

signatory (Ref. 3). 

E. How do I submit data, reports, and 

other documents required under TSCA 

sections 4, 8(a), and 8(d) using CDX? 

This final rule requires submitters to 

register with EPA’s CDX, request access 

to CSPP, and use the CISS tool to 

prepare a file for submission. 

1. Registering with CDX. Registration 

enables CDX to authenticate each user’s 

identity, and to verify each user’s 

authorization to file official submissions 

to EPA on behalf of a company. 

To submit electronically to EPA via 

CDX, individuals must first register in 

CDX through EPA’s Web page at http:// 

cdx.epa.gov/epa_home.asp. 

To register in CDX, the CDX registrant 

(also referred to as ‘‘Electronic Signature 

Holder’’ or ‘‘Public/Private Key 

Holder’’) agrees to the terms and 

conditions, provides information about 

the submitter and organization, selects a 

user name and password, selects a 

program and role, and follows the 

procedures outlined in the CDX user 

guide available on EPA’s Web page at 

http://www.epa.gov/cdr/tools/CDX_

Registration_Guide_v0_02.pdf. 

Users, who have previously registered 

with CDX for TSCA section 5 

submissions, or the Toxics Release 

Inventory TRI–ME web reporting, are 

able to add CSPP to their current 

registration, and use the CISS tool. 

2. Communication through CDX. 

Currently communication through CDX 

between the submitter and EPA is 

focused on transactional activities, 

meaning the submission of information 

to EPA and notification from EPA that 

the submission was received. EPA is 

mandating that all submissions of 

required materials be done through CDX 

but acknowledges that use of certified 

mail and email for correspondence 

related to the submissions is still 

necessary since the ability to do so 

within CDX is not yet available. EPA is 

in the process of enhancing the CDX 

correspondence functionality so the 

two-way emailing between submitters 

and EPA is offered in a secure 

environment. 

3. Preparing the submission. All 

submitters are required to use the CISS 

tool to prepare their submissions. The 

CISS tool guides users through a 

‘‘hands-on’’ process of creating an 

electronic submission. Once a user 

completes the relevant data fields, 

attaches appropriate PDF or other file 

types, such as XML files, and completes 

metadata information, the CISS tool 

validates the submission by performing 

a basic error check and makes sure all 

the required fields and attachments are 

provided and complete. Further 

instructions on submitting voluntary 

submissions, such as under MOUs and 

instructions for uploading PDF 

attachments or other file types, such as 

XML, and completing metadata 

information are available through the 

CISS tool user guide. 

4. Completing the submission to EPA. 

The CISS tool also allows the user to 

choose ‘‘Print,’’ ‘‘Save,’’ or ‘‘Transmit 

through CDX.’’ When ‘‘Transmission 

through CDX’’ is selected, the user is 

asked to provide the user name and 

password that was created during the 

CDX registration process. The CISS tool 

then encrypts the file and submits it via 

CDX. 

F. How must TSCA section 5 NOCs and 

support documents relating to legacy 

TSCA section 5 notices be submitted to 

EPA? 

EPA is requiring that NOCs and 

support documents relating to legacy 

TSCA section 5 notices be submitted to 

EPA using the same process as 

described in 40 CFR 720.40(a)(2), see 

Unit II.A.3. All NOCs and support 

documents are required to be generated 

using e-PMN software and be completed 

through the finalization step of the 

software. See the e-PMN final rule (Ref. 

2) for more detailed information on the 

process for submitting NOCs and 

support documents. 

G. How must CBI be submitted using 

CISS? 

All information sent by the submitter 

via CDX is transmitted securely to 

protect CBI. The CISS tool enables the 

user to submit CBI in an electronic 

format. The CISS tool also guides the 

user through the process of submitting 

CBI by prompting the submitter to check 

a CBI box if using an electronic form or 

by submitting a sanitized document 

containing CBI by bracketing, 

underlining, or otherwise marking the 

confidential information on the 

document to be submitted prior to 

scanning. The submitter must provide a 

sanitized non-CBI document and CBI 

document. Documents containing 

information claimed as CBI must be 

submitted in an electronic format, in 

accordance with the recordkeeping 

requirements (Ref. 3) and the following 

regulations: 

1. TSCA section 4 test rules and ECAs. 

Documents required under TSCA 

section 4 that may contain information 

claimed as CBI include study plans 

submitted in accordance with test rules 

(40 CFR 790.50) and study plans 

submitted in accordance with an ECA 

(40 CFR 790.62). The CISS tool allows 

the submitter to indicate whether a 

study plan contains information 

claimed as CBI by checking the 

appropriate box. The submitter then is 

prompted to submit the study plan 

document in an electronic format. The 

submitter must indicate which 

information in the study plan contains 

information claimed as CBI by marking 

the specific information claimed as 

confidential and designating it with the 

words ‘‘confidential business 

information,’’ ‘‘trade secret,’’ or another 

appropriate phrase in the document 

prior to scanning. Subsequently, if CBI 

is claimed in either a study plan for test 

rules or an ECA, the submitter is 

prompted by the CISS tool to 

substantiate those claims by answering 

the substantiating questions pursuant to 

40 CFR 790.7 in a document submitted 

in an electronic format. 

2. TSCA section 8(a). The CISS tool 

includes areas for indicating CBI on 

Form 7710–35, Manufacturer’s Report, 

(40 CFR 712.28 and 712.30). If CBI is 

indicated on Form 7710–35, 

Manufacturer’s Report, the CISS tool 


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requires the submitter to certify that the 

confidentially statements are true by 

prompting the submitter to select the 

‘‘Confidentiality Certification 

Statement.’’ The Dioxins/Furans Report 

Form (Form 7710–51) and instructions 

for downloading the form required 

under 40 CFR part 766 are available 

online at http://www.epa.gov/oppt/

chemtest/ereporting/index.html. 

3. TSCA section 8(d). Documents 

submitted under TSCA section 8(d) that 

contain information claimed as CBI 

must be indicated as such by using the 

CISS tool. The CISS tool allows the 

submitter to indicate if the document 

contains CBI by checking the 

appropriate box. Then, the submitter is 

prompted to submit the document in an 

electronic format. In submitting a 

document that contains CBI, the CISS 

tool prompts the submitter to submit 

two copies of the document in an 

electronic format. The copy containing 

CBI must identify the confidential 

information by bracketing or 

underlining the information and 

labeling the copy ‘‘confidential,’’ 

‘‘proprietary,’’ or ‘‘trade secret.’’ The 

non-CBI second copy needs to have all 

confidential information deleted. Once 

CBI is claimed, the CISS tool prompts 

the submitter to substantiate their 

claims (40 CFR 716.55). 

The CISS tool user guide also 

instructs users on how to submit and 

substantiate CBI information. 

H. How will the agency provide 

opportunities for potential users to 

become familiar with the reporting tool? 

The Agency will offer a webinar open 

to the public for potential users to 

become familiar with the CISS tool 

before its release following publication 

of this final rule. The webinar will be 

recorded and available at http://

www.epa.gov/oppt/chemtest/ereporting/

index.html. There will also be beta 

testing to allow submitters to become 

familiar with the CISS tool on their own 

and to provide comments to the Agency 

on its functionality and performance. 

IV. Economic Analysis 

The Agency’s estimated economic 

impact of this final rule is presented in 

a document entitled ‘‘Economic 

Analysis for the Electronic Reporting 

under Toxic Substance Control Act 

(TSCA) Final Rule’’ (Economic 

Analysis) (Ref. 4) a copy of which is 

available in the docket and is briefly 

summarized in this unit. 

EPA estimates that this final rule will 

result in cost savings to the affected 

companies because the time required to 

enter, review, edit, and submit their 

reports using CDX will be reduced 

compared to the existing paper-based 

process. 

EPA estimates that this final rule will 

result in total cost to the industry of 

approximately $14,061 in year 1 and a 

cost savings of $66,834 in each 

subsequent year. The cost savings in 

subsequent years are greater than those 

in year 1 because of the one-time CDX 

registration costs incurred at the initial 

submission. EPA assumes that industry 

will continue to realize cost savings 

each additional year. 

EPA estimates that the Agency also 

will experience a reduction in the cost 

to administer submissions of data under 

TSCA in the long-run. Due to the onetime development cost of $200,000 for 

CDX in year 1 and an annual CDX 

Operations and Maintenance (O&M) 

cost of $57,353, EPA will incur a cost 

of $197,918 in year 1, after accounting 

for $59,435 in savings resulting from the 

burden reductions associated with 

electronic processing of submissions 

within the Agency. In subsequent years, 

EPA will incur the $57,353 annually in 

operations and maintenance costs, 

resulting in Agency savings of $2,082 a 

year in subsequent years. 

EPA received 9,280 TSCA section 5 

supporting documents between April 1, 

2005 and June 22, 2011, with an average 

of 1,510 supporting documents each 

year. EPA assumed that the impact of 

this final rule relating to the submission 

of TSCA section 5 supporting 

documents would be very minimal 

given that industry has already 

undertaken electronic submission of 

such supplemental materials. 

V. Response to Comments 

The Agency received comments from 

two persons on the proposed rule for 

electronic reporting for TSCA 

submissions. One was an anonymous 

comment expressing support for 

electronic reporting and the other 

comment was from an industry trade 

association. Copies of all comments 

received are available in the docket for 

this action. The comments received on 

the proposed rule did not result in EPA 

making significant changes to the final 

rule. A discussion of the comments 

germane to the rulemaking and the 

Agency’s responses follow: 

Comment 1: Phased-in the electronic 

reporting requirements. One commenter 

stated that EPA must phase-in the 

electronic reporting requirements. The 

commenter stated that EPA should 

conduct adequate beta testing, and then 

should accept paper submissions as 

well as electronic ones for at least a 2- 

year phase-in period. They said that it 

is essential to avoid excessive burden on 

submitters, as well as to avoid placing 

the regulated community in the position 

of potential late submission or 

noncompliance related to reporting 

system obstacles. In addition, the 

commenter asserted that EPA’s logs of 

calls to its hotline for the Chemical Data 

Reporting Rule (CDR) reporting will 

demonstrate objectively the nature and 

level of problems that users have 

encountered in this electronic reporting 

system, which was mandatory and was 

not phased-in. They asserted that their 

member companies have spent time 

working through the new CDR 

electronic reporting system, consulting 

with EPA’s help desk and other staff, 

and otherwise addressing the various 

issues presented by the mandatory 

electronic reporting under CDR. 

The commenter stated that phasing-in 

is necessary to allow EPA to work with 

users to ensure that the system is 

practical, user-friendly, and free of 

errors. Based on the commenter’s 

experience with developing CDR 

submissions, they noted that it is 

important that persons other than an 

Authorized Official (AO) are able to 

make submissions as appropriate in any 

electronic system, as they also do with 

paper submissions. 

The commenter strongly urged EPA to 

continue to allow submissions through 

alternative means for at least a phase-in 

period. The phase-in period should 

follow a thorough beta-testing period. 

Furthermore, they noted that EPA 

should consider allowing alternative 

means of submission on a case-by-case 

basis. It is possible that future rules 

under TSCA sections 4 and 8 will affect 

entities that have not done prior TSCA 

submissions or even used CDX. They 

noted that such entities should not be 

forced to use any electronic submission 

system (particularly in a short time 

frame) unless and until the system is 

proved to be foolproof, efficient, and 

user-friendly. 

EPA Response: EPA is mandating 

certain electronic reporting under TSCA 

in this final rule because EPA believes 

that the benefits of filing submissions 

electronically are substantial, in terms 

of data quality and timeliness of 

processing and public data availability 

and for records management. The 

Agency also notes that paper 

submissions contain errors that can be 

caught with forms associated with 

electronic submissions thus increasing 

data reliability. Although EPA 

acknowledges the initial burdens 

incurred with registering submitters in 

CDX and in learning how to use the 

CISS tool, EPA has received very 

positive feedback from industry 

submitters for the CDR Rule. Submitters 

have conveyed that the electronic 


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reporting tool for that program, 

eCDRweb, while experiencing some 

initial performance issues, is far 

superior to previous electronic reporting 

applications used by EPA. EPA believes 

that, as more TSCA submitters register 

with CDX and gain experience with the 

CISS tool, concerns with using the 

electronic reporting tool will diminish. 

With regard to IT-related issues that 

arose during the CDR reporting, EPA 

acknowledges that there were some 

issues in the registration process early 

in the reporting period, and that CDX 

registrants were unfamiliar with the 

registration process and how the 

reporting tool worked. EPA responded 

to issues reported through the CDX help 

desk, the CDR help desk and the TSCA 

hotline in a timely manner with patches 

to the system. Most of the issues 

involved delays in CDX registration, 

with the need to reset passwords in the 

system, and in some cases with issues 

related to using the XML schema 

provided by EPA. 

The CDX system has been in 

operation for over 10 years and during 

that time, EPA has continued to 

improve the registration process so that 

it is more efficient for users. For 

example, EPA found that accepting the 

Electronic Signature Agreements of CDX 

registered submitters under Toxic 

Release Inventory for those registering 

in CDX as TSCA submitters significantly 

reduced the burden associated with the 

CDX registration process. EPA expects 

eventually to achieve a one-time 

registration process for all Agency 

submitters, not just for those under 

TSCA, in CDX and is exploring other 

ways to streamline the CDX registration 

process. 

EPA strongly encourages TSCA 

submitters to register with CDX in 

advance so that they are in a position to 

report when the need arises. EPA also 

encourages that multiple submitters in 

each company register as AO with CDX 

so that an alternate AO will be able to 

make the submission in a timely manner 

in the event that one of the registered 

AO CDX users is unavailable. It is 

critical that AO be individuals who can 

make submissions on behalf of their 

company in order to comply with CrossMedia Electronic Reporting Regulation 

(Ref. 5). 

EPA understands the commenter’s 

interest in beta testing and agrees that 

providing the regulated community 

with opportunities to learn how to use 

the CISS tool and provide feedback is 

beneficial. Through these opportunities, 

submitters will gain experience with its 

functionalities and operation, and EPA 

can make refinements as necessary. In 

response to this comment, EPA has 

established a 90-day time frame between 

the publication date and effective date 

of this final rule rather than a 30- or 60- 

day time frame, in order to facilitate 

compliance with the final rule’s 

effective date. During the 90 days, EPA 

will offer webinars and training 

opportunities for submitters to gain 

experience with the reporting tool and 

CDX. EPA also conducted webinars for 

TSCA section 8(a) on September 18, 

2012, and for TSCA section 8(d) on May 

22, 2012, and September 20, 2012. 

During these webinars, industry 

representatives had the opportunity to 

familiarize themselves with both CDX 

and CISS and ask questions regarding 

their functionality. EPA is 

implementing best practices and 

procedures and adding technologies to 

closely monitor the performance of the 

CISS tool and accelerate resolution of 

any problems that may arise with the 

tool. Performance status and scheduled 

updates to the CDX registration process 

and the CISS tool will be made available 

on the EPA electronic reporting Web 

site available online at http://

www.epa.gov/oppt/chemtest/ereporting/

index.html. Use of a web-based 

reporting tool provides assurance that 

upgrades to the system are seamless to 

the user, minimizing downtime and 

disruptions to the reporting process. 

EPA is committed to ensuring that the 

gap between incident and response is 

minimal. 

In light of the substantial 

disadvantages associated with paper 

submissions, and with the reporting tool 

improvements and training 

opportunities, EPA does not believe it is 

necessary to phase-in electronic 

reporting for TSCA sections 4 and 8. As 

a practical matter, electronic reporting 

requirements covered under this final 

rule are invoked by individual rules that 

are not promulgated under a set 

schedule and may not have ongoing 

reporting requirements (e.g., annual 

reporting), so it would be difficult to 

phase-in electronic reporting 

requirements. Further, the phase-in 

period in place for TSCA section 5 

notices is completed therefore the 

regulated community is familiar with 

the ePMN software and an additional 

phase-in period is not needed. In 

addition, EPA and many regulated 

entities have gained experience with 

electronic reporting under TSCA and 

EPA believes that phasing would 

accommodate only a small number of 

new reporters, while potentially 

confusing those submitters already 

filing electronically under other TSCA 

requirements. It would also impose 

burden on EPA to manage both paper 

and electronic systems. EPA believes 

that by providing additional time to 

register in CDX before this final rule 

becomes effective, continuing to 

improve registration and help desk 

functions, and by offering training 

opportunities to industry, both new and 

experienced submitters will be able to 

successfully report electronically to EPA 

and be aware of the status of submitted 

data, reports, and other documents. 

Comment 2: Information about EPA’s 

plans for offering electronic reporting 

for TSCA sections 8(e) and 12(b). One 

commenter requested that EPA explain 

its plans for electronic reporting under 

TSCA section 8(e) and 12(b), 

particularly since EPA has been 

demonstrating its software for electronic 

reporting of TSCA section 8(e) 

submissions. 

The commenter suggested that EPA 

establish voluntary electronic reporting 

options for submissions under TSCA 

section 8(e) and for export notifications 

under TSCA section 12(b). The 

commenter noted that electronic 

reporting should be voluntary, not 

mandatory, due to the short timeframes 

for reporting and the ongoing potential 

for submissions to be made by first-time 

reporters. Also, the commenter noted 

that voluntary electronic reporting 

would allow companies to use any 

internal systems they may have already 

developed to accomplish export 

notification, at least until they are able 

to revise the systems to accommodate 

electronic reporting to EPA. 

EPA Response: EPA will announce 

the availability of an electronic 

reporting option for use both by those 

who are required to submit a 

notification of substantial risk under 

TSCA section 8(e) and by those who 

wish to voluntarily submit related FYI 

notifications. EPA is also considering 

extending electronic reporting for TSCA 

section 12(b) export notifications but is 

not announcing the availability of such 

a reporting method at this time. 

Comment 3: Correspondence through 

CDX. The commenter noted to EPA that 

such correspondence could be useful, 

depending on its format and method of 

delivery. However, the commenter 

noted that EPA should not rely solely on 

CDX as the sole means of 

communication, and requested that any 

material correspondence relating to 

submissions under TSCA sections 4 and 

8(d) rules should be transmitted by 

traditional means (e.g., letter and/or 

email as appropriate) as well as through 

CDX. Finally, it was noted that it is very 

important that any reporting system 

include a clear mechanism for 

documented acknowledgement from 


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EPA that a submission has been 

received. 

EPA Response: EPA acknowledges 

that CDX correspondence with TSCA 

submitters is limited. EPA is 

considering options to enhance CDX 

correspondence functionalities, 

including offering the ability to conduct 

two-way emailing between submitters 

and EPA in a secure environment. EPA 

will continue to allow TSCA submitters 

to correspond with EPA about their 

electronically reported TSCA 

submissions through email and certified 

mail after the submission and all related 

materials are electronically reported 

through CDX. CDX does create and store 

a Copy of Record of the original 

submission and any amendments made 

by the submitter. This functionality 

provides records management benefits 

for EPA as well as the regulated 

community and other stakeholders who 

make TSCA submissions. 

VI. References 

As indicated under ADDRESSES, a 

docket has been established for this 

final rule under docket ID number EPA– 

HQ–OPPT–2011–0519. The following is 

a listing of the documents that are 

specifically referenced in this action. 

The docket includes these documents 

and other information considered by 

EPA, including documents that are 

referenced within the documents that 

are included in the docket, even if the 

referenced document is not physically 

located in the docket. For assistance in 

locating these other documents, please 

consult the technical contact listed 

under FOR FURTHER INFORMATION

CONTACT. 

1. EPA. Electronic Reporting Under the 

Toxic Substances Control Act; Proposed 

Rule. Federal Register (77 FR 22707, April 

17, 2012) (FRL–9337–5). 

2. EPA. TSCA Section 5 Premanufacture 

and Significant New Use Notification 

Electronic Reporting; Revisions to 

Notification Regulations; Final Rule. Federal 

Register (75 FR 773, January 6, 2010) (FRL– 

8794–5). 

3. Transfer of Records to the National 

Archives of the United States. 36 CFR part 

1235. 

4. EPA. Economic Analysis for the 

Electronic Reporting under Toxic Substances 

Control Act (TSCA) Final Rule. June 17, 

2013. 

5. EPA. Cross-Media Electronic Reporting; 

Final Rule. Federal Register (70 FR 59855, 

October 13, 2005) (FRL–7977–1). 

VII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This action is not a ‘‘significant 

regulatory action’’ under the terms of 

Executive Order 12866, entitled 

‘‘Regulatory Planning and Review’’ (58 

FR 51735, October 4, 1993), and is 

therefore not subject to review by the 

Office of Management and Budget 

(OMB) under Executive Orders 12866 

and 13563, entitled ‘‘Improving 

Regulation and Regulatory Review’’ (76 

FR 3821, January 21, 2011). 

EPA has prepared an Economic 

Analysis for this action, which is 

contained in a document entitled 

‘‘Economic Analysis for the Electronic 

Reporting under Toxic Substances 

Control Act (TSCA) Final Rule’’ (Ref. 4). 

A copy of the Economic Analysis is 

available in the docket for this final rule 

and is summarized in Unit IV. 

B. Paperwork Reduction Act 

The information collection 

requirements (ICR) contained in this 

final rule have been submitted for OMB 

approval under PRA, 44 U.S.C. 3501 et 

seq. The ICR document prepared by 

EPA, identified under EPA ICR No. 

2412.02 and OMB Control No. 2070– 

0183, is available in the docket for this 

final rule. The ICR addresses the 

incremental changes to the four 

currently approved ICR documents that 

cover the existing reporting and 

recordkeeping programs that are 

approved under OMB control numbers 

2070–0004, 2070–0012, 2070–0033, and 

2070–0054. An agency may not conduct 

or sponsor, and a person is not required 

to respond to a collection of information 

unless it displays a currently valid OMB 

control number. The amended 

information collection activities 

contained in this final rule are designed 

to assist the Agency in meeting its 

responsibility under TSCA to receive, 

process, and review reports, data, and 

other information. Thus, submissions in 

response to the collection of information 

covered by these ICRs are mandatory 

and respondents are required to use the 

CISS tool, except for TSCA section 5 

submissions, which require the use of 

the existing electronic e-PMN software. 

Burden is defined at 5 CFR 1320.3(b). 

The ICR document for this final rule 

provides a detailed presentation of the 

estimated burden and costs for the first 

year of the program. The rule-related 

burden and cost to chemical 

manufacturers, importers, and 

processors who would submit notices to 

the Agency for review is summarized 

here. The projected total burden to 

industry is 1,228 hours per year for the 

first year of the final rule. This includes 

an estimated average burden per 

response of 0.9 hours for CDX 

registration, 1.8 hours for requesting a 

CDX electronic signature, and 0.8 hours 

for final rule familiarization. 

C. Regulatory Flexibility Act 

Pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA), 5 

U.S.C. 601 et seq., the Agency hereby 

certifies that this final rule will not have 

a significant adverse economic impact 

on a substantial number of small 

entities. 

Small entities include small 

businesses, small organizations, and 

small governmental jurisdictions. For 

purposes of assessing the impacts of this 

final rule on small entities, small entity 

is defined as: 

1. A small business as defined by the 

Small Business Administration’s (SBA) 

regulations at 13 CFR 121.201. 

2. A small governmental jurisdiction 

that is a government of a city, county, 

town, school district, or special district 

with a population of less than 50,000. 

3. A small organization that is any 

not-for-profit enterprise, which is 

independently owned and operated and 

is not dominant in its field. 

In determining whether a rule has a 

significant adverse economic impact on 

a substantial number of small entities, 

an agency may certify that a rule will 

not have a significant adverse economic 

impact on a substantial number of small 

entities if the rule relieves regulatory 

burden, or otherwise has a positive 

economic effect on all of the small 

entities subject to the rule. 

This final rule is expected to reduce 

the existing regulatory burden. The 

factual basis for the Agency’s 

certification is presented in the small 

entity impact analysis prepared as part 

of the Economic Analysis for this final 

rule, and is briefly summarized in Unit 

IV. EPA analyzed reporting data that 

identified individual companies 

submitting information under TSCA 

sections 4, 5, 8(a), or 8(d) and identified 

those companies potentially affected by 

this final rule that qualify for the small 

business status. EPA estimated the cost 

impact ratios for small parent entities 

potentially affected by this final rule 

and has determined that the estimated 

regulatory costs represent a small 

impact of less than 1% of their annual 

revenue. The estimated ratios range 

from less than 0.0001% to 0.014%, 

depending on the NAICS sector and 

employment size category, with an 

average of 0.001%. No small parent 

entities are expected to have a cost 

impact of greater than 1% of annual 

revenue. Since the estimated regulatory 

costs represent a small fraction of a 

typical parent entity’s revenue (i.e., less 

than 1%), the impacts of this final rule 

are likely to be minimal. 


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D. Unfunded Mandates Reform Act 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA), 2 U.S.C. 

1531–1538, requires Federal agencies, 

unless otherwise prohibited by law, to 

assess the effects of their regulatory 

actions on State, local, and tribal 

governments and the private sector. 

This final rule does not contain a 

Federal mandate that may result in 

expenditures of $100 million or more 

for State, local, and tribal governments, 

in the aggregate, or the private sector in 

any 1 year. EPA estimates that this final 

rule will result in total private sector 

cost of approximately $14,061 in year 1 

and a cost savings of $66,834 in each 

subsequent year (Ref. 4). State, local, 

and tribal governments have not been 

affected by the TSCA sections 4, 5, 8(a), 

and 8(d) reporting requirements, and are 

not expected to be affected by this final 

rule. Thus, this final rule is not subject 

to the requirements of UMRA sections 

202 or 205. This final rule is also not 

subject to the requirements of UMRA 

section 203 because it contains no 

regulatory requirements that might 

significantly or uniquely affect small 

governments. 

E. Executive Order 13132 

This action does not have a 

substantial direct effect on States, on the 

relationship between national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999). 

F. Executive Order 13175 

This final rule does not have tribal 

implications because it is not expected 

to have substantial direct effects on 

Indian Tribes. This final rule does not 

significantly nor uniquely affect the 

communities of Indian Tribal 

governments nor does it involve or 

impose any requirements that affect 

Indian Tribes. Accordingly, the 

requirements of Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000), do not apply 

to his final rule. 

G. Executive Order 13045 

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), because this action is 

not an economically significant 

regulatory action as defined by E.O. 

12866, and this action does not address 

environmental health or safety risks 

disproportionately affecting children. 

H. Executive Order 13211 

This final rule is not subject to 

Executive Order 13211, entitled 

‘‘Actions Concerning Regulations that 

Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355, May 

22, 2001), because this action is not 

expected to affect energy supply, 

distribution, or use and because this 

action is not a significant regulatory 

action under E.O. 12866. 

I. National Technology Transfer and 

Advancement Act 

Since this action does not involve any 

technical standards, section 12(d) of the 

National Technology Transfer and 

Advancement Act of 1995 (NTTAA), 15 

U.S.C. 272 note, does not apply to this 

action. 

J. Executive Order 12898 

This final rule does not entail special 

consideration of environmental justice 

related issues as delineated by 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

VIII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and the Comptroller 

General of the United States. EPA is 

submitting a report containing this rule 

and other required information to the 

U.S. Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This rule is not a ‘‘major rule’’ 

as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Parts 712, 

716, 720, 721, 723, 725, 766, 790, and 

799 

Environmental protection, 

Administrative practice and procedure, 

Business and industry, Chemicals, 

Reporting and recordkeeping 

requirements. 

Dated: November 19, 2013. 

James Jones, 

Assistant Administrator, Office of Chemical 

Safety and Pollution Prevention. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 712—[AMENDED] 

■ 1. The authority citation for part 712 

continues to read as follows: 

Authority: 15 U.S.C. 2607(a). 

■ 2. In § 712.3, add new paragraphs (q) 

and (r) to read as follows: 

§ 712.3 Definitions. 

* * * * * 

(q) Central Data Exchange or CDX 

means EPA’s centralized electronic 

submission receiving system. 

(r) Chemical Information Submission 

System or CISS means EPA’s electronic, 

web-based reporting tool for the 

completion and submission of data, 

reports, and other information, or its 

successors. 

■ 3. In § 712.28, revise paragraphs (c) 

and (d) and add new paragraph (e) to 

read as follows: 

§ 712.28 Form and instructions. 

* * * * * 

(c) Persons authorized to report 

information under this subpart must 

include the following information on 

Form 7710–35, Manufacturer’s Report— 

Preliminary Assessment Information 

(Manufacturer’s Report): 

(1) A certification as to the truth and 

accuracy of the information reported 

signed and dated by an authorized 

person located at the plant site or 

corporate headquarters of the 

respondent company. 

(2) A confidentiality statement signed 

and dated by an authorized person 

located at the plant site or corporate 

headquarters of the respondent 

company. 

(3) The specific chemical name and 

Chemical Abstracts Service (CAS) 

Registry Number listed in 40 CFR 

712.30. 

(4) The name, company, address, city, 

State, ZIP code, and telephone number 

of a person who is submitting the form, 

which may be a person located at a 

plant site or corporate headquarters that 

will serve as the respondent, and will be 

able to answer questions about the 

information submitted by the company 

to EPA. A respondent to this subpart 

must include the appropriate Dun and 

Bradstreet Number for each plant site 

reported. 

(5) The plant site activities, such as 

the manufacturing of a chemical 

substance, including the total quantity 

of the chemical substance (in kilograms) 

imported in bulk during the reporting 

period. 

(6) The total number of workers and 

total worker-hours in each process 

category, which includes enclosed 

process, controlled release process, and 

open process. 


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(7) The information related to 

chemical substance processing by 

customers, including customers’ use in 

industrial and consumer products, the 

market names under which the 

chemical substance is manufactured or 

imported, and the customer’s process 

categories that are sold to customers for 

further processing. 

(d) Persons must use the CISS tool to 

complete and submit Form 7710–35, 

Manufacturer’s Report, and 

accompanying letters, via CDX. 

Submission requires registration with 

CDX, and must be made only as set forth 

in this section. 

(e) To access the CISS tool go to 

https://cdx.epa.gov/ssl/CSPP/ 

PrimaryAuthorizedOfficial/Home.aspx 

and follow the appropriate links, and for 

further instructions to go http:// 

www.epa.gov/oppt/chemtest/ereporting/ 

index.html. 

■ 4. In § 712.30, revise paragraphs 

(a)(3)(i), (a)(3)(ii), and (c)(2) to read as 

follows: 

§ 712.30 Chemical lists and reporting 

periods. 

(a) * * * 

(3) * * * 

(i)(A) The respondent has previously 

and voluntarily provided EPA with a 

Manufacturer’s Report on a chemical 

substance or mixture subject to subpart 

B of this part, which contains data for 

a 1-year period ending no more than 3 

years prior to the effective date 

described in paragraph (a)(2) of this 

section. Respondents meeting this 

condition must notify EPA by letter of 

their desire to have the voluntary 

submission used in lieu of a current 

data submission and must verify the 

completeness and current accuracy of 

the voluntarily submitted data. Such 

letters, sent in accordance with the 

method specified in § 712.28(d) to EPA, 

must contain the following language: 

I hereby certify that, to the best of my 

knowledge and belief, all information entered 

on this form is complete and accurate. I agree 

to permit access to, and the copying of 

records by, a duly authorized representative 

of the EPA Administrator, in accordance with 

the Toxic Substances Control Act, to 

document any information reported on the 

form. 

(B) Notification letters must be 

submitted in accordance with the 

method specified in § 712.28(d) prior to 

the reporting deadline. 

(ii)(A) The respondent has previously 

submitted a Manufacturer’s Report on a 

chemical substance or mixture subject 

to subpart B of this part to the 

Interagency Testing Committee, but not 

to EPA, and that Manufacturer’s Report 

contained data for a 1-year period 

ending less than 3 years prior to the 

effective date described in paragraph 

(a)(2) of this section. Respondents 

meeting this condition must submit a 

copy of the Manufacture’s Report, in 

accordance with the method specified 

in § 712.28(d) to EPA, and must submit 

an accompanying letter, also in 

accordance with the methods specified 

in § 712.28(d), notifying EPA of the 

respondent’s intent that the submission 

be used in lieu of a current 

Manufacturer’s Report. The notification 

letter must verify the completeness and 

current accuracy of the voluntarily 

submitted data. Such a letter must 

contain the following language: 

I hereby certify that, to the best of my 

knowledge and belief, all information entered 

on this form is complete and accurate. I agree 

to permit access to, and the copying of 

records by, a duly authorized representative 

of the EPA Administrator, in accordance with 

the Toxic Substances Control Act, to 

document any information reported on the 

form. 

(B) The submission must be made 

prior to the reporting deadline. 

* * * * * 

(c) * * * 

(2) You must submit the information 

using the method specified in 

§ 712.28(d). 

* * * * * 

PART 716—[AMENDED] 

■ 5. The authority citation for part 716 

continues to read as follows: 

Authority: 15 U.S.C. 2607(d). 

■ 6. In § 716.3, add the following 

definitions in alphabetical order to read 

as follows: 

§ 716.3 Definitions. 

* * * * * 

Central Data Exchange or CDX means 

EPA’s centralized electronic submission 

receiving system. 

Chemical Information Submission 

System or CISS means EPA’s electronic, 

web-based tool for the completion and 

submission of data, reports, and other 

information, or its successors. 

* * * * * 

■ 7. In § 716.30, revise paragraph (c) and 

add new paragraph (d) to read as 

follows: 

§ 716.30 Submission of copies of studies. 

* * * * * 

(c) Persons must use the CISS tool to 

complete and submit all data, reports, 

and other information required by 40 

CFR part 716, via CDX. Submission 

requires registration with CDX, and 

must be made only as set forth in this 

section. 

(d) To access the CISS tool go to 

https://cdx.epa.gov/ssl/CSPP/ 

PrimaryAuthorizedOfficial/Home.aspx 

and follow the appropriate links and for 

further instructions to go http:// 

www.epa.gov/oppt/chemtest/ereporting/ 

index.html. 

■ 8. In § 716.35, revise paragraph (c) and 

add new paragraph (d) to read as 

follows: 

§ 716.35 Submission of lists of studies. 

* * * * * 

(c) Persons must use the CISS tool to 

complete and submit all data, reports, 

and other information required by 40 

CFR part 716, via CDX. Submission 

requires registration with CDX, and 

must be made only as set forth in this 

section. 

(d) To access the CISS tool go to 

https://cdx.epa.gov/ssl/CSPP/ 

PrimaryAuthorizedOfficial/Home.aspx 

and follow the appropriate links and for 

further instructions to go http:// 

www.epa.gov/oppt/chemtest/ereporting/ 

index.html. 

■ 9. In § 716.55, revise paragraph (b)(3) 

to read as follows: 

§ 716.55 Confidentiality claims. 

* * * * * 

(b) * * * 

(3) Failure to furnish a second copy 

when information is claimed as 

confidential in the first copy will be 

considered a presumptive waiver of the 

claim of confidentiality. EPA will notify 

the respondent by certified mail that a 

finding of a presumptive waiver of the 

claim of confidentiality has been made. 

The respondent will be given 30 days 

from the date of his or her receipt of this 

notification to submit the required 

second copy in accordance with the 

method specified in § 716.30(d). If the 

respondent fails to submit the second 

copy within the 30 days, EPA will place 

the first copy in the docket. 

* * * * * 

■ 10. In § 716.60, revise paragraphs (a), 

(b)(2), (c), and (d), and add new 

paragraph (e) to read as follows: 

§ 716.60 Reporting schedule. 

(a) General requirements. Except as 

provided in § 716.5 and paragraphs (b) 

and (c) of this section, submissions 

under §§ 716.30 and 716.35 must be 

submitted using the electronic method 

specified in §§ 716.30(c) and 716.35(c), 

on or before 60 days after the effective 

date of the listing of a substance or 

mixture in § 716.120 or within 60 days 

of proposing to manufacture (including 

import) or process a listed substance or 

listed mixture (including as a known 

byproduct) if first done after the 


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effective date of the substance or 

mixture being listed in § 716.120. 

(b) * * * 

(2) Submission of copies of completed 

studies. Persons must submit studies 

listed as ongoing or initiated under 

§ 716.35(a)(1) and (2) within 30 days of 

completing the study, using the method 

specified in §§ 716.30(c) and 716.35(c). 

(c) Requests for extensions of time. 

Respondents who cannot meet a 

deadline under this section may apply 

for a reasonable extension of time. 

Extension requests must be submitted 

on or before 40 days after the effective 

date of the listing of a substance or 

mixture in § 716.120, using the 

electronic method specified in 

§§ 716.30(c) and 716.35(c). The Director 

of EPA’s Office of Pollution Prevention 

and Toxics will grant or deny extension 

requests. 

(d) Submission methods. Persons 

must use the CISS tool to complete and 

submit all data, reports, and other 

information required by 40 CFR part 

716, via CDX. Submission requires 

registration with CDX, and must be 

made only as set forth in this section. 

(e) To access the CISS tool go to 

https://cdx.epa.gov/ssl/CSPP/ 

PrimaryAuthorizedOfficial/Home.aspx 

and follow the appropriate links and for 

further instructions to go http:// 

www.epa.gov/oppt/chemtest/ereporting/ 

index.html. 

■ 11. In § 716.105, revise paragraph (d) 

and add new paragraph (e) to read as 

follows: 

§ 716.105 Additions of substances and 

mixtures to which this subpart applies. 

* * * * * 

(d) Persons who wish to submit 

information that shows why a substance 

should be withdrawn must submit their 

comments by using the CISS tool to 

complete and submit all data, reports, 

and other information required by 40 

CFR part 716, via CDX. Submission 

requires registration with CDX, and 

must be made only as set forth in this 

section. 

(e) To access the CISS tool go to 

https://cdx.epa.gov/ssl/CSPP/ 

PrimaryAuthorizedOfficial/Home.aspx 

and follow the appropriate links and for 

further instructions to go http:// 

www.epa.gov/oppt/chemtest/ereporting/ 

index.html. 

PART 720—[AMENDED] 

■ 12. The authority citation for part 720 

continues to read as follows: 

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

■ 13. In § 720.40: 

■ a. Remove paragraphs (a)(2)(i) and 

(a)(2)(ii). 

■ b. Redesignate paragraphs (a)(2)(iii) 

and (a)(2)(iv) as paragraphs (a)(2)(i) and 

(a)(2)(ii). 

■ c. Revise newly redesignated 

paragraph (a)(2)(i). 

■ d. Revise paragraph (c). 

The amendments 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. To obtain a version of 

e-PMN software that contains an 

encryption module you must register 

with CDX. A version without encryption 

may be downloaded without registering 

with CDX. 

* * * * * 

(c) Where to submit a notice or 

support documents. For submitting 

notices or support documents via CDX, 

use the e-PMN software. 

* * * * * 

■ 14. In § 720.75, revise paragraphs 

(b)(2) and (e)(1) to read as follows: 

§ 720.75 Notice review period. 

* * * * * 

(b) * * * 

(2) A request for suspension may only 

be submitted in a manner set forth in 

this paragraph. The request for 

suspension also may be made orally, 

including by telephone, to the 

submitter’s EPA contact for that notice, 

subject to paragraph (b)(3) of this 

section. Requests for suspension may be 

submitted electronically to EPA via 

CDX. Such requests must be generated 

and completed using e-PMN software. 

See § 720.40(a)(2)(ii) for information on 

how to obtain e-PMN software. 

* * * * * 

(e) Withdrawal of a notice by the 

submitter. (1)(i) A submitter may 

withdraw a notice during the notice 

review period by submitting a statement 

of withdrawal in a manner set forth in 

this paragraph. The withdrawal is 

effective upon receipt by EPA of the 

CDX submission. 

(ii) Submission of withdrawal notices. 

EPA will accept statements of 

withdrawal only if submitted in 

accordance with this paragraph. 

Statements of withdrawal must be 

generated, completed, and submitted to 

EPA (via CDX) using e-PMN software. 

See § 720.40(a)(2)(ii) for information on 

how to obtain e-PMN software. 

* * * * * 

■ 15. In § 720.102: 

■ a. Remove paragraph (d)(1). 

■ b. Designate the introductory text of 

paragraph (d) as paragraph (d)(1). 

■ c. Revise paragraph (d)(2). 

The amendments read as follows: 

§ 720.102 Notice of commencement of 

manufacture or import. 

* * * * * 

(d) * * * 

(2) Submission of notice of 

commencement. EPA will accept 

notices of commencement only if 

submitted in accordance with this 

paragraph. All notices of 

commencement must be submitted 

electronically to EPA via CDX. Prior to 

submission to EPA via CDX, such 

notices of commencement must be 

generated and completed using e-PMN 

software. See § 720.40(a)(2)(ii) for 

information on how to obtain e-PMN 

software. 

PART 721—[AMENDED] 

■ 16. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

■ 17. In § 721.30, revise the introductory 

text of paragraph (b) to read as follows: 

§ 721.30 EPA approval of alternative 

control measures. 

* * * * * 

(b) Persons submitting a request for a 

determination of equivalency to EPA 

under this part must submit the request 

to EPA via CDX using e-PMN software 

in the manner set forth in 40 CFR 

720.40(a)(2)(i). See 40 CFR 

720.40(a)(2)(ii) for information on how 

to obtain e-PMN software. Support 

documents related to these requests 

must be submitted in the manner set 

forth in 40 CFR 720.40(c). A request for 

a determination of equivalency must 

contain: 

* * * * * 

■ 18. In § 721.185, revise paragraph 

(b)(1) to read as follows: 

§ 721.185 Limitation or revocation of 

certain notification requirements. 

* * * * * 

(b) * * * 

(1) Any affected person may request 

modification or revocation of significant 

new use notification requirements for a 

chemical substance that has been added 

to subpart E of this part using the 

procedures described in §§ 721.160 or 

721.170 by submitting a request that is 

accompanied by information sufficient 

to support the request. Persons 

submitting a request to EPA under this 

part must submit the request to EPA 


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using e-PMN software in the manner set 

forth in 40 CFR 720.40(a)(2)(i). See 40 

CFR 720.40(a)(2)(ii) for information on 

how to obtain the e-PMN software. 

Support documents related to these 

requests must also be submitted to EPA 

in the manner set forth in 40 CFR 

720.40(c). 

* * * * * 

PART 723—[AMENDED] 

■ 19. The authority citation for part 723 

continues to read as follows: 

Authority: 15 U.S.C. 2604. 

■ 20. In § 723.50, revise paragraph (e)(1) 

to read as follows: 

§ 723.50 Chemical substances 

manufactured in quantities of 10,000 

kilograms or less per year, and chemical 

substances with low environmental 

releases and human exposures. 

* * * * * 

(e) * * * 

(1) A manufacturer applying for an 

exemption under either paragraph (c)(1) 

or (c)(2) of this section must submit an 

exemption notice to EPA at least 30 

days before manufacture of the new 

chemical substance begins. Exemption 

notices and modifications must be 

submitted to EPA on EPA Form No. 

7710–25 via CDX using e-PMN software 

in the manner set forth in this 

paragraph. See 40 CFR 720.40(a)(2)(ii) 

for information on how to obtain e-PMN 

software. Notices and any related 

support documents, must be generated 

and completed (via CDX) using e-PMN 

software. See 40 CFR 720.40(a)(2)(ii) for 

information on how to obtain e-PMN 

software. 

* * * * * 

PART 725—[AMENDED] 

■ 21. The authority citation for part 725 

continues to read as follows: 

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

2625. 

■ 22. In § 725.25, revise paragraph (c) to 

read as follows: 

§ 725.25 General administrative 

requirements. 

* * * * * 

(c) Where to submit information 

under this part. MCANs and exemption 

requests, and any support documents 

related to these submissions, may only 

be submitted in a manner set forth in 

this paragraph. MCANs and exemption 

requests, and any related support 

documents, must be generated, 

completed, and submitted to EPA (via 

CDX) using e-PMN software. See 40 CFR 

720.40(a)(2)(ii) for information on how 

to obtain e-PMN software. 

* * * * * 

■ 23. In § 725.54, revise paragraphs (b) 

and (d) to read as follows: 

§ 725.54 Suspension of the review period. 

* * * * * 

(b)(1) Request for suspension. A 

request for suspension may only be 

submitted in a manner set forth in this 

paragraph. The request for suspension 

also may be made orally, including by 

telephone, to the submitter’s EPA 

contact for that notice, subject to 

paragraph (c) of this section. 

(2) Submission of suspension notices. 

EPA will accept requests for suspension 

only if submitted in accordance with 

this paragraph. Requests for suspension, 

must be generated, completed, and 

submitted to EPA (via CDX) using ePMN software. See 40 CFR 

720.40(a)(2)(ii) for information on how 

to obtain e-PMN software. 

* * * * * 

(d) If the submitter has not made a 

previous oral request, the running of the 

notice review period is suspended as of 

the date of receipt of the CDX 

submission by EPA. 

■ 24. In § 725.60, revise paragraph (a) to 

read as follows: 

§ 725.60 Withdrawal of submission by the 

submitter. 

(a)(1) Withdrawal of notice by the 

submitter. A submitter may withdraw a 

notice during the notice review period 

by submitting a statement of withdrawal 

in a manner set forth in this paragraph. 

The withdrawal is effective upon receipt 

of the CDX submission by EPA. 

(2) Submission of withdrawal notices. 

EPA will accept statements of 

withdrawal only if submitted in 

accordance with this paragraph. 

Statements of withdrawal must be 

generated, completed, and submitted to 

EPA (via CDX) using e-PMN software. 

See 40 CFR 720.40(a)(2)(ii) for 

information on how to obtain e-PMN 

software. 

* * * * * 

■ 25. In § 725.190, revise paragraph (d) 

to read as follows: 

§ 725.190 Notice of commencement of 

manufacture or import. 

* * * * * 

(d) How to submit. All notices of 

commencement must be generated, 

completed, and submitted to EPA (via 

CDX) using e-PMN software. See 40 CFR 

720.40(a)(2)(ii) for information on how 

to obtain e-PMN software. 

■ 26. In § 725.975, revise the 

introductory text of paragraph (b) to 

read as follows: 

§ 725.975 EPA approval of alternative 

control measures. 

* * * * * 

(b) Persons submitting a request for a 

determination of equivalency to EPA 

under this part must submit the request 

to EPA (via CDX) using e-PMN software. 

See 40 CFR 720.40(a)(2)(ii) for 

information on how to obtain e-PMN 

software. Support documents related to 

these requests must also be submitted to 

EPA via CDX using e-PMN software. A 

request for a determination of 

equivalency must contain: 

* * * * * 

■ 27. In § 725.984, revise paragraph 

(b)(1) to read as follows: 

§ 725.984 Modification or revocation of 

certain notification requirements. 

* * * * * 

(b) * * * 

(1) Any affected person may request 

modification or revocation of significant 

new use notification requirements for a 

microorganism that has been added to 

subpart M of this part using the 

procedures described in § 725.980. The 

request must be accompanied by 

information sufficient to support the 

request. Persons submitting a request to 

EPA under this part must submit the 

request to EPA (via CDX) using e-PMN 

software. See 40 CFR 720.40(a)(2)(ii) for 

information on how to obtain e-PMN 

software. Support documents related to 

these requests must also be submitted to 

EPA via CDX using e-PMN software. 

* * * * * 

PART 766—[AMENDED] 

■ 28. The authority citation for part 766 

continues to read as follows: 

Authority: 15 U.S.C. 2603 and 2607. 

■ 29. In § 766.3, add the following 

definitions in alphabetical order to read 

as follows: 

§ 766.3 Definitions. 

* * * * * 

Central Data Exchange or CDX means 

EPA’s centralized electronic submission 

receiving system. 

Chemical Information Submission 

System or CISS means EPA’s electronic, 

web-based reporting tool for the 

completion and submission of data, 

reports, and other information, or its 

successors. 

* * * * * 

■ 30. Revise § 766.7 to read as follows: 

§ 766.7 Submission of information. 

(a) All information (including letters 

of intent, protocols, data, forms, studies, 

and allegations) submitted to EPA under 

this part must bear the applicable Code 


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of Federal Regulations (CFR) section 

number (e.g., § 766.20). 

(b) You must use the CISS tool to 

complete and submit all data, reports, 

and other information required under 

this part except for records and reports 

of allegations of significant adverse 

reactions, which must be submitted in 

accordance with paragraph (c) of this 

section. 

(1) Submissions must be submitted to 

EPA via CDX. 

(2) To access the CISS tool go to 

https://cdx.epa.gov/ssl/CSPP/ 

PrimaryAuthorizedOfficial/Home.aspx 

and follow the appropriate links and for 

further instructions to go http:// 

www.epa.gov/oppt/chemtest/ereporting/ 

index.html. 

(c) You must submit records and 

reports of allegations of significant 

adverse reactions and the accompanying 

cover letters by one of the following 

methods: 

(1) Mail, preferably certified, to the 

Document Control Office (DCO) 

(7407M), Office of Pollution Prevention 

and Toxics (OPPT), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001, 

ATTN: Dioxin/Furan report part 766, 

Allegations of significant adverse 

reactions. 

(2) Hand delivery to OPPT Document 

Control Office (DCO), EPA East, Rm. 

6428, 1201 Constitution Ave. NW., 

Washington, DC, ATTN: Dioxin/Furan 

report part 766, Allegations of 

significant adverse reactions. The DCO 

is open from 8 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The telephone number for the 

DCO is (202) 564–8930. Such deliveries 

are only accepted during the DCO’s 

normal hours of operation. 

■ 31. In § 766.35, revise paragraph 

(c)(1)(i) to read as follows: 

§ 766.35 Reporting requirements. 

(c) * * * 

(1) * * * 

(i) A completed form (EPA 7710–51) 

for that chemical substance. The form 

and instructions are available online at 

http://www.epa.gov/oppt/chemtest/ 

ereporting/index.html. One form must 

be submitted for each chemical 

substance for which a positive test 

result has been submitted. 

* * * * * 

PART 790—[AMENDED] 

■ 32. The authority citation for part 790 

continues to read as follows: 

Authority: 15 U.S.C. 2603. 

■ 33. In § 790.3, add the following 

definitions in alphabetical order to read 

as follows: 

§ 790.3 Definitions. 

* * * * * 

Central Data Exchange or CDX means 

EPA’s centralized electronic submission 

receiving system. 

* * * * * 

Chemical Information Submission 

System or CISS means EPA’s electronic, 

web-based tool for the completion and 

submission of data, reports, and other 

information, or its successors. 

* * * * * 

■ 34. Revise § 790.5 to read as follows: 

§ 790.5 Submission of information. 

(a) All submissions and 

correspondence to EPA under this part 

must bear the Code of Federal 

Regulations (CFR) section number of the 

subject chemical test rule consent 

agreements. 

(b) You must use the CISS tool to 

complete and submit via CDX all data, 

reports, other information, and 

correspondence required by rules 

promulgated under TSCA section 4, and 

for correspondence pertaining to 

consent agreements as required under 

this part. The submissions must be 

made only as set forth in this section. 

(c) To access the CISS tool go to 

https://cdx.epa.gov/ssl/CSPP/

PrimaryAuthorizedOfficial/Home.aspx 

and follow the appropriate links and for 

further instructions to go http://

www.epa.gov/oppt/chemtest/ereporting/

index.html. 

■ 35. In § 790.45, revise paragraph (a) to 

read as follows: 

§ 790.45 Submission of letter of intent to 

conduct testing or exemption application. 

(a) No later than 30 days after the 

effective date of a test rule described in 

§ 790.40, each person subject to that test 

rule and required to comply with the 

requirements of that test rule as 

provided in § 790.42(a) must, for each 

test required, send his or her notice of 

intent to conduct testing, or submit to 

EPA an application for exemption from 

testing by the method specified in 

§ 790.5(b). 

* * * * * 

■ 36. In § 790.48, revise paragraphs 

(b)(3), (b)(5), (c)(2), and (c)(3) to read as 

follows: 

§ 790.48 Procedure if no one submits a 

letter of intent to conduct testing. 

* * * * * 

(b) * * * 

(3) No later than 30 days after the date 

of publication of the Federal Register 

notice described in paragraph (b)(2) of 

this section, each person described in 

§ 790.40(a)(4) and (a)(5) and each person 

processing the subject chemical as of the 

effective date of the test rule described 

in § 790.40 or by 30 days after the date 

of publication of the Federal Register 

notice described in paragraph (b)(2) of 

this section must, for each test specified 

in the Federal Register notice, either 

notify EPA of his or her intent to 

conduct testing, or submit to EPA an 

application for an exemption from 

testing requirements for the test. Each 

such notification to conduct testing or 

application for exemption from testing 

must be submitted to EPA by the 

method specified in § 790.5(b). 

* * * * * 

(5) If no manufacturer or processor 

submits a letter of intent to EPA through 

CDX within 30 days after either receipt 

of the certified letter or publication in 

the Federal Register notice described in 

(b)(4) of this section, all manufacturers 

and processors subject to the test rule 

will be in violation of the test rule from 

the 31st day after receipt of the certified 

letter or publication in the Federal 

Register. 

(c) * * * 

(2) If no processor subject to the test 

rule has notified EPA through CDX of its 

intent to conduct one or more of the 

required tests within 30 days after the 

effective date of the test rule described 

in § 790.40, EPA will notify all the 

processors by certified mail or publish 

a notice in the Federal Register of this 

fact, specifying the tests for which no 

letter of intent has been submitted and 

to give the processors an opportunity to 

take corrective action. 

(3) If no processor submits a letter of 

intent through CDX to conduct one or 

more of the required tests within 30 

days after receipt of the certified letter 

or publication of the Federal Register 

notice described in paragraph (c)(2) of 

this section, all processors subject to the 

test rule will be in violation of the test 

rule from the 31st day after receipt of 

the certified letter or publication of the 

Federal Register notice described in 

paragraph (c)(2) of this section. 

■ 37. In § 790.50, revise paragraphs 

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

§ 790.50 Submission of study plans. 

* * * * * 

(b) * * * 

(1) EPA may grant requests for 

additional time for the development of 

study plans on a case-by-case basis. 

Requests for additional time for study 

plan development must be submitted to 

EPA by the method specified in 

§ 790.5(b). Any extension request must 

state why EPA should grant the 

extension. 

* * * * * 


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(e) Amendments to study plans. Test 

sponsors must submit all amendments 

by the method specified in § 790.5(b). 

■ 38. In § 790.55, revise paragraph (a) to 

read as follows: 

§ 790.55 Modification of test standards or 

schedules during conduct of test. 

(a) Application. Any test sponsor who 

wishes to modify the test schedule for 

the mandatory testing conditions or 

requirements (i.e., ‘‘shall statements’’) in 

the test standard for any test required by 

a test rule must submit an application 

in accordance with this paragraph. 

Application for modification must be 

made by the method specified in 

§ 790.5(b). Applications must include an 

appropriate explanation and rationale 

for the modification. Where a test 

sponsor requests EPA to provide 

guidance or to clarify a non-mandatory 

testing requirement (i.e., ‘‘should 

statements’’) in a test standard, the test 

sponsor must submit these requests to 

EPA by the method format specified in 

§ 790.5(b). 

* * * * * 

■ 39. In § 790.62, revise paragraph (c)(4) 

to read as follows: 

§ 790.62 Submission of study plans and 

conduct of testing. 

* * * * * 

(c) * * * 

(4) The test sponsor shall submit any 

amendments to study plans to EPA 

using the method specified in § 790.5(b). 

* * * * * 

■ 40. In § 790.68, revise paragraph (b)(1) 

to read as follows: 

§ 790.68 Modification of consent 

agreements. 

* * * * * 

(b) * * * 

(1) Any test sponsor who wishes to 

modify the test schedule for any test 

required under a consent agreement 

must submit an application in 

accordance with this paragraph. 

Application for modification must be 

made using the method specified in 

§ 790.5(b). Applications must include an 

appropriate explanation and rationale 

for the modification. EPA will consider 

only those applications that request 

modifications to mandatory testing 

conditions or requirements (‘‘shall 

statements’’ in the consent agreement). 

Where a test sponsor requests EPA to 

provide guidance or to clarify a nonmandatory testing requirement (i.e., 

‘‘should statements’’), the test sponsor 

shall submit these requests to EPA using 

the method specified in § 790.5(b). 

* * * * * 

■ 41. In § 790.87, revise paragraph (c) to 

read as follows: 

§ 790.87 Approval of exemption 

applications. 

* * * * * 

(c)(1) EPA will give exemption 

applicants final notice that they have 

received a conditional exemption 

through one of the following ways: 

(i) A final Phase II test rule that 

adopts the study plans in a two-phase 

rulemaking. 

(ii) A separate Federal Register notice 

in a single-phase rulemaking. 

(iii) A letter by certified mail will give 

exemption applicants final notice that 

they have received a conditional 

exemption. 

(2) All conditional exemptions thus 

granted are contingent upon the test 

sponsors’ successful completion of 

testing according to the specifications of 

the test rule. 

■ 42. In § 790.90, revise paragraph (c)(2) 

to read as follows: 

§ 790.90 Appeal of denial of exemption 

application. 

* * * * * 

(c) * * * 

(2) Hearing requests must be 

submitted using the method specified in 

§ 790.5(b) and be received by EPA 

within 30 days of receipt of the 

Agency’s notification under § 790.88(b). 

Hearing requests must provide reasons 

why a hearing is necessary. 

* * * * * 

■ 43. In § 790.93, revise paragraphs (c) 

and (d)(2) to read as follows: 

§ 790.93 Termination of conditional 

exemption. 

* * * * * 

(c) Within 30 days after receipt of a 

letter notification or publication of a 

notice in the Federal Register that EPA 

intends to terminate a conditional 

exemption, the exemption holder may 

submit information using the method 

specified in § 790.5(b) either to rebut 

EPA’s preliminary decision or notify 

EPA of its intent to conduct the required 

test pursuant to the test standard 

established in the test rule. Such a letter 

of intent shall contain all of the 

information required by § 790.45(c). 

(d) * * * 

(2) Hearing requests must be 

submitted using the method specified in 

§ 790.5(b) and must be received by EPA 

within 30 days after receipt of the letter 

or publication in the Federal Register 

notice described in paragraph (b) of this 

section. 

* * * * * 

■ 44. In § 790.97, revise paragraph (a) to 

read as follows: 

§ 790.97 Hearing procedures. 

(a) Hearing requests must be 

submitted using the method specified in 

§ 790.5(b). Such requests must include 

the applicant’s basis for appealing EPA’s 

decision. 

* * * * * 

PART 799—[AMENDED] 

■ 45. The authority citation for part 799 

continues to read as follows: 

Authority: 15 U.S.C. 2603, 2611, and 2625. 

■ 46. Revise § 799.5 to read as follows: 

§ 799.5 Submission of information. 

(a) Information (e.g., letters, study 

plans, or reports) submitted to EPA 

must be submitted using the method 

specified in paragraph (b) of this 

section. All information submitted 

under this part must bear the Code of 

Federal Regulations (CFR) section 

number of the subject chemical test rule 

(e.g., § 799.1053 for trichlorobenzenes). 

(b) You must use CISS to complete 

and submit all data, reports, and other 

information required under this part. 

Submissions must be submitted to EPA 

via the Central Data Exchange (CDX). 

(c) To access CISS go to https://

cdx.epa.gov/ssl/CSPP/

PrimaryAuthorizedOfficial/Home.aspx 

and follow the appropriate links and for 

further instructions to go http://

www.epa.gov/oppt/chemtest/ereporting/

index.html. 

[FR Doc. 2013–28510 Filed 12–3–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Part 21 

[Docket No. FWS–HQ–MB–2013–0110; 

FF09M21200–134–FXMB1231099BPP0] 

RIN 1018–BA01 

Migratory Bird Permits; Delegating 

Falconry Permitting Authority to 17 

States 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Final rule. 

SUMMARY: The States of Alabama, 

California, Connecticut, Delaware, 

Florida, Georgia, Illinois, Louisiana, 

Maryland, Minnesota, Nevada, New 

York, Rhode Island, South Carolina, 

Vermont, West Virginia, and Wisconsin 

have requested that we delegate 

permitting for falconry to the State, as 

provided under our regulations. We 

have reviewed regulations and 


wreier-aviles on DSK5TPTVN1PROD with RULES