Federal Register / Vol. 77, No. 74 / Tuesday, April 17, 2012 / Proposed Rules 22707 

examines the reasonable alternatives 

and assesses their potential 

environmental impact. It also identifies 

the preferred alternative and how it 

affects the proposed rulemaking. 

We request your comments on 

environmental concerns that you may 

have related to the draft EA. This 

includes suggesting analyses and 

methodologies for use in the EA or 

possible sources of data or information 

not included in the draft EA. Your 

comments will be considered in 

preparing the final EA. 

This notice is issued under the 

authority of 5 U.S.C. 552(a), and 33 CFR 

1.05–1, 100.35, and 165.5. 

Dated: March 29, 2012. 

Cynthia L. Stowe, 

Captain, U.S. Coast Guard, Captain of the 

Port San Francisco. 

[FR Doc. 2012–9070 Filed 4–16–12; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

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

725, 766, 790, and 799 

[EPA–HQ–OPPT–2011–0519; FRL–9337–5] 

RIN 2070–AJ75 

Electronic Reporting Under the Toxic 

Substances Control Act 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing to require 

electronic reporting for information that 

must be submitted under Toxic 

Substances Control Act (TSCA) section 

4 (pursuant to test rules and enforceable 

consent agreements (ECAs)), TSCA 

section 8(a) Preliminary Assessment 

Information Rule (PAIR), and TSCA 

section 8(d) Health and Safety Data 

Reporting rules. Additionally, EPA is 

proposing amendments to certain TSCA 

section 5 reporting regulations that 

would extend electronic reporting 

requirements to Notices of 

Commencement of Manufacture or 

Import (NOCs) and support documents 

(e.g., correspondence, amendment, and 

test data) relating to TSCA section 5 

notices submitted to EPA before April 6, 

2010. This proposed rule would require 

the use of EPA’s Central Data Exchange 

(CDX) and the Chemical Information 

Submission System (CISS) web-based 

reporting tool for the submission of 

forms, reports, and other documents 

except for TSCA section 5 submissions, 

which would use existing e-PMN 

software. This action is intended to 

streamline the reporting process and 

reduce the administrative costs 

associated with information submission 

and recordkeeping. 

DATES: Comments must be received on 

or before June 18, 2012. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2011–0519, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

• Mail: Document Control Office 

(7407M), Office of Pollution Prevention 

and Toxics (OPPT), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001. 

• Hand Delivery: OPPT Document 

Control Office (DCO), EPA East Bldg., 

Rm. 6428, 1201 Constitution Ave. NW., 

Washington, DC. Attention: Docket ID 

Number EPA–HQ–OPPT–2011–0519. 

The DCO is open from 8 a.m. to 4 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

DCO is (202) 564–8930. Such deliveries 

are only accepted during the DCO’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

Instructions: Direct your comments to 

docket ID number EPA–HQ–OPPT– 

2011–0519. EPA’s policy is that all 

comments received will be included in 

the docket without change and may be 

made available online at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through regulations.gov or 

email. The regulations.gov Web site is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an email comment directly 

to EPA without going through 

regulations.gov, your email address will 

be automatically captured and included 

as part of the comment that is placed in 

the docket and made available on the 

Internet. If you submit an electronic 

comment, EPA recommends that you 

include your name and other contact 

information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. 

Docket: All documents in the docket 

are listed in the docket index available 

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

listed in the index, some information is 

not publicly available, e.g., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

will be publicly available only in hard 

copy. Publicly available docket 

materials are available electronically at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPPT 

Docket. The OPPT Docket is located in 

the EPA Docket Center (EPA/DC) at Rm. 

3334, EPA West Bldg., 1301 

Constitution Ave. NW., Washington, 

DC. The EPA/DC Public Reading Room 

hours of operation are 8:30 a.m. to 

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

excluding legal holidays. The telephone 

number of the EPA/DC Public Reading 

Room is (202) 566–1744, and the 

telephone number for the OPPT Docket 

is (202) 566–0280. Docket visitors are 

required to show photographic 

identification, pass through a metal 

detector, and sign the EPA visitor log. 

All visitor bags are processed through 

an X-ray machine and subject to search. 

Visitors will be provided an EPA/DC 

badge that must be visible at all times 

in the building and returned upon 

departure. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: 

Katherine Sleasman, Chemical Control 

Division, Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (202) 564–7716; email address: 

sleasman.katherine@epa.gov. 

For general information contact: The 

TSCA–Hotline, ABVI–Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCA– 

Hotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you manufacture 

(including import), process, or 

distribute in commerce chemical 

substances and mixtures. Potentially 

affected entities may include, but are 

not limited to: 

• Chemicals and Allied Products 

Manufacturers (NAICS 32411). 

• Petroleum Refining (NAICS Codes 

325 and 32411). 

This listing is not intended to be 

exhaustive, but rather provides a guide 


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for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the technical person listed under FOR

FURTHER INFORMATION CONTACT. 

B. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or email. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When submitting comments, remember 

to: 

i. Identify the document by docket ID 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

ii. Follow directions. The Agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

iii. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

iv. Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

vi. Provide specific examples to 

illustrate your concerns and suggest 

alternatives. 

vii. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

viii. Make sure to submit your 

comments by the comment period 

deadline identified. 

II. Background 

A. What action is the Agency taking? 

The Agency is proposing regulations 

to require electronic reporting of 

information submitted under TSCA 

section 4 (including test rules and 

ECAs), TSCA section 8(a) PAIR rule at 

40 CFR part 712, and TSCA section 8(d) 

Health and Safety Data Reporting rules 

to require use of CISS, a web-based 

reporting tool. 

The Agency is also proposing to 

extend TSCA section 5 electronic 

reporting requirements to NOCs and 

support documents (e.g., 

correspondence, amendments, and test 

data) relating to TSCA section 5 notices 

submitted to EPA prior to April 6, 2010, 

the effective date of the e-PMN final rule 

(Ref. 1). Currently, follow-up 

submissions for TSCA section 5 notices 

submitted before this date are not 

subject to electronic reporting 

requirements. 

The Government Paperwork 

Elimination Act (GPEA) (44 U.S.C. 

3504) provides that, when practicable, 

Federal organizations use electronic 

forms, electronic filings, and electronic 

signatures to conduct official business 

with the public. EPA’s Cross-Media 

Electronic Reporting Regulation 

(CROMERR) (40 CFR part 3) (Ref. 2), 

provides that any requirement in title 40 

of the CFR to submit a report directly to 

EPA can be satisfied with an electronic 

submission that meets certain 

conditions once the Agency published a 

document in the Federal Register 

announcing that EPA is prepared to 

receive certain documents in electronic 

form. For more information about 

CROMERR, go to http://www.epa.gov/ 

cromerr. 

This action would require electronic 

reporting under TSCA section 4 test 

rules and ECAs, TSCA section 8(a) 

PAIR, TSCA section 8(d) regulations, 

and TSCA section 5-related reporting 

provisions where electronic reporting is 

not already required, taking into 

consideration the frequency of reporting 

under these regulations. EPA is 

considering undertaking additional 

rulemaking regarding requiring 

electronic reporting for other TSCA 

requirements that currently include 

paper-reporting obligations. Once this 

proposed rule becomes effective, EPA 

would accept only data, reports, and 

other information submitted through 

CDX. Data, reports, and other 

information not submitted in the 

manner required would be considered 

invalid by EPA. In addition, the Agency 

encourages that voluntary submissions, 

such as those under Memoranda of 

Understandings (MOUs), also be 

submitted through CDX. The following 

regulations would be affected: 

1. TSCA section 4 test rules and ECAs. 

Documents required under TSCA 

section 4, include but are not limited to, 

letters of intent to conduct testing (40 

CFR 790.45), extension requests (40 CFR 

790.50), modification requests (40 CFR 

790.55), exemption requests (40 CFR 

790.80 and 40 CFR 790.82), hearing 

requests (40 CFR 790.90), and data 

required to be developed under rules at 

40 CFR part 799, and documents and 

correspondence related to ECAs 

negotiated pursuant to 40 CFR part 790. 

Affected sections would include those 

relating to submission or modification 

of a study plan (40 CFR 790.62), and 

requests to modify the test schedule for 

any test required under the consent 

agreement (40 CFR 790.68). Electronic 

reporting requirements for TSCA section 

4 rules and ECAs would be added to 40 

CFR 766.7, 790.5, and 799.50. 

2. TSCA section 5. Additionally, EPA 

is proposing amendments to certain 

TSCA section 5 reporting regulations 

that would extend electronic reporting 

requirements to NOCs and support 

documents (e.g., correspondence, 

amendment, and test data) relating to 

TSCA section 5 notices submitted to 

EPA before April 6, 2010. The e-PMN 

final rule (Ref. 1) requires submitters of 

NOCs and support documents whose 

original notices were submitted to EPA 

prior to April 6, 2010 (‘‘legacy notices’’) 

to submit those NOCs and support 

documents to EPA in hard copy. At the 

time the final rule was published, EPA 

believed the hard-copy submission of 

these documents was necessary because 

the Agency intended to operate two 

different databases; one for storing 

TSCA section 5 notices submitted to 

EPA after April 6, 2010, and another for 

storing legacy notices. EPA originally 

intended to enter legacy notices only 

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

database used prior to April 6, 2010, 

and so a subsequent NOC or support 

document would not have been able to 

be linked up with its original or 

‘‘parent’’ legacy notice if it was entered 

into EPA’s new database. 

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

reporting program has evolved and EPA 

now has the ability to house both legacy 

notices and notices submitted after 

April 6, 2010, in the same database. EPA 

is therefore proposing to amend the 

regulations at 40 CFR parts 720, 721, 

723, and 725 to require NOCs and 

support documents for TSCA section 5 

notices originally submitted prior to 

April 6, 2010, to be submitted 

electronically allowing them to be 


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stored with their legacy TSCA section 5 

notices in the new database. 

Within the e-PMN final rule, EPA 

phased-in electronic reporting of TSCA 

section 5 notices and their related NOCs 

and support documents over a 2-year 

period that ends April 6, 2012. Within 

this proposed rule, EPA would remove 

the regulatory text related to the phasein because by the time this proposed 

rule is finalized, EPA expects the phasein period will be over and all TSCA 

section 5 notices, NOCs, and support 

documents would be required to be 

submitted to EPA via CDX. 

3. TSCA section 8(a) PAIR. Electronic 

reporting requirements for Form 7710– 

35, Manufacturer’s Report—Preliminary 

Assessment Information (Manufacturer’s 

Report) would be included in 40 CFR 

712.28 and 712.30. 

4. TSCA section 8(d). The submission 

of data, reports, and other documents 

are required under the TSCA section 

8(d) Health and Safety Data reporting 

rule at 40 CFR part 716 and the 

Dibenzo-para-dioxins/Dibenzofurans 

rule at 40 CFR part 766 (specifically 40 

CFR 716.30, 716.35, 716.60, and 766.7). 

Additional affected sections of 40 CFR 

part 716 would include: The submission 

of underlying data, preliminary reports 

of ongoing studies, additional copies of 

studies (40 CFR 716.40), requests for 

extension of time (40 CFR 716.60), and 

requests for withdrawal of a chemical 

substance from a rule (40 CFR 716.105). 

B. What is the Agency’s authority for 

taking this action? 

The Agency collects information from 

manufacturers and processors of 

chemical substances under TSCA 

section 4 regulations, TSCA section 8(a) 

PAIR, and TSCA section 8(d) 

regulations. Section 4 of TSCA 

authorizes EPA to require manufacturers 

and processors of chemical substances 

and mixtures to perform testing to 

generate data relevant to a 

determination whether the manufacture, 

distribution in commerce, processing, 

use, or disposal of such chemical or 

mixtures presents an unreasonable risk 

of injury to health or the environment. 

Some TSCA section 4 testing data are 

required via ECAs. Section 8(a) of TSCA 

gives EPA authority to promulgate rules 

to require that manufacturers (includes 

importers) and processors of chemical 

substances and mixtures report such 

data as EPA may reasonably require. 

One TSCA section 8(a) reporting rule is 

the PAIR at 40 CFR part 712. The PAIR 

requires chemical manufacturers and 

importers to complete and submit to 

EPA a standardized reporting form with 

information to help facilitate the 

evaluation of the potential adverse 

human health and environmental effects 

from exposure to identified chemical 

substances, mixtures, or categories. 

Under TSCA section 8(d), EPA has the 

authority to promulgate rules to require 

manufacturers (including importers), 

processors, and distributors to submit 

lists and/or copies of ongoing and 

completed unpublished health and 

safety studies. 

Section 5(a)(1)(A) of TSCA requires 

persons to notify EPA at least 90 days 

before manufacturing a new chemical 

substance for commercial purposes 

(under TSCA manufacture includes 

import). Section 3(9) of TSCA defines a 

‘‘new chemical substance’’ as any 

chemical substance that is not on the 

TSCA Inventory of Chemical Substances 

compiled by EPA under TSCA section 

8(b). Section 5(a)(2) of TSCA authorizes 

EPA to determine that a use of a 

chemical substance is a ‘‘significant new 

use.’’ EPA must make this 

determination by a Significant New Use 

Rule (SNUR) after considering all 

relevant factors, including those listed 

in TSCA section 5(a)(2). Once EPA 

determines that a use of a chemical 

substance is a significant new use, 

TSCA section 5(a)(1)(B) requires persons 

to submit a Significant New Use Notice 

(SNUN) to EPA at least 90 days before 

manufacturing or processing the 

chemical substance for that use. 

C. Is electronic reporting currently 

required in other EPA TSCA programs? 

Since 2006, under the TSCA section 

8(a) Inventory Update Reporting rule 

(IUR), manufacturers (including 

importers) have been able to submit IUR 

information electronically to the EPA 

through CDX (Ref. 3). EPA is improving 

upon the 2006 IUR electronic reporting 

software by making electronic reporting 

easier and more accessible to potential 

reporters, including non-U.S. companies 

and those submitters filing jointly. On 

August 16, 2011 (Ref. 4), the Agency 

published the final Chemical Data 

Reporting (CDR) rule, amending and 

renaming the IUR rule and making 

electronic reporting mandatory, 

beginning with the 2012 submission 

period. In addition, on January 6, 2010, 

EPA published the e-PMN final rule, 

which phased in electronic reporting 

requirements for TSCA section 5 notices 

and other related documents over a 2- 

year period. After the 2-year phase-in 

period ends on April 6, 2012, the final 

rule mandates electronic reporting for 

these documents (Ref. 1). 

III. Description of Proposed Changes to 

Reporting Procedures 

This unit provides an overview of 

EPA’s CDX, CISS, and e-PMN software 

for NOCs and support documents 

associated with legacy TSCA section 5 

notices, the proposed changes to the 

TSCA reporting process, and the 

benefits of electronic reporting to both 

industry and EPA. 

A. What is CDX? 

CDX is EPA’s electronic system for 

environmental data exchange to the 

Agency. CDX also provides the 

capability for submitters to access their 

data through the use of web services. 

CDX enables EPA to work with 

stakeholders, including governments, 

regulated industries, and the public to 

enable streamlined, electronic 

submission of data via the Internet. For 

more information about CDX, go to 

http://epa.gov/cdx. 

B. What is CISS? 

EPA developed CISS for use in 

submitting data for TSCA sections 4, 

8(a), and 8(d) electronically to the 

Agency. The tool is available for use 

with Windows, Macs, Linux, and UNIX 

based computers, using ‘‘Extensible 

Markup Language’’ (XML) specifications 

for efficient data transmission across the 

Internet. CISS, a web-based reporting 

tool, provides user-friendly navigation, 

works with CDX to secure online 

communication, creates a completed 

Portable Document Format (PDF) for 

review prior to submission, and enables 

data, reports, and other information to 

be submitted easily as PDF attachments, 

or by other electronic standards, such as 

XML. 

C. What is the e-PMN software for TSCA 

section 5? 

EPA developed e-PMN software for 

use in preparing and submitting 

Premanufacture Notices (PMNs) and 

other TSCA section 5 notices and 

support documents electronically to the 

Agency. For further information on the 

software capabilities, please visit the 

TSCA New Chemicals Program Web site 

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

Also, see the e-PMN final rule for 

further guidance (Ref. 1). 

D. What are the benefits of CDX 

reporting and use of CISS and the ePMN software? 

The effort to eliminate paper-based 

submissions in favor of CDX reporting, 

including use of CISS, is part of broader 

government efforts to move to modern, 

electronic methods of information 

gathering. CISS and e-PMN software 

enable more efficient data transmittal 

and reduce errors with the built-in 

validation procedures. EPA believes the 

adoption of electronic reporting reduces 

the reporting burden for submitters by 


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reducing the cost and time required to 

review, edit, and transmit data to the 

Agency. It also allows submitters to 

share a draft submission within their 

organization, and more easily save a 

copy for their records or future use. The 

resource and time requirements to 

review and process data by the Agency 

will also be reduced and document 

storage and retrieval will require fewer 

resources. EPA expects to benefit from 

receiving electronic submissions and 

communicating back electronically with 

submitters. In addition, the use of CDX, 

CISS, and e-PMN software ensures the 

legal dependability of electronic reports 

so that they meet the needs of the 

compliance and enforcement programs. 

The legal dependability of electronically 

submitted documents is enhanced by 

valid electronic signatures that can be 

submitted into evidence, assurance that 

electronic documents can be 

authenticated to provide evidence of 

what an individual submitted and/or 

attested to, and assurance that electronic 

signatures resist repudiation by the 

signatory (Ref. 5). 

E. How would data, reports, and other 

documents required under TSCA 

sections 4, 8(a) PAIR, and 8(d) be 

submitted via the Internet using CDX? 

This proposed rule would require 

submitters to register with EPA’s CDX 

and use CISS to prepare a data file for 

submission. 

1. Registering with CDX. Registration 

enables CDX to perform two important 

functions: 

i. Authentication of identity. 

ii. Verification of authorization. 

To submit electronically to EPA via 

CDX, individuals must first register with 

that system at 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, and follows 

the procedures outlined in the guidance 

document for CDX available 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 Toxic Release 

Inventory TRI–ME web reporting flow, 

will be able to add the ‘‘Submission for 

Chemical Safety and Pesticide Program 

(CSPP)’’ CDX flow to their current 

registration, and use the CISS web-based 

reporting tool. 

2. Preparing the submission. All 

submitters would be required to use 

CISS to prepare their submissions. CISS 

guides users through a ‘‘hands-on’’ 

process of creating an electronic 

submission. Once a user completes the 

relevant data fields, attaches appropriate 

PDF files, or other file types, such as 

XML files, and completes metadata 

information, the web-based tool 

validates the submission by performing 

a basic error check and makes sure all 

the required fields and attachments are 

provided and complete. Further 

instructions on submitting voluntary 

submissions, such as under MOUs, are 

available, and instructions for uploading 

PDF attachments or other file types, 

such as XML, and completing metadata 

information would be available through 

CISS reporting guidance. 

3. Completing the submission to EPA. 

CISS, a web-based reporting tool, also 

allows the user to choose ‘‘Print,’’ 

‘‘Save,’’ or ‘‘Transmit through CDX.’’ 

When ‘‘Transmission through CDX’’ is 

selected, the user is asked to provide the 

user name and password that was 

created during the CDX registration 

process. CISS then encrypts the file and 

submits it via CDX. 

4. Correspondence through CDX. The 

user will log in to the application and 

check the status of their submissions. 

Upon successful receipt of the 

submission by EPA, the status of the 

submissions will be flagged as 

‘‘Completed.’’ The CDX inbox is 

currently used to notify the users of any 

correspondence related to user 

registration. Information on accessing 

the CDX user inbox is provided in the 

guidance document for CDX at http:// 

www.epa.gov/cdr/tools/ 

CDX_Registration_Guide_v0_02.pdf. 

F. How would TSCA section 5 NOCs 

and support documents relating to 

legacy TSCA section 5 notices be 

submitted to EPA? 

EPA is proposing that NOCs and 

support documents relating to legacy 

TSCA section 5 notices be submitted to 

EPA using the same process and 

timeline as described in 40 CFR 

720.40(a)(2), see Unit II.A.3. All NOCs 

and support documents would be 

required to be generated using e-PMN 

software and be completed through the 

finalization step of the software. See the 

e-PMN final rule (Ref. 1) for more 

detailed information on the process and 

timeline for submitting NOCs and 

support documents. 

G. How would CBI be submitted using 

CISS? 

All information sent by the submitter 

via CDX is transmitted securely to 

protect CBI. CISS enables the user to 

submit CBI in an electronic format. The 

reporting tool guides the user through 

the process of submitting CBI by 

prompting the submitter to check a CBI 

checkbox if using a form or by 

submitting a scanned document 

containing CBI by bracketing, 

underlining, or otherwise marking the 

confidential information on the 

document to be submitted prior to 

scanning. Documents containing 

information claimed as CBI would have 

to be submitted in an electronic format, 

in accordance with the recordkeeping 

requirements (Ref. 5) and the following 

regulations: 

1. TSCA section 4 test rules and ECAs. 

Documents required under TSCA 

section 4 that may contain information 

claimed as CBI include study plans 

submitted in accordance with test rules 

(40 CFR 790.50) and study plans 

submitted in accordance with an ECA 

(40 CFR 790.62). CISS would allow the 

submitter to indicate if a study plan 

contains information claimed as CBI by 

checking the appropriate box. Then, the 

submitter would be prompted to submit 

the study plan document in an 

electronic format. The submitter would 

need to indicate which information in 

the study plan contains information 

claimed as CBI by marking the specific 

information claimed as confidential and 

designating it with the words 

‘‘confidential business information,’’ 

‘‘trade secret,’’ or another appropriate 

phrase in the document prior to 

scanning. Subsequently, if CBI is 

claimed in either a study plan for test 

rules or an ECA, the submitter would be 

prompted by CISS to substantiate those 

claims by answering the substantiating 

questions pursuant to 40 CFR 790.7 in 

a document submitted in an electronic 

format. 

2. TSCA section 8(a) PAIR. CISS 

would include areas for indicating CBI 

on Form 7710–35, Manufacturer’s 

Report (40 CFR 712.28 and 712.30). If 

CBI is indicated on Form 7710–35, the 

reporting tool would prompt the 

submitter to certify that the 

confidentiality statements are true by 

prompting the submitter to select the 

‘‘Confidentiality Certification 

Statement.’’ 

3. TSCA section 8(d). Documents 

submitted under TSCA section 8(d) that 

contain information claimed as CBI 

would have to be indicated as such by 

using CISS. CISS would allow the 

submitter to indicate if the document 

contains CBI by checking the 

appropriate box. Then, the submitter 

would be prompted to submit the 

document in an electronic format. In 

submitting a document that contains 

CBI, CISS would prompt the submitter 

to submit two copies of the document in 

an electronic format. The copy 


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containing CBI would need to identify 

the confidential information by 

bracketing or underlining the 

information and labeling the copy 

‘‘confidential,’’ ‘‘proprietary,’’ or ‘‘trade 

secret.’’ The non-CBI second copy 

would need to have all confidential 

information deleted. Once CBI is 

claimed, CISS would prompt the 

submitter to substantiate their claims 

(40 CFR 716.55). 

The user guide would also instruct 

users on how to submit and substantiate 

CBI information using CISS. 

H. Would CBI be protected when 

submitting via CDX? 

All information sent by the submitter 

via CDX would be transmitted securely 

to protect CBI. Furthermore, if anything 

in the submission is claimed as CBI, a 

non-CBI copy of the submission would 

have to be provided by the submitter. 

The guidance document would instruct 

users on how to submit and substantiate 

CBI information using CISS. 

The Agency ensures secure 

transmission of the data, reports, and 

other documents sent from the user’s 

desktop through the Internet via the 

Transport Layer Security (TLS) 1.0 

protocol. TLS 1.0 is a widely used 

approach for securing Internet 

transactions and is endorsed by the 

National Institute of Standards and 

Technology (NIST) as a means for 

protecting data sent over the Internet. 

See NIST Special Publication 800–52, 

‘‘Guidelines for the Selection and Use of 

Transport Layer Security (TLS) 

Implementations.’’ Available online at 

http://csrc.nist.gov/publications/ 

nistpubs/800-52/SP800-52.pdf. 

In addition, CISS enables the 

submitter to electronically sign, encrypt, 

and transmit submissions which EPA 

subsequently provides back to the 

submitter as an unaltered copy of 

record. This assures the submitter that 

the Agency has received exactly what 

the submitter sent to EPA. CISS 

encrypts using a module based on the 

256-bit Advanced Encryption Standard 

(AES) adopted by NIST. Details about 

AES can be found on the NIST Web site 

at http://csrc.nist.gov/publications/fips/ 

fips197/fips-197.pdf, and EPA may 

incorporate other encryption modules 

into future versions of the tool (such 

versions might be developed before or 

after the final rule is to take effect 

depending upon availability and 

suitability). Information submitted via 

CDX is processed within EPA by secure 

systems certified for compliance with 

Federal Information Processing 

Standards. 

I. Would EPA offer any exceptions to the 

proposed requirements? 

The Agency does not expect to offer 

any exceptions to any final 

requirements to submit data, reports, 

and other documents affected by this 

proposed rule electronically. The 

Agency believes that the overall benefits 

of using CISS and e-PMN software, and 

submission through CDX exceed those 

associated with maintaining a paperbased reporting approach. The proposed 

electronic reporting requirements are 

not the first that would mandate 

electronic reporting as explained in Unit 

II.C. For example, the e-PMN final rule 

provided for a phased-in approach using 

CDX in three phases over a 2-year 

period. During the first year following 

the April 6, 2010 effective date of the 

final rule, the Agency allowed 

submissions via CDX, optical disc (CD 

or DVD), and paper. Paper submissions 

are no longer accepted, and optical discs 

will no longer be accepted after April 6, 

2012. The phased-in approach was 

designed to allow submitters to gain 

experience using the e-PMN software 

and the submission delivery system 

(Ref. 6). 

On August 16, 2011, the Agency 

published the final rule for the TSCA 

Inventory Update Reporting 

Modifications; Chemical Data Rule (Ref. 

4). This final rule requires electronic 

reporting and does not provide for a 

phased-in approach. Previously, in 2006 

EPA accepted the 2006 IUR submissions 

electronically via CDX, optical discs, 

and paper-based methods. However, by 

allowing submissions to be received 

through a variety of mechanisms, the 

time and resources needed to review 

and correct submitter and scanningrelated errors took the Agency over 2 

years to validate and process for the 

2006 IUR. By requiring submissions to 

be sent via CDX and the e-CDR webbased reporting tool, called e-CDRweb, 

resources and the number of errors 

should be greatly reduced. 

The Agency recognizes that there is 

the potential for costs and burdens 

associated with predictable or 

unanticipated technical difficulties in 

electronic filing or with conversion to 

an electronic format. Since the use of 

CDX has been in existence for a number 

of years and has undergone a number of 

enhancements, EPA expects the 

potential for difficulty to be minimal. 

However, EPA expects that reduced 

reporting costs to submitters would 

ultimately exceed the transition costs 

(see Economic Analysis referenced in 

Unit IV.). 

J. How will the agency provide 

opportunities for potential users to 

become familiar with the reporting tool? 

The Agency will offer a webinar open 

to the public for potential users to 

become familiar with CISS before its 

release following publication of the final 

rule. The webinar will be recorded and 

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

chemtest/ereporting/index.html. An 

‘‘Industry Day’’ will be scheduled to 

allow users to become familiar with 

CISS in a collaborative setting. Industry 

Day details will be announced in the 

Federal Register. There will also be a 

week-long familiarization opportunity 

to allow users to become accustomed 

with CISS on their own and to provide 

comments to the Agency on its 

functionality. 

IV. Economic Analysis 

The Agency’s estimated economic 

impact of this proposed rule is 

presented in a document entitled 

‘‘Economic Analysis for the Electronic 

Reporting under TSCA Section 4, 

Section 5 NOCs, Section 8(a) PAIR, and 

Section 8(d)’’ (Ref. 7) (Economic 

Analysis), a copy of which is available 

in the docket and is briefly summarized 

in this unit. If a TSCA section 5 PMN 

or a SNUN was submitted after the 

effective date (April 6, 2010) of the ePMN final rule it would be subject to 

the e-PMN final rule and is required to 

be submitted electronically online. 

However, if a TSCA section 5 PMN or 

SNUN was submitted prior to the 

effective date of the e-PMN final rule 

(April 2010), it must be printed and 

mailed as hard copy to the Agency. This 

proposed rule would require all NOC 

and supporting documents whose 

original notices were submitted on 

paper before the new system was 

implemented to now be submitted 

electronically via the CDX system. 

EPA estimated that this proposed 

rule, if finalized, would result in cost 

savings to the affected companies 

because the time required to enter, 

review, edit, and submit their reports 

using CDX would be reduced compared 

to the existing paper-based process. 

EPA estimated that this proposed rule 

would result in total cost to the industry 

of approximately $14,061 in year 1 and 

a cost savings of $66,834 in each 

subsequent year. The cost savings in 

subsequent years are greater than those 

in year 1 because of the one-time CDX 

registration costs incurred at the initial 

submission. EPA assumed that industry 

would continue to realize cost savings 

each additional year. 

EPA estimates that the Agency also 

would experience a reduction in the 


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cost to administer submissions of data 

under TSCA in the long-run. Due to the 

one-time development cost of $200,000 

for CDX in year 1 and an annual CDX 

Operations and Maintenance (O&M) 

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

of $197,918 in year 1, after accounting 

for $59,435 in savings resulting from the 

burden reductions associated with 

electronic processing of submissions 

within the Agency. However, in 

subsequent years, EPA would only incur 

the $57,353 annually in O&M costs, 

resulting in the Agency savings of 

$2,082 a year in subsequent years. 

In addition to the quantifiable cost 

savings, EPA believes this proposed rule 

would result in other benefits. For 

example, electronic reporting would 

allow for faster review and transmission 

of submissions to EPA. For studies 

containing CBI, electronic reporting 

would also improve security during 

transmission of CBI data to EPA. 

Additionally, all information submitted 

electronically could be linked in a 

tracking system, which would facilitate 

document management efforts. This 

would allow companies to manage past 

and future submissions more easily. 

EPA received 9,280 TSCA section 5 

supporting documents between April 1, 

2005 and June 22, 2011, with an average 

of 1,510 supporting documents each 

year. EPA assumed that the impact of 

this proposed rule on TSCA section 5 

supporting documents would be very 

minimal given that industry has already 

undertaken electronic submission of 

such supplemental materials. 

V. Request for Comment 

The Agency is specifically soliciting 

comments on the following five topics. 

EPA encourages all interested persons to 

submit comments on these five topics or 

other relevant topics and submission of 

data via CDX. This input will assist the 

Agency in developing a final rule that 

addresses information needs while 

minimizing reporting burdens 

associated with paper-based reporting. 

EPA requests that comments include 

specific recommendations, where 

appropriate, including cost and burden 

estimates. 

1. EPA expects that reporting health 

and safety information electronically 

would reduce the burden associated 

with current paper-based submission 

method under TSCA. EPA is seeking 

information that might further inform 

the Agency’s burden estimates. 

Estimated costs presented by EPA for 

submitters (reporting burden) and the 

Agency (time required for manual 

processing of data) may overstate actual 

costs to the extent that submitters are 

able to use the electronic submission 

tool. EPA invites comment on the 

relative time and resource burden of 

completing CDX registration 

requirements and making an electronic 

submission, versus making a submission 

via the current paper-based method. 

2. EPA seeks comment on its belief 

that persons required to report 

information under TSCA section 4 or 

8(d) rules, or under the TSCA 8(a) PAIR 

would benefit from moving from paper 

based reporting to electronic because it 

is less expensive, faster, and easier. 

3. CISS enables submitters to send 

CBI electronically. EPA invites 

comments on the submission of CBI 

information via CDX. The Agency is 

requesting submitters use a Portable 

Document Format (PDF) to send 

documents to the Agency. Would this be 

an acceptable format for submitters to 

send CBI to the Agency or is there 

another format submitters would prefer? 

4. EPA is also considering using CDX 

to send correspondence relating to 

submissions under TSCA sections 4 and 

8(d) rules. EPA invites comments on 

whether persons required to report 

under these sections of TSCA would 

benefit from receiving electronic 

correspondence from EPA via CDX. 

5. CISS allows submitters to provide 

some information to EPA in fielded 

formats, such as the chemical identity, 

while also allowing submitters to 

upload files as attachments to a webbased form. EPA invites comments on 

the submission of forms, reports, and 

other documents in fielded formats. 

Would it be feasible for submitters to 

enter data and information in a fielded 

format, e.g., the Organisation for 

Economic Co-operation and 

Development (OECD) harmonized 

template formats? The OECD 

harmonized template formats are 

available online at: http://www.oecd.

org/document/18/0,3746,en_21571361_

43392827_44169746_1_1_1_1,00.html. 

VI. References 

As indicated under ADDRESSES, a 

docket has been established for this 

proposed rule under docket ID number 

EPA–HQ–OPPT–2011–0519. The 

following is a listing of the documents 

that are specifically referenced in this 

action. The docket includes these 

documents and other information 

considered by EPA, including 

documents that are referenced within 

the documents that are included in the 

docket, even if the referenced document 

is not physically located in the docket. 

For assistance in locating these other 

documents, please consult the technical 

contact listed under FOR FURTHER

INFORMATION CONTACT. 

1. EPA. TSCA Section 5 Premanufacture 

and Significant New Use Notification 

Electronic Reporting; Revisions to 

Notification Regulations; Final Rule. 

Federal Register (75 FR 773, January 

6, 2010) (FRL–8794–5). 

2. EPA. Cross-Media Electronic 

Reporting; Final Rule. Federal 

Register (70 FR 59848, October 13, 

2005) (FRL–7977–1). 

3. EPA. TSCA Inventory Update 

Reporting Rule; Electronic Reporting; 

Direct Final Rule. Federal Register 

(71 FR 52494, September 6, 2006) 

(FRL–7752–8). 

4. EPA. Inventory Update Reporting 

Modification; Chemical Data 

Reporting; Final Rule. Federal 

Register (76 FR 50816, August 16, 

2011) (FRL–8872–9). 

5. Transfer of Records to the National 

Archives of the United States. 36 CFR 

part 1235. 

6. EPA. Electronic Toxic Control Act 

(eTSCA)/e-PMN Reporting Tool 

User’s Guide. 

7. EPA. Economic Analysis for 

Electronic Reporting under TSCA 

Section 4, Section 5 NOCs, Section 

8(a) PAIR, and Section 8(d). February 

21, 2012. 

VII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

This action is not a ‘‘significant 

regulatory action’’ under the terms of 

Executive Order 12866, entitled 

‘‘Regulatory Planning and Review’’ (58 

FR 51735, October 4, 1993), and is 

therefore not subject to review by the 

Office of Management and Budget 

(OMB) under Executive Orders 12866 

and 13563, entitled ‘‘Improving 

Regulation and Regulatory Review’’ (76 

FR 3821, January 21, 2011). EPA has 

prepared an economic analysis of this 

action, which is contained in a 

document entitled ‘‘Economic Analysis 

for Electronic Reporting under TSCA 

Section 4, Section 5 NOCs, Section 8(a) 

PAIR, and Section 8(d)’’ (Ref. 7). A copy 

of the economic analysis is available in 

the docket for this proposed rule and is 

summarized in Unit IV. 

B. Paperwork Reduction Act 

The information collection 

requirements contained in this proposed 

rule have been submitted for OMB 

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

seq. The ICR document prepared by 

EPA, identified under EPA ICR No. 

2412.01 and OMB control number 

2070–NEW, is available in the docket 

for the proposed rule. The ICR addresses 

the incremental changes to the five 

currently approved ICR documents that 


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cover the existing reporting and 

recordkeeping programs that are 

approved under OMB control numbers 

2070–0004, 2070–0012, 2070–0033, 

2070–0054, and 2070–0156. An agency 

may not conduct or sponsor, and a 

person is not required to respond to a 

collection of information unless it 

displays a currently valid OMB control 

number. The amended information 

collection activities contained in this 

proposed rule are designed to assist the 

Agency in meeting its responsibility 

under TSCA to receive, process, and 

review reports, data, and other 

information. As such, responses to the 

collection of information covered by 

this ICR would still be mandatory, but 

with the final rule, respondents would 

be required to use the CISS reporting 

tool, except for TSCA section 5 

submissions, which would require the 

use of existing e-PMN software. 

Burden is defined at 5 CFR 1320.3(b). 

The ICR document for this proposed 

rule provides a detailed presentation of 

the estimated burden and costs for the 

first year of the program. The rulerelated burden and cost to chemical 

manufacturers, importers, and 

processors who would submit notices to 

the Agency for review is summarized 

here. The projected total burden to 

industry is 363 hours per year for the 

first year of the final rule. This includes 

an estimated average burden per 

response of 0.9 hours for CDX 

registration, 1.8 hours for requesting a 

CDX electronic signature, and 0.8 hours 

for final rule familiarization. 

Any comments on the Agency’s need 

for this information, the accuracy of the 

provided burden estimates, and any 

suggested methods for minimizing 

respondent burden, should be submitted 

to the docket for this proposed rule, 

under docket ID number EPA–HQ– 

OPPT–2011–0519. You may also submit 

a copy of your comments on the ICR to 

OMB. See ADDRESSES for submission of 

comments to EPA. Send comments to 

OMB at the Office of Information and 

Regulatory Affairs, Office of 

Management and Budget, 725 17th St. 

NW., Washington, DC 20503, Attention: 

Desk Office for EPA. Since OMB is 

required to make a decision concerning 

the ICR between 30 and 60 days after 

April 17, 2012, a comment to OMB is 

best assured of having its full effect if 

OMB receives it by May 17, 2012. The 

final rule will respond to any OMB or 

public comments on the information 

collection requirements contained in 

this proposed rule. 

C. Regulatory Flexibility Act 

Pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA), 5 

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

certifies that this proposed rule, if 

promulgated as proposed, would not 

have a significant adverse economic 

impact on a substantial number of small 

entities. 

Small entities include small 

businesses, small organizations, and 

small governmental jurisdictions. For 

purposes of assessing the impacts of this 

proposed rule on small entities, small 

entity is defined as: 

1. A small business as defined by the 

Small Business Administration’s (SBA) 

regulations at 13 CFR 121.201. 

2. A small governmental jurisdiction 

that is a government of a city, county, 

town, school district, or special district 

with a population of less than 50,000. 

3. A small organization that is any 

not-for-profit enterprise, which is 

independently owned and operated and 

is not dominant in its field. 

In determining whether a rule has a 

significant adverse economic impact on 

a substantial number of small entities, 

an agency may certify that a rule will 

not have a significant adverse economic 

impact on a substantial number of small 

entities if the rule relieves regulatory 

burden, or otherwise has a positive 

economic effect on all of the small 

entities subject to the rule. This 

proposed rule is expected to reduce the 

existing regulatory burden. The factual 

basis for the Agency’s certification is 

presented in the small entity impact 

analysis prepared as part of the 

Economic Analysis for this proposed 

rule, and is briefly summarized in Unit 

IV. EPA analyzed reporting data that 

identified individual companies 

submitting information under TSCA 

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

identified those companies potentially 

affected by this proposed rule that 

qualify for the small business status. 

EPA estimated the cost impact ratios for 

small parent entities potentially affected 

by this proposed rule and has 

determined that the estimated 

regulatory costs represent a small 

impact of less than 1% of their annual 

revenue. The estimated ratios range 

from less than 0.0001% to 0.014%, 

depending on the NAICS sector and 

employment size category, with an 

average of 0.001%. No small parent 

entities are expected to have a cost 

impact of greater than 1% of annual 

revenue. Since the estimated regulatory 

costs represent a small fraction of a 

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

than 1%), the impacts of this proposed 

rule are likely to be minimal. 

D. Unfunded Mandates Reform Act 

State, local, and tribal governments 

have not been affected by the TSCA 

sections 4, 5, 8(a) PAIR, and 8(d) 

reporting requirements, and EPA does 

not have any reason to believe that any 

State, local, or tribal government would 

be affected by this proposed rule. 

Therefore, EPA has determined that this 

proposed rule would not impose any 

enforceable duty, contain any unfunded 

mandate, or otherwise have any effect 

on small governments subject to the 

requirements of sections 202, 203, 204, 

or 205 of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Pub. L. 

104–4). 

E. Executive Order 13132 

Under Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999), EPA has determined 

that this proposed rule would not have 

federalism implications because the 

proposed rule would not have 

substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in the 

Executive Order. This proposed rule 

would establish electronic notification 

requirements that apply to 

manufacturers (including importers) 

and processors of certain chemicals. 

This proposed rule would not apply 

directly to States and localities and 

would not affect State and local 

governments. Thus, Executive Order 

13132 does not apply to this proposed 

rule. 

F. Executive Order 13175 

Under Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000), EPA has 

determined that this proposed rule 

would not have tribal implications 

because it would not have substantial 

direct effects on tribal governments, on 

the relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in the Executive Order. EPA 

has no information to indicate that any 

tribal government manufactures or 

imports the chemical substances 

covered by this action. Thus, Executive 

Order 13175 does not apply to this 

proposed rule. 

G. Executive Order 13045 

This proposed rule would not require 

special consideration pursuant to the 

terms of Executive Order 13045, entitled 

‘‘Protection of Children from 

Environmental Health Risks and Safety 

Risks’’ (62 FR 19885, April 23, 1997), 


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because this action is not an 

economically significant action as 

defined by EO 12866, nor does EPA 

expect the environmental health or 

safety risks addressed by this action to 

present a disproportionate risk to 

children. 

H. Executive Order 13211 

This proposed rule is not subject to 

Executive Order 13211, entitled 

‘‘Actions Concerning Regulations that 

Significantly Affect Energy Supply, 

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

22, 2001), because this proposal is not 

an economically significant action as 

defined by EO 12866, nor would it have 

any significant adverse effect on the 

supply, distribution, or use of energy. 

I. National Technology Transfer and 

Advancement Act 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (NTTAA), 15 U.S.C. 272 

note) directs EPA to use voluntary 

consensus standards in its regulatory 

activities unless to do so would be 

inconsistent with applicable law or 

impractical. Voluntary consensus 

standards are technical standards (e.g., 

materials specifications, test methods, 

sampling procedures, etc.) that are 

developed or adopted by voluntary 

consensus standards bodies. This action 

is not expected to impose technical 

standards, and whether an available and 

applicable voluntary consensus 

standard needs to be evaluated. 

J. Executive Order 12898 

This proposed rule does not have an 

adverse impact on the environmental 

and health conditions in low-income 

and minority communities that require 

special consideration by the Agency 

under Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). This document proposes to 

establish procedures for satisfying 

existing regulatory requirements 

through electronic reporting. It would 

not affect the level of protection 

provided to human health or the 

environment. 

List of Subjects in 40 CFR Parts 712, 

716, 720, 721, 723, 725, 766, 790, 799 

Environmental protection, 

Administrative practice and procedure, 

Business and industry, Chemicals, 

Reporting and recordkeeping. 

Dated: March 30, 2012. 

Louise P. Wise, 

Acting Assistant Administrator, Office of 

Chemical Safety and Pollution Prevention. 

Therefore, it is proposed that 40 CFR 

chapter I be amended as follows: 

PART 712—[AMENDED] 

1. The authority citation for part 712 

continues to read as follows: 

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

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

and (r) to read as follows: 

§ 712.3 Definitions. 

* * * * * 

(q) Central Data Exchange or CDX 

means EPA’s centralized electronic 

document receiving system, or its 

successors. 

(r) Chemical Information Submission 

System or CISS means EPA’s electronic, 

web-based reporting tool for the 

completion and submission of data, 

reports, and other information 

associated with TSCA sections 4 and 8. 

3. In § 712.28, revise paragraphs (c) 

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

read as follows: 

§ 712.28 Form and instructions. 

* * * * * 

(c) Information to be reported. 

Persons authorized to report 

information under this subpart must 

include the following information on 

Form 7710–35, Manufacturer’s Report— 

Preliminary Assessment Information 

(Manufacturer’s Report): 

(1) A technical certification statement 

signed and dated by an authorized 

person located at the plant site or 

corporate headquarters of the 

respondent company. 

(2) A confidentiality statement signed 

and dated by an authorized person 

located at the plant site or corporate 

headquarters of the respondent 

company. 

(3) The specific chemical name and 

Chemical Abstracts Service (CAS) 

Registry Number listed in 40 CFR 

712.30. 

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

State, ZIP code, and telephone number 

of a person who is submitting the form, 

which may be a person located at a 

plant site or corporate headquarters that 

will serve as the respondent, and will be 

able to answer questions about the 

information submitted by the company 

to EPA. A respondent to this subpart 

must include the appropriate Dun and 

Bradstreet Number for each plant site 

reported. 

(5) The plant site activities, such as 

the manufacturing of a chemical 

substance, including the total quantity 

of the chemical substance (in kilograms) 

imported in bulk during the reporting 

period. 

(6) The total number of workers and 

total worker-hours in each process 

category, which includes enclosed 

process, controlled release process, and 

open process. 

(7) The information related to 

chemical substance processing by 

customers, including customers’ use in 

industrial and consumer products, the 

market names under which the 

chemical substance is manufactured or 

imported, and the customer’s process 

categories that are sold to customers for 

further processing. 

(d) Persons must use CISS to complete 

and submit Form 7710–35, 

Manufacturer’s Report, (40 CFR part 

712, subpart B) and accompanying 

letters, via CDX. Submission requires 

registration with CDX, and must be 

made only as set forth in this section. 

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

cdx.epa.gov/ssl/CSPP/ 

PrimaryAuthorizedOfficial/Home.aspx 

and follow the appropriate links and for 

further instructions go to 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 


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method specified in § 712.28(d) prior to 

the reporting deadline. 

(ii) The respondent has previously 

submitted a Manufacturer’s Report on a 

chemical substance or mixture subject 

to subpart B of this part to the 

Interagency Testing Committee, but not 

to EPA, and that Manufacturer’s Report 

contained data for a 1-year period 

ending less than 3 years prior to the 

effective date described in paragraph 

(a)(2) of this section. Respondents 

meeting this condition must submit a 

copy of the Manufacture’s Report, in 

accordance with the method specified 

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

an accompanying letter, also in 

accordance with the methods specified 

in § 712.28(d), notifying EPA of the 

respondent’s intent that the submission 

be used in lieu of a current 

Manufacturer’s Report. The notification 

letter must verify the completeness and 

current accuracy of the voluntarily 

submitted data. 

* * * * * 

(c) * * * 

(2) You must submit the information 

using the method specified in 

§ 712.28(d). 

* * * * * 

PART 716—[AMENDED] 

5. The authority citation for part 716 

continues to read as follows: 

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

6. In § 716.3, add the following 

definitions in alphabetical order to read 

as follows: 

§ 716.3 Definitions. 

* * * * * 

Central Data Exchange or CDX means 

EPA’s centralized electronic document 

receiving system, or its successors. 

Chemical Information Submission 

System or CISS means EPA’s electronic, 

web-based tool for the completion and 

submission of data, reports, and other 

information. 

* * * * * 

7. In § 716.30, revise paragraph (c) 

and add new paragraph (d) to read as 

follows: 

§ 716.30 Submission of copies of studies. 

* * * * * 

(c) Persons must use CISS to complete 

and submit all data, reports, and other 

information required by 40 CFR part 

716, via CDX. Submission requires 

registration with CDX, and must be 

made only as set forth in this section. 

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

cdx.epa.gov/ssl/CSPP/ 

PrimaryAuthorizedOfficial/Home.aspx 

and follow the appropriate links and for 

further instructions to go 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 CISS to complete 

and submit all data, reports, and other 

information required by 40 CFR part 

716, via CDX. Submission requires 

registration with CDX, and must be 

made only as set forth in this section. 

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

cdx.epa.gov/ssl/CSPP/ 

PrimaryAuthorizedOfficial/Home.aspx 

and follow the appropriate links and for 

further instructions to go http:// 

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

index.html. 

9. In § 716.40, revise the introductory 

text of the section to read as follows: 

§ 716.40 EPA requests for submission of 

further information. 

EPA may request a person to submit 

or make available for review the 

following information after the initial 

reporting under §§ 716.30 and 716.35. If 

the requested submissions are not made, 

EPA may subpoena them under TSCA 

section 11, 15 U.S.C. 2610. 

* * * * * 

10. In § 716.55, revise paragraph (b)(3) 

to read as follows: 

§ 716.55 Confidentiality claims. 

* * * * * 

(b) * * * 

(3) Failure to furnish a second copy 

when information is claimed as 

confidential in the first copy will be 

considered a presumptive waiver of the 

claim of confidentiality. EPA will notify 

the respondent that a finding of a 

presumptive waiver of the claim of 

confidentiality has been made. The 

respondent will be given 30 days from 

the date of his or her receipt of this 

notification to submit the required 

second copy. If the respondent fails to 

submit the second copy within the 30 

days, EPA will place the first copy in 

the public docket. 

* * * * * 

11. In § 716.60, revise paragraphs (a), 

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

paragraph (e) to read as follows: 

§ 716.60 Reporting schedule. 

(a) General requirements. Except as 

provided in § 716.5 and paragraphs (b) 

and (c) of this section, submissions 

under §§ 716.30 and 716.35 must be 

submitted using the electronic method 

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

on or before 60 days after the effective 

date of the listing of a substance or 

mixture in § 716.120 or within 60 days 

of proposing to manufacture (including 

import) or process a listed substance or 

listed mixture (including as a known 

byproduct) if first done after the 

effective date of the substance or 

mixture being listed in § 716.120. 

(b) * * * 

(2) Submission of copies of completed 

studies. Persons must submit studies 

listed as ongoing or initiated under 

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

of completing the study, using the 

method specified in §§ 716.30(c) and 

716.35(c). 

(c) Requests for extensions of time. 

Respondents who cannot meet a 

deadline under this section may apply 

for a reasonable extension of time. 

Respondents may request an extension 

under this section. Extension requests 

must be submitted on or before 40 days 

after the effective date of the listing of 

a substance or mixture in § 716.120, 

using the electronic method specified in 

§§ 716.30(c) and 716.35(c). EPA’s 

Director of the Office of Pollution 

Prevention and Toxics will grant or 

deny extension requests. 

(d) Submission methods. Persons 

must use CISS to complete and submit 

all data, reports, and other information 

required by 40 CFR part 716, via CDX. 

Submission requires registration with 

CDX, and must be made only as set forth 

in this section. 

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

cdx.epa.gov/ssl/CSPP/ 

PrimaryAuthorizedOfficial/Home.aspx 

and follow the appropriate links and for 

further instructions to go http:// 

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

index.html. 

12. In § 716.105, revise paragraph (d) 

and add new paragraph (e) to read as 

follows: 

§ 716.105 Additions of substances and 

mixtures to which this subpart applies. 

* * * * * 

(d) Persons who wish to submit 

information that shows why a substance 

should be withdrawn must submit their 

comments by using CISS to complete 

and submit all data, reports, and other 

information required by 40 CFR part 

716, via CDX. Submission requires 

registration with CDX, and must be 

made only as set forth in this section. 

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

cdx.epa.gov/ssl/CSPP/ 

PrimaryAuthorizedOfficial/Home.aspx 

and follow the appropriate links and for 

further instructions to go http:// 

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

index.html. 


wreier-aviles on DSK5TPTVN1PROD with PROPOSALS
22716 Federal Register / Vol. 77, No. 74 / Tuesday, April 17, 2012 / Proposed Rules 

PART 720—[AMENDED] 

13. The authority citation for part 720 

continues to read as follows: 

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

14. In § 720.40: 

i. Remove paragraphs (a)(2)(i) and 

(a)(2)(ii). 

ii. Redesignate paragraphs (a)(2)(iii) 

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

(a)(2)(ii). 

iii. Revise newly redesignated 

paragraph (a)(2)(i). 

iv. Revise paragraph (c). 

The amendments read as follows: 

§ 720.40 General. 

(a) * * * 

(2) * * * 

(i) Submission via CDX. TSCA section 

5 notices and any related support 

documents must be submitted 

electronically to EPA via CDX. Prior to 

submission to EPA via CDX, such 

notices must be generated and 

completed on EPA Form 7710–25 using 

e-PMN software. To obtain a version of 

e-PMN software that contains an 

encryption module you must register 

with CDX. A version without encryption 

may be downloaded without registering 

with CDX. 

* * * * * 

(c) Where to submit a notice or 

support documents. For submitting 

notices or support documents via CDX, 

use the e-PMN software. 

* * * * * 

15. In § 720.75, revise paragraphs 

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

§ 720.75 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)(iv) for information on 

how to obtain e-PMN software. 

* * * * * 

(e) Withdrawal of a notice by the 

submitter. (1)(i) A submitter may 

withdraw a notice during the notice 

review period by submitting a statement 

of withdrawal in a manner set forth in 

this paragraph. The withdrawal is 

effective upon receipt by EPA of the 

CDX submission. 

(ii) Submission of withdrawal notices. 

EPA will accept statements of 

withdrawal only if submitted in 

accordance with this paragraph. 

Statements of withdrawal must be 

generated, completed, and submitted to 

EPA (via CDX) using e-PMN software. 

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

how to obtain e-PMN software. 

* * * * * 

16. In § 720.102. 

i. Remove paragraph (d)(1). 

ii. Designate the introductory text of 

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

iii. Revise paragraph (d)(2). 

The amendments read as follows: 

§ 720.102 Notice of commencement of 

manufacture or import. 

* * * * * 

(d) * * * 

(2) Submission of notice of 

commencement. EPA will accept 

notices of commencement only if 

submitted in accordance with this 

paragraph. All notices of 

commencement must be submitted 

electronically to EPA via CDX. Prior to 

submission to EPA via CDX, such 

notices of commencement must be 

generated and completed using e-PMN 

software. See § 720.40(a)(2)(ii) for 

information on how to obtain e-PMN 

software. 

PART 721—[AMENDED] 

17. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

18. In § 721.30, revise paragraph (b) 

introductory text to read as follows: 

§ 721.30 EPA approval of alternative 

control measures. 

* * * * * 

(b) Persons submitting a request for a 

determination of equivalency to EPA 

under this part must submit the request 

to EPA via CDX using e-PMN software 

in the manner set forth in 40 CFR 

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

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

to obtain e-PMN software. Support 

documents related to these requests 

must be submitted in the manner set 

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

a determination of equivalency must 

contain: 

* * * * * 

19. In § 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 

using e-PMN software in the manner set 

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

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

how to obtain the e-PMN software. 

Support documents related to these 

requests must also be submitted to EPA 

in the manner set forth in 40 CFR 

720.40(c). 

* * * * * 

PART 723—[AMENDED] 

20. The authority citation for part 723 

continues to read as follows: 

Authority: 15 U.S.C. 2604. 

21. In § 723.50, revise paragraph (e)(1) 

to read as follows: 

§ 723.50 Chemical substances 

manufactured in quantities of 10,000 

kilograms or less per year, and chemical 

substances with low environmental 

releases and human exposures. 

* * * * * 

(e) * * * 

(1) A manufacturer applying for an 

exemption under either paragraph (c)(1) 

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

exemption notice to EPA at least 30 

days before manufacture of the new 

chemical substance begins. Exemption 

notices and modifications must be 

submitted to EPA on EPA Form No. 

7710–25 via CDX using e-PMN software 

in the manner set forth in this 

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

for information on how to obtain e-PMN 

software. Notices and any related 

support documents, must be generated 

and completed (via CDX) using e-PMN 

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

information on how to obtain e-PMN 

software. 

* * * * * 

PART 725—[AMENDED] 

22. The authority citation for part 725 

continues to read as follows: 

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

2625. 

23. In § 725.25, revise paragraph (c) to 

read as follows: 

§ 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 


wreier-aviles on DSK5TPTVN1PROD with PROPOSALS
Federal Register / Vol. 77, No. 74 / Tuesday, April 17, 2012 / Proposed Rules 22717 

be submitted in a manner set forth in 

this paragraph. MCANs and exemption 

requests, and any related support 

documents, must be generated, 

completed, and submitted to EPA (via 

CDX) using e-PMN software. See 40 CFR 

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

to obtain e-PMN software. 

* * * * * 

24. In § 725.54, revise paragraphs (b) 

and (d) to read as follows: 

§ 725.54 Suspension of the review period. 

* * * * * 

(b)(1) Request for suspension. A 

request for suspension may only be 

submitted in a manner set forth in this 

paragraph. The request for suspension 

also may be made orally, including by 

telephone, to the submitter’s EPA 

contact for that notice, subject to 

paragraph (c) of this section. 

(2) Submission of suspension notices. 

EPA will accept requests for suspension 

only if submitted in accordance with 

this paragraph. Requests for suspension, 

must be generated, completed, and 

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

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

to obtain e-PMN software. 

* * * * * 

(d) If the submitter has not made a 

previous oral request, the running of the 

notice review period is suspended as of 

the date of receipt of the CDX 

submission by EPA. 

25. In § 725.60, revise paragraph (a) to 

read as follows: 

§ 725.60 Withdrawal of submission by the 

submitter. 

(a)(1) Withdrawal of notice by the 

submitter. A submitter may withdraw a 

notice during the notice review period 

by submitting a statement of withdrawal 

in a manner set forth in this paragraph. 

The withdrawal is effective upon receipt 

of the CDX submission by EPA. 

(2) Submission of withdrawal notices. 

EPA will accept statements of 

withdrawal only if submitted in 

accordance with this paragraph. 

Statements of withdrawal must be 

generated, completed, and submitted to 

EPA (via CDX) using e-PMN software. 

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

information on how to obtain e-PMN 

software. 

* * * * * 

26. In § 725.190, revise paragraph (d) 

to read as follows: 

§ 725.190 Notice of commencement of 

manufacture or import. 

* * * * * 

(d) How to submit. All notices of 

commencement must be generated, 

completed, and submitted to EPA (via 

CDX) using e-PMN software. See 40 CFR 

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

to obtain e-PMN software. 

27. In § 725.975, revise paragraph (b) 

introductory text to read as follows: 

§ 725.975 EPA approval of alternative 

control measures. 

* * * * * 

(b) Persons submitting a request for a 

determination of equivalency to EPA 

under this part must submit the request 

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

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

information on how to obtain e-PMN 

software. Support documents related to 

these requests must also be submitted to 

EPA via CDX using e-PMN software. A 

request for a determination of 

equivalency must contain: 

* * * * * 

28. In § 725.984, revise paragraph 

(b)(1) to read as follows: 

§ 725.984 Modification or revocation of 

certain notification requirements. 

* * * * * 

(b) * * * 

(1) Any affected person may request 

modification or revocation of significant 

new use notification requirements for a 

microorganism that has been added to 

subpart M of this part using the 

procedures described in § 725.980. The 

request must be accompanied by 

information sufficient to support the 

request. Persons submitting a request to 

EPA under this part must submit the 

request to EPA (via CDX) using e-PMN 

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

information on how to obtain e-PMN 

software. Support documents related to 

these requests must also be submitted to 

EPA via CDX using e-PMN software. 

* * * * * 

PART 766—[AMENDED] 

29. The authority citation for part 766 

continues to read as follows: 

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

30. In § 766.3, add the following 

definitions in alphabetical order to read 

as follows: 

§ 766.3 Definitions. 

* * * * * 

Central Data Exchange or CDX means 

EPA’s centralized electronic document 

receiving system, or its successors. 

Chemical Information Submission 

System or CISS means EPA’s electronic, 

web-based reporting tool for the 

completion and submission of data, 

reports, and other information. 

* * * * * 

31. Revise § 766.7 to read as follows: 

§ 766.7 Submission of information. 

(a) All information (including letters 

of intent, protocols, data, forms, studies, 

and allegations) submitted to EPA under 

this part must bear the applicable Code 

of Federal Regulations (CFR) section 

number (e.g., § 766.20) and must be 

submitted using the method specified in 

paragraph (b) of this section. 

(b) You must use CISS to complete 

and submit all data, reports, and other 

information required under this part. 

(c) Submissions must be submitted to 

EPA via CDX. 

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

cdx.epa.gov/ssl/CSPP/ 

PrimaryAuthorizedOfficial/Home.aspx 

and follow the appropriate links and for 

further instructions go to http:// 

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

index.html. 

PART 790—[AMENDED] 

32. The authority citation for part 790 

continues to read as follows: 

Authority: 15 U.S.C. 2603. 

33. In § 790.3, add the following 

definitions in alphabetical order to read 

as follows: 

§ 790.3 Definitions. 

* * * * * 

Central Data Exchange or CDX means 

EPA’s centralized electronic document 

receiving system, or its successors. 

* * * * * 

Chemical Information Submission 

System or CISS means EPA’s electronic, 

web-based tool for the completion and 

submission of data, reports, and other 

information. 

* * * * * 

34. Revise § 790.5 to read as follows: 

§ 790.5 Submission of information. 

(a) All submissions and 

correspondence to EPA under this part 

must bear the Code of Federal 

Regulations (CFR) section number of the 

subject chemical test rule or, for the 

consent agreements. 

(b) You must use CISS to complete 

and submit via CDX all data, reports, 

other information, and correspondence 

required by rules promulgated under 

TSCA section 4, and for correspondence 

pertaining to consent agreements as 

required under this part. The 

submissions must be made only as set 

forth in this section. 

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

cdx.epa.gov/ssl/CSPP/ 

PrimaryAuthorizedOfficial/Home.aspx 

and follow the appropriate links and for 

further instructions go to http:// 

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

index.html. 


wreier-aviles on DSK5TPTVN1PROD with PROPOSALS
22718 Federal Register / Vol. 77, No. 74 / Tuesday, April 17, 2012 / Proposed Rules 

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

read as follows: 

§ 790.45 Submission of letter of intent to 

conduct testing or exemption application. 

(a) No later than 30 days after the 

effective date of a test rule described in 

§ 790.40, each person subject to that test 

rule and required to comply with the 

requirements of that test rule as 

provided in § 790.42(a) must, for each 

test required, send his or her notice of 

intent to conduct testing, or submit to 

EPA an application for exemption from 

testing by the method specified in 

§ 790.5(b). 

* * * * * 

36. In § 790.48, revise paragraphs 

(a)(2), (a)(3), (b)(3), (b)(4), (b)(5), (c)(2), 

and (c)(3) to read as follows: 

§ 790.48 Procedure if no one submits a 

letter of intent to conduct testing. 

(a) * * * 

(2) If no manufacturer subject to the 

test rule has notified EPA of its intent 

to conduct one or more of the required 

tests within 30 days after the effective 

date of the test rule described in 

§ 790.40, EPA will notify all 

manufacturers, including those 

described in § 790.42(a)(4) and (a)(5), 

through CDX or by publishing a notice 

of this fact in the Federal Register 

specifying the tests for which no letter 

of intent has been submitted and will 

give such manufacturers an opportunity 

to take corrective action. 

(3) If no manufacturer submits a letter 

of intent to conduct one or more of the 

required tests within 30 days after 

receipt of EPA’s notification under 

paragraph (a)(2) of this section, all 

manufacturers subject to the test rule 

will be in violation of the test rule from 

the 31st day after receipt of the 

submission or publication of the 

Federal Register notice described in 

paragraph (a)(2) of this section. 

(b) * * * 

(3) No later than 30 days after the date 

of publication of the Federal Register 

notice described in paragraph (b)(2) of 

this section, each person described in 

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

processing the subject chemical as of the 

effective date of the test rule described 

in § 790.40 or by 30 days after the date 

of publication of the Federal Register 

notice described in paragraph (b)(2) of 

this section must, for each test specified 

in the Federal Register notice, either 

notify EPA of his or her intent to 

conduct testing, or submit to EPA an 

application for an exemption from 

testing requirements for the test. Each 

such notification to conduct testing or 

application for exemption from testing 

must be submitted to EPA by the 

method specified in § 790.5(b). 

(4) If no manufacturer or processor of 

the test chemical has submitted a letter 

of intent to conduct one or more of the 

required tests within 30 days after the 

date of publication of the Federal 

Register notice described in paragraph 

(b)(2) of this section, EPA will notify all 

manufacturers and processors through 

CDX or publish a Federal Register 

notice of this fact specifying the tests for 

which no letter of intent has been 

submitted. The CDX notification or 

Federal Register notice will give the 

manufacturers and processors an 

opportunity to take corrective action. 

(5) If no manufacturer or processor 

submits a letter of intent to EPA through 

CDX within 30 days after either receipt 

of the CDX notification from EPA under 

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

manufacturers and processors subject to 

the test rule will be in violation of the 

test rule from the 31st day after receipt 

of such notification or publication of the 

Federal Register notice. 

(c) * * * 

(2) If no processor subject to the test 

rule has notified EPA through CDX of its 

intent to conduct one or more of the 

required tests within 30 days after the 

effective date of the test rule described 

in § 790.40, EPA will notify all the 

processors through CDX or publish a 

notice in the Federal Register of this 

fact, specifying the tests for which no 

letter of intent has been submitted and 

to give the processors an opportunity to 

take corrective action. 

(3) If no processor submits a letter of 

intent through CDX to conduct one or 

more of the required tests within 30 

days after receipt of the Agency’s 

notification under paragraph (c)(2) of 

this section, all processors subject to the 

test rule will be in violation of the test 

rule from the 31st day after receipt of 

the CDX notification or publication of 

the Federal Register notice described in 

paragraph (c)(2) of this section. 

37. In § 790.50, revise paragraphs 

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

§ 790.50 Submission of study plans. 

* * * * * 

(b) * * * 

(1) EPA may grant requests for 

additional time for the development of 

study plans on a case-by-case basis. 

Requests for additional time for study 

plan development must be submitted to 

EPA by the method specified in 

§ 790.5(b). Any extension request must 

state why EPA should grant the 

extension. 

* * * * * 

(3) EPA will notify the submitter of 

EPA’s decision to grant or deny an 

extension request through CDX. 

* * * * * 

(e) Amendments to study plans. Test 

sponsors must submit all amendments 

by the method specified in § 790.5(b). 

38. In § 790.55, revise paragraphs (a) 

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

§ 790.55 Modification of test standards or 

schedules during conduct of test. 

(a) Application. Any test sponsor who 

wishes to modify the test schedule for 

the mandatory testing conditions or 

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

the test standard for any test required by 

a test rule must submit an application 

in accordance with this paragraph. 

Application for modification must be 

made by the method specified in 

§ 790.5(b). Applications must include an 

appropriate explanation and rationale 

for the modification. Where a test 

sponsor requests EPA to provide 

guidance or to clarify a non-mandatory 

testing requirement (i.e., ‘‘should 

statements’’) in a test standard, the test 

sponsor must submit these requests to 

EPA by the method format specified in 

§ 790.5(b). 

(b) * * * 

(2) Where, in EPA’s judgment, the 

requested modification of the test 

standard or schedule would not alter the 

scope of the test or significantly change 

the schedule for completing the test, 

EPA will not ask for public comment 

before approving the modification. EPA 

will notify the test sponsor of EPA’s 

decision via CDX. EPA will place copies 

of each application and EPA approval 

notification in the docket for the test 

rule in question. EPA will publish a 

notice annually in the Federal Register 

indicating the test standards or 

schedules for tests required in test rules 

which have been modified under this 

paragraph (b)(2) and describing the 

nature of the modifications. Until the 

Federal Register notice is published, 

any modification approved by EPA 

under paragraph (b)(2) of this section 

shall apply only to the test sponsor who 

applied for the modification under 

paragraph (a) of this section. 

* * * * * 

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

to read as follows: 

§ 790.62 Submission of study plans and 

conduct of testing. 

* * * * * 

(c) * * * 

(4) The test sponsor shall submit any 

amendments to study plans to EPA 

using the method specified in § 790.5(b). 

* * * * * 


wreier-aviles on DSK5TPTVN1PROD with PROPOSALS
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40. In § 790.68, revise paragraphs 

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

§ 790.68 Modification of consent 

agreements. 

* * * * * 

(b) * * * 

(1) Any test sponsor who wishes to 

modify the test schedule for any test 

required under a consent agreement 

must submit an application in 

accordance with this paragraph. 

Application for modification must be 

made using the method specified in 

§ 790.5(b). Applications must include an 

appropriate explanation and rationale 

for the modification. EPA will consider 

only those applications that request 

modifications to mandatory testing 

conditions or requirements (‘‘shall 

statements’’ in the consent agreement). 

Where a test sponsor requests EPA to 

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

‘‘should statements’’), the test sponsor 

shall submit these requests to EPA using 

the method specified in § 790.5(b). 

(2) * * * 

(ii) Where, in EPA’s judgment, the 

requested modification of a test 

standard or schedule would not alter the 

scope of the test or significantly change 

the schedule for completing the test, 

EPA will not ask for public comment 

before approving the modification. EPA 

will notify the test sponsor and any 

other persons who have signed the 

consent agreement through CDX of 

EPA’s approval. EPA will place copies 

of each application and EPA approval 

notification in the docket maintained for 

the consent agreement in question. EPA 

will publish a notice annually in the 

Federal Register indicating the test 

standards or schedules for test required 

in consent agreements which have been 

modified under paragraph (b)(2)(ii) of 

this section and describing the nature of 

the modifications. 

* * * * * 

41. In § 790.87, revise paragraphs 

(b)(2)(i), (b)(2)(ii), and (c) to read as 

follows: 

§ 790.87 Approval of exemption 

applications. 

* * * * * 

(b) * * * 

(2) * * * 

(i) If EPA finds an equivalence claim 

to be in error or inadequately supported, 

the applicant will be notified through 

CDX. The applicant will be given 15 

days to provide clarifying information. 

(ii) Exemption applicants will be 

notified through CDX that equivalence 

has been accepted or rejected. 

(c)(1) EPA will give exemption 

applicants final notice that they have 

received a conditional exemption 

through one of the following ways: 

(i) A final Phase II test rule that 

adopts the study plans in a two-phase 

rulemaking. 

(ii) A separate Federal Register notice 

in a single-phase rulemaking. 

(iii) CDX. 

(2) All conditional exemptions thus 

granted are contingent upon the test 

sponsors’ successful completion of 

testing according to the specifications of 

the test rule. 

42. In § 790.88, revise paragraph (b) to 

read as follows: 

§ 790.88 Denial of exemption application. 

* * * * * 

(b) EPA will notify the exemption 

applicant through CDX or by a Federal 

Register notice of EPA’s determination 

that the exemption application is 

denied. 

43. In § 790.90, revise paragraph (c)(2) 

to read as follows: 

§ 790.90 Appeal of denial of exemption 

application. 

* * * * * 

(c) * * * 

(2) Hearing requests must be 

submitted using the method specified in 

§ 790.5(b) and be received by EPA 

within 30 days of receipt of the 

Agency’s notification under § 790.88(b). 

Hearing requests must provide reasons 

why a hearing is necessary. 

* * * * * 

44. In § 790.93, revise paragraphs (b), 

(c), (d)(2), and (e) to read as follows: 

§ 790.93 Termination of conditional 

exemption. 

* * * * * 

(b) If EPA determines that one or more 

of the criteria listed in paragraph (a) of 

this section has been met, EPA will 

notify each holder of an affected 

conditional exemption through CDX or 

a Federal Register notice of EPA’s intent 

to terminate that conditional exemption. 

(c) Within 30 days after receipt of 

notification under paragraph (b) of this 

section that EPA intends to terminate a 

conditional exemption, the exemption 

holder may submit information using 

the method specified in § 790.5(b) either 

to rebut EPA’s preliminary decision or 

notify EPA of its intent to conduct the 

required test pursuant to the test 

standard established in the test rule. 

Such a letter of intent shall contain all 

of the information required by 

§ 790.45(c). 

(d) * * * 

(2) Hearing requests must be 

submitted using the method specified in 

§ 790.5(b) and must be received by EPA 

within 30 days after receipt of the CDX 

notification or after publication of a 

notice in the Federal Register as 

described in paragraph (b) of this 

section. 

(e) EPA will notify the exemption 

holder through CDX or by Federal 

Register notice of EPA’s final decision 

concerning termination of conditional 

exemptions and will give instructions as 

to what actions the former exemption 

holder must take to avoid being found 

in violation of the test rule. 

45. In § 790.97, revise paragraphs (a) 

and (c) to read as follows: 

§ 790.97 Hearing procedures. 

(a) Hearing requests must be 

submitted using the method specified in 

§ 790.5(b). Such requests must include 

the applicant’s basis for appealing EPA’s 

decision. 

* * * * * 

(c) EPA will notify each applicant of 

EPA’s decision through CDX within 60 

days after the hearing. 

PART 799—[AMENDED] 

46. The authority citation for part 799 

continues to read as follows: 

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

47. Revise § 799.5 to read as follows: 

§ 799.5 Submission of information. 

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

plans, or reports) submitted to EPA 

must be submitted using the method 

specified in paragraph (b) of this 

section. All information submitted 

under this part must bear the Code of 

Federal Regulations (CFR) section 

number of the subject chemical test rule 

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

(b) You must use CISS to complete 

and submit all data, reports, and other 

information required under this part. 

Submissions must be submitted to EPA 

via CDX. 

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

cdx.epa.gov/ssl/CSPP/ 

PrimaryAuthorizedOfficial/Home.aspx 

and follow the appropriate links and for 

further instructions to go http:// 

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

index.html. 

[FR Doc. 2012–8937 Filed 4–16–12; 8:45 am] 

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