Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations 773 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes, or otherwise have any unique 

impacts on local governments. Thus, the 

Agency has determined that Executive 

Order 13132, entitled Federalism (64 FR 

43255, August 10, 1999) and Executive 

Order 13175, entitled Consultation and 

Coordination with Indian Tribal 

Governments (65 FR 67249, November 

9, 2000) do not apply to this final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Public 

Law 104–4). 

Although this action does not require 

any special considerations under 

Executive Order 12898, entitled Federal 

Actions to Address Environmental 

Justice in Minority Populations and 

Low-Income Populations (59 FR 7629, 

February 16, 1994), EPA seeks to 

achieve environmental justice, the fair 

treatment and meaningful involvement 

of any group, including minority and/or 

low-income populations, in the 

development, implementation, and 

enforcement of environmental laws, 

regulations, and policies. As such, to the 

extent that information is publicly 

available or was submitted in comments 

to EPA, the Agency considered whether 

groups or segments of the population, as 

a result of their location, cultural 

practices, or other factors, may have 

atypical or disproportionately high and 

adverse human health impacts or 

environmental effects from exposure to 

the pesticide discussed in this 

document, compared to the general 

population. 

XI. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this rule in the Federal 

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

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: December 7, 2009. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In §180.960, the table is amended 

by adding alphabetically the following 

polymers to read as follows: 

§ 180.960 Polymers; exemptions from the 

requirement of a tolerance. 

* * * * * 

Polymer CAS No. 

* * * * * 

Acrylic acid-benzyl 

methacrylate-1- 

propanesulfonic 

acid, 2-methyl-2- 

[(1-oxo-2-propenyl)amino]-, 

monosodium salt, 

minimum number 

average molecular 

weight (in amu), 

1500.

1152297-42-1 

* * * * * 

[FR Doc. E9–31174 Filed 1–5–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 700, 720, 721, 723, and 

725 

[EPA–HQ–OPPT–2008–0296; FRL–8794–5] 

RIN 2070–AJ41 

TSCA Section 5 Premanufacture and 

Significant New Use Notification 

Electronic Reporting; Revisions to 

Notification Regulations 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is amending Toxic 

Substances Control Act (TSCA) section 

5 reporting regulations at 40 CFR parts 

700, 720, 721, 723, and 725. The 

amendments establish electronic 

reporting requirements for TSCA section 

5 submissions. This action is intended 

to streamline and reduce the 

administrative costs and burdens of 

TSCA section 5 notifications for both 

industry and EPA by establishing 

standards and requirements for the use 

of EPA’s Central Data Exchange (CDX) 

to electronically submit premanufacture 

notices (PMNs) and other TSCA section 

5 notices and support documents to the 

Agency. EPA is also amending TSCA 

section 5 user fee regulations by adding 

a new User Fee Payment Identity 

Number field to the PMN form, to 

enable the Agency to match more easily 

a particular user fee with its notice 

submission. Lastly, EPA is amending 

the PMN form by removing the Agent 

signature block field, and thus the 

requirement for designated agents to 

sign the form. 

DATES: This final rule is effective April 

6, 2010. 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPPT–2008–0296. 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., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket 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. 


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774 Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations 

FOR FURTHER INFORMATION CONTACT: For 

general information contact: Colby 

Lintner, Regulatory Coordinator, 

Environmental Assistance Division 

(7408M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (202) 554–1404; e-mail address: 

TSCA-Hotline@epa.gov. 

For technical information contact: 

Greg Schweer, Chemical Control 

Division (7405M), Office of Pollution 

Prevention and Toxics, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001; telephone number: (202) 564– 

8469; e-mail address: 

schweer.greg@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Does this Action Apply to Me? 

You may be affected by this action if 

you manufacture, import, or process 

chemical substances for commercial 

purposes that are subject to TSCA. 

Potentially affected entities may 

include, but are not limited to: 

• Manufacturers, importers, and 

processors of chemical substances or 

mixtures (NAICS codes 325 and 324110, 

e.g., chemical manufacturing and 

processing and petroleum refineries). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

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. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions in 

40 CFR parts 700, 720, 721, 723, and 

725 for TSCA section 5–related 

obligations. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the 

technical person listed under FOR

FURTHER INFORMATION CONTACT. 

II. Background 

A. What Action is the Agency Taking? 

EPA is issuing these amendments 

pursuant to TSCA section 5, 15 U.S.C. 

2604. The amendments are to the TSCA 

Section 5 Premanufacture and 

Significant New Use Notification 

regulations and related provisions. This 

final rule was proposed in the Federal 

Register issue of December 22, 2008 

(Ref. 1). The purpose of the amendments 

is to require use of an electronic 

reporting mechanism for TSCA section 

5 notices. 

The Government Paperwork 

Elimination Act (GPEA) (Public Law 

105–277 (44 U.S.C. 3504)) requires 

Federal agencies to provide for the: 

1. Option of electronic maintenance, 

submission, or disclosure of 

information, when practicable as a 

substitute for paper. 

2. Use and acceptance of electronic 

signatures, when practicable. EPA’s 

Cross-Media Electronic Reporting 

Regulation (CROMERR) (40 CFR part 3), 

published in the Federal Register issue 

of October 13, 2005 (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 publishes a 

notice that electronic document 

submission is available for that 

requirement (See Unit III.F. for more 

information on electronic signatures.). 

In light of GPEA and CROMERR, EPA 

is issuing these amendments to require 

manufacturers (including importers) 

and processors of TSCA chemical 

substances to use the Internet, through 

EPA’s CDX, to submit TSCA section 5 

notices and related documents to the 

Agency. These include PMNs (40 CFR 

part 720), Significant New Use Notices 

(SNUNs) (40 CFR part 721), Test Market 

Exemption Applications (TMEAs) (40 

CFR part 720), Low Volume Exemption 

notices (LVEs) (40 CFR 723.50), Low 

Exposure/Low Release Exemption 

(LoRex) notices (40 CFR 723.50), 

biotechnology notices for genetically 

modified microorganisms (40 CFR part 

725), Notices of Commencement of 

Manufacture or Import (NOCs) (40 CFR 

720.102), and other support documents 

(e.g., correspondence, requests for 

suspensions of the notice review period, 

amendments, and test data). 

The Agency is introducing CDX 

reporting in three phases over a 2–year 

period. During the first year following 

the effective date of this final rule, the 

Agency will allow submissions via CDX, 

optical disc (CD or DVD), and paper. 

Regardless of the method of submission, 

EPA will require that all submissions be 

generated using the new electronic-PMN 

(e-PMN) software. One year after the 

effective date of this final rule, paper 

submissions will no longer be accepted 

for any new notices and support 

documents (including NOCs), though 

optical discs may continue to be used. 

Two years after the effective date of this 

final rule, optical discs will no longer be 

accepted, and all submitters must 

submit the notices and support 

documents identified in Table 1 of Unit 

III.I. via CDX. The phased approach 

allows submitters to gain experience in 

using the e-PMN software and the 

submission delivery system. 

EPA is also amending the TSCA 

section 5 User Fee regulations at 40 CFR 

700.45 to add a new User Fee Payment 

Identity Number field to the PMN form. 

This new field will enable the Agency 

to more easily match a particular user 

fee with its notice submission. The 

second new information element on the 

amended PMN form will be optional 

and consist simply of the e-mail address 

for the Authorized Official (AO) 

submitting the notice listed on the 

‘‘Submitter Identification’’ section on 

page 3 of the PMN form. EPA is also 

removing the required Agent signature 

block field on page 2 of the form. 

B. What is the Agency’s Authority for 

Taking this Action? 

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 

substance that is not on the TSCA 

Inventory of Chemical Substances 

compiled by EPA under section 8(b) of 

TSCA. 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 rule 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 notice to EPA at least 90 

days before manufacturing or processing 

the chemical substance for that use. 

GPEA requires Federal agencies to 

provide for the: 

1. Option of electronic maintenance, 

submission, or disclosure of 

information, when practicable as a 

substitute for paper. 

2. Use and acceptance of electronic 

signatures, when practicable. 

C. How are Premanufacture Notices and 

Other TSCA Section 5 Notices Currently 

Submitted and Processed by the 

Agency? 

Currently, TSCA section 5 

submissions must be sent to EPA on 

paper through the U.S. mail or delivered 

by courier. Submitters are able to use 

electronic means to generate hard copies 

for certain TSCA section 5 notices, 

using the PMN form available on EPA’s 

TSCA New Chemicals Program website 

(https://cdx.epa.gov/ssl/pmn/ 

download.asp). The form can be filled 

out using the free Adobe Reader, which 


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allows submitters to complete the form 

electronically and then print out and 

mail it to EPA as hard copy. The Adobe 

Reader allows the user to complete and 

print the form, but it does not allow the 

user to save the form. Approximately 

35% of TSCA section 5 notices are 

currently generated using this software. 

Most of the remaining submissions are 

generated using other software that has 

been developed by industry trade 

groups or individual notice submitters. 

A very small percentage of submitters 

choose to fill out the PMN form by hand 

or typewriter, using a version of the 

form downloaded from EPA’s TSCA 

New Chemicals Program website (See 

http://www.epa.gov/opptintr/ 

newchems/pubs/pmnpart1.pdf and 

http://www.epa.gov/opptintr/ 

newchems/pubs/pmnpart2.pdf.). 

If the submitter marks anything on the 

PMN form as CBI, then the submitter 

must submit one version of the form 

containing the CBI and another version 

of the form without CBI. The latter 

version is referred to as the sanitized or 

non-CBI version and is required for the 

public docket. 

Upon receipt at EPA, paper 

submissions are assigned a ‘‘mail 

received’’ number, which is used to 

identify the submission until an official 

document control number (DCN) is 

generated, which does not occur until 

EPA verifies that the notice is complete. 

Once the mail information is captured, 

the submission is sent for prescreening. 

During prescreening, the submission is 

checked for completeness using criteria 

listed at 40 CFR 720.65. If the notice 

does not pass prescreening, EPA 

declares the original notice 

‘‘Incomplete’’ and notifies the submitter 

that information is missing or incorrect, 

and that the submitter must correct the 

package and provide a new submission 

to EPA. If a new notice is not submitted, 

EPA will return the user fee. 

After a successful prescreening, EPA 

generates a DCN and barcode for the 

submission. EPA also generates a DCN 

and barcode for the non-CBI version of 

a CBI submission and places the nonCBI version in the public docket. The 

original CBI submission is then kept in 

a hard copy case file folder in a TSCA 

CBI storage area for reference. Any 

supporting documents for the CBI 

submission are also assigned DCNs and 

barcodes, and placed in the hard copy 

case file folder. 

III. Description of Changes for TSCA 

Section 5 Reporting 

This unit provides a detailed 

description of EPA’s electronic 

reporting software, the changes to the 

reporting process, the benefits of 

electronic reporting to both industry 

and EPA, and how EPA is phasing-in 

the electronic reporting. 

A. What is CDX? 

EPA’s CDX is the point of entry on the 

Environmental Information Exchange 

Network (Exchange Network) for 

environmental data submissions to the 

Agency. CDX provides the capability for 

submitters to access their data through 

the use of web services. CDX enables 

EPA and participating program offices 

to work with stakeholders–including 

State, tribal, and local governments and 

regulated industries–to enable 

streamlined electronic submission of 

data via the Internet. For more 

information about CDX, go to http:// 

www.epa.gov/cdx. 

B. What is the e-PMN Software? 

EPA has developed e-PMN software 

for use in preparing and submitting 

PMNs and other TSCA section 5 notices 

and support documents electronically to 

the Agency. EPA is providing two 

different variations of the e-PMN 

software, one with encryption and one 

without encryption. The e-PMN 

software with encryption, available on 

EPA’s CDX website (http://cdx.epa.gov/ 

epa_home.asp), accommodates 

electronic submission through CDX. The 

e-PMN software without encryption is 

available through EPA’s TSCA New 

Chemicals Program website (http:// 

www.epa.gov/oppt/newchems). Both 

variations of the e-PMN software are 

available free of charge as Internet 

downloads. The e-PMN software 

without encryption will also be 

available on optical discs provided by 

the Agency upon request (See Unit III.H. 

for more details.). 

The e-PMN software works with 

Windows, Macs, Linux, and UNIXbased computers, using Extensible 

Markup Language (XML) specifications 

for more efficient data transmittal across 

the Internet. The e-PMN software 

operates using the Java 6 programming 

language, which can be downloaded 

free from http://www.java.com, if it is 

not already installed on your computer. 

The e-PMN software provides userfriendly navigation, works with CDX to 

secure on-line communication, and can 

create a completed Portable Document 

Format (PDF) file using the PMN form 

to accommodate internal company 

review prior to submission or for 

submission to EPA during the 2–year 

period before which CDX submission is 

required. 

The e-PMN software includes features 

intended to be helpful for preparing 

PMNs and other notices using the PMN 

form, such as SNUNs. A validation 

mechanism alerts users when a field on 

the form, required by regulation, is 

either missing information or contains 

certain kinds of potentially incorrect 

information. For example, if ‘‘use’’ 

information is claimed CBI, then the ePMN software indicates that the form is 

not complete unless the submitter has 

provided both specific use information 

on the CBI version of the form and 

generic use information on the non-CBI 

version of the form. The e-PMN software 

includes header pages for biotechnology 

notices (i.e., Microbial Commercial 

Activity Notices (MCANs), TSCA 

Experimental Release Applications 

(TERAs), TMEAs, and Tier I or Tier II 

Exemption Requests), support 

documents, and attachments—any 

document not submitted on the PMN 

form itself—that identify submitters and 

the nature of their communications. 

Guidance documents developed by 

EPA for TSCA section 8(a) Inventory 

Update Rule (IUR) reporting via CDX are 

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

opptintr/iur/pubs/factsheet.pdf and 

http://www.epa.gov/opptintr/iur/pubs/ 

cdx_qanda.pdf. These documents 

provide background information on 

reporting via CDX that is relevant and 

useful for TSCA section 5 reporting as 

well. EPA has developed similar 

specific guidance for TSCA section 5 

reporting via CDX, along with the ePMN submission software, available on 

EPA’s TSCA New Chemicals Program 

website (http://www.epa.gov/oppt/ 

newchems). 

C. What Are the Benefits of CDX 

Reporting and Use of the e-PMN 

Software, Compared to the Existing 

Paper Method? 

The change to phase-out paper-based 

submissions in favor of CDX reporting, 

including use of the e-PMN reporting 

software, is in concert with broader 

government efforts to move to modern, 

electronic methods of information 

gathering. The use of CDX for 

submission of TSCA section 5 notices 

and support documents is consistent 

with GPEA, that requires Federal 

agencies to provide for the: 

1. Option of electronic maintenance, 

submission, or disclosure of 

information, when practicable as a 

substitute for paper. 

2. Use and acceptance of electronic 

signatures, when practicable. 

The e-PMN software and electronic 

submission via CDX will change the 

way that companies interact with the 

Agency regarding many TSCA section 5 

submissions. Companies will register 

with EPA to submit their data 

electronically to the Agency via CDX 

and the Agency will benefit from 


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776 Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations 

receiving electronic submissions. Data 

systems that once were populated 

manually will now be populated 

electronically, reducing the potential for 

error that exists when data are entered 

by hand. 

Agency personnel will also be able to 

communicate more efficiently with 

submitters electronically, compared to 

using U.S. mail or courier services. PMN 

electronic reporting software allows for 

more efficient data transmittal, and the 

software’s validation mechanism should 

help industry users submit fewer 

incomplete notices, which ultimately 

will save EPA and industry processing 

resources and reduce transaction times. 

EPA believes the adoption of electronic 

communications will reduce the 

reporting burden on industry by 

reducing both the cost and the time 

required to review, edit, and transmit 

data to the Agency (See Unit V. for more 

detail.). It also will allow submitters to 

share a draft notice within the company 

during the creation of a notice and to 

save a copy of the final file for future 

use. A ‘‘Profiler,’’ available in the 

software, will also allow for certain 

information to be kept on file by the 

submitter to avoid re-entering the same 

information into a new form. 

Please note that although submitters 

will be able to communicate to EPA via 

CDX after the effective date of this final 

rule, the capacity will not initially be 

available for EPA to communicate back 

to submitters via CDX at the time this 

final rule becomes effective (except for 

e-mails related to CDX registration and 

copy of record notifications). Two 

examples of routine communications 

from EPA that are planned to be sent via 

CDX rather than the U.S. mail are the 

‘‘Acknowledgement Letter’’ 

(acknowledging receipt of a notice) and 

the ‘‘Incomplete Letter’’ (stating why a 

notice has been declared incomplete by 

EPA). EPA will continue sending these 

letters by paper until approximately 1 

year after the effective date of this final 

rule. EPA will issue a document in the 

Federal Register when EPA has the 

ability to send these letters 

electronically. 

All information sent by the submitter 

via CDX will be transmitted securely to 

protect CBI. Furthermore, if anything in 

the submission has been claimed CBI, a 

non-CBI copy of the notice must be 

provided by the submitter. The new ePMN software will facilitate the creation 

of this non-CBI version, eliminating the 

need for the submitter to do this 

manually. 

D. What Are the Changes to the Existing 

PMN Form? 

EPA is amending the PMN form in 

order to collect two new information 

elements. First, 40 CFR part 700 

requires submitters to pay a fee when 

they submit PMNs, MCANs, certain 

PMN exemption application notices, 

and SNUNs to the Agency. The 

amended PMN form will include a new 

User Fee Payment Identity Number field 

to enable the Agency to match more 

easily a particular user fee with a 

particular notice submission. A User 

Fee Payment Identity Number will be 

required and may be a check number, a 

wire transfer number, or a ‘‘Pay.gov’’ 

transaction number used to transmit the 

user fee electronically. The second new 

information element on the amended 

PMN form will be optional and consist 

simply of the e-mail addresses for the 

AO or AOs listed on the Submitter 

Identification section on page 3 of the 

PMN form. The e-mail address will 

enable the Agency to contact the 

submitter through e-mail, facilitating 

communications related to the 

submission. 

EPA is also removing the required 

Agent signature block field on page 2 of 

the PMN form. On the existing PMN 

form, if a manufacturer/importer subject 

to the notice requirements in 40 CFR 

part 720 designates an agent to submit 

the form pursuant to 40 CFR 720.40(e), 

both the manufacturer/importer and the 

agent must sign the form. EPA is 

removing the requirement that agents 

sign the PMN form because few agents 

have submitted forms in the past, and 

the Agent signature block is rarely used 

by the Agency. Eliminating the second 

signature also simplifies development of 

the e-PMN form. Note that a form 

submitted by an agent will still have to 

be signed by the manufacturer/ 

importer’s AO (an electronic signature if 

submitted via CDX), and the agent’s 

name and contact information will still 

be provided on page 3 of the PMN form. 

The AO remains responsible for false or 

misleading statements in the notice. 

The e-PMN software will allow users 

to print paper copies for internal 

company use. The printed version of the 

amended e-PMN form will have the 

same general look of the current paper 

PMN form, i.e., containing the same 

fields (with the modifications to the 

form discussed in Unit III.D.) and the 

same pagination. However, fields have 

been expanded to make more room for 

submitter information, resulting in a 

larger total number of pages, and 

realigned to make the form easier to 

scan. Persons who choose to submit 

PMNs on paper during the first year 

after the effective date of this final rule 

will be required to use the new e-PMN 

software to generate the paper form for 

each PMN or other TSCA section 5 

notices they submit. EPA is requiring 

use of the new paper form because the 

Agency has incorporated into the form 

many scanning efficiencies for the 

electronic capturing of data that will be 

lost if a blank PMN form is printed, 

photocopied, and used for another 

submission. 

E. How Will PMNs be Submitted via the 

Internet Using CDX? 

In order to submit TSCA section 5 

notices via the Internet, submitters will 

have to register with EPA’s CDX and use 

the e-PMN software to prepare a data 

file for submission through CDX. 

1. Registering with CDX. To register 

with CDX, the submitter can click on 

the website, http://cdx.epa.gov/ 

epa_home.asp. The submitter will be 

asked to agree to terms and conditions, 

provide information about the submitter 

and his or her organization, select a user 

name and password, and download, 

complete, and mail an electronic 

signature agreement to EPA (discussed 

further in Unit III.F.). The electronic 

signature agreement is needed to 

identify an authorized person and 

establish a method to electronically sign 

the submission. Once EPA receives the 

electronic signature agreement, the 

submitter’s user name and password 

will be activated, and only then will the 

submitter be able to send a submission 

to EPA through CDX. For planning 

purposes, please allow up to 1 week for 

EPA to process the electronic signature 

agreement and activate the submitter’s 

user name and password. 

EPA has established a 90–day timeframe between the publication date and 

effective date of this final rule. 

Companies can use this time to register 

with CDX so they are prepared to 

submit notices to EPA via CDX on the 

effective date of this final rule. 

2. Preparing the submission. All 

submitters must use the new e-PMN 

software to prepare their submissions of 

TSCA section 5 notices. EPA is 

providing two different variations of the 

e-PMN software, one with encryption 

and one without encryption. The e-PMN 

software with encryption, available on 

EPA’s CDX website (http://cdx.epa.gov/ 

epa_home.asp), accommodates 

electronic submission through CDX. The 

e-PMN software without encryption is 

available through EPA’s TSCA New 

Chemicals Program website (http:// 

www.epa.gov/oppt/newchems). Both 

variations of the e-PMN software are 

available free of charge as Internet 

downloads. The e-PMN software 


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without encryption will also be 

available on optical discs provided by 

the Agency upon request (See Unit III.H. 

for more detail.). 

The e-PMN software guides users 

through the process of creating a PMN 

submission on their computers. Once a 

user completes the relevant data entry, 

the software will validate the 

submission by performing basic error 

checks and making sure all the required 

fields are completed, allow the user to 

create and save the submission for 

company records, and prompt users to 

choose a submission method. 

3. Completing the submission to EPA. 

During the 2–year phase-in period when 

paper and/or optical disc submission 

will still be allowed, the software will, 

as appropriate, also allow the user to 

choose ‘‘Print,’’ ‘‘Save as a PDF,’’ ‘‘Save 

as an XML file’’ for a submission on an 

optical disc, or ‘‘Transmission through 

CDX.’’ While permitted, submissions 

made in paper or using an optical disc 

will need to be mailed or delivered to 

EPA in the same manner that they are 

currently. When ‘‘Transmission through 

CDX’’ is selected, the user will be asked 

to provide the user name and password 

that were created during the CDX 

registration process. The software will 

then encrypt the file and submit it via 

CDX to EPA. 

F. What is the Electronic Signature 

Agreement for the e-PMN? 

In order to submit electronically to 

EPA via CDX, submitters of all TSCA 

section 5 documents must first register 

with CDX. One must register either as: 

1. An AO of a company who can send 

all types of TSCA section 5 documents 

to EPA via CDX or 

2. Someone authorized by the AO to 

send TSCA section 5 supporting 

documents to EPA via CDX. Note, 

however, that AOs are the only persons 

allowed to send TSCA section 5 notices 

and Letters of Support to EPA via CDX. 

There are two ways that joint 

submissions can be submitted to EPA 

via CDX. The first way is for each joint 

submitter to fill out his or her portion 

of the submission in separate notice 

forms. These forms are linked to each 

other within EPA via a common 

identifying number—a ‘‘TS’’ number 

(See regulatory text language in 40 CFR 

700.45(e)(3).)—which both companies 

are required to develop together and put 

on their respective forms. The second 

way is for one of the joint submitters to 

provide supporting information in a 

Letter of Support. Both will require the 

AOs of the joint submitting companies 

to register in order to submit to EPA via 

CDX. 

To register in CDX, the CDX registrant 

(also referred to as ‘‘Electronic Signature 

Holder’’ or ‘‘Public/Private Key 

Holder’’) downloads two forms: The 

Electronic Signature Agreement and the 

‘‘Verification of Company Authorizing 

Official’’ form. Registration enables CDX 

to perform two important functions: 

Authentication of identity and 

verification of authorization. Within the 

‘‘Electronic Signature Agreement’’ form, 

the AO agrees to certain CDX security 

conditions. On the ‘‘Verification of 

Company Authorizing Official’’ form, 

the AO designates himself or herself as 

the AO and attests to the completeness 

and accuracy of the submitted 

information. 

There is a third form generated by 

CDX that the AO needs to fill out if the 

AO wants to authorize other persons to 

submit support documents on his or her 

behalf, including a paid employee of the 

company, an outside consultant for the 

company, or an authorized 

representative agent for the company. 

This form is entitled, ‘‘Authorization 

and Verification for Section 5 Notice 

Support Submitter by Company 

Authorizing Official.’’ On this form, the 

AO designates various persons to 

submit support documents on his or her 

behalf, and attests to the completeness 

and accuracy of the submitted 

information. Persons designated by the 

AO to submit on his or her behalf must 

also sign this form along with the 

Electronic Signature Agreement form, in 

order to be ‘‘linked’’ to the AO by EPA; 

and therefore, be able to submit support 

documents via CDX on the AO’s behalf. 

When these forms described in Unit 

III.F. are received, EPA activates the 

submitter’s registration in CDX and 

sends him or her an e-mail notification. 

Submitters will need to complete and 

sign these forms only once. 

G. Will CBI be Protected When 

Submitting via CDX? 

Yes. EPA will ensure secure 

transmission of PMN data 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) 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,’’ 

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

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

In addition, e-PMN software supports 

EPA’s CROMERR requirements, as 

described under 40 CFR part 3, by 

enabling the submitter to electronically 

sign, encrypt, and submit 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. The current 

version of the e-PMN encrypts using 

Federal Information Processing 

Standards (FIPS)-validated RSA BSAFE 

Crypto-J. EPA may incorporate other 

encryption modules into future versions 

of e-PMN. Information submitted via 

CDX is processed within EPA by secure 

systems certified for compliance with 

FIPS. 

H. Will EPA Make a Version of the 

Software Without Encryption Available 

for Users Who Want to Obtain the 

Software Without Registering via CDX? 

Yes. EPA is providing two different 

variations of the e-PMN software, one 

with encryption and one without 

encryption. The e-PMN software with 

encryption, available on EPA’s CDX 

website (http://cdx.epa.gov/ 

epa_home.asp), accommodates 

electronic submission through CDX. 

This software contains an application 

program interface that allows the 

submitter to interact with CDX to 

encrypt the submission using FIPSvalidated RSA BSAFE Crypto-J. The 

encryption software is subject to 

restrictions under the Export 

Administration Act of 1979, Public Law 

96–72, 93 Stat. 503, as amended. 

Making this e-PMN software with 

encryption available only through EPA’s 

CDX website will enable EPA to restrict 

and monitor the issuance of this 

‘‘Encryption Software’’ according to 

export control requirements by 

requiring CDX registration before the 

controlled software can be downloaded. 

The e-PMN software without 

encryption, available through EPA’s 

TSCA New Chemicals Program website 

(http://www.epa.gov/oppt/newchems), 

does not contain FIPS-validated RSA 

BSAFE Crypto-J or the application 

programming interface to enable the 

submitter to interact with CDX to 

encrypt the submission. 

The e-PMN software, both with and 

without encryption, produce identical ePMN files; however, only by registering 

through CDX can the e-PMN software 

with encryption (containing the 

application program interface to encrypt 

submissions) be downloaded and used 

for sending files to EPA via CDX. Users 

of the e-PMN software without 

encryption do not have to register with 

CDX. The e-PMN software without 

encryption can be used to create a paper 

PMN form for submission during the 

first year after the effective date of this 

final rule, or to create a PMN file that 


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778 Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations 

can be saved to an optical disc and 

submitted to EPA during the first 2 

years after the effective date of this final 

rule. The software without encryption 

also allows users to create an e-PMN file 

that can be uploaded to the e-PMN 

software with encryption, to send to 

EPA via CDX. 

The variations of the e-PMN software, 

both with and without encryption, are 

accessible through EPA’s TSCA New 

Chemicals Program website (http:// 

www.epa.gov/oppt/newchems). There is 

a link on EPA’s TSCA New Chemicals 

Program website to EPA’s CDX website 

(http://cdx.epa.gov/epa_home.asp), 

where users can download the e-PMN 

software with encryption after they 

register with CDX and EPA approves 

their registration. Units III.E. and III.F. 

describe how to register with CDX and 

the information that is necessary to 

provide to EPA for approval 

consideration. It will take EPA 

approximately 1 week to process and 

approve CDX registrations. The e-PMN 

software without encryption can be 

downloaded directly from EPA’s TSCA 

New Chemicals Program website 

without CDX registration or EPA 

approval. 

If and when EPA makes changes to 

the e-PMN software, an automatic 

download of the updated software will 

be triggered when a submitter opens 

their existing variation of the software 

(i.e., the with and without encryption 

variations). Submitters will then be 

required to validate their submissions 

with this new version before submitting 

to EPA. e-PMN software installed from 

optical discs will not automatically be 

updated with new versions of the 

software. However, EPA will keep a list 

of all submitters that request optical 

discs. If major revisions to the software 

are made during the first two years after 

the effective date of the final rule, EPA 

will notify these submitters of the 

availability of the updated software. 

I. Must I Use the e-PMN Software for 

Any Paper or Optical Disc Submissions 

During the 2–Year Phase-In Period? 

Yes. On the effective date of this final 

rule, submitters must use the e-PMN 

software to generate TSCA section 5 

notices, NOCs, and support documents 

regardless of whether they are submitted 

via CDX, on optical disc, or in paper 

form (40 CFR part 720.3 defines 

‘‘support documents’’ as materials and 

information submitted to EPA in 

support of a TSCA section 5 notice, 

including but not limited to, 

correspondence, amendments, and test 

data. The term ‘‘support documents’’ 

does not include orders under TSCA 

section 5(e) (either consent orders or 

orders imposed pursuant to TSCA 

section 5(e)(2)(B))). EPA will not accept 

paper submissions that use either the 

old version of the paper PMN form or 

the amended form filled in by hand or 

typewriter. The Agency will make 

available free Internet downloads or, 

upon request, optical discs that contain 

the version of e-PMN software lacking 

encryption. All e-PMN software users, 

regardless of how a document is 

submitted, must undergo a 

‘‘finalization’’ step in generating a 

document. During the finalization step, 

the e-PMN software checks that all 

required fields contain information and 

provides warnings for certain kinds of 

missing, incomplete, or incorrect data. 

Notices submitted on paper or optical 

disc containing data which have not 

undergone finalization will be declared 

‘‘Incomplete’’ by EPA. This step is 

necessary to allow for an accurate and 

efficient transfer of data from an optical 

disc or a paper form to the EPA data 

systems, and also enables the generation 

of a non-CBI version. 

Anyone submitting the paper form 

generated using the e-PMN software 

must submit the notice to the Agency 

via U.S. mail or a courier service. The 

paper form must be hand signed on page 

2. If the submitter makes any CBI 

claims, the original submission needs to 

include both the CBI version and a nonCBI version. 

Optical discs must be submitted with 

an original hand-signed hard copy of 

page 2 (Certification page) and a hard 

copy of page 3 (a copy of page 3 is 

needed for contact information in the 

event that the optical disc is not 

readable). Optical discs must be 

delivered only by courier service, to 

avoid damage to the disk from the 

Agency’s mail screening equipment. 

J. How Will Electronic Submission of 

TSCA Section 5 Notices that Currently 

Have No Required or Official Forms be 

Handled by CDX or the e-PMN 

Software? 

Certain TSCA section 5 notices such 

as LVE modifications, LoREX 

modifications, TMEAs, and 

biotechnology notices currently have no 

required or official forms. In order to 

allow for electronic and paper 

submission of these notices using the ePMN software and CDX, the Agency is 

requiring the following: 

1. For exemption modifications, 

submitters must use the e-PMN form by 

checking the ‘‘modification’’ box on 

page 1, filling in contact information on 

page 3, and including the previous 

exemption number and chemical 

identity information. A submitter may 

send a cover letter with the new 

revisions to the original exemption 

notice or the pertinent pages of the ePMN form. 

2. For a TMEA, the submitter will 

check the ‘‘TMEA’’ box on page 1 of the 

e-PMN form, and either fill out the form 

or attach a cover letter for the 

submission containing the information 

required by 40 CFR 720.38. 

3. Biotechnology notices (Form 6300– 

07) will have their own menu option. 

Instead of selecting ‘‘Premanufacture 

Notice,’’ a submitter will select 

‘‘Biotechnology,’’ which will prompt the 

software to present a header page to the 

submitter with choices of biotechnology 

notices, and space to fill in contact 

information. The information required 

by 40 CFR part 725 must be submitted 

as an attachment(s). 

The notices listed in Unit III.I.1.–3. 

must undergo the ‘‘finalization’’ step 

(See Unit III.H.). An exemption 

submission on an optical disc must be 

accompanied by a complete signed hard 

copy of page 2 and a complete hard 

copy of page 3 of the e-PMN form for 

contact information in case the optical 

disc is not readable. The TMEA will 

only need a complete page 3. The 

optical discs for both types of 

submissions will need to be delivered 

by courier to the Agency to avoid 

damage to the optical disc from the 

Agency’s mail screening equipment. If 

submitted by paper, the forms must be 

generated using the e-PMN software and 

sent to the Agency. For biotechnology 

notices, a signed hard copy of a 

biotechnology certification must 

accompany the optical disc. The printed 

form must follow the same procedures: 

Use the e-PMN software to generate a 

finalized ‘‘header’’ sheet with contact 

data, add an attachment with notice 

information, and include a signature 

page. 

The submission process for 

completing the various notice and 

document types is summarized in Table 

1 of this unit. After the effective date of 

this final rule, all of these notices must 

be prepared using the new e-PMN 

software. 


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TABLE 1.—PROCESS FOR PREPARING TSCA SECTION 5 NOTICES AND SUPPORT DOCUMENTS

TSCA Section 5 Document Process 

PMNs and SNUNs Form 7710–25 generated and finalized by e-PMN software. 

LVE Form 7710–25 generated and finalized by e-PMN software. 

LoREX Form 7710–25 generated and finalized by e-PMN software. 

TMEA e-PMN software to generate finalized submission either using Form 7710–25 or cover letter and attached 

information. 

NOC e-PMN software to generate finalized submission using Form 7710–56. 

Biotechnology notices e-PMN software to generate finalized ‘‘header’’ sheet with contact data, add attachment with notice information, include signature page using Form 6300–07. 

Modifications to previous notices Form 7710–25 generated and finalized by e-PMN software. Fill in pages 1, 2, and 3 of the Form, plus either applicable pages of Form, cover letter, or attachment. 

Support documents e-PMN software to generate finalized ‘‘header’’ sheet identifying reason for submission and contact data. 

K. How Will Submission Requirements 

and Delivery Methods to EPA Vary for 

Submissions via Paper, Optical Disc, or 

CDX? 

Depending upon how a notice is 

submitted, the following submission 

requirements and delivery methods 

must be used: 

1. Paper. Printed, signed, and 

‘‘header’’ sheets for attachments; 

delivered by U.S. mail or courier. 

Allowed for the first year. 

2. Optical discs. Data must be saved 

as XML files rather than as PDF files. 

Optical discs submitted with an original 

signed hard copy of page 2 (Certification 

page) and a hard copy of page 3. 

Delivered by courier only. Allowed for 

the first 2 years only. 

3. CDX. Document developed on-line; 

simply hit ‘‘send button’’ to deliver to 

EPA via CDX. 

L. Over What Time-Frame Will the 

Internet-Based CDX Reporting 

Requirement be Phased-In? 

The Agency is introducing electronic 

reporting in three phases. In the first 

phase, the Agency is allowing the 

submission of TSCA section 5 notices 

and support documents via CDX, on 

optical disc, and on paper. All 

submissions (whether submitted via 

CDX, on optical disc, or on paper) must 

be generated using the new e-PMN 

software. 

In the second phase, occurring 1 year 

after the effective date of this final rule, 

paper submissions will no longer be 

accepted for any new notices and 

support documents (including NOCs). 

In the third phase, at the end of the 

second year after the effective date of 

this final rule, optical disc submissions 

for all new notices and support 

documents will no longer be accepted. 

Thereafter, EPA will accept TSCA 

section 5 notices and support 

documents only through CDX. TSCA 

section 5 notices and support 

documents not submitted in the 

appropriate manner as set forth in 40 

CFR parts 720, 721, and 725 will be 

considered invalid by EPA and returned 

to the submitter. 

Note that NOCs and support 

documents whose original notices were 

submitted before the effective date of 

this final rule will still need to be 

mailed as hard copy to the Agency. This 

is necessary because, although the 

notices received after implementation of 

the new system will be entered into the 

newly created EPA database, notices 

submitted before the effective date of 

this final rule will only exist in EPA’s 

‘‘legacy’’ database, i.e., the database 

used prior to the effective date of this 

final rule, and so a subsequent support 

document will not be able to be linked 

up with its parent notice within EPA’s 

new database. The phase-in schedule for 

submissions is displayed in Table 2 of 

this unit. 

TABLE 2.—E-PMN PHASE-IN SCHEDULE FOR TSCA SECTION 5 NOTICES AND SUPPORT DOCUMENTS1

Submission 

Method 

Before Effective Date of 

Final Rule 

First Year After Effective Date 

of Final Rule 

Second Year After Effective 

Date of Final Rule 

Third Year After Effective 

Date of the Final Rule, and 

Thereafter 

Paper Existing PMN form Scanner-friendly paper form, 

generated and finalized 

using e-PMN software 

Invalid Invalid 

Optical disc Not applicable Electronic submission 

generated and finalized using 

e-PMN software with hard 

copies of pages 2 and 3 

Electronic submission 

generated and finalized using 

e-PMN software with hard 

copies of pages 2 and 3 

Invalid 

CDX/Internet Not applicable Available and optional Available and optional Mandatory 

1 NOCs and support documents for notices originally submitted on paper before the effective date of this final rule must still be mailed as hard 

copy. 


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780 Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations 

M. Will EPA Offer Any Exceptions to the 

e-PMN Requirements? 

No. After careful consideration, the 

Agency has concluded that the overall 

benefits from everyone using the e-PMN 

software and submission through CDX 

exceed those associated with 

maintaining a multi-optioned reporting 

approach (Ref. 3). The Agency 

recognizes that there is the potential for 

costs and burden associated with 

predictable or unanticipated technical 

difficulties in electronic filing or with 

conversion to an electronic CDX 

reporting format. However, EPA expects 

that reduced reporting costs to 

submitters will ultimately exceed the 

transition costs and that any transition 

difficulties will be mitigated by: 

1. The phase-in periods. 

2. EPA’s planned outreach and 

training sessions prior to the effective 

date of this final rule. The Agency has 

allowed ample time between the date of 

publication and the effective date of this 

final rule for submitters to install and 

become proficient with the e-PMN 

software. 

3. EPA’s technical support following 

the effective date of this final rule. 

N. Will All Types of TSCA Section 5 

Notices and Communications be 

Submitted via e-PMN Software? 

At this time, the Agency does not 

have electronic reporting capability for 

all TSCA section 5-related notices (i.e., 

Bona Fide Intent to Manufacture (bona 

fide) notices and polymer exemption 

annual reports); support documents 

(i.e., TSCA section 5(e) consent orders 

or orders imposed pursuant to TSCA 

section 5(e)(2)(B)); and certain 

communications (e.g., pre-notice 

communications and TSCA Inventory 

Correspondence), due to the variability 

and infrequent nature of these types of 

submissions. EPA may consider offering 

electronic reporting of these and other 

submissions in the future. 

IV. Response to Comments 

The Agency received comments from 

three persons on the proposed rule. 

Copies of all comments received are 

available in the public docket for this 

action. The comments received on the 

proposed rule did not result in EPA 

making significant changes to the final 

rule. A discussion of the comments 

germane to the rulemaking and the 

Agency’s responses follow: 

1. Comment—i. Response to Two 

Questions Listed in Unit V. of the 

Proposed Rule. Unit V. of the proposed 

rule identified two issues on which the 

Agency was specifically requesting 

public comment. These issues were: 

• Whether the proposed 2–year 

phase-in period following the effective 

date of the final rule, during which time 

paper and/or optical disc submissions 

would be accepted, is reasonable or 

necessary to allow sufficient time to 

transition to the new Internet-based 

method. 

• Did industry have information that 

could further inform EPA’s estimate 

regarding burden. For example, EPA 

asked whether submitters intended on 

submitting notices via CDX as soon as 

it becomes available, or if not, when 

during the 2–year phase-in period 

would they expect to begin using CDX? 

The public comments 

overwhelmingly supported the 2–year 

phase-in period following the effective 

date of the final rule. Commenters 

agreed that the 2–year phase-in period 

is reasonable and necessary to allow 

sufficient time for transition to the new 

electronic reporting method. 

Although, EPA did not receive any 

comments directly related to its burden 

estimate, EPA did receive positive 

feedback on the proposed electronic 

submittal system. Commenters strongly 

supported the Agency’s effort to move to 

electronic methods of information 

gathering. Commenters agreed with the 

Agency’s statements that this change 

will allow for more effective and 

efficient reviews of TSCA section 5 

notices and that the changes will 

improve communication with 

submitters. One commenter appreciated 

aspects of the e-PMN software such as 

the ability of the e-PMN software to 

check for completeness of a PMN 

submission and create non-CBI versions 

of notices. Another commenter was 

pleased to see the addition of the new 

User Fee Payment Identity Number field 

to track payments. 

ii. Response. EPA retained the 2–year 

phase-in period for electronic 

submissions which is supported by the 

comments received. EPA did not receive 

any comments directly related to its 

burden estimate and therefore did not 

revise the estimate. 

2. Comment—i. Dedicated technical 

assistance. EPA received comments 

regarding the importance of providing 

robust technical assistance both during 

and after the 2–year transition period. 

Commenters requested that Agency 

resources be available for quickly 

resolving any software problems. One 

commenter asked that the technical 

assistance contacts be knowledgeable 

about both the system software as well 

as the PMN TSCA section 5 process. 

ii. Response. EPA will provide 

dedicated technical assistance to help 

submitters. For help with CDX 

registration, submitters can contact the 

CDX Help Desk. Submitters will be able 

to call the TSCA Hotline for help with 

basic questions on the TSCA section 5 

process. For answers to more complex 

questions, the TSCA Hotline will be 

equipped to refer callers to EPA 

technical staff experienced with the ePMN software and TSCA section 5. 

Contact information for the TSCA 

Hotline, CDX Help Desk, and relevant 

EPA staff are available through EPA’s 

TSCA New Chemicals Program website 

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

EPA will not, however, have a 

designated hotline staffed with experts 

who can provide both system software 

assistance on CDX and the e-PMN and 

respond to detailed TSCA section 5 

process questions. 

3. Comment—i. Non-routine 

information and the e-PMN form. One 

commenter asked how EPA would 

handle non-routine information that the 

submitter may need to report on the 

electronic form, but for which there is 

no standardized field. The commenter 

asked that EPA provide consistent and 

informed guidance for handling these 

situations for which a workaround may 

be needed. 

ii. Response. A submitter who is 

unable to enter the necessary 

information on the e-PMN form can 

contact the TSCA Hotline and/or EPA 

technical experts for assistance. EPA 

will work with submitters on how to 

express non-routine information on the 

e-PMN form on a case-by-case basis. The 

‘‘Helpful Hints: Q and A for Use of the 

e-TSCA/e-PMN Submission Software,’’ 

accessible via EPA’s TSCA New 

Chemicals Program website (http:// 

www.epa.gov/oppt/newchems), 

addresses workaround issues that EPA 

has encountered to date. EPA will 

update the Q and A on a regular basis 

with new issues and solutions to those 

issues as they arise. 

4. Comment—i. Who will be able to 

use the electronic submission process? 

One commenter requested that EPA 

clarify whether the e-PMN form will be 

available only to the manufacturer or 

importer, or whether consultants will be 

able to prepare and submit PMNs and 

other TSCA section 5 submissions on 

behalf of clients as well. 

ii. Response. Consultants will not be 

able to submit PMN notices or Letters of 

Support. Only the AO for the client, 

registered with CDX, can submit PMN 

notices and/or Letters of Support. 

However, a consultant will be able to 

submit all other support documents on 

behalf of the client as long as the 

consultant is: 

• Registered in CDX. 

• Authorized by the AO in CDX to 

submit documents on the client’s behalf. 


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EPA will be using a two-tiered 

approach for registration and 

submission of PMNs. The first tier is the 

company AO, who, for the purposes of 

EPA’s CROMERR and this final rule, is 

the person who certifies and signs the 

notice. The second tier will be 

comprised of persons designated and 

authorized by the company’s AO to 

submit supporting documents. 

The AO has the ability to submit all 

documents on the company’s behalf via 

CDX. During CDX registration, all AOs 

will be required to fill out two forms: 

The ‘‘Electronic Signature Agreement’’ 

form in which the AO agrees to certain 

CDX security conditions and the 

‘‘Verification of Company Authorizing 

Official’’ form in which the AO 

designates himself or herself as the AO 

and attests to the completeness and 

accuracy of the submitted information. 

There is a third form generated by 

CDX that the AO needs to fill out if the 

AO wants to authorize other persons to 

submit support documents on his or her 

behalf. This form is entitled, 

‘‘Authorization and Verification for 

Section 5 Notice Support Submitter by 

Company Authorizing Official.’’ On this 

form, the AO designates various persons 

to submit support documents on his or 

her behalf, and attests to the 

completeness and accuracy of the 

submitted information. Persons 

designated by the AO to submit on his 

or her behalf must also sign this form in 

order to be ‘‘linked’’ to the AO by EPA; 

and therefore, be able to submit support 

documents via CDX on the AO’s behalf. 

Note, that a client, or company, can 

have multiple AO’s. 

The approach described in Unit IV.4. 

was discussed in the preamble of the 

proposed rule. To clarify the different 

responsibilities of the AO and persons 

designated to submit support 

documents on the AO’s behalf, EPA has 

added regulatory text at 40 CFR 

720.40(e)(3)(i) and (ii). 

5. Comment—i. Downloading e-PMN 

software. One commenter had a 

question about downloading the e-PMN 

software. The commenter was 

concerned that only individuals within 

a company could download the software 

from the EPA site onto their individual 

computers, as opposed to a single 

download onto a company network. The 

commenter expressed the opinion that 

the system should allow for shared 

software on a computer network. 

ii. Response. The e-PMN software is 

designed to be used either as a standalone program on an individual’s 

computer or as a shared system on a 

company’s LAN. Many users may access 

the program at the same time. Upon 

request, EPA will also provide the 

software to a company on optical disc. 

6. Comment —i. Barrier for small and 

foreign businesses. One commenter 

suggested that for smaller companies, 

especially those outside the United 

States where English is not the primary 

language, the requirements to register on 

EPA’s CDX and to use the electronic 

reporting software could be overly 

burdensome. They recommended that 

EPA develop an on-line training module 

to help address this potential problem. 

ii. Response. EPA has options to aid 

small and foreign businesses. These 

companies can utilize the 2–year phase 

period to familiarize themselves with 

sending documents via CDX, during 

which time they may still submit 

information on paper or optical disc for 

the first year, and on optical disc for the 

second year. These companies will also 

be able to call the TSCA Hotline, CDX 

Help Desk, and EPA technical staff for 

help with basic questions. Note, that 40 

CFR 720.22(a)(3) states that, ‘‘Only 

manufacturers that are incorporated, 

licensed, or doing business in the 

United States may submit a notice.’’ 

Foreign entities not meeting the 

requirement of 40 CFR 720.22(a)(3), 

however, may submit Letters of Support 

(See also response to comment 7. in this 

unit.). 

7. Comment —i. Capability for 

collaborative efforts with third parties. 

Many companies, particularly smaller 

businesses, use third parties, such as 

consultants or law firms, in the 

preparation of TSCA section 5 notices. 

As such, one commenter suggested that 

the e-PMN process should be capable of 

allowing collaborative efforts with these 

parties and should be as ‘‘user-friendly’’ 

as possible. The commenter was 

concerned that the process could 

increase burden for smaller companies 

by requiring the company to cut and 

paste input from the third party into the 

company’s final electronic submission. 

ii. Response. EPA believes the new ePMN form is as ‘‘user-friendly’’ for 

collaborating with third parties as the 

current form. To work with a third 

party, the notice preparer will create the 

draft e-PMN file. This file is essentially 

a folder, i.e., one unit made up of many 

documents. The preparer may send the 

file (which includes the attachments as 

a part of the file structure) to the third 

party electronically, via e-mail, or they 

can save the file onto an optical disc for 

mailing. This is similar to the current 

way of doing business using the 

electronic Adobe PMN. There is, 

however, no process in place to use 

CDX to exchange files between e-PMN 

users, i.e., the preparer and a third 

party. CDX is only for exchange of 

information between a submitter and 

EPA. 

8. Comment —i. Linkage with 

computer models. One commenter 

recommended that the program have the 

ability to link the output of the 

Sustainable Future’s computer modeling 

and other EPA modeling directly into 

the e-PMN form. 

ii. Response. The xml schema for the 

e-PMN is available for anyone to use to 

create a program to download data from 

other models or databases into the ePMN form. Upon installation of the ePMN software a program folder called 

‘‘eTSCA’’ is created. Within the eTSCA 

program folder is another folder called 

‘‘user.’’ The schema is available in the 

eTSCA/user folder, entitled 

‘‘eTSCA_v1.0.xsd.’’ 

9. Comment —i. Unique 

circumstances that may not easily fit 

within electronic reporting 

requirements. One commenter noted 

that there are unique circumstances that 

may not easily fit within electronic 

reporting requirements. An example 

given by the commenter was in regards 

to submitters that work with companies 

who file Letters of Support for a PMN, 

where the information provided by the 

supporting company is not revealed to 

the PMN submitter. Under current 

business practices, the company 

providing the Letter of Support 

discloses the trade secret information 

that is necessary to complete the PMN 

directly to the Agency. The commenter 

expressed concern that if those 

companies have difficulty with the 

requirement to register for CDX, and 

need to gain expertise with the software 

only to submit what may be a few data 

points, it could impede or block the 

PMN completion process. 

ii. Response. EPA will remain 

attentive to these unique circumstances 

and work to develop workable 

processes. EPA will consider providing 

additional outreach tailored to answer 

the questions and meet of the needs of 

unique submitter groups. For assistance 

with CDX, submitters can call the CDX 

Help Desk. For e-PMN or TSCA section 

5 process questions, submitters can call 

either the TSCA Hotline or the 

appropriate EPA technical experts. 

V. Estimated Economic Impact 

The Agency’s evaluation of the 

economic impact of this final rule is 

present in a document entitled 

‘‘Economic Analysis of the 

Amendments to TSCA Section 5 

Premanufacture and Significant New 

Use Notification Requirements Final 

Rule’’ (Ref. 3), a copy of which is 

available in the docket and is briefly 

summarized in this unit. EPA estimates 


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782 Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations 

that the electronic submission of TSCA 

section 5 notices and support 

documents will reduce the burden and 

cost currently associated with the paperbased reporting of TSCA section 5 

notices and support documents. The 

burden estimation of 95 to 114 hours to 

complete the currently existing paper 

PMN form includes the time spent 

reading and becoming familiar with the 

form, gathering the required information 

and preparing the report, producing 

non-CBI responses for items claimed as 

CBI, and maintaining a file of the 

submission (Ref. 4). 

In its economic analysis for the final 

rule (Ref. 3), EPA estimated cost and 

burden savings at the industry level, at 

the individual company level, and on a 

per-form basis. Estimates presented in 

this unit are for all TSCA section 5 

notices; estimates for PMNs separately 

can be found in the economic analysis. 

At the industry level for all TSCA 

section 5 notices, EPA estimates a net 

total burden decrease of 14,972 hours in 

the first year of the final rule, 15,700 

hours in the second year of the final 

rule, and 16,178 hours in the third year 

of the final rule. Industry savings are 

estimated at 16,187 hours per year for 

subsequent years of the final rule. At the 

company level for all TSCA section 5 

notices, EPA estimates an average net 

total burden decrease of 50.4 hours in 

the first year of the final rule, 51.2 hours 

in the second and third years of the final 

rule, and 50.4 hours per year for 

subsequent years of the final rule. 

At the industry level for all TSCA 

section 5 notices, EPA estimates a net 

cost savings of $379,271 in the first year 

of the final rule, $424,863 in the second 

year of the final rule, and $457,066 in 

the third year of the final rule. Industry 

savings are estimated at $457,628 per 

year for subsequent years of the final 

rule. When taking into account the 

lower total number of TSCA section 5 

notices expected during this 3–year 

Information Collection Request (ICR) 

period in addition to savings 

attributable to the final rule, the average 

annual reduction in industry costs is 

$5.7 million. At the company level for 

all TSCA section 5 notices, EPA 

estimates an average cost savings of 

$1,352 in the first year of the final rule, 

$1,396 in the second and third years of 

the final rule, and $1,352 in subsequent 

years of the final rule. 

EPA estimates that the Agency also 

will experience a reduction in both 

burden and cost to administer the TSCA 

section 5 premanufacture notification 

program as a result of the final rule. 

Specifically, EPA expects to experience 

a net burden reduction of 4,521 hours in 

the first year of the final rule, a 

reduction of 9,042 hours in the second 

year of the final rule, and a reduction of 

13,563 hours in the third and 

subsequent years of the final rule. The 

Agency expects to experience a net 

savings of $214,377 in the first year of 

the final rule, a net savings of $586,108 

in the second year of the final rule, and 

a net savings of $1,057,838 in the third 

and subsequent years of the final rule. 

EPA recognizes that information and 

feedback received during the 2–year 

phase-in period, along with experience 

gained during this phase-in period, can 

be used to further improve the use of the 

new Internet-based reporting 

mechanism. This information will also 

inform the Agency’s estimates, which 

will be reflected in the ICR, which EPA 

must complete every 3 years under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq. 

VI. References 

The following is a listing of the 

documents referenced in this preamble 

that have been placed in the public 

docket for this final rule under docket 

ID number EPA–HQ–OPPT–2008–0296, 

which is available for inspection as 

specified under ADDRESSES. 

1. EPA. TSCA Section 5 

Premanufacture and Significant New 

Use Notification Electronic Reporting; 

Revisions to Notification Regulations; 

Proposed Rule. Federal Register (73 FR 

78261, December 22, 2008) (FRL–8395– 

8). Available on-line at: http:// 

www.gpoacess.gov/fr/index.html. 

2. EPA. Cross-Media Electronic 

Reporting; Final Rule. Federal Register 

(70 FR 59847, October 13, 2005) (FRL– 

7977–1). Available on-line at: http:// 

www.gpoacess.gov/fr/index.html. 

3. EPA. Economic and Policy Analysis 

Branch, Office of Pollution Prevention 

and Toxics (OPPT). Economic Analysis 

of the Amendments to TSCA Section 5 

Premanufacture and Significant New 

Use Notification Requirements Final 

Rule. July 13, 2009. 

4. EPA. Regulatory Impacts Branch, 

OPPT. Regulatory Impact Analysis of 

Amendments to Regulations for TSCA 

Section 5 Premanufacture Notifications. 

September 9, 1994. 

5. EPA. Supporting Statement for a 

Request for OMB Review Under The 

Paperwork Reduction Act. Information 

Collection Request (ICR): New 

Information Collection Activities 

Related to Electronic Submission of 

Certain TSCA Section 5 Notices EPA 

ICR No. 2327.02. OMB Control No. 

2070–0173. 

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 under the 

Executive Order. 

B. Paperwork Reduction Act 

The information collection 

requirements contained in this final rule 

have been submitted for OMB approval 

under the Paperwork Reduction Act 

(PRA), 44 U.S.C. 3501 et seq. The ICR 

document prepared by EPA, identified 

under EPA ICR No. 2327.02 and OMB 

control number 2070–0173, is available 

in the docket for the final rule (Ref. 5). 

The information collection requirements 

described in the final rule are not 

enforceable until OMB approves them. 

This rule-related ICR covers 

amendments to existing reporting and 

recordkeeping programs that are 

approved under OMB control numbers 

2070–0012 and 2070–0038. The final 

rule amends these existing information 

collections in two ways. First, 

respondents will be required to use the 

e-PMN software to generate TSCA 

section 5 notices and support 

documents. After a 2–year phase-in 

period following the effective date of 

this final rule, respondents will be 

required use the e-PMN software to 

submit this information to EPA 

electronically via the Agency’s CDX. 

Second, respondents will be required to 

provide a new data element, a User Fee 

Payment Identity Number, when 

preparing and submitting TSCA section 

5 notices and support documents. 

The information collection activities 

contained in this final rule are designed 

to assist the Agency in meeting its 

responsibility under TSCA to receive, 

process, and review TSCA section 5 

notices and support documents in a 

timely manner and further the proper 

performance of the functions of the 

Agency. Information collection for 

review of PMNs and all other TSCA 

section 5 notices and support 

documents is authorized by TSCA 

section 5 and confidentiality of 

submitted information is protected 

under TSCA section 14. 

Responses to the collection of 

information are mandatory. 

Respondents will be required to use the 

e-PMN software to generate, complete, 

and, ultimately, submit the form. The 

methods for submitting the completed 

form to EPA will change over a 2–year 

period following the effective date of 


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this final rule to allow for the new 

required submission through CDX to be 

fully implemented. In the third year 

after the effective date of this final rule, 

all TSCA section 5 notices and support 

documents must be submitted to EPA 

electronically via CDX using the e-PMN 

software. 

The ICR document for this final rule 

provides a detailed presentation of the 

estimated burden and costs for 3 years 

of the program. The aggregate burden 

varies by year during the first 3 years of 

the final rule because of the phase-in 

schedule of the requirements. 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 3 years 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, 0.1 hours for 

establishing an account for electronic 

fee payments, and 0.8 hours for final 

rule familiarization. Burden is defined 

at 5 CFR 1320.3(b). 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. The OMB control 

numbers for EPA’s regulations in 40 

CFR are listed in 40 CFR part 9. After 

approval of this rule-related ICR by 

OMB, the Agency will amend the 

existing ICRs (OMB control numbers 

2070–0012 and 2070–0038) to reflect the 

new information collection activities 

and resulting changes in burden. Upon 

OMB’s approval of the amendments to 

the existing, approved ICRs, EPA will 

discontinue the ICR approved under 

OMB control number 2070–0173. 

C. Regulatory Flexibility Act 

Pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA), 5 

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

certifies that this final rule will not have 

a significant adverse economic impact 

on a substantial number of small 

entities, due to the burden-reducing 

nature of this action which will benefit 

all submitters regardless of the size of 

the entity. 

Small entities include small 

businesses, small organizations, and 

small governmental jurisdictions. For 

purposes of assessing the impacts of this 

action 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, 

among other reasons, an agency may 

certify that a rule will not have a 

significant adverse economic impact on 

a substantial number of small entities if 

the rule relieves regulatory burden or 

otherwise has a positive economic effect 

on all of the small entities subject to the 

rule. This final rule is expected to 

reduce the existing regulatory burden. 

The factual basis for the Agency’s 

certification under the RFA is presented 

in the small entity impact analysis 

prepared as part of the Economic 

Analysis for this final rule (Ref. 3), and 

is briefly summarized in Unit IV. 

D. Unfunded Mandates Reform Act 

Based on EPA’s experience with past 

PMNs and SNUNs, State, local, and 

tribal governments have not been 

affected by these reporting 

requirements, and EPA does not have 

any reason to believe that any State, 

local, or tribal government will be 

affected by this final rule. As such, EPA 

has determined that this regulatory 

action does not impose any enforceable 

duty, contain any unfunded mandate, or 

otherwise have any affect on small 

governments subject to the requirements 

of sections 202, 203, 204, or 205 of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

E. Executive Order 13132 

Under Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999), EPA has determined 

that this final rule does not have 

‘‘federalism implications’’ because it 

will 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 

final rule will establish electronic 

notification requirements that apply to 

manufacturers (including importers) 

and processors of certain chemical 

substances. This final rule will not 

apply directly to States and localities 

and will not affect State and local 

governments. Thus, Executive Order 

13132 does not apply to this final 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 final rule does not 

have tribal implications because it will 

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 final rule. 

G. Executive Order 13045 

This final rule will 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), 

because it is not likely to have an 

annual effect on the economy of $100 

million or more, nor does it establish an 

environmental standard, or otherwise 

have a disproportionate effect on 

children. 

H. Executive Order 13211 

This final rule is not subject to 

Executive Order 13211, entitled Actions 

Concerning Regulations that 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001), because this final rule does 

not 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 final 

rule will not impose any technical 

standards that will require EPA to 

consider any voluntary consensus 

standards. 

J. Executive Order 12898 

This final rule will not have an 

adverse impact on the environmental 


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784 Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations 

and health conditions in low-income 

and minority communities. Therefore, 

under Executive Order 12898, entitled 

Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994), the Agency does not need to 

consider environmental justice-related 

issues. 

VIII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

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

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

List of Subjects in 40 CFR Parts 700, 

720, 721, 723, and 725 

Environmental protection, Chemicals, 

Electronic reporting, Hazardous 

substances, Reporting and 

recordkeeping requirements. 

Dated: December 22, 2009. 

Stephen A. Owens, 

Assistant Administrator, Office of Prevention, 

Pesticides and Toxic Substances. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 700—[AMENDED] 

■ 1. The authority citation for part 700 

is revised to read as follows: 

Authority: 15 U.S.C 2625 and 2665, 44 

U.S.C. 3504. 

■ 2. Section 700.45 is amended by 

revising paragraphs (e)(1) through (e)(3); 

(e)(4)(i), (ii), and (iv); and (e)(5)(i), (ii), 

and (iv) to read as follows: 

§ 700.45 Fee payments. 

* * * * * 

(e) * * * 

(1) Each remittance under this section 

shall be in United States currency and 

shall be paid by money order, bank 

draft, wire transfer, Pay.gov service 

provided through the Department of the 

Treasury, or check drawn to the order of 

the Environmental Protection Agency. 

(2) Each paper remittance shall be 

sent to the Environmental Protection 

Agency, Washington Finance Center, 

Toxic Substances Control Act User Fees, 

P.O. Box 979073, St. Louis, MO 63197– 

9000. 

(3) Persons who submit a TSCA 

section 5 notice shall place an 

identifying number and a payment 

identity number on the front page of 

each TSCA section 5 notice submitted. 

The identifying number must include 

the letters ‘‘TS’’ followed by a 

combination of 6 numbers (letters may 

be substituted for some numbers). The 

payment identity number may be a 

check number, a wire transfer number, 

or a ‘‘Pay.gov’’ transaction number used 

to transmit the user fee. The same TS 

number and the submitter’s name must 

appear on the corresponding fee 

remittance under this section. If a 

remittance applies to more than one 

TSCA section 5 notice, the person shall 

include the name of the submitter and 

a new TS number for each TSCA section 

5 notice to which the remittance 

applies, and the amount of the 

remittance that applies to each notice. 

Any remittance not having the 

identifying name and numbers 

described in this paragraph will be 

returned to the remitter. 

(4)(i) Each person who remits the fee 

identified in paragraph (b)(1) of this 

section for a PMN, consolidated PMN, 

intermediate PMN, or significant new 

use notice shall insert a check mark for 

the statement, ‘‘The company named in 

part 1, section A is a small business 

concern under 40 CFR 700.43 and has 

remitted a fee of $100 in accordance 

with 40 CFR 700.45(b).’’ under 

‘‘CERTIFICATION’’ on page 2 of the 

Premanufacture Notice for New 

Chemical Substances (EPA Form 7710– 

25). 

(ii) Each person who remits the fee 

identified in paragraph (b)(1) of this 

section for an exemption application 

under TSCA section 5(h)(2) shall insert 

a check mark for the statement, ‘‘The 

company named in part 1, section A is 

a small business concern under 40 CFR 

700.43 and has remitted a fee of $100 in 

accordance with 40 CFR 700.45(b).’’ in 

the exemption application. 

* * * * * 

(iv) Each person who remits the fee 

identified in paragraph (b)(1) of this 

section for a MCAN for a microorganism 

shall insert a check mark for the 

statement, ‘‘The company named in part 

1, section A is a small business concern 

under 40 CFR 700.43 and has remitted 

a fee of $100 in accordance with 40 CFR 

700.45(b).’’ in the certification required 

in § 725.25(b) of this chapter. 

(5)(i) Each person who remits a fee 

identified in paragraph (b)(2) of this 

section for a PMN, consolidated PMN, 

intermediate PMN, or significant new 

use notice shall insert a check mark for 

the statement, ‘‘The company named in 

part 1, section A has remitted the fee 

specified in 40 CFR 700.45(b).’’ under 

‘‘CERTIFICATION’’ on page 2 of the 

Premanufacture Notice for New 

Chemical Substances (EPA Form 7710– 

25). 

(ii) Each person who remits a fee 

identified in paragraph (b)(2) of this 

section for an exemption application 

under TSCA section 5(h)(2) shall insert 

a check mark for the statement, ‘‘The 

company named in part 1, section A has 

remitted the fee specified in 40 CFR 

700.45(b).’’ in the exemption 

application. 

* * * * * 

(iv) Each person who remits the fee 

identified in paragraph (b)(1) of this 

section for a MCAN for a microorganism 

shall insert a check mark for the 

statement, ‘‘The company named in part 

1, section A is a small business concern 

under 40 CFR 700.43 and has remitted 

a fee of $100 in accordance with 40 CFR 

700.45(b).’’ in the certification required 

in § 725.25(b) of this chapter. 

* * * * * 

PART 720—[AMENDED] 

■ 3. The authority citation for part 720 

continues to read as follows: 

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

■ 4. Section 720.3 is amended by adding 

paragraphs (ii), (jj), (kk), and (ll) to to 

read as follows: 

§ 720.3 Definitions. 

* * * * * 

(ii) Central Data Exchange or CDX 

means EPA’s centralized electronic 

document receiving system, or its 

successors. 

(jj) e-PMN software means electronicPMN software created by EPA for use in 

preparing and submitting 

Premanufacture Notices (PMNs) and 

other TSCA section 5 notices and 

support documents electronically to the 

Agency. 

(kk) Optical disc means compact disc 

(CD) or digital video disc (DVD). 

(ll) Support documents means 

materials and information submitted to 

EPA in support of a TSCA section 5 

notice, including but not limited to, 

correspondence, amendments, and test 

data. The term ‘‘support documents’’ 

does not include orders under TSCA 

section 5(e) (either consent orders or 

orders imposed pursuant to TSCA 

section 5(e)(2)(B)). 

■ 5. Section 720.40 is amended by 

revising paragraphs (a)(2), (c), (d)(2), 

and (e) to read as follows: 

§ 720.40 General. 

(a) * * * 


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(2) All notices must be submitted on 

EPA Form 7710–25. Notices, and any 

support documents related to these 

notices, may only be submitted in a 

manner set forth in this paragraph. 

(i) Paper-based submissions. Notices, 

and any support documents related to 

these notices, may be submitted on 

paper on or before April 6, 2011. All 

paper-based notices must be generated 

using e-PMN reporting software and be 

completed through the finalization step 

of the software, and e-PMN software 

must be used to print EPA Form 7710– 

25 for submission to EPA. Paper notices, 

and any support documents related to 

such notices, must be submitted either 

via U.S. mail to the Document Control 

Office (DCO) (7407M), Office of 

Pollution Prevention and Toxics, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001 or submitted via courier 

to the Environmental Protection 

Agency, OPPT Document Control Office 

(DCO), EPA East Bldg., 1201 

Constitution Ave., NW., Rm. 6428, 

Washington, DC 20004. 

(A) Support documents for notices 

that are submitted before April 6, 2010 

must be submitted on paper either via 

U.S. mail to the Document Control 

Office (DCO) (7407M), Office of 

Pollution Prevention and Toxics, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001 or submitted via courier 

to the Environmental Protection 

Agency, OPPT Document Control Office 

(DCO), EPA East Bldg., 1201 

Constitution Ave., NW., Rm. 6428, 

Washington, DC 20004. 

(B) [Reserved] 

(ii) Submissions on optical disc—(A) 

Notices may be submitted as electronic 

files on optical disc on or before April 

6, 2012. All notices submitted as 

electronic files on optical disc must be 

generated using e-PMN reporting 

software and be completed through the 

finalization step of the software. Optical 

discs containing electronic notices must 

be submitted by courier to the 

Environmental Protection Agency, 

OPPT Document Control Office (DCO), 

EPA East Bldg., 1201 Constitution Ave., 

NW., Rm. 6428, Washington, DC 20004. 

(B) Persons submitting on optical disc 

must also complete and submit on paper 

the Certification and Submitter 

Identification sections of EPA Form 

7710–25. 

(iii) Submissions via CDX. Notices 

and any related support documents may 

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 reporting 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. 

(iv) You can obtain the e-PMN 

software as follows: 

(A) Website. Go to EPA’s TSCA New 

Chemicals Program website at http:// 

www.epa.gov/oppt/newchems and 

follow the appropriate links. 

(B) Telephone. Call the EPA CDX 

Help Desk at 1–888–890–1995. 

(C) E-mail. HelpDesk@epacdx.net. 

* * * * * 

(c) Where to submit a notice or 

support documents. For submitting 

notices or support documents via CDX, 

use the e-PMN software. Paper notices 

or support documents must be 

submitted either via U.S. mail to the 

Document Control Office (DCO) 

(7407M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001 or 

submitted via courier to the 

Environmental Protection Agency, 

OPPT Document Control Office (DCO), 

EPA East Bldg., 1201 Constitution Ave., 

NW., Rm. 6428, Washington, DC 20004. 

Optical discs containing electronic 

notices or support documents must be 

submitted by courier to the 

Environmental Protection Agency, 

OPPT Document Control Office (DCO), 

EPA East Bldg., 1201 Constitution Ave., 

NW., Rm. 6428, Washington, DC 20004. 

Persons submitting on optical disc must 

also complete and submit on paper the 

Certification and Submitter 

Identification sections of EPA Form 

7710–25. 

(d) * * * 

(2) If information is claimed as 

confidential pursuant to § 720.80, a 

person who submits a notice to EPA in 

the manner set forth in § 720.40(a)(2)(i), 

(ii), or (iii) must also provide EPA with 

a sanitized copy. 

(e) Agency or joint submissions—(1) A 

manufacturer or importer may designate 

an agent to assist in submitting the 

notice. If so, only the manufacturer or 

importer, and not the agent, signs the 

certification on the form. 

(2) A manufacturer or importer may 

authorize another person, (e.g., a 

supplier or a toll manufacturer) to report 

some of the information required in the 

notice to EPA on its behalf. The 

manufacturer or importer should 

indicate in a cover letter accompanying 

the notice which information will be 

supplied by another person and must 

identify that other person as a joint 

submitter where indicated on their 

notice form. The other person supplying 

information (i.e., the joint submitter) 

may submit the information to EPA 

using either the notice form or a Letter 

of Support, except that if the joint 

submitter is not incorporated, licensed, 

or doing business in the United States, 

the joint submitter must submit the 

information to EPA in a Letter of 

Support only, not in a notice form. The 

joint submitter must indicate in the 

notice or Letter of Support the identity 

of the manufacturer or importer. Any 

person who submits a notice form or 

Letter of Support for a joint submission 

must sign and certify the notice form or 

Letter of Support. 

(3) Only the Authorized Official (AO) 

of a company can submit all TSCA 

section 5 documents. 

(i) The AO can authorize other 

persons to submit only support 

documents on their behalf. 

(ii) To authorize a support registrant 

to submit support documents, both the 

AO and support registrant must sign the 

‘‘Authorization and Verification for 

Section 5 Notice Support Submitter by 

Company Authorizing Official’’ 

available from the CDX website at 

http://cdx.epa.gov/epa_home.asp. 

* * * * * 

■ 6. Section 720.65 is amended by 

revising the section heading and 

paragraphs (a) and (c)(1)(iv) and adding 

paragraph (c)(x) to read as follows: 

§ 720.65 Acknowledgement of receipt of a 

notice; errors in the notice; incomplete 

submissions; and false and misleading 

statements. 

(a) Notification to the submitter. EPA 

will acknowledge receipt of each notice 

by sending a letter via CDX or U.S. mail 

to the submitter that identifies the 

premanufacture notice number assigned 

to the new chemical substance and date 

on which the review period begins. The 

review period will begin on the date the 

notice is received by the Office of 

Pollution Prevention and Toxics 

Document Control Officer. The 

acknowledgment does not constitute a 

finding by EPA that the notice, as 

submitted, is in compliance with this 

part. 

* * * * * 

(c) * * * 

(1) * * * 

(iv) The submitter does not submit the 

notice in the manner set forth in 

§ 720.40(a)(2). 

* * * * * 

(x) The submitter does not include an 

identifying number and a payment 

identity number as required by 40 CFR 

700.45(e)(3). 

* * * * * 


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■ 7. Section 720.75 is amended by 

revising paragraphs (b)(2) and (e)(1) and 

adding paragraphs (b)(3) and (b)(4) 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. 

(i) Older notices. Requests for 

suspension for premanufacture notices 

submitted before April 6, 2010 must be 

submitted on paper either via U.S. mail 

to the Document Control Office (DCO) 

(7407M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001 or 

submitted via courier to the 

Environmental Protection Agency, 

OPPT Document Control Office (DCO), 

EPA East Bldg., 1201 Constitution Ave., 

NW., Rm. 6428, Washington, DC 20004. 

(ii) Newer notices. For notices 

submitted on or after April 6, 2010, EPA 

will accept requests for suspension only 

if submitted in accordance with this 

paragraph: 

(A) Requests for suspension may be 

submitted on paper on or before April 

6, 2011. All paper-based requests for 

suspension must be generated using ePMN reporting software and be 

completed through the finalization step 

of the software, and e-PMN software 

must be used to print the request for 

suspension for submission to EPA. 

Paper requests for suspension must be 

submitted either via U.S. mail to the 

Document Control Office (DCO) 

(7407M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001 or 

submitted via courier to the 

Environmental Protection Agency, 

OPPT Document Control Office (DCO), 

EPA East Bldg., 1201 Constitution Ave., 

NW., Rm. 6428, Washington, DC 20004. 

(B) Requests for suspension may be 

submitted as electronic files on optical 

disc on or before April 6, 2012. All 

requests for suspension submitted as 

electronic files on optical disc generated 

using e-PMN reporting software and be 

completed through the finalization step 

of the software, and e-PMN software 

must be used to print the request for 

suspension for submission to EPA. 

Paper requests for suspension must be 

submitted either via U.S. mail to the 

Document Control Office (DCO) 

(7407M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001 or 

submitted via courier to the 

Environmental Protection Agency, 

OPPT Document Control Office (DCO), 

EPA East Bldg., 1201 Constitution Ave., 

NW., Rm. 6428, Washington, DC 20004. 

(C) Requests for suspension may be 

submitted electronically to EPA via 

CDX. Such requests must be generated 

and completed using e-PMN reporting 

software. See § 720.40(a)(2)(iv) for 

information on how to obtain e-PMN 

software. 

(3) An oral request for suspension 

may be granted by EPA for a maximum 

of 15 days only. Requests for a longer 

suspension must only be submitted in 

the manner set forth in this paragraph. 

(4) 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 written paper 

request, electronic request on optical 

disc, or CDX submission by EPA. 

* * * * * 

(e) * * * 

(1) 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 written paper request, electronic 

request on optical disc, or CDX 

submission by EPA. 

(i) Older notices. Statements of 

withdrawal for premanufacture notices 

submitted before April 6, 2010 must be 

submitted on paper either via U.S. mail 

to the Document Control Office (DCO) 

(7407M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001 or 

submitted via courier to the 

Environmental Protection Agency, 

OPPT Document Control Office (DCO), 

EPA East Bldg., 1201 Constitution Ave., 

NW., Rm. 6428, Washington, DC 20004. 

(ii) Newer notices. For notices 

submitted on or after April 6, 2010, EPA 

will accept statements of withdrawal 

only if submitted in accordance with 

this paragraph: 

(A) Statements of withdrawal may be 

submitted on paper on or before April 

6, 2011. All paper-based statements of 

withdrawal must be generated using ePMN reporting software and be 

completed through the finalization step 

of the software, and e-PMN software 

must be used to print the statement of 

withdrawal for submission to EPA. 

Paper statements of withdrawal must be 

submitted either via U.S. mail to the 

Document Control Office (DCO) 

(7407M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001 or 

submitted via courier to the 

Environmental Protection Agency, 

OPPT Document Control Office (DCO), 

EPA East Bldg., 1201 Constitution Ave., 

NW., Rm. 6428, Washington, DC 20004. 

(B) Statements of withdrawal may be 

submitted as electronic files on optical 

disc on or before April 6, 2012. All 

statements of withdrawal submitted as 

electronic files on optical disc must be 

generated using e-PMN reporting 

software and be completed through the 

finalization step of the software. Optical 

discs containing electronic statements of 

withdrawal must be submitted by 

courier to the Environmental Protection 

Agency, OPPT Document Control Office 

(DCO), EPA East Bldg., 1201 

Constitution Ave., NW., Rm. 6428, 

Washington, DC 20004. 

(C) Statements of withdrawal may be 

submitted electronically to EPA via 

CDX. Prior to submission to EPA via 

CDX, such statements of withdrawal 

must be generated and completed using 

e-PMN reporting software. See 

§ 720.40(a)(2)(iv) for information on 

how to obtain e-PMN software. 

* * * * * 

■ 8. Section 720.80 is amended by 

revising paragraph (b)(2)(i) to read as 

follows: 

§ 720.80 General provisions. 

* * * * * 

(b) * * * 

(2) * * * 

(i) The notice and attachments must 

be complete. The submitter must 

designate that information which is 

claimed as confidential in the manner 

prescribed on the notice form, via EPA’s 

e-PMN software. See § 720.40(a)(2)(iv) 

for information on how to obtain e-PMN 

software. 

* * * * * 

■ 9. Section 720.102 is amended by 

revising paragraphs (c)(1) introductory 

text and (d) to read as follows: 

§ 720.102 Notice of commencement of 

manufacture or import. 

* * * * * 

(c) * * * 

(1) The notice must be submitted on 

EPA Form 7710–56, which is available 

as part of EPA’s e-PMN software. See 

§ 720.40(a)(2)(iv) for information on 

how to obtain e-PMN software. The 

form must be signed and dated by an 

Authorized Official (AO). All 

information specified on the form must 

be provided. The notice must contain 

the following information: 

* * * * * 


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(d) Where to submit. All notices of 

commencement must be submitted to 

EPA on EPA Form 7710–56. Notices 

may only be submitted in a manner set 

forth in this paragraph. 

(1) Older notices. Notices of 

commencement for premanufacture 

notices submitted before April 6, 2010 

must be submitted on paper either via 

U.S. mail to the Document Control 

Office (DCO) (7407M), Office of 

Pollution Prevention and Toxics, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001 or submitted via courier 

to the Environmental Protection 

Agency, OPPT Document Control Office 

(DCO), EPA East Bldg., 1201 

Constitution Ave., NW., Rm. 6428, 

Washington, DC 20004. 

(2) Newer notices. For premanufacture 

notices submitted on or after April 6, 

2010, EPA will accept notices of 

commencement only if submitted in 

accordance with this paragraph: 

(i) Notices of commencement may be 

submitted on paper on or before April 

6, 2011. All paper-based notices of 

commencement must be generated using 

e-PMN reporting software and be 

completed through the finalization step 

of the software, and e-PMN software 

must be used to print the notice of 

commencement for submission to EPA. 

Paper notices of commencement must 

be submitted either via U.S. mail to the 

Document Control Office (DCO) 

(7407M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001 or 

submitted via courier to the 

Environmental Protection Agency, 

OPPT Document Control Office (DCO), 

EPA East Bldg., 1201 Constitution Ave., 

NW., Rm. 6428, Washington, DC 20004. 

(ii) Notices of commencement may be 

submitted as electronic files on optical 

disc on or before April 6, 2012. All 

notices of commencement submitted as 

electronic files on optical disc must be 

generated using e-PMN reporting 

software and be completed through the 

finalization step of the software. Optical 

discs containing electronic notices of 

commencement must be submitted by 

courier to the Environmental Protection 

Agency, OPPT Document Control Office 

(DCO), EPA East Bldg., 1201 

Constitution Ave., NW., Rm. 6428, 

Washington, DC 20004. 

(iii) Notices of commencement may be 

submitted electronically to EPA via CDX 

on or after April 6, 2010. After April 6, 

2012 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 reporting software. See 

§ 720.40(a)(2)(iv) for information on 

how to obtain e-PMN software. 

PART 721—[AMENDED] 

■ 10. The authority citation for part 721 

continues to read as follows: 

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

2625(c). 

■ 11. Section 721.25 is amended by 

revising paragraph (c) to read as follows: 

§ 721.25 Notice requirements and 

procedures. 

* * * * * 

(c) EPA will process the notice in 

accordance with the procedures of part 

720 of this chapter, except to the extent 

they are inconsistent with this part. 

* * * * * 

■ 12. Section 721.30 is amended by 

revising 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, unless allowed by 40 

CFR 720.40(a)(2)(i), (ii), or (iii), must 

submit the request to EPA via EPA’s 

Central Data Exchange (CDX) using 

EPA-provided e-PMN software in the 

manner set forth in 40 CFR 720.40(a)(2). 

See 40 CFR 720.40(a)(2)(iv) 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(a)(2)(i), (ii), or (iii). If submitted 

by paper, requests must be submitted 

either via U.S. mail to the Document 

Control Office (DCO) (7407M), Office of 

Pollution Prevention and Toxics, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; ATTN: SNUR 

Equivalency Determination or submitted 

via courier to the Environmental 

Protection Agency, OPPT Document 

Control Office (DCO), EPA East Bldg., 

1201 Constitution Ave., NW., Rm. 6428, 

Washington, DC 20004; ATTN: SNUR 

Equivalency Determination. Optical 

discs containing electronic requests 

must be submitted by courier to the 

Environmental Protection Agency, 

OPPT Document Control Office (DCO), 

EPA East Bldg., 1201 Constitution Ave., 

NW., Rm. 6428, Washington, DC 20004; 

ATTN: SNUR Equivalency 

Determination. A request for a 

determination of equivalency must 

contain: 

* * * * * 

PART 723—[AMENDED] 

■ 13. The authority citation for part 723 

continues to read as follows: 

Authority: 15 U.S.C. 2604. 

■ 14. Section 723.50 is amended by 

revising 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 the EPA at least 30 

days before manufacture of the new 

chemical substance begins. Unless 

allowed as described by 

§ 723.50(e)(1)(i), (e)(1)(ii), or (e)(1)(iii), 

exemption notices and modifications 

must be submitted to EPA on EPA Form 

No. 7710–25 via EPA’s Central Data 

Exchange (CDX) using EPA-provided ePMN reporting software in the manner 

set forth in this paragraph. Support 

documents related to these notices must 

also be submitted to EPA via CDX using 

e-PMN software in the manner set forth 

in this paragraph. See 40 CFR 

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

to obtain e-PMN software. 

(i) Paper-based submissions—(A) 

Such notices, and any support 

documents related to these notices, 

submitted before April 6, 2010 must be 

submitted on paper either via U.S. mail 

to the Document Control Office (DCO) 

(7407M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001 or 

submitted via courier to the 

Environmental Protection Agency, 

OPPT Document Control Office (DCO), 

EPA East Bldg., 1201 Constitution Ave., 

NW., Rm. 6428, Washington, DC 20004. 

(B) All other notices and related 

support documents may be submitted 

on paper on or before April 6, 2011. All 

paper-based notices must be generated 

using e-PMN reporting software and be 

completed through the finalization step 

of the software, and e-PMN software 

must be used to print EPA Form 7710– 

25 for submission to EPA. Paper notices 

must be submitted either via U.S. mail 

to the Document Control Office (DCO) 

(7407M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001 or 

submitted via courier to the 

Environmental Protection Agency, 


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OPPT Document Control Office (DCO), 

EPA East Bldg., 1201 Constitution Ave., 

NW., Rm. 6428, Washington, DC 20004. 

(ii) Submissions on optical disc—(A) 

Notices may be submitted as electronic 

files on optical disc on or before April 

6, 2012. Notices submitted as electronic 

files on optical disc must be generated 

using e-PMN reporting software and be 

completed through the finalization step 

of the software. Optical discs containing 

electronic notices must be submitted by 

courier to the Environmental Protection 

Agency, OPPT Document Control Office 

(DCO), EPA East Bldg., 1201 

Constitution Ave., NW., Rm. 6428, 

Washington, DC 20004. 

(B) Persons submitting on optical disc 

must still complete and submit on paper 

the Certification and Submitter 

Identification sections of EPA Form 

7710–25 accompanying the optical disc. 

(iii) Submissions via CDX—(A) On or 

after April 6, 2010, notices, and any 

related support documents, may be 

submitted electronically to EPA via 

CDX. Prior to submission to EPA via 

CDX, notices must be generated and 

completed on EPA Form 7710–25 using 

e-PMN reporting software. 

(B) On or after April 6, 2012, all 

notices must be generated and 

completed on EPA Form 7710–25 using 

e-PMN reporting software and 

submitted electronically, along with any 

support documents related to these 

notices, to EPA via CDX. 

(iv) Support documents for notices 

that are submitted before April 6, 2010 

must be submitted on paper either via 

U.S. mail to the Document Control 

Office (DCO) (7407M), Office of 

Pollution Prevention and Toxics, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001 or submitted via courier 

to the Environmental Protection 

Agency, OPPT Document Control Office 

(DCO), EPA East Bldg., 1201 

Constitution Ave., NW., Rm. 6428, 

Washington, DC 20004. 

* * * * * 

PART 725—[AMENDED] 

■ 15. The authority citation for part 725 

continues to read as follows: 

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

2625. 

■ 16. Section 725.25 is amended by 

revising paragraphs (c), (e)(1), and (e)(2) 

to read as follows: 

§ 725.25 General administrative 

requirements. 

* * * * * 

(c) Where to submit information 

under this part. MCANs and exemption 

requests, and any support documents 

related to these submissions, may only 

be submitted in a manner set forth in 

this paragraph. 

(1) Paper-based submissions. MCANs 

and exemption requests, and any 

support documents related to these 

submissions, may be submitted on 

paper on or before April 6, 2011. All 

paper-based submissions must be 

generated using e-PMN reporting 

software and be completed through the 

finalization step of the software, and ePMN software must be used to print the 

biotechnology notice submission to be 

sent to EPA. Paper notices must be 

submitted either via U.S. mail to the 

Document Control Office (DCO) 

(7407M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001 or 

submitted via courier to the 

Environmental Protection Agency, 

OPPT Document Control Office (DCO), 

EPA East Bldg., 1201 Constitution Ave., 

NW., Rm. 6428, Washington, DC 20004. 

(2) Submissions on optical disc—(i) 

MCANs and exemption requests may be 

submitted as electronic files on optical 

disc on or before April 6, 2012. MCANs 

and exemption requests submitted as 

electronic files on optical disc must be 

generated using e-PMN reporting 

software and be completed through the 

finalization step of the software. Optical 

discs containing electronic notices must 

be submitted by courier to the 

Environmental Protection Agency, 

OPPT Document Control Office (DCO), 

EPA East Bldg., 1201 Constitution Ave., 

NW., Rm. 6428, Washington, DC 20004. 

(ii) Persons submitting on optical disc 

must still prepare, sign, and submit on 

paper, the Certification statement in 40 

CFR 725.25(b) along with submitter 

identification and contact information. 

(iii) Support documents for MCANs or 

exemption requests that are submitted 

before April 6, 2010 must be submitted 

on paper either via U.S. mail to the 

Document Control Office (DCO) 

(7407M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001 or 

submitted via courier to the 

Environmental Protection Agency, 

OPPT Document Control Office (DCO), 

EPA East Bldg., 1201 Constitution Ave., 

NW., Rm. 6428, Washington, DC 20004. 

(3) Submissions via CDX. MCANs and 

exemption requests, and any related 

support documents, may be submitted 

electronically to EPA via CDX. Prior to 

submission to EPA via CDX, notices 

must be generated and completed on 

EPA Form 6300-07 using e-PMN 

reporting software. 

* * * * * 

(e) * * * 

(1) A manufacturer or importer may 

designate an agent to assist in 

submitting the MCAN. If so, only the 

manufacturer or importer, and not the 

agent, signs the certification on the 

form. 

(2) A manufacturer or importer may 

authorize another person, (e.g., a 

supplier or a toll manufacturer) to report 

some of the information required in the 

MCAN to EPA on its behalf. The 

manufacturer or importer should 

indicate in a cover letter accompanying 

the MCAN which information will be 

supplied by another person and identify 

that other person as a joint submitter 

where indicated in their MCAN. The 

other person supplying information (i.e., 

the joint submitter) may submit the 

information to EPA either in the MCAN 

or a Letter of Support, except that if the 

joint submitter is not incorporated, 

licensed, or doing business in the 

United States, the joint submitter must 

submit the information to EPA in a 

Letter of Support only, rather than the 

MCAN. The joint submitter must 

indicate in the MCAN or Letter of 

Support the identity of the manufacturer 

or importer. Any person who submits 

the MCAN or Letter of Support for a 

joint submission must sign and certify 

the MCAN or Letter of Support. 

* * * * * 

■ 17. Section 725.29 is amended by 

revising paragraph (a) to read as follows: 

§ 725.29 EPA acknowledgement of receipt 

of submission. 

(a) EPA will acknowledge receipt of 

each submission by sending a letter via 

CDX or U.S. mail to the submitter that 

identifies the number assigned to each 

MCAN or exemption request and the 

date on which the review period begins. 

The review period will begin on the 

date the MCAN or exemption request is 

received by the Office of Pollution 

Prevention and Toxics Document 

Control Officer. 

* * * * * 

■ 18. Section 725.33 is amended by 

adding paragraphs (a)(10) and (a)(11) to 

read as follows: 

§ 725.33 Incomplete submissions. 

(a) * * * 

(10) The submitter does not include 

an identifying number and a payment 

identity number as required by 

§ 700.45(e)(3) of this chapter. 


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(11) The submitter does not submit 

the notice in the manner set forth in 

§ 725.25(c). 

* * * * * 

■ 19. Section 725.36 is amended by 

revising paragraph (a) to read as follows: 

§ 725.36 New information. 

(a) During the review period, if a 

submitter possesses, controls, or knows 

of new information that materially adds 

to, changes, or otherwise makes 

significantly more complete the 

information included in the MCAN or 

exemption request, the submitter must 

send that information within 10 days of 

receiving the new information, but no 

later than 5 days before the end of the 

review period. The new information 

must be sent in the same manner the 

original notice or exemption was sent, 

as described in § 725.25(c)(1), (c)(2), and 

(c)(3). 

* * * * * 

■ 20. Section 725.54 is amended by 

revising paragraph (b) and adding 

paragraphs (c) and (d) to read as follows: 

§ 725.54 Suspension of the review period. 

* * * * * 

(b) 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. 

(1) Older notices. Requests for 

suspension for notices submitted before 

April 6, 2010 must be submitted on 

paper either via U.S. mail to the 

Document Control Office (DCO) 

(7407M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001 or 

submitted via courier to the 

Environmental Protection Agency, 

OPPT Document Control Office (DCO), 

EPA East Bldg., 1201 Constitution Ave., 

NW., Rm. 6428, Washington, DC 20004. 

(2) Newer notices. For notices 

submitted on or after April 6, 2010, EPA 

will accept requests for suspension only 

if submitted in accordance with this 

paragraph: 

(i) Requests for suspension may be 

submitted on paper on or before April 

6, 2011. All paper-based requests for 

suspension must be generated using ePMN reporting software and be 

completed through the finalization step 

of the software, and e-PMN software 

must be used to print the request for 

suspension for submission to EPA. 

Paper requests for suspension must be 

submitted either via U.S. mail to the 

Document Control Office (DCO) 

(7407M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001 or 

submitted via courier to the 

Environmental Protection Agency, 

OPPT Document Control Office (DCO), 

EPA East Bldg., 1201 Constitution Ave., 

NW., Rm. 6428, Washington, DC 20004. 

(ii) Requests for suspension may be 

submitted as electronic files on optical 

disc on or before April 6, 2012. All 

requests for suspension submitted as 

electronic files on optical disc generated 

using e-PMN reporting software and be 

completed through the finalization step 

of the software, and e-PMN software 

must be used to print the request for 

suspension for submission to EPA. 

Paper requests for suspension must be 

submitted either via U.S. mail to the 

Document Control Office (DCO) 

(7407M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001 or 

submitted via courier to the 

Environmental Protection Agency, 

OPPT Document Control Office (DCO), 

EPA East Bldg., 1201 Constitution Ave., 

NW., Rm. 6428, Washington, DC 20004. 

(iii) Requests for suspension may be 

submitted electronically to EPA via 

CDX. Such requests must be generated 

and completed using e-PMN reporting 

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

information on how to obtain e-PMN 

software. 

(c) An oral request for suspension 

may be granted by EPA for a maximum 

of 15 days only. Requests for longer 

suspension must only be submitted in 

the manner set forth in this paragraph. 

(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 written paper 

request, electronic request on optical 

disc, or CDX submission by EPA. 

■ 21. Section 725.60 is amended by 

revising paragraph (a) to read as follows: 

§ 725.60 Withdrawal of submission by the 

submitter. 

(a) 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 written paper request, electronic 

request on optical disc, or CDX 

submission by EPA. 

(1) Older notices. Statements of 

withdrawal for notices submitted before 

April 6, 2010 must be submitted on 

paper either via U.S. mail to the 

Document Control Office (DCO) 

(7407M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001 or 

submitted via courier to the 

Environmental Protection Agency, 

OPPT Document Control Office (DCO), 

EPA East Bldg., 1201 Constitution Ave., 

NW., Rm. 6428, Washington, DC 20004. 

(2) Newer notices. For notices 

submitted on or after April 6, 2010, EPA 

will accept statements of withdrawal 

only if submitted in accordance with 

this paragraph: 

(i) Statements of withdrawal may be 

submitted on paper on or before April 

6, 2011. All paper-based statements of 

withdrawal must be generated using ePMN reporting software and be 

completed through the finalization step 

of the software, and e-PMN software 

must be used to print the statement of 

withdrawal for submission to EPA. 

Paper statements of withdrawal must be 

submitted either via U.S. mail to the 

Document Control Office (DCO) 

(7407M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001 or 

submitted via courier to the 

Environmental Protection Agency, 

OPPT Document Control Office (DCO), 

EPA East Bldg., 1201 Constitution Ave., 

NW., Rm. 6428, Washington, DC 20004. 

(ii) Statements of withdrawal be 

submitted as electronic files on optical 

disc on or before April 6, 2012. All 

statements of withdrawal submitted as 

electronic files on optical disc must be 

generated using e-PMN reporting 

software and be completed through the 

finalization step of the software. Optical 

discs containing electronic statements of 

withdrawal must be submitted by 

courier to the Environmental Protection 

Agency, OPPT Document Control Office 

(DCO), EPA East Bldg., 1201 

Constitution Ave., NW., Rm. 6428, 

Washington, DC 20004. 

(iii) Statements of withdrawal may be 

submitted electronically to EPA via 

CDX. Prior to submission to EPA via 

CDX, such statements of withdrawal 

must be generated and completed using 

e-PMN reporting software. See 40 CFR 

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

to obtain e-PMN software. 

* * * * * 

■ 22. Section 725.67 is amended by 

revising paragraph (a)(1) to read as 

follows: 

§ 725.67 Applications to exempt new 

microorganisms from this part. 

(a) * * * 

(1) Any manufacturer or importer of a 

new microorganism may request, under 

TSCA section 5(h)(4), an exemption, in 

whole or in part, from this part by 


cprice-sewell on DSK2BSOYB1PROD with RULES
790 Federal Register / Vol. 75, No. 3 / Wednesday, January 6, 2010 / Rules and Regulations 

sending a Letter of Application in the 

manner set forth in § 725.25(c). 

* * * * * 

■ 23. Section 725.190 is amended by 

revising paragraph (d) to read as 

follows: 

§ 725.190 Notice of commencement of 

manufacture or import. 

* * * * * 

(d) Where to submit. All notices of 

commencement must be submitted to 

EPA in a manner set forth in this 

paragraph. 

(1) Older notices. Notices of 

commencement for a MCAN submitted 

before April 6, 2010 must be submitted 

on paper either via U.S. mail to the 

Document Control Office (DCO) 

(7407M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001 or 

submitted via courier to the 

Environmental Protection Agency, 

OPPT Document Control Office (DCO), 

EPA East Bldg., 1201 Constitution Ave., 

NW., Rm. 6428, Washington, DC 20004. 

(2) Newer notices. For MCANs 

submitted on or after April 6, 2010, EPA 

will accept notices of commencement 

only if submitted in accordance with 

this paragraph: 

(i) Notices of commencement may be 

submitted on paper on or before April 

6, 2011. All paper-based notices of 

commencement must be generated using 

e-PMN reporting software and be 

completed through the finalization step 

of the software, and e-PMN software 

must be used to print the statement of 

withdrawal for submission to EPA. 

Paper notices of commencement must 

be submitted either via U.S. mail to the 

Document Control Office (DCO) 

(7407M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001 or 

submitted via courier to the 

Environmental Protection Agency, 

OPPT Document Control Office (DCO), 

EPA East Bldg., 1201 Constitution Ave., 

NW., Rm. 6428, Washington, DC 20004. 

(ii) Notices of commencement may be 

submitted as electronic files on optical 

disc on or before April 6, 2012. All 

notices of commencement submitted as 

electronic files on optical disc must be 

generated using e-PMN reporting 

software and be completed through the 

finalization step of the software. Optical 

discs containing electronic notices of 

commencement must be submitted by 

courier to the Environmental Protection 

Agency, OPPT Document Control Office 

(DCO), EPA East Bldg., 1201 

Constitution Ave., NW., Rm. 6428, 

Washington, DC 20004. 

(iii) Notices of commencement may be 

submitted electronically to EPA via CDX 

on or after April 6, 2010. After April 6, 

2012 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 reporting software. See 40 CFR 

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

to obtain e-PMN software. 

■ 24. Section 725.975 is amended by 

revising 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, unless allowed by 

§ 725.25(c) (1), (2), or (3), must submit 

the request to EPA via EPA’s Central 

Data Exchange (CDX) using EPAprovided e-PMN software in the manner 

set forth in § 725.25(c). See 40 CFR 

720.40(a)(2)(iv) 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. If submitted on 

paper, requests must be submitted either 

via U.S. mail to the Document Control 

Office (DCO) (7407M), Office of 

Pollution Prevention and Toxics, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; ATTN: SNUR 

Equivalency Determination or submitted 

via courier to the Environmental 

Protection Agency, OPPT Document 

Control Office (DCO), EPA East Bldg., 

1201 Constitution Ave., NW., Rm. 6428, 

Washington, DC 20004; ATTN: SNUR 

Equivalency Determination. Optical 

discs containing electronic requests 

must be submitted by courier to the 

Environmental Protection Agency, 

OPPT Document Control Office (DCO), 

EPA East Bldg., 1201 Constitution Ave., 

NW., Rm. 6428, Washington, DC 20004; 

ATTN: SNUR Equivalency 

Determination. A request for a 

determination of equivalency must 

contain: 

* * * * * 

■ 25. Section 725.984 is amended by 

revising 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 by 

writing to the Director, or a designee, 

and stating the basis for such request. 

The request must be accompanied by 

information sufficient to support the 

request. Persons submitting a request to 

EPA under this part, unless allowed by 

§ 725.25(c)(1), (c)(2), or (c)(3), must 

submit the request to EPA via EPA’s 

Central Data Exchange (CDX) using 

EPA-provided e-PMN reporting software 

in the manner set forth in § 725.25(c). 

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

information on how to obtain the e-PMN 

software. Support documents related to 

these requests must also be submitted to 

EPA via CDX using e-PMN software. 

Paper requests must be submitted either 

via U.S. mail to the Document Control 

Office (DCO) (7407M), Office of 

Pollution Prevention and Toxics, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; ATTN: Request to 

Amend SNUR or submitted via courier 

to the Environmental Protection 

Agency, OPPT Document Control Office 

(DCO), EPA East Bldg., 1201 

Constitution Ave., NW., Rm. 6428, 

Washington, DC 20004; ATTN: Request 

to Amend SNUR. Optical discs 

containing electronic requests must be 

submitted by courier to the 

Environmental Protection Agency, 

OPPT Document Control Office (DCO), 

EPA East Bldg., 1201 Constitution Ave., 

NW., Rm. 6428, Washington, DC 20004; 

ATTN: Request to Amend SNUR. 

* * * * * 

[FR Doc. E9–31004 Filed 1–5–10; 8:45 am] 

BILLING CODE 6560–50–S 

GENERAL SERVICES 

ADMINISTRATION 

41 CFR Part 301–10 

[FTR Amendment 2010–01; FTR Case 2010– 

301; Docket Number 2009–0020, Sequence 

1] 

RIN 3090–AJ01 

Federal Travel Regulation; Privately 

Owned Vehicle Mileage 

Reimbursement 

AGENCY: Office of Governmentwide 

Policy, General Services Administration 

(GSA). 

ACTION: Final rule. 

SUMMARY: GSA is amending the Federal 

Travel Regulation (FTR) to update the 

mileage reimbursement rates for using a 

privately owned automobile (POA), 

motorcycle or airplane for official travel. 

The new rates reflect the current vehicle 

operating costs as determined by 


cprice-sewell on DSK2BSOYB1PROD with RULES