## Electronic Toxic Substances Control Act

(eTSCA)/e-PMN Reporting Tool

User’s Guide

Version 1.2 December 28, 2009eTSCA Tool User Guide Table of Contents

December 28, 2009 i 

### Table of Contents

Version 1.2........................................

................................................... .......................................1 November 20, 2009 ..................................

................................................... ...............................1

1 Introduction .......................................

................................................... ..............................6

2 Getting Started ....................................

................................................... ............................7

2.1 System Requirements ................................

................................................... ...............7

2.2 Installation .......................................

................................................... ..........................7

2.2.1 Web Start Installation (with encryption)...........

................................................... .....7

2.2.2 InstallAnywhere CD Installation ....................

................................................... .....10
2.3 Uninstalling the eTSCA/e-PMN software ..............

................................................... ...13

2.4 The User Interface.................................

................................................... ..................14
2.5 Creating a new Project .............................

................................................... ...............15
2.6 Navigation .........................................

................................................... ......................17
2.6.1 Navigating using only the keyboard .................

................................................... ..17
3 Using the eTSCA/e-PMN Reporting Software ...........

................................................... ....18
3.1 Saving a project...................................

................................................... ....................18
3.2 Closing a project..................................

................................................... ....................19
3.3 Opening an existing project ........................

................................................... .............19
3.4 Getting User Help..................................

................................................... ..................20
3.4.1 Page-level Help ....................................

................................................... .............20
3.4.2 Field-level Help...................................

................................................... ...............21
3.4.3 Application-level Help .............................

................................................... ...........22
3.5 Confidential Business Information (CBI) ............

................................................... ......23
3.6 Contact Profiles ...................................

................................................... ....................23
3.7 Validation.........................................

................................................... ........................26
3.7.1 Field-level Validation.............................

................................................... .............26
3.7.2 Application-level Validation .......................

................................................... .........26
3.8 Printing ...........................................

................................................... .........................27
3.9 Attachments ........................................

................................................... ....................33

4 Central Data Exchange (CDX)........................

................................................... ...............35
5 Pre-Manufacture Notice Form ........................

................................................... ...............36
5.1 Usage..............................................

................................................... ........................36
5.2 PMN Navigation.....................................

................................................... ..................36
5.3 Consolidated Submissions ...........................

................................................... ...........36eTSCA Tool User Guide Table of Contents

December 28, 2009 ii 5.4 PMN-specific actions ...............................

................................................... ................38
5.4.1 Sanitization .......................................

................................................... .................38
5.4.2 Adding, Deleting or Cloning a PMN page............. .................................................40
5.5 PMN Pages ..........................................

................................................... ...................41
6 Notice of Commencement Form........................

................................................... ............42
6.1 Usage..............................................

................................................... ........................42
6.2 Notice of Commencement tab .........................

................................................... ........42
6.3 CBI Substantiation tab.............................

................................................... ................44
6.4 Optional Cover Letter tab..........................

................................................... ...............44
6.5 Printed PDF form sample ............................

................................................... ............45

7 Biotechnology Form (MCAN, TERA, TIER I & TIER 2) ... ..................................................4 6

7.1 Regulation .........................................

................................................... ......................46

7.2 Screenshot .........................................

................................................... .....................47
7.3 Printed PDF Form Sample............................

................................................... ...........48
8 PMN Support Document Form ..........................

................................................... ............49
8.1 Usage..............................................

................................................... ........................49
8.2 Screenshot .........................................

................................................... .....................50
8.3 Printed PDF Form sample ............................

................................................... ...........51
9 Submission Process.................................

................................................... .....................52
9.1 Finalize Command...................................

................................................... ................52
9.2 Paper Submission ...................................

................................................... ................53
9.3 CD Submission......................................

................................................... ..................53
9.4 Online CDX Submission ..............................

................................................... ............54
9.4.1 User Certificate and Key Pair Generation ........... ..................................................5 7
9.5 Transaction History................................

................................................... ..................62
9.5.1 Transaction Details ................................

................................................... ............62
10 Administrator’s Guide ..............................

............................ Error! Bookmark not defined.

11 Contact Information................................

................................................... .......................66eTSCA CDX Registration Guide List of Exhibits

December 28, 2009 iii

Use of the data contained herein is subject to CGI Federal restrictions and applicable Federal Acquisition Data Rights Clau ses 

### List of Exhibits
Figure 2-1 MyCDX Page / Link to eTSCA/e-PMN softwar e download ......................................... 8 Figure 2-2 eTSCA/e-PMN software download page......

................................................... ...........8 Figure 2-3 Display Blocked Content option ..........

................................................... ....................9 Figure 2-4 eTSCA/e-PMN Java WebStart software downl oad................................................ .....9 Figure 2-5 eTSCA/e-PMN Client Lite launch ..........

................................................... ................10 Figure 2-6 eTSCA/e-PMN software load ...............

................................................... .................10 Figure 2-7 Install Anywhere Installation...........

................................................... .......................11 Figure 2-8 Install Anywhere Wizard Introduction ....

................................................... ................11 Figure 2-9 Install Anywhere Wizard Installing......

................................................... ...................12 Figure 2-10 Install Anywhere Wizard Install Complet e .................................................. ............12 Figure 2-11 Control Panel Add or Remove Programs ...

................................................... .........13 Figure 2-12 Confirm eTSCA/e-PMN software removal...

................................................... ........14 Figure 2-13 eTSCA/e-PMN software welcome screen ....

................................................... .......14 Figure 2-14 New Project Selection Window ...........

................................................... ................15 Figure 2-15 Project Types Tables ...................

................................................... .......................15 Figure 2-16 Name File Window.......................

................................................... .......................16 Figure 2-17 eTSCA/e-PMN software user interface ....

................................................... ...........16 Figure 2-18 Navigation Pane........................

................................................... ..........................17 Figure 2-19 Navigation arrows ......................

................................................... .........................17 Figure 3-1 File saved with validation errors.......

................................................... .....................18 Figure 3-2 File saved without validation errors ....

................................................... ...................18 Figure 3-3 Closing a project .......................

................................................... ............................19 Figure 3-4 Opening an existing project.............

................................................... ......................19 Figure 3-5 Selecting an existing project...........

................................................... .......................20 Figure 3-6 Toolbar .................................

................................................... ................................20 Figure 3-7 Dynamic Help Window.....................

................................................... .....................21 Figure 3-8 Field Question Mark Help Icons ..........

................................................... ..................21 Figure 3-9 Field Specific Help Window..............

................................................... .....................22 Figure 3-10 Application Help.......................

................................................... ...........................22 Figure 3-11 Confidential Business Information......

................................................... .................23 Figure 3-12 Profiles List Window...................

................................................... .........................23 Figure 3-13 Create/Edit Profile Window .............

................................................... ....................24 Figure 3-14 Submitted Identification...............

................................................... ........................25 Figure 3-15 Using a stored profile .................

................................................... .........................25 Figure 3-16 Profile information transferred........

................................................... .....................26 Figure 3-17 Field-level validation.................

................................................... ...........................26 Figure 3-18 Toolbar Validation icon................

................................................... ........................27eTSCA CDX Registration Guide List of Exhibits

December 28, 2009 iv

Use of the data contained herein is subject to CGI Federal restrictions and applicable Federal Acquisition Data Rights Clau ses Figure 3-19 Application-level validation...........

................................................... .......................27 Figure 3-20 Printing from the File menu ............

................................................... .....................28 Figure 3-21 Printing from the toolbar icon .........

................................................... .....................28 Figure 3-22 Saving a PDF...........................

................................................... ...........................28 Figure 3-23 PMN Sample Output ......................

................................................... .....................29 Figure 3-24 Notice of Commencement sample output...

................................................... .........30 Figure 3-25 PMN Support Document sample output .....

................................................... .........31 Figure 3-26 Biotech sample output..................

................................................... .......................32 Figure 3-27 Attachment Dialog Box..................

................................................... ......................34 Figure 5-1 Navigator Windows with titled by page na me and page number ..............................36 Figure 5-2 PMN Form: PNC Number ....................

................................................... .................37 Figure 5-3 Denoting a consolidated PMN.............

................................................... ..................38 Figure 5-4 Sanitizing a PMN ........................

................................................... ..........................39 Figure 5-5 Sanitized file required .................

................................................... ..........................39 Figure 5-6 Cloning a chemical group................

................................................... ......................40 Figure 5-7 Navigation for chemical cloning or delet ion ................................................ ..............40 Figure 5-8 Adding a PMN page.......................

................................................... .......................41 Figure 5-9 Cloning a PMN page......................

................................................... .......................41 Figure 6-1 Notice of Commencement main form tab ....

................................................... ..........43 Figure 6-2 Sample PDF NOC form....................

................................................... ....................45 Figure 7-1 Biotech Form ............................

................................................... ............................47 Figure 7-2 PDF Biotech Form sample .................

................................................... ...................48 Figure 8-1 PMN Support Document Form...............

................................................... ...............50 Figure 8-2 PMN Support Document PDF Sample Form....

................................................... .....51 Figure 9-1 Cannot finalize due to validation errors

................................................... .................52 Figure 9-2 New report number generated .............

................................................... .................52 Figure 9-3 Finalize Submission Dialog Box..........

................................................... ..................53 Figure 9-4 Login to CDX from eTSCA/e-PMN software..

................................................... ........55 Figure 9-5 Finalization in progress ................

................................................... .........................55 Figure 9-6 Select destination for finalized file ...

................................................... ......................56 Figure 9-7 Node Client.............................

................................................... ..............................57 Figure 9-8 CROMERR page ............................

................................................... ......................58 Figure 9-9 20-5-1 Security Question ................

................................................... ......................58 Figure 9-10 Submission in progress.................

................................................... ......................59 Figure 9-11 Document submitted to CDX..............

................................................... .................59 Figure 9-12 Transaction Details tab ................

................................................... .......................60 Figure 9-13 E-mail Submission Notification.........

................................................... ...................61 Figure 9-14 Copy of Record Available for Download..

................................................... ............61eTSCA CDX Registration Guide List of Exhibits

December 28, 2009 v
Use of the data contained herein is subject to CGI Federal restrictions and applicable Federal Acquisition Data Rights Clau ses Figure 9-15 Transaction Search and Results .........

................................................... ................62 Figure 9-16 Audit Details Dialog...................

................................................... ..........................63 Figure 9-17 Save Downloaded File ...................

................................................... .....................64eTSCA CDX Registration Guide Introduction

December 28, 2009 vi

Use of the data contained herein is subject to CGI Federal restrictions and applicable Federal Acquisition Data Rights Clau ses 

### Revision Log

Date Version

No. Description Author Reviewer Review Date
11/20/09 1.0 Updated to reflect Web Start changes L . Kramer V. Tran-Lam 11/18/09eTSCA CDX Registration Guide Introduction

December 28, 2009 6 

### 1 Introduction
The eTSCA/e-PMN reporting software is a multi-funct ion desktop application that helps industry comply with TSCA by providing a user-friendly inter face for the submission of various TSCArelated forms to the Environmental Protection Agenc y (EPA).

The eTSCA/e-PMN reporting software is able to perfo rm the following main functionalities:

• Create an electronic version of the Premanufacture Notice Form (PMN)

• Create an electronic version of the Notice of Comme ncement Form (NOC)

• Create an electronic version of the Biotech form

• Create a supporting/supplemental form to submit inf ormation for a previously submitted PMN

• Validate the data in a form

• Sanitize PMN data

• Create PDF versions of a form suitable for printing

• Allow attachments

• Edit form data

• Save incomplete form data

• Open a previously saved form

• Provide integrated help

• Allow forms to be submitted on paper, on CD, or onl ine.

• Be standalone and platform-independenteTSCA CDX Registration Guide Getting Started

December 28, 2009 7 

### 2 Getting Started 2.1 System Requirements Systems must meet the following set of minimum requ irements to run the eTSCA/e-PMN software:

Machine Specifications

• 200 MB Hard Drive Space

• 1GB RAM

• 500Mhz Pentium PC or equivalent (2.0 Ghz recommende d)

• 800 x 600 screen resolution (1280 x 1024 recommende d) Operating System

• Windows XP

• Mac OSX

• Linux Fedora 10 Browser

• Internet Explorer 6 or higher

• Firefox 3.5 or higher

• Safari 4 or higher Additional Software

• Java Version 6 or greater

• Java Web Start version 1.6 or greater

These requirements reflect those of Java Web Start version 1.6. For questions concerning Java requirements, please refer to the Sun Microsystems website at http://java.sun.com

. For questions concerning the eTSCA/e-PMN software r equirements, please contact the CDX Help Desk at helpdesk@epacdx.net or call 1-888-890-1995 between the hours of 8am – 6pm EST. 2.2 Installation There are two methods for installing the eTSCA/e-PM N software. The Web Start installation option can be accessed and downloaded via two CDX i nternet sites. The version of the eTSCA/e-PMN software with encryption requires a CDX login, whereas the version of the software without encryption can be accessed at https://cdx.epa.gov/ssl/cdx/eTSCADownloadLiteClient.asp . The InstallAnywhere version runs off a CD and ma y be more suitable for users without an internet connection. 2.2.1 Web Start Installation (with encryption) To download the eTSCA/e-PMN reporting software from the CDX website, log in normally to http://cdx.epa.gov. The installation files can be r etrieved from the “TSCA: eTSCA Client Download” link located on the user’s MyCDX page [Fi gure 2-1]. This link will only appear if the user has registered and been approved under th e TSCA Program.eTSCA CDX Registration Guide Getting Started

December 28, 2009 8

Figure 2-1 MyCDX Page / Link to eTSCA/e-PMN softwar e download

The page seen in Figure 2-2 contains a link to the install file for the eTSCA/e-PMN software. There are two (2) versions of the software: a full version and a lite version. The full client includes all of the required encryption libraries t o enable online file submission, whereas the lite client does not include the encryption libraries an d submissions must be made via CD. Note that only the full client is available for download from this page. To download the lite client, users must visit https://cdx.epa.gov/ssl/cdx/eTSCA-DownloadLiteClien t.asp

.

Figure 2-2 eTSCA/e-PMN software download pageeTSCA CDX Registration Guide Getting Started

December 28, 2009 9 To download a file, simply click the “Download Clie nt” button. If browser issues arise with security certificates, the download may be blocked. This can be remedied by allowing blocked content, as seen in Figure 2-3 below. Figure 2-3 Display Blocked Content option

Users may be prompted to download an updated versio n of Java before installing the eTSCA/ePMN Client. When the download starts, the screen wi ll look similar to the image seen below in Figure 2-4. Figure 2-4 eTSCA/e-PMN Java WebStart software downl oadeTSCA CDX Registration Guide Getting Started

December 28, 2009 10 Once downloaded, the eTSCA/e-PMN software will auto matically launch [Figure 2-5] and load the application [Figure 2-6].

Figure 2-5 eTSCA/e-PMN Client Lite launch

Figure 2-6 eTSCA/e-PMN software load

Once the software has loaded, a shortcut icon will appear on the user’s desktop. 2.2.2 InstallAnywhere CD Installation To install from a CD, navigate to the correct folde r corresponding to the operating system and double click the .exe file. Once the file is execut ed, follow the on-screen directions to install the eTSCA/e-PMN reporting software. Users with a previo us version of the program should uninstall first before installing the updated versi on. A system restart will be required after installation is complete.eTSCA CDX Registration Guide Getting Started

December 28, 2009 11 Double click on the install file and InstallAnywher e begins the installation process.

Figure 2-7 Install Anywhere Installation

Figure 2-8 Install Anywhere Wizard IntroductioneTSCA CDX Registration Guide Getting Started

December 28, 2009 12 Figure 2-9 Install Anywhere Wizard Installing

Figure 2-10 Install Anywhere Wizard Install Complet eeTSCA CDX Registration Guide Getting Started

December 28, 2009 13 2.3 Uninstalling the eTSCA/e-PMN software Uninstalling the eTSCA/e-PMN software can be done t hrough the operating system’s Control Panel Add or Remove Programs option.

Figure 2-11 Control Panel Add or Remove Programs

Windows will prompt the user to confirm removal of the eTSCA/e-PMN client, as seen in Figure 2-12 below.eTSCA CDX Registration Guide Getting Started

December 28, 2009 14

Figure 2-12 Confirm eTSCA/e-PMN software removal

Clicking the “Cancel” button will cancel un-install ation. The “OK” button will proceed with software removal. Once complete, the software will no longer be listed amongst the other applications in the Add or Remove Program control p anel, and will be absent from the Programs folder of the user’s start menu. 2.4 The User Interface The following welcome screen appears when the eTSCA /e-PMN reporting software is first started.

Figure 2-13 eTSCA/e-PMN software welcome screeneTSCA CDX Registration Guide Getting Started

December 28, 2009 15 The left side navigation pane allows users to maneu ver between forms, while the editor window on the right provides a space for the user to view and complete these forms. 2.5 Creating a new Project New projects can be created by clicking on the “ Create New Form ” button ( ) or selecting this option from the File menu. A new window will appear prompting the user to select a project type. Figure 2-14 New Project Selection Window

There are four (4) project type options as seen in the figure below.

Figure 2-15 Project Types Tables

Project Types
Name File Extension Pre-manufacture Notice (PMN) .pmn_tsca

PMN Support Document .sup_tsca

Notice of Commencement (NOC) .noc_tsca

Biotech (MCANS, TERA, TIER I & TIER II) .bio_tsca

After a selection is made, the user will be asked t o name the project.eTSCA CDX Registration Guide Getting Started

December 28, 2009 16 Figure 2-16 Name File Window

The project is created and the main user interface is displayed.

Figure 2-17 eTSCA/e-PMN software user interfaceeTSCA CDX Registration Guide Getting Started

December 28, 2009 17 2.6 Navigation Navigating the eTSCA/e-PMN software is simple and i ntuitive. Most users will move through the forms in the navigation pane simply by using a mouse. Clicking on a section will highlight the title and open the corresponding form in the fo rm editor window.

Figure 2-18 Navigation Pane

The left-right arrows on the upper-right corner of the toolbar [Figure 2-19] can be used as well.

Figure 2-19 Navigation arrows

2.6.1 Navigating using only the keyboard For users who prefer to work without a mouse, there are a number of keyboard shortcuts to navigate the eTSCA/e-PMN software. When the applica tion focus is on the navigator window, the Up Arrow and Down Arrow will move forward and backward respectively through the forms in the navigation pane. Pressing Ctrl+F will manually give focus to the form editor window

. With the application focus on this window, the Ctrl + Right Arrow and Ctrl + Left Arrow combinations will work to traverse the forms. Pres sing the Tab button will toggle between fields within a form. If a table is encount ered, tabbing will only move the focus amongst fields within that table. To exit the table and mov e the focus to the field following the table, press Ctrl+Tab

.eTSCA CDX Registration Guide Using the eTSCA/e-PMN Reporting Software

December 28, 2009 18 

### 3 Using the eTSCA/e-PMN Reporting Software 3.1 Saving a project Projects can be saved in an incomplete state to be finished later. Note that incomplete forms cannot be submitted to EPA. When Save or Save As is selected from the toolbar or the file menu, eTSCA/e-PMN automatically runs a validation c heck on the currently open form. If there are validation errors (due to invalid data or incom plete fields), the error message seen in Figure 3-1 will appear, stating that the file was saved wi th validation errors. A validation window will appear at the bottom of the screen detailing the er rors.

Figure 3-1 File saved with validation errors

Double-clicking one of the listed items in the vali dation window will allow users to jump to the page of the error for easy correction.

Saving a file without any validation errors produce s the following dialog box, seen in Figure 3-2.

Figure 3-2 File saved without validation errorseTSCA CDX Registration Guide Using the eTSCA/e-PMN Reporting Software

December 28, 2009 19 3.2 Closing a project Projects can be closed by selecting the Close command from the File menu. Selecting the Exit command from the File menu will close the application completely.

Figure 3-3 Closing a project

3.3 Opening an existing project Opening an existing project is similar to creating a new one. Simply select the Open an Existing Form button ( ) or choose Open an Existing Form from the File menu to pop up the dialog box. Selecting a file type will filter the files th at will appear on the following screen for file selection.

Figure 3-4 Opening an existing projecteTSCA CDX Registration Guide Using the eTSCA/e-PMN Reporting Software

December 28, 2009 20 After selecting a form type, a file dialog box will appear prompting the user to select the desired file to be opened. Users will only see projects of the type they have selected in the previous step. Double-clicking or highlighting and clicking the OK button will select the file that the eTSCA/ePMN software will open.

Figure 3-5 Selecting an existing project

3.4 Getting User Help 3.4.1 Page-level Help Pressing the Question Mark button ( ) on the top right side of the toolbar [Figure 3-6 below] will activate the dynamic help window, which provid es contextual help specifically for the page currently open on the form.

Figure 3-6 ToolbareTSCA CDX Registration Guide Using the eTSCA/e-PMN Reporting Software

December 28, 2009 21 Figure 3-7 Dynamic Help Window

3.4.2 Field-level Help Specific fields and sections may also contain the Question Mark icon [Figure 3-8]. Pressing this icon will launch a pop-up window with informat ion specific to that field or section, as seen in Figure 3-9 below.

Figure 3-8 Field Question Mark Help IconseTSCA CDX Registration Guide Using the eTSCA/e-PMN Reporting Software

December 28, 2009 22 Figure 3-9 Field Specific Help Window

3.4.3 Application-level Help Application-level help is available by choosing the Help Contents menu item in the Help menu or by pressing F1 . A separate help window will appear.

Figure 3-10 Application HelpeTSCA CDX Registration Guide Using the eTSCA/e-PMN Reporting Software

December 28, 2009 23 3.5 Confidential Business Information (CBI) Fields marked as CBI are highlighted in red for eas ier identification. These fields will be stripped out when a sanitized version is created. (See secti on 5.4.1 for details on sanitation). Some fields allow for curvy brackets (e.g., {CBI name}) to desi gnate CBI. Any data between the curvy brackets in these large text fields will be replace d with XXX in the sanitized version.

Figure 3-11 Confidential Business Information

3.6 Contact Profiles Profiles make form completion more efficient by all owing users to pre-establish and save static information. With the simple click of a button, use rs can fill in contact information fields such as name, address, phone number, etc. or site informati on fields such as address and site name. Profiles are not Notice-specific. Once a profile is established for a current Notice, that profile is stored on the user’s local machine (as profiles.xml ) and can be utilized later for any other eTSCA/e-PMN project. eTSCA/e-PMN has the ability to store multiple profiles.

A profile can be added/modified by choosing Create/Edit Profile from the Tools menu or by clicking on the Profile button ( ) in the toolbar. The following window will appear. Figure 3-12 Profiles List Window

The box displays a list of profiles currently store d on the machine. Clicking Edit or New will bring up the Create/Edit Profile dialog box, as see n in Figure 3-13 below. To edit an existing profile, highlight the profile name and click the Edit button.eTSCA CDX Registration Guide Using the eTSCA/e-PMN Reporting Software

December 28, 2009 24 Figure 3-13 Create/Edit Profile Window

Existing profiles will display all fields currently populated, as well as any blank fields. New profiles will display all blank fields. The Profile ID field is used to identify the profile in the Profiles List dialog box—this field is required. Al l other fields are optional. To save the profile information, click the OK button.

Note: If creating a profile for a user registered with t he Central Data Exchange (CDX), it is imperative that the First Name

, Last Name , and Company fields remain consistent with the information entered at the point of CDX registratio n. This information will be used for authentication. Incorrectly entered information wil l not pass validation upon submission via CDX.

To use a profile within a form or dialog box, look for the “ Copy from Profile ” or “ Profile ” link wherever a contact or site information section is l ocated on a form or dialog box.

Figure 3-14 below exemplifies a section where a pro file may be used.eTSCA CDX Registration Guide Using the eTSCA/e-PMN Reporting Software

December 28, 2009 25 Figure 3-14 Submitted Identification

Clicking the “ Copy from Profile ” section will display the Profiles List dialog box , as seen below.

Figure 3-15 Using a stored profile

Double clicking the John Smith profile (or highligh ting and pressing OK ) will add all of John Smith’s profile information into the fields.eTSCA CDX Registration Guide Using the eTSCA/e-PMN Reporting Software

December 28, 2009 26 Figure 3-16 Profile information transferred

3.7 Validation eTSCA/e-PMN provides data and business validations on both a field level and an application level.

3.7.1 Field-level Validation Some fields contain special business rules that req uire inline validation. In the example seen below, the “TS Code” field requires a six-character alphanumeric string value. eTSCA/e-PMN handles these special validation cases by throwing an error at the point of field exit, preventing an invalid value to be entered. The error will spec ify the type of input expected for the given field. Figure 3-17 Field-level validation

3.7.2 Application-level Validation eTSCA/e-PMN also performs application-level validat ion for the entire form. Validation can be activated manually at any time by choosing Validate from the Tools menu or clicking the validate icon ( ) from the toolbar. This action will start the vali dation checker, which opens the Validation window at the bottom of the screen and d isplays any validation errors and warnings.eTSCA CDX Registration Guide Using the eTSCA/e-PMN Reporting Software

December 28, 2009 27 Figure 3-18 Toolbar Validation icon

Figure 3-19 Application-level validation

Validation errors are critical errors that prevent the form from being submitted. Validation warnings point to potential problems in the form, b ut are not required to be corrected.

Double-clicking one of the listed items in the vali dation window will allow users to jump to the page of the error for easy correction.

Validation is automatically performed upon saving an existing project or finalizing a project for EPA submission. 3.8 Printing Forms are easily printed with eTSCA/e-PMN. The soft ware will create printer-friendly versions of forms in PDF format to facilitate this process. A PDF reader tool, such as Adobe Reader, will be needed to open the PDF files.

A PDF copy can be generated by clicking on the Print command from the File menu [Figure 3-20] or from the toolbar [Figure 3-21].eTSCA CDX Registration Guide Using the eTSCA/e-PMN Reporting Software

December 28, 2009 28 Figure 3-20 Printing from the File menu

Figure 3-21 Printing from the toolbar icon

A PDF file will be generated with the file name “<P roject Name>.pdf” and placed in the current working directory. Figure 3-22 Saving a PDF

Examples of PDF forms are shown below in Figures 3- 23 through 3-26.eTSCA CDX Registration Guide Using the eTSCA/e-PMN Reporting Software

December 28, 2009 29 Figure 3-23 PMN Sample OutputeTSCA CDX Registration Guide Using the eTSCA/e-PMN Reporting Software

December 28, 2009 30

Figure 3-24 Notice of Commencement sample outputeTSCA CDX Registration Guide Using the eTSCA/e-PMN Reporting Software

December 28, 2009 31

Figure 3-25 PMN Support Document sample outputeTSCA CDX Registration Guide Using the eTSCA/e-PMN Reporting Software

December 28, 2009 32 Figure 3-26 Biotech sample outputeTSCA CDX Registration Guide Using the eTSCA/e-PMN Reporting Software

December 28, 2009 33 3.9 Attachments

Some forms will call for a file attachment for EPA submission. The following is a list of the allowable file types:

• Chemical structure files

o .mol

o .skc

o .pdf or image type

• Image files

o .gif

o .jpg

o .png

o .bmp

• Document files

o .pdf

o .ppt

o .doc

o .txt

o .rtf

o .xls

• For nucleic acid, amino acid or sequence data submi tted for Biotechnology MCANs and TERAs or enzyme related PMNs, the preferred file fo rmats are

o FASTA files (.fas)

o GenBank (.gbk)

o EMBL (.embl)

Attaching a file displays the following dialog box.eTSCA CDX Registration Guide Using the eTSCA/e-PMN Reporting Software

December 28, 2009 34 Figure 3-27 Attachment Dialog Box

The ID field is a unique key to identify the attachment i n the project. This ID is automatically generated by the eTSCA/e-PMN reporting software to insure that there are no duplicates.

The File field contains path of the file to attach. This fi eld is required for electronic attachments. If the “Check here if this is a hardcopy attachment ” field is checked, a paper submission will be expected instead.

The Name/Description displays the attachment’s title or description.

The # of Pages field is for the total number of pages in the atta chment.

The Confidential checkbox is to indicate whether or not the attachme nt contains Confidential Business Information (CBI)

The Sanitized File field is the path of the sanitized file in the cas e where the main file contains CBI.

The Sanitized Name/Description field displays the sanitized attachment’s title or description.eTSCA CDX Registration Guide Central Data Exchange (CDX)

December 28, 2009 35 

### 4 Central Data Exchange (CDX)
The EPA Central Data Exchange (CDX) is a service th at enables users to electronically submit data to EPA.

Pre-registration with CDX is required to submit onl ine. Please see the CDX Registration Guide for more information on how to register with CDX (h ttps://cdx.epa.gov/TSCA/ eTSCACDX_Registration_Guide.pdf)

eTSCA/e-PMN contains a CDX component that performs the following tasks:

• Connecting to the CDX Node

• Validation of the submission information with CDX R egistration

• Generation of the cryptographic key pair

• Encryption of the file

• Decryption of the file

• Transmission of the document – ability to electroni cally submit eTSCA projects to EPA via the CDX Node

• Transaction Search – ability to search the submitte d documents by CDX Transaction ID number

• Document Download – ability to download ancillary d ocuments related to submission, e.g., Copy of RecordeTSCA CDX Registration Guide Pre-Manufacture Notice Form

December 28, 2009 36 

### 5 Pre-Manufacture Notice Form 5.1 Usage Any organization planning to manufacture or import a new chemical substance for a non-exempt commercial purpose is required by Section 5 of TSCA to provide the Environmental Protection Agency with notice before initiating the activity. This Pre-manufacture notice, or PMN, must be submitted at least 90 days prior to the manufacture or import of the chemical. For more information on the New Chemicals Program, please vi sit: http://www.epa.gov/oppt/newchems/index.htm

.
The PMN form should be used to submit PMNs, SNUNs, LVEs and LoRex Exemptions and Modifications, TMEA exemptions, and Mock PMNs.

5.2 PMN Navigation The toggle button seen in Figure 5-1 below will swi tch the view of the navigator window between displaying forms by name and by page number

.
Figure 5-1 Navigator Windows with titled by page na me and page number

5.3 Consolidated Submissions Up to six cases may be included in one submission. Any submission containing more than one case is considered a consolidated submission

. Consolidated submissions require preapproval from t he EPA. Contact EPA to receive a PreNotice Communication (PNC) number before attempting to submit a consolidated submission.eTSCA CDX Registration Guide Pre-Manufacture Notice Form

December 28, 2009 37 Figure 5-2 PMN Form: PNC Number

Users submitting a consolidated submission should d enote this using the checkbox located on the “General Instructions” page of the PMN.eTSCA CDX Registration Guide Pre-Manufacture Notice Form

December 28, 2009 38 Figure 5-3 Denoting a consolidated PMN

Consolidated submissions do not need to be specifie d on the PMN page 1 in advance of adding extra chemicals. See the Adding, Deleting, or Cloning Chemical Data section for information on how to dynamically add or delete a chemical group.

5.4 PMN-specific actions 5.4.1 Sanitization

Sanitization removes CBI data from the form so that the data can be shared with the general public. 5.4.1.1 Creating a sanitized version of the PMN for m
Submitters should create a sanitized PDF to confirm that all CBI has been properly denoted and removed. A PDF file of a sanitized PMN form can be created by selecting Print Sanitized PMN from the File menu or by selecting the Sanitize button ( ) from the toolbar.eTSCA CDX Registration Guide Pre-Manufacture Notice Form

December 28, 2009 39 Figure 5-4 Sanitizing a PMN

5.4.1.2 Sanitizing attachment files File attachments marked as CBI require a sanitized version. The sanitized version must be created by the submitter and attached before submis sion. The validation checker prevents finalization of the submission until all CBI attach ments have corresponding sanitized files attached as well. Figure 5-5 Sanitized file required

5.4.1.3 Submitting a sanitized version of the PMN f orm When a PMN project is finalized for submission, a s anitized copy of the data is automatically generated within the finalized file. A separate sub mission is not required. 5.4.1.4 Adding, Deleting or Cloning Chemical Data Users can add, delete, or create an exact copy (clo ne) of a chemical group (PMN Pages 4-6) by clicking on the respective menu items from the Edit menu or using the toolbar icons.eTSCA CDX Registration Guide Pre-Manufacture Notice Form

December 28, 2009 40 Figure 5-6 Cloning a chemical group

Chemical groups may be added at any time, but cloni ng or deleting a chemical group will require the software focus to be on the header page for tha t group.

Figure 5-7 Navigation for chemical cloning or delet ion

5.4.2 Adding, Deleting or Cloning a PMN page The eTSCA/e-PMN reporting software allows adding mu ltiple copies of specific PMN pages:

• PMN Page 7 – Part I, Section C., Production, Import and Use Information

• PMN Pages 8-9a – Part II, Section A., Industrial Si tes Controlled by the Submitter

• PMN Page 10-10a – Part II, Section B., Industrial S ties Controlled by Others

• PMN Page 13 – Physical & Chemical Properties Worksh eet

To add, remove, or clone PMN pages, click on the re spective menu items from the Edit menu or use the toolbar icons.eTSCA CDX Registration Guide Pre-Manufacture Notice Form

December 28, 2009 41 Figure 5-8 Adding a PMN page

Figure 5-9 Cloning a PMN page

5.5 PMN Pages The paper PMN form contains 13 PMN pages. eTSCA/e-P MN follows that convention by splitting the eTSCA/e-PMN version of the PMN form a s closely as possible into those 13 pages. The PMN pages are as follows:

• PMN Page 1 – General Instructions

• PMN Page 2 – Certification

• PMN Page 3 – Submitter ID

• PMN Page 4—Class 1 or 2 Chemical Substance

• PMN Page 5 – Polymers

• PMN Page 6 – Chemical ID Info—continued

• PMN Page 7 – Production, Import, and Use Informatio n

• PMN Pages 8-9 – Section A—Submitter Controlled Sit es

• PMN Page 10 – Other Controlled Sites

• PMN Page 11 – Optional Pollution Prevention

• PMN Page 12 – List of Attachments

• PMN Page 13 – Physical and Chemical Properties Work sheet

• Optional Cover Letter

For specific help with any of these pages, click th e dynamic help button on the toolbar. See the Page-level Help section for more information.eTSCA CDX Registration Guide Notice of Commencement Form

December 28, 2009 42 

### 6 Notice of Commencement Form 6.1 Usage A new chemical is eligible for addition to TSCA Inv entory after the PMN review period has expired and the PMN submitter has commenced non-exe mpt commercial manufacture or import. The submitter of a PMN must provide a Notice of Com mencement of Manufacture or Import (EPA Form 7710-56) to EPA within 30 days of the dat e the substance is first manufactured or imported for nonexempt commercial purposes. It will then be listed on the TSCA Inventory. Once a substance is listed on the TSCA (Toxic Subst ances Control Act) Inventory, it is considered an "existing" chemical.

For more information on filing a Notice of Commence ment, please visit http://www.epa.gov/oppt/newchems/pubs/filenoc.htm

.
6.2 Notice of Commencement tab

The main form tab contains all the fields needed to complete a Notice of Commencement form.eTSCA CDX Registration Guide Notice of Commencement Form

December 28, 2009 43

Figure 6-1 Notice of Commencement main form tabeTSCA CDX Registration Guide Notice of Commencement Form

December 28, 2009 44 6.3 CBI Substantiation tab Users submitting NOCs with Confidential Business In formation (CBI) will be required to substantiate a claim in this section. 6.4 Optional Cover Letter tab Additional information can be added on the Optional Cover Letter tab. When printed out, this information will appear on the first printed page a s the cover letter.eTSCA CDX Registration Guide Notice of Commencement Form

December 28, 2009 45 6.5 Printed PDF form sample Figure 6-2 Sample PDF NOC formeTSCA CDX Registration Guide Biotechnology Form (MCAN, TERA, TIER I & TIER 2)

December 28, 2009 46 

### 7 Biotechnology Form (MCAN, TERA, TIER I & TIER 2) 7.1 Regulation Under a 1986 intergovernmental policy statement and TSCA Section 5, intergeneric microorganisms (microorganisms created to contain g enetic material from organisms in more than one taxonomic genera) are considered new chemi cals. The Biotechnology rule sets forth the manner in which the Agency will review and regulate the use of intergeneric microorganisms in commerce, or commercial research. For more informat ion, please visit: http://www.epa.gov/oppt/biotech/pubs/biorule.htm

. These regulations create a reporting vehicle specif ically designed for microorganisms, the Microbial Commercial Activity Notice (MCAN). Person s intending to use intergeneric microorganisms for commercial purposes in the Unite d States would submit an MCAN to EPA at least 90 days before such use. EPA has 90 days t o review the submission in order to determine whether the intergeneric microorganism may present an unreasonable risk to human health or the environment.

The rules also address intergeneric microorganisms used in R&D for commercial purposes and create a vehicle for reporting on testing of new mi croorganisms in the environment, a TSCA Experimental Release Application (TERA). A TERA wou ld be submitted to EPA at least 60 days prior to initiating such field trials. The TER A is designed, in recognition of the needs of researchers, to provide a high measure of flexibili ty and a shorter review period of 60 days. Research & Development for commercial purposes are those activities which are funded directly, in whole or in part, by a commercial entity, regard less of who is actually conducting the research; or which will obtain for the researcher a n immediate or eventual commercial advantage. For more information on Microbial Produc ts of Biotechnology, please visit: http://www.epa.gov/oppt/biotech/pubs/fs-001.htm

.eTSCA CDX Registration Guide Biotechnology Form (MCAN, TERA, TIER I & TIER 2)

December 28, 2009 47 7.2 Screenshot

Figure 7-1 Biotech FormeTSCA CDX Registration Guide Biotechnology Form (MCAN, TERA, TIER I & TIER 2)

December 28, 2009 48 7.3 Printed PDF Form Sample

Figure 7-2 PDF Biotech Form sampleeTSCA CDX Registration Guide PMN Support Document Form

December 28, 2009 49 

### 8 PMN Support Document Form 8.1 Usage The PMN Support Document provides users with an opp ortunity to add supporting or supplemental information for an original PMN or Bio technology submission.

A support document may include the following types of information:

• Letter of Support

• Withdrawal Request

• Test Data (Health/Ecotoxicity/Fate)

• Amendment (changes made to PMN pages 1-13, MSDS or Physical/Chemical properties)

• Other CorrespondenceeTSCA CDX Registration Guide PMN Support Document Form

December 28, 2009 50 8.2 Screenshot Figure 8-1 PMN Support Document FormeTSCA CDX Registration Guide PMN Support Document Form

December 28, 2009 51 8.3 Printed PDF Form sample

Figure 8-2 PMN Support Document PDF Sample FormeTSCA CDX Registration Guide Submission Process

December 28, 2009 52 

### 9 Submission Process

9.1 Finalize Command Projects must be finalized before submission. The f inalization process insures that the submitted data is valid and that all preliminary steps have b een completed.

Select Finalize from the Tools menu, or click the Finalize icon ( ) on the toolbar to begin the finalization process. The validation checker will t hen run. If a project fails validation, the user will not be able to continue until the necessary fi xes are made.

Figure 9-1 Cannot finalize due to validation errors

If no critical errors are found, the software will alert the user that a new report number has been generated for the current submission [Figure 9-2], and the Finalize Submission dialog box will appear [Figure 9-3].

Figure 9-2 New report number generatedeTSCA CDX Registration Guide Submission Process

December 28, 2009 53 The user will be prompted to select a method of sub mission to the EPA. Three options will be displayed:

• “I will submit my data electronically via CDX”

• “I will submit my data via delivery service on a CD ”

• “I will submit my data on paper”

Figure 9-3 Finalize Submission Dialog Box

9.2 Paper Submission If the paper submission option is chosen, eTSCA/e-P MN will create a PDF file in your current working directory called “<Project Name>_finalized.pdf” and, if necessary, a suitable for submission sanitized PDF file called “<Project Name>_sanitized_finalized.pdf.” For example, a PMN project called “ proj1.pmn_tsca ” will produce a “ proj1_finalized.pdf ” submission file.

PDF files will contain a barcode on the top-left c orner of each page. This is used by EPA for scanning purposes.

If the form contains attachments, the finalized PDF will have a header page for each attachment. Attachments should be printed out (if not already a hardcopy) and placed behind each attachment header page. 9.3 CD Submission If the CD submission option is chosen, eTSCA/e-PMN will create a “finalized” project file called “ <Project Name>_finalized.<project_type_extension>” in the current working directory. For example, a PMN project called “ proj1.pmn_tsca ” will produce a “proj1_finalized.pmn_tsca” read-only file. The finalized file will contain th e sanitized data.eTSCA CDX Registration Guide Submission Process

December 28, 2009 54 eTSCA/e-PMN will also create a certification PDF pr int out containing the MD5 checksum value of the file. This checksum number uniquely id entifies the content of the finalized file. If the finalized file is changed in any way, the check sum will not be reproducible. In other words, the checksum guarantees that data has not been tamp ered with after it leaves the user’s hands. This file will use the naming convention “ <Project Name>_cert.<project_type_extension> ” (e.g., “ proj1.pmn_tsca ” will produce a “ proj1_cert.pdf ” file).

The certification file will also contain the cover letter, the certification/signature page (PMN page 2) and the contact information page (PMN page 3). Please certify and sign when appropriate and submit the original with the CD to the EPA by courier.

The finalized file must be burned to a CD and submi tted along with a copy of the PDF printout containing the checksum. PMN and NOC form printouts must also be signed and dated.

9.4 Online CDX Submission Only CDX registered users will be able to use the C DX submission option. Please see the CDX Registration Guide for more information on how to r egister with CDX ((https://cdx.epa.gov/TSCA/ eTSCA-CDX_Registration_Guide.pdf). Users submitting on behalf of another organization must have registered the na mes of those companies and be authorized to submit for those organizations.

After selecting the Finalize button and after choos ing to submit via CDX, eTSCA/e-PMN creates a “finalized” project file called “ <Project Name>_finalized.<project_type_extension>” in a directory of your choosing. For example, a PMN proj ect called “ proj1.pmn_tsca ” will produce a “proj1_finalized.pmn_tsca” read-only file.

Users will be prompted to enter a username and pass word in order to login before submission [Figure 9-4].eTSCA CDX Registration Guide Submission Process

December 28, 2009 55

Figure 9-4 Login to CDX from eTSCA/e-PMN software

eTSCA/e-PMN software will verify the submission inf ormation with CDX registration. If the data agrees, eTSCA/e-PMN will display a message inf orming the user that a finalized version of the file is being created. Figure 9-5 Finalization in progresseTSCA CDX Registration Guide Submission Process

December 28, 2009 56 After clicking “OK” the following screen will appea r. The user will be asked to select a destination folder to house the finalized version o f the file. Figure 9-6 Select destination for finalized file

Once a location is selected, eTSCA/e-PMN will save the finalized file and open the CDX Node Client, seen in Figure 9-7 below.eTSCA CDX Registration Guide Submission Process

December 28, 2009 57 Figure 9-7 Node Client

Click the “Submit File to CDX” button to continue t he submission process. 9.4.1 User Certificate and Key Pair Generation

A user certificate and Private/Public Key pair is u sed to digitally sign and encrypt the submitted documents, providing security protection for eTSCA/ e-PMN submissions. The certificate and key pair will be automatically obtained by the Node Client after the first login.

The Node Client stores the following data into a ke ystore under the user home directory:

• user ID

• user private key

• user certificate

• creation time

The following file will be created: \<userHome>\ .< userId>-cromerr-keystore.jks where <userHome> is a local user home directory (C:\Docum ents and Settings\myuser) and <userId> is an eTSCA/e-PMN user ID registered with CDX Web. Sin ce this file is stored on the user’s local drive, the user will only be able to access the sub mitted documents from this specific machine unless the key file is copied into the same locatio n of another machine. In any case, the user can copy this file to another safe location for backup, if desired.eTSCA CDX Registration Guide Submission Process

December 28, 2009 58 Upon clicking the “Submit File to CDX” button, the user will need to complete the electronic signature agreement and verify his or her identify. The following screens will be displayed. Figure 9-8 CROMERR page

Figure 9-9 20-5-1 Security Question

When the security question is answered correctly, t he system will encrypt the document with the public key of the back-end server and transmit the encrypted document with related metadata to CDX. The CDX Transaction ID will act as a unique id entifier for the submission and will be presented to the user for reference.eTSCA CDX Registration Guide Submission Process

December 28, 2009 59 Figure 9-10 Submission in progress

Figure 9-11 Document submitted to CDXeTSCA CDX Registration Guide Submission Process

December 28, 2009 60 To check submission status, click the “Check Transa ction Status” button. The screen below will display the appropriate status. The following is a list of possible statuses and what each status denotes:

• Processing – the CDX server has received the document

• Received – the backend server has processed the document bu t the CoR has not been generated yet

• Completed –the backend server has processed the document and the CoR is available

• Failed –the document failed to transmit or was not receiv ed. Please contact the CDX Help Desk.

Figure 9-12 Transaction Details tab

After the file has been successfully submitted and processed, a Copy of Record (CoR) will be available for download to the submitter via the “do wnload” icon ( ) on the “ESTCA Transaction Details” tab of the Node Client. The Co R will be in read-only format—no changes can be made to this document.

The user will receive two automated e-mails from th e node after successful submission.eTSCA CDX Registration Guide Submission Process

December 28, 2009 61 Figure 9-13 E-mail Submission Notification

Figure 9-14 Copy of Record Available for DownloadeTSCA CDX Registration Guide Submission Process

December 28, 2009 62 9.5 Transaction History

The eTSCA/e-PMN software allows users to search for files they have previously submitted. The “Search Transaction History” button can be found un der the “ETSCA Transaction Search” tab of the Node Client as seen in Figure 9-15. Figure 9-15 Transaction Search and Results

The user can search for a specific transaction usin g the “Transaction ID” and “Transaction Status” fields, or request a complete list of trans actions during a given period by using the “Start Date” and “End Date” fields. Search results will be presented to the user in the “Transaction Search Results” panel.

There are two icons located next to each transactio n listed in the search result: the “Check Status” button and the “Details” button. The “Check Status” button will refresh the status column of a given transaction with a new CDX status. This provides the user a simple and effective method of monitoring transactions. The “Details” bu tton will open the transaction details dialog.
9.5.1 Transaction Details The “Transaction Details” tab (pictured in Figure 9 -12 above) displays the detailed transaction information, including all of the documents and rep orts associated with the transaction. Transaction status can be viewed by clicking the “C heck Status” button. The “Audit Details” button will display audit information related to th e transaction, as seen in Figure 9-16.eTSCA CDX Registration Guide Submission Process

December 28, 2009 63 Figure 9-16 Audit Details DialogeTSCA CDX Registration Guide Submission Process

December 28, 2009 64 The “Done” button located at the bottom of the wind ow will close the audit details. The user may also download available reports by cli cking the “Download” icon located to the left of the desired report. This will automatically initiate the download process. The document will get decrypted with the current user private ke y and the “Save File” dialog will be presented to a user [Figure 9-17]. Reports can be saved on a local hard drive and accessed with the appropriate application.

Figure 9-17 Save Downloaded FileeTSCA CDX Registration Guide Administrator’s Guide

December 28, 2009 65 

### 10 Administrator’s Guide

Windows XP

To setup *.jnlp association for Java Web Start in W indows, please follow the following steps:

1. In Windows, Click Start | Settings| Control Panel| Folder Options | File Types.

2. Check to see if there is already an association for *.jnlp files.

3. If there is no entry for *.jnlp files already then click new | advanced | select “jnlp file”

4. If there is an entry, Select it and click advanced
5. Then edit the open application used to perform acti on field and make sure it is set to “C:\Program Files\java\jre6\bin\javaws.exe”

Mac OSX 10.5 (Leopard)

JNLP files may lose association with Java Web Start after a Java software update. This will disable Mac OS users from downloading the eTSCA/e-P MN software using the Safari browser. There are two ways to re-associate JNL with the Jav a Web Start application. Option 1 is recommended for novice users, while option two may be more suitable for Mac OS experts. Option 1

1. Navigate to the Core Services folder located at /System/Library/Core Services

2. Open this folder. Opening the Core Services folder re-associates the .jnlp files with the Java Web Start application

3. Close the window and reattempt to load the eTSCA/e- PMN software Option 2

1. Navigate to the Terminal (/Applications/Utilities/Terminal)

2. Enter the following command:

/System/Library/Frameworks/CoreServices.framework/F rameworks/LaunchServices. framework/Support/lsregister "/System/Library/CoreS ervices/Java Web Start.app"

3. Close Terminal and reattempt to load the eTSCA/e-PM N softwareeTSCA CDX Registration Guide Contact Information

December 28, 2009 66 

### 11 Contact Information
For further questions or concerns about the eTSCA/e -PMN software not covered in this user guide, please contact the CDX Help Desk at helpdesk @epacdx.net or call 1-888-890-1995 between the hours of 8am – 6pm EST.