CD& For Your Information (FYI) User Guide - Primary Support Environmental Protection Agency Office of Pollution Prevention and Toxics Manage Toxic Substances ------- CD)Sr Table of Contents 1 Introduction 3 1.1 Overview 3 1.2 Labeling Confidential Information 4 2 System Requirements 5 2.1 Supported Browsers 5 2.2 Screen Resolution 5 3 Primary Support Functions 6 3.1 Log into FYI Application 6 3.2 Home Screen Navigation 7 3.3 Edit FYI Submission 8 3.3.1 FYI Submissions Screen 8 3.3.2 Enter Passphrase Screen 9 3.3.3 Navigation Tree 10 3.3.4 Action Bar 12 3.3.5 Technical Contact Information Screen 13 3.3.6 Submitting on Behalf of Company Screen 17 3.3.7 Submitting on Behalf of Consortium Screen 18 3.3.8 Chemical Identification Screen 20 3.3.9 Search Substance Registry Services 23 3.3.10 Chemical Not Found in Substance Registry Services Window 24 3.3.11 Document Management Screen 27 4 Validate 32 5 Complete an Amendment 34 6 Resources 35 Appendix A. Definitions, Acronyms, and Abbreviations 36 Appendix B. Submission Types, Effects, and Endpoints 37 FYI User Guide Primary Support i ------- CD)Sr List of Exhibits Exhibit 3-1: Chemical Information Submission System Screen 7 Exhibit 3-2: FYI Home Screen 8 Exhibit 3-3: FYI Submissions Screen 9 Exhibit 3-4: Enter Passphrase Screen 10 Exhibit 3-5: Navigation Prompt 11 Exhibit 3-6: Navigation Tree 12 Exhibit 3-7: Action Bar-Validate 13 Exhibit 3-8: Action Bar - Save 13 Exhibit 3-9: Action Bar - Preview 13 Exhibit 3-10: Action Bar - Help Links 13 Exhibit 3-11: Technical Contact Information Screen 16 Exhibit 3-12: Submitting on Behalf of Company Screen 18 Exhibit 3-13: Submitting on Behalf of Consortium Screen 20 Exhibit 3-14: Chemical Identification Screen: Submission Is for a Mixture 22 Exhibit 3-15: Chemical Identification Screen: Submission Is Not For a Mixture 23 Exhibit 3-16: Search Substance Registry Services Pop-Up Window 24 Exhibit 3-17: Chemical Not Found in Substance Registry Services Pop-Up Window 26 Exhibit 3-18: Chemical Identification Screen (Populated with chemical not found in SRS Search)27 Exhibit 3-19: Document Management Screen 28 Exhibit 3-20: Document Management Pop-Up Window 30 Exhibit 3-21: Document Management Screen (Populated) 31 Exhibit 4-1: FYI Submission Validation Pop-Up Window 33 Exhibit 6-1: Resources Screen 35 FYI User Guide Primary Support ------- CD)Sr 1 Introduction 1.1 Overview This document presents the user guide for the Office of Pollution Prevention and Toxics (OPPT) For Your Information (FYI) application submission process. This document is the user guide for the Primary Support user of the FYI tool. General information on FYIs is available on the TSCA Section 8(e) website available at http://www.epa.gov/oppt/tsca8e/. Information on CDX registration, including user roles that apply to completing a FYI Submission Notice, is available at http://cdx.epa.gov/About/UserGuide. FYI submissions are from a classification system established by the Environmental Protection Agency (EPA) to distinguish voluntary submissions from substantial risk notices, also known as Section 8(e) Notices, which are formally submitted to EPA under TSCA Section 8(e). The FYI classification was created by EPA to capture submissions by people and organizations not subject to the reporting requirements, but who desire to inform EPA of potential toxic substances that may pose a risk to human health or to the environment. EPA has received FYI submissions covering a wide variety of chemical substances and mixtures from chemical companies, trade associations, unions, public interest groups, civic associations, private citizens, academic institutions, state and other federal agencies, as well as similar organizations and agencies in foreign countries. These submissions contain information on human exposure, epidemiology, toxicity test results, monitoring studies, environmental fate, and other information that may be important to risk assessment. Sometimes FYIs are submitted when a manufacturer, importer, or processor is not sure the information they have gathered supports a conclusion of substantial risk. FYI submissions are often submitted to the Agency when a person or company that is not required to submit would like to bring a chemical's risk information to EPA's attention. Chemical companies, trade associations, public interest groups, and academic institutions are among those who submit FYIs. The FYI application is an electronic, web-based tool provided by EPA for the submission of FYI data. As a Primary Support, you can edit a submission created by a Primary Authorized Official (AO). You are only able to access submissions to which the Primary AO has granted access.. This electronic application is optional for the production and submission of these filings. Potential users may find that the use of this application saves time, burden and, because it is in an electronic format, provides easy access to reporting forms. Potential users are reminded to carefully read and follow application instructions. Persons who wish to use this application must address all provisions in the application including those relating to indexing information (i.e., company name, address, chemical name, etc.) and those related to Confidential Business Information (CBI) submissions, including the requirement for the submission of sanitized or redacted filings. If data is claimed as CBI, it will not be made available to the public unless EPA determines that the information is not entitled to confidential treatment in accordance with the Agency confidentiality regulations at 40 Code of Federal Regulations (CFR) part 2, subpart B. For questions concerning the FYI software requirements, please contact the CDX Help Desk at helpdesk@epacdx.net or call 1-888-890-1995 between the hours of 8am - 6pm Eastern Standard FYI User Guide Primary Support 3 ------- CD)Sr Time (EST). For Toxic Substances Control Act (TSCA) FYI submissions, please contact the TSCA Hotline at TSCA-Hotline@epamail.epa.gov or call 202-554-1404. 1.2 Labeling Confidential Information This user guide presents instructions and screenshots for the 'TSCA FYI Submission' electronic application as if you were logged in as a Primary Support. As the Primary Support you are able to edit or modify an FYI submission. The user may claim certain information as Confidential Business Information (CBI). If the data is claimed as CBI, it will be treated in accordance with the Agency confidentiality regulations at 40 CFR part 2, subpart B.. This TSCA 'FYI Submission' electronic application is optional for the production and submission of these filings. The paper option for filing will continue to be allowed. Potential users may find that the use of this application saves time, burden and, because it is in an electronic format, provides easy access to reporting forms. Potential users are reminded to carefully read and follow application instructions. Persons who wish to use this application must address all provisions in the application, including those relating to indexing information (i.e., company name, address, chemical name etc.) and those related to CBI submissions, including the requirement for the submission of sanitized or redacted filings. Please note that certain CBI claims will not be accepted if you choose to use this electronic application for TSCA FYI Submission. For example, chemical name and/or chemical identity, if the chemical is listed on the public portion of the TSCA Inventory, may not be claimed as CBI in a submission using this application. Similarly, the user must enter a non-confidential study title, because it may not be claimed as CBI. EPA does not expect that such information, if evaluated under procedures at 40 CFR part 2, subpart B, would generally be found entitled to confidential treatment. If the user believes that these or other data elements must be treated as CBI, then the user may use the paper option to file the FYI Submission and assert CBI claims. If the user claims an uploaded document as CBI, a sanitized document must be provided. The following fields can be claimed as CBI within the 'FYI Submission' application: • Technical Contact Information • Submitting on Behalf of Company information • Submitting on Behalf of Consortium information • A single chemical substance that is not on the public TSCA Inventory • The chemical substances comprising a mixture • The percent concentrations of individual chemical substances in a mixture • Any document uploaded within the 'Document Management' pop-up window FYI User Guide Primary Support 4 ------- CD)Sr 2 System Requirements In order to use the FYI application the following are required: • An e-mail account • A supported web browser (see Section Error! Reference source not found, below) with Java Script enabled. • Internet access • Adobe Acrobat Reader 5.0 or higher • CDX username and password 2.1 Supported Browsers One of the following supported browsers is required to access the FYI application: • Internet Explorer 7 or above - Go to the following link to download: http://windows.microsoft.com/en-US/internet-explorer/downloads/ie • Mozilla Firefox 3.5 or above - Go to the following link to download: http://www.mozilla.com/en-US/firefox/all-older.html • Safari 4 or above - Go to the following link to download: http: // support. appl e. com/kb/dl 8 7 7 • Google Chrome - Go to the following link to download: http://www.google.com/chrome 2.2 Screen Resolution • Screen resolution should be set to 1024 x 768 or greater. FYI User Guide Primary Support 5 ------- CD)Sr 3 Primary Support Functions This section describes how to: • Access the application • Navigate the FYI 'Home' screen • Complete an FYI submission • Complete an amendment As a Primary Support, you can edit a submission created by a Primary Authorized Official (AO). You are only able to access submissions to which the Primary AO has granted access. You can save the submission at any point during the data entry process. The save functionality will allow you to return to that same submission at any point in the future. You can print the document at any point; however, the 'Not For Submission' watermark will be placed on the portable document format (PDF) document. 3.1 Log into FYI Application After you create an account in CDX and click the 'Submissions for Chemical Safety and Pesticide Programs (CSPP): Primary Support' link, you will be taken to the 'Chemical Information Submission System' screen. Note: Information on CDX registration, including user roles that apply to completing a FYI Submission, is available at http://cdx.epa.gov/About/UserGuide Exhibit 3-1 shows a screen capture of the 'Chemical Information Submission System' screen: FYI User Guide Primary Support 6 ------- CD)Sr Exhibit 3-1: Chemical Information Submission System Screen • Logged in as: John Doe, Primary Support Log Out CHEMICAL INFORMATION SUBMISSION SYSTEM TSCA FYI Submission OK For Your Information (FYI) submissions are submissions from a classification system that was established by EPA to distinguish voluntary submissions from "substantial risk" notices submitted formally to EPA under TSCA Section 8(e). The FYI classification was created by EPA to capture submissions by persons or organizations not subject to the reporting requirements, but who wished to inform EPA of a potential risk or information related to a chemical substance or mixture. This electronic application is optional for FYI submissions. The paper option for filing will continue to be allowed. Paperwork Reduction Act Notice The information collection requirements contained in the information collection request (ICR) have been submitted for OMB approval under 15 U.S.C. 2607(e). The ICR prepared by EPA. identified under EPA ICR No. 0794.13 and OMB control number 2070-0046. is available in the docket for the ICR. ICR No. 0794.13 addresses the incremental changes to the currently approved ICR documents that cover the existing reporting and record keeping programs that are approved under OMB control number 2070-0046. 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. Authority The Government Paperwork Elimination Act (GPEA) (44 U.S.C. 3504) provides that, when practicable. Federal organizations use electronic forms, electronic filings, and electronic signatures to conduct official business with the public. Navigation: Select 'TSCA FYI Submission' from the drop-down menu and click the 'OK' button to navigate to the FYI 'Home' screen. 3.2 Home Screen Navigation You can access the FYI 'Home' screen by selecting 'FYI Submission' from the 'Chemical Information Submission System' screen drop-down menu and by clicking the 'OK' button. The FYI 'Home' screen is the first screen within the FYI application. It provides you with links and tabs to access the 'FYI' submissions and 'Resources' screens. To navigate to any of these screens, click the screen link (in blue text), or click the screen tab (located within the application header). The links and tabs provide the same functionality. • Submissions: Click the 'Submissions' link or tab to navigate to the 'FYI' submissions screen. You can modify an FYI submission using the 'FYI' submissions screen. For additional details about the 'FYI' submissions screen, please refer to Section 3.3.1. • Resources: Click the 'Resources' link or tab to navigate to the 'Resources' screen. You can find the FYI user guide, as well as useful links for further usability instruction on the 'Resources' screen. For additional details about the 'Resources' screen, please refer to Section 6. FYI User Guide Primary Support 7 ------- CD)Sr Exhibit 3-2 shows a screen capture for the FYI 'Home' screen: Exhibit 3-2: FYI Home Screen Logged in as John Doe, Primary Support 1 Log Out II I 1 # HOME Submissions For Your Information (FYI) submissions are submissions from a classification system that was established by EPA to distinguish voluntary submissions from "substantial risk" notices submitted formally to EPA under TSCA Section 8(e). The FYI classification was created by EPA to capture submissions by persons or organizations not subject to the reporting requirements, but who wished to inform EPA of a potential risk or Information related to a chemical or mixture- Resources A helpful guide that describes the FYI Submission system and provides useful links for further usability Instruction. Support A Support has the ability to modify any unlocked submission that he/she is assigned to by the Authorizing Official. CDX Homepage | MyCDX Homepage I EPA Homepage | Terms and Conditions | Privacy Notice | CDX Helpdesk: (888) 890-1995 Navigation: Click the 'Submissions' link or tab to access the 'FYI' submissions screen to edit existing submissions. 3.3 Edit FYI Submission As a Primary Support, you can edit an FYI submission. You will be able to access only those submissions for which the Primary AO has assigned you to complete. 3.3.1 FY! Submissions Screen You can access the 'FYI' submissions screen by clicking the 'Submissions' link from the FYI 'Home' screen, or by clicking the 'Submissions' tab located within the application header You are only allowed to edit FYI submissions for which the Primary AO has granted you access. Each column in the 'FYI' submission screen can be sorted by clicking the column headers. Edit a Submission: Submissions will not be available on this screen until one has been created by the Primary AO and you have been assigned to it. To modify an existing FYI submission, click the submission alias link for a submission that has a status of 'In Progress.' You will be required to enter the passphrase associated with that particular submission in order to access and continue editing the submission. The Primary AO creates the passphrase when they create the submission. Contact the Primary AO to obtain the passphrase for the submission. In addition to the 'Status' column, the 'FYI' submissions screen displays the following columns: FYI User Guide Primary Support 8 ------- CDJfr • Submission Alias: Displays the submission alias provided by the user on the 'Technical Contact Information' screen. The 'Submission Alias' column will display a time stamp unless the user defines a unique submission alias on the 'Technical Contact Information' screen. The purpose of the submission alias is to help identify each FYI submission. • Case Number: Displays the case number for the submission. The case number is automatically generated upon submission. The 'Case Number' column will display as blank until the FYI submission has been submitted successfully. • Modify Date: Displays the date the submission was last modified. • Submission Date: Displays the date when the Primary AO completes the submission to EPA. This date populates only after a Primary AO submits the FYI submission. • Export Options: Displays 'CSV,' 'Excel,' 'XML,' and 'PDF' links for you to export the 'FYI' submissions screen in one of the specified formats as an Excel spreadsheet, Comma- Separated Values (CSV), Extensible Markup Language (XML), or Portable Document Format (PDF). Exhibit 3-3 shows a screen capture of the 'FYI' submissions screen: 'i Exhibit 3-3: FYI Submissions Screen Logged in as: John Doe, Primary Support FYI To edit an In Progress submission, click the submission alias link in the Submission Alias column in the table below. Page 1 of 1 3 items found. Submission Alias - | Mon Jul 08 11:42:54 EDT 20131 Tue Jul 02 13:48:33 EDT 2013 Wed Jul 03 10:22:16 EDT 2013 Case Number Status r Hi In Progress In Progress Hi In Progress Modify Date : 07/08/2013 07/02/2013 07/03/2013 Items per page: Submission Date Export options: £] CSV | }c] Excel | £| XF.1L | -g PDF CDX Homepage | MyCDX Homepage | EPA Homepage | Terms and Conditions | Privacy Notice | CDX Helpdesk: (888) 890-1995 Navigation: Click the submission alias link that has a status of 'In Progress' to navigate to the 'Enter Passphrase' screen. 3.3.2 Enter Passphrase Screen To edit a submission, click the submission alias link for a submission with a status of 'In Progress' on the 'FYI' submissions screen. The 'Enter Passphrase' screen allows you to enter the passphrase that is associated with the submission. FYI User Guide Primary Support 9 ------- CDJfr Enter Passphrase: Enter the passphrase associated with the submission; the passphrase for the submission you have authority to edit will be given to you by the Primary AO. Exhibit 3-4 shows a screen capture of the 'Enter Passphrase' screen: Exhibit 3-4: Enter Passphrase Screen n • Logged in as: John Doe, Primary Support ENTER PASSPHRASE Please enter your user passphrase and click Next Forgot Your Passphrase? For security reasons, the system administrator does not have access to your passphrase and cannot retrieve it or reset it to a new one. If you have forgotten your passphrase, you must complete a new FYI Submission. CDX Homepage | MyCDX Homepage | EPA Homepage | Terms and Conditions | Privacy Notice | CDX Helpdesk: (888) 890-1995 Navigation: Enter the passphrase that was originally created by your Primary AO and associated with the submission and click the 'Next' button to navigate to the 'Technical Contact Information' screen. 3.3.3 Navigation Tree The navigation tree is located on the left hand side of each screen. You can perform the following functions using the navigation tree: • Collapse and Expand folders: Each section of the submission falls under a collapsible folder within the navigation tree, which allows you to save space or easily view items in the navigation tree. When a folder is expanded, you can click the minus sign (-), the folder icon ( ), or the folder title link to collapse that section of the navigation tree. When a folder is collapsed, you can click the plus sign (+), the folder icon ( ), or the folder title link to expand that section of the navigation tree. When you place your cursor over a folder title link, it will highlight in red. • Open and Close the Navigation Tree: To provide more visual form space, a navigation arrow (^) that opens and closes the navigation tree is located to the right of the navigation tree. Click the arrow (*) to close the navigation tree and increase the space of the form content. Likewise, click the arrow (* ) on the closed navigation tree to open the navigation tree. FYI User Guide Primary Support 10 ------- CD)Sr • Navigate between screens: You can use the navigation tree to navigate between the various screens within the application. Each screen of the submission is denoted with a form icon ( ). You can click the form icon ( ) or the screen title link to navigate to the selected screen. You are required to save all information entered on a particular screen before navigating to the next screen or all entered information will be lost. A prompt will appear after you click a link in the navigation tree indicating, 'Are you sure you want to leave the current page? Any unsaved changes will be lost.' If you click the 'OK' button, you will be taken to the requested screen without saving any of the data in the previous screen. If you click the 'Cancel' button, the prompt will close and you will not be taken to the requested screen. • Add Chemical: You can click the 'Add Chemical' button located at the bottom of the navigation tree to add another chemical report within a single submission. Clicking the 'Add Chemical' button will generate another chemical report folder containing a 'Chemical Information' screen and a 'Document Management' screen. The system provides a 'Remove' icon ( ¦¦-*) that allows you to delete any unwanted chemical report folders. Exhibit 3-5 shows a screen capture of the navigation prompt window: Exhibit 3-5: Navigation Prompt Windows Internet Explorer W Are you sure you want to leave the current page? Any unsaved changes will be lost, OK Cancel Exhibit 3-6 shows the screen capture of the navigation tree: FYI User Guide Primary Support 11 ------- CD)Sr Exhibit 3-6: Navigation Tree FYI Submission Primary Support B Contact Information I "p Technical Contact Information Submitting on Behalf of Consortium E3"L Chemical Report ; rj^j Chemical Identification Document Management ^Remove B Chemical Report Chemical Identification Document Management ^Remove 3.3.4 Action Bar The action bar is located at the bottom of each screen. You can perform the following functions using the action bar: • Validate: You can click the 'Validate' icon (' > ) at any stage of completing an FYI submission. An 'FYI Validation' pop-up window generates when you click the 'Validate' icon (V ). The 'FYI Validation' pop-up window displays a report of all validation errors that failed validation. Refer to Section 4 for more information on validating a submission. The following exhibits Exhibit 3-7, Exhibit 3-8, and Exhibit 3-9 show the screen captures for the action bar: FYI User Guide Primary Support 12 ------- CD)Sr Exhibit 3-7: Action Bar-Validate 9 ¦ Validate Save Preview • Save: You can click the 'Save' icon ( ) at any stage of completing an FYI submission. After you click the 'Save' icon ( ), the data entered on the screen will save. The 'Save' function does not validate any entered data. Exhibit 3-8: Action Bar - Save B H Validate Save Preview • Preview: You can click the 'Preview' icon ( ) at any stage of completing an FYI submission to preview the submission. After you click the 'Preview' icon ( ), a watermarked PDF version of the submission will generate. Exhibit 3-9: Action Bar - Preview 9 n Validate Save Preview • Help Links: You can click any of the 'Help' links, located at the bottom of each screen, at any stage of completing an FYI submission. - If you click the 'CDX Homepage' link, you will be taken to the CDX Homepage. - If you click the 'MyCDX Homepage' link, you will be taken to the CDX Login screen. - If you click the 'EPA Homepage' link, you will be taken to the EPA Homepage. - If you click the 'Terms and Conditions' link, you will be taken to the CDX Terms and Conditions screen. - If you click the 'Privacy Notice' link, you will be taken to the CDX Privacy and Security Notice screen. Exhibit 3-10 shows the screen capture of the action bar 'Help' links: Exhibit 3-10: Action Bar - Help Links CDXHomepage | MyCDX Homepage | EPAHomepage | Terms and Conditions | Privacy Notice | CDXHelpdesk: (888)890-1995 3.3.5 Technical Contact Information Screen You can access the 'Technical Contact Information' screen by clicking the submission alias link of a form that has a status of 'In Progress' and entering the associated passphrase. FYI User Guide Primary Support 13 ------- CD)Sr The 'Technical Contact Information' screen allows you to submit on behalf of another company or submit on behalf of a consortium. To identify if you are submitting on behalf of another entity, the system provides the radio button for 'This is a submission on behalf of a consortium.' To identify if you are submitting on behalf of another company, the system provides the radio button 'This is a submission on behalf of another company.' The system will not allow you to select more than one radio button per submission. If you are submitting on behalf of another company, select the 'This is a submission on behalf of another company' radio button. This functionality has been implemented to accommodate a company that may use an agent or another individual. If this radio button is selected, you can enter the contact information for the manufacturing or processing establishment on whose behalf the submission is being made on the 'Submitting on Behalf Of Company' screen upon clicking the 'Next' button. If the radio button for 'This is a submission on behalf of a consortium' is selected, you are taken to the 'Submitting on Behalf of Consortium' screen upon clicking the 'Next' button. The following fields are displayed on the 'Technical Contact Information' screen: • CBI: Checking this checkbox will claim the technical contact information as CBI. • Submission Alias: This field is auto-populated with a time stamp and displays on the 'FYI' submissions screen within the 'Submission Alias' column. This field is editable should you choose to provide your own submission alias. • N/A: Selecting the 'N/A' radio button allows you to signify that you are neither making a submission on behalf of a consortium nor making a submission on behalf of another company. • This is a submission on behalf of a consortium: Selecting the 'This is a submission on behalf of a consortium' radio button allows you to identify yourself as an individual submitting on behalf of a consortium. • This is a submission on behalf of another company: Selecting the 'This is a submission on behalf of another company' radio button allows you to identify yourself as an individual submitting on behalf of another company. • Copy CDX Registration: Clicking the 'Copy CDX Registration' button will automatically populate the fields with your contact information provided during CDX registration. • Prefix: Displays all optional prefixes. If applicable, select the appropriate prefix. If you have clicked the 'Copy CDX Registration' button, the fields populate with information entered during CDX registration. • First Name: Enter the technical contact's first name. If you have clicked the 'Copy CDX Registration' button, the fields populate with information entered during CDX registration. This is a required field. • Middle Initial: Enter the technical contact's middle initial. If you have clicked the 'Copy CDX Registration' button, the fields populate with information entered during CDX registration. • Last Name: Enter the technical contact's last name. If you have clicked the 'Copy CDX Registration' button, the fields populate with information entered during CDX registration. This is a required field. FYI User Guide Primary Support 14 ------- CD)Sr • Suffix: Displays all optional suffixes. If applicable, select the appropriate suffix. If you have clicked the 'Copy CDX Registration' button, the fields populate with information entered during CDX registration. • Company Name: Enter the technical contact's company name. If you have clicked the 'Copy CDX Registration' button, the fields populate with information entered during CDX registration. This is a required field. • Phone Number: Enter the technical contact's daytime phone number; US or international. If you have clicked the 'Copy CDX Registration' button, the fields populate with information entered during CDX registration. This is a required field. • Email Address: Enter the technical contact's email address. The email address must follow the standard email address format: iohn.doe@abc.com. If you have clicked the 'Copy CDX Registration' button, the fields populate with information entered during CDX registration. This is a required field. • Mailing Address 1: Enter the first line of the technical contact's mailing address. If you have clicked the 'Copy CDX Registration' button, the fields populate with information entered during CDX registration. This is a required field. • Mailing Address 2: Enter the second line of the technical contact's mailing address. If you have clicked the 'Copy CDX Registration' button, the fields populate with information entered during CDX registration. • City: Enter the city of the technical contact's mailing address. If you have clicked the 'Copy CDX Registration' button, the fields populate with information entered during CDX registration. This is a required field. • State: Enter the state of the technical contact's mailing address. If you have clicked the 'Copy CDX Registration' button, the fields populate with information entered during CDX registration. This is a required field if the 'Country' field is 'United States.' • Postal Code: Enter the postal code of the technical contact's mailing address. If you have clicked the 'Copy CDX Registration' button, the fields populate with information entered during CDX registration. This is a required field. • Country: Displays all available countries. Select the country of the technical contact's mailing address. If you have clicked the 'Copy CDX Registration' button, the fields populate with information entered during CDX registration. This is a required field. Exhibit 3-11 shows the screen capture of the 'Technical Contact Information' screen: FYI User Guide Primary Support 15 ------- CD)Sr Exhibit 3-11: Technical Contact Information Screen KSR0 7 T - Logged in as John Doe, Primary Support Log Out FYI Submission Primary Support Contact Information —p Technical Contact Information Chemical Report -|j Chemical Identification Document Management ^ FYI Submission > Contact Information > Technical Contact Information TECHNICAL CONTACT INFORMATION Identify the technical contact who is capable of answering questions related to the chemical(s) submitted to EPA within this submission- Identity if this submission is being submitted on behalf of another company or consortium by selecting the appropriate radio button. If submitting on behalf of is not applicable, select the N/A radio button. Click the Copy CDX Registration button below to import your CDX registration contact information. The submission alias is an optional field that changes the submission name on the Submissions Screen Its purpose is to make it easier to distinguish between multiple submissions. If an alias is not selected, the field will default to the date and time it was created. The submission alias may be changed at any time. Submission Alias: jTue Sep 1011:06:57 EDT 2013 | O N/A: © This Is a submission on behalf of a consortium: C1 This is a submission on behalf of another company: Copy CDX Registration CBI: Prefix: First Name: Middle Initial: Last Name: Suffix: Company Name: Phone Number: n ~ Email Address: Mailing Address 1: Mailing Address 2: City: State Postal Code: Country: Ext: 'Do not enter any dashes (-) in Phone Number field above.) Street address,. P.O. box, company name, etc. Apartment, suite, etc. IE Next >/ Validate B H Save Preview CDX Homepage | | MyCDX Homepage | ERA Homepage | I Terms and Conditions | Privacy Notice | CDX HelpdesIc (888) 890-1995 Navigation: Click the 'Next' button to navigate to the 'Chemical Identification' screen if you are not submitting on behalf of a consortium or another company. You can also access this screen by clicking the 'Chemical Identification' link within the navigation tree. If you are submitting on behalf of another company, you are taken to the 'Submitting on Behalf Of Company' screen. Click the 'Submitting On Behalf of Company' link within the navigation tree to access this screen. If you are submitting on behalf of a consortium, you are taken to the 'Submitting on Behalf of Consortium' screen. You can also access this screen by clicking the 'Submitting On Behalf of Consortium' link within the navigation tree. FYI User Guide Primary Support 16 ------- CD)Sr 3.3.6 Submitting on Behalf of Company Screen You can access the 'Submitting on Behalf Of Company' screen by selecting the 'This is a submission on behalf of another company' radio button and by clicking the 'Next' button from the 'Technical Contact Information' screen. You can also access this screen by clicking the ' Submitting on Behalf of Company' link within the navigation tree. The 'Submitting on Behalf Of Company' screen presents the user with a list of fields that allow you to input the contact information for the manufacturing or processing establishment on whose behalf the submission is being made. • CBI: Checking this checkbox will claim the 'Submitting on Behalf of Company' as CBI. • Prefix: The 'Prefix' drop-down menu displays all optional prefixes. If applicable, select the appropriate prefix. • First Name: Enter the first name of the manufacturing or processing establishment contact for which the submission is being made. This is a required field. • Middle Initial: Enter the middle initial of the manufacturing or processing establishment contact for which the submission is being made. • Last Name: Enter the last name of the manufacturing or processing establishment contact for which the submission is being made. This is a required field. • Suffix: The 'Suffix' drop-down menu displays all optional suffixes and captures the suffix of the manufacturing or processing establishment contact for which the submission is being made. If applicable, select the appropriate suffix. • Company Name: Enter the company name of the manufacturing or processing establishment. This is a required field. • Phone Number: Enter the daytime telephone number of the manufacturing or processing establishment contact for whom the submission is being made; US or international. This field does not accept dashes. This is a required field. • Email Address: Enter the email address of the manufacturing or processing establishment contact for which the submission is being made. The email address must follow the standard email address format: iohn.doe@abc.com. This is a required field. • Mailing Address 1: Enter the first line of the mailing address of the manufacturing or processing establishment contact. This is a required field. • Mailing Address 2: Enter the second line of the mailing address of the manufacturing or processing establishment contact. • City: Enter the city of the mailing address of the manufacturing or processing establishment contact. This is a required field. • State: Enter the state of the mailing address of the manufacturing or processing establishment contact. This is a required field if the 'Country' field is defined as 'United States.' • Postal Code: Enter the postal code of the mailing address of the manufacturing or processing establishment contact. This is a required field. FYI User Guide Primary Support 17 ------- CD)fr • Country: Enter the country of the mailing address of the manufacturing or processing establishment contact. This is a required field. Exhibit 3-12 shows the screen capture of the 'Submitting on Behalf of Company' screen: Exhibit 3-12: Submitting on Behalf of Company Screen •*» Logged in as John Doe, Primary Support FYI Submission Primary Support E|3 i_ Contact Information {¦] [Technical Contact Information ; • [2 Submitting on Behalf of Company Ep l_ Chemical Report "Q Chemical Identification -p iDocument Management X Remove B QjChemical Report [Chemical Identification (Document Management ^ Remove Home y Submissions y Resources FYI Submission > Contact Information > Submitting on Behalf of Company SUBMITTING ON BEHALF OF COMPANY Fill out the fields below for the manufacturing or processing establishment on whose behalf this submission is being made. CBI: Prefix: First Name: Middle Initial: Last Name: Suffix: Company Name: Phone Number: Email Address: Mailing Address 1: Mailing Address 2: City: State: Postal Code: Country: B ~ JB (Do not enter any dashes (-) in Phone Number field above. J Street address, P.O. box, company name, etc. Apartment, suite, etc. IZ Previous Next Add Chemical >/ Validate Save Preview CDX Homepage | MyCDX Homepage | EPA Homepage | Terms and Conditions | Privacy Notice | CDXHelpdesk: (888)890-1995 Navigation: Click the 'Next' button to navigate to the 'Chemical Identification' screen. You can also access this screen by clicking the 'Chemical Identification' link within the navigation tree. 3.3.7 Submitting on Behalf of Consortium Screen You can access the 'Submitting on Behalf of Consortium' screen by selecting the 'This is a submission on behalf of a consortium' radio button and by clicking the 'Next' button from the 'Technical Contact Information' screen. You can also access this screen by clicking the 'Submitting on Behalf of Consortium' link within the navigation tree. The 'Submitting on Behalf of Consortium' screen allows you to enter contact information for each consortium member. The system provides you with the ability to identify the consortium FYI User Guide Primary Support 18 ------- CD)Sr name. The contact information of the logged in user will pre-populate the first consortium field set. This information is editable. To add a consortium member, click the 'Add' button to display fields that can be populated and saved. You can click the 'Save' button for each consortium member added to capture all information entered on the screen. A minimum of two consortium members must be added to pass validation. • CBI: Checking this checkbox will claim the 'Submitting on Behalf of Consortium' as CBI. • Consortium Name: Enter the name of the consortium. • Prefix: The 'Prefix' drop-down menu displays all optional prefixes and captures the consortium member contact's prefix. If applicable, select the appropriate prefix. • First Name: Enter the consortium member contact's first name. This field is required. • Middle Initial: Enter the consortium member contact's middle initial. • Last Name: Enter the consortium member contact's last name. This field is required. • Suffix: The 'Suffix' drop-down menu displays all optional suffixes and captures the consortium member contact's suffix. • Company Name: Enter the consortium member contact's company name. This field is required. • Phone Number: Enter the consortium member contact's day time telephone number; US or international. This field does not accept dashes. This field is required. • Email Address: Enter the consortium member contact's email address. The email address must follow the standard email address format: iohn.doe@abc.com. This field is required. • Mailing Address 1: Enter the first line of the consortium member contact's mailing address. This field is required. • Mailing Address 2: Enter the second line of the consortium member contact's mailing address. • City: Enter the city of the consortium member contact's mailing address. This is a required field. • State: Enter the state of the consortium member contact's mailing address. This field is required only if the country field is set to 'United States.' • Postal Code: Enter the postal code of the consortium member contact's mailing address. This field is required. • Country: Enter the country of the mailing address of the consortium contact. This is a required field. Exhibit 3-13 show the screen capture for the 'Submitting on Behalf of Consortium' screen: FYI User Guide Primary Support 19 ------- CD)Sr ESERJ Exhibit 3-13: Submitting on Behalf of Consortium Screen • Logged in as: John Doe. Primary Support FYI Submission Primary Support EH Contact Information ^Technical Contact Information "¦ ( Submitting on Behalf of Consortium S Chemical Report !""[ Chemical Identification j-Q|Document Management ^Remove &•[ Chemical Report j-'l Chemical Identification ]-¦[ Document Management & Remove Home J Submissions y Resources , FYI Submission > Contact Information > Submitting on Behalf of Consortium SUBMITTING ON BEHALF OF CONSORTIUM Provide the consortium name and click the Add button to enter member contact information. Consortium Name: ~ CGI FEDERAL (John Doe) Expand All | Collapse All Edit X CBI: Prefix: First Name: Middle Initial: Last Name: Suffix: Company Name: Phone Number Email Address: Mailing Address 1: Mailing Address 2: City: State: Postal Code: Country: ~ J - ~ (Do not enter any dashes (-) in Phone Number field above.) Ext: Street address, P.O. box, company name, etc. Apartment, suite, etc. Save Click the Add button to add a new consortium member Add CDX Homepage | MyCDX Homepage | EPA Homepage | Terms and Conditions | Privacy Notice | CDX Helpdesk: (888) 890-1995 Navigation: Click the 'Next' button to navigate to the 'Chemical Identification' screen. You can also access this screen by clicking the 'Chemical Identification' link within the navigation tree. 3.3.8 Chemical Identification Screen You can access the 'Chemical Identification' screen by clicking the 'Next' button from the 'Submitting on Behalf Of Company' screen (if you selected the 'This is a submission on behalf of another company' radio button), by clicking the 'Next' button from the 'Submitting on Behalf of Consortium' screen (if you selected the 'This is a submission on behalf of a consortium' radio button), or by clicking the 'Next' button from the 'Technical Contact Information' screen (if you selected the 'N/A' radio button). You can also access this screen by clicking the 'Chemical Identification' link within the navigation tree. FYI User Guide Primary Support 20 ------- CD)Sr The 'Chemical Identification' screen provides a 'Chemical Alias' field to help distinguish between chemical reports when there is more than one. If you provide a chemical alias, the chemical alias will be displayed within the navigation tree. If you do not provide a chemical alias, 'Chemical Report' will remain as the title of each chemical report folder. To access the Substance Registry Services (SRS) Search you will identify if you are reporting for a mixture by selecting the 'Yes' or 'No' radio button for 'This is a submission for a mixture.' If you identify you are submitting for a mixture, the system provides a 'Please provide the mixture, compound, or product name' optional text box. The mixture name text box does not appear if you select 'No' for 'This is a submission for a mixture.' The following fields are displayed on the 'Chemical Identification' screen: • Chemical Alias: The chemical alias is used to help distinguish between chemical reports within the navigation tree when there is more than one. A chemical alias can be created for each chemical report folder. If a chemical alias is not identified, 'Chemical Report' will remain as the chemical report folder title within the navigation tree. • This is a submission for a mixture: Selecting the 'Yes' radio button captures if you are reporting for a mixture. • Please check this checkbox if the mixture is CBI: Clicking this checkbox will claim the entire chemical mixture as CBI. Checking the CBI checkbox will disable all individual chemical CBI checkboxes. • Please provide the mixture, compound, or product name: Enter the mixture, compound, or product's name. • Add: Clicking the 'Add' button will generate a chemical substance field set. • Search SRS: Clicking the 'Search SRS' button will generate a pop-up window to perform an SRS search. Refer to Section 3.3.9 for further details. • Chemical Identifying Number: Displays the chemical identifying number for the specified chemical substance. • Chemical Name: Displays the chemical name of the specified substance. • Synonym: Displays the chemical synonym(s) identified by the user. Clicking the 'Add' icon ( ) will allow you to enter up to three synonyms for the identified chemical substance. Click the 'Delete' icon ( -<¦) to delete a synonym. • Mixture (%): Enter the percent composition of each chemical within a mixture. This displays only when you have identified the submission is for a mixture. • Mixture % CBI: Checking this checkbox will claim all mixture percent information as CBI. Exhibit 3-14 shows the screen capture of the 'Chemical Identification' screen for reporting for a mixture: FYI User Guide Primary Support 21 ------- CD)Sr Exhibit 3-14: Chemical Identification Screen: Submission Is for a Mixture FYI Submission Primary Support f3 _ Contact Information '(^Technical Contact Information B Chemical Report l~(? Chemical Identification Document Management Logged in as: John Doe, Primary Support Log Out Home y Submissions J Resources ^ FY) Submission > Chemical Report > Chemical Identification CHEMICAL IDENTIFICATION The chemical alias is an optional field user to help identify each chemical report when there is more than one chemical per submission. The alias will display in the navigation tree to help distinguish between multiple chemical reports. Chemical Alias: Is this a submission for a mixture? Please check this checkbox if the mixture is CBI: @Yes ©No B9 Please provide the mixture, compound, or product name: Expand All | Collapse All - Cancel X Click the button below to search EPA's Substance Registry Services (SRS) for the desired chemical. Search SRS Chemical Identifier: Chemical Name: Synonym: I# Mixture %: Mixture % CBI: 0 Save Click the Add button to add a new mixture component. Add Previous Next >/ Validate B ¦ Save Preview CDX Homepage | I MyCDX Homepage I ERA Homepage | I Terms and Conditions | Privacy Notice | I CDXHelpdesk: (888) 8£ 10-1995 • CBI: Checking the CBI checkbox will claim the chemical as CBI. The CBI checkbox only appears if the chemical is not found on the TSCA inventory list. • This is a submission for a mixture: Selecting the 'No' radio button captures that the user is not reporting for a mixture. • Search SRS: Clicking the 'Search SRS' button will generate a pop-up window to perform an SRS search. Refer to Section 3.3.9 for further details. • Chemical Identifier: Displays the chemical identifying number for the specified chemical substance. • Chemical Name: Displays the chemical name of the specified substance. FYI User Guide Primary Support 22 ------- CD)Sr • Synonym: Displays the chemical synonym(s) identified by the user. Clicking the 'Add' icon ("I ) will allow you to enter up to three synonyms for the identified chemical substance. Click the 'Delete' icon .() ) to delete a synonym. Exhibit 3-15 shows the screen capture for the 'Chemical Identification' screen for reporting for a single chemical substance: Exhibit 3-15: Chemical Identification Screen: Submission Is Not For a Mixture • Logged in as John Doe, Primary Support Log Out FYI Submission Primary Support B _ Contact Information '^Technical Contact Information B Chemical Report Chemical Identification i" Document Management Home y Submissions J Resources FYI Submission > Chemical Report > Chemical Identification CHEMICAL IDENTIFICATION The chemical alias is an optional field user to help identify each chemical report when there is more than one chemical per submission. The alias will display in the navigation tree to help distinguish between multiple chemical reports. # Chemical Alias: Is this a submission for a mixture? ©Yes ®No Click the button below to search EPA's Substance Registry Services (SRS) for the desired chemical. Search SRS CBI: Chemical Identifier: Chemical Name: Synonym: n Accession Number: 11111 Ricinoleic acid homopolymer Previous Next >/ Validate = n Save Preview CDX Homepage | | MyCDX Homepage | ERA Homepage | | Terms and Conditions | Privacy Notice j | CDX Helpdesk: (888)85 >0-1995 Navigation: Click the 'Next' button to navigate to the 'Document Management' screen. You can also access this screen by clicking the 'Document Management' link within the navigation tree. 3.3.9 Search Substance Registry Services Click the 'Search SRS' button to initiate the SRS pop-up window. You can search for the chemical(s) being reported by the 'CASRN,' 'CA Index Name,' 'Synonym,' 'Accession Number,' or 'Generic Name.' After you have searched and selected a chemical and clicked 'OK,' the selected chemical information will populate the 'Chemical Identification' screen. See Section 3.3.10 below if you don't know the CAS or Accession Number. • CASRN: Enter the CASRN of the chemical. • CA Index Name or Other Synonym: Enter the CA Index Name or Other Synonym of the chemical. Displays the following search options: 'Contains,' 'Begins With,' and 'Matches Exactly.' • Accession Number: Enter the accession number of the chemical. Displays the following search options: 'Contains,' 'Begins With,' and'Matches Exactly.' FYI User Guide Primary Support 23 ------- CD)Sr • Generic Name: Enter the generic name of the chemical. Displays the following search options: 'Contains,' 'Begins With,' and 'Matches Exactly.' Exhibit 3-16 shows the screen capture for the 'Search Substance Registry Services' pop-up window: Exhibit 3-16: Search Substance Registry Services Pop-Up Window C^CSPP SEARCH SUBSTANCE REGISTRY SERVICES Enter the specific or partial, currently correct Chemical Abstracts (CA) Index name as listed on the TSCA Inventory and/or the exact corresponding Chemical Abstract Services Registry Number (CASRN) for each reportable chemical substance at your site. Click Search and select the appropriate CA Index name/ CASRN combination from EPA's Substance Registry Services (SRS). Please search by CASRN or CA Index Name 1. CASRN: Matches exactly 2. CA Index Name or Other Synonym: Matches Exactly - Search OR Enter the specific or partial, currently correct Accession Number as listed on the TSCA Inventory and/or the exact or partial corresponding Generic Name for each reportable chemical substance at your site. Click Search and select the appropriate Accession Number/ Generic Name combination from EPA's Substance Registry Services (SRS). Please search by Accession Number and/or Generic Name 1. Accession Number: Matches Exactly " 2. Generic Name: Matches Exactly ~ Search Navigation: Click the 'X' button to close out of the 'Search Substance Registry Services' pop- up window and return to the 'Chemical Identification' screen. 3.3.10 Chemical Not Found in Substance Registry Services Window You can access the 'Chemical Not Found in Substance Registry Services' screen by entering known information into the SRS window and performing a search. If there are no results, a message will be returned stating 'There were no results returned.' If you are sure the chemical does not exist in SRS, please click the 'Create New Chemical' button to enter the chemical information. Clicking the 'Create New Chemical' button on the 'Search Substance Registry Services' screen takes you to the 'Chemical Not Found in Substance Registry Services' screen. FYI User Guide Primary Support 24 ------- CD)Sr Click the 'Cancel' button to go back to the 'Search Substance Registry Services' screen. When entering information into the 'Chemical Not Found in Substance Registry Services' screen at least one of the following four fields is required; 'Accession Number,' 'CASRN,' 'Premanufacture Notice (PMN) Number,' or 'International Union of Pure and Applied Chemistry (IUPAC) Name' If you do not know the accession number, CASRN, PMN number, or IUPAC number, check the 'Unknown' checkbox. Once you check the 'Unknown' checkbox, the above mentioned fields are disabled and you are only required to enter a chemical name (or descriptor). • Unknown: Checking the 'Unknown' checkbox disables the 'Accession Number,' 'CASRN,' 'PMN Number,' and 'IUPAC Name' fields and requires you to enter the chemical name in the 'Chemical Name (descriptor)' field. • Accession Number: If known, enter the accession number of the chemical. • CASRN: If known, enter the CASRN of the chemical. • PMN Number: If known, enter the PMN number of the chemical. • IUPAC Name: If known, enter the IUPAC name of the chemical. • Chemical Name (descriptor): Enter the chemical name/descriptor of the chemical being reported. This is a required field when the 'Unknown' checkbox is checked. Exhibit 3-17 shows the screen capture for the 'Chemical Not Found in Substance Registry Services' pop-up window: FYI User Guide Primary Support 25 ------- CD)Sr Exhibit 3-17: Chemical Not Found in Substance Registry Services Pop-Up Window CSPP # CHEMICAL NOT FOUND IN SUBSTANCE REGISTRY SERVICES Complete all known chemical substance information in the below fields. Click the 'OK' button when all known chemical substance information has been fulfilled. If you need to go back to the SRS search screen, please click 'Cancel1. Chemical ID Unknown: Accession Number CASRN PMN Number: IUPAC Name: Chemical Name (descriptor): ~ Cancel OK Navigation: Click the 'OK' button to populate the entered information and navigate to the 'Chemical Identification' screen. Click the 'Cancel' button to navigate to the 'Search Substance Registry Services' screen. The following fields are displayed on the 'Chemical Identification' screen if a chemical is not found in SRS Search: • CBI: Checking this checkbox will claim the chemical as CBI. • Chemical Identifier: Displays which identifier you used to label the chemical as. The chemical identifier will vary depending on the data entered in the 'Chemical Not Found In Substance Registry Services' screen. • Chemical Name (descriptor): Displays the chemical name (or descriptor) of the chemical being reported entered in the 'Chemical Not Found In Substance Registry Services' screen. • Synonym: Enter the chemical synonym(s).. Clicking the 'Add' icon (c ) will allow you to enter up to three synonyms for the identified chemical substance. Click the 'Delete' icon (^ ) to delete a synonym. Exhibit 3-18 shows the screen capture for the 'Chemical Identification' screen when the chemical is not found in SRS: FYI User Guide Primary Support 26 ------- CD)fr Exhibit 3-18: Chemical Identification Screen (Populated with chemical not found in SRS Search) r. KSRRJ Logged in as John Doe, Primary Support FYI Submission Primary Support @ i_ Contact Information ""^Technical Contact Information B Chemical Report •j=r Chemical Identification Document Management lome J Submissions y Resources ^ FYI Submission > Chemical Report > Chemical identification CHEMICAL IDENTIFICATION The chemical alias is an optional field user to help identify each chemical report when there is more than one chemical per submission. The alias will display in the navigation tree to help distinguish between multiple chemical reports. # Chemical Alias: Is this a submission for a mixture? Yes ° No Click the button below to search EPA's Substance Registry Services (SRS) for the desired chemical. Search SRS CBI: Chemical Identifier: Chemical Name (descriptor): Synonym: 0 Accession Number: 11111 Test Chemical Previous Next Add Chemical s/ Validate Save Preview COX Homepage | MyCDX Homepage | EPA Homepage | Terms and Conditions | Privacy Notice | CDXHelpdesk: (888) 890-1995 Navigation: Click the 'Next' button to navigate to the 'Document Management' screen. 3.3.11 Document Management Screen You can access the 'Document Management' screen by clicking the 'Next' button from the 'Chemical Identification' screen. You can also access this screen by clicking the 'Document Management' link within the navigation tree. The 'Document Management' screen allows you to upload documents related to FYI Submission reporting requirements. To add FYI Submission documents, click the 'Add Document' button. Clicking the 'Add Document' button generates the 'Document Management' pop-up window. The 'Document Management' pop-up window allows you to attach the submission types: 'Initial Submission,' 'Follow-up Submission, and 'Final Report Submission.' The 'Document Management' table displays the 'Report Study Title' of the document, the document type, the date the document was attached, and the CBI status of the document. The system allows you to delete unwanted documents by clicking the 'Delete' icon (3 ) located under the 'Action' column. Clicking the report study title link generates the 'Document Management' pop-up window. This allows you to view and edit the attached documents. FYI User Guide Primary Support 27 ------- CD)fr • Add Document: Clicking the 'Add Document' button generates the 'Document Management' pop-up window. • Report Study Title: Displays the file name and file extension of the attached file. Clicking the file name link displays the 'Document Management' pop-up window and allows you to view and edit the attached document. • Submission Type: Displays the submission type chosen in the 'Document Management' pop-up window. • Attachment Date: Displays the date the document was attached. • CBI: Displays 'N' or ' Y' depending on if the CBI checkbox was checked. • Action: Clicking the 'Delete' icon () ) will delete the specified row and all contents within. A warning message displays to confirm the deletion of the document. Exhibit 3-19 shows the screen capture of the 'Document Management' screen: Exhibit 3-19: Document Management Screen FYI Submission Primary Support 0 Contact Information (Technical Contact Information S Chemical Report I" i | Chemical Identification H^Dooimeiif Management Logged in as: John Doe, Primary Support Home y Submissions J Resources ^ FYI Submission > Chemical Report > Document Management DOCUMENT MANAGEMENT Upload the corresponding FYI Submission document(s) by clicking on the Add Document button below. Add Document Report Study Title Submission Type Attachment Date CBI Action Previous Add Chemical CDX Homepage | MyCDX Homepage | EPA Homepage | Terms and Conditions | Privacy Notice | CDXHelpdesk: (888) 890-1995 The 'Document Management' pop-up window allows you to browse for a document from your local hard drive and attach one document at a time. You must enter a report study title and attach one document. Clicking the 'Browse' button will generate the 'File Upload' window on your local hard drive. Select the document you wish to attach and click the 'Open' button. If a document is marked as 'CBI' then a sanitized copy of the document must be attached. To save the attached document to the 'Document Management' screen, click the 'OK' button within the 'Document Management' pop-up window. • Report Study Title: Enter the report study title that is unique to this chemical report. This field is required. This study title must be non-confidential. • CBI: Checking the 'CBI' checkbox will claim the uploaded document as CBI. FYI User Guide Primary Support 28 ------- CD)Sr • Submission Type: Allows you to select the submission type for the attachments. Displays the following options: 'Initial Submission,' 'Follow-up Submission,' and 'Final Submission.' • Original Document: Clicking the 'Browse' button will generate the 'File Upload' window for you to search for a particular file on your hard drive. • CBI: Checking the 'CBI' checkbox will claim the uploaded summary/abstract document as CBI. • Summary/Abstract: Displays 'Yes' and 'No' radio buttons. If you select the 'Yes' radio button a document upload will generate. Click the 'Browse' button to generate the 'File Upload' window for you to search for a particular file on your hard drive. • Effects: Allows you to select the effect specific to the chemical report. Displays the following options: 'Health Effects,' 'Environmental Fate,' 'Ecotoxicity,' and 'Physical Chemical Properties.' • Endpoints: Allows you to select an endpoint that is specific to the chemical report. The endpoints will be specific to the effect chosen from the 'Effects' drop-down menu. If no effect is chosen, no endpoints will display. Refer to Error! Reference source not found, for a complete list of values that are found within each of the drop-down menus on the 'Document Management' pop-up window. If you have multiple documents that share the same effects and/or endpoints, you must upload each individual document separately and select values from the drop-down menus. Exhibit 3-20 shows the screen capture of the 'Document Management' pop-up window: FYI User Guide Primary Support 29 ------- CD)Sr Exhibit 3-20: Document Management Pop-Up Window 4CSPP DOCUMENT MANAGEMENT Select the submission type and browse for the document. Note: For security purposes, documents are only saved when there are no validation errors. If there are any validation errors, all documents must be reattached. Report Study Title Submission Type - CBI m Document Upload. Browse Sanitized Document Upload Browse Summary/Abstract: Yes ® No: CBI m Document Upload Browse Sanitized Document Upload Browse Effects: EndPoints: OK Cancel Navigation: Upload all required documentation and click the 'OK' button to save all data to the 'Document Management' table. Exhibit 3-21 shows the screen capture for the 'Document Management' screen populated with data: FYI User Guide Primary Support 30 ------- CD)Sr FYI Submission Primary Support B i Contact Information :""j ^Technical Contact Information B '| Chemical Report {""[jChemical Identification |~[ Document Management Exhibit 3-21: Document Management Screen (Populated) Home j Submissions J User Management y Resources • Logged in as John Doe, Primary Support Log Out ^ FYI Submission > Chemical Report > Document Management DOCUMENT MANAGEMENT Upload the corresponding FYI Submission document(s) by clicking on the Add Document button below. Add Document Report Study Title Test Report Submission Type Initial Submission Attachment Date 08/15/2013 CBI Action Y X Previous >/ Validate B Save Preview CDX Homepage ! | MyCDX Homepage | | EPA Homepage | Terms and Conditions I Privacy Notice ! | CDX Helpdesk: (888) 890-1995 Navigation: Once all data has been uploaded, click the 'Save' button located in the action bar to save all information. FYI User Guide Primary Support 31 ------- CD)Sr 4 Validate You can click the 'Validate' icon ( ) at any stage of completing an FYI submission. The 'FYI Submission Validation' pop-up window is displayed when you click the 'Validate' icon ( ) in the action bar. The 'FYI Submission Validation' pop-up window displays a report of all validation errors. During the validation process, the application validates each screen of the FYI submission to find missing and invalid data. For example, if a document is claimed as CBI a sanitized version of the document must be uploaded. If a sanitized version if not uploaded, you will be unable to complete the submission. Validation Errors: Errors are denoted by an 'Error' icon ( -¦) and can be fixed by clicking the error link. The links will display the Screen Title Name (e.g., Chemical Identification) and the associated error. For example, if you claimed an uploaded document as CBI and have not attached a sanitized copy prior to validation, the system would display a validation error similar to 'Document Management: @ You have uploaded a CBI document. A sanitized copy is required. ' After you click a link, the main application screen will display the screen where the error occurred so you can easily fix the error. Once you have fixed the error, click the 'Validate' icon ( ) again to refresh the 'FYI Submission Validation' pop-up window. If the information you fixed passes validation, the error will be removed from the 'FYI Submission Validation' pop-up window. All validation errors must be fixed, by the Primary Support or by the Primary AO, before the Primary AO can successfully submit to EPA via CDX. Warning Messages: Warnings are denoted by a 'Warning' icon ( ) and can be fixed by clicking the warning link. The links will display the Screen Title and the associated warning. After you click a link, the main application screen will display the section where the warning occurred so you can easily fix the warning. Once you have fixed the warning(s), click the 'Validate' icon (*> again to refresh the 'FYI Submission Validation' pop-up window. If the information you fixed passes validation, the warning will be removed from the 'FYI Submission Validation' pop-up window. You can pass validation and continue to submit a form to CDX with active warning messages. You can close the 'FYI Submission Validation' pop-up window by clicking the 'X' button located at the top right of the window. FYI User Guide Primary Support 32 ------- CD)Sr Exhibit 4-1 shows the screen capture for the 'FY I Submission Validation' pop-up window: Submitting on Behalf of Consortium There must be at least 2 consortium members for the entered consortium. Chemical Report (1) Chemical Identification # A chemical (or chemicals} must be populated using Substance Registry Systems Search or by manually entering a chemical. Document Management At least one document must be uploaded. Chemical Report (2) Chemical Identification C' A response option for Is this a submission for a mixture is required. Document Management m At least one document must be uploaded. Warnings: Chemical Report (1) Chemical Identification (A Sum of Mixtures for the chemical components does not total 100% Exhibit 4-1: FYI Submission Validation Pop-Up Window FYI Submission Validation Errors: FYI User Guide Primary Support 33 ------- CD)Sr 5 Complete an Amendment Only the Primary AO can unlock an FYI submission to create an amendment. After the AO has unlocked the submission and logged out, you (the Primary Support) can login and edit the submission. At this point, the 'FYI' submissions screen will display a status of 'In Progress' under the 'Status' column for the unlocked submission. Click the submission alias link for the submission you wish to amend to navigate to the 'Enter Passphrase' screen. You must enter the passphrase originally associated with the submission to complete the amendment process. FYI User Guide Primary Support 34 ------- CD)Sr 6 Resources You can access the 'Resources' screen by clicking the 'Resources' tab located at the top of the screen at any time during the submission process. You can also access the 'Resources' screen by clicking the 'Resources' link from the FYI 'Home' screen. The 'Resources' screen provides you with a link to the FYI user guide as well as additional helpful links. Click the 'User Guide' link to access the FYI user guide document. Toxic Substances Control Act (TSCA) Section 8(e) Notices and FYI Submissions: If you click this link, a new internet browser window will generate displaying the TSCA Section 8(e) Notices screen. CDX Home: If you click this link, a new internet browser window will generate displaying the CDX Homepage. TSCA Chemical Substances Inventory: If you click this link, a new internet browser window will generate displaying the TSCA Chemical Substances Inventory screen. Exhibit 6-1 shows the screen capture of the 'Resources' screen: Exhibit 6-1: Resources Screen Logged in as John Doe, Primary Support i Home y Submissions y Resources Log Out ¦& RESOURCES FYI Submission User Guide This guide describes each screen of the FYI Submission application software and provides information on how to use the system to complete a FYI Submission. The guide also contains instructions for registering with CDX7 submitting a FYI Submission, and amending a previous submission. You can download and print the guide for quick reference. User Guide Helpful Web Links Click the link provided below to access additional information related to FYI Submissions. Toxic Substances Control Act (TSCA) Section 8(e) Notices and FYI Submissions Click the link provided below to access additional information related to Central Data Exchange (CDX). CDX Home Click the link provided below to access additional information related to the Toxic Substances Control Act (TSCA). TSCA Chemical Substances Inventory If you need assistance, please call (202) 564-3011 or e-mail the TSCA Hotline at TSCA-Hotiine@epamaii.epa.gov. FYI User Guide Primary Support 35 ------- CD)Sr Appendix A. Definitions, Acronyms, and Abbreviations The following table displays all the definitions, acronyms, and abbreviations used in this document and their full name. Definitions, Acronyms, and Abbreviations Acronym Full Name AO Authorized Official CASRN Chemical Abstract Service Registry Number CDX Central Data Exchange CSPP Submissions for Chemical Safety and Pesticide Programs CSV Comma-Separated Values EPA Environmental Protection Agency EST Eastern Standard Time FYI For Your Information IUPAC International Union of Pure and Applied Chemistry OPPT Office of Pollution Prevention and Toxics PDF Portable Document Format PMN Premanufacture Notice SRS Substance Registry Services TSCA Toxic Substances Control Act XML Extensible Markup Language FYI User Guide Primary Support 36 ------- CD)Sr Appendix B. Submission Types, Effects, and Endpoints The following appendix displays all possible options within each drop-down menu on the 'Document Management' pop-up window. First Dropdown: • Title: Submission Type • Contains the following values o Initial Submission o Follow-Up Submission o Final Submission Second Dropdown • Title: Summary/Abstract Submission • Contains the following values o Yes o No Third Dropdown • Title: Effects • Contains the following values o Health Effect o Ecotoxicity o Environmental Fate o Physical-Chemical Properties Fourth Dropdown • Title: Endpoints • Contains the following values o For Health Effect (shows when Health Effect is selected from third dropdown) ¦ Basic Toxic kinetics ¦ Dermal Absorption ¦ Acute Toxicity: oral ¦ Acute Toxicity: inhalation ¦ Acute Toxicity: dermal ¦ Acute Toxicity: other routes ¦ Skin irritation/corrosion ¦ Eye irritation ¦ Skin sensitization ¦ Respiratory sensitization ¦ Repeated Dose toxicity: oral ¦ Repeated Dose toxicity: inhalation FYI User Guide Primary Support 37 ------- ¦ Repeated Dose Toxicity: dermal ¦ Repeated Dose Toxicity: other routes ¦ Genetic Toxicity in vitro ¦ Genetic Toxicity in vivo ¦ Carcinogenicity ¦ Toxi city to Reproducti on ¦ Developmental Toxicity/teratogenicity ¦ Toxicity to reproduction: other studies ¦ Neurotoxicity ¦ Immunotoxi city ¦ Specific investigations: other studies ¦ Health surveillance data ¦ Epidemiological data ¦ Direct observations: clinical cases, poisoning incidents and other ¦ Sensitization data (humans) ¦ Exposure related observations in humans: other data ¦ Toxic effects on livestock and pets ¦ Additional toxicological information ¦ Other For Ecotoxicity (shows when Ecotoxicity is selected from third dropdown) ¦ Short-term toxicity to fish ¦ Long-term toxicity to fish ¦ Short-term toxicity to aquatic invertebrates ¦ Long-term toxicity to aquatic invertebrates ¦ Toxicity to aquatic algae and cyanobacteria ¦ Toxicity to aquatic plants other than algae ¦ Toxi city to mi croorgani sm s ¦ Toxicity to other aquatic organisms ¦ Sediment toxicity ¦ Toxicity to soil macroorganisms except arthropods ¦ Toxicity to terrestrial arthropods ¦ Toxicity to terrestrial plants ¦ Toxicity to soil microorganisms ¦ Toxicity to birds ¦ Toxicity to other above-ground organisms ¦ Biological effects monitoring ¦ Biotransformation and kinetics ¦ Additional ecotoxicological information ¦ Other ------- CD)Sr o For Environmental Fate (shows when Environmental Fate is selected from third dropdown) ¦ Photo transformation in air ¦ Hydrolysis ¦ Photo transformation in water ¦ Photo transformation in soil ¦ Biodegradation in water: screening test ¦ Biodegradation in water and sediment: simulation tests ¦ Biodegradation in soil ¦ Mode of degradation in actual use ¦ Bioaccumulation: aquatic/sediment ¦ Bioaccumulation: terrestrial ¦ Adsorption/desorption ¦ Henry's Law constant ¦ Distribution Modeling ¦ Other Distribution Data ¦ Monitoring Data ¦ Field Studies ¦ Additional Information on Environmental Fate and Behavior ¦ Other o For Physical-Chemical Properties (shows when Physical-Chemical Properties is selected from third dropdown) ¦ Appearance/Physical ¦ Melting Point ¦ Boiling Point ¦ Density ¦ Particle size distribution ¦ Vapor Pressure ¦ Partition Coefficient ¦ Water Solubility ¦ Solubility in Organic Solvent ¦ Surface Tension ¦ Flash Point ¦ Auto Flammability ¦ Flammability ¦ Explosiveness ¦ Oxidizing Properties ¦ Oxidation Reduction Potential ¦ Stability in organic solvents and identity of relevant degradation products ¦ Storage stability and reactivity towards container material FYI User Guide Primary Support 39 ------- CD)Sr ¦ Stability: thermal, sunlight, metals ¦ pH ¦ Dissociation constant ¦ Viscosity ¦ Additional physic-chemical information ¦ Other FYI User Guide Primary Support 40 ------- |