Last Updated - April 2020 TSCAFEES AMENDING INITIAL RESPONSE IN CDX Step-By-Step Instructions For Amending Self-Identification and Other Certifications AS PART OF THE INITIAL RESPONSE FOR EPA-lNITIATED RISK EVALUATIONS 40 CFR 700.45(B)(5) 1 ------- Last Updated - April 2020 Step 1. Log into CDX (https://cdx.epa.gov,) For general questions about CDX; see the "FAQ" or "Help" tabs, or the "Contact Us" link at the top of the screen. The CDX link is also available on the TSCA Fees website at www.eDa.gov/TSCA-fees under the "Reporting and Paying Fees" section vvEPA United States Environmental Protection Agency Home About Recent Announcements Terms and Conditions FAQ Help CDX: Central Data Exchange Log in to CDX 1 > Show Password Log In Register with CDX Forgot your Password? Forgot your User ID? Warning Notice and Privacy Policy Welcome Welcome to the Environmental Protection Agency (EPA) Central Data Exchange (CDX) - the Agency's electronic reporting site. The Central Data Exchange concept has been defined as a central point which supplements EPA reporting systems by performing new and existing functions for receiving legally acceptable data in various formats, including consolidated and integrated data. Warning Notice and Privacy Policy Warning Notice In proceeding and accessing U.S. Government information and information systems, you acknowledge that you fully understand and consent to all of the following: 1. you are accessing U.S. Government information and information systems that are provided for official U.S. Government purposes only; 2. unauthorized access to or unauthorized use of U.S. Government information or information systems is subject to criminal, civil, administrative, or other lawful action; 3. the term U.S. Government information system includes systems operated on behalf of the U.S. Government; 4. you have no reasonable expectation of privacy regarding any communications or information used, transmitted, or stored on U.S. Government information systems; 5. at any time, the U.S. Government may for any lawful government purpose, without notice, monitor, intercept, search, and seize any authorized or unauthorized communication to or from U.S. Government information systems or information used or stored on U.S. 2 ------- Last Updated - April 2020 Step 2. Open the "CSPP: Submissions for Chemical Safety and Pesticide Programs" link as the Primary Authorized Official Lvyycu in oa wuiu/lim iuiu uuu Status » Program Service Name » Roje CSPP: Submissions for Chemical Accreditation Body fAB) Safety and Pesticide Programs Authorized Official S CSPP: Submissions for Chemical Accreditation Body fAB) Safety and Pesticide Programs Support CSPP: Submissions for Chemical Primary Authorized Official ^^_^^J5afety_andjjffitiddeiPro2rams^^^^^^_^^^^^^_ & CSPP: Submissions for Chemical Safety and Pesticide Programs Prinw Support & CSPP: Submissions for Chemical Safety and Pesticide Programs Secondary Authorized Official a CSPP: Submissions for Chemical Safety and Pesticide Programs Third-Partv Certifier fTPCl Authorized Official a CSPP: Submissions for Chemical Safety and Pesticide Programs Third-Partv Certifier fTPCl Support : TRIMEweb: Toxic Release Inventory Made Easy Web TRI-MEweb (Certify™ Official) Add Program Service ¦ Manage Your Program Services See the status for all program services News and Updates No news/updates, 3 ------- Last Updated - April 2020 Step 3. Select "TSCA Risk Evaluation Rule" from the drop-down list and click OK" CHEMICAL INFORMATION SUBMISSION SYSTEM TSCA Chemical Data Reporting (CDR) TSCA Section 5 Notices and Supports - ePMN TSCA Section 4 TSCA Section 8(e) Notice TSCA Section 12(b) TSCA Section 8(a) Nanoscale Materials TSCA Section 8(b) - Notice of Activity j' —: j TSCA Risk Evaluation Rule Mercury Electronic Reporting - MER TSCA Chemical Data Reporting (CDR) 2020 Welcome to the EPA's Chemical drop-down menu. TSCA FYI Submission ;e select an application from the 4 ------- Last Updated - April 2020 Step 4. Click on the Lock icon in the Action column for the submission you need to amend. The lock icon should appear to be locked. If the icon is appearing as unlocked\ this step can be ignored. Submission History Show | 10 t entries Search: Form Alias Ji Form Type Case Number Submission Date Status Action EIRE-20191204- 10:09:15 EPA Initiated Risk Evaluation El RE-19- 0011 12/19/2019 In Progress i m Eval for Formaldehyde Manufacturer Requested Risk Evaluation MRRE-17- 0007 06/27/2017 Completed ± <2 Fees Test Submission Manufacturer Requested Risk Evaluation MRRE-18- 0029 06/24/2019 Failed - Awaiting Payment ± $ IR-20191114- 11:46:45 Initial Response IR-19-0006 12/17/2019 In Progress ± i6 IR-20200210- 12:16:23 Initial Response IR-20-0007 03/30/2020 Completed i a 5 ------- Last Updated - April 2020 Step 5. Click "Ok" to confirm unlocking of the submission. Clicking 'Cancel' will end the process of unlocking the submission. Attention This will begin the amendment process. Please be aware that once this form is unlocked, the only way to lock it again is to resubmit it to EPA. Do you wish to proceed? Cancel 6 ------- Last Updated - April 2020 Step 6. Enter your Passphrase and click "Continue". HOME USER MANAGEMENT TSCA Risk Evaluation Eval for Formaldehyde Enter Passphrase Form Alias Eval for Formaldehyde Enter Passphrase > V A You are responsible for remembering your passphrase! If you lose or forget your passphrase, you will not be able to access your Risk Evaluation Form to print, submit, or make changes. You will also not be able to make a payment or access an invoice without the passphrase. You will need to complete a new Risk Evaluation Form and create a new passphrase for the form. For security reasons, the system administrator will not have access to your passphrase and will not be able to retrieve it or reset it. / N Cancel 1 Continue LI 7 ------- Last Updated - April 2020 Step 7. Enter your reason for amending the submission. Edit contact information if necessary and click "Continue". \ HOME USER MANAGEMENT TSCA Risk Evaluation IR-20191114-11:46:45 Step 1 Step 2 Contact Company Contact * Amendment Explanation test Submission Alias IR-20191114-11:46:45 Please do not include CBI information in the Submission Alias field. Contact (U.S./non-U.S.) ~ cbi Copy From CDX - First Name C - Last Name G Position - ComDanv Name H Save ~ Validate Preview Gf Submit 8 ------- Last Updated - April 2020 Step 8. Edit your company information if necessary and click "Continue". This screen includes the certification as to whether the company is a "small business concern" For more information on how to determine whether your company is a "small business concern" as defined in the TSCA Fees Rule, see our website at httos://www.epa.gov/tsca-fees/tsca-fees- and-small-businesses HOME USER MANAGEMENT t | Company Response Information Submitting Official Information Certification Company Manufacturer/Importer (in U.S.) * Company Name I ~ CBI * Mailing Address 1 Mailing Address 2 * City * State Please select a state... T * Postal Code * Country United States T - Company Size Certification The company named above is not a "small business concern" as defined under 40 CFR 700.43. O The company named above is a "small business concern" as defined under 40 CFR 700.43. * The criteria for a "small business concern" has been changed in the final fees rule. View the full definition of a small business concern. A PDF version of the final fees rule is available at https://www.regulations.gov/contentStreamer?documentld=EPA-HQ-OPPT-2016-0401-0072&contentType=pdf - Will you be joining a consortium? Q Yes O No O Not sure [ Previous l I HSave ^Validate O Preview G Submit 9 ------- Last Updated - April 2020 Step 9. Edit the "Response Option" if necessary and click "Continue". Options include Self-Identification"Certification of No Manufactureor "Certification of CessationSee next page for closer view. For specific questions on how to respond, please review EPA's FAQs on reporting for EPA- Initiated Risk Evaluations on our website at www.epa.gov/tsca-fees. There is an Additional Information" box below the Response Options for any additional information companies feel necessary to provide. Note that EPA is not requiring any upfront submission of supporting information for purposes of completing the Initial Response. 1 H0ME USERMANAGEMENT ICG.a wstest (Primary Authorized Olidar) 1 TSCA Risk Evaluation IR-20200210-12:16:23 ¦ Response Information ¦ Submitting Official Information Certification Substantiating CBI Claims Response Information Please select the Risk Evaluation Activity you are responding to in the drop-down below. - Risk Evaluation Activity Response Options /" Self-Identification - 40 CFR 700.45(b)(5): I represent a company that is a manufacturer or importer of the chemical substance subject to this Risk Evaluation Activity I understand the fee obSgation for this activity The company was included on the Preliminary List. The company was not included on the Preliminary List Certification of No Manufacture - 40 CFR 700.45(b)(5)(n«): I represent a company that was included In error on EPA's Preliminary List of responsible fee payers for this Risk Evaluation Activity I certify that the company has not manufactured or imported the chemical substance subject to the Risk Evaluation Acfivity at any point in the five-year penod preceding publication of the Preliminary List The company s not subject to fee obligations for this activity. Certification of Cessation - 40 CFR 700.45fb)(S)(ii): I represent a company that was a manufacturer or importer of the chemical substance subject to this Risk Evaluation Activity, and either was or was not included on the Preliminary List. I certify that Bie company has ceased manufacturingi'importing the chemical substance prior to initiation of the prioritization process for Bie chemical substance (March 21,2019) and further certify that the company will not manufacture or import the chemical substance again for at least five years from the date of this certification The company is not subject to fee obligations for this activity. Additional Information and Attachments (Only if Requested by Agency) Page Count No document information found Additional Information HSave ~Validate 8Preview C7Submit Raise a Bug COX Links . COX Hetpdesk: (888) 890-1995 10 ------- Last Updated - April 2020 Response Options* Self-Identification - 40 CFR 700.45(b)(5): I represent a company that is a manufacturer or importer of the chemical substance subject to this Risk Evaluation Activity. I understand the fee obligation for this activity. The company was included on the Preliminary List. The company was not included on the Preliminary List. • Certification of No Manufacture - 40 CFR 700.45(b)(5)(iii): I represent a company that was or was not included on the Preliminary List. I certify that the company EITHER has not manufactured or imported the chemical substance subject to the Risk Evaluation Activity at any point in the five-year period preceding publication of the Preliminary List, OR falls into one or more of the following categories: (1) imports the chemical in an article, (2) produces the chemical as a byproduct, or (3) produces or imports the chemical as an impurity. ***Based on this certification, the company should not be included on the final list of responsible fee payers subject to fee obligations for this activity. Certification of Cessation - 40 CFR 700.45(b)(5)(ii): I represent a company that was a manufacturer or importer of the chemical substance subject to this Risk Evaluation Activity, and either was or was not included on the Preliminary List. I certify that the company has ceased manufacturing/importing the chemical substance prior to initiation of the prioritization process for the chemical substance (March 21, 2019) and further certify that the company will not manufacture or import the chemical substance again for at least five years from the date of this certification. The company is not subject to fee obligations for this activity. ii ------- Last Updated - April 2020 Step 10. Confirm "Submitting Official" information and click "Continue' HOME USER MANAGEMENT TSCA Risk Evaluation IR-20200210-12:16:23 Step 1 Step 2 Step 3 Contact Company Response Information Submitting Official Information The information below has been pre-populated from CDX registration If the information listed is incorrect please make the appropriate edits to your user information in CDX registration Check the associated checkbox to confirm your acknowledgement of the legally responsible certification statement and activate the Continue' button ~ Submitter is CBI First Name: Last Name: Company Name: Phone Number: Email: Mailing Address 1: City: State: Postal Code: Country: St£ Ce c G Christest 2025640710 clg6783@gmail.com 123 Main Street City WA 12345 US 12 ------- Last Updated - April 2020 Step 11. Certify as to completeness and accuracy of submission and click "Continue". TSCA Risk Evaluation IR-20200210-12:16:23 Step 1 Step 2 Step 3 Contact Company Response Information Step 4 Submitting Official Information Step 5 Submission of Referenced Information Upon request I commit to provide to EPA any referenced information contained in this request I certify that to the best of my knowledge and belief: This confirmation is required to proceed with the submission process I certify to the above statement. ~ 13 ------- Last Updated - April 2020 Step 12. Substantiate any Confidential Business Information (CBI) Claims and click "Start Submission Process". Note that this screen will riot be generated unless information in your response is claimed CBI, Click on "Attach Document for CBI Substantiation" link and provide CBI substantiations as required. Additional information on substantiating CBI claims can be found at https://www.epa.gov/tsca-cbi. HOME USER MANAGEMENT TSCA Risk Evaluation IR-20200210-12:16:23 Contact Company Response Information Submitting Official Information Instructions for Substantiating Confidential Business Information (CBI) Claims StepS Certification Substantiating CBI Claims iv requirements for those making confidential information (CBI) claims in TSCA Among these requirements is an obligation to substantiate The Frank R Lautenberg Chemical Safety for the 21st Century Act created a nun most CBI claims at the time of submission. Information which may be claimed as CBI without substantiation is identified at TSCA 14(c)(2). This information includes: A. Specific information describing the processes used in manufacture or processing of a chemical substance, mixture, or article: 8 Marketing and sales information: C. Information identifying a supplier or customer D In the case of a mixture details of the full composition of the mixture and the respective percentages of constituents: E Specific information regarding the use, function or application of a chemical substance or mixture m a process, mixture, or article; F Specific production or import volumes of the manufacturer or processor and G Prior to the date on which a chemical substance is first offered for commercial distribution, the specific chemical identity of the information that would identify the specific chemical substance if the specific chemical identity was claimed as confidential at the time it For other submissions where the submitter has claimed information as CBI, the submitter will be required to upload a document substantiating those CBI claims at the time of submission The substantiation document should provide EPA any information believed to support the validity of the CBI claims In order to assist submitters in substantiating their CBI claims, EPA has developed substantiation templates that may be used as a starting point in preparing their CBI substantiations Submitters are encouraged to use these substantiation template documents, but are not required to do so The templates and other information relating to substantiating CBI claims can be found at https://Vvww epa.goWtsca-cbi/what-information-tnclude-cbi-subsiantiations The Agency is required to review and make a determination on the validity of many CBI claims. Failure to substantiate a CBI claim oi of information. If you have any questions concerning the options or the substantiation process please contact: a substantiation that does not adequately justify the claim may result in a denial of claims and subsequent public release Scott Sherlock 202-564-8257. sherlock.scott@epa.gov Jessica Barkas. 202-250-8880. barkas jessica@epa gov If you believe all of the information you have claimed a you believe substantiation is not required. CBI is exempt from substantiation under TSCA section 14(c)(2) or has been previously substantiated, select the following "Substantiation Opt Out" checkbox and provide a detailed explanation why Substantiation Opt-Out O Attach Document for CBI Substantiation 14 ------- Last Updated - April 2020 Step 13. Final Submission Process Click on the blue "Start Submission Process" button and follow the steps to submit TSCA Risk Evaluation IR-20200210-12:16:23 Contact Company Response Information Submitting Official Information Certification Instructions for Substantiating Confidential Business Information (CBI) Claims Substantiating CBI Claims nents for those making confidential bi is information (CBI) ct nents is an obligation :h may be claimed as CBI without substantiation is id at TSCA 14(c)(2). This information in A. Specific information describing the processes used in manufacture or processing of a chemical substance, mixture, or article; B Marketing and sales information; C Information identifying a supplier or customer D In the case of a mixture details of the ftill composition of the mixture and the respective percentages of constituents: E. Specific information regarding the use. function, or application of a chemical substance or mixture in a process, mixture, or article; F Specific production or import volumes of the manufacturer or processor and G Prior to the date on which a chemical substance is first offered for commercial distribution, the specific chemical identity of the chemical substance including the chemical name, molecular formula. Chei information that would identify the specific chemical substance, if the specific chemical identity was claimed as confidential at the time it was submitted in a notice under TSCA 5 For other submissions where the submitter has claimed information as CBI. the submitter ivill be required to upload a document substantiating those CBI claims at the time of submission The substantiation document believed to support the validity of the CBI claims In order to assist submitters in substantiating their CBI claims. EPA has developed substantiation templates that may be used as a starting point in preparing their CBI encouraged to use these substantiation template documents, but are not required to do so The templates and other information relating to substantiating CBI claims can be found at httpstfwwwepa govrtsca-cbt/what- Service number and should provide EPA any information substantiations The Agency is required to review and make a determination on the validity of many CBI claims. Failure to substantiate a CBI claim or a substantiation that does not adequately justify the claim may result in a denial of claims and subsequent public release of information If you have any questions concerning the options or the substantiation process please contact . Scott Sherlock. 202-564-8257 sherlock.scott@epa.gov • Jessica Barkas. 202-250-8880. barkas jessica@epa gov If you believe all of the information you have claimed as CBI is exempt from substantiation under TSCA section 14(c)(2) or has been previously substantiated, select the following 'Substantiation Opt Out" checkbox and provide a detailed explanation why you believe substantiation is not required Substantiation Opt-Out 15 ------- |