Document
Attachment C_PublicComment_ACC
ICR 202610-2070-003 · OMB 2070-0162 · Object 174136100.
Document Viewer [pdf]
Status: Original and derived artifacts are available for this document.
Download: pdf
Loading document viewer…
Document Metadata
| File Type | application/pdf |
|---|---|
| File Title | Attachment C_PublicComment_ACC |
| Author | Johnson, Amaris |
| File Modified | 2026-10-22 |
| File Created | 2026-10-22 |
| Conversion State | complete |
Extracted Text
November 22, 2021 Ms. Susan Sharkey Data Gathering and Analysis Division (7404T) Office of Pollution Prevention and Toxics Environmental Protection Agency 1200 Pennsylvania Ave. NW Washington, D.C. 20460-000 [email protected] RE: Comments of the American Chemistry Council on the Agencys Information Collection Activities; Proposed Renewal of an Existing Collection and Request for Comment; Chemical Data Reporting Under TSCA, 86 Fed. Reg. 52457 (September 21, 2021); Docket No. EPAHQ-OPPT-2013-0721; FRL-8768-01-OCSPP Dear Ms. Sharkey: The American Chemistry Council (ACC)1 is pleased to submit these comments on the Environmental Protection Agencys (EPA) Information Collection Activities; Proposed Renewal of an Existing Collection and Request for Comment; Chemical Data Reporting Under the Toxic Substance Control Act (TSCA). The chemical industry is committed to helping EPA meet its goals to enhance the quality of information available on chemicals in commerce. As part of EPAs efforts to improve and inform the development of changes to the CDR program for 2024, it is important that the EPA consider key information regarding industrys burden under current program requirements. EPA has requested comment for this Information Collection Request (ICR) on the following four topics: (1) whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (2) the accuracy of the Agencys estimates of the burden of the proposed collection of information, including the validity of the methodology and assumption used; (3) the quality, utility, and clarity of the information to be collected; (4) the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other forms of 1 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. ACC members apply the science of chemistry to make innovative products and services that make people's lives better, healthier, and safer. ACC is committed to improved environmental, health and safety performance through Responsible Care®, common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $486 billion enterprise and a key element of the nation's economy. It is among the largest exporters in the nation, accounting for ten percent of all U.S. exports. Chemistry companies are among the largest investors in research and development. Safety and security have always been primary concerns of ACC members, and they have intensified their efforts, working closely with government agencies to improve security and to defend against any threat to the nations critical infrastructure. americanchemistry.com® 700 Second St., NE | Washington, DC 20002 | (202) 249.7000 Comments of the American Chemistry Council November 22, 2021 Page 2 informational technologies, e.g. permitting electronic submission response. ACCs comments that follow address the four topic areas. In addition, we have attached to these comments in Appendix A ACCs Summary of Key Lessons Learned, Issues, and Recommendations from the 2020 Chemical Data Reporting (CDR) Period, which we submitted to EPA in June 2021. The summary identifies how the CDR can be strengthened and improved based on the experience ACC members had complying with the 2020 CDR, e.g., the recommendation for a complete overhaul of the Central Data Exchange (CDX).2 A. Necessity and Practical Utility of the Proposed Collection of Information ACC supports both EPAs need to collect relevant information on chemicals in commerce and the practical use of the data collected to assist in the agencys implementation of the Toxic Substances Control Act (TSCA). B. EPAs Burden Estimate Is Conditional On The Overhaul of the CDX Reporting System ACC appreciates that EPA increased the burden estimates for industry to implement the changes introduced in the 2020 CDR rule but must note that these estimates are only accurate if a complete overhaul of the CDX reporting system is finalized and properly beta tested prior to the start of the 2024 reporting period. Although the 2020 eCDRweb reporting tool underwent a significant upgrade prior to the 2020 reporting period, the CDX reporting system was, and continues to be, plagued with significant and ongoing technical issues that impeded the reporting process throughout the entire reporting period. These technical issues included errors with the validation process, preview generation process, confidential business information (CBI) substantiations, co-manufacturing submissions, and other general reporting processes. Throughout this unprecedented seven-month reporting period, updates were implemented attempting to correct the technical issues, and many times following these updates, new or previously corrected technical issues would occur causing validation errors. Following each system update, submitters were forced to delete full Form Us and re-enter data before proceeding. At times, this delete and reenter process had to be performed multiple times depending on the issue. Technical issues continued to be discovered and updates continued to be implemented throughout the reporting period through the deadline. Concerns with the data quality submitted to EPA through the CDX reporting tool arose during the analysis phase, which triggered EPA to send quality assurance (QA) emails to industry requiring review and certification of the submitted information. Although ACC supported EPA performing these QA checks, issues resurfaced within the CDX system causing several companies to be unable to comply with EPAs certification deadline. Both the compliance with the QA certifications and the additional CDX errors (some currently ongoing) added to the increased 2020 CDR time burden. Due to the ongoing technical issues occurring during the 2020 CDR, ACC member companies reported spending approximately 70-100 hours each, or three times the amount of time as in previous 2 ACCs Summary of Key Lessons Learned, Issues, and Recommendations from the 2020 Chemical Data Reporting (CDR) Period americanchemistry.com® 700 Second St., NE | Washington, DC 20002 | (202) 249.7000 Comments of the American Chemistry Council November 22, 2021 Page 3 years, over the course of the 2020 reporting period managing the technical issues associated with the eCDRweb reporting tool. This is in addition to the time required to collect, interpret, and enter the data into the system, and is not reflected in EPAs current burden estimates. If EPA is unable to provide a fully functional reporting tool for the 2024 CDR, the burden estimates should be updated to reflect an accurate time burden based on the 2020 experience using the eCDRweb reporting tool. The table below shows two scenarios under which EPA can correct the burden estimate. Under Scenario 1, EPA undertakes beta testing as it did during the 2020 reporting period and the estimates should assume the same system problems will occur again. Under Scenario 2, EPA performs a complete overhaul of the eCDRweb reporting tool and undertakes more extensive beta testing consistent with ACC recommendations and the systemic reporting difficulties are eliminated. Revised Estimate, Scenario 2 EPA Estimate Revised Estimate, Scenario 1 5,460 5,460 5,460 135 159 137 731,361 862,861 825,205 4,095 4,095 4,095 Total Annual Burden (hours) 735,456 866,956 744,501 Annual reporting cost (2020$) $78,968,301 $93,087,883 $80,380,259 $299,058 $299,058 $299,058 $79,267,359 $93,386,941 $80,679,317 Category Respondents Average burden per response (hours) Annual reporting burden (hours) Annual recordkeeping burden (hours) Annual recordkeeping cost (2020$) Total Annual cost (2020$) americanchemistry.com® 700 Second St., NE | Washington, DC 20002 | (202) 249.7000 Comments of the American Chemistry Council November 22, 2021 Page 4 In addition, EPAs burden estimates fail to account for the burden industry expends each reporting cycle to complete the CDX registration process, which includes assigning and/or connecting new Primary Supports to Primary Authorized Officials and locating and connecting facility site names to the parent accounts, and to configure their internal systems to meet, comply with, track, and report the data for any new requirements EPA implements. One ACC member audit reported that its internal cost per reporting period is approximately $50,000 for system upgrades to meet the new requirements, such as configuring the new CDX upload schemas (Excel / XML) and managing new data reporting requirements; and an additional $10,000 for efficiency and other improvements. ACC suggests that EPA consider these costs in its burden estimates for this ICR and all future ICR renewals. C. Enhancing the Quality, Utility, and Clarity of Information Collected ACC supports incorporating the OECD harmonized use codes into the CDR, which aligns the U.S. chemical reporting process with the rest of the chemical reporting world. However, there were several issues identified in our Lessons Learned memo (Appendix A) where the descriptions and definitions used in the new guidance document were vague and confusing. 3 EPA could improve the quality, utility, and clarity of the information collected, and the burden on industry reporting this data, by revising and clarifying the descriptions for the new OECD Harmonized Consumer and Commercial Use Codes Instructions for Reporting to align them with other agencies terminology/use codes prior to the opening of the 2024 CDR reporting period. Further, most companies must track data annually to ensure robust compliance for the 2024 reporting period because of the complexities involved. ACC requests that the 2024 CDR rule be finalized six months prior to the start of the reporting period. This extended time would allow for a robust beta testing of the eCDRweb reporting tool and the revised templates, and would provide industry ample time to perform the internal configurations needed to comply with any new requirements. D. Minimizing Burden Collection Electronic Reporting ACC commends EPA on the incorporation of the two Form U templates (Excel / XML). They have substantially eased the reporting burden on industry. However, the CBI substantiation section of the templates continue to require manual data entry. This manual data entry causes a significant burden during the CDR reporting period. EPA should alleviate the burdens associated with entering CBI substantiation data by: 1) including CBI substantiation questions on the templates; 2) linking all of the CBI elements in a processing or use row to a single set of substantiation questions; 3) adding a check-box that users can check to automatically copy over CBI substantiations from one field to the next; or 4) allowing a PDF upload of CBI substantiations. The PDF upload template could/should be the same or similar to the CDR template used in the Section 14 program. At a minimum, companies should be able to use EPAs CDR template form as an option in the 2024 CDR. Most importantly, ACC recommends a comprehensive overhaul of the eCDRweb reporting tool. The system crashes, recurring technical issues, and system timeouts that occurred during the 2020 reporting period can likely only be repaired only with a system-wide overhaul or full-out replacement of the CDX. 3 Lessons Learned Memorandum, pages 6, 9-10 americanchemistry.com® 700 Second St., NE | Washington, DC 20002 | (202) 249.7000 Comments of the American Chemistry Council November 22, 2021 Page 5 Additionally, the eCDRweb reporting tool should be thoroughly tested and updated prior to the beginning of the 2024 CDR reporting period. EPA should incorporate a longer beta-testing window for industry to test the CDR data elements approximately six months before the 2024 CDR reporting period. If EPA is unable to provide a fully functional eCDRweb reporting tool prior to the start of the 2024 CDR cycle, the burden estimates should be amended and updated as noted in the Table above. E. Conclusion In its proposed ICR renewal, EPA has relied on inaccurate and incomplete data and information to develop its burden and cost estimates to renew its ICR on Chemical Data Reporting. As a result, the data and information should not be relied upon to support the ICR on Chemical Data Reporting under TSCA. The technical issues industry experienced with the 2020 CDX reporting tool are not limited to the CDR; they are systemic and impact most, if not all, TSCA compliance communications between industry and EPA. The agency must provide a functional reporting tool not only to improve CDR submissions but to improve the capability of the CDX for all TSCA-related submissions by industry. In addition, EPA should work with stakeholders to discuss the noted issues and concerns before renewing this ICR in order to ensure they have been addressed This ICR will not expire until April 30, 2022, and thus provides stakeholders and the agency adequate time to work together to resolve any issues potentially impacting the 2024 CDR. ACC appreciates the opportunity to comment. If you have any further questions regarding these comments, please feel free to contact me at [email protected] or at (202) 249-6129. Sincerely, Kat Gale Kat Gale Manager, Regulatory and Technical Affairs American Chemistry Council cc: Tala Henry, Deputy Director for Programs David Widawsky, Director Enclosure: Appendix A ACCs Summary of Key Lessons Learned, Issues, and Recommendations from the 2020 Chemical Data Reporting (CDR) Period americanchemistry.com® 700 Second St., NE | Washington, DC 20002 | (202) 249.7000 June 1, 2021 Susan Sharkey Lead, Chemical Data Reporting Existing Chemicals Branch USEPA Headquarters William Jefferson Clinton Building 1200 Pennsylvania Avenue, N. W. Washington, DC 20460 [email protected] Re: ACCs Summary of Key Lessons Learned, Issues, and Recommendations from the 2020 Chemical Data Reporting (CDR) Period Dear Ms. Sharkey: The American Chemistry Council (ACC) and its members are committed to enhancing the quantity and quality of data and information provided to EPA on chemicals in commerce. ACC supports EPAs commitment to strengthen chemical management in the US, and is dedicated to the overall success of the Chemical Data Reporting (CDR) effort. We fully recognize that information gathered in the CDR supports the agencys mission to protect the health and safety of the public and environment. ACC and its members were actively engaged with EPA and its Central Data Exchange (CDX) contractor to identify and navigate numerous issues that impacted the 2020 CDR period from the beginning of the 2020 CDR period in June 2020 through its close on January 29, 2021. Based on this experience, ACC member companies undertook a comprehensive review of the issues that arose during the 2020 CDR submission, reflected on the key lessons we learned in the process, and developed some recommendations to improve the overall efficiency of the system for the upcoming 2024 CDR. I have enclosed ACCs summary and our recommendations in an effort to strengthen the 2024 CDR report. ACC and its members recommend that EPA perform a complete overhaul of the current, issueridden, eCDRweb reporting tool to eliminate the extensive problems identified during the 2020 reporting period. Further, ACC and its members recommend that EPA and industry begin working together early in 2022 on some targeted areas where the CDR can be strengthened and improved. ACC appreciates the opportunity to provide comments to the agency and hopes that by sharing this information with you, we can begin the discussion to ensure the most robust data set for the 2024 CDR report. Similarly, ACC and its members are equally committed to providing high quality data to EPA and would welcome an opportunity to work together to build a more robust reporting tool. americanchemistry.com® 700 Second St., NE | Washington, DC 20002 | (202) 249.7000 We would like to meet with you at your earliest convenience to begin what we hope will be an ongoing discussion and collaboration to improve the 2024 and future CDR reporting period. In the interim, please do not hesitate to contact me if you have any questions or comments on the enclosed summary. Sincerely, Kat Gale Kat Gale Manager, Regulatory & Technical Affairs cc: Tala Henry Meredith Comnes Thomas A. Smith americanchemistry.com® 700 Second St., NE | Washington, DC 20002 | (202) 249.7000 Strengthening the 2024 Chemical Data Reporting (CDR) Aspects of the 2020 CDR that Worked Well ACC and its members appreciate the amount of work that went into the revamp of the 2020 eCDRweb tool. When the tool worked as designed, the upload of data from the templates was fast and efficient, and the overall system operated faster than prior years. Additionally, ACC members appreciated that few regulatory changes were finalized for the 2020 CDR, and therefore, most of the changes were focused on the programmatic changes. Some additional items that worked well are identified below. 1. EPAs early and continuous engagement with industry on the Central Data Exchange (CDX) reporting tool. 2. EPAs improvements to and delivery of the schemas that companies could use for uploading bulk data into the CDX reporting tool. 3. EPAs delivery of an XLSX formatted schema that companies could use for uploading bulk data into the CDX reporting tool. 4. The level of technical support provided by EPA staff and its contractor CGI both were responsive and willing to help rectify issues. 5. Overall improvement of chemical search capabilities by using the Chemical Abstract Service (CAS) number and/or accession numbers. 6. Incorporating the OECD harmonized use codes into the CDR aligns the U.S. chemical reporting process with the rest of the chemical reporting world. Suggested improvements to this process will be noted below. 7. The addition of the copy and paste functionality eased the time burden associated with manual data entry of the confidential business information (CBI) substantiation process. 8. Except as noted below, the overall speed of the 2020 CDX reporting tool improved significantly from the 2016 reporting period. 9. EPA provided a number of webinars and instruction manuals for industry that helped navigate both the rule and the new electronic submission process. 2020 CDR Concern Areas A. TIMING ISSUES An overriding concern of industry related to the 2020 reporting requirements was directly related to the short timing within which to comply with the rule and the new and/or modified reporting requirements. 1 The length of time between the publication of the final rule and the opening of the reporting window was extremely short. It was neither a long enough a period of time for EPA to deploy a fully functional eCDR system nor for EPA to provide industry with the clarifications necessary for industry implementation of the new requirements within a new electronic system. EPA and CGI implemented an expansive overhaul of the CDX reporting tool following the 2016 CDR reporting period. A one-week beta-testing period approximately oneweek before the official start of the reporting period was insufficient to identify and remedy technical issues. As a result of this short beta-testing period, industry struggled through significant technical issues that interfered substantially with data entry and timely reporting submissions throughout the 2020 reporting period. There were many significant clarifications needed concerning the reporting requirements and issues that arose with the functionality of the CDX reporting tool. While EPA did provide webinar and online training, industry still had to engage actively with EPA and CGI on both regulatory clarifications and system issues throughout the entire reporting period. While many system and regulatory issues were addressed promptly by EPA and CGI, several guidance documents (e.g., byproducts and OECD Harmonized Use Code Instructions for Reporting) were not available until several months after the reporting period opened and/or were vague and difficult to understand. An especially complex CDR requirement was the calculation of chemical substances in imported mixtures and exported chemical products. This complexity has not been acknowledged sufficiently by EPA and industry believes this is an especially important timing issue that should be recognized by EPA with the release of the 2024 CDR. Recommendation: ACC recommends that prior to the official start of the 2024 reporting period, the eCDRweb tool undergo a complete overhaul to remove all internal system errors and be updated, tested, and beta-tested approximately six month prior to the start of the reporting period to identify and correct problems. A fully functioning system should be available to industry on the very first day of the reporting period. The system-wide issues in particular added to the compliance burden for most companies and required a significant amount of time for industry to navigate and ensure that they are able to report accurate and high quality data to EPA. Further, ACC recommends that EPA acknowledge the significant burdens on both EPA and industry presented by the necessary overhaul of the eCDR reporting tool and the implemented OECD Harmonized Use Codes requirement for the 2024 reporting period, and not make additional substantial changes to the rule for the 2024 reporting. Assuring the eCDR reporting tool is fully functional for the 2024 reporting period and that industry has the guidance necessary to transition to the OECD Harmonized Use Codes should be the agencys top priority. 2 B. SYSTEM ISSUES ACC recommends that EPA begin working with industry early on in the process to ensure that the eCDRweb tool is fully operational well before the 2024 CDR reporting period opens. The lack of a robust pilot in early 2020 caused a multitude of issues with the CDXweb tool. ACC members were very active reporting these issues and working with EPA and CGI to develop appropriate updates and solutions or remedies to the CDXweb reporting tool. Based on our experience, we recommend that EPA and industry begin working together early in the process, especially with the eCDRweb tool, to strengthen the tool for the 2024 reporting period. 1. CDX Registration and Site Selection Many companies experienced significant delays with the CDX registration process. Many were unable to register and/or connect new Primary Supports to Primary Authorized Officials or were unable to locate and/or connect accounts to Parent Companies and/or facilities in the first two months of the reporting window. Recommendation: Open the CDX registration process for reporting officials well in advance of the 2024 submission period. Facility Site Names Site names uploaded to the eCDR web tool from the Facility Registry System (FRS) were not always consistent with actual company site names and often had multiple listings with different spelling and abbreviations for the same location. This issue contained with the FRS system creates a confusing and time-consuming process when beginning the CDR process, often requiring submitting officials to walk through the process multiple times with EPAs contractor HelpDesk representatives. Recommendation: Update and correct the FRS system with accurate site names or populate the 2024 eCDR site names from a database of sites created from the 2020 CDR. Complete eCDRweb System Overhaul The 2020 CDXweb reporting tool was plagued with significant and ongoing technical issues that impeded the reporting process throughout the reporting period, which closed on January 29, 2021. These technical issues included errors with the validation process, preview generation process, CBI substantiations, and other general reporting processes. Each time an update was implemented to correct a technical issue, new or previously corrected technical issues would appear causing validation errors. Following each system update, submitters were forced to delete full Form Us and re-enter data before proceeding. At times, this delete and re-enter process had to be performed multiple times depending on the issue. Technical issues continued to be discovered and updates continued to be implemented throughout the reporting period until the January 29, 2021, deadline. Recommendation: Perform a complete overhaul of the eCDRweb reporting tool to eliminate the technical issues that impeded the 2020 reporting period and provide a longer, more robust beta testing period. Validation Process Certainty The validation process should identify all errors contained within the Form U prior to preview generation and submission. The validation process 3 routinely missed errors that were due to incorrect spellings, abbreviations, hidden spaces, or characters. Additionally, once a submission contained more than 100 substances, the individual validation process (i.e., check marks next to responses) contained within the CBI substantiation section was inoperablea submitter would only receive a validation at the end of the section. As a result of this dysfunctional validation process, inadvertently inaccurate Form Us were submitted, becoming trapped in the processing stage, requiring EPA or CGI intervention. Additionally, on occasions when submitters needed to amend a submission, forms that had previously passed the validation process would fail due to new technical issues that arose following the original submission. All of these issues with the validation process caused signification delays with the data entry and submission process. Recommendation: Update the validation system so that all errors are captured prior to submission regardless of the number of substances listed within the Form U. Communication to Industry EPA should create a more transparent system to notify industry of issues and subsequent updates to the eCDRweb reporting tool. As noted, the 2020 CDR experienced significant technical issues. Neither the issues nor the updates to repair the issues were reported to the general public. ACC and its members were in regular communication with EPA and its contractor throughout the course of the reporting period and as a result, were kept up-to-date. However, when speaking to members of other trade associations and/or industry, it became apparent that these non-ACC members and staff were not receiving the same status reports and updates. Additionally, the submission notification system should be updated to automatically send the submitter a notification advising the submitter if its Form U has been accepted or rejected. It was discovered that if a submission became stuck in the processing phase of the review process, the submitter was never notified of the problem. This resulted in submissions sitting in the processing phase for weeks until the submitter identified the trapped submission and contacted EPA or its contractor for assistance. Recommendation: EPA should implement a system to notify industry of all technical issues and updates released to correct the issues. Additionally, EPA should correct the submission review process so that a notification is triggered to notify EPA, its consultants, and the submitter that there is a problem associated with a submission. Preview Generation The ability to preview and review a CDR submission prior to the formal submission is essential to having a successful CDR period with high quality data submissions. The preview generation process never worked as anticipated. The technical issues related to the preview generation took several months to identify and understand, and rather than being able to correct the technical issues, a tedious and time-consuming workaround had to be implemented. In addition to a fully functional preview generation process, industry should have the ability to view and download a sanitized version of their submissions to confirm the CBI substantiations are accurate and complete. Recommendation: As part of the complete system overall recommended above, specific 4 focus is recommended on ensuring industry can easily generate a PDF preview of both the complete and the sanitized versions of their submissions to review for accuracy. This is particularly important given the highly valuable and sensitive CBI information at stake. 2. eCDRweb Reporting Roles Primary Authorized Officials and CBI Substantiation The current procedure requiring the Primary Authorized Official (PAO) to complete the CBI designation and justifications stalled the final submission process for many ACC members. This issue was not identified until the end of the reporting period, and as a result of the other numerous technical issues with the eCDRweb reporting tool, caused additional delays. The PAO should be tasked with beginning the submissions, approving and signing the submissions. The Primary Supports should have the ability to complete all sections within the Form U prior to the final review performed by the PAO. Recommendation: Amend the reporting roles within the Form U and eCDRweb reporting tool to allow Primary Supports to complete all questions associated with CBI substantiations. Co-Manufacturing Submissions The 2020 CDR Rule significantly changed the process for reporting co-manufactured substances by removing the option for a Contracting Company to complete the submission in its entirety and forcing companies to submit jointly or only allowing the manufacturing company to report. By removing this option, the new process required the Contracting Company to send an email via the CDX system to the Producing Company that contained the Contracting Companys Unique Identifier to enable the Producing Company to access the Contracting Companys CDR and submit its required data. However, this initial email did not always reach its intended recipient, and the initial email did not copy the Contracting Company employee who sent the email, so it was unclear if the email sent or failed to send. Further, a Producing Company could be locked out of the Contracting Companys CDR and the Unique Identifier rendered useless. This resulted in the Contracting Company needing to create an Amendment to re-issue the Unique Identifier. ACC members spent a tremendous amount of time attempting to contact and work with their co-manufacturers so that the forms and submissions were complete and accurate. Recommendation: There should be three options for submitting co-manufacturing reports: (1) by the Contracting Company (the option originally used in the 2016 CDR but unexpectedly removed from 2020 CDR); (2) by the Producing Company (referred to as procedure 2 on Form U); and (3) by joint submission (referred to as procedure 1 on Form U). Additionally, as part of the eCDRweb overhaul, the co-manufacturing process should be simplified. The Unique Identifier should be configured so it can be used by any individual at the Producing Company with CDX/eCDR access, or any individual that Producing Company designates to complete the work. Further, the email notification procedure needs to be reprogramed so that: Contracting Companies automatically receives courtesy copies of all emails sent to Producing Companies; a tracking system should be implemented that would notify the Contracting Company when emails sent to each Producing Company are rejected; and 5 when the Producing Company has completed its data entry so the Contracting Company does not submit their CDR prematurely. Confidential Business Information (CBI) The changes to the co-manufacturing requirements allowed, and at times, required an entity that did not have sufficient knowledge of a CBI claim to provide the substantiation of a CBI claim on the CDR. Once this issue was identified, ACC member were forced to invent creative methods to work around this CDR structural flaw in order to protect the CBI claim. Recommendation: Review and assign all roles properly within joint submissions to confirm the correct entity is prompted to enter the correct data and CBI substantiations. EPA should never assume that confidential chemical identities are shared among co-manufacturing entities. While some companies may enter into such a contractual relationship; it is by no means commonplace and should not be expected by the agency. 3. Electronic Reporting Forms OECD Harmonized Use Code Descriptions Several of the descriptions for the Consumer and Commercial Use Codes in the Instructions for Reporting document were vague, confusing, and/or inaccurate. ACC members struggled to decipher the difference between codes CC303 and CC304, and the CC990 Non-TSCA Use code doesnt align with the Food and Drug Administrations definition and uses. Recommendation: Revise and clarify the descriptions for the new OECD Harmonized Consumer and Commercial Use Codes in the Instructions for Reporting to align with uses and definitions across the agencies. General Form Inconsistencies The addition of the excel template was helpful and, when both templates functioned properly, the upload was fast and efficient. However, during the first several months of the reporting period template uploads into the CDX platform often did not align and uploaded data into incorrect data fields. Further, uploads did not recognize and/or created unacceptable hidden characters (i.e., spaces), symbols, and/or upper- and 6 lower-cased words and/or abbreviations. These formatting errors often proceeded undetected through the validation procedure and later trapped the submitted Form U in the processing phase of the submission process, rendering the Form U irretrievable without the submitter actively engaging with EPA or CGI to unlock the submission and identify the errors. There were also issues with: entering values of zero or above 100; ongoing error with the partially exempt chemical data fields inappropriately requiring data entry; email issues with co-manufacturing submissions where CDX generated emails to comanufacturing companies were not sent; Default Technical Contact button not functional requiring the user to manually edit every chemical in a Form U to select a Technical Contact; and Errors with other exempt data fields requiring data entry to validate. CBI Substantiation The CBI substantiation section of the eCDR reporting tool did not allow for a bulk upload and the original copy and paste function that ACC members attempted to perform caused hundreds of pages of corrupted symbols and special characters in the preview section of the CBI substantiations. The update deployed to remedy this error not only created new issues, it crashed the entire CDX system for approximately two weeks. The major issues within this section included, but were not limited to: headings, questions, and/or full section disappearing from the preview after entry; data entered and saved but not appearing in the preview; deleted data continually appearing on the PDF preview; CBI substantiations duplicating without cause; and once a submission was greater than 300 substances the copy to all function was lost, forcing the submitter to individually copy each substantiation from one substance to another. PDF Preview Functionality The PDF preview functionality never worked as planned. Several updates were implemented in an attempt to repair the error, and inevitably a tedious and time-consuming work-around, that included downloading and reviewing each section of the Form U individually, had to be implemented to allow industry the ability to preview and review all submissions prior to finalization. The preview and review process is a critical step for companies during the reporting process. Without the ability to view their complete Form U prior to submission, companies cannot ensure the reliability of the submitted data or have confidence that their CBI substantiations are reflected accurately. This, in turn, creates serious concerns that EPA may erroneously believe that a CBI claim was not substantiated when, in fact, it was. Consequently, EPA should not disclose any CBI claim on the 2020 CDR based on a lack of substantiation without first conducting a thorough investigation to determine that a submitter did not, in fact, prepare and attempt to include a substantiation. Validation Warnings The validation warnings did not identify all of the errors contained within the forms, and once a submission contained more than 100 substances, the warnings within the CBI substantiation section stopped validating each question individually. The validation warnings failed to detect hidden characters, unacceptable symbols, abbreviations, 7 etc. and, as a result of the undetected errors, these submitted Form Us would become trapped in the processing stage after submission, requiring intervention from EPA and/or CGI. Recommendation: It is estimated that each ACC member company spent approximately 70100 hours, or three times the amount of time as in previous years, over the course of the 2020 reporting period managing the technical issues associated with the eCDRweb reporting tool, and working directly with EPAs contractor to identify and remedy the issues. This is above and beyond the time required to collect, interpret, and enter the data into the system. Based on our experience from the 2020 CDR reporting period, ACC recommends a comprehensive overhaul of the eCDRweb reporting tool. Additionally, the eCDRweb reporting tool and templates should be thoroughly tested and updated prior to the beginning of the reporting period to ensure proper functionality. EPA should incorporate a longer beta-testing window to permit industry to test the operability of the system. This beta-testing period should occur approximately six months before the 2024 CDR reporting period. Saving Changes Currently, the eCDRweb tool only allows a submitter to save changes to a Form U section once the entire section is complete. Some sections within the Form U require substantial data entry, while others do not. Having the ability to save changes more frequently alleviates the burden associated with losing work. Recommendation: We recommend modifying this function to allow submitters to save their changes and leave the draft submission at the end of every page. 4. Automated Upload of Data Templates - There were significant issues associated with the data upload templates. Neither of the templates were fully updated and ready for use at the time the reporting period opened, and it was not until approximately September that the templates were fully operational. Recommendation: Based on our experience, EPA should provide working and validated templates for industry ahead of the submission window to minimize issues that might be associated with uploading errors during the submission window. Additionally, EPA should allow for these templates to be beta-tested at least six-months before the opening of the reporting period. 5. Manual Data Entry CBI Substantiation The CBI substantiation section did not allow for the bulk upload of data from a template. An update was implemented that allowed for a copy and paste of data from another section; however, each individual element that is claimed CBI requires substantiation and must be entered individually, which is both time-consuming and burdensome. The answers to the substantiation questions are usually the same for all fields in a given data row, resulting in a lot of copy and paste work. As a result of the substantial technical errors identified within the CBI section of the Form U, significant and unnecessary amount of time was wasted waiting for technical errors within the system to be corrected, and reentering information after the correction updates were implemented. One member company 8 estimates it likely spent more than four weeks waiting for confirmation from EPAs contractor that errors were corrected before it could proceed with additional CDR entries. Recommendation: The burdens associated with entering CBI substantiation data could be reduced by: 1) including CBI substantiation questions on the templates; 2) linking all of the CBI elements in a processing or use row to a single set of substantiation questions; 3) adding a check-box that users can check to automatically copy over CBI substantiations from one field to the next; or 4) or allowing for a PDF upload of CBI substantiations. The PDF upload template could/should be the same or similar to the CDR template used in the Section 14 program. At a minimum, companies should be able to use EPAs CDR template form as an option in the 2024 CDR. 6. System Speed The 2020 eCDR system was faster than previous years and when operational, the data entry process was seamless; however after the system crash in October 2020, the system was slow to open, navigate, and validate forms for large numbers of chemicals (especially when the number of chemicals was > 100) and when attempted later in the week as opposed to early in the week or on weekends. Most companies worked off-hours and weekends to reduce the time delays to ensure that the forms could be accessed and the data could be entered; however many weekends experienced complete system crashes throughout the fall. System Timeouts System timeouts during data entry and system access required users to re- enter the system or utilize the back button on the browser (in some instances) when: Entering data; Moving between sections or pages; Accessing report Primary Support and Primary Authorized Official; Generating *.pdf files for review; Submitting Report Primary Authorized Official; and System response time (slow to almost non-responsive). Recommendation: ACC recommends a comprehensive overhaul of the eCDRweb reporting tool. The system crash, ongoing technical issues, and system timeouts indicates a likely significant and systemic problem in the eCDRweb reporting tool that can be repaired only with a system-wide overhaul or full-out replacement. Additionally, the eCDRweb reporting tool should be thoroughly tested and updated prior to the beginning of the 2024 CDR reporting period. EPA should incorporate a longer betatesting window for industry to test the CDR data elements approximately six months before the 2024 CDR reporting period. C. 2024 REPORTING REQUIREMENTS In addition to ensuring that the technical issues with the eCDR are addressed and resolved for the 2024 CDR, industry requests the new OECD Harmonized Consumer and Commercial Use Codes Instructions for Reporting be updated, clarified, and better aligned with other 9 agencies terminology/use codes prior to the opening of the 2024 CDR reporting period. Recommendation: We encourage EPA to avoid making significant regulatory changes to the 2024 CDR rule and focus on the successful implementation of a fully functional 2024 eCDR reporting tool and updated guidance documents for the implementation of the OECD Harmonized Consumer and Commercial Use Codes. Most companies must track data annually to ensure robust compliance for the 2024 reporting period because of the complexities involved. Without early EPA guidance, industry will not have the appropriate clarifications needed to track data successfully. We have outlined a considerable number of recommended improvements to the eCDRweb in these comments. Therefore, we believe early engagement between EPA and ACC will ensure appropriate clarifications in the rule and improvements to the eCDRweb are implemented in the 2024 CDR. 10