EPA Webinar: Chemical Data Reporting Requirements March 31, 2020 1:00 p.m. ET Operator: Ladies and gentlemen, thank you for standing by, and welcome to the 2020 Chemical Data Reporting requirements conference call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. To ask a question during this session, you will need to press “star,” “1” on your telephone. Please be advised that today’s conference is being recorded. If you require any further assistance, please press “star,” “0.” I would now like to hand the conference over to your speaker today, Meredith Comnes. Thank you. Please go ahead. Meredith Comnes: Thank you. Good afternoon, everyone, and thank you for calling in today. We really appreciate your patience and willingness to participate in this webinar. My name is Meredith Comnes. I’m in the Office of Pollution Prevention and Toxics here at EPA. I’ll be presenting today along with my colleague Tom Smith, and Carolina Falaiye, who is a contractor with the organization CGI Federal. Today, we are providing an overview of the 2020 Chemical Data Reporting collection period, which will begin this year on June 1, 2020. The way that this webinar will function is that we ask that you to follow along with the PDF version of the slides that we have provided to you in the confirmation email. In that email, there should be a link to the EPA website. There are two documents there, one called “CDR Regulatory Overview,” which will be part one of this webinar, and the second document is the “CDR Reporting Tool Walkthrough,” which is part two. Before moving on to each slide, I will indicate what number I am on. So, right now, I am in the first of those two documents. I am on the title slide of the first document called “CDR Regulatory Overview.” I would just like to note that after this title slide, all of the slide numbers will be in the lower right-hand corner. I am now transitioning to slide one. Here is an overview of our presentation. Today’s presentation will last about two hours and have two parts. The first part will be background on the Toxic Substances Control Act, the Chemical Data Reporting program, and an overview of the reporting requirements. Second, we will do a walkthrough with screenshots of the reporting tool. That will be the second document that you have downloaded. If time allows, we will allow for a question-and-answer section. I am now on slide two. I will quickly provide some history on the Toxic Substances Control Act, which is abbreviated as TSCA. TSCA is a premier chemical safety legislation in the U.S. TSCA gives EPA the authority to require reporting, record-keeping and testing requirements and restrictions related to chemical substances and/or mixtures. TSCA was passed in 1976 and most recently updated in 2016 with the Frank R. Lautenberg Chemical Safety for the 21st Century Act, also called the Lautenberg Act. For the Chemical Data Reporting program, we are focused on substances that are listed on the TSCA Inventory. The TSCA Inventory is a comprehensive listing of chemicals in commerce in the U.S. This was created in the late 1970s and currently lists about 85,000 chemical substances with around 42,000 of those identified as active in commerce. I am now transitioning to slide three. And we will provide a quick overview of the Chemical Data Reporting program, which we abbreviate as CDR. CDR is really a first look or high-level view of chemicals in commerce in the U.S., and it is essential for the work that we do here at EPA. CDR is a collection of basic exposure-related information on the types, quantities and uses of chemical substances manufactured domestically or imported into the United States. This applies only to chemical substances listed on the TSCA Inventory, and certain classes of chemicals are exempted from reporting. This information is submitted every four years, and the last submission period ended in 2016. It’s four years later. We are in 2020. So, the current submission period will begin on June 1, 2020 and will cover the calendar years of 2016 through 2019. Many of you are familiar with the CDR Revisions Rule, which was finalized in March of 2020. The finalization of this rule will affect the CDR reporting requirements. We will go into more detail on that in a moment. It is also important to note that the end of the submission period was extended from September 30 to November 30 of this year to provide additional time for reporters to become familiar with these requirements. We are also in the process of finalizing a small manufacturer definition, which has been proposed but not yet final. I am now on slide four. Here, I will go into more detail on what was included in the final CDR Revisions Rule, which will affect this reporting period. There were three main goals for this Revisions Rule – first, to update the CDR to align with the new statutory requirements under TSCA. This is to coincide with the Lautenberg Act in 2016 and the implementation of TSCA here at the agency, and we are constantly re-evaluating our data needs. The second goal was to improve CDR data to support the implementation of TSCA. Third, we have the goal of reducing burden for certain CDR reporters. In order to meet these goals, the summary of the changes we made were: first, exemptions for reporting of certain by-products; changes to claiming confidentiality to align with Lautenberg Act; modifications to reportable data elements; changes to simplify reporting processes for co-manufactured chemicals. This rule was proposed in April 2019 and, as mentioned, was finalized in March of this year. I would also like to note that in this presentation, green text indicates new reporting requirements or an updated reporting requirement. As we go through this presentation, anything that is in green indicates that it is different from the last reporting period. You can keep track of that as we go through this today. And then, also, if you reference these slides at a later date, you can recall that anything green is new. I am now transitioning to slide five. This is just a title slide indicating that we are transitioning to the portion of the presentation where we will be talking about the 2020 reporting requirements for CDR. I am now on slide six, which is an overview of the CDR reporting requirements. First, the submission period will be from June 1 to November 30 of 2020. Again, that is an extension of the initial deadline of the reporting period. This applies to all – the CDR applies to all manufacturers which, under TSCA, includes importers, of chemical substances that are listed on the TSCA Inventory as of June 1, 2020, have a production volume of 25,000 pounds or greater at a site in at least one of the years from 2016 through 2019 unless they are subject to certain TSCA actions in which the production is – I’m sorry – the production volume is 2,500 pounds or greater, not 25,000. You are also required to report if you are not eligible for a full or partial exemption from the CDR. I am now on slide seven. For each chemical that is reported, certain information is required. And you must provide the following information – the annual production volume from 2016 through 2019, certain manufacturing information for 2019, processing and use information for 2019. And certain exemptions may reduce reporting, which will be explained later in this presentation. All submissions are sent to EPA electronically through EPA’s Central Data Exchange, which is also called CDX, in which a participant must register with CDX, access the e-CDRweb, which is the CDR reporting tool, create and submit a separate Form U for each site, and submit the completed Form U following the instructions that are available on e-CDRweb. I am now on slide eight. We will now move through an exercise to determine your need to report. You must consider each chemical substance that you domestically manufacture or imported at a single site from 2016 through 2019. First, you must consider if your chemical substance is subject to CDR and, second, are you a manufacturer that is required to report. I am now transitioning to slide nine. Here are some things to consider when you are evaluating if your chemical is subject to the CDR. First, is your chemical substance listed on the TSCA Inventory? Next, is your chemical substance manufactured for commercial purposes, which means to import, produce or manufacture with the purpose of obtaining an immediate eventual commercial advantage to the manufacturer? Next, is your chemical substance used only for non-TSCA uses, as defined by TSCA Section 3(2)(B)? Is your chemical – and, additionally, you should consider is your chemical substance partially exempt from reporting? And, also, is your chemical substance ineligible for exemption? I am now moving on to slide 10. Here is an overview of chemical-specific exemptions which are outlined in the CFR at 40 CFR 711.6. Some chemicals are fully exempt from reporting, which includes polymers, microorganisms and certain forms of natural gas and water as well as naturally occurring chemical substances. Some chemicals are partially exempt from processing and use reporting. This includes listed petroleum processing streams and chemicals whose processing and use information is of low current interest. Some chemicals are not eligible for exemption if they are subject to certain TSCA actions. So, we are now going to transition from slide 10 to slide 11. Here on slide 11, we have a chart. This is a list of TSCA actions that would make your chemical ineligible for an exemption. And it is slightly difficult to see, but in the middle of the chart, Section 4 orders – that is the green check mark, the green indicating that it is a new requirement – so, this is new for this reporting period. I am now on slide 12. We are going to look at a chemical-specific example and determine if this chemical is subject to being reported to CDR. This is a screenshot from EPA’s Substance Registry Service, the link of which is at the bottom of the slide. Tom is going to go into a bit more detail about how do use SRS in a moment. But, I’d just like to note that this is a search for a generic chemical. The CAS registry number is 123-45-6. And this is an output of the regulations that it’s subject to. So, we have here in the screenshot a list of the regulations that this chemical is subject to. Here on slide 13 – I am now on slide 13 – we have a red circle around the 2016 CDR TSCA Inventory. We can see that this chemical is subject to the 2016 TSCA Inventory and, therefore, is subject to the CDR. Here on slide 14 – I have transitioned to slide 14 – we would like to note that this example still references 2016, which is the last reporting period. But, the time – reporting for this cycle begins on June 1 of this year. We will have updated information for 2020, which includes two lists which indicate if the chemical is active or inactive on the TSCA Inventory. I am now moving on to slide 15. We will now evaluate if the production volume threshold for your chemical meets the requirement to report to CDR. Remember that the production volume threshold for chemicals is at 25,000 pounds or, for certain TSCA actions, it is lower at 2,500 pounds. You must consider the production volume for each of the calendar years of the reporting period. So, for this year in 2020 means for the years 2016, 2017, 2018 and 2019. I am now moving on to slide 16. Let’s evaluate the production of a sample company. Here, we have a sample company called ChemIncA. ChemIncA manufactures three chemicals, chemical A, chemical B and chemical C. For this example, let’s assume that these chemicals are not subject to any certain TSCA actions and the lower reporting threshold. Looking first at chemical A, in 2016, 2017 and 2018, the production volume was under 25,000 pounds. But, in 2019, it exceeded 25,000 pounds. This makes the company required to report on that chemical. For chemical B, we see that in 2016, 2018 and 2019, they did not product this chemical at all. However, in 2017, they made this chemical and it exceeded the 25,000-pound threshold. Therefore, they must report on this chemical. For chemical C, we can see that for all four years, they did not meet the reporting threshold and, therefore, are not required to report on this – on this chemical. I am now on slide 17. In general, the reporting threshold (remains) at 25,000. However, a reduced reporting threshold at 2,500 pounds applies to chemical substances subject to certain TSCA actions. We are going to transition to the chart on slide 18. I am now on slide 18. This table here lists TSCA actions that may affect the reporting threshold. The first three here – it does not affect the reporting threshold, so it remains at 25,000 pounds. And, then, the remainder of this chart are all actions that would trigger the lower reporting threshold for certain chemicals. You can see – and I would just like to note again that the Section 4 orders – that has a green check mark because that indicates that that is a new requirement. I am now transitioning to slide 19. Again, here is an export of the regulations that this generic CAS number is subject to. We have a list of the regulations that impact this chemical. And I’d just like to take a moment and see if there is anything that might trigger the lower threshold for this substance. So, if we transition to slide 20, we have a red circle around the TSCA Section 6, Unreasonable Risk, which would trigger the lower reporting threshold. I am now transitioning to slide 21. Here, we are going to check in again with our company ChemIncA. We have already talked about chemicals A through C that they manufacture. They also manufacture three more chemicals, chemicals D, E and F. For chemical D, we see they are subject to a TSCA Section 6 rule, which triggers the lower reporting threshold. And in 2016, they manufactured 3,000 pounds, which exceeds the lower reporting threshold. And, so, they are required to report on this chemical. For chemical E, chemical E is subject to one of the previous listed TSCA action. They are not required to report because they did not meet or exceed the 2,500-pound reporting threshold in any of the four reporting years. For chemical F, we see that chemical F is also subject to the TSCA Section 5 SNUR. And we see that in 2018 and 2019, they exceeded the 2,500-pound reporting threshold. I am now transitioning to slide 22. We have covered determining the need to report based on your chemical. And we are now going to cover whether or not you are exempted as a small manufacturer and if you qualify for any other reporting exemptions. I am now moving on to slide 23. As I have mentioned before, the small manufacturing definition has been proposed, but it has not yet been finalized. EPA has proposed this based on the update of the current two-standard definition on inflation by adjusting the sales standard level. So, this means basically that we would raise the current standard total annual sales based on the $4 million and $11 million and the production volume modified standard equivalently to the $40 million and $110 million with no change to the modifier of 100,000 pounds. Just to clarify, the total annual sales are – the total annual sales are of the submitter combined with the parent company, whether the parent company is foreign or domestic. We also proposed to change the inflation index to determine future changes to the revenue level and to add a definition for small government, which would be municipalities with populations less than 50,000 people. This rule is currently in interagency review. And keep in mind it has not yet been finalized, so the definitions may not ultimately be exactly how we are presenting them here today. We are going to transition now to slide 24. If you are subject – you can see this new column on the far right here. If your substance is subject to any of these listed in the last column, you are not eligible for a small manufacturer exemption. And, again, just to point out the Section 4 orders here. That is a new requirement with a green check mark. I am now transitioning to slide 25. And I am going to pass the speaking off to my colleague Tom Smith. So, Tom, please take it away. Tom Smith: Thanks, Meredith. Thanks for the introduction and the transition. And thanks, everyone, for continuing to follow along with us manually. Now, I am going to shift our focus a bit and will walk through finding your substance or substances and their status on SRS which is, again, the Substance Registry Service. There you will find whether your substance is on the TSCA Inventory, if it is potentially partially or fully exempt from reporting and whether or not it is subject to certain TSCA actions, which may impact the reporting requirements. Updates specific to the 2020 CDR will be added to SRS prior to the upcoming reporting period. On to slide 26, we will find what that homepage looks like. Keep in mind also that when you are using the reporting tool, it will search SRS for you. And, you can search on your own here before entering information into the reporting tool –you will be able to search SRS by list, single chemical or CAS number or by multiple chemicals. We will quickly go through a few examples. Initially, we will go by list on slide 27. We will have a number of lists here to choose from. The few examples shown here are the 2016 or 2012 CDR eligible chemicals as well as those that are partially or fully exempt. On or before June 1 this year, there will be 2020’s CDR list as well. But, we will start by clicking on the 2016 partially exempt list, for example, on the next slide, number 28. This list is showing us that you can filter it and browse through it in SRS. The chemicals on the partially exempt list require reporting and basic identity and manufacturing information but not the processing and use information unless they are subject to certain TSCA actions that we laid out earlier, in which case the agency will require it for reporting. The 2016 partially exempt list should be the same as that for 2020 as nothing has been added or changed to that on that list since then. On to slide 29. We will see the page that appears when we click on 2016 full exempt list. These chemicals don’t require reporting but, again, with the same caveat given that they are not also subject to certain TSCA actions, as we discussed previously. In contract to the partially exempt list, there have been additions or changes to this list. So, the 2016 full exempt list will not be exactly the same as that for 2020. We are also displaying this page of the results. Some searches can be too large to display on SRS. You can, however, download the list, which we will see in the following slide, number 30. This, for example, is the downloaded list of those chemicals that are fully exempted, again, unless otherwise included. As we can see, the output list provides a good amount of information on each chemical that is included, for example: the substances’ identity, the common generic or the registry name, also other identifiers like the CAS number and EPA ID as well as the effective date for when this substance was officially added to the list. Moving on to slide 31, we will head back to the SRS page or the home page. From here, we will now start walking through searching by individual substance. Single entry should be the default selection. But, if not, we will click on it and enter a single substance name or CAS number. On slide 32, we will see our first example chemical. Here, you will see that by searching the CAS number listed in the title, we pulled up the results for ethylene dibromide. When clicking on the substance – we will see that next step on slide 33. Here, we will see what statutes or regulations the substance may be subject to. This is an example of another substance that you can see as both on the 2016 inventory as well as the partially exempt list, meaning, again, that they require reporting and manufacturing information but not the processing and use unless subject to certain TSCA actions mentioned earlier. On to slide 34. We will see another example chemical. Hydrofluoric acid, similarly, is also on the 2016 inventory. And as we can see, it is subject to a variety of other actions and statutory EPA programs as well. Listed are a few from the Clean Air Act and one from the Resource Conservation and Recovery Act or RCRA. So, now that we have gone through determining your need to report in the SRS and whether or not your chemical may be exempt, on slide 35, we will shift our attention again and I’ll give an overview of the information to be reported, starting with what’s associated with the sites. And, again, refer to the green text for changes since the last reporting in 2016. Previously, only the highest-level U.S. parent company was reported. But, now, if applicable – the highest-level parent company will be reported as well. Note that there is a new definition for highest-level parent company in 40 CFR 711.3. This definition now includes multiple scenarios. Along with the manufacturing or importing site information, the new requirement of the NAICS code associated with that site will be reported. For context, NAICS is the North American Industry Classification System. Submitters will only be required to report one NAICS. But, considering multiple codes may be applicable for a single site, up to three three NAICS codes will be allowed to be reported. Technical contact information is also required. This should be the person whom EPA may contact for clarification of the information in your CDR submission, someone who can answer questions about the reported substances. Typically, a person located at the manufacturing site is best able to answer such questions. And on to slide 36. After the site-associated information, you will provide manufacturing-related data, which includes the chemical identity by name and CAS number or by generic and the – generic name and the accession number if your chemical is on – is listed on the confidential portion of the inventory. Also reported is the production volumes for the past four years – 2016, 2017, 2018 and 2019. For the principal reporting year, 2019, much more information will be provided, including whether the volumes are imported or domestically manufactured or both and, if imported, whether the chemical is never physically at the site, also the volumes used onsite or exported from the site. Additional information for 2019 specifically includes the number of workers that are reasonably likely to be exposed, which is to be reported in ranges; the maximum concentration, also in percent ranges; the physical form and the associated percent production volume; also, the indication of whether the chemical is recycled or otherwise used instead of being treated as a waste. On top of recycling, this element used to include remanufactured, reprocessed or reused. But, we have streamlined the requirement to avoid confusion and refine the information that is being requested. Lastly, there is a new voluntary data element that reporters can choose to report, the percent production volume that is a by-product. There will be a couple of options - reporting this as zero or 100 percent of the production volume or using two wide ranges in between– those are greater than zero but less than 50 percent or greater than or equal to 50 percent but less than 100 percent. Note that this isn’t asking for the percent of your substance that contains the by-product, rather the percent of the production volume that is the by-product versus a product. As such, we expect in most cases this will be reported as zero or 100 percent. On slide 37, we return back to a familiar table to exhibit a few examples reporting scenario per chemical that a single company could come across when determining the need to submit manufacturing information as well as processing and use. So, for chemical A, it requires full reporting, including processing and use on the 2019 volume of 26,000 while B only requires reporting of the manufacturing because the 2019 – the principal reporting year production volume is equal to zero. Chemical C doesn’t meet the threshold for any year, so it doesn’t require reporting manufacturing, processing, and use. And with chemical B, we are illustrating quite a few things – one, triggering the threshold based on an earlier year like with chemical B due to the 2017 volume; two, triggering with a lower threshold because of the Section 6; and, three, the need to report the full information on a year – the principal reporting year even though that year 2019 volume is below the threshold. Moving on to slide 38. We will talk about what that information this actually entails. So, as we already indicated, processing- and use-related data is required if meeting this threshold, the regular or the reduced, unless otherwise exempted. And a lot of green here – so, we will focus on some of the pressing new sort of changes. Reporting the function category will now be required for commercial and consumer products as well – commercial and consumer products, not just for the industrial processing and use. And we are phasing in the replacement of the CDR industrial function and commercial consumer product use codes with codes based on the OECD function product and article use categories or just the OECD-based codes, as I will be referring to those. This will be familiar to companies that have also reported internationally and are helpful to EPA with other programs that also collect OECD information. By phasing in, we meant that during the upcoming 2020 CDR submission period reporting, using the OECD-based codes is only required for the chemicals designated by EPA as a high-priority for risk evaluation. The full list of these 20 chemicals can be found at this URL and will be shown in a few slides. For all other chemicals, to allow reporters time to familiarize themselves with the OECD-based codes, they may use either these or the current CDR codes, the same as those used in 2016. Reporting using the OECD-based codes will be fully implemented and required for all chemicals during the 2024 submission period. In other words, this (will be) phased in completely at that point. Now on to slide 39 to see the rest of the required processing and use information. Looking at the first table, on the industrial side of things, you will report the type of processing and use operation, the sector, functional use and the associated percent production volume, number of workers and number of sites. And looking at the bottom table on the commercial or consumer side, you will report the product category, whether the use is consumer, commercial or both, the functional use and whether used in a product intended for use by children and the associated percent production volume, max concentration and the number of commercial workers. And to reiterate on the circled reporting elements, functional use for the commercial and consumer products in the bottom table is a new data element and the other two are not new elements. They are the ones impacted by the phase in of the new OECD-based codes. Now, for a little context and a little bit of information, one combination of the first three elements in the top table, the industrial type, sector and function, is considered a unique exposure scenario. The same goes for the combination of the first four consumer and commercial use elements on the bottom table, which together also amount to a unique exposure scenario. For example, these scenarios are critical at attaining the bigger picture of the chemical’s conditions of use. Now on to slide 40. Here, we have a snapshot of the available function categories that you can use. At the beginning of the table, you can see that the new OECD-based codes are listed in column A and are associated or crosswalked with the current CDR codes in column B. The table of product categories isn’t shown in this presentation, but those are displayed similarly with a column A and the connection to column B. These full crosswalked tables can be found in the rule as well as the 2020 instructions for reporting, which will be available in the rule docket and on the CDR website. On to slide 41 for another table that I mentioned earlier. Here is the list of the 20 high-priority chemicals designated for risk evaluation. And if you are reporting any of these substances, you are required to use the OECD-based codes. And if reporting any other substances, you are allowed to but not required to use the OECD-based codes. Moving on to slide 42. Here, we want to re-emphasize a few things. Reporting is site-specific, meaning there is one Form U per site, which could have one or many chemical substance reports. So, that’s each chemical reported by a site. So, again, for some perspective, there were about 8,700 chemicals reported in 2016 but around 42,500 chemical reports as a number of sites were manufacturing the same chemicals. We also want to stress that the reporting standard is known to or recently ascertainable by for all data. That term or phrase is defined at 40 CFR 704.3 and means all information in a person’s possession or control plus all information that a reasonable person similarly situated might be expected to possess control or know. Generally, this is information known by management or supervisory employees of the submitter. More in-depth examples of this type of information or standard can be found in the instructions for reporting. On to slide 43. We will go over some of the changes associated with making confidentiality claims. The TSCA amendments in June 2016 required substantiation for most confidentiality claims. Now, up-front substantiation is required for all claims of confidentiality at the time they are made except for product volume, which includes five separate data elements, one per year 2016 through 2018, plus the domestically manufactured and the imported volumes for 2019. Also, supplier identity, trade name and the formulation information associated with the joint submission don’t require substantiation. The substantiation questions and certification statement have also been updated. And general use data elements that we discussed previously can no longer be claimed as confidential. Specific elements are listed here for the processing and industrial or consumer and commercial use. Moving on to slide 44 to talk about requirements for importers. Under TSCA, manufacture includes import. And importers have much of the same requirements but has a few additional factors to consider. Site is defined for importers in 40 CFR 711.3 and is the U.S. location of the unit directly responsible for the importing. And that must be a U.S. address even if it is for an agent acting for the importer. An importer will indicate whether each imported chemical is never physically present at the reporting site. It’s one of the elements I mentioned previously. If a mixture is imported, the importer reports the individual chemical components of the mixture including the percent composition. A joint submission with the supplier is used when the chemical identity or mixture composition is unknown. And one of the new requirements for imported mixtures – the secondary submitter of a joint submission reports the function of the chemical within the mixture. Lastly, imported articles are exempt under 40 CFR 711.10(b). Moving on to slide 45. When identifying your imported substances and and determining its requirements; for sources of composition information, you can refer to the Material Safety Data Sheet or the MSDS or the SDS, the Safety Data Sheet, or the supplier can provide composition information as well. If that information is claimed as confidential, you can ask the supplier to provide the information directly to EPA. And one of the new capabilities for joint submissions – both the primary and secondary submitters are able to identify parts of their submission as confidential. And similar to domestic manufacturer, use known or reasonably ascertainable information to determine whether your production volume triggers reporting. For imported mixtures, that would be the overall production volume for the chemical from each source, including from different imported mixtures or manufactured volumes. [EPA corrected statement] And, again, you can ask your supplier or refer to the MSDS or SDS for composition information. Moving on to slide 46 where we will shift to information specific to by- products. Now, I will just be giving us some background on by-products and talking about some of the new by-product-specific exemptions. A by-product is a substance produced without a separate commercial intent during the manufacture, processing, use or disposal of another chemical substance or mixture. They are typically manufactured for a commercial purpose and reportable when used for a non-exempt commercial purpose. On slide 47, we will go over the first new by-product-specific exemption. EPA will now exempt specifically listed by-products that are recycled or used in physically enclosed systems in a site-limited manner and when the site is reporting the by-product or another substance from the same overall manufacturing process. By site-limited, meaning the by-product remains onsite after manufacturing in this process. The industries and by-products that were listed and eligible for this exemption are cement kiln dust from Portland cement manufacturing and black liquor, oxidized black liquor and calcium carbonate from the (craft pulping cycle). Moving on to slide 48. As part of this exemption, a petition process was implemented to identify additional industries and by-products that meet these criteria. These considerations for the petition process follow the criteria I mentioned in the previous slide as well as whether or not EPA may have a current interest in the by-product. Note that not time for a petition for the 2020 submission period. But, petitions for consideration for the 2024 submission period will be due before December 31, 2022. On slide 49, we will move on to the second exemption. This exemption is for by-products that are generated in equipment that is not integral to the production process. The equipment we are referring to specifically is pollution control and boiler equipment. For context, an integral process, for the purpose of this exemption is the portion of the manufacturing process that is chemically necessary or provides primary operational support for the production of the intended product. And for a few examples of what equipment is likely to be integral or non- integral, reverberatory furnaces used for smelting and utilities using boilers to product electricity as a product would be considered integral to the production process whereas sites using boilers to produce heat or electricity for their facility would not be considered integral. Examples of pollution control equipment that is likely to be non-integral includes flue gas desulfurization and selective catalytic reduction systems – both types of air pollution control – as well as for instances when a by-product is produced while treating wastewater from cleaning tanks from a manufacturer’s production process water treatment pollution control. These are not listed here. But, examples can also be found in the 2020 instructions when those are made available. On slide 50, we will shift to talking about co-manufacture of chemicals. The reporting mechanism for co-manufacturing has been updated. In the past, this was referred to as toll manufacturing. For a little background, a co- manufacturing relationship occurs when a chemical substance manufacturer, other than by import, is produced exclusively for another person who contracts for such production. Note that the co-manufacturer’s reports are done as part of the overall Form U. It doesn’t require a separate report. So, using the first new reporting methodology, the contracting company initiates the co-manufactured chemical report and notifies the producing company using the e-CDRweb reporting tool. So, looking at the table, both the contracting company and the producing company reporting their own production volumes, and the contracting company reporting the chemical identity and the processing and use information and the producing company reporting all of the manufacturing information. On to slide 51. Using the second new reporting methodology, the contracting and producing company, upon written agreement, work together to complete the reporting. In this scenario, the producing company initiates and completes the report – the reporting, providing exposure-related manufacturing information while the contracting company provides additional information [as needed, to the producing company]. Although the producing company submits the report, both parties are responsible for the report. On slide 52, we will shift our focus again. Just to finish out this portion of the presentation, I am going to walk us through a number of our non-regulatory updates. These are all intended to improve and streamline the reporting process. So, we have completed the portion on the regulatory updates. There are a variety of IT and functionality enhancements that are being incorporated into the reporting tool. This includes a new application platform that lags less and has faster validation. There is a streamlined CBI substantiations [process], auto filling data from 2016 submissions and improving the process of uploading data. In 2016, there were issues with uploading from an XML file. So, now, the reasons for the failures will be explained. We also will allow uploading data by CSV file now. An agent role has also been added to make the reporting process more versatile or flexible. We will talk more about that on slide 54. Previously, there were just two roles, the authorized official, who creates, signs and submits the form; and support people who help to fill in the details of the form. As you are looking at the table, you can see that the support person has only the capacity to edit the form. So, as requested, the agent role has been added, which is modeled after the new chemicals program and the (PMN) or pre-manufacturing notice submission process. Agents will have the ability or access to do the following in this middle column of the table, which include editing, unlocking and providing amendments to the original created form. Moving on to slide 55 for additional resources. We are in the process of updating all the 2016 guidance documents including the various fact sheets. On slide 56 we will talk about where you can find this updated guidance. So, you can visit the CDR page where the updated information and guidance that I mentioned will be posted as it is developed. There, you will be able to find instructions for reporting and CDR frequently-asked questions, both of which have been updated to reflect the rule changes to reporting requirements, as well as you will also be able to find any of the very informative industry- specific fact sheets. Lastly, reporting-related questions can be sent to ecdrweb@epa.gov. On slide 57, we will have a break for a Q&A session. But, to make sure we get through both presentations fully, we’d like to postpone questions until we finish the reporting tool demo. And I’m just going to transition over to hand it over to Carolina Falaiye. I think Meredith may have something to mention before switching to the reporting tool demo. Meredith Comnes: Yes. Thank you, Tom. I’d just like to mention that we have completed going through the first section – the first document, that is, the slide deck which you downloaded from the website. So, we are now transitioning to the second slide deck, which is going to be a walkthrough of screenshots of the reporting tool. So, just take a moment and close out the first PDF and transition to the second PDF. And I’ll pass it over to Carolina. Carolina Falaiye: Thank you, Meredith. Good afternoon, everyone. This is Carolina Falaiye. I am with CGI Federal. And for the past one and a half years, we have been working with EPA to understand the needs of the industry for a more flexible solution that allows them to accommodate all the different manufacturing scenarios. So, I will go over the application with the screenshots. I am moving on to slide number one for a quick disclaimer that the screenshots included in this presentation are draft and they may be subject to change. Moving on to slide number two. We will go over the prerequisites to get access to the CDR 2020 application, how to complete a Form U, which includes the formal review that captures information related to the parent company and site, the chemical information and the different scenarios that were considered during the redesign of the application. We will cover the process to report the chemicals manually or using a file to do bulk upload. We will also go over the process to provide the confidential business information, which I will refer to as CBI claims, and the reporting requirements and how to substantiate or provide answers to the required questions. And I’ll also go over the submission process and the existence of a secondary and tertiary forms. I am now moving on to slide number three, which contains the Central Data Exchange homepage. As some of you may be familiar with other TSCA reporting applications, users are required to register in CDX to get access to all the TSCA applications. The user guide and the CDX provides an explanation of the user roles available for CDX and guidance on how to enroll in order to have the correct access to the CDR tool. This includes access and directions on how to sponsor a primary agent consultant or a secondary agent consultant. Slide number four displays the first page that the user will see where they need to select the role that they register as, to get access to the application. Slide number five contains the Chemical Information Submission System that the TSCA application displays. Something Tom mentioned is that all your prior data for 2012-2016 will be available in the 2012-2016 application. And the 2020 link will take you to the newly upgraded application only for CDR 2020 reporting. Moving on to slide number six. This is what the user will see on their homepage, which allows them to see all the sites associated with the organization that they registered with. The Create New button will allow them to start the form, creating the passphrase, which I will go over in a few slides. The pencil icon will allow them to edit an in-progress form. At the bottom for the left side, I have an example of how to download a copy of record or the XML file once the submission has been received by EPA. And the lock button will allow you to unlock to make any edits after the form has been submitted. Slide number seven displays a couple of things that we have included to help you navigate the application. This includes the resources links and frequent questions and quick reference guides to how – on how to do things and navigate through the application and also access the North American Industry Classification System to identify the NAICS codes required for the site information. On the right-hand side, you will see the primary authorized official in this case because the user logged in as primary authorized official. So, this gives you a brief description of the privileges that user will have. And it is basically different for each role. Slide number eight will display after the user has selected the Create New Form. This provides the opportunity to secure your form. So, this,the user, is required to provide a specific guidance in how to create the passphrase. And we are adding a new option to provide a hint to serve as a reminder of what the passphrase is. As any in secure system, it is recommended that you don’t use the passphrase as your reminder but that you use something that will trigger the memory to remember what you used as your passphrase. Slide number eight will take us through the creation of the form. As Tom mentioned, earlier, the requirement is to have one form per site. So, we will start with the form information, which includes the parent company information. And the information displayed on this screen will come from the registration in CDX. So, if you have registered under a U.S. company, this will display the domestic parent company. After you save, in slide 11, you will see that your organization will display on that summary table. If you need to report a foreign parent company, you can select the Add Foreign Parent Company button, and all the fields required will display. If, on the contrary, you have registered as a foreign parent company, the requirement is to have a domestic parent company. So, you must provide one before you can continue forward. The next slide, slide number 12, displays the site information and the required fields. So, we have the site Dun & Bradstreet number that needs to be provided as well as the NAICS code. Slide 13 will allow you to select from the NAICS code dropdown, which you can search by selecting the code or the description. In the activity classification, you can select for manufacture, import or both. And once those two fields have provided, you can add to list, and you will see it reflected, as in slide 14. The requirement is to add at least one NAICS code. But, you can add up to three. The hyperlink under the header that says “North American Industry Classification (NAICS) Code” – this hyperlink will direct you to the NAICS code website in case you can’t find your code. Moving on to slide 15. This will guide us through the process and the different scenarios that we consider when reporting a chemical. The first page that you will see once you get to this Chemicals tab is the Chemical Summary table. This table will hold all the chemicals that that you will report under that form or that site. There are two ways to report those chemicals. One is the Add Chemical, which is the manual process. And the second one is the bulk chemical upload, which we will discuss later in this presentation. Slide 17 contains the Chemical Identification page, which includes a couple of decision points that will direct you how or what you need to provide, depending on the answers provided. So, the question is, “Do you know the chemical identity of the substance you are reporting?” If the answer is “Yes,” you will be taken to the SRS search. If you are an importer and you don’t know the chemical identification, you will need to select the “No, I’m an importer.” And if you are a producing-only company, when you will select the “No, I’m a producing company.” For this first scenario, we will select the “Yes, I know the chemical identity,” and we will select the “Click here to add chemical.” Page 18 will display the SRS search, as Tom described, the functionality for finding your chemical in the Substance Registry Services. We have implemented communication with SRS. And, so, you will be able to search either by using the CASRN number of the accession number or the chemical name. They are all different ways to search. Once you select the Search button, slide 19 will show that the system is searching. Once the system has found this chemical on the SRS – if you search by accession or CASRN number, slide 20 will show you the Results page. And this will contain only one record. But, if you use a generic name or the chemical name, you may have multiple results. And, then, you can use the filter functionality to search for the one that you wish to report. Once you identify the specific substance, you can select the radio button the farther left and select the Save Chemical button to save the chemical. Moving on to slide 21. Once you have saved the chemical, you will see the chemical name displaying, the chemical name that came from SRS, the chemical identifier number, which is the number that you used to search in the registry. And, in this case, because this is a substance that was in the confidential portion of the TSCA Inventory, the user must select one of the two statements, whether he wishes to maintain an existing claim for the confidentiality of the chemical substance’s identity as listed in the confidential portion of the TSCA Inventory or if he does not wish to maintain it in the confidentiality. The three check boxes at the bottom are to indicate whether you want to claim this information as confidential – the company information, site information and technical contact information. If you are wanting to claim all these three items for all the chemicals that you are reported, you might select them for each chemical. Otherwise, only the chemicals that are – have been selected will be considered – will consider this information as confidential. Moving on to slide 22. As Tom mentioned, each chemical should provide a technical contact information. We have implemented a functionality where you can add all of your technical contacts with the first chemical that you report and, then, by each chemical you can select the technical contact that applies for each specific chemical. In this case, we will create a new contact which you can add a new individual or you can copy from your registration. Slide 23 contains the second part of the Technical Contact page. Once you save that information – moving on to slide 24 – you will see the technical contact that you added listed on that table. You can create a new contact or you can select this as the contact that applies for the chemical we are adding at the moment. If you select this contact, Jane E. Doe, then you can select (them as default) and it will be the technical contact applied to all subsequent reported chemicals. Or you can create and update as you go. Moving on to slide 25. We have reached our information for manufacturing – or our page for manufacturing information. In this page, the manufacturer and the manufacturer acting as contracting company are required to provide the production volume for the prior years. And, then, we will study or go over the following scenarios shortly. So, slide 26. We are going to go over the report as a manufacturing company. As a manufacturing company, you will select the first check box that reads “My site is reporting the production and use of the chemical.” We have the manufacturing-related information, including the percentage of total production volume by weight that is manufactured as a by-product, which is a new field, and, then, the report exposure-related information. And on slide 28, the bottom part of that page is the report physical form for 2019 production volume. Slide 29 will take us through a similar – the same page but the second scenario, which is the co-manufacturing company reporting as a contracting company. As a contracting company, you would select the second check box saying “My company contracted a co-manufacturer to produce the chemical at their site.” In that case, you will be required to provide the chemical alias, the calendar 2019 contracted production volume and the volume that – whether it was never physically at the site and the producing company information. Slide 31 will contain additional information for the producing company as well as generate the unique identifier the producing will require – will need to use during the reporting. You can add their email addresses and then send the email. Slide 33 will cover how the producing company will use that unique identifier that was provided by the contracting company. So, the producing company will come into the application and select the Chemical Identification page as “No, I am a producing company,” which will take them to the Producing Company and the Manufacturing and Information page. And that will display the unique identifier data entry that once you select the populated contracting company, it will retrieve the information provided with that unique identifier for the primary company that contracted the services to produce the chemical. Aside from that, you should provide the chemical alias, the total production volume and whether any of that percentage was produced as a by-product. In slide 36, we see the bottom page of the manufacturing information, which includes the exposure-related information as well as the physical form. Because they are producing only, they are not required to provide the use information. That information will be provided by the contracting company. Moving on to slide 37, we will cover the reporting as an importer. So, in this case, in the Chemical Identification page, the importer will select the, “No, I am an importer” option. They can claim their relationship with the importing company as confidential by selecting the check box on – the first check box. They also need to provide the trade product name or other designation that they use to facilitate the reporting with the secondary or joint submitter. Once they have provided that, they need to provide the secondary company information and an email address so that the email can be sent with a unique identifier. Moving on to slide 39. We will be able to see the rest of the email section where they can add the email address and send out the email on slide 40. Once they have sent out the email, that concludes for the importer the chemical identification page. And they can move on to provide the industrial processing and use information for that chemical. In this, we have the Add Process or Use for that particular chemical. And slide 42 displays all the fields that become a unique use by selecting the type of process and use, sector and function category. The other change that happened during 2020 is now only the percentage production volume number of sites and number of workers can be claimed as CBI. The function category, as explained earlier – we have added the new codes or – you see codes that start with an F. So, the user can select – find the codes by using the code or the description. This also includes the previous codes, the U codes. For the high-priority chemicals, you will only see the list for the F codes. Once you select and add all the information, you can select the Add To List in slide – and the use will be added to the table. Moving on to slide 44. We have a similar concept for the consumer and commercial use. When the user selects the Add Product Category, slide 45 will display. And they can select the product category, the function category, the commercial – consumer and commercial and whether the product – the product was used for products intended for children. Similar concept with the CBI claims apply to the percentage production volume, maximum concentration or number of commercial workers reasonably likely to be exposed. Slide 46 displays the updated codes. This will include the C codes as well as the CC codes. And the functionality works the same. You can find it by using the code or the description. That concludes the manual submission. Now, on slide 47, we will talk about how to upload a file – or chemicals using a file. We will provide a template for the Excel file that will contain some dropdown values to help facilitate this submission. And the XML – if you have your XML from 2016, you may upload that file or you may download it. If you know the passphrase for your form, you may go to the 2016 application and use the green arrow to download the copy of record (that you will find) your XML. Once you have the file, you can select it from the location, as it’s shown in slide 48. In slide 49, we will perform – or the system will perform a couple of validations. Moving on to slide 50. The first validation that we will do is schema validation. So, if you are uploading an XML file, we will validate it against the schema and provide the lines where your file may be failing because it doesn’t meet the formatting requirements. And once that has been solved, you have to reupload the file, and we will conduct the second validation, which includes checking against SRS to make sure that your CASRN or your accession number is listed there. If we don’t find it in there, you will see the CASRN displayed on the bottom section that says the number of chemicals not found in SRS so you can proceed with the troubleshooting process that will help you identify a way the chemical wasn’t found. Once all your chemicals have been added and the slide 16, the Chemical Summary page, has been updated with all the chemicals that you are ready to report, we will move on to the CBI substantiation that’s in slide 51. Slide 52. We will take you to a review of the CBI Claims page which contains a brief explanation of what the icons mean. And on the left-hand side, we will have the list of chemicals that you are reporting and their status. At this point, none of them have been substantiated. So, that’s why you don’t see neither a green mark or gray mark. Chemicals with a gray mark will indicate that they have CBI claims, but none of the claims require substantiation versus the green ones that will indicate that will indicate that they have claims that require substantiation, but the substantiation has been provided. Moving on to slide 53. We will have an example of a chemical who has – who was – that was claimed CBI or has CBI claims. And we have included the sections where the claims were made and the links that will take you to the applicable questions to substantiate. Each data element is required to provide answers for the general – the general answers, which include six questions for each data element. And we will go over the specific chemical identity substantiation questions later one. Moving on to slide 54. After the user has provided all the questions, you will see the status has changed to a check mark – a green check mark that allows you to know that that chemical is in good order. Slide 55 will allow you to edit the following chemicals. So, using the information provided for the first chemical, you can reuse some of those answers as long as the same data elements are being claimed in CBI. Slide 56 –displays how you can select from good-standing chemical. You can select that chemical to retrieve answers that can be copied over. Slide 57. Once you have selected that chemical, you will have a couple of options. You can copy only to the chemical that you are editing or you can select to copy all – to (transit) the same answers across multiple chemicals for the same data element. Moving on to slide 58. You can see that only two were completed despite the fact that I used the Copy All. This is because the accession number will require additional information for the chemical identity claim. Slide 59 will display how those sections that have been completed will have a check mark indicating that that substantiation has been provided. In this case, the chemical identification substantiation questions have not been provided. Slide 60 will display the additional questions for the chemical identity. And, therefore, once you complete it, slide 61 will display that all the chemicals have been properly substantiated and you can continue with the submission of the form. Slide 62 will take us through the submission process. Once the user selects the Continue button, they will find the submitting official information, which can also be claimed CBI. They are required to provide the position and to agree that they are the submitting – legally responsible party for submitting the company. Once that check box on the bottom has been checked, this Start Submission Process button is enabled. And we can move on to slide 65. The user is required to agree to a couple of certifications. The first one is the TSCA CBI Certification. And once the user selects Continue, slide 66 will allow them to certify to their CDR Certification as well. Once that has taken place, we run an additional validation to make sure that all the data elements required are provided and that nothing is missing. The review validation – if there are errors, we will see a validation window that will display the chemicals that are missing information and a link to return to that particular section to make any changes required. Slide 68 would allow you to download a draft of the submission. This is not an official submission. It is not to be submitted to the EPA. It’s just for your record. Once you have submitted, the final submission can be downloaded by the copy of record download functionality. Once you are ready to submit, then you can select the Sign, Encrypt and Submit button, and the slide 69 certification will display. Once you accept, slide 70 will display the authentication. This is the password from CDX. And, then, you provide the information from your slide one question and you electronically sign the form. After the the signature has been completed, your form will be sent to EPA, processed. And once it is received and complete, you will see a case number assigned to your form. Slide 71 will display the secondary or joint form. For access to the secondary or tertiary form, the user would use the secondary authorized official or any of the secondary user roles. Secondary users (see one form) (inaudible) per year and they as well have the resources and description of their role selected. Moving on to slide 74. They can enter all the chemical substance that make up the trade product name. Slide 75 will allow them to enter the unique identifier for the primary company that is reporting as imported. Once they select the Populate Primary Company, they can see the information from that primary company on the table. They can enter more – one or multiple companies. And this concludes the overview of the application tool. Meredith, that’s all I have. Thank you. Meredith Comnes: Great. Thank you, Carolina. So, we are going to transition to slide 76. The title of this slide is Reporting Tool Beta Test. EPA is currently looking for up to 25 volunteers to test the e-CDRweb reporting tool. So, that would involve going into the tool and testing it out before we open it up on June 1. We ask the volunteers to represent a range of the CDR submitters. So, that means whether you are manufacturer or import, whether you company is large or small, whether or not you utilize a co-manufacturer when you report. So, we are planning to do this in mid-April, and it will last for one week. If you are interested in volunteering, please send an email to ecdrweb – we have the email address right here – ecdrweb@epa.gov – no later than this Friday, April 3. And we hope that we can find some participants for our best testing. Well, I think that we have ran through all of our slides. We have plenty of time. So, we are going to transition into a question-and-answer section. Operator: At this time, if you would like to ask an audio question, press “star” then the number “1” on your telephone keypad. If you wish to withdraw your question, press the pound key. Once again, that is “star” then the number “1”. Your first question comes from the line of (Heidi). (Heidi): Yes. So, when will the 2020 update to the SRS going to be completed? Susan Sharkey: Hi. This is Susan Sharkey. The 2020 listings in SRS will be – draft versions will be put in place in May. But, because they represent the status of the chemicals as of June 1, they will not be final until June 1. OK. Next question. Operator: Caller, if you pressed “star,” “1” and did not record your name, your line is open. Male: I want to find out what’s the requirement for the beta test. Is that (inaudible) ready to submit at that time or how – what is the scope of the beta test? Susan Sharkey: No. We expect to use – to just make up data. It’s an opportunity to go in and have the systems to make sure that it’s functioning as it should be functioning and trying to find out if there is any problems or issues. The beta testers will be provided a test link to use. So, you will not be using your own – your own information to do so. You may choose to use your specific chemical data to conduct the testing. But, it is not – it will not be giving you a chance to start working on your submission. Male: OK. Thank you. Susan Sharkey: OK. Next question. Operator: Your next question comes from the line of (Deborah Otter). (Deborah Otter): Yes. Actually, my question has been asked and answered. Meredith Comnes: Thank you. Operator: Your next question – caller, please, your line is open. Female: (Inaudible) so that has, say, the vehicle windshield washer fluid from a foreign plant. Do you still have to report the number of workers exposed in the foreign plant when they filled up the vehicle with that windshield washer fluid and whether there is any recycling activity in that foreign entity? Susan Sharkey: No. Any of the information that you are providing on this CDR has to do with activities within the United States. So, you have to look at if you are … Female: Thank you. Susan Sharkey: Yes. OK. Female: OK. Thanks. And, then, the other question is I did use the SRS to look up the ingredients on the vehicle windshield washer fluid and the result was a very long list. It was difficult to explore how – whether that’s one ingredient have the 2,500 or the 25,000 threshold. Does the CDX tool – if I have the CAS number of that ingredient, does the CDX tool recognize that it’s subject to the 2,500 or the 25,000 threshold? And if yes, (there is no) … Susan Sharkey: Yes, it does. Female: (Inaudible). OK. Susan Sharkey: No. The answer is yes, it does. Yes. It will let you … Female: OK. (Inaudible). Susan Sharkey: It will give you a response back as to what the reporting requirements are for that particular CAS number. Operator: Caller, please go ahead with your question. Female: My question has to do with co-manufactured chemicals. Why would both the co-manufacturer – why would both companies report the calendar year 2019 production volume on the form? Shouldn’t that value be the same for both of them? Susan Sharkey: One would hope that it would be the same. But, there is a potential that the information each one has is different because other information that’s reported on each of the forms is based on the percent production volume. We just wanted to make sure that we knew exactly what production volume that percent production volume was referring to. Female: But, since they are talking to each other and have to communicate with each other, wouldn’t they confirm that they are both reporting the same production volume for calendar year 2019? Susan Sharkey: One would hope so. Female: OK. Susan Sharkey: There are a variety of different manufacturing scenarios that are possible. And, so, a contracting company may have – be using multiple producing companies. Female: Right. Susan Sharkey: And in that case, their production volume would be larger than the producing company’s production volume. And they might not want to share that information. Female: Yes, that would be (inaudible) if they are making the same chemical for a bunch of different companies, then the quantity of the chemical that’s associated with each company would be – would add up to a larger volume. I could see that. Susan Sharkey: Right. Actually, it would be the other way around because (inaudible) would only be making it for one contracting company. Female: Right. OK. Operator: Caller, go ahead with your question. Caller, please go ahead with your question. Caller, please go ahead with your question. Male: (Inaudible). Susan Sharkey: I’m sorry, sir. Your question again. Male: Yes. Does the authorizing official have to be the one to go in to create the new form and to create the passphrase? Or can the agent that’s doing most of the input take care of that? Susan Sharkey: No. The authorized official is required to initiate the report and create the passphrase. After that’s done, the authorized can do pretty much everything else and can even go in and make amendments, if needed, at a later date. Male: And, then, I can assign the supporting personnel that can do the data entry as well as the agent? Or does the certified official have to authorize everybody that’s going to be working on that project? Susan Sharkey: I am not sure. Carolina Falaiye: Sorry, Susan. This is Carolina. Yes, the primary agent consultant will be able to assign supports, if needed. Male: Thank you. Operator: Caller, please go ahead with your question. Caller, please go ahead with your question. Female: Hello. I assume that – I assume that I am open. When will the instructions be ready for the 2020 reporting? I heard them alluded to. Susan Sharkey: The instructions are currently waiting for publication of the final rule. Once it’s actually finalized or published – it’s been signed. The pre-publication version is available on the EPA website. But, it has not yet been published by the Federal Register. Once that happens, the instructions will be submitted to OMB for review as guidance materials and we will be placing them in the docket associated with the final rule. We are hoping to be able to also provide a link to that directly from our website. But, I am still waiting for confirmation from OMB that we are able to do that. So, the short answer to your question is you will have access to the 2020 instructions through the final rule docket at the time that the Federal Register published the final rule. Operator: Caller, please go ahead with your question. Christina Franz: Hello. Can you hear me? Susan Sharkey: Yes, we can hear you. Christina Franz: OK. It’s – this is Christina Franz from ACC. So, first of all, thank you so much for hosting the webinar. It’s really very helpful. I would not that it’s very difficult out which caller the operator is referring to when she says that your – “Please proceed with your question.” So, if there is some way to identify who she is calling upon, that would be really helpful. I have a question about the CBI substantiation. It was unclear to me during the presentation – and forgive me if I misunderstood – but, it was unclear to me that when substantiating a CBI claim that has been claimed and substantiated previously in some other TSCA activity, whether in the CDR you can reference that prior substantiation. It seems that there should be some coordination. You are undertaking an entire process for folks to be claiming chemical identity in the active inventory. And it seems like there is a lot of potential for duplicative substantiation and activity, which would be not only imposing a huge burden on companies but also on EPA to have to be doing multiple rounds of review of claims. Susan Sharkey: At this point, there is not a way to connect substantiations that were previously provided. I recognize the issue that you are identifying. But, there is also not – there is no requirement that the entity that is submitting the CBI – sorry – the CDR reporting form is the same entity that submitted the CBI substantiation when it was listed on the inventory. So, there is – there is a lot of different issues associated with that. But, the bottom line is that right now there is not a way to connect the substantiation. Operator: Once again, ladies and gentlemen, that is “star” then the number “1” for any audio questions. Your next question is from (Linda Rogers). (Linda Rogers): Yes. I am – I am still confused about co-manufactured chemicals. If we manufacture a chemical and sell that chemical under our trade name and we also place that chemical in the company-specific bag of a customer of ours and ship that chemical directly from our facility to their end user, are they considered a co-manufacturer? Susan Sharkey: Not likely. (Linda Rogers): OK. Susan Sharkey: So, a co-manufacturer is a – when you have – not a – it’s more than just a contract between the contracting company and the producing company. But, it’s also where the contracting company is specifying a lot of things about that particular chemical, including how it’s manufactured, what the technology is to manufacture it. And it’s a one-to-one relationship. So, it’s doesn’t – it is not meant to cover the situation where you have a contract with a company to supply a chemical that you are also making for other reasons. (Linda Rogers): OK. Thank you. Susan Sharkey: Next question. Hello, (Christy). Are you there? Operator: (Roxanne Casey), your line is open. (Roxanne Casey): Hi. I just have a question in regard to a manufacturer versus importing. We (blend) or process chemistry. But, we also import finished goods from our (inaudible) locations around the globe. So, it’s unclear to me whether or not we need to report as a manufacturer or an importer. Susan Sharkey: If you are domestically procuring the ingredients for your mixtures, then you are not manufacturing. If you are just mixing them and there is no reaction occurring where you are not making a new substance, then you are not triggering a need to report. For the items that you are importing, you need to consider whether they – you are importing an article or if you are importing a – when you say finished product, if you mean a mixture, then you do need to consider the components of the mixture you are importing and whether each of those individual components need to be reported. There are two fact sheets on our website. And for the basics, you can use the 2016 fact sheets. One has to do with importing and one has to do with imported articles, how to tell if you have something that is an article or is not an article. (Roxanne Casey): It is definitely – it’s chemistry. It’s a mixture. But, when we were going through the slides for the actual CDX reporting, it confused me as to whether or not I should be reporting as an importer or a manufacturer because we are importing the finished chemistry as a mixture. Susan Sharkey: Right. So, the definition of manufacturer includes importer. (Roxanne Casey): OK. Susan Sharkey: And, so, you report as a manufacturer and you report that you are importing the chemical. (Roxanne Casey): I just wanted to be clear. Thank you very much for answering my question. Susan Sharkey: Certainly. Operator: Your next question comes from the line of (Beth Krudders). (Beth Krudders): Hello. I actually have a two-fold question regarding the agent consultant role. First off, I wanted to check will the onboarding – sponsorship of a new agent consultant follow the same process as is followed for other CSPP areas such as TSCA Section 5? Carolina Falaiye: Hi. This is Carolina. Yes, it will follow the same process. (Beth Krudders): OK. And just as a follow up, if someone has already been sponsored as an agent consultant for – again, the same example, Section 5 – will they already have access to the 2020 CDR tool as well? Or will a separate sponsorship be required? Carolina Falaiye: They should have access to CDR. (Beth Krudders): OK. Great. Thanks. Carolina Falaiye: Yes. Operator: Your next question comes from the line of (Mike Oshansie). (Mike Oshansie): Yes. I am an importer of mixtures. Right? And if I have a mixture that I am bringing in that are under 25,000 pounds per year but one of the components in that mixture is present in another mixture where I am bringing in over 2,500 pounds per year, do I report both components? Susan Sharkey: Yes. You need to consider each individual chemical in the mixture and then look across everything that you are importing or manufacturing and combine the production volumes to determine for that particular substance do you need to report it. So, you might have – in that situation you described, it sounds like one of the components of the lower-volume substance – the volume of that component would be added to the same chemical from the other substance – the other mixture that you are importing. (Mike Oshansie): OK. But, if in the – since they are used sometimes in very different applications, how do you will out the rest of the data for that one substance? Susan Sharkey: Right. So, you have – so, you have 100,000 pounds of the one substance and 90 percent of it goes to use A and 10 percent of it goes to use B. Then you would just say that. (Mike Oshansie): OK. Operator: Your next question comes from the line of (Joe Fable). (Joe Fable): Hi. My question is regarding processing and use information when reporting for a substance that is not subject to certain regulatory actions under TSCA. So, slide 37 is my reference. And you have an example for chemical D where there is a volume for the primary reporting year of 2019 and it indicates to report processing and use on that 1,200. And my question is simply for substances that are at the 25,000-pound threshold, if you had a similar scenario, let’s say, chemical B that had met the threshold for one of the previous reporting years, 2017, but only have, let’s say, 1,000 kilograms for 2019, would you also need to report the processing and use on that 1,000 kilograms for 2019? Susan Sharkey: Yes. Basically, you trigger the need to report based on any of those four years. But, you only report the processing and use information based on the 2019 volume. So, if it’s zero, there won’t be anything to report. If it’s 1,000, then you would have – you would be reporting on a small volume even though that volume is under the level that would trigger the need to report. (Joe Fable): OK. Thank you. Susan Sharkey: Yes. Operator: Your next question comes from the line of (Heidi). (Heidi): Yes. My question is for the (inaudible) is the CDX (inaudible). Susan Sharkey: (Heidi), I’m having trouble hearing you. (Heidi): OK. (Inaudible). Susan Sharkey: Can you start over? (Heidi): Yes. Sure. So, when you (inaudible). So, my question is (inaudible) authorized (inaudible) to do or (inaudible) ahead of time (inaudible)? Susan Sharkey: I’m sorry. I still wasn’t able to hear your question. It has to do with the authorized official, but I wasn’t sure what the rest of the question was. (Heidi): Yes. Let me try again. So, (inaudible) or that (inaudible)? Susan Sharkey: I still wasn’t able to hear you. Can anybody else understand what she is asking? Your voice is very, very far away. Meredith Comnes: Yes, (Heidi). It sounds like you start up close. We could hear you at the beginning. But, if you can just try again. (Heidi): Is this better? Susan Sharkey: Much better. (Heidi): OK. Sorry about that. Let me repeat my question again. So, the question is about data validation. Female: As an agriculture company rooted in our connection to food, farming and the land, we are always looking for new ways to carry forward the (Simplat) legacy of bringing earth’s resources to life. (Heidi): Hello. Did you hear my question? Susan Sharkey: No because some recording came on during it. (Heidi): Oh, dear. OK. Well, let me try one more time. I’m sorry. So, for the data validation step in CDX, is that something that could be done ahead of time by the agent or someone else preparing the report just to avoid any issues that might be coming up with the data? Or I just wanted to see if that would be possible to do ahead of time before it actually gets to the authorized official. Carolina Falaiye: Yes. This is Carolina. Yes, the validation can be done at any point. We have – but not at the bottom. I can look for this slide for reference. If you look on slide 42, at the bottom, we have the Save, Validate and Preview buttons. The Validate button will grant those validations at any point during the submission. So, yes, it can be validated way before it goes to the primary authorized official for submission. (Heidi): Thank you so much. I apologize for the technical issues I was having. Operator: Your next question comes from the line of (Peter Miranda). (Peter Miranda): Hi. Thank you. I had a question. And let me give the example here. If I’m an importer of a chemical formulation and one those chemicals that’s in that formulation is an impurity but that chemical is one of the 20 prioritized TSCA chemicals now planned for future review, should I be concerned if that chemical impurity is – meets the 25,000-pound threshold? Susan Sharkey: Can you – I knew the answer to it until you mentioned that it was one of the priority chemicals. Can you please email that question to ecdrweb@epa.gov? (Peter Miranda): I sure can. Susan Sharkey: Thank you very much. Operator: Your next question will be from the line of (David Corrari). Your next question comes from the line of (Kat Gale). Female: As an agriculture company rooted in our connection to food, farming and the land, we are always looking for new ways to carry forward the … Operator: (Carrie Wells), your line is open. (Carrie Wells): Is the expectation that if the small manufacturer definition is not finalized prior to June 1 that it would not apply to the CDR? Are you expecting it’s going to be finalized prior to the CDR? Susan Sharkey: Answering the second question first. We do anticipate that it will be finalized prior to the beginning in the CDR. However, if it is not, it will – when it is finalized, it will go into effect. So, if you are a – if you think that you might qualify as a small business under the new definition, you might want to wait to submit your report until later in the submission period. Operator: Your next question will come from (Raine Anderson). (Raine Anderson): Yes. Hi. Thank you. If we acquired a manufacturing site, let’s say, on 2017 or 2018, can we use the 2016 data that was reported? Will we be able to use their data from 2016? Susan Sharkey: You can if they provide you the information to access the – that data. They have the ability to – they have the passcode and can provide that to you. It also might vary depending upon what type of acquisition that was. (Raine Anderson): OK. Susan Sharkey: If it was a – yes. OK. (Raine Anderson): OK. Thank you. Susan Sharkey: Yes. Meredith Comnes: So, this is Meredith. I know that we are getting to the 3 o’clock cutoff. My suggestion would be that we take one more question. And, then, for people who are still interested and if you still have questions, we are going to ask that you send them to e-CDRweb. Operator: Your next question will come from (Robert Roe). (Robert Roe): Yes. I got – may I try to squeeze in two questions in here? One is – the first question would be what if a facility closed down in 2019? Does that company, I guess, still need to file and EDR for the four-period if they did exceed any of the thresholds? And number two, real quick, is can you give a little better explanation on the importation, what’s supposed to be – what’s supposed to be done in that – in 2016, we basically indicated that we were importing a material and we indicated the volume of that. I think roughly that was about it. Now, it looks like we have to send an email, I guess, or the email goes to whoever the supplier is of that chemical and then they have to also do a – do (inaudible) CDR or CDX and do a CDR report also. I guess I am trying to get that figured out a little bit clearer. Susan Sharkey: I’ll start with your import question. (Robert Roe): OK. Susan Sharkey: The only time you need to do a joint submission with the importer is if you do not know the identify of the chemical substance. (Robert Roe): OK. Susan Sharkey: That happens sometimes when you are importing a mixture and it’s a proprietary composition. (Robert Roe): OK. Susan Sharkey: And, so, that’s the only time. Otherwise, you can just report it if you know the chemical identify. (Robert Roe): OK. (Inaudible). Thank you. Susan Sharkey: Your first question – right – had to do with a company that closed down in 2019. Is that what you said? (Robert Roe): They stopped operation – yes – in 2019. So, (Inaudible) operation. So, theoretically – I guess the company doesn’t exist anymore per se or the facility doesn’t exist at least anymore. So, I’m assuming someone still needs to put a report in for them. Susan Sharkey: I am not sure the answer to that question. (Robert Roe): OK. Susan Sharkey: If you could send it to us … (Robert Roe): OK. Susan Sharkey: … through ecdrweb@epa.gov, that’d be great. (Robert Roe): OK. Thank you. I will do that. Meredith Comnes: All right. We have reached 3 o’clock which, unfortunately, is the cutoff time for our webinar today. We apologize that we don’t have enough time to answer all of the questions in real time. But, we, of course, want to hear from you and respond to any additional questions that you may have. So, if you have any more questions, please email them to ecdrweb@epa.gov. Again, that is ecdrweb@epa.gov. It’s also listed in the slides that you referenced today. So, if you send a question to that email address, we will do our best to answer it in a timely manner. But, again we – I would just like to reiterate we appreciate your participating today. I know a lot of people are working remotely and technical issues are a bit more complicated. So, we really appreciate the engagement from the reporting community. And that’s all I have to say, unless anyone else who – a leader on the phone wants to add anything to that. All right. Well, thank you. I’m signing off here. Operator: Ladies and gentlemen, you may disconnect at this time. Presenters, please hold. END EPA 03-31-20/1:00 p.m. ET Page 1