EPA Moderator: Meredith Comnes May 19, 2020 1:00 p.m. ET OPERATOR: This is Conference #: 2499985. 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’ lines are in a listen-only mode. After the speaker’s presentation, there will be a question-and-answer session. To ask a question during the 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: All right, thank you. Good afternoon everyone and thank you for calling in today. My name is Meredith Comnes. I’m in the Office of Pollution Prevention and Toxics here at EPA. I’ll be presenting along with my colleagues Kelly Summers, Scott Sherlock and Carolina Falaiye who is a contractor at 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 I ask that you follow along with the PDF version of the slides that we have provided you in your confirmation email. You must download both links from the EPA website, and they have two different titles. The first one is the CDR Regulatory Overview. That will be part one of the webinar. And the second one is the CDR Reporting Tool Walkthrough, which will be part two of the webinar. Right now, I’m on the first of those two PDFs, so this is the CDR Regulatory Overview. And before moving on to each slide, I will indicate what slide number I am on. Right now I’m on the title slide of the first of the two PDFs. And you will see starting on the next slide, the slide number is in the lower right-hand corner of each page. I’m now transitioning to Slide 1. This is an overview of our presentation. Today’s presentation will last about two hours and have two parts. The first will be background on TSCA, the Chemical Data Reporting program, and an overview of the reporting requirements. The second part of today’s webinar will be a walkthrough with screenshots from the reporting tool. If time allows, we will have a question-and-answer section at the end. I’m now on Slide 2. I will quickly provide some history on the Toxic Substances Control Act, which is abbreviated as TSCA, and which most people call TSCA. TSCA is the premier chemical safety legislation in the U.S. It gives EPA the authority to require reporting, recordkeeping and testing requirements, and restrictions related to chemical substances and/or mixtures. TSCA was initially passed in 1976 and most recently updated in 2016 with the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which is also called the Lautenberg Act. For the Chemical Data Reporting program, we’re focused on substances that are listed on the TSCA Inventory. The TSCA Inventory is the comprehensive listing of chemicals in commerce in the U.S. This was first created in the late 1970’s and currently lists about 85,000 chemical substances with about 42,000 of them identified as being active in commerce. I’m now on Slide 3. I’ll provide a quick overview of the Chemical Data Reporting program, which is also called CDR. CDR is really the first look or a 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 of quantities and uses of chemical substances manufactured domestically or imported into 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, which happened most recently in 2016. The current submission period will begin on June 1, 2020 and cover the calendar year of 2016 through 2019. Many of you are likely familiar with the CDR Revisions Rule, which was finalized in March of 2020. The finalization of this rule will affect the CDR Reporting requirements, and we’ll go into more detail on that in this presentation. It is also important to note that we have extended the end of the submission period from September 30th to November 30th to provide additional time for reporters to become familiar with these new requirements. And one more thing is that EPA has also finalized the small manufacturing definition, which we will also go into more detail during this presentation. I am now on Slide 4. Here we’ll go into more detail on what was included in the final CDR Revisions Rule, which I have mentioned will affect reporters this reporting period. There are three main goals for the Revisions Rule. First, to update CDR to align with new statutory requirements of TSCA. Next, CDR is essential for the implementation of TSCA. We are constantly evaluating our data needed, and so the second goal was to improve CDR data to support the implementation of TSCA. And third, we have the goal of reducing burden for certain CDR reporters. In order to meet these goals, a summary of changes we made were exemptions for reporting on certain byproducts, changes to claim and confidentiality to align the Lautenberg Act, modifications to reportable data elements, and changes to simplify the reporting processes for co-manufactured chemicals. This was proposed in April 2019 and finalized very recently in March of 2020. And one thing I would just like to note is that any green text in this presentation indicates a new reporting requirement or an updated reporting requirement. So that is just to help you as we go through the presentation today to keep track of what might be different if you reported in the last reporting cycle or if you’re going to use these slides as a reference while preparing your submission to EPA. I am now on Slide 5. This is just the title slide indicating that we are moving into the portion of the presentation in which I will discuss the CDR reporting requirements. I am now on Slide 6. And first off, I would just like to reiterate the submission period will be from June 1st to November 30th of 2020. This applies to all manufacturers, which under TSCA includes importers, of chemical substances that are listed on the TSCA Inventory as of 6/1/2020, 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 volume is 2,500 pounds or greater. 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 7. For each chemical that is reported, certain information is required to be reported. You must provide the following information – the annual production volume from 2016 to 2019, certain manufacturing information for 2019, processing and use information for 2019. And 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, in which a submitter will register in CDX, access e-CDRweb, which is the CDR reporting tool, create and submit a separate Form U for each site, and submit completed Form U following instructions on the e-CDRweb. I am now transitioning to Slide 8. And we’re going to move through an exercise to determine the need to report. You must consider each chemical substance that you domestically manufactured or imported at a single site from 2016 to 2019, and you must ask first is your chemical substance subject to CDR, and next, are you a manufacturer that is required to report. I am now on Slide 9. Here are some things to consider when determining your need to report. First, is your chemical substance listed on the TSCA Inventory? Next, is your chemical substance manufactured for commercial purposes, which means to produce, import or manufacture with the purpose of obtaining an immediate or 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 substance potentially exempt from reporting or is your chemical substance ineligible for an exemption? I am now on 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, and that includes listed petroleum processing streams and chemicals whose processing and use information is of low current interest. Some chemicals are not eligible for exemptions if subject to certain TSCA actions. If we transition to Slide 11 we have a chart. This is a list of TSCA actions that would make your chemical ineligible for an exemption. And I just like to point out that in this chart, the Section 4 orders in the center, that is the green checkmark, so I just like to indicate that that is a new requirement for this reporting period. I am now transitioning to Slide 12. We’re going to look at a chemical-specific example and determine if this chemical is subject to the CDR. This is a screenshot from the Substance Registry Service, the link of which is at the bottom of the slide. And I’m going to be going into a bit more detail about how to best use the Substance Registry Service in a couple of slides. But the main thing I’d like you to take away from this slide is that you can search for an individual chemical and the SRS will produce an output of the regulations that this chemical is subject to. I have inputted this generic chemical. I have a chemical list whose CAS number is 123456. And these are the regulations that my chemical is subject to. Let’stransition to Slide 13. Here we can see that this chemical is subject to the 2016 TSCA Inventory and, therefore, must be considered to be reported to the CDR. I am now on Slide 14. And I would just like to note that this example still references 2016, which was the last reporting period. But by the time reporting begins on June 1st, we will have updated information for 2020, which includes two lists in the SRS, which indicate if a chemical is active or inactive on the TSCA Inventory. I am now on Slide 15. We will now go through an extra slide to evaluate if the production volume threshold for your chemical makes it necessary to be reported to the Chemical Data Reporting program. Remember that the production volume threshold for chemicals is at 25,000 pounds, but for certain TSCA actions, for chemical subject to 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 upcoming report period, that means the years 2016, 2017, 2018 and 2019. I am now on Slide 16, and let’s evaluate the production volume of a sample company. So here we have a company called ChemIncA. ChemIncA manufactures three different chemicals – Chemical A, Chemical B and Chemical C. And for this example, let’s assume that these chemicals are not subject to certain TSCA actions which would trigger the lower reporting threshold. For Chemical A, in 2016, 2017 and 2018, the production volume was under 25,000 pounds, but in 2019, it exceeded 25,000 pounds. Thishis makes the chemical need to be reported to the CDR. For Chemical B, we see that in 2016, 2018 and 2019 they did not produce this chemical at all, but in 2017, they made the chemical and they exceeded the 25,000-pound production volume threshold. And therefore, they must report on this chemical. For Chemical C, we see that in all four years they did not meet the reporting threshold and, therefore, do not need to report this chemical to CDR. I am now on Slide 17. In general, the reporting threshold remains at 25,000 pounds. However, a reduced reporting threshold at 2,500 pounds applies to chemical substances subject to certain TSCA actions. And in the next slide we will see which TSCA actions we’re talking about. Now on Slide 18, this table lists TSCA actions that trigger the lower reporting threshold. So the first three listed actions do not affect the reporting threshold, so it remains at 25,000 pounds. The remainder of the TSCA actions do trigger the lower reporting threshold. I am now on Slide 19, and this is an output again for my generic CAS Number that I inputted earlier, CAS Number 123-45-6. And I just want to look at this output of the list provided here and see if I can see any of these TSCA actions that would result in a lower reporting threshold for this substance. If we transition to Slide 20, you can see that TSCA Section 6 Unreasonable Risk is listed here, so that would trigger the lower reporting threshold. I am now on Slide 21. We’re going to check back in with our example company, ChemIncA. We’ve already discussed Chemicals A, B and C that this company makes, but they also make three more chemicals – Chemicals D, E and F. We’re going to just look at these chemicals and evaluate whether or not they need to be reported to CDR. For Chemical D, we see that they are subject to a TSCA Section 6 rule, which would trigger the lower reporting threshold. And in 2016, we see that they manufactured 3,000 pounds of this chemical so that means that they must report this chemical to CDR. For Chemical E, Chemical E is subject to one of the previously listed TSCA actions but is not reportable because it does not meet or exceed the lower reporting threshold in any of the reporting years. You can see that in all four years they did not exceed 2,500 pounds. For Chemical F, which is subject to a TSCA Section 5 SNUR, we see that in 2018 and 2019 they exceeded the reporting thresholds of 2,500 pounds, so they must report on this chemical. I am now transitioning to Slide 22. We have covered determining the need to report on your chemical, and we’ll also discuss briefly whether you are exempted as a small manufacturer and if you qualify for any other reporting exemptions. I am transitioning to Slide 23. We’re going to focus on the small manufacturing definition, which has just been finalized and will affect this reporting period. And just to note, the small manufacturing definition was proposed combined with the CDR Revisions Rule, but we finalized it as a separate action, and it has just been finalized in time for the reporting period. This will affect reporters of this reporting cycle. And here is the final definition for small manufacturing, which would raise the current size standard total annual sales base to $12 million and the production volume modified standard equivalently to $120 million with no changes in the modifier of 100,000 pounds. And just to clarify, the total annual sales are of the submitter combined with the parent company, whether foreign or domestic. We’ve also added the definition to the small government, which would be municipalities with populations of less than 50,000 people. And we’ll go into a little bit more information on this on Slide 24. So here we are on Slide 24, this is our chart again with some more information added. We’ve seen the first three columns on earlier slides, but we’ve added a new column here, which is the small manufacturer exemption. If your substance is subject to any of those listed in the last column, you are not eligible for the small manufacturer exemption. I am now transitioning to Slide 25. And we’re going to talk a little bit more about the Substance Registry Service, and I’ll walk through an example of finding your substance and its status on the SRS. Onn SRS, you will find out if your chemical substance is listed on the TSCA Inventory, if your chemical substance is potentially partially or fully exempt from reporting, or if your chemical substance is the subject of certain TSCA actions, which may impact reporting requirements. And I just like to note that updates specific to the 2020 CDR will be added to SRS prior to the 2020 reporting period, but that has not happened yet. Some of these examples will reference 2016, but they will be updated in time for the reporting period, which begins soon. I am now on Slide 26. This is a screenshot of the homepage for SRS on EPA’s website, and on the top you can see we have provided the link to this page. And keep in mind that the reporting tool actually searches SRS for you or you can search on your own here before entering this information into the reporting tool. You will be able to search SRS by list, by a single chemical or CAS registry number, or by multiple chemicals. And we’ll go through a couple of the ways you can search through SRS, and initially we’ll go by list. Here you can see I have selected the By List option in the Search function. On Slide 27, this is what the page will look like if you select the By List option. You’ll have a number of lists to choose from here and the few examples shown here are the 2016 and 2012 CDR eligible chemicals, as well as those that are partially or fully exempt. And again, on or before June 1st, there will be a 2020 list as well. But if we transition to Slide 28, the chemicals on the partially exempt list require reporting of 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 they would be required to provide full reporting information. The 2016 partially exempt list should be the same as that for 2020 as nothing has been added or changed since the last reporting period. I am now on Slide 29. If we click on the 2016 full exempt list, this is what you would see. These chemicals do not require reporting, but again with the same caveat given that they are also not subject to certain TSCA actions as we previously listed. The result of some of these searches is too large to display directly on the website, but you can download that. I’m transitioning to Slide 30. Here on Slide 30, this is the downloaded example of the full list of chemicals that are fully exempted, unless otherwise excluded. I am now on Slide 31, and we’re moving back to the SRS homepage in which we’ll start walking through searching by an individual chemical substance. You can select single entry, which should be the default selection. You can see the circle is around the highlighted single entry option for the input search. I am now on Slide 32. Here we pull the results for chemical ethylene dibromide that the CAS Number is 106-93-4. And then when you click on the substance you’ll see what happens on the next step on Slide 33. And here I am on Slide 33. 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 it will require reporting of processing and use information unless subject to certain TSCA actions laid out earlier in the presentation. I am now on Slide 34, and I’ve searched for another chemical, hydrofluoric acid. The CAS Number is 7664-39-3. Hydrofluoric acid, similarly, is also on the 2016 inventory and as we can see is subject to a variety of other actions, statutes or EPA programs. Some of which you can see listed here are CERCLA, the Clean Air Act and one from RCRA. Now we’ve gone through determining your need to report and how to use the SRS. And on Slide 35, we’re going to shift our attention again and give an overview of the information to be reported. I am now transitioning to Slide 35 and I am going to pass off the speaking role to my colleague, Kelly. Thanks, Kelly. Kelly Summers: Thank you, Meredith, and thanks again to all of our listeners for continuing to follow along with this manually. I want to remind everyone that the green text on the slide deck refers to changes or updates since the last reporting period. The focus thus far in the presentation has been on determining the need to report. We will now shift our focus to what information is reported under the CDR rule. Reporters will submit site identification information, including highest-level U.S. parent company, manufacturing site, and technical contact information. Previously, only the highest-level U.S. parent company was reported, but now, if applicable, the highest-level foreign parent company will be reported as well. As noted on this slide, there is a new definition for highest-level parent company in the CDR regulatory text that includes a list of scenario-specific guidelines to make the ownership situation easier to understand. Along with the manufacturing or importing site information, there is a new requirement to report a NAICS code associated with that site. For context, NAICS is the North American Industry Classification System. Submitters are required to report at least one NAICS code, but up to three NAICS codes may be reported. Technical contact information is also required. The technical contact 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. If you turn to Slide 36, after the site-associated information, reportets provide manufacturing-related data, which includes the chemical identity by name and CAS Number or by generic name and the accession number if your chemical is on the confidential portion of the inventory. Also reported is the production volume for the past four years – 2016, ’17, ’18 and ’19. For the principal reporting year of 2019, reporters provide much more in-depth information, including whether the volumes are imported or domestically manufactured and, if imported, whether the chemical is never physically at the site; also, the volumes used onsite or directly exported from the site. Additional information for the principal reporting year specifically includes the number of workers that are reasonably likely to be exposed, the maximum concentration, 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. Note that in prior reporting years, this data element used to include remanufactured, reprocessed or reused, but we have streamlined the requirement to avoid confusion and refine the information that is being reported. Lastly, there is a new voluntary data element that submitters can choose to report, the percent production volume that is a byproduct. 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. And 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 is not asking for the percent of your substance that contains the byproduct, rather the percent of the production volume that is the byproduct versus a product. As such, we expect, in most cases,– this will be reported as zero or 100 percent. Now onto Slide 37, we return back to a familiar table for ChemIncA to exhibit a few example reporting scenarios per chemical that a single company could come across when determining the need to submit manufacturing information and processing and use-related data. Chemical A requires full reporting, including processing and use information because the 2019 production volume exceeds the reporting threshold of 25,000 pounds. Chemical B only requires reporting for the manufacture because in the principal reporting year of 2019, the production volume equaled zero, but the production volume in 2017 exceeded the threshold. Chemical C does not meet the threshold for any year, so it doesn’t requirereporting. And with Chemical D, we are illustrating a few things. First, since the chemical is subject to a Section 6 rule, it is subject to the lower reporting threshold of 2,500 pounds. Second, reporting is triggered based on an earlier year like Chemical B due to the 2017 production volume. Third, the need to report the full information on the principal reporting year even though that principal reporting year volume is below the threshold. Moving on to Slide 38, we will talk about what that information this actually entails. As you can see, there is a lot of green text on this slide, so we will focus on some of the processing and use-related changes. Reporting the function category will now be required for commercial/consumer products as well as industrial processing and use. We are also phasing in the replacement of the existing CDR industrial function and commercial/consumer product use codes with codes based on the OECD function, product and article use categories. I will be referring to these just as the OECD-based codes from now on. This will be familiar for companies that also report internationally and helpful to synthesize data with other programs that also collect OECD information. By phasing in, we mean 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 the displayed URL here and will be shown in a few slides. For all other chemicals, to allow reporters time to familiarize themselves with the new OECD-based codes, they may use either these or the existing CDR codes. Reporting using the OECD-based codes will be fully implemented and required for all chemicals during the 2024 CDR submission period. Now on to Slide 39, we will talk about the rest of the required processing and use information. The first table shows the industrial processing and use data that you will need to report, including type of processing and use operation, sector, functional use and the associated percent production volume, number of workers and number of sites. The second table shows the commercial and consumer use data that you will need to report, including product category, whether the use is consumer, commercial or both, the functional use and use in products intended for children and the associated percent production volume, maximum concentration and number of commercial workers. Note the three data elements that are marked with green circles. Functional use for commercial/consumer products in the bottom table is a new data element. The other two circles are not new elements, but they are impacted by the phase-in of the new OECD-based codes. For a little context and what this information means to EPA, one combination of the first three elements that appear 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/commercial use elements on the bottom table, which together also amount to a unique exposure scenario. Essentially, each of these scenarios ties into a specific condition of use for a chemical that may be used in a risk evaluation or management activities, among others under TSCA. Now on to Slide 40, we have a snapshot of the available function categories that you can use. We can see that the new OECD-based codes are listed in Column A and are associated or cross-walked with the existing CDR codes in column B. The table of product categories, which is not shown in this presentation, is displayed similarly with the Column A and the connection to Column B. These full cross-walked tables can be found in the rule and in the 2020 instructions for reporting, both of which are currently available in the rules docket and on the CDR website. On Slide 41, you will see another table I referred to earlier. The list of the 20 chemical substance designated by EPA is a high priority for risk evaluation. As a reminder, if you are reporting any of these substances, you are required to use the new OECD-based codes. And if reporting any other substance, you’re allowed but not required to use the new OECD-based codes. Moving on to Slide 42, we want to re-emphasize a few things. Reporting is site-specific, meaning that there is one Form U per site, which could have one or many chemical substance reports. 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 reasonably ascertainable by for all data. That term 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 the information known by management and supervisory employees of the submitter. More in-depth examples of this type of information or standard can be found in the instructions for reporting. I will now briefly hand the presentation over to Scott who will discuss confidentiality claims, which are described on Slide 43. Scott Sherlock: Thank you, Kelly. The TSCA amendments in June 2016 imposed a substantiation requirement for most confidentiality claims, and this requirement is now reflected in the CDR. Currently, upfront substantiation is required for all claims of confidentiality at the time they are made except for the following – production volume, which includes the five separate data elements per year 2016 through 2018, plus domestically manufactured and imported volumes for 2019. Also, supplier identity, trade name and formulation information associated with joint submissions do not require substantiation. The substantiation questions and certification statement have also been updated. We believe that these questions are self-explanatory. Note also that general use data elements can no longer be claimed as confidential. Specific elements are listed here, either the – specific elements include either industrial or commercial or consumer use. One additional point is this, over the last several months, the agency has been reviewing and internally updating the TSCA Inventory to reflect current status, chemical identities authorized to be on the confidential portion of the inventory. The ballpark 2,000 chemicals listed on the confidential portion of the inventory that we expect will be moved to the public portion of the inventory. Some of these chemicals are CDR reportable. What triggered this update were voluntary declassifications by companies, CBI challenges resulting in the finding that the substance was ineligible for CBI status or a failure to reassert the CBI claim in the active/inactive reporting process. We have not been able to update the public version of the TSCA Inventory to reflect this though. Please go to the EPA’s CBI website before you report a CBI chemical. If you see the chemical on the declassification list, think long and hard before making it CBI claim as the agency believes that the chemical identity CBI claims for these substances will be denied. You may have some questions on them. Please call or email me or Jessica Barkas. Our contact information is provided in the slide at the end of this PowerPoint. Thank you. Kelly Summers: Thank you, Scott. Moving on Slide 44 to talk about requirements for importers, under TSCA the definition for manufacture includes import, and importers have much of the same requirements but have a few additional factors to consider. Site is defined for importers at 40 CFR 711.3 and is the U.S. location of the unit directly responsible for importing. This site must be a U.S. address even if it is for an agent acting as the importer. An importer will indicate whether each imported chemical is never physically present at the reporting site. 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 is that 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). Onto Slide 45, when identifying your imported substances in determining its requirements, for sources of composition information, you can refer to the Material Safety Data Sheet, or SDS, or to the supplier to provide composition information. If composition is claimed as confidential, you can ask your supplier to provide the information directly to EPA. One of the new capabilities for joint submission is that both primary and secondary submitters are able to identify parts of their submission as confidential. And similar to domestic manufacturers, use known or reasonably ascertainable information todetermine 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. And again, you can ask your supplier or refer to the MSDS for composition information. Moving on to Slide 46, we will shift to information-specific to byproducts. Here, I will provide a background on byproducts and then transition to a new byproduct-specific exemption. A byproduct is a substance produced without a separate commercial intent during the manufacture, processing, use or disposal of another chemical substance or mixture. These are typically manufactured for a commercial purpose and reportable when used for a non-exempt commercial purpose. On Slide 47, we will talk about the first byproduct-specific exemption. EPA will now exempt specifically listed byproducts that are recycled or used in physically enclosed systems, in a site-limited manner, and when the site is reporting the byproduct or another substance from the same overall manufacturing process. Site-limited means the byproduct remains onsite after it is manufactured or processed. The industries and byproducts 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 Kraft pulping cycle. Onto Slide 48, as part of this exemption, a petition process was implemented to identify additional industries and byproducts that meet these criteria. The considerations for the petition process follow the criteria I mentioned on the previous slide as well as whether or not EPA may have a current interest in the byproduct. Note that there is no time to submit a petition for the 2020 submission period, but petitions for consideration for the 2024 submission period will be due before December 31, 2022. Onto Slide 49, we will move to the second byproduct-specific exemption. This exemption is for byproducts that are generated in equipment that is not integral in the production process. The equipment we are referring to specifically is pollution control and boiler equipment. For context, an integral process for the purposes 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 produce electricity as a product would be considered integral to the production process, whereas sites using boilers to produce heat or electricity for the facility, but not as a product would not be considered integral. Examples of pollution control equipment that is likely to be non-integral include flue gas desulfurization and selective catalytic reduction systems, as well as, for instance, when a byproduct is produced while treating wastewater from cleaning tanks from a manufacturer’s production process. These are not listed here, but examples can also be found in the 2020 instructions for reporting that is available on the website and in the docket. On Slide 50, we will shift to talking about co-manufactured chemicals. The reporting mechanism for co-manufacturing has been updated. In the past, this was referred to as toll manufacturing. For a little background, co-manufacturing refers to a kind of manufacturing situation involving two parties – the contracting company and the producing company. The contracting company contracts with the producing company to domestically produce a chemical substance exclusively for the contracting company. Note that the contracting and producing companies report on the same Form U. They do not submit separate forms. There are now two reporting procedures co-manufacturers can use to report. Under 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. With this procedure, both the contracting company and producing company report their own production volumes. The contracting company reports the chemical ID and the processing and use information, and the producing company reports all of the manufacturing information. On Slide 51, we talk about the second reporting methodology. Using the second method, the contracting and producing company, upon written agreement, work together to complete the reporting. In this scenario, the producing company initiates and completes 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. Now onto Slide 52, to finish out this portion of the presentation, I know that we have completed going over all of the regulatory updates. 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 and can be found on Slide 53. There are a variety of I.T. and functionality enhancements that have been incorporated into the reporting tool. This includes a new application platform that lags less and has faster validation, a streamlined CBI substantiation 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. Now the reasons for upload failures will be explained to users. We also will allow uploading data by CSV files. An agent role has also been added to make the reporting process more versatile and flexible. If you turn to Slide 54, we will talk more about the agent role. Previously, there were just two roles – the authorized official who creates, signs and submits the form, and support who help to fill in the details of the form. Looking at the table, we can see that the support person only has the capacity of editing the form. It does not have the capacity to do much else. As requested, the agent role has been, which is modeled after the new chemicals program and the Pre-Manufacturing Notice submission process. Agents will have the ability or access to do the following on the middle column of the table, which includes creating the form and passphrase, editing, unlocking and providing amendments to the form. Now onto Slide 55, we have developed and updated additional resources you can refer to when making your CDR submission, including various topic-specific fact sheets and guidance documents. On Side 56, we have listed where you can find this updated guidance. For the simplest resource, you can visit the CDR web page where the updated information and guidance that I mentioned will be posted as it is developed. There, you will be able to find the instructions for reporting and CDR frequent questions, both of which have been updated to reflect the rules changes to the reporting requirements, as well as any of the very informative industry-specific fact sheets. Any reporting-related questions can also be sent to ecdrweb@epa.gov. And lastly, any CBI-related questions can be sent to Scott Sherlock or Jessica Barkas in the email addresses provided in the slide. Slide 57 lists that we will have a break for a Q&A session, but to make sure we get through both presentations fully, we would like to postpone questions until we finish the reporting tool demo. And onto Slide 58, before handing it over to Carolina to provide the demo over the reporting tool, I want to pass it back to Meredith for a quick note before we move on. Meredith Comnes: All right. Thank you, Kelly. This concludes the first portion of our webinar today. We have completed the first slide deck, which is titled the “2020 Chemical Data Reporting Requirements.” We’re going to transition to the second download, the part two of the webinar. This is a demo of the reporting tool. The title on this page should say “2020 Chemical Data Reporting eCDR Reporting Tool Demonstration.” So please transition from this first slide deck onto the second set of slides. And I’m going to pass it off to Carolina who’s going to take us through these. Thank you. Carolina Falaiye: Thank you, Meredith. Good afternoon everyone. My name is Carolina Falaiye, and I am with CGI Federal. For the past one and a half years, we have been working with EPA to understand and implement the CDR application requirements. I’m now on Slide Number 1 and I’ll be moving through the disclaimer. Some of the screenshots were grabbed before during our development, so some of them may have changed, and that may not be reflected on this screenshot, but it’s a pretty good demonstration of what the application will look like. Moving on to Slide 2, we will go over the prerequisites to get access to the CDR application – the CDR 2020 application, completing the Form U, which includes the formal review section that captures information related to the parent company and site, the chemical information, which identifies different scenarios in relation to the chemical identification, and the manufacturing information, which involves the scenarios of whether you are reporting that particular chemical as the manufacturing company as the contracting company or as the producing company. And given the new confidentiality business information requirements, we will go over how to provide those answers or substantiations to any claims made during the submission of the form. We will also briefly visit the secondary forms and tertiary forms. I am now moving to Slide 3. Some of you may already be familiar with the CDX portal that allows us to have access to the TSCA applications. The process will be the same. In the FAQ tab, you will find instructions on how to add new roles or add the access to the CDR 2020. We have included a couple of quick reference guides within the application to demonstrate how to provide access to users to your form and to provide access to the newly added role for the primary agent consultant. I am now moving onto Slide Number 4. Once you have obtained access to the CDX portal, you can select the role, but you enroll that whether it is the primary authorized official, the primary agent consultant or the primary support, and similarly for the secondary role. Once you select that role, you will be navigated to the chemical information submission system. For those of you that are familiar with this dropdown, we have updated the order of the application. Yoou may notice that old applications have been listed alphabetically. You will have the option to select CDR 2020 or the old application for submission in 2012 or 2016. Moving on to Slide Number 6, this is how the homepage will display. In this case, my user has several sites that I report for. Your organization may only have one or a couple. Depending on the role that you have, you will see they create new form buttons and all roles will definitely see the pencil, and the log down, and the download for your copy of record. One thing either an authorized official or a primary agent consultant creates the form by selecting the Create New Form, you will see what shows in Slide 8. But before I go there, on Slide 7, you will see that resources where we have the user guide link, we have added a couple of quick reference guides that guide you step-by-step on how to create and submit a form, how to assign roles, how to report a chemical that was co-manufactured versus how to submit a chemical that you or your organization produced for a contracting company or a chemical that you produce for your own use, as well as on the right-hand side, you’ll see the description of the role that you have logged in. Slide Number 8, this is applicable for primary authorized officials and primary aging consultants who are the ones creating the form, so they will create the passphrase. And this has changed a little bit. In the first screen you will see this and be able to create your passphrase, confirm the passphrase and add a reminder or hint that will allow you to remember what the passphrase for that form is. For primary authorized official and primary agent consultants, they will be able to reset that passphrase, if needed. Primary supports will not be able to do that, and so they’re screened. And to be able to provide them or see the reminder word, it will happen when you failed to remember the passphrase for three times. After the third fail, that reminder will display. Moving onto Slide Number 9, this is our first section, so it is our form information, which includes the company and site information. Earlier in the presentation, Meredith went over the need to describe the highest domestic or parent company information. Initially, if you have registered under a new domestic or U.S. company, your information will display here and entered in CDX. If this information is incorrect, you have the ability to update correctly and save. Slide 11 shows that the domestic company has been added, but if you have to report a foreign parent company, you can select the Add Foreign Company button and add the information, the corresponding information. Moving onto Slide Number 12, it’s how the site information will display. This is also coming from the CDX registration information, so you’re able to enter the Dun & Bradstreet number and as a new requirement for 2020, at least one of the NAICS codes, the North American Industry Classification System. To do that, you can move on to Slide 13. Selecting the Add NAICS button, you will see a pop-up that displays the NAICS Code dropdown and the activity classification. Right now, the NAICS Code is being provided directly by that website, so any codes that are updated there will display this dropdown. Once you select the dropdown, you have the ability to select whether it is for manufacturing, for import or both, if you wish to do, but the classification is an option out for you. Once you select the add to list, Slide 14 shows how you can add up to three codes, but at least one is required. Moving on to Slide 15, we’re going to go over the chemical information section. Slide 16 takes us to the Chemical Summary page. We have two options to add the chemicals. I will go over the manual process, and then later on we’ll cover the bulk chemical upload functionality. For adding a chemical manually, the user would select the Add Chemical button. And Slide 17 shows the navigation to the Chemical Identification page where the user can select the Yes option when the chemical identification is known; No, if it’s an importer relationship where a joint submission will provide that chemical identification information or No, indicates where your company or your site is a producing company and a co-manufacturing relationship where the contracting company will be reporting the chemical identification. In that case, we’ll start with the option where your site knows the chemical identity, so you would select the Yes radio button, and Slide 17 displays the “Click here to add chemical.” This will take you over the SRS search on Slide 18. On Slide 18 you’ll see that you’re able to search using the CASRN or the accession number. Once you select the Search button, Slide 19 shows that the system is processing and retrieving the information in the system – Substances Registry Services, SRS. And Slide 20 will show you all that results if you search by generic name or the individual result of your search by the ID. Once you select that radio button, you can save the chemical. And Slide 21 displays, in this case, an accession number because accession numbers are on the confidentiality or a confidential list of the TSCA Inventory. You will be required to answer to whether you wish to maintain the existing claim for the confidentiality of the chemical substance or you do not wish to maintain that functionality. In cases where you search by an accession number, but it wasn’t found, a flag is not really showing on the screen, but that pink flag on the top of the screen will have a link to the Classification page that will show what the new CASRN for that substance is, and then you can research for using the CASRN number, and that will be populated here. Moving on to the bottom of the page, we have three checkboxes to claim the relationship between the company site technical contact information and the chemical as confidential. Selecting any of those checkboxes will determine that you are claiming this information as business information – confidential business information. Slide 22 takes us to the technical contact information where you can copy from CDX registration and the information from your user will be populated here or you create – can create a new technical contact. Slide 24 show how once you added one contact the table is populated, and you can select that to be the default for all of your chemicals that you are going to add or you can create a new contact and select them chemical. Moving onto Slide 25, we’re going to go over the manufacturing information and different scenarios that may be possible based on how you are reporting the chemical. Slide 26 will guide us through the steps to report as a manufacturing company. If you manufacture the chemical, you would follow these steps. After entering the prior year’s production volume, you would need to select, “My site is reporting the production and use of the chemical.” With this, you can enter your domestically manufactured important production volume and make the selections for the imported chemical number physically outside at site, volume in site, use on site or volume exported, as well as the percent of total production volume by weight that is by product. It also has the ability to enter the number of work (inaudible) concentration and whether the chemical is being recycled or not. Slide 28 will go – displays the physical form for 2019 production volume. Going to Slide 29, we’ll have a selection for when the company has contracted a co-manufacturer to produce the chemicals at their site. In this case, you are the contracting company and will notify the producing company of the production of this chemical. The first screen that you will see would be the table with a button that says Add Co-Manufacturer. When you select that Add Co-Manufacturer button, then you will see the bottom side of the screen. In this case, you are required to provide the chemical alias or the chemical name or an alias that you use to make business with the producing company. The 2019 contracted production volume and the – whether the volume contracting was never physically up site. The producing company information can be provided as well as the email address, which will be where the producing company receives the email with the unique identifier that will help us join the two forms. Moving on to Slide 31, you will see the bottom part of that page is the email notification. You can add that to (MCC) emails. In Slide 32, you can see the body of the email, add any additional comments that you may want to provide to your producing company and send out the emails. Slide 33 will take us over to the other side of the co-manufacturing relationship, which includes the producing company view. As a producing company, the contracting company may have already entered their chemical information and they provided that email with a unique identifier for you to provide the manufacturing information. In that case, you would select, “No, I’m not reporting the chemical identification. I am a producing company.” Once you select the Continue button, Slide 35 will take you directly to the Manufacturing information page. There, you will see the space to populate the unique identifier that you may have received on the email. And when you populate the company – contracting company, the table below would populate the company – the contracting company that – provided that unique identifier. You can add the chemical alias as well as the produced volume that was part of that arrangement and select whether the percentage of total production volume that was manufactured as a byproduct. Also, the report exposure-related information at the bottom of the page is part of the information the producing company will provide. I’m moving on to Slide 36, which has the bottom part of that previous page. And as we know, the report reporting the exposure-related information corresponds to the number of workers’ maximum concentration and whether the chemical is being recycled or not as well as the physical form for the 2019production volume. Once you select the Continue button, you can continue to enter all the information for your primary form. Completing then – in Slide 37, we are completing the form as our importer. In that case, we are making the selection in the chemical identification as, “No, I am an importer.” We are going to provide a chemical alias that we are going to use to communicate with our joint submitter and the secondary company name, usually, somebody in a foreign country as well as the email address. This functionality is similar to the one we went over a few slides before. Moving on to Slide 39, is the bottom part of the email that will be sent to the secondary company. Again, they will receive a unique identifier as well as the email with instructions on how to report using a secondary form. Slide 40 has the buttons to send the email. And once the email is sent out, it is on the secondary form to report the chemical identity on behalf of the primary submitter. That concludes the manufacturing scenarios. After the manufacturing information has been provided in one of those scenarios, the next step is the industrial processing and use when the user selects the Add Process or use, I am now on Slide 41. Moving on to Slide 42, this view will display the type of processing and use with dropdowns that contain the newly updated value from OECD. The factors and the function category that depending on the chemical selected will display both the new and the old OECD codes. For the 20 high priority chemicals, you will only see the newly added codes, the F codes. You can select the percent production volume, the number of sites, the number of workers, and whether any of that information is confidential. Once you select the Add to List, in Slide 43, you will see the list of the percent production volume with the F code. Once you select Done, that information – the table will display and you can add as many users as you need to. I think that requirement is at least one if you select Applicable. Moving on to Slide 44, a similar concept applies to the consumer and commercial use. So, when the user select the Add Product Category, Slide 45 will display the values that need to be provided. So, the product category, the function category, consumer and commercial or both, whether the chemicals being used in products intended for children and the production volume, maximum concentration, and the number workers exposed. Again, you can select the information to be confidential. Anything that has (NKI) will not be allowed to be marked as confidential. Selecting the product category will include the CC codes as well as the C codes. So, that is the two sets of updated codes on – by OECD. Now, I am on Slide 47. I will cover the bulk chemical upload. In Slide 48, once the user selects the Bulk Chemical Upload button on the Chemical Summary page, this Bulk Chemical Upload page will display with a Browse button that allows you to select the file. In the Resources page, we have the template – the latest template for the Excel file as well as the (XMD) schema for the XML files that can be created. Once you select the Browse button on page or Slide 48, you can browse and find your file, and when you upload, you will see a summary on Slide 49. A couple of validations will be done because we are allowing users to upload their 2016 XML. If you have access to your 2016 submission, you may use the Download button to have access to the copy of records, and there, you will find your XML file that then can be uploaded for 2020. Then manually, you will be required to add the newly added information to make sure that the validations passed. In the first validation, we validate that your XML file matches the – either the 2016 schema or the 2020 schema. Once that has been validated, we check that your chemicals match the SRS so that we are sure that the names matched with what it is provided in effect. Once your chemicals have no errors, you will see the count of chemicals submitted and how many of them matched in SRS and then you can select the Save Chemical Information button. In cases where you may have issues finding or the system may have issues finding one or more of the mechanicals, you will see a list of the chemicals that don’t match SRS. It requires a little bit of investigation to make sure that the correct ID is being used. Now, I will move on to Slide 51 and we’ll talk about the CBI substantiation. Once all the chemicals have been added, all the validations have been run, and the data elements that may have errors have been fixed, we’ll see the next step is the CBI substantiation. Any of the chemicals that you may report, they have a set of exempt fields that don’t require substantiation. Those will have gray mark once they are added. And if they do require substantiation, you will see a little green checkmark. Slide 53 shows how each chemical will have a list or section. The collapsible menu displays the section and then the individual links will display the items that – or the data elements that you decided to claim a CBI. For each chemical, you are required to provide the answers to the substantiation questions. Most claims will require six general substantiation questions, and for the chemical identification, we will require a different set of questions specific to the claim for the chemical ID plus the general CBI claims substantiation questions. Slide 54 shows how once you have provided that information, the status will be marked as green check indicating that you have successfully or properly entered all the answers for that substantiation requirement. Slide 55 covers a little bit the functionality to copy from chemical to chemical. So, it is possible that you may provide substantiation for one data element, and that substantiation applies across all the chemicals that you are claiming that data element as confidential. To facilitate the provision of that substantiation, you can select the paper icon on the Action column and then this right-hand side menu will display which chemicals have been substantiated, and so they become the source of their substantiation answers. Slide 56 shows an example. In this case, 126830 is my chemical that I have substantiated, so that is the chemical that is available for me to copy from. Once I select that Copy From, I have two options as displayed on Slide 57. Slide 57 shows how I can copy the substantiation from 126830 to 126023 or I can select the Copy Substantiations to All and it will apply to all my chemicals. This functionality will copy from – validate the elements to the elements, but if you do not see a green check, you need to go in and verify each individual chemical to make sure all the answers have been provided. Slide 58 displays how after I have entered all my chemicals, all the substantiation checkmarks are displayed accordingly. As I mentioned before, for the accession numbers, in case you have selected that you wish to maintain the confidentiality of the chemical, you’ll see that that chemical did not get a green check. I am moving on to Slide 60 to display how the chemical substance identity-specific questions will display. Similarly to the general CBI claims, it will show the chemical identity CBI claim. Slide 61 will show how all my chemicals are ready for submission. Slide 62 will walk us through the process for submission of this form. So, once we have identified that all our submissions, all our chemicals are in order and we are ready to submit, one last step is to confirm and identify that the submitted official information provided is correct. You can have the option to mark that submission – submit and official information as CBI, in which case, the same general questions for substantiation will display and you will be required to provide the answers. Once you enter the position and select the, “Please confirm that you’re legally responsible for, for the submitting company,” checkbox, the Start Submission Process button becomes enabled. I am moving now into Slide 65. You’ll go through a series of certifications and the first one is the CBI certification for TSCA. Once you select Continue, the CDR certification will display. Once you select the “I Certify” on Slide 66, you will be navigated to Slide 67 that shows the validation. This is a global validation that covers the entire form. Once there are no errors, the Review and Submit button becomes available. Moving on to Slide 68, you have the ability to download your chemicals. In cases where you are reporting more than 50 chemicals you will see separate PDFs that are created. Each PDF will contain up to 50 chemicals, and so, you will have 2 PDFS if you are submitting 100. You may have five different PDFs. Once you are ready to submit, you select the Green button, Sign, Encrypt and Submit. And Slide 69 shows what we call the (primary) certification that allows you to electronically sign your form. You select the Accept button, and Slide 70 displays the request for your CDX password and the answers to your questions and the ability to sign. Once you select the Sign button, on Slide 70, you will be prompted or taken to the homepage as you have successfully submitted your form. Moving on to Slide 71, this is a brief overview of the secondary and tertiary forms. So, in this case, I’ll move on to Slide 72, the user selects the Secondary Role whether it is the secondary authorized official, secondary agent consultant or secondary support. And a similar process will display for the secondary form except they wouldn't have multiple sites, they will have one form per year. Once the user edits the form, they can enter the unique identifier provided by the primary company. And in Slide 74, it provides the substances that make up the chemical identity that they provided to the primary submitted. Slide 75 displays how the unique identifier allows us to join or keep track of which form. Primary form corresponds to the secondary form. So, the primary company information will display on this table. Slide 76 is just our questions and answers and I am passing the speaker role to Meredith again. Thank you. Meredith Comnes: Great. Thank you so much, Carolina. We have now completed both sections of our webinar today. And it looks like some time remains in order to do a question-and-answer section. I’m going to ask the operator to queue up the participants who’d be interested in asking questions. Operator: As a reminder, to ask a question, you will need to press star-1 on your telephone. To withdraw your question, press the pound key. And we’ll pause for just a moment to allow the participants to enter the queue. And you have a question from Michael O’Shaughnessy with Brüggemann Chemical. Michael O’Shaughnessy: Yes, good afternoon. I am an importer of products from a parent company in Europe and I warehouse the product at four different public warehouses. I don’t need to do a different Form U for each warehouse, do I? Susan Sharkey: Hi, this is Susan Sharkey. Whatever site controls the import is the site that reports, and so if you have one site controlling the import and just shipping it to different locations, you can use just that. It’d be one Form U from just that one site. Michael O’Shaughnessy: OK. And then a second follow-up question, what if I’m an importer that knows the chemical composition of the products? Susan Sharkey: Then you just report by the chemical by chemical – right, just by the chemical substance. The only time you have to do a joint submission is when you don’t know the chemical composition of what you’re importing. Michael O’Shaughnessy: OK, thank you. Operator: Your next question comes from a line of (Gerry Eppelin) with (Suretank Technologies). (Gerry Eppelin): Hello, yes. Can you have more than one primary agent? Susan Sharkey: Yes, Carolina? Carolina Falaiye: Yes, this is Carolina. Yes, we support the same functionality that other apps do. So, it is handled by the CDX roles, yes. (Gerry Eppelin): OK, thank you very much. Operator: Your next question comes from the line of (Ryan Crosby) with (CRA Americas). (Ryan Crosby): Yes, hi. Do we have the Dun & Bradstreet numbers required for the parent corporation and foreign company? Is that absolutely required? Carolina Falaiye: Yes, that is part of the regulatory requirements for this reporting. (Ryan Crosby): Perfect, thank you. Operator: Your next question comes from the line of (Tracey Bigget) with (Brenn Technologies Pacific). (Tracey Bigget): Hi. I’m a chemical distributor. I import as well as buy from domestic sources the same chemical. When I buy them domestically, that manufacturer should have already or should be the one to report that chemical. So, do I report that chemical also or just the domestic manufacturers? Carolina Falaiye: You just – in that case – in the case where you are both importing a chemical and procuring one from a domestic source under CDR, you report only the chemical amount of the chemical that you imported. The domestic manufacturer will be reporting the other portion. (Tracey Bigget): OK. Now, also to that person, is the person I buy it from domestically, imported that, that person will also be the person to report it because they were the importer, it’s still not me? Carolina Falaiye: That’s correct. (Tracey Bigget): OK. And then I have one follow-up question about the CBI. If my chemical plants are under DHS and my chemical is under DHS, how do you cut the confidentiality under the Department of Homeland Security and CDX? Scott Sherlock: Hi, this is Scott Sherlock. So you said that the chemicals are identified by DHS. Is that what you said? (Tracey Bigget): Yes, under the CBI. Scott Sherlock: And what does that mean? I’m not sure what that means. (Tracey Bigget): The Department of Homeland Security. And they have a list of chemicals of interest and those chemicals are classified chemicals. So, they don’t want us to basically have any of those chemicals publicized, where they are and what they are. So, I have your email. I’m going to send that to you. Scott Sherlock: That makes sense. (Tracey Bigget): Then we can discuss it. Scott Sherlock: Very good. (Tracey Bigget): Yes. So they’re – and it’s not published to the CBI, but I will contact you separately about this. Scott Sherlock: I – I’ve got that, I understand that. I – OK, looking forward to seeing your communication. (Tracey Bigget): OK. Operator: Your next question comes from the line of (John Wheeler). (John Wheeler): Yes, thank you. Currently, on EPA’s Web site, the instructions for reporting for the 2020 CDR are labeled draft. Will the draft become final prior to the June 1 start date for reporting? Susan Sharkey: As the instructions are and included as part of the ICR addendum, and which is currently under review by the Office of Management and Budget. We cannot change that from draft to final until it clears the Office of Management and Budget. We are not anticipating that there is not going to be any changes to the instructions. But other than – I should say other than to add the small manufacturing definition change from that recent rule. So as soon as they clear the document, we will make it final. (John Wheeler): Great. And one follow-up, a similar question, will EPA publish a new TSCA inventory for CDR reporting prior to the June 1 start date for reporting or will EPA’s current published inventory dated March 2020 on EPA’s Web site not be revised prior to June 1? Female: The only – the change that we’re anticipating, which is not likely to happen before June 1 is something that Scott alluded to during his comments on the confidentiality portion where we will be moving chemicals, declassifying chemicals from the confidential portion of the inventory and placing them on the public version of the inventory. So, there will actually – there will be an update after June 1 although the chemicals themselves are currently on the active inventory. (John Wheeler): Thank you. Operator: Your next question comes from the line of (Rich Webber) with EPA. (Rich Webber): Yes, hi, this is (Rich Webber) inside EPA. Before I ask my question, could you just follow up on what you just said in terms of the – there will be a public revision on the – on the chemicals being put onto the public portion? Will that be happening before June 1 or after June 1? Susan Sharkey:Scott, do you want to answer that? Scott Sherlock: I could. The revisions to the inventory will not be able to occur until sometime after June 1. (Rich Webber): OK, right. So those – so those chemicals that are on confidential, they’ll be moved to the public portion but that will be happening after June 1. Scott Sherlock: That’s right. And on our ... (Rich Webber): OK. Scott Sherlock: ... the agency’s Web page, there will be a compilation of chemicals which have gone and been reviewed, which the agency believes are no longer qualified for CBI status. (Rich Webber): OK, OK, right. Sorry for that. I just wanted to clarify that last comment. So, my question is, could you please explain the decision to base the small manufacturer definition on volume and revenue rather than employee – numbers of employees as some of the commenters had proposed? Susan Sharkey: That is fully explained in the – in the Federal Register notices associated with the final rule. (Rich Webber): OK. Susan Sharkey: But basically, the – because of the type of – the information that we’re collecting and with the changing to a different type of definition, we lost the greater amounts of submitters and a greater number of chemicals that are of direct interest right now, the information associated with these chemicals, then staying with the revenue definition, and if there were a few other reasons as well that are included in the Federal Register notice. (Rich Webber): OK, all right, thank you. Operator: Your next question comes from the line of (Cynthia Eggleston) with (Advent Chemical). (Cynthia Eggleston): I think my question was already answered, but on that small manufacturer definition, that’s – it’s for the whole sales, right? It’s not per substance that’s being reported? I thought I heard that. Susan Sharkey: Yes, you look at the company’s sales, not just the site but the whole company, and if the company’s sales are under 12 million then the company is a small manufacturer and it’s not required to report unless subjects – the chemicals are subject to some of the certain TSCA actions that we mentioned earlier. If the sale is between 12 million and 120 million, that’s when you look at each chemical on a chemical by chemical basis, and you’re looking at the production volume associated with that chemical. And for any chemicals that are – for the site under 100,000 pounds then those chemicals would not need to be recorded. (Cynthia Eggleston): OK, so it’s the volume of the chemicals and not the dollar amount? Susan Sharkey: Correct, yes. (Cynthia Eggleston): OK, all right, thank you. Operator: Your next question comes from the line of (Blanca). (Blanca): Yes, hi, good afternoon. My name is (Blanca) and we are actually importers of chemicals. On the EPA’s CDX Web site, when I click on the program CSPP, submissions for Chemical Safety and Pesticide Programs, I do not see the TSCA 2020 reporting. I only see the one from the 2016 and the other sections that are available there in the dropdown. My question is, how do I go ahead and access that, the 2020? Susan Sharkey: You will be able to access it on June 1st. It’s not available at this time, it’s not live yet. (Blanca): I see. Is there any way that we can get a sample of the Form U? That way, we can at least begin gathering the information that we need to gather. Susan Sharkey: There are samples on our Web site. They’re marked Sample but are – but they have the right information on them. (Blanca): OK. And if I can find them on the Web site? Susan Sharkey: Right. If you go to the How to Report page, go to www.epa.gov/cdr and then click on How to Report, and you’ll see a link there to the reporting form. (Blanca): OK. Susan Sharkey: And at this time, it takes you to the docket from the CDR revisions rule, which is where the ICR addendum is. And the Form U and attachment to that, that’s also one of the items that we’re waiting for OMB, the Office of Management and Budget, to complete the review. (Blanca): OK, got it. OK, all righty, thank you. Operator: Your next question comes from the line of (Sarah Wujiteski). (Sarah Wujiteski): Hi, this is (Sarah). I’m calling – I met a chemical manufacturer who was sold in 2019. What company do you want us to enter as our business entity, the current owner or the previous owner? And is there a way to link those two companies in this form? Susan Sharkey: Answering the last question first, there is not a way to link the two companies. We do have a fact sheet that explains because there’s different ways to do a purchase, so if you can look at our fact sheet and see what it says when a company is changing its identity. It depends on an asset-only purchase or a full purchase, so with assets and liabilities. (Sarah Wujiteski): And then my next question is because of the sale, there’s been a tremendous amount of turnover in personnel and nobody who was involved with the 2016 CDR is currently available. Do we – should we be starting from scratch or how can we access a previous username password to gain access to our 2016 submission? Susan Sharkey: If you can send us an email, we can send you information on how to do that. (Sarah Wujiteski): OK. And who is – am I contacting, just EPA/ Susan Sharkey: Epa.gov – I mean, sorry, ecdrweb@epa.gov. (Sarah Wujiteski): Ecdrweb? Susan Sharkey: Yes, yes. If you look on the ... (Sarah Wujiteski): OK. Susan Sharkey: ... the one of the last slides of the first presentation ... (Sarah Wujiteski): OK. Susan Sharkey: ... it has then reporting-related questions to ecdrweb@epa.gov. (Sarah Wujiteski): Fantastic, thank you very much. Operator: Your next question comes from the line of (Tiffany Bokie). (Tiffany Bokie): Hello. Susan Sharkey: Hey, Tiffany. (Tiffany Bokie): Hi. A quick question, I’m a little bit newer to this and I wanted to know, we bring in a lot of our chemicals to sell to customers in the United States, but we are also selling to some customers in other countries. When we sell to other countries, are we reporting that quantity as part of our chemicals since it’s going to different countries but it’s still part of our company in the United States or does that not get reported? Susan Sharkey: Do you import the chemical into the United States and then ship it back out to those other companies? (Tiffany Bokie): No, ma’am, that’s going directly to those other countries usually. Susan Sharkey: OK. Then only report – only consider the volume and report for what is imported into the U.S. (Tiffany Bokie): OK, and that sounds good, thank you. Operator: You have a question, caller, please state your name and your question, from (AVC Chemicals). (Stan): (Stan). The parent company thing, my company is owned by – fully owned by a company in the U.S. that’s then fully owned by a company that’s out of the U.S. Is the highest level parent company is a company that’s out of the U.S. then? Susan Sharkey: You record both of those companies. (Stan): So (inaudible) if the Japanese company has a Dun & Bradstreet, and I guess that’s an issue if they don’t, right? Susan Sharkey: The – yes, I mean they can easily apply for one. I mean our information directs you to have them apply for one. (Stan): Ok. Well, what was the reason behind having that? I mean there are a lot of companies that are owned by companies that are owned by companies. Is it just to get to the highest level or something or ... Susan Sharkey: For the – yes, when we’re considering how we make the information publicly available that’s reported, when the information is claimed as confidential, we consider who already knows the information because we often consolidate data and make the consolidated data publicly available. But if there are multiple sites that are owned by the same company, that reduces the number of sites that are – the number of reporters that are actually providing the information. And we take that into account when we consider whether something can be publicly released. (Stan): OK, thank you. Operator: Your next question comes from the line of Scott de Ridder with Calbag Medical Company. Scott de Ridder: Calbag Metals, yes, hello. I have two simple clarifying questions about the new definition for small manufacturer. The annual sales and annual production value criteria, are those based on 2019 only or any one of the years in the reporting period? Susan Sharkey: You said 2019 information ... Scott de Ridder: OK. Susan Sharkey: ... for the – yes, for the sales volume. Scott de Ridder: OK. And then the follow-up question is the production volume, if we have more than one site. is that 100,000 pounds per site or combined for the company? Susan Sharkey: You consider that on a site-by-site basis. So, you could ... Scott de Ridder: OK. Susan Sharkey: ... have one site that is considered small for that substance and another site that is not. Scott de Ridder: OK and – OK, I follow, thank you. Operator: You have another question, caller, please state your name and your question. Your line may be on-mute. Caller, please un-mute your line and state your name and your question. (Harry Fink): (Harry Fink). Am I – can I continue? Susan Sharkey: Hello, yes. What’s your name? (Harry Fink): My name is (Harry Fink). Susan Sharkey: OK. (Harry Fink): My first question – I mean I’m at (OCI). I’ve got a question – two questions actually. One is related to the fact, we are a European producer, but our American entity is importing. So, I just want to make sure that when you go to the chemical information, actually, we know the ... Susan Sharkey: Sorry, you got cut off, (Harry Fink). Operator: Yes, I think he – I think his line disconnected. Susan Sharkey: OK. Operator: (Inaudible) question. As a reminder, if you would like to ask a question, please press star-1 on your telephone. Once again, that is star-1 on your telephone to ask a question. And you have another question from (Tracey Bigget) with se with (Brenn Tech Pacific). (Tracey Bigget): Hi. I had a question. When you’re trying to figure out whether your chemical is subject to the other regulations or the other actions, for example, TSCA section 4, 5A, 5B, et cetera, do you take the sunset dates into consideration because some of those other actions have sunset dates on them? Susan Sharkey: In some – yes, you do. If the action has sunset then it is no longer applicable, so you do take the sunset dates into consideration. (Tracey Bigget): Now, when it comes up on that list that you showed us in your presentation, does the sunset come up there or do you have to go search for the sunset date separately? Susan Sharkey: That’s a good question. I’m not sure. I will have to find that one out. (Tracey Bigget): Yes, because if you look up like (TALLOU), (T-A-L-L-O-U), that had a sunset date for the last reporting period, but when you look it up, for the last reporting period, that didn’t come on. So the EPA had actually come back and asked and said, “When I exported that product that it had a – it was subject to one of the other ...” Susan Sharkey: One of those certain TSCA actions? (Tracey Bigget): Yes, one of the actions, and I thought, but it had sunset. So, why should it be even reportable even though it was only 12B list? It had a sunset date. So, I didn’t think it was reportable. So, that – that’s kind of sketchy when it comes to the actions and how it’s reportable. I don’t know if they took care of that. Susan Sharkey: OK. (Tracey Bigget): There’s new reporting period but I know it hadn’t been settled for the old reporting period. Susan Sharkey: I will follow up on that and – so that I can get back to you and give you a definitive answer. Can you send an email to ecdrweb@epa.gov? (Tracey Bigget): Yes, I sure will and I will reference that. Susan Sharkey: Yes. (Tracey Bigget): OK. If – because I have several chemicals that fall into the sunset date on – because I import as the other lady was saying, but I export them too. So, I have two places where I have to report because some of the chemicals have to have the separate reporting for the export as well as reporting on the CDR. Susan Sharkey: OK. Yes, and so, if you have the questions about the export also, include that in the email that you send and I can make ... (Tracey Bigget): OK. Susan Sharkey: ... sure an appropriate person provides information for that aspect of the question as well. (Tracey Bigget): OK, great, thank you. Operator: Your next question comes from the line of (Catherine Crowe) with (Evonik Corporation). (Catherine Crowe): Hello. I just have a confirmatory question about imports from partner legal entities outside of the U.S. If we are familiar with the composition and we’re an importer then we do not need to assign them a unique identifier and have them co-submit with that – with us. Is that correct? Susan Sharkey: That is correct. (Catherine Crowe): OK, thank you. Operator: Your next question comes from the line of (Gorth Batson) with (Tech Middle East Limited). (Gorth Batson): Hi, thanks very much. Could you provide a bit more information or perhaps some clarity for me about how impurities are handled under this CDR reporting? Susan Sharkey: Impurities are not required to be reported under CDR. They are exempted by 7011. – I’m forgetting the specific reference, 711.10 I think it was, (d), which refers to 720.30(h). And there is an exemption for impurities there. Is that – does that address the question you’re asking or was – were you looking for some different types of detail? (Gorth Batson): Perhaps just some clarity on how do you determine of some – if a substance has impurity. Is it just by – because it’s incidentally present and at very low levels? Is that – is that sufficient to determine that something is an impurity? Susan Sharkey: And it’s – probably, if it’s – I mean there’s almost always some kind of an exception to things. If it’s – if that’s the situation and it’s not – it’s kind of like not a substance you desire to have there in the sense that it’s not adding to the function of the substance then it’s likely to be an impurity. (Gorth Batson): Thanks very much. I guess the sort of weird situation is if you – if the impurity happened to be a hazardous chemical and because – even though this person at very low levels because it exceeded the 2,500 pounds because of the high volume of the – of the substance, would it be something of interest to EPA? Susan Sharkey: Well, it might be something of interest to EPA, but that’s a different question because there are certainly substances that are – or there’s the potential for substances that are of interest to EPA that are excluded from the need to report under CDR because of the way CDR is – the reporting is set up for CDR. (Gorth Batson): Thanks very much. Operator: OK. And you have (Harry Fink) with (OCI) on the line again. (Harry Fink): Yes. Sorry, my connection got lost. But I have a short question related to the software you used to report. Is it possible to stop filling out the program and then make a save in between so you can continue at another time? Susan Sharkey: Yes, absolutely. (Harry Fink): OK. Susan Sharkey: The one thing – if anyone is using the bulk upload, I would make sure to do that first before entering any other information because it could overwrite the information that you already put into the program. (Harry Fink): OK, thank you. Operator: Your next question comes from Andrew Pawlisz with Trihydro. Andrew Pawlisz: Thank you. Discussions regarding the anticipated deadline for reporting on November – kind of November, I’m fully cognizant that the deadline was already extended by 60 days for the reasons stated earlier but because the country is dealing with the COVID-19 crisis, is there anticipated extension of potentially that reporting deadline beyond November 30th? Susan Sharkey: There has been no discussion of that type of an extension. Andrew Pawlisz: Thank you. Operator: Your next question comes from the line of (Gorth Batson) with (Tech Middle East Limited). (Gorth Batson): Hi. In 2016, we didn’t use the bulk uploading, but is it possible to go into the system then – and download – I think you alluded that it’s possible to go into the system and download a bulk report in either the XML or (CVS) format, is that correct? Susan Sharkey: Yes, you can upload using your copy of records. Carolina, are you still on the line? Carolina Falaiye: Yes, Susan, I’m here. So yes, so we have included in the Resources page. Once you log into CDR, on the homepage, you will see the Resources. There is some link to download the Excel file that has all the fields that are required depending on how you’re reporting the chemical and it has the values selective dropdowns that you can select. So, it should be pretty straightforward. And we also have a quick reference guide to explain how to create the form. (Gorth Batson): OK. And then can we also, as an alternative, download the previous – I got the impression we could download the 2016 Form U and then perform updates to that document. Is that correct? Carolina Falaiye: You can download the copy of that, (Gorth), which contains your PDF Form U and also the XML file. So, you can make updates to the XML file to update the corresponding data and upload that. But because there are new fields for 2020, you will need to then manually revise every record to make sure that you are providing all the information. Did that answer the question? (Gorth Batson): Yes, but I guess I was just thinking if we – yes, can we download the existing Form U and which would have the previous information in it and then just go through that form, update, add the additional required information and then resubmit? Susan Sharkey: No. Well, it’s a – it’s a very different form and we’ve added new fields. So, you – it’s not using the same 2016 forms. (Gorth Batson): OK. Susan Sharkey: But you can take the data from 2016 and – but it’s not using the – and you’re taking the data from the 2016 report, downloading that into an XML file, and then you can make changes to that data there and upload it into the 2020 Form U and then go in for each chemical and add in the additional data that’s needed to address the new data elements. (Gorth Batson): OK. So you can do in two steps? Susan Sharkey: Right. (Gorth Batson): OK. Carolina Falaiye: To add to that, they could also just simply download the 2016 XML file and re-upload it and then make the changes within the application. Since some people are not familiar with the XML structure, that would allow them to see them in the – see the data and the UI that needs to be updated. (Gorth Batson): OK, thank you. Operator: Your next question comes from the line of (Tren Jen) with (Santech). Hello, (Jen), your line open. Your line may be on-mute. Could you un-mute your line? All right. You have another question from (Tracey Bigget) with (Brenn Techs Pacific). (Tracey Bigget): Yes. When it comes to multiple locations, if you are both distributor and you import a chemical in bulk that’s on the task list and then you drum it off into smaller drums and you distribute that to your other location, is it OK to just report that at that one location or do you have to report the multiple locations? Susan Sharkey: You would be reporting that from just the one location assuming the site that you’re drumming it off of, that that is the import site then – so you would report the fact that you imported the chemical, you would indicate that it was at that site and then you would report in the processing and use section the repackaging portion of it. And you would not identify the site that you were sending it to. (Tracey Bigget): OK, OK, thank you. Operator: You have another question from the phone, caller, please state your name and your question. Caller, your line may be on-mute. Could you, please, un-mute your line? (Kesai Kekaso): So how to un-mute? I don’t – I cannot un-mute. Susan Sharkey: Now, you’re un-muted. Operator: No, you’re un-muted. (Kesai Kekaso): I cannot – do you hear me? Susan Sharkey: Yes, yes. (Kesai Kekaso): OK. This is (Kesai Kekaso) from (Deutsche Chemicals America). We are also a distributor and we’ve been reporting the last two – I mean two times and then so far, the location we filed is about three or four locations. And now, during the reporting year 2019, we changed the location where – who is responsible at a certain products and therefore, in the middle of that year, the product in charge is a different location. How I can really report? So, is that OK just so I’m keeping under one location and not moving to the other location for the year 2019? Susan Sharkey: Was the chemical received at the other location? (Kesai Kekaso): Yes, we do have a few locations we filed. Then one of the – I mean a few products moved to – from, let’s say, New York to Michigan. So then Michigan office is in charge for that product in – after, I think, April 2019. Then how I can really report? Is that – should include the Michigan office or New York office? Susan Sharkey: I believe the correct answer is that each site would submit a report and the ... (Kesai Kekaso): I know we do, but just for the volume. So far, we’ve been filing (inaudible) in New York on product, but in the middle of that year 2019, the product moved to – in charge in Illinois – I mean Michigan. So ... Susan Sharkey: OK. So then for that 2019, you assign the volume that was associated with the New York office to the New York report and the volume that is associated with the Michigan office to the Michigan report. And you identify the production volume and looking at the threshold for each site individually. (Kesai Kekaso): I see. So, it means that up to March, at least we have to look at it, how much the volume for our New York office we dealt and then have another rest of the year. In Michigan, we have to report. Susan Sharkey: That’s correct. (Kesai Kekaso): OK, thank you so much. Meredith Comnes: This is Meredith. I think miraculously, we’ve gotten through all of the folks hoping to ask the questions today and we are just up time for the webinars. So, we are going to wrap things up here. If you have additional questions or if questions come up while you’re preparing your submission, please keep in mind that you can always contact us. On Slide 56 or the first set of slides, we have our email address. It’s ecdrweb@epa.gov. Again, that’s ecdrweb@epa.gov. We appreciate everyone calling in today and for those of EPA participating in the call and please reach out if you have more questions. I’m going to pass this off to our operator to close out the call. Operator: Ladies and gentlemen, this concludes today’s conference call. Thank you for participating. You may now disconnect. Presenters, please hold. END EPA Moderator: Meredith Comnes 05-19-20/1:00 p.m. ET Confirmation # 2499985 Page 1