EPA Moderator: Meredith Comnes April 9, 2020 1:00 p.m. ET Operator: This is Conference #: 6138247. Operator: Thank you for standing by and welcome to the Repeat Session of 2020 Chemical Data Reporting Requirements. At this time, all participants are on a listen-only mode. After the speakers' remarks, there will be question and answer session. To ask a question during the session, you will need to press star one on your telephone. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Ms. Meredith Comnes. Please go ahead. Meredith Comnes: Thank you and good afternoon, everyone. We appreciate your patience and willingness to participate in this webinar. My name is Meredith Comnes. I'm in the Office of Pollution Prevention and Toxics here at the EPA. I'll be presenting today along with my colleague, Tom Smith, and Carolina Falaiye, who is a contractor with CGI Federal. Today, we will be providing an overview of 2020 Chemical Data Reporting Collection Period, which begins this year on June 1, 2020. The way this webinar will function is that we ask that you follow along with the PDF version of the slides that we have provided you in the confirmation e-mail that you received either last night or this morning. You must download this from the EPA website and they have two different titles. The first one is called “CDR Regulatory Overview” and the second one is called “The CDR Reporting Tool Walkthrough.” The two different files will be presented as the two parts of the webinar. Right now, I'm looking at the title page of the first of those two documents. Again, I'm looking at the title page for the document titled “CDR Regulatory Overview.” Before moving on to each slide, I will indicate what slide number I am on. Right now, I'm on the title slide. And starting on the next slide, you will see the slide number in the lower right-hand corner. Right now, I'm moving on to Slide 1 of the first document. You can see in the lower right-hand corner the number indicating what slide we're on. Here is an overview of our presentation. Today's presentation will last about two hours and have two parts. The first part will be background on TSCA, the Chemical Data Reporting Program, and an overview of the reporting requirements. Second, we will have a walk through with screenshots of the reporting tool. If time allows, we will have a question-and-answer section at the end. I'm now transitioning to Slide 2. Here, we'll provide some history on the Toxic Substances Control Act, which we abbreviate as T-S-C-A and call TSCA. TSCA is the premier chemical safety legislation in the U.S. It gives EPA the authority to require reporting, record keeping 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 we abbreviate as the Lautenberg Act. For the Chemical Data Reporting Program, we are focused on substances that are listed on the TSCA Inventory. The TSCA Inventory is comprehensive listing of chemicals and commerce in the U.S. This was created in the late 1970s and currently lists 85,000 chemical substances with about 42,000 of them identified as being active in commerce. I'm now transitioning to Slide 3 and provide a quick overview of the Chemical Data Reporting Program, which we abbreviate as CDR. CDR is really a first look or high-level view of chemicals in commerce in the U.S. and it is essential for the work that we do here at EPA. CDR is a collection of basic exposure-related information on the types, quantities, and uses of chemical substances manufactured domestically or imported into the United States. This applies only to chemical substances listed on the TSCA Inventory and certain classes of chemicals are exempted from reporting. The information is submitted every four years, which most recently happened in 2016, and the currently submitted period, which we are preparing to open up, will begin on June 1, 2020 and will cover and collect information from the calendar years between 2016 and 2019. Many of you are likely familiar with the CDR revisions rule, which was finalized this month -- actually last month now -- in March of 2020. The finalization of this rule will affect the CDR reporting requirements and we will 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. We are also in the process of finalizing the small manufacturing definition, which has been proposed but not yet finalized. I'm now transitioning to Slide 4. Here, I'll go into more detail on what was included in the final CDR revisions rule, certain provisions of which will affect this reporting period. There were three main goals for the revisions rule: First, update CDR to align with the new statutory requirements for TSCA. CDR is essential for the implementation of TSCA here at the agency and we are constantly evaluating our data needs. The second goal was to improve the 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, the summary of the changes we made are: exemptions s for reporting certain byproducts, changes to claiming confidentiality to align with the Lautenberg Act, modifications to reportable data elements, and changes to simplifying reporting processes for co-manufactured chemicals. I would also like to note that in this presentation any green text indicates a new reporting requirement or an updated reporting requirement. That is to help you as we go through the slides today, and you can keep track of what's going to be different this submission period from prior submission periods. If you use these slides as a reference at a later date, just keep that in mind, that any green text is new or updated. I'm now on Slide 5. This is just the title slide, indicating that we are moving to the portion of the presentation in which I will be discussing the 2020 reporting requirements. I'm now in Slide 6. And I would just like to first point out that the submission period will be from June 1st to November 30th of this year. Again, the end of the submission period is an extension of how long it's been in the past. This [reporting] is for manufacturers, which under TSCA includes importers, of chemical substances that are listed on the TSCA Inventory as of June 1, 2020, have a production volume of 25,000 pounds or greater at a site in at least one of the years from 2016 through 2019, unless they are subject to certain TSCA actions, in which the production volume is lower at 2,500 pounds or greater. You are also required to report if you're not eligible for full or partial exemption from the CDR. I'm now on Slide 7. For each chemical that is reported, certain information is required, including the annual production volume from 2016 through 2019, certain manufacturing information for 2019, processing and use information for 2019, and certain exemptions may reduce reporting, which will be explained later in this presentation. All submissions are sent to EPA electronically through EPA's Central Data Exchange, which is also called CDX, in which an individual must register in CDX, access e-CDRweb, which is the CDR reporting tool; create and submit a separate Form U for each site; and submit Form Us following instructions within e-CDRweb. I'm now transitioning to Slide 8. We will now move through an exercise to determine your need to report. You mist consider each chemical substance that you domestically manufactured or imported at a single site from 2016 through 2019, and you must consider: first, is your chemical substance subject to CDR and second, are you a manufacturer that is required to report? I'm now on Slide 9. Here are some other things to consider when determining your need to report to the CDR. First, is your chemical substance listed on the TSCA Inventory? Is your chemical substance manufactured for commercial purposes, (which means to import, produce, or manufacture with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer)? Next, is your chemical substance use only for non-TSCA uses, as defined by Section 3(2)(B)? Next, 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, in which include polymers, microorganisms, and certain forms of natural gas and water, as well as naturally occurring chemical substances. Some chemicals are partially exempt from processing and use reporting. This includes listed petroleum processing streams and chemicals whose processing and used information is of low current interest. Some chemicals are not eligible for exemptions if they're subject to certain TSCA actions. So, let's transition to Slide 11. I'm now on Slide 11. This is a chart which shows the list of TSCA actions that would make your chemical ineligible for an exemption. And it's a bit difficult to see here, but the Section 4 orders, that has the green checkmarks to indicate that as a new requirement for this reporting period. I'm now transitioning to Slide 12. Here on Slide 12, I'm going to look at the 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 on the bottom of the slide. Tom is going to go over in more detail how to best use our SRS, but for now I want to explain that I've searched the SRS for a generic path number, one, two, three, four, five, six. And this is an output of the regulations that this chemical is subject to. If we transition to Slide 13 – now on Slide 13, we can see that this chemical is subject to the 2016 TSCA Inventory, and therefore, is subject to the CDR. Let's transition to Slide 14. We would just like to note that these examples in this presentation will still refer to 2016, which was the last reporting period. But before the June 1st reporting period opens up this year, we will have updated information for 2020, which includes two lists and the SRS indicates that the chemical is active or inactive on the TSCA Inventory. I'm now transitioning to Slide 15. We will now evaluate the production volume threshold for your chemical and determine if it is required to be reported to the CDR. Remember that the production volume threshold for chemicals is at 25,000 pounds. While for certain TSCA actions, it triggers a lower reporting threshold of 2,500 pounds. You must consider the production volume for each of the calendar years of the reporting period, so that means for this reporting period that is 2016, 2017, 2018 and 2019. I'm now transitioning to Slide 16. Let's evaluate the production volume of a sample company. Here, we have a sample company called ChemIncA and they manufacture three chemicals, Chem A, Chem B and Chem C. For this example, let's assume that these chemicals are not subject to certain TSCA actions triggering the lower reporting threshold. For Chem A, in 2016, 2017 and 2018, the production volume was under 25,000 pounds. But in 2019, it exceeded 25,000 pounds. The company is required to report on this chemical. For Chem B, we see that in 2016, 2018 and 2019 they actually did not produce this chemical at all. But in 2017, they made the chemical and it exceeded the 25,000-pound production volume threshold. Therefore, they must report on this chemical. For Chemical C, we can see that in all four years, they did not meet the reporting threshold, and therefore, are not required to report. I'm transitioning to Slide 17. In general, the reporting threshold remains at 25,000 pounds. However, a reduced reporting threshold of 2,500 applies to chemicals subject to certain TSCA actions. And let's transition to Slide 18. Here on Slide 18 you can see a table of TSCA actions that would trigger the lower reporting threshold. The first three TSCA actions do not affect the reporting threshold but the remainder in this chart do. And again, the Section 4 order has a green checkmark in the middle of the chart, indicating, that is a new requirement. I am now on Slide 19. We're checking in again with our generic chemical CAS Number 123-45-6. And here is an output of the regulations that is subject to and I want you to take a look and see if there are any TSCA actions that would result in triggering the lower reporting threshold for this subset. Let’s transition to Slide 20. We see a circle around TSCA Section 6 Unreasonable Risk, which would trigger the lower reporting threshold. I am now on Slide 21. We are going to circle back then on ChemIncA. We've already talked about the first three chemicals that they manufactured, Chem A, B and C. They also manufactured three more chemicals, Chem D, E and F, and these three chemicals are subject to certain TSCA actions. So, we'll go over that in more detail. For Chemical D, we see that they are subject to the TSCA Section 6 rule, which triggers the lower reporting threshold. And in 2017, we see that they manufactured 3,000 pounds, which makes them required to report on this chemical. For Chemical E, even though Chemical E is also subject to the same TSCA action, we see it is not reportable because it does not meet or exceed the lower reporting threshold and in none of the years did they exceed 2,500 pounds. For Chemical F, it is also subject to the TSCA Section 5 SNUR. And we see that in 2018 and 2019 they exceeded the lower reporting threshold of 2,500 pounds and they are required to report on this chemical. I'm now transitioning to Slide 22. We'll cover whether you exempt the small manufacturer and if you qualify for any other reporting exceptions, and we'll focus later on the new byproduct specific exemptions. I'm now transitioning to Slide 23. As I mentioned earlier, we have proposed a small manufacturer definition, which has not yet been finalized. EPA proposed this based on the update of the current two standard definitions on inflation by adjusting the sales standard level. This means that we would raise the current (size) standard total annual sales based on the $4 million to $11 million and the production volume modified standard equivalently from $40 million to $110 million with no change in the modifier of 100,000 pounds. And just to clarify, the total annual sales are combined with the parent company, whether foreign or domestic. We also proposed a change in the inflation index to determine future changes to the revenue level and to add a definition for small government, which will be municipalities with population less than 50,000 people. The rule is currently in interagency review. And again, keep in mind that since this has not yet been finalized, the definition maybe slightly different from the way that it is presented here today. We will find out a little bit more information on this on Slide 24. I'm now transitioning to Slide 24. And we've seen the first three checkmark columns on this table in earlier reports of this presentation, but we now have a new column on the far right. If your substance is subject to any of those listed in the last column, you are not eligible for the small manufacturing exemption. And we are going to transition to Slide 25 and I'm going to pass off the presentation to my colleague, Tom Smith, who is going to walk us through using the Substance Registry Service. Tom Smith: Thanks for the introduction and taking us through the first half of the presentation, Meredith, and thanks to all the listeners for continuing to follow along with us manually and it's not the ideal set up. Now, I'm going to shift our focus a bit and we'll walk through finding your substance or substances and their status on SRS, which again is the Substance Registry Service. Here, you'll find whether your substance is on the TSCA Inventory, if it is potentially partially or fully exempt from reporting, and whether or not it is subject to certain TSCA actions, which may impact the reporting requirements. Updates specific to the 2020 CDR will be added to SRS prior to the upcoming reporting period. On slide 26, we'll find what the homepage looks like. Keep in mind also that when you're using the reporting tool, it will search SRS for you. And so, you can search it on your own here before entering information into the reporting tool. Again, that's at epa.gov/srs. You will be able to search by list, single chemical or CAS number or by multiple chemicals. We'll quickly go through these ways and look at few example chemicals. But initially, we will go by list on Slide 27. You’ll have a number of these to choose from. A few examples shown here are the 2016 or 2012 CDR eligible chemicals as well as those that are partially or fully exempt. On or before June 1st this year, there will be a2020 CDR list as well, but we'll start by clicking on the 2016 partially exempt list, for example, on your next slide, 28. This listis short enough that you can filter it and browse through it in SRS. The chemicals on the partially exempt list require reporting basic identity and manufacturing information, but not the processing and use information unless this specific chemical is subject to certain TSCA actions that we laid out earlier. In which case, that chemical is required for reporting. So, the 2016 partially exempt list should be the same as that for 2020. Nothing has been added or changed on that list. Onto Slide 29, we'll see the page that appears when we click on the 2016 Full Exempt List. These chemicals don't require reporting. But again, with the same caveat, given that they are not also subject to certain TSCA actions we listed previously. And in contrast to the partially exempt list, there have been additions to or changes to this list. So the 2016 full exempt list will not be exactly the same as that for 2020. We're also displaying this page and the results of some searches can be too large to display.. We can, however, download the list which we'll see in the following slide number 30. This resembles the downloaded list of those chemicals that are fully exempted, again unless otherwise excluded. As we can see, the output list provides a good amount of information on each chemical that is included. For example, the substance identities, the common generic or the registry names, also, identifiers, like the CAS number and EPA ID, as well as the effective date or when this substance was officially added to the list. Moving on to slide 31, we'll head back to the SRS homepage. From here we'll now start walking through searching by an individual substance. Single entry should be the default selection but if not, we'll click on it and enter a single substance name or CAS number. On slide 32, we'll see our first example chemical. Here you'll see that by searching the CAS number listed in the title, we pulled up the results for ethylene dibromide. When clicking on a substance, we'll see that next step on slide 33. Here we'll see what statutes or regulations a substance may be subject to. This is an example of another substance that you can see as both on the 2016 Inventory as well as the partially exempt list, meaning again, that it would require reporting of manufacturing information but not the processing and use. Again, unless subject to certain TSCA actions mentioned earlier. On to slide 34, we'll see another example chemical. Hydrofluoric acid similarly is also in the 2016 Inventory and as we can see, it is subject to a variety of other actions, statutes or EPA programs as well. Listed are CERCLA, the Superfund, a few from the Clean Air Act and one Resource Conservation and Recovery Act (or RCRA) at the top. So now that we've gone through determining your need to report in SRS, whether or not your chemical may be exempt. On slide 35, we'll shift our attention again and I'll give an overview of the information to be reported starting with what's associated with the site. And again refer to the green text for the changes since the last reporting in 2016. Previously, only the highest-level U.S. parent company was reported, but now if applicable, the highest-level foreign parent company will be reported as well. And note that there is a new definition for highest-level parent company in CDR’s regulations at 40 CFR 711.3. This definition now includes multiple scenarios. Along with the manufacturing or importing site information, the new requirement of the NAICS code associated with that site will be recorded. For context, NAICS is the North American Industry Classification System. Submitters will only be required to report one NAICS code. But considering multiple codes may be applicable for a single site, up to three NAICS codes will be allowed to be reported. Technical contact information is also required. This should be the person EPA may contact for clarification of the information in your CDR submission, someone who can answer questions about the reported substances. Typically, that's a person located at the manufacturing site. The person that is best able to answer such questions or, as a person located there that can answer the question. On to slide 36, after the site-associated information, you'll provide manufacturing related data which includes the chemical identity by name and CAS number or by a generic name and accession number if your chemical is on the confidential portion of the inventory. Also reported are the production volumes for the past four years, 2016, 2017, 2018 and 2019. For the principal reporting year, 2019, much more in depth information is provided including whether the volumes are imported or domestically manufactured or both, and if imported, whether the chemical was never physically at the site. Also, the volumes used on site or directly exported from the site. Additional information for 2019 specifically includes the number of workers that are reasonably likely to be exposed, which is to be reported in ranges; the maximum concentration also in percent ranges; 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. So on top of recycling, this element used to include remanufactured, reprocessed or reused, but we've streamlined the requirement to avoid confusion and refine the information that is being requested. Lastly, there's a new voluntary data element that submitters can choose to report - the percent production volume that is the byproduct. There will be a couple of options for 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 also this isn't asking for the percent of your substance that contains the byproduct, rather the percent of the production volume that is a byproduct versus a product. As such, we expect in most cases this will be reported as zero or 100 percent. On slide 37, we return back to a familiar table to exhibit a few example reporting scenarios per chemical that a single company would come across when determining the need to submit manufacturing information as well as processing and use. Chemical A requires full reporting including processing and use on the 2019 volume of 26,000, while B only requires reporting for the manufacturer because the 2019 principal reporting year production volume is zero. Chemical C doesn't meet the threshold for any year, so doesn't require reporting, manufacturing or processing and use. And with chemical D, we're illustrating quite a few things. One, triggering the threshold based on an earlier year like chemical B due to the 2017 volume and two, triggering with a lower threshold because of a Section 6 rule. And three, the need to report the full information on a year – the principal reporting year even though that year, 2019 volume is below the threshold. Moving on to slide 38, we'll talk about what this information actually entails. So, as we've already indicated, processing and use related data is required if meeting the threshold, the regular or reduced unless otherwise exempted. And there's a lot of green here, so we'll focus on some of the processing and use related changes. Reporting the function category will now be required for commercial and consumer products as well, not just for the industrial processing and use. And we're phasing in the replacement of the CDR industrial function and commercial/consumer product use codes with codes based on the OECD function, product and article use categories. I'll be referring to these just as the OECD-based codes. These will be familiar for companies that also report internationally and helpful for EPA to synthesize data with other programs that also collect OECD information. By saying that we mean that during the upcoming 2020 CDR submission period, reporting using the OECD-based code is only required for chemicals designated by EPA as high priority for risk evaluation. The full list of these chemicals can be found at the displayed URL here and will be shown in a few slides also. For all of their chemicals, to allow reporters time to familiarize themselves with the OECD-based codes, they may use either these or the current CDR codes - the same as those used in 2016. Reporting using OECD-based codes will also be fully implemented and be required for all chemicals during the 2024 CDR submission period. In other words, these codes will be phased in completely at that point. Now on to slide 39 to see the rest of the required processing and use information. Looking at the first table on the industrial side of things, you report the type of processing and use operation, the sector, functional use and the associated percent production volume, number of workers and number of sites. And looking at the bottom table on the consumer/commercial side, you'll report product category; whether the use is consumer, commercial or both; functional use; whether used in products intended for use by children; and the associated percent production volume, max concentration and the number of commercial workers. To reiterate on each of the circled reporting elements, functional use for commercial/consumer products, in the bottom table is a new data element and the other two are not new elements, but are the others impacted by the phase-in of the new OECD-based codes. Now, for a little more context, one combination of the first three elements in the top table - 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 in the bottom table, which together also amount to a unique exposure scenario. For example, each of these scenarios tie into a specific condition of use for a chemical. Now on to slide 40, here we just 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 with or crosswalked with the current CDR codes in column B. The table of product categories, which is not shown in this presentation, are displayed similarly with a column A and the connection to column B. These whole crosswalk tables can be found in the rule as well as the 2020 Instructions for Reporting, which will be available in the rule docket and on the website. On to slide 41, for another table that I mentioned earlier, here is the list of the 20 high priority chemicals designated for risk evaluation. Again, if you're reporting any of these substances, you are required to use the OECD-based code. And if reporting any other substances you're allowed to, but not required to, use the new OECD-based code. Again, these are the codes that were displayed in column A. Moving to slide 42, here we want to re-emphasize a few things. Reporting is site specific, meaning there is one Form U per site, which could have one or many chemical substance reports so that each chemical reported by that site [is included in the site’s Form U submission]. Again, for some perspective, there were about 8,700 chemicals reported in 2016, around 42,500 chemical reports as a number of sites were manufacturing the same chemicals. We also want to stress 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 or supervisory employees as a submitter. More in depth examples of this type of information and the standard can be found in the Instructions for Reporting as well. Onto slide 43, we'll go over some of the changes associated with making confidentiality claims. The TSCA amendments in June 2016 required substantiation for most confidentiality claims. And now, upfront substantiation is required for all claims of confidentiality at the time they are made, except for production volume, which includes five separate data elements, one per year, 2016 to 2018, plus domestically manufactured and imported volumes for 2019. Also, a supplier, trade name and formulation information associated with the joint submissions don't require substantiation. The substantiation questions and certification statement have also been updated. And general use data elements can no longer be claimed as confidential. Specific elements [that cannot be claimed as confidential] are listed here for processing and use - either the industrial or the consumer commercial use. Moving on to slide 44, to talk about requirements for importers. Under TSCA, “manufacturer” includes import and importers have much of the same requirements but had a few additional factors to consider. Site is assigned for importers in 40 CFR 711.3 and is the U.S. location of the unit directly responsible for importing. And that must be a U.S. address even if it is for an agent acting for the importer. An importer will indicate whether each imported chemical is never physically present at the reporting site, one of the data elements I mentioned previously. And if a mixture is imported, the importer reports the individual chemical components of the mixture, including the percent composition. Joint submission with the supplier is used when the chemical identity or mixture composition is unknown, and one of the new requirements for imported mixtures, the secondary submitter of a joint submission reports the function of the chemical within the mixture. Lastly, imported articles are exempt under 40 CFR 711.10(b). On to slide 45, when identifying your imported substance and determining its requirements - for sources of its composition information, you can refer to the Material Safety Data Sheet or MSDS or Safety Data Sheet, SDS, or the supplier to provide composition information. If composition information is claimed as confidential, you can ask your supplier to provide the information directly to EPA and one of the new capabilities for joint submissions, both the primary and secondary submitters are able to identify parts of their submissions as confidential. And similar to domestic manufacture, use “known or reasonably ascertainable” information to determine whether your production volume triggers reporting. For imported mixtures that would be the overall production volume of 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 or SDS for composition information. And moving on to slide 46, we will shift to information specific to byproducts, and I will provide a background there and then transition to the new byproduct-specific exemptions. 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 commercial purposes and reportable when used for a non-exempt commercial purpose. On slide 47, we'll talk about the first byproduct specific exemption. So, EPA will now exempt specifically listed byproducts that are recycled or used in physically enclosed systems in a site-limited manner and when site is reporting byproduct or another substance from the same overall manufacturing process. By site-limited, meaning the byproduct remains on site after manufacture and if processed. The industries and byproducts that we listed and are eligible for this exemption are cement kiln dust from Portland Cement manufacture and black liquor, oxidized black liquor and calcium carbonate from the Kraft pulping cycle. Moving on to 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 in the previous slide as well as whether or not EPA may have a current interest in the byproduct. Note that there is not time to submit a petition for the 2020 submission period but petitions for consideration for the 2024 submission period will be due before December 31st, 2022. On slide 49, we'll move onto the second exemption. This exemption is for byproducts that are generated in equipment that is not integral to the production process. The equipment we're 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 two 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 the product would be considered integral to the production process. Whereas sites using boilers to produce heat or electricity for their facility but not as the product would not be considered integral. Examples of pollution control equipment that is likely to be non-integral includes flue gas desulfurization and selective catalytic reduction systems. Both types of air pollution control as well as for instance when a byproduct is produced while treating wastewater from cleaning tanks from the manufacturer's production process, from water treatment. These are not listed here but examples can also be found in the 2020 instructions when those are made available. And on slide 50, we'll 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, the co-manufacturing relationship occurs when a chemical substance manufactured other than by import is produced exclusively for another person who contracts for such production. The contracting company directs this process. Note that the co-manufactured reports are done as part of the overall Form U and it does not require separate report. Using the first new reporting methodology, the contracting company initiates the co-manufactured chemical report and notifies the producing company using the e-CDRweb reporting tool with both the contracting company and producing company reporting their own production volume. And the contracting company reporting chemical identity and the processing and use information and the producing company reporting on the manufacturing information On slide 51, using the second new reporting methodology, the contracting and producing company, upon written agreement, work together to complete the reporting. In this scenario, the producing company initiates and completes the reporting, providing exposure-related manufacturing information while the contracting company provides additional information as needed to the producing company. Although the producing company submits the report, both parties are responsible for the report. On slide 52, we'll shift our focus again. So to finish out this portion of the presentation and now that we've concluded going over the regulatory update, I'm 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 seen on slide 53. There are a variety of IT and functionality enhancements that are to be incorporated into the reporting tool that 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. During 2016, there were issues with uploading from an XML file. So, now the reasons for failures will actually be explained. We will also allow uploading data by CSV file and agent role has also been added to make the reporting process more versatile, flexible. Moving on to slide 54. Previously, there were just two roles, the authorized official who creates, signs and submit the form and support people who help to fill in details of the form. Looking at the table, we can see that the support person only has the capability of editing the form. As requested, the agent role has been added which is modeled after the new chemicals program and the PMN submission process. Agents will have the ability or access to do the following in this middle column of the table which includes editing, unlocking and providing amendments to the original created form. [EPA correction – the Agency can initiate the form] On slide 55, I will walk us through some of the additional resources we're going to refer to when making CDR submission. We are in the process of updating all the 2016 guidance documents including the various fact sheets. On slide 56, we'll see where you can find the updated guidance. For the simplest resource, you can – the CDR page where the updated information and guidance that I mentioned will be posted as it is developed. There, you'll be able to find Instructions for Reporting and CDR’s frequently asked questions, both which [are being] updated to reflect the rule’s changes to the reporting requirement as well as any of the very informative industry-specific fact sheets. And lastly, reporting-related questions can be sent to eCDRweb@epa.gov. On slide 57, this was the Q&A session. But to make sure we get through both presentations fully, we'd like to postpone questions until we finish the reporting tool demo. Before – and before handing it over to Carolina Falaiye to provide that demo, I'll pass it back to Meredith for a quick note before we move on. Meredith Comnes: Thank you, Tom. We've now concluded the first half of today's webinar. We've completed the first slide deck which on the website is the presentation one. We're now transitioning to presentation two which is part two of the webinar. The title page on that set of slides is 2020 Chemical Data Reporting e-CDRweb Reporting Tool Demonstration. Again, we've completed the first slide deck and you need to move on to the second slide deck which is available on our website. And I'm now going to pass it off to Carolina. Thank you. Carolina Falaiye: Thank you, Meredith.. This is Carolina Falaiye representing CGI Federal. We have been working with EPA for the past year to understand and implement the CDR requirements both from the rule’s perspective as well as the enhancement and modernization of the tool. I'm now on slide number 1 but we're going to move to the quick disclaimer. The screen shots that you will find in this presentation may change in the real application once we go to production. But, these are pretty similar to what we have currently. I'm now on slide number 2 with just the agenda. We'll go over the Central Data Exchange, registration and form management as well as completing the Form U which includes the company and site information and particular information about the chemicals and how different chemicals can be reported. We have tried to provide a more usable user interface that will guide you through the different scenarios and how to report the chemical, depending on their relationships for the production of a chemical. We'll also go over the bulk chemical upload functionality, the CBI substantiation, implementation, the submission process and the secondary and tertiary forms. I am now on slide 3 which has the Central Data Exchange portal which allows us access to the TSCA applications. The user guide for CDX contains the newly added roles for the primary agent consultant and secondary agent consultant and the different privilege and uses that they have. Slide number 4 contains the different roles in how once you have access to the CDX portal, you can select the use that you need to perform the activities in the application. For the purpose of this presentation, we'll go over the primary authorized official. Some of these things will not be available for their supports [or] different roles within the application. I'm moving on now to slide number 5 and going forward you will have two options from the chemical information submission system dropdown. One will be for you to access your old data from 2016 and the new one will be marked as 2020. Once that they select the OK button, slide number 6 displays the homepage that the user sees once it's logged in to the CDR application. This contains a list of the sites that are registered under the organization the user registered and logged in for. The create button will allow you to start the form as a primary authorized official. We can create the form and assign the users in the user management tab listed on the top left of the page. And once the form has been created, the pencil icon will display, which allows you to make edits to the form or to your users assigned, like the support or the primary agent consultants, to make modifications to that form. Once the form has been submitted, the bottom test facility, 999, displays the option that you have to download the copy of record or the XML file as well as the lock which will allow you to make amendments once the submission has been completed. I'm moving now to slide number 7. On that homepage, you will also find a list of resources that will guide you through additional information about the regulatory information, the active-inactive rule for the TSCA inventory and the CBI substantiation frequent question. On the righthand side, you'll have a description of the role that you have logged in and the different abilities and privileges that you have under that role. Slide number 8, once you have created or select the create new form, you will be required to create a passphrase. One of the things we have added in this update is the ability to have a hint to help you remember what the passphrase was. We do recommend that you treat this passphrase as a security question or security access key, so the hint shouldn't be your passphrase. As of right now on the small cap, we don't have the ability to reset that passphrase but we are working on it. Slide number 9 will give us just the introduction to the company and site information which is the overview part of the form. If you register as a U.S. or domestic company, your information will be displayed and with the information provided and, during the registration, you can enter your company D&B number and the county or parish and save that information. Slide number 11 shows once you have saved that domestic company, you have the option to add a foreign parent company if that is necessary. If you register under a foreign company, the process will be the opposite. What you would see, the foreign company information first and once you have saved that information you are required to enter domestic company before you can proceed. Once the user select that continue button on slide 11, we'll move on to slide 12, where you will see the site information. As Tom mentioned before, we have added the ability to provide your NAICS codes, up to three codes can be added with the classification whether it is for manufacture, import or both. Slide number 13 guides us through that process where the user will select the NAICS code from the dropdown. This is connected or related to the National North American Industry Classification System. The link under the header will guide you through that website, so that you can identify which code corresponds to your industry. And then, the activity classification will have three options to manufacture, import or both. Once you select the Add to List, slide 14, shows how the NAICS codes will be listed under the site information. Once the user selects the continue button, we'll go over slide 15 which details the chemical information and how each chemical can be reported. The first step is the chemical summary with all your chemical for display. You have the ability to sort by any of the columns or search by search functionality. Once you select the add chemical button, will guide you through the steps to add your chemical manually or the bulk chemical upload will guide you through the process of using either an XML file or XLSX which is an Excel file. We'll go first over the steps of adding the chemical manually. When the user selects the add chemical in slide 16, slide 17 will display several steps. So, one of them is first identifying whether you know the identity of the substance or if you are providing a joint submitter the ability to enter that information for you, or if you are just producing that chemical for somebody else. In this scenario, we'll go with the fact that we do know the chemical identity. And so the users will select the “click here to add chemical”, that is a hyperlink and then the hyperlink will guide us through the steps on slide 18 onward. I'm now on slide 18 where the user can select by using the CASRN number or the accession number if the chemical is in the confidential portion of the TSCA inventory. In this case, I selected an accession number but when I select the search button, slide 19 will display that the system is checking with SRS. And in slide 20, we'll receive the list of results. If you search by generic name or by EPA inventory flag, you may find multiple results. You need to select the button on the far left to select which is the correct chemical identity. Once you have done that, the “save chemical” button will be enabled. And slide 21 shows how the chemical is now displayed on the chemical identity page. As you can see, you can provide your chemical alias but also because this chemical was in the confidential portion of the TSCA inventory, you must select one of these statements according to what you need to do. One is to maintain the existing claim of the confidentiality of the chemical substance identity as listed on the confidential portion of the TSCA inventory or the second option is not to maintain that claim. All the data elements that you can claim as confidential business information or CBI will have a corresponding checkbox. In this case, you can claim the company site or technical contact information as CBI by selecting one of or all of those checkboxes. Once the user selects the continue button, slide 22 will display, for the user to enter the corresponding technical contact information. This should be someone who can answer questions about that particular chemical in this site. Slide 23 shows the fields that you must provide. You can copy from CDX which will bring in the information of the user that is registered, filling up the form or you can type in anyone. Once the user selects the save button, slide 24 shows the technical contact information listed on that table. At this point, the user can create multiple chemicals and then assign them as he's entering the following chemicals or can also select a default technical contact that will carry over by for each additional chemical. Once the user selects the continue button, slide 25 shows the manufacturing information page. In this case, the user can provide the total production volumes of the prior or previous years, from 2016 through 2018 and make a selection for which or how the chemical was produced for 2019. And the first option is my site is reporting the production and use of the chemical. This this would apply for chemicals that the company knows the chemical identity or they have imported or generated joined submission. And then, the second option would be my company contracted a co-manufacturer to produce the chemical at their site. And the third option is in case that the company also produced for someone else. In n this case, we'll follow up with the first scenario in slide 26, which is I am reporting as a manufacturer or importing company. In that case, the user selected in slide 26– my site is reporting the production and use of the chemical. This provides the required information whether the chemical was manufactured, import, and the all required production volume information as well as the exposure, and in slide 28, the physical form. Slide 29 will show the different fields that we would collect for a contracting company. So, in case that your company contracted a producing company or is in a co-manufacturing relationship, the contracting company will provide the information for the producing company. So, slide 30, we have a list of the information that the contracting company must provide such as the chemical name, the 2019 contracted production volume, whether the volume was contracted was never physically at site, and the producing company information. Slide 31 shows how the contracting company will notify the producing company via e-mail, providing a unique identifier for the producing company to then report their information on behalf of the contracting company. Slide 32 is just an extension of that e-mail. It shows the body of the e-mail and how they would send out that information. In slide 33, we will cover how that producing company would then complete their part of their form on behalf of the contracting company. In that case, we'll go back to how the producing company would select the – No, I am a producing company on slide 34. Slide 35 will show where the user could add the unique identifier provided in the previous slides and select the populate company – contracting company, which will display and populate the information related to that table. If the contracting company selected that they wanted to make that relationship confidential, the column called relationship is CBI will be marked as yes. Then, the producing company must provide a chemical alias and produced volume, the percentage after total production volume by weight that was manufactured as byproduct. And I'm moving on to slide 36 for the additional information they need to provide which are related to the exposure-related information and the physical form. Once the user – the producing company - selects the continue button, they can save that information and that would be their part for that contracted chemical. Slide 37 we'll quickly go over the scenario where user or the company is a manufacturer for an imported substance. So, the user will select the – No, I am an importer option, and enter the information for the secondary company that will provide the chemical identity information. Slide 39 shows the bottom part of that page which is the generation of that e-mail which will contain the unique identifier. Slide 40 shows the body of the e-mail. And once the information has been provided for the manufacturing, the contracting company and the manufacturing company or the manufacturing company, they will be required to provide the uses for the chemical. They will move on to the industrial processing and use page. In Slide 42, we display how the user would enter each use one at a time up to 10, selecting the type of process or use, the sectors, function category, percent production volume, number of sites, and number of workers. A change from 2016 is before all of these items were allowed to be claimed CBI. But for 2020, we're only restricting [the ability to claim as CBI] to the percent production volume, number of sites, and number of workers. Each drop down has the ability for you to search using the code or the description. Slide 43 displays that a little bit better where you can see a list of the codes. This list will include the newly added F codes as well as the previous reporting U codes. Slide 44 shows a similar concept that was used for the consumer and commercial use. Slide 45 has the different selections that need to be made to add each use better for consumer or commercial. Again, the function category was updated to include the C codes as well as the CC codes. One thing to mention before I move on from the uses is for the high visibility [correction – high priority] chemicals. We have limited the function category to display only the F codes. But all others, you can select from F or U codes. Moving onto slide 47, the bulk chemical upload functionality, we will provide the ability to upload the XML for 2016, if you have it. We won't be able to reset your passphrase or to retrieve those. But if you have already your passphrase or you have downloaded from previous reporting period then you can use those to upload. We will provide the 2020 XML as well as the CSV file. In slide 48, this will be the page where you can select the file once you have compiled the information. And slide 49 will have a couple of validations run. So, before we will verify if you're uploading an XML file from 2016, we will compare to the schema that the system will accept and we'll provide you with specific lines or rows where we have identified any errors with the formatting of the file. Once that has been fixed and you upload the corrected file, we will run a validation and [check against] the SRS to make sure that the chemicals reported match and are found in SRS. Once that has been completed, you'll see on slide 49that has the [file] successfully uploaded and the count of chemicals that were uploaded in that file. You can select the save chemical information button on that page. Slide 50 is a quick display of how an error or a chemical that is not found in SRS will display, so you can quickly identify the specific chemical that needs to be revised. Slide 51 will walk us through the process of providing the CBI substantiation. So, once all your chemicals have been added, then the system will identify those claims that will require CBI substantiation and those chemicals will be listed on the CBI substantiation review tab. The plus sign will expand each chemical and the paper-over-paper copy icon would allow you to copy the substantiations from one chemical to the next and we'll go over this the following slides. Slide 53 shows how once you expand the chemical would have these different sections that you've filled in the form. And each section has URLs or links to the information that was claimed confidential. In this case, we have the company information. On the right-hand side, we have the chemical that we're looking at and the data element that we will be substantiating. The questions are listed for each item that was claim CBI. So, on the right-hand side, you will see the general claims. So, each element will require the substantiation for these six questions. Slide 54 shows how once you have provide all the answers to the questions, the substantiation questions, and everything has been validated, you're chemical will be on a good status, which is a green check. Slide 55 shows how you can potentially use some of that answer – some of those answers and copy them over to the next chemical. In this case, we are editing 126013. And so, you'll see that editing chemical for substantiation on the top or right-hand of the page. And then selecting from this drop down in slide (56) will show which chemical has been substantiated and you can use as reference to copy from. In slide (57), once you select the chemical that you think will have the most information that you can reuse, we will have a couple of options. One of them – the first one is copy substantiations. This functionality will allow you to copy from the chemical selected to the current chemical that you're editing or copy substantiation to all will use those answers and copy them over to all the chemicals that have any CBI claims. Please note that if there are claims that were not part of the first chemical they will be still required to be answered or substantiated in the second chemical or the other chemicals, depending on how you did the copy. Slide 58 will show a good example where most of the substantiation from the first chemical selected mapped to the last chemical, in this case, the trade product one. Both of those are good – in good standing from a CBI substantiation standpoint. But our accession number, the chemical in the middle, 126013, will need some reviewing. Slide 59 will take us over the process to identify what is missing. So, once you expand with the plus sign, you will see that the chemical identification page has two claims out of six possible, but it sounds like it's missing something. Sn slide 60, you'll see that the company information has a little check continuing or showing that the substantiation has been provided but the chemical substance identity is missing. When you select that, you will a couple of additional questions that are specific to the chemical identity claims and the additional general claim. In slide 61, you will see that now all your chemicals are in good standing. They all have been substantiating, and you can move on with the submission process. Slide 62 will will take us through the submission process. Once you have all your form ready to go, the next step will be to confirm that you are the submitting official identified for this form. You can claim your information as CBI, provide your position. And once you select the bottom check box to confirm that you are the legally responsible party for submitting the form, the start submission process button will become available. Slide 65, will take you to the certification for the CBI substantiation claim. One thing to note – and we don't have them on the slides – is you will be prompted that the substantiations are final at the time of submission. So, if you have any doubts, we recommend that you wait until you confirm that all your CBI claims are in good standing and that everything that you want to claim CBI has been marked as such. Because once you submit, you won't be able to go back and change your selections. Slide 66 has the CDR certification statement. Once you certify, slide 67 will provide a global validation to ensure everything was in place and everything that is required is provided. Slide 68 will give you the opportunity to download the draft PDF. This is not to be send to EPA and is not a final submission. And then, the final submission can be downloaded via the download copy of record once the submission has been completed. Selecting the sign and encrypt and submit button will guide you through the CROMERR process that secures and submits the form to EPA. That is demonstrated on slide 69. Slide 70 has the steps that CROMERR will require, which is the entering the password from CDX and then verifying with your (5/21) questions and selecting the sign button. That will complete the submission of the primary form. Once the form has migrated and EPA has received it, you will see a case number assigned to your form on the homepage. Slide 71 will take us over the secondary and tertiary forms. I'm now in slide 72. And so, this will get us to using the secondary authorize official role. Slide 73, you'll notice that this is a little bit different from the primary in the sense that they have only one form to report per year and not multiple sites. They also have the resource information and the secondary or the user information on the right-hand side. In this case, they would provide trade product identification that they have agreed upon with the contracting or the manufacturing company and then provide all the substances that make that trade product. On the bottom half of that page will have – they are really to enter the unique identifier and populate that primary company or company's information. Slide 76 will allow us to have some questions and answers. So, I'm passing it back to Meredith. Thank you for listening. Meredith Comnes: Great. Thank you so much, Carolina. It looks like we have plenty of time for questions today. But before we transition to the question and answer section, I just want to point out two things. First, we have a slide correction on the first slide deck. If you go to slide 54, this is the e-CDR management and user roles. We just want to point out that the agent role also has the functionality of being able to create the form and set the passcode. Again, this is on slide 54. The agent role could also create the form and set the password. And one other thing we would like to point is that our CDR revisions rule actually published today. If you're interested in reading more in-depth about the revisions rule, you could find the rule itself and then also accompanying documents at regulations.gov. I have the docket number here. It's epa-hq-oppt-2018-0321. Again, that's epa-hq-oppt-2018-0321. So again, this is just published today. We encourage you to get a head start and review that rule in preparation for the CDR reporting period. And with that, I'm going to pass it over to our operator who is going to be helping open lines for the question and answer section. And Susan Sharkey who is also in our office in the office of Pollution Prevention and Toxics will take the lead on responding to questions of participants. And thank you again for following along with the slides and engaging with the webinar up to this point. Thanks. Operator: At this time, I would like to remind everyone, in order to ask a question, press star then the number one on your telephone keypad. Again, that is star then the number one on your telephone keypad. We'll pause for just a moment to compile the Q&A roster. Your first question, please state your first and last name. Your line is open. (David Hearn): On slide deck one, slide 21, it said the reporting was yes. On slide 37, it was no. Can you explain the difference for that chemical? Susan Sharkey: OK. Let me take a quick look at the two pages. The first one was on slide 21? (David Hearn): Yes. Susan Sharkey: And it's – which chemical are you talking about? (David Hearn): Chemical B is yes. Susan Sharkey: Chemical B, reporting is yes because it hit the production volume of 34,000. And then on the second slide was which number? (David Hearn): Thirty-seven. That same chemical B is now no. I don't understand the difference. Susan Sharkey: We added another column to the table. There's still the column on the far right is associated with just processing and use information. The column second from the right is reporting required and that remains yes because the production was triggered in 2017. It's over 25,000 pounds. That chemical does need to be reported. However, because the production volume in 2019 is zero, the processing and use portion of the information is reported only for the 2019 production volume because that zero there is no processing and use information to be reported. (David Hearn): Yes. OK. I understand. I misread where the no was. Thank you. Susan Sharkey: Certainly. Operator: You have next question. Please state your first and last name. Your line is open. (James Lee): I have the same – similar question for slide deck – the first as well, the pages 21 and 37. So, what I'm trying to figure out is – on 21, it says for chemical – is it – where's that slide – for A and B reporting are required. But do you report on every single year even though the production volume is below 25,000? Or do you report only on the year that exceeded the threshold? Susan Sharkey: You report for all of the years. (James Lee): OK. Susan Sharkey: There's two different things to consider. First is whether you trigger the need to report. And so, you look at each individual year and see if in any year you exceed the applicable threshold for that chemical. If you exceed the threshold in any of those years, then you report information for all of the years. (James Lee): OK. Even though the production volume is zero, you report on that year, like 2016 let's say, for example, on Chemical B. Susan Sharkey: Right. In that case, you would report zero. (James Lee): OK. Got you. But then, you're saying that for production or the processing and use information, only the principal reporting there, which is 2019, matters. Susan Sharkey: Correct. And that's also true for other manufacturing information that you report only for the principal reporting year. The only information you report for the 2016, 2017, and 2018 is the total production volume for that chemical for that year. (James Lee): OK. And that goes the same for the chemicals that are under some kind of TSCA order 4, 5, and 6 is 2,500 production limit but then only applies for production or processing and use information that only applies if 2019 principal year is triggered. Susan Sharkey: If there is any production in 2019, then you report the processing and use information. And that's true even if the production volume in 2019 is below the threshold and you triggered – the reporting was triggered by different year. You would still report the processing and use information. So, if you look at say Chemical D, the reporting was triggered for the year 2017 with 3,000 pounds. And there's only 1,200 pounds in 2019. So, you would report the processing and use information for that 1,200 pounds. (James Lee): OK. So, the processing and use information is going to apply to the chemicals that are under subjects of 4, 5, and 6 orders. Susan Sharkey: Yes. (James Lee): Yes. OK. Got it. Thank you. Susan Sharkey: OK? Operator: Your next question coming from the line of (Diane Welch). Your line is open. (Diane Welch): I have a question on the second presentation talking about the secondary and tertiary forms. How do I know whether or not I have to submit these? Is that only if I'm submitting as part of my parent company or how does that work? Susan Sharkey: So, the second and tertiary forms are mostly associated with imported chemicals when you don't know the composition of the substance that's being imported and you're asking your foreign supplier to provide that information. If you, as the primary or if you, as the importer, know the chemical identity of the chemicals, then there is no need to use the secondary form. The tertiary form only comes in when the foreign supplier doesn't know the information either and has to go to another party to be able to supply the information. (Diane Welch): OK. So, as long as I have the chemical information, I don't have to worry about the secondary and tertiary forms. Susan Sharkey: That's correct. (Diane Welch): OK. Susan Sharkey: Next question? Operator: We have our next question coming from the line of (Christy Miller). Your line is open. (Christy Miller): Hi. I have a question. When I'm in the CDX database, when I add a program and service and I use the submissions for chemical safety and pesticides program, my facility is already in there because of TRI reporting. Do I use the same facility number to add this additional reporting service? Susan Sharkey: Carolina, can you answer that one please? Carolina Falaiye: Yes. So, yes, it should be the same facility that you're reporting for. Yes. That will (inaudible). Sorry. If you log into the CDX, you will see that side we call it in CDR, that side listed on your homepage. (Christy Miller): OK. It's not there. And when I go to search for it, I suppose I just have to call the help desk then and get some direct help. OK. Thank you. Operator: We have our next question coming from the line of (Radmila Petrovic). Your line is open. (Radmila Petrovic): Hello. I have several questions. First of all is related to slide 36. And it is about volume directly exported from reporting site. Our substance that we produce is further mixed with another additive and further exported as mixture. Do we report only the single substance volume or total volume of the mixture? Susan Sharkey: If I understand correctly, you are manufacturing the substance that at the same site you're mixing it with another substance before exporting it, is that correct? (Radmila Petrovic): Correct. Yes. Susan Sharkey: So, you would report the chemical that you manufactured. You would then in processing and use – because you are mixing it with another substance, you're not – it does not fall into the direct export. You would, in the processing and use information, fill out the information associated with incorporating the substance into a mixture and that's what you would report. If the other substance that you're mixing it with is one that you domestically purchased and so that you're not a manufacturer, then you have no reporting requirements for that substance. (Radmila Petrovic): OK. My export is which is volume directly exported from reporting site. So, I would use only the amount that we actually produce, not the … Susan Sharkey: For… (Radmila Petrovic): for export. Susan Sharkey: Right. But you don't have – because you are processing it on your site by mixing it with another substance, you are no directly exporting it from your site. (Radmila Petrovic): OK. Susan Sharkey: You're processing it first. (Radmila Petrovic): I got it. Susan Sharkey: OK? (Radmila Petrovic): OK. Next question is about the slide (60) and it is related to contract manufacturing where using a producing manufacture. And question is, in the past, our contracting companies wanted to take care of everything. And question is, is that still an option or do we have to go to the two-step reporting process? Susan Sharkey: We do not have an option for the contracting company to report all of the information. (Radmila Petrovic): OK. Now, what if our contracting company is no longer in the business? How do we report because, on occasion, we run to some small companies and they're no longer in the business? Susan Sharkey: Right. (Radmila Petrovic): We need to report somebody but we have no contact with – which did happen in the past. When we don't have a contact's name, we don't even know if their – I mean, they're not basically reporting anything. So, what do we do in a situation like that? Susan Sharkey: Well, as a producing company, you can report all of the information yourself. (Radmila Petrovic): Let's say, if I do not know the chemical – let's say we're making a complex polymer mixture and we really don't know the polymer involved whether it is reportable or not. And we don't know the chemical composition. We just know the ingredients that go in but we don't know the final CAS number of the polymer that we are making. Susan Sharkey: Right. (Radmila Petrovic): So, we really don't know whether it should be reported or not. Susan Sharkey: The best – in that situation, the best path forward would be to ask us directly so that we can get into some more details about it. But one thing – for the most part, polymers are exempted from the need to report– there are some exemptions to that. (Radmila Petrovic): OK. Next question. Is the scrap quantity integral part of the produced quantity? Let's say I'm making a 100,000 pounds of Chemical A and – but basically, a batch failed – 50,000 failed. So, is my produced quantity together, scrap and the good material or just the good material that is actually end up in the (commerce)? Susan Sharkey: Are you – there's a couple of different options there. If you are – if the substance – if the substance that you manufactured that is scrap is actually a different substance then it would not be counted as part of the total volume that you have because it's actually a different substance. If it has the same substance identity, you – I need to think about the answer to that question. So, can you send it… (Radmila Petrovic): OK. So, I can send that. Susan Sharkey: Yes. If you can send it to me, it's ecdrweb@epa.gov. I can get the answer back to you. (Radmila Petrovic): OK. And I have one more last question about the importing, what if the manufacturer is actually in Europe or Asia? What are we supposed to do for the (importer) but we do not know the trade secrets –I mean, the chemical composition and trade secret? So, what do we do in a situation when manufacture who knows the exact component of the material or I mean, whether it's a substance or a mixture? Susan Sharkey: Right. Yes. In that situation, you would make use of the joint reporting. You would be the primary submitter and when you are filling out your reporting form, you would be able to send a note to your foreign supplier and ask them to complete the secondary reporting form. And they would be able to go in and register with CDX and obtain the secondary form and then submit the information directly to EPA and that protects their confidentiality of – the confidentiality of their composition but gives EPA the information needed for the work we're doing. (Radmila Petrovic): And would we be held responsible if they do not reply by certain date? Susan Sharkey: We encourage you – well, we encourage you to encourage them to respond. And as long as you document the fact that you have made efforts to do so such as by sending a request to them through the reporting tool, then you would be fine. (Radmila Petrovic): OK. Thank you. Susan Sharkey: Next question? Operator: We have our next question from the line of (Trev Bahal). Your line is open. Susan Sharkey: Hi, (Trev). Are you there? Please move on to the next question. Operator: We have our next question from the line of (Susan Velers). Your line is open. (Susan Velers): Yes. I'm referring to slide 49 in the first slide deck where Mr. Smith had made a comment about – if electricity was generated and it was used on site, it was one scenario. But if it was sold off site, it was a different scenario. Can you elaborate on that a little more? Susan Sharkey: Yes. In the situation where the electricity is produced as a product, then any of the substances associate with that production of the product are considered part of the integral process of manufacturing the electricity; and therefore, would not be eligible for this exemption. However, if you have the situation where you are producing it for your own use, it's considered not integral to the production of your product which presumably is something other than the electricity. (Susan Velers): Right. Yes. In all cases, the electric generation is a totally separate function. And so, in our situation, I feel like it's not integral even though we do export some electricity. Susan Sharkey: If you would like to delve into a little – in a little more detail, we can do that offline. (Susan Velers): All right. That's fine. Thank you. Susan Sharkey: Next question? Operator: We have our next question from the line of (Jerome Nest). Your line is open. (Jerome Nest): Hello. Hey. I was – wanted to get some clarification on slide 21 once again. So basically, as long as you broken the threshold for the three-year period, you still have to report. And whatever amount you have for the preceding or other years then you got to report that also, which as long as you break the threshold. Susan Sharkey: That's correct. Yes. (Jerome Nest): OK. That's all I need to know. Thank you so much. The presentation was outstanding. Susan Sharkey: OK. Thank you, (Jerome). (Jerome Nest): Bye-bye. Operator: We have our next question from the line of (Ping Lee). Your line is open. (Ping Lee): Hi. How are you? So, one of my question is regarding to the co-facturing – the co-manufacture. We are a company that we have a partner with the oversea manufacturer and we import the chemical to the U.S., but we have not – we never participate in the manufacturing process. So, do – if we have to report a chemical, do we report it as contracting company or an importer? Susan Sharkey: In that situation, you would report it as the importer. For CDR purposes, the co-manufacturing is associated with domestic manufacturing and not import. (Ping Lee): OK. Got you. Yes. Thank you and that's all I have. Susan Sharkey: OK. Great. Operator: We have our next question. Please state your first and last name. Your line is open. To the person who hit star one, your line is open. (Lorraine Anderson): Hi. This is (Lorraine Anderson). I think you've already answered this question but I want to ask it again about co-manufacturing. Susan Sharkey: Certainly. (Lorraine Anderson): OK. So, what – in a co-manufacturing scenario, what if the contract company has an agreement with the producing company to submit all reports? Did I understand correctly that only the producing company can submit the CDR report? Susan Sharkey: There are two different methodologies. One is that the contracting company initiate the report and produce – and provide part of the information, but – and send the request to the producing company to report some of the manufacturing related information or for the producing company to report all of the information obtaining information from the contracting company outside as a reporting tool as needed. (Lorraine Anderson): OK. So then, it would – if it's a single reporter scenario, then the producing company would have to report. Susan Sharkey: Yes. (Lorraine Anderson): OK. All right. Thank you. Operator: We have our next question coming from the line of (Trev Bahal). Your line is open. Hello, (Trev), your line is open. You may ask your question. Susan Sharkey: (Trev), it seems like we're having problems hearing you if you're asking the question. If you could go ahead and e-mail it to ecdrweb@epa.gov and we can address your question that way. Operator: Moving on to the next question, we have our next question from the line of (Matthew Taylor). Your line is open. (Matthew Taylor): This goes back to the previous question about the slide 36 with the volume used at the reporting site versus directly exported. So, if you have a product that's made and then diluted with a different, non-manufactured chemical in the same pot and then shipped out as a separate product, does that – the original manufactured material – is that 100 percent used at reporting site, zero percent directly exported? Susan Sharkey: It'sright because you're processing it by turning it into a mixture at your site and then shipping it off site. So, you do have the processing on your site and then it would be used on site. (Matthew Taylor): OK. And then as a follow up to that, so the used – like the used code or whatever for that chemical does then that be there? Is the used code for that, the blending, in the industrial setting or is the final used code for the finished, diluted material? Susan Sharkey: It would be the incorporation into a product, the blending at the site. Yes. (Matthew Taylor): Great. Thank you. Susan Sharkey: Certainly. Operator: We have our next question from the line of (Mark Francis). Your line is open. (Mark Francis): Yes. My question is really in regard to the new byproducts exemptions, slide 49 of the first slide deck. Question is related to byproducts manufacturing in non-integral equipment pollution control equipments, boiler equipment as examples. The question is, if that applies to byproducts only to if applies only to byproducts that are actually manufactured or produced within the – within the pollution control equipment or if it applies to byproducts that are collected by the pollution control equipment? In other words, does it only apply to chemicals if a chemical reaction occurs within the pollution control equipment such that manufacturing it is defined actually occurs within the equipment itself? Or does the exemption apply to perhaps where you're just collecting a dust within that pollution control equipment. Susan Sharkey: No. It's the former. It's byproducts that are actually manufactured in the pollution control equipment. (Mark Francis): OK. So, the equipment is just collecting the byproduct, the exemption doesn't apply. Susan Sharkey: That's correct because the byproduct would have been produced elsewhere as part of an integral process. (Mark Francis): OK. Thank you. That answers the question. Susan Sharkey: OK. Operator: We have our next question from the line of (Gil Lesto). Your line is open. (Gil Lesto): Yes. Can you hear me? Susan Sharkey: Yes. (Gil Lesto): Good. I have a question. I have been struggling with slide 49 also. So, if you – for example, we acidulate a product which we then further distill. During this acidulation, it releases sulfur dioxide which we capture in a scrubber. That sulfur dioxide that we capture in the scrubber we then send to a customer who uses it. Is it still exempt if it's made in that pollution control equipment? Susan Sharkey: I think I would need a little bit more information about that particular scenario. Can you e-mail it to ecdrweb@epa.gov so that we can consider it more directly? (Gil Lesto): Sure. Susan Sharkey: Thank you. (Gil Lesto): Will do. Operator: We have our last question. Please state your first and last name. Your line is open. Male: Hello? Susan Sharkey: Hello. Male: Yes. Can you hear me? Susan Sharkey: Yes. Can you state your name please? Male: Yes. I'm Sidharthur. My question is – can you please touch on who are required to submit 2020 CDR report? I'm not sure if we are required to submit CDR report. On slide 8, it is mentioned if we manufacture any chemical substance or import any chemical substance are meeting this threshold quantity then we need to report, right? Susan Sharkey: That's correct. Male: Yes. But we now – when you say import, import from outside of United States of America, right? Susan Sharkey: That's correct. Male: And if we – we don't directly import but we – if we buy any chemical from any supplier within U.S.A., is it considered as import? We don't know if that supplier is importing from outside of U.S.A. Susan Sharkey: So, if you are not the one that is importing the substance, the person responsible for the – for importing the substance is the entity that is required to report. So, if you are procuring from a domestic supplier and are not considered an importer of the substance, then you would not need to report and the person who did the importing of that would have been responsible for reporting. We do have a fact sheet on importers. We have not yet updated it for the 2020 reporting but we will within the next – it will be updated before the reporting period starts. But for this aspect of it, you can rely on the 2016 fact sheet for some description of how to determine if you're the importer or not, that there is a definition of importer that you can use. Male: Yes. And my next question is – we are not manufacturing any chemical substances but we use chemical as part of manufacturing our products. So, do we need to report? Susan Sharkey: You do not need to report for chemicals that you purchased. And depending on the activities when you're using the chemicals, you may end up producing a chemical that is reportable as perhaps a byproduct. So, you do need to look at your overall process and see if you are manufacturing anything that does trigger the need to report. Often, if you're say just mixing chemicals together and there's no chemical reaction where you're creating a different chemical substance, then you would not trigger the need to report. Male: OK. That means we are not required to report that chemicals that we purchased? Susan Sharkey: That's correct. Male: OK. All right. Is there any contact number in case we have any questions we can contact you? Susan Sharkey: Can you please send an e-mail to ecdrweb@epa.gov and I have a team of people who can help answer the questions no it's not just relying on me. Male: OK. Thank you. Susan Sharkey: Certainly. Operator: We have our next question from the line of (James Lee). Your line is open. (James Lee): (Sorry). It's me again. One more question about the CBI substantiation. There is a recent rule that gave eight questions on CBI substantiation. Are those eight rules – eight questions are going to be on the CDX now or is it different? Susan Sharkey: They are going to – we have a series of questions that need to be answered depending on the data element that you're claiming as confidential. And it's all incorporated – you'll access them as part of the reporting tool when you move through there. If you would like to see them ahead of time, they are in the regulatory text and you can take a look at the rule that was published today. And I don't know. Do you need the docket number? (James Lee): No. I have it. Susan Sharkey: OK. (James Lee): Another question – so, with the inactive and active recent rule, we have obligation to do substantiation – CBI question. So, do we still need to do those inactive/active substantiation process even though we're going to be doing CBI substantiation through CDX? (Are they two separate rules)? Susan Sharkey: Each time – right. So, each time you submit information to the EPA and claim that information as CBI, then it's considered a new claim and requires a new substantiation. For the information that you're submitting through CDR, you would need to provide the substantiation. (James Lee): OK. Like at the both for CDR and for the inactive/active substantiation rule you're saying. Susan Sharkey: Yes. Carolina Falaiye: Yes. Susan, just to add to that, they are captured into different applications. So, they are kind of separate. Those will be part of the section A for the notice of activity. So, that's kind of different from CDR. So, yes, you are required to answer those questions separately. (James Lee): OK. Operator: We have our last question coming from the line of (Trev). Your line is open. Hello to the person who has pressed star one on the telephone. Your line is open. You may ask your question. (Trev Bahal): Hello? Susan Sharkey: Hi, (Trev). (Trev Bahal): Hello? Susan Sharkey: (Trev), can you hear me? Operator: Yes, sir. Your line is open. You may ask you question. (Trev Bahal): Can you hear me? Susan Sharkey: Yes. (Trev Bahal): I have a question about – is the agency still treating hydrates as mixtures under this version of the rule? Susan Sharkey: Yes. Hydrate is still a mixture, so you would report the anhydrous version and not include the water part of the production volume. (Trev Bahal): OK. Thank you. And second and last, when does the agency anticipate to publish all 2020 guidance documents instructions and the sample Form U on the 2020 CDR website going forward? Is there a precise date when that might appear? Susan Sharkey: It will appear by June 1st. We will be putting documents up as we are able to. The draft instructions and a draft Form U printouts from the reporting tool are currently on the – in the docket as part of the ICR addendum that's accessible there. (Trev Bahal): Thank you. Meredith Comnes: Great. Thank you to all who have participated in the question and answer section. We have reached the end of our webinar. It's now 3 p.m. and we need to close the line. I appreciate everyone calling in today and for engaging with the slides as well as staying on the line to participate in the question and answer section. If you have any more questions or if you think of anything in the near future, please contact us at ecdrweb@epa.gov. Again, that E as in elephant, cdrweb@epa.gov and we will do our best to respond to you there. And thank you to Tom and Susan and Carolina for presenting today on this webinar. I am going to close out the line and pass it over to the operator. Operator: This concludes today's conference call. You many now disconnect. Presenters, please stay on the line for the post-conference. END EPA Moderator: Meredith Comnes 04-09-20/1:00 p.m. ET Confirmation # 6138247 Page 48