Preparing for 2020 CDR Reporting

With the next Toxic Substances Control Act (TSCA) chemical data reporting (CDR) season beginning June 1, 2020 through September 30, 2020, and the proposed revisions to the CDR not yet finalized, you may be left with questions on how to best prepare for reporting requirements.

To help you organize and prioritize your reporting preparations, we have gathered insights and provided them in easy-to-digest video snippets.  Watch all the videos in one sitting for a comprehensive overview, or just click on the topics you need to get started.

If you have any questions after watching the videos, we would be happy to answer those for you. Our subject matter experts are trained on TSCA requirements and have extensive experience interpreting CDR reporting requirements.

TSCA Overview and History

The Toxic Substance Control Act (TSCA), passed by the United States Congress in 1976, is administered by the Environmental Protection Agency (EPA). The law governs the use and safety of chemical substances manufactured, processed, or imported in the United States. Governing over 86,00 industrial and consumer chemicals, TSCA is intended to assure the protection of human health and the environmental from unreasonable risks associated with these chemicals. In 2016, TSCA underwent significant changes and revisions when the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA) was signed into law. Watch this video to learn more about the history and governing regulations of TSCA.  


Lautenberg Act Reformation – 2016

2016 marked the beginning of a new risk-based process for TSCA with the goal of building a safer inventory.  But what has that process looked like? In the four years since the Lautenberg Act was signed, EPA has performed an inventory reset, undergone a new chemical prioritization cycle, implemented a risk evaluation phase, and begun developing risk management actions.  Several new framework rules have been developed, some of which have not yet been finalized. Watch this video to learn what’s happened with the reformed TSCA since 2016, what to be aware of with regard to high and low priority substances, and key upcoming deadlines.


CDR Reporting

CDR reporting occurs every four years and is probably the most interesting and important TSCA requirement.  Manufacturers must report data based on each physical site location, whereas importers must report based on headquarters records.  There are numerous reporting exemptions for companies to be aware of, including some partial exemptions to the extent of required reporting.  Watch this video to learn what has changed since the 2016 cycle and how to best prepare for the 2020 cycle, which starts on June 1, 2020.


Import and Export Certification, Allegations/Substantial Risk

These topics may not be as important as the CDR or other compliance factors for some businesses, but they are still worth your attention.  For importers and exporters, attaining proper certification not only keeps you in TSCA compliance, but also reduces possible disruptions to your business operations.  Additionally, organizations are required to report chemicals to EPA that have previously unknown adverse reactions or new exposure risks. Watch this video clip for a summary of these requirements with key takeaways.


Reporting and Recordkeeping Requirements (RRRs)

If your organization is subject to TSCA, you’ll need to perform thorough reporting and accurate recordkeeping to avoid possible penalties.  Organizations typically run into compliance issues due to underreporting, chemical nomenclature issues, or faulty recordkeeping.  Watch this section of the presentation to learn key requirements and helpful tips for staying in compliance.


TSCA Resources

There are various additional resources, training modules, and helplines available to you as you prepare for the new TSCA.  Watch this video for some quick links and contact information you can use to get compliance advice and support. 


Contact Us

Andrew Pawlisz, DABT
Senior Scientist 

Full Video Transcript

VIDEO 1 - TSCA Overview and History

My name is Andrew Pawlisz. I'm a toxicologist with Trihydro Corporation. Today I'll be talking to you a little bit about the Toxic Substances Control Act or commonly known as the TSCA. I'll cover a range of topics. However, most of my presentation I'll devote to the upcoming chemical data reporting or CDR. Here's my contact information. If you would like to confer with me on anything on TSCA, I'll be more than glad to provide guidance and assistance.

I like to begin my talk with an overview of TSCA and its history, which I feel is quite interesting then we'll describe how the original TSCA was reformed in 2016, which was relatively recently then I'll describe what the new TSCA looks like and also highlight the very significant reporting and record-keeping requirements or as I call them the RRR’s associated with this law. I would like to point out some of the practical aspects that you might find useful as you comply with TSCA.

TSCA dates back all the way to 1976. And of course we had a different president in the Oval Office. We drove different cars. We listened to different music, even used very different equipment to listen to music. But without a doubt 1976 was right in the middle of the Golen era of environmental laws. Then, fast forward 40 years to 2016.

The law underwent significant change with preservation and the overarching component of it is that it's highly science-based risk assessment paradigm and the risk management that goes with it in currently covers over 86,000 consumer products so it’s an umbrella type of regulation for chemicals.

The primary intent of TSCA, especially the reformed version of this law, is the comprehensive assurance of the protection of human health in the environment from any unreasonable risks that these chemicals industry or environment consumer goods may cause. And there's distinction or indication that the law does not really differentiate whether these chemicals are in fact produced domestically or whether they are imported.

So as I mentioned befor, it’s an all-encompassing and an umbrella type of regulation that indeed applies to the majority of chemical substance in US Commerce. It applies to existing chemicals as well as the new chemicals or new uses of existing chemicals.

With intent of ensuring the protection of human health and environment, EPA has developed a number of new rules. And those have been or are currently being implemented and others are still in development phase but nevertheless I think the new TSCA appears that there is focus on audits compliance with this law. The issuance of violations enforcement and fines whenever I get questions about any issues with TSCA, particularly in their interpretation of the law, EPA has great guidance with that respect but there's still questions and uncertainties.

I always refer folks to the original source, which is the CFR Title 42 and specifically this great online tool that EPA has and then you can have access to all these different aspects in various parts. And those are listed on the slides that you see in front of me. So I think the take-home message with respect to the new TSCA is always check with the primary reference source for this law.

VIDEO 2 - Lautenberg Act Reformation 2016

Looking at the reformed TSCA, there's certain aspects of it that have a certain pattern to it. And there's also certain milestones that can describe the overlying mechanics of the new law and the consistent with the intent of the looking at the former TSCA and then working with the reformed TSCA. I think the overall intent the goal is to essentially produce a safer chemical inventories and to do this EPA implemented a number of steps. And the first of them was the inventory reset. And through that was the first filter, so to speak. Looking at the collective inventory, the former inventory in determining which are actually being used a potentially old like to be used in current comments. So a lot of chemicals filter out or were not identified as something that was of interest to anyone and then the next step will be to prioritize that subset of former TSCA inventory chemicals to which are important which should be evaluated first. Once the prioritization is made, then the third step – the risk evaluation phase – can be implemented accordingly and then finally step 4 based on the results of those risk evaluations as needed certain risk management actions can be taken. So as you can see on a timeline, this inventory redo started back in June 2016 with a signing of the revised TSCA and then also the development of number of rules, and finally we are in 2020 and are well under way in its implementation.

And then looking at the practical aspects, there are some things that one should keep in mind. One thing is that there was quite vigorous initial activity in terms of developing of the framework rules. And then those rules were rather quickly implemented and then at the risk evaluation stage or step there were already 10 chemicals identified as priority and then additional 20 were identified as the next set of priority chemicals and there's two sets. There's the low priority substance, so LPS, and there's the other 20, which is the high priority substances. I think the main feature of the reformed TSCA is that by a rule that shall also always be many low priority and 20 high priority substances that are in effect.

So it means to the regulatory community is that there's necessarily vigilance required to make sure that whoever's in charge of monitoring tasks of developments and compliance is to stay on top of things and things move pretty quickly throughout this repeating cycle. There is numerous commenting opportunities on the some of the EPA’s deliverables documentation. There's also the requirement that some of these risk evaluations would be subject to fee recovery and I'll talk about that also later in this presentation, and also there's opportunity for the industry to provide information to influence any the rulemaking or some of these deliverables that EPA is issuing.

So, you know, this is a very interactive and evolving in terms of the nature of the new TSCA. One of the steps I showed you in the previous slide was the filter whittling down of number of former inventory TSCA constituents. And this is what's called the inventory reset that process has been completed and here are some of the statistics that had currently the current TSCA inventory. There's about 50/50 split between the inactive and then active chemicals and some of the features of those former TSCA inventory chemicals is that with that notice or activation there are off they're simply not allowed in US Commerce or importation on the flipsides those that were designated as active they are in lawful status for their use importation providing the comply with the original uses as its registered and then those are the chemicals the rest of them in that active inventory pool that will be subject to subsequent prior authorization and risk evaluation cycles and also from the practical perspective the regulatory community should keep on checking whether that chemicals inactive. Commerce do indeed have the active status associated with them. 

So here are some of the practical aspects. And the inventory checking can sometimes be a little challenging because your initial search for some of the chemicals may not identify match, but this is not something that necessarily is done because the chemical is brand-new to us, but it may be very likely that it's an exam or it's claimed as confidential. So further investigation would be appropriate before taking any more actions. Now there is a standard of what information can be found and even reported it is two standard of reasonably known as sustainable, or in other words, What would one be expected to possess control over now? There's also the other aspect that's practical is that if you did go through the inventory reset you are required to keep your forms in your records for five years. So that's the housekeeping requirement.

Looking out that the next step is the proprietary cycle. There are certain features that are worth noting is that it's a continuous process and wanting some of the criteria for including anyone chemical as high priority or a candidate as high priority is it's hazardous nature persistence bio cumulative properties and necessarily toxicity. But there's another interesting aspect of this is that the conditions of use is also considered which is an attractive feature because the industry can provide feedback to EPA to tell them that although they may be persistent bioaccumulative and toxic but due to the particular nature of the use they really are not in contact receptor. So that's very important pragmatic aspect – this opportunity to influence that.

So here are some of the summary features of the 20 high priority substance list. Interesting component of that is costs are not considered in determining what is a high priority and once does chemicals and they divide us go priority, they directly fed into the risk evaluation stage and because it's a screening level type assessment those evaluations, in terms of the prior authorization, are conservative. They look at the subset of the populations and they could be depending your results of risk evaluation that could be subject to risk management or even bans in some severe cases. What's a little more complicated is for the lower priority substances industry has commented on is that this relatively high bar to any one chemical being designated as low priority.

Another aspect is that once the chemical is indeed designated lesser priority, they will not go into the risk evaluation phase. Nevertheless low priority substances can be called into the high priority evaluation at any time. So this is not a final designation. Some of the ethical aspects of the prior authorization. It's really good to constantly monitor EPA’s pipeline. In particular if there's anything on the high priority list potentially and those happen to be mission- or process- critical chemicals, it may be worthwhile to pay further attention and possibly influence the decision-making. And also one of that influencing characteristics that you may be able to provide information to better inform EPA on its conditions of use. There's also a high interest in lower priority designations, because these could be the low impact replacement chemistry's that might be of course, they will be less likely to be regulator. So that could be something of use.

A real quick overview of the risk evaluation. It's a fairly complex process. I'm not going to spend too much time on it. This slide is really just for your awareness that there's other aspects of TSCA. I talked about the overall scope in terms of the continues high priority low priority cycling. Talked about the approach of using the signs weight of evidence-based systematic reviews. And then there's certain milestones that one needs to be looking for is to scoping documents the problem formulation documents. And that's where the information gathering is taking place. At the end of the risk evaluation cycle, which can take up to three and a half years. There will be certain assessments conclusions and public disclosures made in terms of the need and nature of the risk management. Something that's actually current and now we'll talk about it later in this video is that the risk evaluation process is very costly. Millions of dollars. I've seen figures and those fees will be recovered from the manufacturers and importers and in some type of divisive way, but I'll touch upon those later on so stay tuned in terms of the overview of the practical aspects again, you have some bullets you can refer to but I think it's worthwhile to look a little deeper in those risk evaluation documentation to make sure that what EPA is looking at is consistent with the real world scenarios of the way these chemicals are actually used. So that's critical.

And then also another heads up that if you are somehow involved with the first 20 high priority substances identified by the EPA, and EPA even went as far as identifying and in fact, some of the business entities may be linked to these chemicals. You have a requirement to self-identify if you're not on the list by March 27th of this year.

VIDEO 3 - CDR Reporting

We are coming to potentially the most interesting in the most important component of my talk, which is an overview of the chemical data reporting.

Looking at the overall intent and the regulatory requirement, it's a reporting requirement that industry has to submit production and use information to EPA in a recurring cycle. This cycle is quite extended unlike some of the other chemical or pouring.

This one is every four years which some may indicate that could be a challenge because a lot of institutional knowledge is lost between the cycles. The staff trained or familiar with this reporting transitions out and then additional training is required. So hopefully this slide deck can help your organization with getting a refresher on CDR.

And then once the EPA received this information on a repeated basis from the industry, EPA keeps that information in an evergreen database and that paints a picture to the agency in terms of the entire universe that applied to the task of course of chemicals that are present that could potentially be an issue of exposure to workers consumers in environment.

And then of course and hopefully that will inform the overall reform tasks system where the ultimate objective is to produce a safer inventory.

As I mentioned before the reporting requirements to quite extended the last cycle was back in 2016 and if you remember the other slides the TSCA was reformed also in 2016, but that previous reporting cycle will still under the previous former TSCA rules and so what's distinguishing this cycle, the 2020 cycle, would be this first one ever under the new TSCA. So this is rather exciting. The reporting requirement will begin on June 1st of this year and run through September 30th also of this year and essentially will cover production in use data back from 2016, 2017, 2018, and 2019. Interesting aspect of this reporting is that there's certain threshold below which reporting is not required. So essentially EPA’s really interested mostly in the high-volume production or importation chemicals, and this is mostly for commercial purposes.

Another interesting aspect of this requirement is that unlike some of the other reporting requirements it is to be on facility-specific basis rather than organizational basis, unless you are a reporter and in that case it is acceptable to report the importation quantities and chemical identities. For example, at the at the headquarters of the organization there's also the question. Okay, fine. Well, which chemicals am I to report?

Well, the law says that it applies to individual chemical constituents, but also to all compounds with specific cast names and numbers. So one of those bulk compounds are known as the unknown a variable composition complex reaction or are of biological materials more commonly referred to as UV CBS. So even though they may contain many chemicals, individual constituents within it, they have been assigned a CAS name and number so that EPA is interested in reporting of those UV CBS.

This also requires if you have a mixture of individual components that need to be reported, even if you have a low voice that's solid. There's also potential for applicability to CDR and even solutions so liquids it applies to both organic and inorganic compounds and little bit of nuanced aspects of it is to intermediaries may also be need to be reported. Reaction products byproducts…has and what specifically excluded from CDR and actually in fact from the overall TSCA is the pesticides…food…materials. For some foods, drugs, medical, cosmetics simply due to the fact that they are covered by other US laws.

This is very important. There is number of exemptions that are available within the chemical data reporting which should be considered before producing the final CDR database candidate. The law says the polymers to be excluded in general microorganisms are certain listing of natural gas that not to be reported.

There's also the non-isolated intermediates in close continuous processes that exclusion also applies to. Byproducts with no commercial use if somehow they end up as fuel or are disposed of as waste and also, if they are feed stock for extracting another substance.

Looking at additional filter mechanisms, you have impurities at incidental reaction products.


And if in small quantities some of the research and development substances are excluded as well. And then the second to last bullet talks about the exclusion for any chemicals that might be imported as part of an article of an inert non-removable nature. And finally there's the exclusion for naturally occurring substances. But they must not be processed and there are subjects solely to physical processing and there is some exemptions and nuances that probably are not a good subject to dive to go far into this sort of recap type presentations. There is also that very useful feature in terms of the partial exemptions. By the rule processing and use information is not required for certain process petroleum process streams and low-interest substances, and there's certain CFR sections that there are listed in…with majority of rules and regulation. There's certain exemptions as noted.

So let's talk about the practical aspect of what one needs to do to prepare a CDR database. The main starting point is to gather the side information and the identity of the site has something fairly administrative nature then looking at the chemical inventories one means to identify its name and CAS number for each entry.

And then this is something that you would need later on is that you need to assess how much of that product or a special group of products was manufactured and or imported for each of the years dating back to 2016. And then there's the decision management point or decision point is the sum of all that of all the chemicals greater than 25,000 pounds in any year. And if it is then it is subject to reporting if it's less than that. It's unlikely there's some exceptions but it's unlikely and then with this 2020 reporting cycle for CDR, there's additional processing in use information that will be needed for the principal reporting year, which is 2019.

And as I mentioned in the previous slide, some of the petroleum streams may be exempt from a requirement, which is a very nice useful feature reduces unnecessary burden on your reporting requirements. Part of the CDR is also interesting is that because there is potential to provide confidential business information claim identity and its use if it's needed. And then a lot of folks ask is how deep I have to dig to get information because facility records change over time, ownership changes, staff changes, some of the records transition from paper form to electronic and not everything scanned was archived may even just being destroyed invariably. So how much information are we were responsible for and I think there is that general standard known as the reasonable ascertainable standard. In other words, available and attainable institutional data. Even simpler said -- If an EPA inspector can find it, chances are it should be considered as part of the available information to be searched.

And what's also interesting not only you are to look at your own process, but also the downstream process information which may require some type of coordination between the value chain members in terms of the information needed for the types of uses.

Those are also listed and there's some sensitive uses that EPA is highly interested in. Worker exposure using children's products the extent of potential exposure so number of Commercial Workers Exposed. This little bit of extra requirements need to be extracted as well.

All right. So then how do you submit that information once you have gathered it?  Everything is electronic so data can be entered electronically into the Central Data Exchange. This is an online system that EPA has. From the practical perspective, the data entry can be performed by multiple individuals who are cleared to get the access be it internal or external consultancy, for example, but the final submittal has to be by the authorized official so somebody who is qualified to submit documentation to US EPA.

I want to spend a few minutes talking about what changes have been made to the CDR reporting. I talked about how TSCA was reformed in 2016 and how the previous report was still performed under the old system. But now the CEO has been amended and there's number of amendments have been made since 1986 and the latest in fact still not has been published in Federal Register. It's in its final form and commenting period has been closed but it just not have been published just yet by the time of this video. And some of the rule changes are listed in these bullets. There is some exemptions for small entities exemption for byproducts simplified reporting and so on. I think that the overall intent of the latest amendment is to indeed reduce the regulatory burden, which is a positive development.

Now coming to the practical aspects of CDR reporting. I can never enough emphasize the importance of starting early. If you have maybe produced an interim reports on an annual basis, even though they're not required by law to be submitted. Maybe your organization has kept track of those yearly. That's great.

And if you have not, you have little more work to do prior to June 1st, but by all means do not wait to the last moment, even though you do have some time in the reporting window to submit your reports. Finding the reports in production volumes identity working out all the uncertainties in your data and QA/QC can take significant time. The other complicating component of producing CDR is that it's really not up to any single individual department. Often times, you do have to engage a multi-stakeholder team from regulatory compliance folks to production to procurement to marketing to engineering and even research as well as the legal department. So a lot of folks to visit with and get information from to be able to produce a good quality CDR database.

QA/QC is also very important for correct and accurate submittal of the CDR and perhaps, you can engage internal or external subject matter experts to make sure you're doing everything as to rule requires and it's consistent with EPA’s interpretation.

VIDEO 4 - Import and Export Certification, Allegations/Substantial Risk

The next set of slides we'll talk about some of the other aspects of the TSCA Rule and the reporting requirements. These may not necessarily be as important as the CDR or potential the risk evaluation and the fees that are subject. But nevertheless, I think they're important for some business sector. And if you are an importer and what it is, it's essentially a certification process required by TSCA… an importer of record is indicating to the US Customs agency that the chemicals indeed are indeed in compliance with the TSCA rule. And this is what so-called A+ certification so essentially you are stating that it's not in a violation of tasks or rules and regulation. There's also another type of certification is called the negative certification which simply indicates that this chemical import is not applicable to TSCA.

And there's what the positive certification maybe look like what agency might be interested in acquiring and I think this input certification is important early as required by TSCA and non-compliance can lead to two fines and other regulatory actions. But also it could be a serious business description where your input is being held by the border until their certification is produced.

In terms of the practical aspects. It's really each and every applicable shipment chemical is subject to certification. So if you are working with your broker, for example, each bit shall have the certification associated with it. There's constant changes in TSCA in terms of what chemicals are deemed as acceptable. So little bit of due diligence is required to ensure that the certification is indeed true and applies with TSCA. Application statements in the old days used to be a paper based but now it's all via electronic systems and customs and typically this is service performer brokers, but nevertheless if you do have a business relationship with the broker you can issue, let's say, on recurring annual basis most able to keep our clients when you provide them a letter that this shipment and they're listed here below comply with TSCA so they act on your behalf. So there's utility of those blanket paper-based certification. Having sufficient records is also important because as the rule states that if you act in a good faith to make sure that you did everything you could with in your zone of influence to ensure that the chemicals you are about to import indeed comply of TSCA. I fully recognize that there's other players in the value chain, but if you show to the inspector that you have followed the proper due diligence, the likelihood of adverse actions affecting your organization would be lessened if not eliminated. So something important to keep in mind.

So like the import certification is also a requirement to a lesser extent. We see it less frequently applied export certification. So really the intent here is to ensure that none of the controlled substance subject to TSCA rules are exported outside the country. And unlike the importation those certification can be done on an annual or one-time basis, but there is no minimum quantities to do that and there's no exemption. So that's some of the key features for that.

So here are the practical aspects some development monitoring and then if you haven't changed your inventory that you import you can sort of duplicate it with your broker. So I have a recurring touchpoint now. I would like to touch upon little bit on the other important requirement under TSCA. This is more maybe in terms of working with your staff employees. And this is the requirement by law in terms of allegations and substantial risk information reporting. So allegations focus on claims that a chemical has a new and the key word is previously unknown significant adverse reaction, but this is not something that's too common. And the other component of this part of TSCA is the substantial risk information.

So if the agency is not already aware of any spills of effects, there is a requirement to report to EPA or for example, if some novel chemical has unsuspected, previously unknown distribution and environment of there is a new type of exposure to hazardous chemicals or if there's new studies and serious effects. So this is the extent of the requirement to report. So in terms of practical aspects if the allegations reports of being made within the organization, there's the requirement for record-keeping of course, you may investigate those internally to determine if they are bona fide, but there is there is that requirement corporate and individual liability and penalties for failing to report.

And from the administrative perspective, the law requires employers to issue annual employee notifications as to their individual requirements to report allegation and substantial risks. I would like to touch upon the aspects of the new substances reviews and users. That the ability to identify and also assess the risk of any new produced or imported chemicals in US Commerce. And how are they used for the new users? There is a continuous requirement to ensure that they are in compliance with TSCA. So that specifically applies to the existing inventory. And for some reason if there are new substances to TSCA, they are indeed subject to pre manufacturing notices. They may have test-marketing exemptions, but nevertheless if there is new chemicals or even specific uses there's other notification and even registration is required.

So this is really a slide to just give you guys a heads up that beyond a regular let's say CDR reporting or anything else along those line one needs to remain vigilant in terms of making sure that the chemicals that you are using are in compliance with the new substances new users aspect of it. And if they're not, the specific procedure that EPA wants you to follow to make them so.

So here is the outline of the some of the practical aspects registrations of the chemicals might be needed and that could have consequences on your business if there's denials in applications. So there's the quantities of the type of exposure controls imposed that you were not anticipating the initial business plan and then frequently that also has consequences because you may already have invested significantly into research and development and you’re about to implement the marketing and the commercial application of those. So I think the Lessons Learned here is to make sure that your research and development department is engaged with your TSCA representative director or coordinator early on. There's also that aspect of value chain implication because there's a lot of players in the value chain and they may not know what's exactly in the products and whether or not these comply with TSCA, so that's another flag that you may want to think of.

VIDEO 5 - Reporting and Recordkeeping Requirements

Keeping accurate record-keeping. The EPA audits and there is specific requirements for archiving of really essentially all and any TSCA records as it pertains to this law. Typically you need to keep the records for five years.

Make sure that requirement is siding with your company’s retention policy…so make sure that the backup is also there. I think in general it's better to keep more records than fewer records. And I know organization these days we want to minimize the number of records kept for various reasons, but it's never bad idea to have little extra in case you are audited.

The typical pitfalls we see out there is underreporting. So when you do think about your next CDR, for example, make sure that you have talked and covered all the departments who may have the relevant information.

There's also frequently chemical nomenclature issues in this is particular with complex substances, which sometimes are confusing and they may not fall under the right category. But these are the nuances that you really need to seek an expert to help you with as well as your process engineers, and finally there's also faulty record-keeping. The inspectors are simply unable to find the records that he or she may be looking for or you have claimed that you have in your previous scenario.

Now we come to enforcement. So in this scenario that the EPA auditor may find that something is not quite right, violation would be applicable the task of law has significant strength in terms of implementation and enforcement. So there's civil penalties. And there's also criminal code enforcement for the worst offenders. The penalties are typically monetary penalties, but they run into ten thousands of thousands of dollars per violation per day. So if you have multiple issues over multiple days, they can add up pretty quickly and that can ultimately affect the bottom line of the project department or the business unit.

So certainly something that you might want to avoid and there's also ability to imprison the responsible company official. There was significant bipartisan support of the reformed TSCA. This program is very well funded. I think everyone is interested in making sure that it's fully implemented and as such there's rather vigorous inspections and enforcement going on. And there have been many cases of cumulative funds in the millions of dollars.

And then this is one of the last slides here before I switch to some of the resources that you may need in your line of work. A Look at 2020 and Beyond.

So one outstanding item is that when will the final CDR rule amendment be published in the in the Federal Register.

It's late February or now potentially March and certainly will be good to have that rule out by June 1st, which is the opening of the CDR season so to speak it is also not too long ago The confidential business information rule was issued in February 19 of this year and then the scoping documentation for the next 20 chemicals that high priority chemicals are about to be published and that's on March 27th for the self-reporting deadline. I talked about it in the other slide is that if you are somehow linked as a manufacturer imported, even if part of an article, which typically is excluded from TSCA, for one of the 20 high priority substances, you have the requirement to self-report by Mark 27 of this year. And then you may be assessed a certain portion of the overall cost of performing risk valuations. Now if you fail to self-report, there might be consequences as I mentioned before civil penalty most unlikely criminal, but that's what could happen to the organization.

Then we talked about the June 1st commencement of the CDR reporting and then later that month will be the final risk evaluations issued for the first 10 chemicals in that risk evaluation pipeline and so on. So at the end of this year and then going forward, there are some dates that are mentioned in the slide, but ultimately essentially from now on there is that continuous loop of risk prioritization, risk evaluation, and then risk management on the active current TSCA inventory.

VIDEO 6 - TSCA Resources

I constantly refer to these sources. The EPA’s website is very informative and is regularly updated. So it's great source of first information.

If there's some uncertainties, if I'm not too sure if EPA has covered it, then I go to the CFR web approach and then finally there's some training available by EPA on the website and help desks. Also great. Fantastic, these individuals are well-informed and most often can provide answers right on the spot. If they don't have the answers, they reach out to their experts or their supervisors and they are actually very responsive in terms of getting back to you. 

If this is something that you are unable or you just don't have the full information or you really you need hands-on support, we are capable of providing you as little or as much support as you need. So that range is anything from entire CDR reports to just consultations on a specific basis. So here's my information by all means if you could send me an email or give me a call.

Please reach out to these resources or to myself and, collectively, I believe you'll be in a good spot in terms of TSCA and also in terms of the refresher and general awareness of what the law means in terms of reporting, recordkeeping, and requirements.

Contact Us

Andrew Pawlisz, DABT
Senior Scientist 


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Andrew Pawlisz, DABT
Andrew Pawlisz, DABT
Senior Toxicologist, Tulsa, OK

Andrew is a board-certified toxicologist with over 20 years of experience in risk assessment and evaluation; hazard assessment; and regulatory compliance, including the legacy and reformed Toxic Substances Control Act (TSCA). Andrew specializes in finding practical solutions to regulatory and human health/environmental issues related to toxicants.
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