Good afternoon on Dr. Debbie Lander, a Senior Risk Assessor at the Chemours Company working in the space for over 15 years.  I'd like to say we are also committed to being a stakeholder in the implementation of the Frank R. Lautenberg Chemical Safety for the 21st Century Act and I appreciate the opportunity to comment today.  We will incorporate my comments in the written comments provided.  As the Frank R. Lautenberg Chemical Safety for the 21st Century Act is a risk based statute the importance of having high quality reliable exposure data is really necessarily elevated.  The exposure data must also be fit for purpose.  As an international chemical company we've been doing exposure and risk evaluation all over the globe over the last several years and we have observed that detailed exposure for the downstream use has led us to models to screen for exposure and one of the models is an exposure and risk evaluation tool that allows a non-expert to conduct a screening level assessment of exposures and you can basically get a snapshot all in one tool as to what the level of exposure is for screening purposes and screen out what you need to focus on.  This tool has also been adopted and implemented in other tools using the TRA tool for reliable regulatory decision-making with the minimum amount of data at the screening level.  The risk can be in an integrated approach and communicated in a manner that's relative and understandable.  We encourage the EPA to explore this tool for the high-quality implementation of the statute.  These tools can be particularly helpful of the scoping and screening step of the risk evaluation process.  Funding the use scenarios of greatest concern eliminating from concern the pathway scenarios unlikely to present a risk by using inputs and assumptions will allow EPA to focus expertise in the right places and conserve resources.  Once screening-level assessments are conducted for the scenarios that remain in the refined risk evaluation step we encourage the EPA to use probabilistic approaches that rely on high-quality data.  A probabilistic approach will prevent reliance on data approaches and may not be producible.  We also encourage EPA to continue to improve the transparency and clarity of exposures ensuring that all default assumptions and uncertainties are clearly articulated to help everyone understand the process.  These recommendations are consistent with section 26 of the statute which requires EPA use the best available data tools and still allow EPA to ensure protection of highly exposed susceptible populations.  In addition, EPA should focus valuation on populations that are reasonably exposed under approved conditions of use.  Finally, I would like to note that engagement within and across the industry is essential for reliable decision-making especially when it comes to having accurate and high quality exposure data.  We encourage EPA to engage industry early in the process when data gaps are identified.  It's likely the industry will be able to provide important exposure information to provide the quality risk evaluation.  This should include not only manufacturers, byprocessors, and downstream users.  Thank you again for the opportunity to provide comment today.  That's all.

Speaker 40: James Williams, Environmental Technology Council
Good afternoon my name is James Williams I serve as Vice President of Governmental Affairs for the Environmental Technology Council.  We are a leading trade association that represents industrial and hazardous waste removal treatment and disposal industry.  I would like to thank EPA and the staff for providing this forum today to allow us to present comments.  With the signing of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, EPA is required to issue a rule no later than one year after commencement that would establish a process to conduct risk evaluation to determine whether a chemical substance presents an unreasonable risk of injury to human health and the environment.  In making this determination Congress believes that improper disposal should be considered a means by which exposure to human health and the environment is achieved.  This was evident by the fact during the TSCA reform legislative process both the House and Senate saw to address this issue when they included important language in both versions of the bill that stated, "if the administrator determines that a risk to human health and the environment associated with exposure of a chemical substance could be eliminated or reduced to a significant extent under the solid waste disposal act the administrator should uses the authority to protect against the risk."  Members of Congress further expanded on this issue when senators and the committee chairman James Inhoff placed in the Congressional record dated 6/7/16 the language explaining what Congress' intent was as it related to the usage of the solid waste disposal act as a mean of proper disposal of TSCA chemicals when the administrator determines that a risk to human health and the environment associated with disposal of chemical substance could be eliminated or reduced to a significant extent by using said act.  We support Congress' position and recommend when EPA evaluates chemical substances to determine if they pose an unreasonable risk to human health and the environment that improper disposal be considered a means by with the exposure is achieved.  Additionally, when the evaluation process results in a determination that a chemical substance does present an unreasonable risk of injury to human health and the environment, that such chemicals be properly disposed of at written permitted facilities.  The Resource Conservation and Recovery act resulted in a natural infrastructure of regulated facilities that are capable of properly disposing chemical waste.  For example, member companies dispose of chemicals at their facilities and likewise most TSCA chemicals are considered organic and high-temperature incineration would be the best method for proper disposal.  In addition, these facilities have stringent emission control such as maximum achievable control technology for those chemicals disposed of in landfills they would go to a permitted landfill that has double synthetic liners, groundwater control monitoring systems and corrective actions required under the law.  It's worth noting that the only time EPA has regulated disposal under TSCA is for PCBs to be disposed of at TSCA permitted facilities.  This section has consistently been duplicative since the only facilities with TSCA permits for disposal are permitted facilities.  With this being the case following the risk evaluation if a high priority chemical substance is found to pose an unreasonable risk to human health and the environment as a result of improper disposal such chemicals should be disposed of at a permitted facility.  Let me be clear we are not proposing that TSCA high priority chemicals be classified as hazardous waste.  We are recommending disposal be considered in the risk evaluation process as a means of exposure and finally, EPA should be able to use the authority to ensure those chemicals are disposed of at permitted facilities.  Thank you for the opportunity.

Speaker 41: Sarah Brozena, American Chemistry Council
Thank you.  My name is Sarah Brozena.  I am a Senior Director with the American Chemistry Council regulatory and technical affairs department.  I have been working with ACC on their support for TSCA modernization since 2008.  I wanted to highlight three points today.  First off I want to speak to the characterization of what you all are thinking about doing as a procedural rule.  And note that as I read the Lautenberg Chemical Safety Act section six as well as legislative history I don't think Congress merely meant by the phrase "establish by rule a process", just a legal procedural process.  I want to draw that distinction because section 6(4)(B) says EPA must establish a process by rule a process to conduct risk evaluations in accordance with subparagraph A, subparagraph A then lays out the general standard by which EPA must conduct risk evaluations to determine whether chemical substance presents unreasonable risk without consideration of cost including unreasonable risk to exposed subpopulations identified as relevant to the risk evaluation under the condition of the use. So, a lot is packed into that subparagraph A but it is all about determining risk.  So the requirement to establish by rule a process is as much about a scientific process of conducting the risk evaluations as it is about the legal procedures for doing so.  So that is really my first point that I wanted to bring up and suggest that really EPA has to certainly lay out the procedural steps and timelines by which EPA will initiate a risk evaluation, publish it, deal with requests from manufactures to evaluate chemicals, to receive public comments, all of those procedural things, but at the same time lay out a process for evaluating and determining whether a substance presents an unreasonable risk under conditions of use.  This takes me to my second point which is really one about the need to read section six and section 26 together; they can't be read in isolation.  Section 26H has been hit on by commenters today and really requires EPA in any of its decisions to address these and use information, technical procedures, measures, methods consistent with the best available plans and it specifies what some of these considerations must be.  The scientific information must be reasonable, consistent with the use of the information, relevant to EPA's decision, documented with clarity, the extent to which variability in independent verification is peer reviewed.  Another key provision in section 26 is of course the provisions relating to the weight of the scientific evidence and my colleague Kimberly just went into that and I think bottom line there is it really is all about EPA's judgment of the quality of the information used to make the science decisions under section six and other provision, so EPA has to read these provisions together and read them together in the risk evaluation process role.  My final point is about rules versus guidance.  Commenters have said that this rule should be simple process procedures and EPA it may in fact, believe that the section 26 science standards best available science and etc. can be built into guidance on risk assessment, but there's a difference here. The law really mandates EPA's consideration of these important scientific concepts.  They are not just guidance, they are legal requirements that should be addressed in the rule, so bottom line, in our view the greater certainty EPA can provide and the Risk Evaluation Rule about the risk evaluation process that EPA will be applying under this new law, the greater the consistency in EPA's decision-making on the chemical risk, the greater the reliability of the information to make decisions, the better opportunity EPA will have to meet the deadlines under this law and with all of this should come greater public confidence in EPA's regulation of chemicals.  Thank you so much for the opportunity to comment.
Speaker 42: Karyn Schmidt, American Chemistry Council
I'm Karen Schmidt also from the American Chemistry Council, Senior Director as well so as I've been enjoying the afternoon I've been dying to say something about the Olympics and it is finally my moment.  One of the things we did not talked about today is international cooperation and the use of things internationally.  The Olympics brings that to mind so we will talk about that briefly.  We do think that EPA's risk evaluation process should include reliance on the assessments of other jurisdictions notably Canada and the EU when exposures and conditions are consistent with those in the U.S.  That's not going to happen all the time, but it will happen a lot so we should be actively looking for those opportunities to share those assessments and use them.  The assessments of course have to be of sufficient quality and they are going to have to meet standards and also best available science and weight of the evidence meet those criteria. We think this is an excellent opportunity for EPA to save itself some work, use those international products and further the purposes of the Lautenberg Act itself.  We also wanted to point out there some really important learnings from the partnership under way between the U.S. and Canada under the RCC and should also be incorporated in EPA's risk evaluation process.  We believe the information and evaluation of that information particularly concerning use and exposure patterns is greatly enhanced when the entire supply chain is engaged as is here today in the discussion with EPA, with the regulators and we hope EPA will integrate stakeholders fully into the risk evaluation process under the new act.  We've heard a number of commentators make that same request today.  That is the end of our Olympic moment but we have one more request of EPA and that is during the risk evaluation process we would like to ask that intellectual property interest continue to be maintained and respected.  We appreciate the CBI protections continue under Lautenberg Act, but it's going to be very important they be strong and certain protection throughout risk evaluations if the U.S. can maintain its global competitiveness. Thank you for this opportunity and on behalf of ACC, thank you for the additional time to submit written comments.  We find that very helpful as we think about the excellent feedback we've heard today.  Thank you.

Speaker 43: Rosemary Ahtuangaruak, Native Village of Nuiqsut
My name is Rosemary Ahtuangaruak from the Native American Village Nuiqsut.  This process is very important as we are facing a lot of concerns.  The Arctic environment brings chemicals from all over the world and they get into our bodies and food and our future generations.  This process is really important, but we also cannot be a person on the side of the process.  We need to be engaged fully and know all the information that is going into this process, even the data points of what is being done.  Our people are at the center of some of these concerns with the introduction of over 120 different chemicals in our body.  If our priorities and who we are as Tribal people is not brought into the process effectively, if you don't eat the tons of traditional foods that we eat and if you don't take into consideration the way we live our lives and our exposures are different than other people, that assessments are not done in ways that are helpful to us as well as our concern for the way that the process is built into the community. There's been a lot of good comments, but for our Tribal people, we are going to be included in this process in ways that others are going to include us but it can't be at a token process.  We need to be included in this process for generations to come.  It did not take one year to get accumulation of chemicals into our bodies, it's taken generations and in this process we need to grow the understanding of what's happening to our bodies into generations and we need to have this process where it's looking at the information of the chemical exposure risks and take the concerns into the grounds and waters where the people who live and are being exposed to these chemicals looking at it.  A tremendous amount of change happening in our environment changes the effects of what studies have been done in the past without the protective mechanism of the frozen Arctic, the increased risk factors for the rapid meltdown of our ice pack and the amount of exposures that occur, but if we are not looking at the way the environment is changing and the way the exposures are occurring then we are not getting a full assessment.  Our community needs to control our data.  We need to be in this process and control the process of reports and science that's being done around our bodies.  We can't be engaged with a process that takes our bones into another process and take samples and assesses.  What is happening to us, if you look at our bodies and our bones, you need to come to our community and work with us in the process as we go forward because we need to know what is happening for the generations.  Many of you will be doing studies and you will see our families will continue to live in the Arctic and the communities into the generations and our process cannot be dealt with and many others who want to do good work, but not come to our village to look at what is happening to us so thank you all for this opportunity to communicate.  Please take into consideration that this process really has to be a proactive process.  It needs to be cautious and needs to be preventative, but needs to be protective.  It needs to tie into the regulatory process and not allow statistics to continue to increase.  There has to be a reaction to the contaminants and the risks that are being identified so the process moves forward in a good way and not allow business to continue as usual.  We want to be engaged in a good process.  Thank you very much.

Speaker 44: Aryenish Birdie, Physicians Committee for Responsible Medicine
Hello.  My name is Aryenish Birdie and I'm the Regulatory Policies Specialist with the Physicians Committee for Responsible Medicine.  We promote test methods over animal testing because these methods often provide more reliable information on how humans react to chemicals and the author of the new law agrees  -  tests that require the EPA to reduce the testing with animals.  This core principle must be included in all evaluation decisions.  The EPA must also apply a tiered testing strategy under which the results of screening level tests or assessments available information should inform the decision as to whether additional tests are necessary.  Assessing chemicals requires additional approaches.  For existing chemicals, non-animal testing can more quickly provide additional data to help assess chemicals rather than in vivo testing.  In addition, adverse outcome pathways are one tool that can be used to reduce uncertainty, increased confidence without asking for new in vivo data.  For new chemicals EPA has a responsibility to facilitate use of existing data and not animal tools.  EPA can do this by making health and safety data available, collaborating with stakeholders, training and outreach activities, and creating a fast-track system that uses creative approaches to assess chemical hazards.  Chemical producers have a responsibility to minimize animal testing.  There's a mandate on any person developing information on submission on a voluntary basis to first attempt to develop information using non-animal test methods when available.  Many resources are available for companies to better understand potential effects of chemicals such as the search toolbox which is software intended to fill those gaps needed for assessing the hazardous chemicals, a portal for a chemical search and procurement, the roster of test guidelines contains many in vitro tests methods and a comprehensive resource for scientific resources for alternatives to animal testing, a wiki for testing and development and tools including EPA's website.  We can also be a resource to any company looking for more information on these methods or wishes to switch to non-animal methods.  This will allow us to ensure better protections for humans and the environment and we look forward to being part of this process as it unfolds.  Thank you.

Speaker 45: Jennifer Sass, NRDC
Hi.  I'm Jennifer Sass with NRCD, the Natural Resources Defense Council.  Thank you for the opportunity to give comments.  I'm going to touch on some major bullet points and of course, we will be turning in written comments on the twenty-fourth.  That's almost completed and they are substantial and I know you are super curious as to what I am going to say, but I am going to hold them until the twenty-fourth and just to give you the bullet points.  First of all, it's particularly critical that EPA do a thorough, modern, credible, health-protective risk assessment.  That EPA now has not only the authority from Congress a mandate to review a specific number of chemicals with deadlines and Congress clearly intended EPA to focus on issues relevant to underserved and vulnerable populations and other commenters touched on that better than I could.  Implications are now greater than they were before since they will have some degree of preemptive effects on states putting greater responsibility on EPA to be health protective and timely.  EPA must not use TSCA to continue to appease the chemical industry by falsely exonerating chemicals either based on poor data, a lack of data or unsupported or presupposed mechanisms or other means.  Implementation of new TSCA poses a critical test to EPA's ability and credibility to protect the public after decades of failures.  Examples asbestos, BPA, flame retardants, things we are still dealing with.  EPA must get serious about implementing some recommendations from National Academy's reports, particularly the Silver Book Science and Decision and the review of the IRIS program and some of the improvements that they have made that the national academies identified.  In particular I want to elevate some of those recommendations and then again we will expand on these in our written comments.  First of all, systematic review, transparent, credible and a systematic approach where we were very impressed by where the national toxicology program is doing as well as the IRIS program.  Conducting accurate assessments of aggregate exposures and also accounting for cumulative exposures.  More detail there and we also have some comments on your guidance as to that.  Using accurate exposure models: we understand EPA will rely on models so making sure those also go through a process to make sure they are accurate.  This is possible and consideration of exposures to vulnerable populations in all of those steps.  Risk estimates and linearity presumptions for both cancer and non-cancer endpoints should be done the same way and that was one of the recommendations in Science and Decision and extending non-threshold assumptions to all carcinogens not just mutagens as is done by the state of California.  Epidemiologic data provides real world important information about people and real-world exposure scenarios including scenarios that are spills, explosions, accidents, things like that and also of course, workplace exposures that happen so very important data to include and also considerations of differences in susceptibility.  It is very important that EPA use the science-based default uncertainty factors as was recommended in numerous national academy reports including Science and Decision and the use of mechanistic information or pathways should not be used to replace health protective defaults or explain away potential hazards.  If we don't know the mechanism that should not be a requirement for knowing that something is hazardous.  The EPA is charged with protecting our health and of course, the health of the environment and it will help its mission and improve the scientific foundation of its decisions by making the sensible recommendations part of the standard practices going forward under the amended TSCA.  Thank you.

Speaker 46: Robert Skoglund, Covestro
Good afternoon, I'm Bob from Covestro.  We are a manufacturer of high tech polymers applications and products that touch every aspect of modern life today.  Our vision to make the world a brighter place is fulfilled through leading technologies and products that benefit both society and the environment.  Covestro advocated for the modernization of TSCA and is committed to the success of the Lautenberg Chemical Safety Act primarily to increase the confidence in both EPA and our industry chemical management practices.  Fundamental to the success of the Frank R. Lautenberg Chemical Safety for the 21st Century Act is a robust, transparent, reproducible, and defensible risk evaluation process.  The following are several key elements of such a process.  The evaluation of the potential hazard must be based on weight of evidence approach.  Obviously this has been brought up by a number of speakers already.  It can't be based on a strength of evidence approach.  Relevant information both positive and negative must be considered as the most weight or consideration must be given to the most relevant and highest-quality information.  Furthermore, to ensure consistent application, it would be beneficial to have a set of priority criteria by which quality and relevance of information is evaluated.  Information that is limited relevance and/or poor quality has the potential to cloud the outcome of the risk evaluation and should be excluded.  It is important to ensure that all relevant data are made available for these evaluations including data that has been submitted.  It's important that EPA work with members to help make this happen.  The evaluation of exposure must take into consideration the reactants and products of reactant chemistry and the limited availability of a chemical after it's been consumed during its intended use.  Furthermore the kinetics of these reactions can also impact exposure during the processing and use of these chemicals.  Exposure associated with reactive chemistries are very different from those associated with non-reactive chemistries and the tools used for assessing exposure must account for both of them appropriately.  And finally, it is critical that the development of the risk evaluation process and robust input and peer review from all stakeholders and that this input begin early in the process.  In addition, in order to ensure consistency with best available science, EPA must be willing to seek out and welcome the input of experts in the various disciplines involved in risk evaluation.  Thank you.

Speaker 47: David Sarvadi, Keller and Heckman LLP
I feel especially privileged to be here today because I was around when this whole thing started.  I started my career in Washington working for what was then known as the Manufacturing Chemist Association.  Those folks that ACC may not know that was the name at one point in time and I was the staff representative that worked setting up the new chemicals program review process so I'm familiar with that.  I'm presently a partner at Keller and Heckman.  Most of you know the firm.  I wanted to make a couple of points about risk evaluation from the standpoint of exposure assessment.  One of the things that I have observed over the years is the valuations of exposure tend to be to qualitative in nature.  Somebody says high, medium, low and we take that as an acceptable approach.  It's really important to be much more numeric and metric about that.  What we measure gets controlled and accepted.  What we don't measure and what we just estimate tends to lead to inappropriate decisions.  Conditions of use are going to be a big topic in the new TSCA.  One of the things you want to watch out for is be careful not to get too specific.  The notion of Sentinel exposures I think you might be able to learn something from OSHA in some of their chemical standards, particularly asbestos, lead, and some of the others.  There's an initial determination process you have to go through in order to determine whether or not your operation should be regulated and that initial determination has to be based on an assessment of what you believe to be the highest exposure and one of the earlier comments mentioned the fact that's one of the things you ought to be looking at as you go through and evaluate the different types of uses, look for that Sentinel exposure, the one that is the highest and when you take that into account, look for the most number of people involved.  So it's always a combination risk to the population; it's always a combination of the number of folks involved and the exposure.  I want to make a comment about the assumptions that are used.  In my experience there's a lot of conservatism built into the process.  We make assumptions that conservative assumptions about the so-called default factors that are used to adjust for exposure and for hazard and toxicity.  In my experience, there are two examples I can give you of overly conservative assumptions and exposure assessment.  One is the use of standards in OSHA that is the basis for an assessment of workplace exposures in the absence of data.  15 milligrams per cubic meter is the number OSHA has in its standard.  That number in a room like this would mean you could not see the end of your hand.  That's how much dust is in the air with that kind of concentration, so one thing EPA should do is go out and ask industry and other interested stakeholders to comment on the default assumptions and one of the things that could help the process of getting the new chemicals and existing chemicals that have Significant New Use Rules to have better data is to include those assumptions in the forms that are used to submit the information so that the person who is submitting it knows what the default assumption is and can provide you with additional data on the potential exposures.  One last point about this, another example, my experience with some of the PMN chemicals we help clients with before, there is an assumption that releases to water just go through either to the treatment system or out into the environment and it tends to discount the NPDES system where chemical releases are controlled through that process.  Finally, I just want to thank you for the opportunity to comment on this and wish you luck.  This is going to be a very interesting process.