Document ID: EPA-HQ-OPPT-2019-0637-0008
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2020-05-04T04:00Z

Public Meeting on TSCA New Chemicals Program 
                               December 10, 2019
   Transcript of Introductory Remarks, Public Comments, and Closing Remarks
                                       
1.	Introductory Remarks

Alexandra Dunn, Assistant Administrator for EPA's Office of Chemical Safety and Pollution Prevention

Good morning, again, everyone in the room, and to the nearly 400 individuals joining us online. I'm Alexandra Dunn, the Assistant Administrator for EPA's Office of Chemical Safety and Pollution Prevention [OCSPP]. It is my great pleasure to welcome you all this morning to our meeting on the Lautenberg TSCA New Chemicals Program. As I know, by looking around the room, and knowing who is attending on the web, products that make our daily lives workable, functional, and comfortable involve chemicals. Smartphones, detergents, automobiles, they get better and better because companies like many in the room here, and those represented by many of you in the room, are constantly looking at the chemical substances that are available to us, and looking for ways to improve performance of materials and products. We are at EPA absolutely committed to working with all stakeholders from all perspectives to bring new chemistry to market in a way that protects public health and the environment while also allowing America's economy to grow. During today's meeting, you will hear quite a bit about our updated Working Approach Document and how we'll be using this Document to make decisions on new chemical submissions. We'll also be giving you an update on efforts to increase transparency, which is extremely important to us, and how we're improving our processes. We are absolutely committed to transparency as we fulfill our responsibilities under the amended TSCA. This is an amazing opportunity for us at the Agency to engage with all of you, and I hope that we have a fulsome discussion. It is important for us to have opportunities like this to come together to share thoughts and to share perspectives. It is now my great honor and pleasure to introduce to you EPA's Administrator, the honorable Andrew R. Wheeler. As many of you know, Administrator Wheeler began his career in OCSPP working on chemical and pollution prevention issues. I want to thank Administrator Wheeler for his deep commitment to our program, his deep interest in our program, and extend my appreciation to him for his leadership during this critical time. Welcome, Administrator Wheeler. 

Andrew Wheeler, EPA Administrator

Thank you, Alex, good morning, everyone. And thank you for joining us today. And hello to everyone participating remotely. I'd like to reiterate something that Alex just mentioned about the importance of transparency at EPA. We are committed to improving transparency across the entire TSCA program, and today's meeting builds on those efforts. When I started at EPA in 1981 as a special assistant, at that time OTS (Office of Toxic Substances), I can say without a doubt that our commitment to transparency now is as strong today as it has ever been in my association with the EPA both in and from outside the Agency looking in. I'm honored to be here today and appreciate the hard work that our career employees continue to put into this program. EPA's New Chemicals Program has a critical role in supporting innovation while identifying and managing potential risk to human health and the environment. There is understandably a lot of interest in how the Agency is evaluating new chemicals before they enter the market. The products we use every day -- our phones, computers, cars, appliances, just to name a few -- get better with each passing year. It can seem that their continuous improvement is just the natural order of things. Yet we know there is nothing natural about it. Products get better because of innovation. Purposeful application of human invention. Things improve because people work hard to make them better. One field in a constant state of innovation is chemistry. And the new chemicals resulting from this innovation do things like make paints and coatings more durable, video displays brighter, batteries more powerful and longer lasting, and materials like metals and plastics stronger and lighter. Not only wouldn't we have improvements and better products without new chemicals, new chemicals replace old chemicals. New chemicals and innovation make products newer and safer for all consumers. We want the products we use, including the chemicals they're made from, to be safe. Both for consumers and the workers who make them as well as the environment. When used properly, approved chemicals are safe. But injuries and environmental pollution have happened. For this reason, EPA reviews new chemicals before they enter the marketplace, under the New Chemicals Program in TSCA. Over the years, EPA has received on average around 700 to 1,000 new chemical notices annually. Once approved, companies have decided to make or import between one third and one half of them. This means tens of thousands of new chemicals have entered the marketplace since the EPA began regulating chemicals under TSCA in 1978. In June of 2016, the Frank Lautenberg Chemical Safety for the 21[st] Century Act was signed into law comprehensively amending TSCA. It was a landmark piece of bi-partisan legislation widely regarded as one of the most significant updates to an environmental law in over 25 years. Since those amendments, EPA has made policy and process changes to align the New Chemicals Program with TSCA requirements, including the appropriate use of science and conducting reviews. The program has reviewed over 2,400 cases since TSCA was amended, and the Agency has worked to streamline and improve the review process. Because new chemicals are important in creating new products, and growing the U.S. economy, we will continue these efforts in order to increase productivity and consistency for American businesses and consumers. Any new statute that amends an old statute so substantially for the first time in 40 years takes time to implement. EPA has reviewed a number of ways to conduct risk evaluations required under the new statute for new chemicals coming on the market. For what authors of the legislation all agreed on was that EPA cannot stifle innovation. New chemicals coming on the market replacing old ones cannot be slowed. Congress maintained the original TSCA deadlines in the Lautenberg Act for improving new chemicals, recognizing that EPA evaluated both planned and foreseeable uses for new chemicals. Congress also recognized that EPA did not allow on the market new chemicals pre-Lautenberg enactment that presented unreasonable risk. And Congress included your practices and standards in the new Lautenberg Act. The Lautenberg Act sought to reach a balance not only addressing new chemicals, but also existing chemicals, ensuring we have a true national standard administered by the EPA and new guidance for evaluating science and risk evaluations of new and existing chemicals. I want to encourage you to keep in mind OCSPP's unique role at EPA. You operate differently from other program offices, you permit products to be introduced into the marketplace. I want you to know that Congress complemented EPA's implementation of TSCA Section 5 so that the U.S. remains a leader in new chemical innovation and production. The new chemical review process requires the evaluation of the potential risk to human health and/or the environment under the condition of use of the chemical in question as determined by the Administrator. At our last public New Chemicals Meeting almost two years ago to the day, we released a decision-making framework to help guide this process. At the heart of these efforts was the desire to be transparent about how EPA was implementing the New Chemicals Program, while considering the updates to TSCA. The public meeting and release of the framework was the first of the many transparency initiatives in the New Chemicals Program. Since then, we've heard from our stakeholders on key issues like the protection of workers, the identification of conditions of use, and the Significant New Use Rules. After consideration of public comments and based on our experience completing hundreds of additional reviews, the Agency has updated and refined our Working Approach to New Chemicals Review. The updated document provides greater clarity for both submitters and the general public on how the Agency makes affirmative decisions on new chemicals. Today, you'll hear from key staff and leaders in our Office of Pollution Prevention and Toxics [OPPT] on a range of topics. You will get a preview of the updated Working Approach Document, including a summary of public comments, and how they were considered, a discussion of general guiding principles, and the key questions EPA asked when making the decisions on new chemical notices. OPPT staff will walk through some examples to illustrate the working approach and action, including how we identify conditions of use, and how we use Significant New Use Rules. OPPT will provide an update on our efforts to review claims of confidential business information, common process issues, and recent rule-making efforts. While it is important that we protect proprietary business information for submitters, we must balance this with our responsibility to the American public to operate in a transparent manner. And OPPT will describe our recent and ongoing efforts to increase public access to chemical information. I want to thank you all for joining us today. I want to especially thank Alex and her team for putting this together and all the career staff in the office for all the work you've done to implement the new Lautenberg Act. I know it hasn't been easy at times. Whenever you take a rewrite of a major statute like this, there's some growing pains. If you look back at the history of TSCA, we had some growing pains back in 1978 when we first implemented the original statute. I think we're experiencing some of the same issues over the last few years. I want to thank all the staff that have gotten us to where we are on the New Chemicals Program today -- a lot of hard work and dedication to make sure we remain innovative and still protect public health and the environment. A shout-out to Erik Baptist in the back row who is joining us today after he left the Agency earlier this year. Thank you to all the staff here today. I look forward to working with you to ensure that the implementation of the New Chemicals Program supports innovation, certainty, consistency, and protection of human health and the environment. 

Alexandra Dunn, Assistant Administrator for EPA's Office of Chemical Safety and Pollution Prevention (OCSPP)

Thank you so much, Administrator Wheeler. It is absolutely wonderful to have Administrator Wheeler as vested in this program as he is. I can tell you as someone who sits down with him one-on-one about every ten days, I usually have to bring him some conundrum that has presented itself under the new statute and ask for his wisdom, guidance, and support as we navigate deadlines, reports, strategies, and implementation. And he is always an incredibly listening ear, very, very supportive of the staff, as you heard. We have almost 300 staff working in the TSCA program, most of them are upstairs working, otherwise they would be in this room filling up every seat. But we have a number of commitments that we have made including reducing the backlog of PMN submissions that are over 90 days by the end of the year -- not completely, but as low as we can get it. We're shooting for under 100. So I know many people are upstairs working on that. We have other staff who are working on current submissions, ensuring that we finish them within the 90 days. So, we're working on those. And we have many, many other staff dedicated to full implementation of this program, including the whole CBI team, which is hard at work constantly working very closely with our Office of General Counsel on those matters. We have a tremendous team. Just a little side bar note too. We are "plus" in hiring in our office. So, many of you had heard -- there was this sort of draining of expertise at the Agency, particularly in the TSCA program, as well as other programs. We have been very fortunate, last year we sort of were net zero. We had the same number of folks retire or move on as we hired. But this year, we are plus 83 so far. I think that's the latest statistic I heard. And we hope it keeps going. Because it means we're getting a lot of new, energetic minds committed to this program, and many of them are drawn to coming to EPA and working with us because of the opportunity to work on a new statute. In fact, it's probably one of the most commonly cited reasons for people applying to work in OCSPP, and OPPT specifically, is the chance to work on one of the nation's recently amended environmental statutes. It is not for everyone. But for those up for a challenge it is definitely that, plus more. With that, again, I want to thank you all, again thank the Administrator for his support, and welcome to the podium, Alice Tome. Alice is with Abt Associates, our contractor helping support this meeting, and Alice will go over some logistics for today. 

2.	Public Comments

Rich Engler, Director of Chemistry, Bergeson and Campbell

On behalf of the New Chemicals Coalition [NCC], I thank EPA for the opportunity to comment on this New Chemicals Program.  There are a number of issues that the NCC views as opportunity for EPA to improve upon its implementation of TSCA.  First, in its health assessments, EPA compares acute doses to chronic points of departure to derive margins of exposure.  For chronic, systemic, or specific target organ toxicity, we believe this approach is not scientifically justified.  To be scientifically justified, EPA must compare two, or single exposure endpoints, to predicted acute doses to calculate a margin of exposure and chronic endpoints to predict chronic doses. Second, in some PMNs, EPA continues to speculate, often without support, that there might be circumstances that EPA has not evaluated in which a concerned threshold might be exceeded so a SNUR is required.  While it may be true that there are conditions of use that EPA has not evaluated, it remains the case that EPA's determination must be based on and bounded by reasonably foreseeable conditions of use.  As EPA has stated, in recent responses to comments on a SNUR, it is not sufficient that EPA has not evaluated the conditions of use to justify a SNUR. EPA must have a basis to conclude the potentially problematic conditions of use are reasonably foreseeable to justify an order of SNUR.  We agree with EPA that reasonably foreseeable must be based on information, knowledge, or experience and not merely hypothetical conditions of use.  Nevertheless, some EPA staff have stated that, once listed on the inventory, a substance can be "used for anything." While this may be hypothetically true, it is certainly not accurate from a chemistry standpoint. An insoluble nano-pigment cannot be used as a solvent, period. A fragrance cannot be used as a rigid material, period. The legal standard is not likely to present unreasonable risk under the reasonably foreseeable conditions of use. The standard is not -- will not present unreasonable risk under any conceivable condition of use. We support EPA's formal assessment of conditions of use and support EPA to continue using reasonable judgment in its assessment of what is likely and what is reasonably foreseeable when deciding on a regulatory action. Third, we note the logical impossibility that EPA has insufficient information of the safety of a new surfactant for use in a spray cleaner at the same time that EPA is promoting dozens of nearly identical surfactants on the Safer Chemical Ingredients list (SCIL) for use in consumer spray cleaners. While it is true that the inhalation hazard is not one of the SCIL criteria, we question EPA's position that a surfactant that is equivalent to a SCIL-listed ingredient that is considered by EPA to be safer when submitted as a PMN may pose unreasonable risk due to insufficient information. EPA cannot have it both ways. We believe that the decades of use of surfactants in consumer cleaning products while not quantitative, provides a qualitative basis for EPA to conclude that common surfactants, especially nonionic and anionic surfactants, are not likely to pose unreasonable risk. If EPA cannot so conclude, EPA should immediately delist from the SCIL all surfactants lacking in supporting inhalation data. To do otherwise sustains an irreconcilable inconsistency in EPA's PMN review process and misrepresents EPA's confidence of the hazards associated with SCIL-listed surfactants. Thank you again for this opportunity to provide EPA our views on its implementation of Section 5.  

Michael Gould, Chairman of the EHS Committee, Radtech North America

Good afternoon, I appreciate the opportunity to speak, as well.  I'm glad I followed Rich who is typically very eloquent.  I echo much of what he just said, but I need to be very specific given that I have two minutes. I am the volunteer EHS chairman for Radtech North America, which is the umbrella industry association of over 120-member companies, roughly $4 billion in commerce in the United States.  We do all things  -  acrylate and methacrylate, UV, and EB Cure of 100% reactive solids into thermosets that range from adhesives to wood coatings, printing inks, and coatings for graphic arts, composites, and very recently additive manufacturing.  I've learned a lot here this morning, and my reason for wanting to speak is it has been brought to my attention since the implementation of Lautenberg in June of 2016, that none of the member companies with whom I work as the EHS chairman for Radtech, none of the companies are able to get any new chemical registrations through the process without SNURs that are described as (and in my own experience that I can validate)...these are onerous, restrictive SNURs that are unnecessary. My industry has a 50-year track record of safely handling acrylate and methacrylate materials, and yet, as I learned this morning, you will extrapolate in your chemical review process to foreseeable uses far outside the bounds of actually -- at what actually appears in the PMN application.  And thus we are seeing SNURs occur in every case of these new chemical registrations, and I'm not sure if you appreciate how unattractive SNURs are in industry.  If I have a product that appeals to my entire customer base, 80% of them will not use it because it has a SNUR.  Maybe ten years from now when four out of every five new chemical registrations comes with a SNUR, they may change their minds. But right now, they don't like SNURs - they're problematic - because as pointed out this morning, the SNUR goes all the way down the value chain, everyone is responsible.  And apparently that is my time. Thank you very much.  

Joel Rothstein, Senior Manager of Regulatory Affairs, Society of Chemical Manufacturers and Affiliates (SOCMA) 

I appreciate the opportunity to comment here today. We acknowledge and are grateful for the ongoing work to resolve the backlog of new chemical notices, reminder of the review process, and adopt more realistic assumptions about workplace protections. We do continue to hear from members, however, that the current program still lacks predictability and transparency.  Submitters continue to face a dilemma of being asked by the agency to suspend a statutory review period for their application. Their only choice is to agree to the suspension request or to withdraw submissions entirely. Our members report that EPA often provides no guidance regarding the basis of suspension, leaving them unable to expedite the review or to resolve concerns with a specific case. We've also seen increasingly a precautionary approach with new chemical review, causing a variety of problems for submitters, including requirements for expensive and time-consuming tests, reliance on default assumptions regarding hazard and exposure and willingness to rely upon robust data summaries. And while the agency has noted it cannot legally require minimum data sets to conduct reviews, case managers do insist on obtaining them in practice. As EPA evaluates potentially new uses of a chemical substance, manufacturers often find that their products are restricted on the basis of hypothetical uses by others, that are often far outside the intended uses described in their PMN.  It is not surprising that the agency has begun to observe fewer and fewer PMNs being submitted. Altogether these practices are greatly impeding the introduction and commercialization of new chemicals, and therefore impeding innovation.  Companies always face some commercial risk that new chemistry will not turn an adequate profit. The uncertainties and delays created by the program will increase that risk and lead many companies to forego opportunities to create new substances.  Their customers and the economy also lose in these cases.  The problems I've described also afflict EPA's review of low volume exemption requests, bottling up a historically important pathway to the marketplace for new chemistries. In fact, we have heard that the LVE review process disproportionately suffered as the EPA shifted that focus toward PMN reviews.  We strongly urge the agency to return to its screening level risk assessment of new chemical applications, and will continue to work toward ensuring that all PMNs and LVEs complete review by the applicable deadlines, thank you.  

Robert Stockman, Senior Attorney, Environmental Defense Fund (EDF)

EPA's working approach described today largely relies on using SNURs to avoid analyzing a new chemical substance as a whole, an approach that is not legally or practically a replacement for the required orders. Section 5 reviews of new chemicals must be reviews of new chemical substance as opposed to specific uses including an analysis of all recently foreseen conditions of use. Under TSCA Section 5(a)(3)(C), EPA needs to make a not likely to present unreasonable risk finding on the chemical substance under the conditions of use. Conditions of use is defined to include the circumstances under which a chemical substance is reasonably foreseen to be used, thus EPA must analyze reasonably foreseen uses together with intended conditions of use when analyzing a new chemical substance. The statute expressly states that if EPA makes one of the Section 5(a)(3)(B) determinations, then EPA shall issue a Section 5(e) order to prohibit or limit the conditions of use.  Nothing in the text of Section 5(a)(3)(B) or 5(e) authorizes EPA to rely on a SNUR to avoid analyzing the substance under all of its conditions of use or to avoid issuing the mandatory order.  Rather, the use of the phrase `shall issue' leaves no room for EPA to decide if they can adopt anything less than an order. Tellingly, EPA has still not advanced any interpretive legal theory behind a SNUR-only approach. Practically speaking, SNURs are not an adequate replacement for consent orders.  Here are three reasons. First, a consent order imposes legally binding conditions on the company that signs it. Second, testing requirements cannot be imposed to SNURs, but can be through consent orders. Third, consent orders can be reopened and revised based on new information, including the results of required testing. As a practical matter, SNURs often cannot be revised to become more stringent based on new information.  Thank you.  

Richard Denison, Lead Senior Scientist, Environmental Defense Fund (EDF)

Let me make two points today.  It's been two years since EPA published its first framework. That was done in response to relentless industry pressure, and in our view, it was aimed at avoiding finding that new chemicals may present unreasonable risk or lack sufficient information. Thereby avoiding the issuance of orders that would impose binding requirements or actually require any testing.  EPA was sued over that framework and dodged the suit, by claiming it was not using the framework, yet EPA continues to imply its most controversial feature which my colleague just described.  Clearing more than 60 new chemicals by relying on so-called non-order SNURs. These not likely determinations identify reasonably foreseen uses and then claim that the SNUR is sufficient to address them.  EPA has also been issued a new kind of SNUR that follows the not likely determination by some length of time.  But these suffer from all of the same legal and technical and policy limitations as applied to the first category.  I do want to secondly briefly address a comment that Administrative Wheeler made this morning that I hear from industry stakeholders all the time, which is that we have to use the New Chemicals Program as a means of innovation and promoting innovation and facilitating it.  In fact, there is no grounding for that argument in TSCA, anywhere in TSCA.  In fact, it is quite the opposite.  Section 2.2(b)(3) has the same language in the original TSCA reaffirmed by Congress in 2016.  And what it says is that innovation is not to be a basis for compromising the fundamental and most significant purpose of the law, which is to assure that innovation and commerce do not present unreasonable risk of injury to health or the environment.  So, I'll stop there.  Thank you.  

Stephanie Schwarz, Legal Fellow, Environmental Defense Fund (EDF)

Good afternoon.  Since EPA changed its approach in late July 2018, EPA's new chemical reviews have regularly found risk to workers, which EPA nevertheless dismisses in making a determination that the chemical is not likely to present an unreasonable risk. Of the 247 chemical substances that have received not likely determinations since then, which represents 80% of all of EPA's new chemical determinations in that time, EPA has identified risk to workers for 192 or 78% of those chemical substances. These include risks such as cancer, reproductive and developmental effects, and lung overload. Despite having found risk, which would necessitate a finding that that the chemical substance may present an unreasonable risk and injury to health and issuance of an order, under its framework, EPA has cleared the chemicals without an order. In each of these cases, EPA has dismissed these identified or unquantified risks by inappropriately assuming that workers will always use the appropriate PPE identified in an SDS. EPA implied SDS recommendations for PPE are mandatory, when in fact, OSHA's standard mandating SDSs states that there is no requirement for employers to implement the recommended controls.  There is also significant evidence that SDSs are frequently not understood or followed.  One recent systematic review of the literature identified serious problems with the use of SDSs because they are often inaccurate and incomplete.  EPA also assumes that the submitters will never modify the SDS language after EPA has made the not likely determination, when in fact the submitter is free to do so at any point.  EPA must provide a both scientific and legal rationale as to how non-binding documents, both the PMNs and SDSs, ensure that new chemical substances with identified risks to workers are not likely to present an unreasonable risk to workers.  Thank you.  

Dr. Jessica Ryman-Rasmussen, Scientific Advisor, American Petroleum Institute (API)

API is a national trade association that represents all facets of the oil and natural gas industry. In addition to our oral comments today, API is planning to prepare written comments. We begin by expressing appreciation for EPA's efforts to reduce disruptions in the review of Section 5 notices, and to make the program more efficient and transparent. We want to emphasize that we strongly believe EPA should defer to OSHA on requirements for personal protective equipment or other workplace measures that aim to reduce occupational exposure. Today, API specifically requests that EPA explain how it is coordinating with OSHA and other entities who have the primary responsibility for addressing and assessing occupational risk.  We encourage EPA to take advantage of the opportunities that new chemical review presents for harmonizing U.S. chemical reviews with those of other countries.  API appreciates the updated information today on how EPA determines reasonably foreseen conditions of use, any additional information that EPA could provide in this regard would be helpful for reducing regulatory uncertainty. From a risk assessment perspective, it's reasonable to adjust hazard information requirements based on exposure information and vice versa. This will ensure that EPA's testing requirements are fit for purpose and creates the efficiency and meet agency goals to reduce animal testing. This also may provide an opportunity to move away from the use of default values to produce more realistic risk assessments.  Meeting the challenges of the New Chemicals Program takes on an added degree of complexity for new chemicals that are UVCB substances.  API is aware that risk assessment of UVCBs is an area of interest of EPA, and API would appreciate any guidance and information on UVCB risk assessment that EPA can share.  Finally, it would be helpful if EPA could respond sooner to requests for pre-notice consultations. Thank you.  

Christina Franz, Senior Director, American Chemistry Council (ACC)

Although there is still some significant progress that needs to be made, we'd like to commend the agency for reducing the average number of days that it's taking to reach a decision in the PMN program. And also for holding this session. Although, I would like to note that it would have been, I think, much more helpful to actually have the written framework document available to all of the stakeholders so that we could actually see the differences between the former framework approach document and what changes have occurred so that we could comment in a more meaningful and intelligent way.  But we will look forward to seeing that document and being able to provide written comments, I suspect, in January. I think we'd also like to note we'd like to hear where the `Points to Consider' document is. I've not heard that mentioned I don't think at all today. And I think that's a document that has indicated that a number of problems in the PMN program could be solved ahead, in advance of submission, and it would be helpful to know where that document is in terms of revision. We'd also like to suggest that EPA needs to be more transparent in its review of PMNs. Particularly with respect to the concerns that are presented in the PMN, as EPA knows, it needs to base its decision on the best available science and the weight of the evidence. And it would be helpful, again we've made this point a number of times that the engineering report and the risk assessment need to be made available to the PMN submitter routinely and in a timely way so that they can respond in an intelligent and meaningful way. EPA should also rely more on measured data rather than modelled data. In reviewing PMNs, EPA has noted that it is wanting, and will rely more on measured data, but we have reports from ACC members that there are times when EPA will disregard actual data and rely on modeled information, some of this information may be contained in CBI information, but to the extent it can, it should be made available to the PMN submitter so that they can respond in a meaningful way.  I will reserve the rest of my comments for when we make our written comments and submission to today's session, so thank you again.  

MK Fletcher, Safety and Health Specialist, American Federation of Labor and Congress of Industrial Organizations (AFL-CIO)

We [AFL-CIO] represent 55 unions and 12.5 million working people. Our unions have members in every sector in stationary and mobile workplaces, workplaces both big and small. We work side by side with millions of non-union workers. The AFL-CIO is very concerned by the new chemical approach presented here today and its ability to protect workers from chemical exposures. Occupational diseases caused by chemical exposures are a significant problem with more than 50,000 deaths, and 19 hundred thousand illnesses each year. TSCA has had a long standing authority to protect workers from chemicals in the workplace and amended TSCA only strengthened this role. We are very concerned about the reliance on PPE and safety data sheets. EPA abuses the hierarchy of controls. The implementation of this widely accepted practice has not been seen. The hierarchy of controls does not come into effect after PPE usage. Also workplace controls are risk management tools -- inappropriate to make risk determinations. Only once risk is assessed can the appropriate management tool be determined. PPE is the lowest on the hierarchy of controls due to the significant limitations to protection and EPA has received extensive comments on this. Therefore, I'll only say it is reasonably foreseeable that PPE will not always be used or effectively used. Finally, EPA must make any risk management controls, preferably engineering controls, and lastly PPE, codified in an order. It is not sufficient to vaguely list used respirators or gloves on a non-binding SDS that will sit in a binder, unlikely to reach any workers. Protections must be enforceable and meaningful. EPA has strong authority to do this, and should use it. Thank you. The AFL-CIO and interested unions look forward to continuing to engage with the EPA in order to truly protect workers from chemical exposures.  

Melanie Benesh, Attorney, Environmental Working Group (EWG)

I'm going to make some very quick high level comments that are largely reflective of things that have already been said by my colleagues at the Environmental Defense Fund and AFL-CIO. My first point is that it has been two years since we saw the New Chemicals Framework and attended a very similar public meeting about EPA's approach to new chemicals. Since then, EPA has said they are no longer using that approach in response to a lawsuit by the National Resources Defense Council.  We are concerned that it has taken this long to see another document outlining the agency's approach, particularly when Administrator Wheeler as part of his confirmation process agreed that a new document would be coming out that would outline the statutory and scientific basis for EPA's decision, the policies and procedures behind these decisions, and incorporating the responses to public comments that were given two years ago.  We're eager to see the new document and weigh in on that process.  But, second, it seems to us that many of the concerns that we raised, and other groups raised, with the initial document, have not been addressed. We are concerned about the emphasis on intended uses included in the PMN as a basis for making an initial risk determination without fully considering reasonably foreseen uses or known uses as part of that initial risk determination.  Third, as a result of that focus on the narrowly identified uses in the PMN, we've seen a shift away from 5(e) orders which as for the reasons described by Mr. Stockman, carry a lot more legal weight, require or allow EPA to ask for valuable testing information, and don't have all the limits of the SNURs which just don't carry the same legal weight and are harder to revise, et cetera.  And last, we share the AFL-CIO's and others' concerns about the assumptions that PPE will be followed, assumptions that safety data sheets will be understood by workers, and will be followed despite a significant amount of evidence that PPE is often not used as intended, and that data sheets are difficult to understand, and that OSHA is under-resourced and may not have the capacity to fully enforce worker safety. So while we encourage collaboration between OSHA and EPA, certainly EPA has a legal obligation to consider workers as part of their new chemical determination.  

Larry Culleen, Partner, Arnold and Porter

I represent clients in what we call the chemical space, typically PMN submitters, but also, in certain instances, users of chemical substances, and that includes certain consortia and trade associations, which, in significant ways, are users of new chemical substances that emerge from review. I have three comment areas. I'll focus on the first which relates to the PMN program, the latter two relate to CBI. The first I would encourage the agency in its continuing efforts to streamline the new chemicals process to consider making more assertive use of the binding boxes in the PMN forms; it's a vehicle which has been in place and could be capitalized and potentially result in an exchange of letters where a short form consent order with submitters who have agreed to be bound by certain terms. I think it would create great efficiencies and perhaps lend credibility to the agency's positions with respect to regulating new substances and respond to some of the assertions about concerns due to the instances where 5(e) orders might not have been employed prior to issuing Significant New Use Rules. The second areas relate to CBI. And, simply stated, I think it would be helpful if the agency expressly described what its current position and procedures would be for responding to those instances in which a company that submitted CBI made the necessary assertions under the statutory requirement as well as the document that is submitted on CDX through the standard recitations but failed to submit detailed substantiation. It's not clear whether the agency having one but not both documents would intend to release CBI without consulting with the submitter of that information. Lastly, with respect to CBI, it would be helpful to get guidance on substantiation that's required when CBI is submitted in response to requests for inspections from the Office of Enforcement. That's an area where I don't think OPPT has provided any guidance and the lack of clarity places companies who respond to those requests in potential jeopardy of having their CBI released. Lastly, and I know I'm over time, but since I'm last, I wanted to commend the agency staff who have just devoted Herculean efforts to achieving the numerous deadlines in the course of three years since enactment and in the context of preparing for this meeting; it is obvious that a great deal of work has also been invested. And I think we've all benefitted from that. So thank you.  

Kelly Moran

Hello, my name is Kelly Moran and I'm a scientist; I work with municipal waste water agencies and municipal urban runoff programs on water pollution from consumer products. I thank you for the opportunity to comment today. Although I'll note in agreement with the ACC's comments that it's not possible as a scientist to provide meaningful comments due to the lack of ability to review the working approach or any of the science behind the examples that were presented today. I will note that I've seen substantial gaps in the quality of the exposure science being used in these reviews, and one of today's examples appears to illustrate that pretty fully. And that is the idea that it appears, although it's impossible because I don't see the science behind the example, it appears that there's an assumption that there is not an environmental exposure route for ingredients in asphalt to water. And of course, in urban settings where asphalt is applied, the runoff runs directly untreated in most locations into surface water bodies.  Asphalt ingredients and asphalt emulsions are after application, when it rains or washing, you can actually see the materials rise to the surface and there have been monitoring data...I believe the state of Minnesota did monitoring to measure surfactants in runoff and found extremely high concentrations. I question the science behind this.  I'm aware that staff have extremely limited time to do these reviews, so while I'm sympathetic to the industry's concerns about not meeting the timeframes, the quality of the science here has very costly repercussions, as I've learned through my work with my agency clients. Since sewage treatment plants are not designed to remove toxic chemicals and there is no treatment for most of the nation's urban runoff, Clean Water Act mechanisms that are often being relied on here simply don't apply. I've also discovered that to many people's surprise that they're unaware of those pathways, particularly the urban run-off pathway for pollutants to reach receiving waters. So it is an important function of this TSCA process to identify and assess those pathways.  I'm also very concerned that predictive toxicology has been used to establish thresholds for environmental exposures, unless there's test data, again the science wasn't revealed in the examples, behind those examples where numbers were said.  It is unclear to me whether those numbers are accurate and whether there are mechanisms in place to prevent exposures such as the one I described in the asphalt example. So, again, thank you for the opportunity to provide comments.  I would strongly urge that there be a scientific review of the Working Approach such as by the Science Advisory Panel so that the exposure science weaknesses that I referred to can be dug into and that EPA devote resources to improving its exposure science since it is so reliant on predictive measures when it is doing its TSCA chemical reviews.  Thank you very much.  
 
James Lee, Hach Company

We make chemical reagents and instruments for water quality osmosis and, as a specialty chemical manufacturer, we take CBI very seriously. And we want to protect our secret ingredient information with utmost care. Specifically, we would like to comment on the question number 2 on identifying the chemical substance by analysis and the supplemental proposal published on November 8. And the second question proposed in the amendment states that if the chemical substance leaves a site in a product that is available to the public or your competitors, can the chemical substance be identified by analysis of the product.  This question does not align with the TSCA or certification statements or the recent EDF vs. EPA case. Under TSCA Section 14(c)(1)(b)(4), to claim the chemical that is evaluated the person has the basis to believe that information is not readily discoverable through reverse engineering, the key phrase is not really discoverable. The determining factor is not whether chemicals can be identified by analysis.  The standard is too broad and does not preclude discovery means that are not readily available or even illicit.  Additionally, the DC circuit in the EDF vs. EPA thought that the essence of the term not really discoverable through reverse engineering during the proposed EPA rule is the problem. Therefore we request that the question should be modified to read if the chemical association leaves the site in a product that's available to the public or your competitors, if its identity is not readily discoverable through reverse engineering.  We believe that this text better aligns with the language of the statute and the case law, which is considered the degree of difficulty or the ease of discoverability as a factor in the EPA's evaluation of CBI claims. We also suggest that EPA should provide a definition of the term not readily discoverable which is not really provided in the regulation. I believe that the reasonable definition should be based on the current available technologies used to determine the chemical identities. We propose to include this in 43 CFR 710.55(a), such as not readily discoverable through reverse engineering means, so the specific chemical identity claimed as CBI cannot be discovered without undue effort or use of specialized technologies in analytical chemistry, such as contour graphs, infrared spectroscopy, mass spectrometers, nuclear mechanical resin spectroscopy, and thermo analyzers. Thank you for your time. 

Robert Sussman, Counsel, Safer Chemicals Healthy Families

I'm here today as counsel for Safer Chemicals Healthy Families, a non-profit organization focusing on the importance of chemical safety.  We have been extremely troubled by the steady trend towards less meaningful scrutiny of new chemical risk and reduced protection of health and the environment in the TSCA PMN program.  To measure this trend we looked at PMN dispositions that took effect in 2019.  We found that today EPA has determined that 150 new chemicals are unlikely to present unreasonable risk.  It did not warrant any restriction.  By contrast, only 46 new chemicals or less than 25% of the total were regulated under Section 5(e) orders. This is a complete reversal from the first 21 months following enactment of the new law, during which Section 5(e) orders accounted for 74% of all PMNs. One major explanation for these trends is the virtual disappearance of any protection for exposed workers in the PMN program. Since October 2018, EPA has issued scores of not likely determinations for new chemicals which its scientists have found to have the potential for serious health effects including developmental and reproductive harm and cancer. In these cases, EPA has estimated that worker exposures do not afford a sufficient margin of exposure to protect against these health risks. However, it is assumed that no harm will occur because workers will voluntarily use personal protective equipment that will prevent exposure. EPA's approach is a wholesale retreat from EPA's long standing practice under the old and new law of issuing 5(e) orders, imposing enforceable worker protections on chemicals with the potential to cause harm. These orders also frequently require testing to better characterize the potential risk to workers and other potentially exposed populations.  Thank you.  

Liz Hitchcock, Director, Safer Chemicals Healthy Families

We are a national campaign to reduce Americans' exposures to toxic chemicals.  We find it very troubling that now that we have a new law that was intended to enhance the effectiveness of TSCA's New Chemicals Program, workers now receive less protection than in the two decades before TSCA was amended. EPA's reliance on voluntary use of personal protective equipment to avoid findings of unreasonable risk is a common thread that's run through all six of the draft risk evaluations that EPA has issued so far under TSCA Section 6(d). However, the draft evaluations have acknowledged that there is no evidence that PPE is uniformly used by workers, and reason to believe that its use is in fact the sporadic and ineffective. In their peer reviews of the draft evaluations, the Scientific Advisory Committee on Chemicals [SACC] has been highly critical of EPA's approach.  For example, the SACC questioned the EPA's PPE assumptions for pigment violet 29 noting that the analysis in the evaluation does not discuss or account for the fact that downstream commercial users may be oblivious to chemical risks and lack even rudimentary industrial hygiene measures. Similarly, in reviewing the evaluation for 1,4-dioxane, the SACC concluded that the consensus of the committee believes PPE may not be consistently and properly worn as EPA assumed and noted that glove use should not always be assumed to be protective, and if worn improperly, the gloves could actually lead to higher exposures. The SACC further emphasized that because respirators are inherently uncomfortable and potentially unreliable for long-term use, the use of respirators for more than relatively short terms is not considered appropriate in typical industrial hygiene practice. As it concluded, eight-hour use of PPEs should not be used in the risk characterization of inhaled 1,4-dioxane. Risk estimates should be presented without the use of PPE as reasonable worst case. These criticisms apply with equal force to EPA's unsupported reliance on PPE to determine that workplace exposure to dangerous levels of new chemicals with suspected adverse health effects are unlikely to present unreasonable risk of injury under Section 5.  EPA should instead conclude that such chemicals may present an unreasonable risk of injury and regulate them under Section 5(e) orders. Again, thank you for the opportunity to present.  

3.	Closing Remarks

Tala Henry, Director, EPA Risk Assessment Division

On behalf of the whole program, including Alex and the Administrator, just thank you all very much for coming. Certainly we engage with many of you on an ongoing basis.  And we encourage you to continue to do so.  If you have issues, bring them up to myself or your program manager.  Several of the comments I heard today certainly are ones that we are working on and work on on a case-by-case basis with many of you daily, if not weekly.  Please go ahead and submit comments about this meeting to the docket by January 24th, and look forward, I'm sure that there will be a FR notice, but you'll get a list serv first when we release the updated Working Approach, and there will be opportunity for comment on that again as well.  So thank you very much for taking the time.