Document ID: EPA-HQ-OPPT-2016-0399-0053
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2020-07-24T04:00Z

Summary of Public Comments
Chemical Prioritization Process Rule under the Toxic Substances Control Act as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act 
                                August 10, 2016

Speaker 1: Barbara Losey, Alkylphenols and Ethoxylates Research Council
I'm Barbara Losey, Director of the Alkylphenols and Ethoxylates Research Council, a research-based trade association that represents and promotes the continued safe use of alkylphenols and their derivative products. We appreciate the opportunity provided today to offer comments in advance of the rule on prioritization under the new Frank R. Lautenberg Chemical Safety for the 21st Century Act. My comments are drawn from our experience with the listing of several chemicals on the 2014 work plan as well as our experience engaging in U.S. regulatory cooperation council workgroups that are evaluating various aspects of the risk assessment process. We encourage U.S. EPA to not just issue a process rule on prioritization that will merely reference the current TSCA work plan and work plan method document but recognize that the prioritization process is a preliminary step and still warrants a more rigorous review of a broader range of available hazard use and exposure data with greater transparency than that used in the 2014 work plan and the 2012 work plan methods document. Prioritization without accurate data will result in resources spent working on the wrong priorities. The work plan itself does not provide any references for the information used as a basis for listing and the ranking of the specific chemicals in the table. 

In the case of octylphenol, we requested more information from EPA about sources used for this chemical. In response, EPA provided a half-page summary factsheet for this compound which clearly indicated that rankings were based on a preliminary review of available data for the compound. The factsheet did not include complete references for some of the data and, in fact, mischaracterized some of the hazard and exposure components. We found there was a transcription error from the factsheet to the work plan summary table. It is listed as having low bioaccumulation on the factsheet, which is consistent with the weight of evidence from the compound. Based on this finding, using the work plan methodology described here, U.S. EPA calculated a normalized PB score of 2. While the PB score of 2 was transcribed correctly to the work plan table, the individual score for bioaccumulation was incorrectly transcribed to the table as being moderate rather than low. The discrepancy between the bioaccumulation ranking as moderate and the PB score of 2 on the table creates confusion and might lead some to think that the compound meets the criteria of a PBT chemical as described in the act. Also, the work plan overstates the persistence and exposure for this compound for reasons that appear to be related to inadequate data and misunderstanding of the use of the product as a chemical intermediate. We submitted comments in 2012 and requested correction to the record in the work plan table, but it still includes the transcription error related to bioaccumulation and overstates the exposure and persistence. Therefore, we ask that EPA review and correct the table for the transcription error and recommend consideration of comments submitted in response to the work plan to correct and revise the work plan before commencing with prioritization. 

The case of this chemical illustrates our concern with the need for more review of available data, more transparency, and completeness in developing the work plan tables. We also encourage a better definition of the exposure criteria for the prioritization than that in the current work plan methods document. Even at the level of prioritization, there's a need to distinguish between intentional use of a chemical and its use as a chemical intermediate with the possibility it may remain in an end product unreactive. The potential for exposure is significantly less in the latter scenario. Reporting a chemical that is solely used as a chemical intermediate as having consumer use overstates the potential exposure to the public. There's currently no use type ranking for chemical intermediates in the work plan. Chemicals that are used solely as intermediates should be addressed appropriately in the prioritization process. Thank you. 

Speaker 2: Tracey Woodruff, University of California San Francisco
My name is Tracey Woodruff. I'm a professor at the University of California San Francisco in the Department of OB/GYN and Reproductive Sciences, and I run the program on reproductive health and the environment. Today I would like to talk about some of the key principles in terms of the prioritization. First, I would like to address that the burden of proof should be matched to the decision that is being made. EPA should clearly state that no data does not mean no risk, and in the rulemaking, the chemicals for which there is no data may pose unreasonable risk or may not. We just don't know. And then I think it should be clear that once a chemical is designated high priority, it does not mean it will necessarily pose an unreasonable risk in the final evaluation by EPA, so being a high priority chemical means EPA will evaluate it but does not necessarily mean there's any a priori decision about what's going to happen with the decision about that chemical. In that context, the information that is used to designate high priority chemicals should be as broad a category as possible. In particular, potential exposures to vulnerable populations such as pregnant women, fetuses, and children should be considered the basis for designating whether a chemical is high priority. Only if the chemical is high priority will we be able to evaluate whether that chemical might pose an unreasonable risk. Biomonitoring data should be considered, but if there's no biomonitoring data that should not be considered a knock against the chemical because we know from our own research at UCS that less than 10 percent of the high volume chemicals currently being considered by EPA actually have methods or approaches for actually even doing biomonitoring. There's a vast majority of chemicals for which we don't have the methods to measure within biological samples. We also think that the category for carcinogens should be expanded. Currently, I know the work plan says that it's probable or known, but I think suggestive carcinogens should also be added as consideration for high priority. Many of the determinations about the carcinogenicity are based on old data or old methods for evaluating, and moving it into the high priority list will allow for a fuller evaluation of that data. Then, finally, there was no discussion of what is going to be designated as low priority, which is obviously a very important category. There should be, in contrast, high burden or high amount of data, sufficient data, to designate a chemical as low priority, and the agency should look to current approaches that are being used in cancer classification to designate a chemical as known to not cause carcinogenicity as a level of evidence needed to declare a chemical -- sufficient data to declare a chemical as low priority. And finally, there will be a lot of emphasis on mechanistic data, which is understandable because there's a lot of data that is missing. No data should be an option for EPA to require data and when using mechanistic data, it should be on EPA to prove the data are both coverage of potential risks among the population as well as vulnerabilities among the population, including to pregnant women, developing fetus and the child. Thank you. 

Speaker 3: Jennifer Lowry, American Academy of Pediatrics
My name is Dr. Jennifer Lowry, and I'm here representing the American Academy of Pediatrics. I also serve as the chair to EPA's Council on Environmental Health. As EPA prepares a framework under which it will prioritize chemicals for review under the new TSCA, we urge you to ensure that key issues related to chemical exposure for children and pregnant women receive prominent consideration. Concerns about a chemical potential for reproductive toxicity, developmental toxicity, or endocrine disruption should be critical factors that necessitate prioritization. EPA's prioritization framework should ensure that chemicals posing risks to children and pregnant women receive expeditious consideration for assessment and any needed risk assessment given that children may be both more vulnerable to chemical exposures, and harms that may occur will be exacted across their entire lifespan. I will offer some examples of chemicals meeting these criteria that we believe necessitate prioritization. These are only examples and others will be submitted in writing. 

I speak first about flame retardants, specifically the class of organohalogen flame retardants PBDEs. Organohalogen flame retardants have a lot of well documented association with significant deleterious health effects. Not only do children have more opportunities to be exposed to environmental chemicals, but as children grow and mature, their unique physiological, developmental, and behavioral differences make them especially vulnerable to chemical exposures. Children will come into more contact with contaminants on many surfaces that have dust from these organohalogen flame retardants. Chemical exposures can disrupt the critical and rapid stages of development that occur in prenatal and early childhood, particularly involving neurologic and endocrine systems. Organohalogen flame retardants are associated with reproductive impairment, IQ decrements, learning deficits, interference with thyroid hormone action and genotoxicity, cancer, and immune disorders. Children exposed to these chemicals could have serious and irreversible health consequences, and banning these flame retardants will help to prevent these adverse effects in children. In addition, to the extensive evidence for the harms these chemicals may cause, the CDC's biomonitoring program estimates 97 percent of U.S. residents have measurable quantities of these chemicals in their blood. Further, the highest levels of harmful flame retardants in the general population are found in young children from communities of low socioeconomic status and communities of color, specifically in children under the age of 12. Flame retardant exposure is ubiquitous, presenting a serious public health threat to children. In fact, these chemicals have been found in human breast milk, which can be the sole source of nutrition for many infants. Given the documented health threats these chemicals pose and the evidence of significant exposure, action is critical. Flame retardants are also a concern and should be prioritized for expeditious consideration under the amended TSCA. A study presented at the 2013 Pediatric Academic Society annual meeting showed prenatal exposure to flame retardants is associated with lower intelligence and hyperactivity in early childhood. Even though PBDEs except Deca-BDE are not used in flame retardants in the United States anymore, they are found on many consumer products. In addition, these chemicals are not easily biodegradable, so they remain in human tissues and are transferred to the developing fetus. 

We also urge you to include the perfluoroalkyl substances, PFAS, in the list of high priority substances. They are fluorine-based, halogenated hydrocarbons with powerful surfactant water-repelling properties. These chemicals have found multiple applications in industrial consumer products, including nonstick cooking pans, water resistant upholstery, textiles, carpets, food-packaging, electronics and others. Thank you again for listening to our comments and we will submit more in writing.

Speaker 4: Lorenz Rhomberg, Gradient
I am Lorenz Rhomberg from Gradient, a consulting firm in Cambridge, Massachusetts, but my comments are my own today. The prioritization step is clearly very important. As we consider how this could be done, there are models out there  -  not only the work plan models for priorities, but other ones. Canada did a big prioritization scheme, California has some, other people have them, and I think it would be a good idea to look over that universe of approaches and look at their strengths and weaknesses, how well they have performed, and the problems that have come up with them in the past as you try to think about this. In other words, try to learn from the experiences of these other things as there are probably some good suggestions there. We have heard about the difficulties already, and I'm sure we will hear more, about the work plan prioritization scheme, and I think that just adopting that would probably be a mistake. So thinking about that would be good. What should go into that? Two things: one, it's probably good to be careful of just too readily accepting authorities of past statements on chemicals, especially about toxicity, just because the way those things are done. It's heterogeneous and many are old and out of date and so on and so forth, so some thoughts about how to do that. Another thing is exposure. Exposure ought to be important in the prioritization and not just production volume as a surrogate of exposure, looking ahead to what's going to be done with these chemicals, and if they are chosen, it's going to be about uses, and so uses ought to come into the exposure consideration as best you can. There's a lot of good modeling that can be done. You can do that without data at least for the prioritization step. The detail of data is an important thing as well. It should not be that there's an incentive not to have data on something because it does not ring up scores. So I think it's important to make sure you do not build accidentally incentives against developing data, especially on exposure on things into the methodology. I think that you could probably think about having more rigorous criteria, certainly near the ends of the scale, because what's going to be important, the things that are near the top and are sort of ready to be designated as ones to be acted on, and things to the bottom are possibly ones to be designated as not issues, low priority, and they are is where more detail is useful and necessary. The ones in the middle, maybe you can leave with sort of a more approximate and quickly executable thing until they get to the point where some action might be taken then you have to have more rigor pulled out. Some sort of two-tiered system evaluation with the ends being different might be useful. One final thing, I think there's communication issue here, and maybe it's just me, but I don't quite get it, but I think it's important to be clear about, and that is, the statements about what is high priority and low priority don't seem to make any middle ground. It's high priority if it's this, and if it's not that it's low priority, so there's nothing that is other than high priority and low priority, and yet the high priority chemicals are supposed to be acted on a fairly short scale. Obviously, you really can't do that, so there's going to have to be some way in which you are saying we are saying this is something we are not calling a low priority, no further action, but we are not acting on it right now as one of our first 10 or 20 chemicals in these things. Understanding how that process works and how you communicate that to the public and not having, sort of shadows hanging over things, because they are saying this is just on the verge of being whatever and it's just as well as about to be regulated. It's important to be clear about that to the public. So those are my comments. Thank you. 

Speaker 5: Lindsay McCormick, Environmental Defense Fund
Good morning, my name is Lindsay McCormick with Environmental Defense Fund. EDF believes that the purpose of prioritization is to provide an orderly, transparent process for EPA to work its way through the huge backlog of chemicals and provide an accountable means by which EPA decides which chemicals need full risk evaluation which have ample. We emphasize ample information, indicating they can be set aside. I'm going to briefly touch on five things that we ask EPA to include in its prioritization rule. First, the legislative record makes clear the intent that EPA is to eventually prioritize and conduct risk reviews for all chemicals in commerce, starting with the worst. The rule needs to establish a process that can be carried out over many years and even decades. While the focus will initially be on chemicals we know a great deal about, the process needs to accommodate chemicals which EPA has very little data. In contrast to the work plan prioritization process, lack of data cannot be used as a rationale to not prioritize chemicals. Hence, it is critical that the prioritization process includes collecting and developing information that does not currently exist or the agency does not have. To do this, the rule should codify EPA's clear authority to identify and fill data needs through both test orders and data call ins and describe how and when EPA will use it. For example, on a routine basis as part of the prioritization process, EPA should require companies to submit existing information they have on their chemicals, especially information that has already been submitted to other governments. Second, as we stated yesterday for the risk evaluation rule, we believe the prioritization rule should establish basic work flows and processes, but is not the appropriate vehicle for tackling significant science policy issues that are broader than just the law and that evolve over time with experience in advance of the science. Such issues are better addressed in guidance documents and policy statements that are more nimble. Third, as noted yesterday, public comment is critical a must be provided for. Yesterday we urged EPA to include public comment on the proposed scope of risk evaluations. However, too many distinct public comment periods raises concerns, including EPA missing its deadlines. We recommend the rule make clear EPA's authority to combine public comment periods where appropriate. For example, EPA could combine the request for information on a chemical being prioritized with public comment on its proposed high or low priority designation, or EPA could simultaneously take comment on its proposed designation, and for the high priority chemicals, its proposed risk evaluation scope. These approaches would be most appropriate where EPA has a lot of information on a chemical, as many of the work plan chemicals. Fourth, the law anticipates the need to coordinate and roughly match the pace of prioritization and risk evaluation processes. Coordination is critical to ensure that there are chemicals able to be designated high priority and ready for risk evaluation every time EPA completes one. We think this will be best achieved through the annual plan called for in section 26, which would allow EPA to align the number of high priority chemical designations with the number of chemicals for which risk evaluations are expected to be completed that year. Lastly, the law clearly lays out the factors EPA must consider when making a prioritization decision. EPA is to consider the hazard and exposure potential. We urge you to clearly articulate in the rule your authority to use a wide range of information to identify chemical as high priority based on hazard or exposure potential, including in vitro tests for hazard, structural similarity to chemicals with known hazards, and exposure modeling. EPA is also to consider the conditions of use, volume, as well as significant changes in either. EPA should routinely consider such changes in volume or use, which can alter the extent of exposure. These approaches should be used both in deciding which chemicals to move into the prioritization pipeline and to determine whether a low priority designation needs to be revised. Thank you for the opportunity to comment. 

Speaker 6: Derek Swick, American Petroleum Institute
I'm Derek Swick with API. API would like to offer a number of points for EPA to consider in the rulemaking on prioritization. As other speakers have noted, the process needs to be transparent at all points. We note that some of EPA's past prioritization processes have not afforded stakeholders with complete information about methods and interim outcomes, and we hope that changes under the new act. Second, we urge EPA to leverage space from other sources. Examples include information from ECHA, specifically publicly available information and robust summary information as opposed to complete study reports. EPA clearly should work closely with Canada through the RCC and other channels and also rely on information developed under your current TSCA program, including the HPV program. Work should encompass exposure scenario work and hazard information, and we urge EPA not to require development of data in new custom EPA formats, simply rely on information and robust summary type information, HPV formats that we've already established in terms of public and private sector development. Third, we urge EPA to move forward quickly in this process to designate low priority chemicals. We feel that the proposed rule should outline timely, scientifically sound, and efficient approaches for designating these low priority chemicals or categories of chemicals. In that vein, we feel that chemicals that are comprehensively already regulated either at the federal or state level should be considered for designation as low priority early on in the process. Along with this, there are certain chemicals and categories of chemicals that are partially exempt from CDR reporting, and we feel these chemicals could also be designated as low priority early on in the prioritization process. Along this low priority argument, we feel that the prioritization process should take into account that a chemical can be low priority for some conditions of use, but high priority for others. EPA should consider a mechanism to designate category of uses as low priority, and I think earlier we heard some examples could be chemicals used in closed processes or intermediates. Regarding the timing of the screening of chemicals, we would urge EPA to communicate to the stakeholders what a schedule could be, and certainly, we would want you to stick to it, and we also feel EPA could group chemicals into batches, and we talked a little yesterday about category approaches, but the petroleum industry had a good experience in Canada's Chemicals Management Plan where they instituted a sectoral approach for petroleum streams that helped build capacity within industry but also for governments in terms of how to assess complex streams, so we would encourage you to really batch different types of chemistries together and push them through the prioritization process in one batch. From a hazard assessment standpoint, we certainly support comments earlier from Dr. Doa regarding relying on the classification criteria. I just want to comment quickly under a couple of topics we think EPA should consider thoroughly in the rule, and in most cases as opposed to guidance, and these include what information sources EPA plans to use for prioritization. Again, the detailed criteria for designated high and low priority chemicals, the timeline, how EPA will address chemicals for which there is currently not enough hazard and exposure information to do a prioritization. Certainly we do not support a minimum data set type requirement that we heard from the speaker before me and certainly continue to engage with stakeholders in a transparent process. Thank you.

Speaker 7: Sarah Brozena, American Chemistry Council
My name is Sarah Brozena. I'm a Senior Director at the American Chemistry Council in the regulatory and technical affairs department. I want to thank Wendy Cleland-Hamnett and Maria Doa for their presentations, first on the LCSA requirements for prioritization process rule and Maria's presentation on the agency's methodology that they used to prioritize the TSCA work plan chemicals. As Wendy noted, the LCSA requires the agency to designate its first 10 substances for risk evaluations from the work plan by the end of this year. Further, at least 50 percent of the 20 substances, which must have risk evaluations underway in three and a half years, must be drawn from the work plan list of chemicals. So with these requirements, I think it's fair to say that Congress indicated it wants EPA to keep working on the work plan chemicals and getting risk evaluations moving on those, but it's also suggesting that the work plan methodology is certainly a place and an approach for EPA to build from as it begins the implementation of the prioritization provisions of the act. That said, as Wendy noted, there are a lot of new requirements in the LCSA that EPA must incorporate into this prioritization risk screening process. My first point is that back in 2011, ACC presented some specific prioritization principles for EPA to consider as they developed their methodology for the TSCA work plan, including principles reflected in the new act, such as the integration of hazard use and exposure based criteria to make prioritization decisions, making these processes and science criteria very transparent, recognizing that prioritization will likely be an iterative process, priorities can be re-examined as new information becomes available, and prioritization criteria and the data and information EPA uses to prioritize must be reliable and up to date. ACC plans to discuss these principles in more detail in our August 24 written comments. My second point is about our expectations about what we think EPA must do to implement the prioritization requirements in this rule. Under section 6b1 of the act, EPA is required to establish a risk-based screening process, including criteria for designating chemical substances as high priority for risk evaluation or low priority for which risk evaluations are not warranted at the time. ACC reads this requirement as a combination of both the procedures for prioritization, for example, how shareholders and stakeholders will meet the aggressive deadlines for providing EPA the information it will need to prioritize chemicals appropriately, as well as a description of the prioritization screening process itself. It is not just a legal procedural rule that EPA must develop. EPA is required by the LCSA to establish a science based rule in this process. Further, because the law describes prioritization as a risk-based screening process that leads to a science based decision, we believe section 26, requiring the best available science and the weight of the scientific evidence, must be incorporated into the prioritization decision. So ACC anticipates that EPA will describe the prioritization process in the rule itself in a way that references the applicable science based site requirements of section 26 and the appropriate steps in the prioritization screening process. We also believe some of the details of EPA's actual methodology will need to be addressed in guidance. The final point is that there are other provisions of the LCSA that need to be addressed in the rule, including the linkages to the section for testing requirements, Section 8 reporting authorities, and Section 14 protections. ACC will be discussing these linkages between the LCSA provision and the other provisions in our written comments on August 24. Thank you for the opportunity today.

Speaker 8: Kari Mavian, SI Group
I'm Kari Mavian, the Senior Director of Global Regulatory Affairs at SI Group. SI Group is a global developer and manufacturer of chemical intermediates, specialty resins, and solutions that are critical to the quality and performance of countless industrial and consumer goods. SI Group is a member of the American Chemical Council and Alkylphenols and Ethoxylates Research Council, both making comments today. SI Group supports the amendments to TSCA and appreciates the opportunity to provide comments. We are committed to working with EPA in making this a successful implementation. I'd like to make two comments on the rule today. First, I'd like to reiterate a comment made earlier. We recommend the EPA review the 2014 work plan table for transcription errors and consider comments previously submitted in response to the work plan to correct and revise it before commencing with prioritization. We will follow-up with EPA on our specific chemical substance, but as noted in an earlier comment, there is an error that shows one of our chemical substances meeting the criteria of a PBT chemical when it does not. Second, we also encourage EPA to consider the unique attributes of chemical intermediates and the low exposure potential when developing the prioritization guidance. Chemical intermediates are further reacted and consumed in industrial processing prior to entering final products. For instance, reporting a chemical that is used solely as a chemical intermediate and is reacted and consumed in processing as having consumer use overstates the potential exposure. Recognizing that EPA may not necessarily know whether a particular substance is a chemical intermediate at the beginning of the prioritization review, we encourage EPA to solicit use type information and address these comments during the prioritization public comment period and develop the use type ranking for these chemical intermediates. We welcome the opportunity to work with EPA on prioritization and assessment of chemical intermediate. Thank you. 

Speaker 9: Kristi Pullen-Fedinick, Natural Resources Defense Council
My name is Kristi Pullen-Fedinick. I'm a staff scientist at Natural Resources Defense Council. Our comments today focus on four main points. First, EPA must adopt the prioritization screening method that ensures most chemical substances are ultimately deemed high priority for risk evaluation. Congress established the prioritization process as a door for which chemicals must proceed prior to being evaluated, but it said little about the appropriate size of that door, other than a chemical that may pose an unreasonable risk to health or the environment, including the susceptible population, should be high priority. EPA, consistent with the mission to protect public health and the environment, must ensure the prioritization step is a wide and inclusive gateway, not a narrow crevice through which few chemicals slip through. Any process to designate chemicals high priority should be flexible and inclusive and take into account uncertainties in underlying data sources, for example, production volume, and variability in susceptibility, for example, critical windows of development, and variability to exposure, for example, highly exposed populations like workers or disproportionately exposed communities. The agency should use methods drawn from multiple data streams that give highest weight to positive evidence of hazard exposure or PBT characteristics. That is, the highest score prevails rather than a normalized score. That assumes data gaps in the areas evaluated, for example, hazard and exposure would be the highest level of concern, a score of three under the current work plan methodology. No chemical with data gaps would be classified as low priority, and weight of evidence would not be a requirement. Second, while broad criteria for broad risk will create a large pool of chemicals designated as high priority, EPA can narrow this at later time via a separate transparent process. Creating a separate process that limits a number of chemicals EPA works on at any given time allows the agency to be the most protective of human health and ecosystems when assigning high priority classifications and creates a system in which a smaller subset of the overall high priority pool is evaluated, lessening the overall burden for the agency. Third, the new TSCA allows chemicals to be designated low priority if they can be shown not to meet a very low bar that they may present an unreasonable risk of injury to health or the environment, including potential exposures to subpopulations. Existing case law makes clear the bar for EPA to establish that a chemical may pose an unreasonable risk to health or the environment is very low. Classifications of chemicals deemed low toxicity or low exposure should be based on sufficient data, which EPA can now more easily obtain under sections 4, 8, and 11 of TSCA. Assumptions based on the lack of data that are not validated, transparent, and adequately supported by data should not be considered sufficient to conclude a chemical is low toxicity or exposure and therefore low priority. As a general matter, the category of chemicals EPA designates as low priority will likely be very small. Fourth and finally, the prioritization process under the new TSCA has greater consequence than the prior prioritization, and adopting a methodology is not sufficiently inclusive of the screening method for the new TSCA. The current work plan prioritization method has significant limitations. For example, it misses several important health endpoints, including endocrine disruption, immunotoxicity, reproductive toxicity, and possible carcinogenicity. It has limited inclusion of various exposure routes and utilizes a limited set of data for steps one and two of the process, and does not adequately weigh and evaluate evidence of characteristics that must be addressed prior to consideration under the new TSCA. We think that chemicals that were excluded taking regulatory action already should be included within the evaluation process. For example, mercury could be included in the original work plan due to the risk posed by this chemical and other chemicals like it. We appreciate the time. Thank you.

Speaker 10: Katie Tracy, Center for Progressive Reform
Thank you for the opportunity to present today. My name is Katie Tracy, and I am a Policy Analyst with the Center for Progressive Reform. I have some comments to share and will follow up with written comments to the docket. As part of the prioritization rule, the Agency must consider unreasonable risk to potentially exposed or susceptible subpopulations. The definition provided in the act gives examples of subpopulations, including infants, children, pregnant women, workers, or the elderly, but it's important for EPA to keep in mind this list is not exhaustive. For example, another vulnerable population EPA should consider is fence line communities. EPA should factor in economic and social vulnerability into the definition of potentially susceptible subpopulations. For example, if a chemical's critical health effect is form of cancer that can be treated if detected early, EPA should take into account the greater susceptibility of impoverished households who lack access to regular cancer screenings. Additionally, with regard to identifying whether workers are exposed or susceptible subpopulations, EPA should consult with OSHA and NIOSH. EPA should take into consideration OSHA's capacity to initiate and complete a rulemaking. It can take over a decade for OSHA to develop a rule, meaning there may be certain cases where EPA should act instead of OSHA. Yet it's also important for EPA to consider what the two agencies can require in terms of protections. OSHA's use of ancillary provisions may have benefits for workers that EPA restrictions under TSCA cannot achieve. EPA should not consider cost in its prioritization of chemicals. For instance, EPA needs to be vigilant about cost considerations taken to the prioritization process through implicit assumptions about chemical uses. Thank you for the opportunity to comment.

Speaker 11: Christina Franz, American Chemistry Council
I'm Christina Franz, a Senior Director at the American Chemistry Council. ACC supports the fact that EPA integrated hazard and exposure potential in the work plan methodology. The integration of hazard and exposure is essential to ensure the process is risk-based and is required by the new act. ACC also supports the two-step process EPA employed in the method in that EPA used step one to identify candidates for prioritization, and in step two, EPA screened those candidates against specific hazard and exposure criteria to develop a range of scores on the candidates to designate them as either high or low priority. I have seven near-term recommendations to improve EPA's current methodology. One, EPA will need to update its work plan method criteria to comply with the criteria specifically outlined in the statute for designating substances as low and high priority for risk evaluation. I won't list them all here, but the statute is very specific on the criteria that must be included in EPA's new or revised methodology. Any adjustments in the criteria must support the need to designate both high and low priority. Two, EPA must update its prioritization criteria by using the best available science under the act. For example, EPA's persistence and bioaccumulation, or P and B, criteria used in the work plan method are outdated. ACC recommends that EPA use the most current scientific criteria on P and B including that from the SETAC Pellston Workshop for use on organic chemicals. That paper is called SETAC Pellston Workshop on Science-Based Guidance and Framework for the Evaluation and Identification of PBTs and POPs, and your very own Tala Henry served on the framework group responsible for that group. Separate criteria are needed for organics and metals. It's especially important that P and B criteria be updated in the prioritization process because of the emphasis placed on P and B provided in the act. Three, EPA should forgo reliance upon established lists of chemicals as its starting point for prioritization. Starting with lists by definition means that all chemicals not named on the various lists are not considered, and EPA excludes the vast majority of those active in commerce from screening. Four, please improve transparency. Although EPA's public method described the criteria applied, how those criteria were applied to score chemicals reviewed in step two and not selected for the work plan is still unknown. We strongly encourage EPA to improve transparency behind its screening, scoring, and prioritization decisions. Five, refresh the 2014 work plan based on new and improved information such as the 2016 CDR, the most recent TRI, and after inventory reset. Six, ACC supports the use of broader categories of views such as those outlined in the CDR as in exposure consideration, but encourages EPA to allow for further granularity to be factored into prioritization based on information received from stakeholders. And then finally, number seven, we urge EPA to use care when communicating the results of the prioritization publicly. As it did with the work plan chemical list, the EPA needs to use neutral terms, such as candidate for priority or high priority substances for risk evaluation, rather than terms that could be misconstrued as indicating substances have already been determined to present unreasonable risk. Thank you very much for the opportunity to comment.

Speaker 12: Steve Bennett, Consumer Specialty Products Association
I'm Steve Bennett, Senior Director of Scientific Affairs with the Consumer Specialty Products Association. We are a trade association representing companies engaged in manufacture, formulation, and distribution sales of many products familiar to consumers, representing both the consumer space and the institutional space. More broadly, we consider the downstream formulated products. By recognizing that space in the formulation industry, we are in a very good position to provide a lot of the use and exposure information that can help the agency appropriately prioritize products. We are also poised as a broad industry to assist with that process to make sure that the agency has the appropriate information and that we give them the most informative information at the right point in time. The critical question is not a yes or no but a how and when can that information be provided in the manner that can be most helpful with the overall prioritization? We will work very actively with the agency and other partners to work toward this process and provide much more detailed comments in our overall comments. Thank you. 

Speaker 13: Michelle Embry, Health and Environmental Sciences Institute
Hi, my name is Michelle Embry. I'm with the Health and Environmental Sciences Institute, and I'm the Associate Director of Environmental Science. Thank you for the opportunity to comment. As we've heard today, the TSCA reform bill requires EPA to prioritize chemicals for safety assessment. Due to the large number of chemicals that must be considered in the initial prioritization, a process that is transparent, efficient, and optimizes resource use is needed. I'm here to highlight Risk 21, a twenty first century initiative that develops a transparent visual framework that can be used to prioritize substances in a risk-based, resource appropriate manner. Risk 21 was collaboratively developed by a group of over 120 scientists from 12 countries in North America and Europe representing 15 government institutions, 20 universities, and 12 corporations. The project was led and facilitated by the Health and Environmental Sciences Institute, my organization, which is a nonprofit 501(c)(3) based in Washington, DC. Risk 21 is a framework by which both pieces of the risk equation, exposure and toxicity, are evaluated in a tiered manner using all relevant and reliable data. It also includes things like read-across modeling and other non-testing methods, as well as traditional tests and evaluations. The concept aims to reduce unnecessary resource use while providing sufficient precision and accuracy to support decisions that protect human health and can also be applied to the environment. It's problem formulation-based, meaning the purpose, scope, and plan for collecting and evaluating information, is the first step of a process. The early integration of both exposure and hazard information facilitates risk-based evaluation, including prioritization, which is, of course, a key component of TSCA reform. Risk 21 developed a web-based tool that allows users to easily communicate risk-based decisions, which is another point that's been raised today, whether for screening and prioritization purposes or risk assessment. This tool is freely available at risk 21.org and has been used over 4500 times in actual sessions  -  where people open and use the tool  -  by people in nearly 90 different countries over the past year. Direct application of this approach, including the use of the web tool, was shown in a recent case study and published in Critical Reviews in Toxicology. Out of an initial list of 20 potential drinking water contaminants, 4 were prioritized for additional assessment based only on low-tier exposure and hazard assessments and already available information. Using this approach, the list of chemicals was reduced by 55 percent by using exposure estimates and low-tier toxicity estimates and then by another 25 percent by using data from existing toxicology studies. Again, this was a prioritization exercise, not any sort of definitive risk assessment. The utility and uptake of this approach and the web tool has been demonstrated via several hands-on case study workshops led by risk 21 team members and sponsored by various groups, including government agencies. These workshops have engaged participants in real world case examples and, combined, have reached over 430 people with direct hands-on-use and application of the web tool in the U.S., China, Taiwan and Brazil with additional workshops in the planning stages in Canada and Europe in late 2016 and in early 2017. Risk 21 provides a framework to prioritize substances in a risk-based, resource appropriate manner. I hope EPA will consider using this approach and the associated web tool as it works to implement the TSCA reform bill. I'll include references and additional materials in the docket. Thank you for your time and consideration.

Speaker 14: Gina Solomon, California EPA
I'm Dr. Gina Solomon, the Deputy Secretary for Science and Health at the California EPA, and I am here to reiterate what I said yesterday, that California is eager to work with U.S. EPA as you move forward on this rulemaking. The work plan that you've developed in this last round really should be commended. It was a thoughtful, excellent piece of work and is a very solid foundation for the next step. The criteria in the work plan very closely parallel the criteria in the statute. The only issue of course  -  well, there are two issues that need to be resolved moving forward  -  one issue relates to the cut offs because obviously the cut offs that you use will only work for a certain period of time. Then you will essentially run out of chemicals that meet those criteria, so, presumably, the criteria will need to move with time, for example, the poundage cut off for release or use, in addition, the hazard type information that you use not only for the cut offs, in other words, known probable carcinogens, but also the scope of the hazard that you are looking at. In California, we developed a regulation on hazard traits that are included in our consumer products regulation for priority setting purposes. We will submit that to you so that you are aware of it. It defines a much broader universe of hazard traits than are in the work plan, so it might be worth evaluation. In addition, on the hazard front, as you sort of lower the bar over time, you will end up with less and less data to review, and so you will be looking at other data sources, including high throughput type data. In that regard, in California, we've been closely evaluating Toxcast data. We found, notably, that the zebrafish data have been quite useful in our experiences in predicting developmental and neurotoxicity. Zebrafish are, unfortunately, vertebrates under the law, but I just learned today that in the embryonic phase, zebrafish actually are not vertebrates. So we could avoid that issue. Using your order authority early and often to gather needed information both on toxicity and on use categories will be great, but the other issue that is going to be a potential problem is the low priority category. Other commenters mentioned that, and in this last round in the work plan, there were quite a few chemicals that were essentially low priority and that was just because they were relative to the ones that were high or medium. But those will ultimately become high priority, so the question is, does EPA want to take that kind of approach going forward? If so, you need to communicate that clearly, that the low priority are not in that category to stay. But if it is going to be a place where chemicals go and stay for a much longer period of time, then the bar is going to have to be quite a bit higher to get into that category. And so we will be very interested in how you resolve that issue. Thanks very much, and I look forward to seeing how this works out.

Speaker 15: Jim Cooper, American Fuel and Petrochemical Manufacturers
I'm Jim Cooper with American Fuel and Petrochemical Manufacturers. Thank you, once again, for convening this meeting as a public forum. It's important, and I want to reiterate that and how much I appreciate that. You are going to hear the word transparent a lot, I guess. You've heard it a lot yesterday, and you will hear it a lot again today. Let me go down a little list. We know why it's important. I think EPA fully understands that, so I don't have to go into that, but we can accomplish this through publication of the list of chemicals the agency is considering for prioritization and providing an opportunity for stakeholders to voluntarily submit existing information. Sufficient time has to be afforded for that opportunity, but that's going to be important and very helpful to the agency. When proposing to add chemicals to the list, EPA should make the information upon which conclusions are based publicly available, including the information used to prioritize chemicals on the work plan list to make sure we have the right chemicals there. There's nothing wrong with revisiting that, and it represents a great deal of potential work in the future. Again pointing to Section 26, you will probably hear that from me over and over again. The letter of the law is pretty explicit about the incorporation of sound science which includes weight of evidence immediately upon enactment, and that will lead to greater transparency as well. And to accomplish any kind of weight of evidence approach, the criteria by which studies and other information are judged is going to have to be developed sooner rather than later. When looking at different hazard and exposure information, obviously in the statute explicitly it says no minimum data set. I think everybody understands that, but there is still a great deal of information that would be voluntarily submitted by companies going through this process. That information should be considered, including things like mechanistic data codes, kinetic work that's been done, and physical properties. These should be considered when you are looking at exposure. This is stuff EPA already knows and already does, and we hope that kind of process is augmented by industry's input. And then the last thing to consider is basically confidential business information. This is going to be a data intensive process. You will probably be receiving, we hope, robust summaries, but in some cases, data you may request has to be protected for two reasons. One is some of it is going to be confidential as far as some of the chemical IDs and that still has to be protected even under this exercise, but those data are worth money, a great deal of money in some cases. Some of the studies that have been conducted already that would be submitted have value and that value also has to be protected just like the intellectual property has to be protected. Again, thank you for the opportunity. I hope these public venues continue.

Speaker 16: Melanie Benesh, Environmental Working Group
My name is Melanie Benesh, and I'm a Legislative Attorney with the Environmental Working Group. Thank you for the opportunity to speak this morning. I have three broad points that I would like to make that largely reflect what other commenters have said, but I think they are worth repeating. 

First and fundamentally, these high and low priority chemicals must be rooted in adequate data because it will inform the rest of EPA's work on a chemical. As data gaps are filled, the potential health risks and susceptible populations to be considered may shift, expand, and narrow, and thus, that data should inform how EPA will derive the risk and ultimately regulate a chemical. As such, the lack of data, as many other commenters have said, should never be the basis for considering a chemical to be low priority. Rather, a low priority designation should be based on science indicating the chemical is unlikely to pose an unreasonable risk. Before prioritizing a risk is high or low, EPA should have an idea of what data it needs, whether the data exists, and how it might get that data. Because having adequate data is so fundamental to the entire review process, we are glad EPA is able to use the order authority to get data early as part of the prioritization process, and we encourage it to do so. 

Second, the required considerations that you reviewed earlier such as persistence, bioaccumulation, storage near drinking waters sources, etc., are all important starting points, but we don't think they should be an exhaustive list of what EPA can take into consideration. I would point out the statute says EPA may consider a chemical or category of chemicals, and we think there are situations where it may make sense to do that in order to quickly and efficiently regulate large groups of chemicals or similar chemicals when it makes sense. As I said, all of the factors mentioned in the statute are good starting points, but they are not exhaustive. Many of the comments made yesterday on the risk evaluation process may also be applicable to prioritization. After all, the framework EPA has for evaluating chemicals should inform the considerations they make when deciding which chemicals will undergo that process. One lesson from yesterday's comments is that aggregate exposures must be part of EPA's consideration. This includes not only the TSCA regulated uses of that chemical, but also uses that may be regulated by other agencies that may become part of the total exposure to that chemical. Furthermore, when possible, EPA should consider the cumulative exposures in conjunction with other chemicals or other potential environmental or other potential stressors that could contribute to the chemical's environmental or health risk. As it will be part of the risk evaluation, EPA should think about these exposures early on in the process. Another lesson from yesterday's comments is the importance of considering the entire lifecycle for the chemical from production, to use, to disposal, and also the different exposures that come along that lifecycle to different workers involved making the chemical or disposing of the chemical, children who may be affected by it differently throughout the different lifecycles, and products that may be marketed to those children in particular. 

And then third, as many others have mentioned, we appreciate the transparency in this process. We hope the process continues to be transparent, not only with regard to EPA's prioritization decisions, but also the corollary to how chemicals may get reviewed, which is through manufacturer request. We don't know yet how many of those requests EPA will get, but we would appreciate transparency in how EPA ultimately decides which chemicals they are going to except based on those requests. Thank you very much for the opportunity to speak today. 

Speaker 17: Nathaniel DeNicola, American Congress of Obstetricians and Gynecologists
My name is Dr. Nathaniel DeNicola, and I would like to thank EPA for the opportunity to speak today on behalf of the American Congress of Obstetricians and Gynecologists, ACOG. I'm a board certified OB/GYN and member of ACOG's Committee on Obstetrics Practice and the liaison between ACOG and the American Academy of Pediatrics Executive Council on Environmental Health. We welcomed the passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, and we are particularly pleased with its definition of exposed subpopulations, which includes pregnant women, infants, and children. We like the update to the standards to make it clear that health and safety, not costs, will be considered during chemical safety assessments and determinations. We know the passage of the law was one step, and now the real work begins. Reducing exposure to toxic environmental agents is a critical area of intervention for all reproductive healthcare professionals. Robust scientific evidence has emerged over the last 15 years demonstrating that preconception and prenatal exposure to toxic environmental agents have a profound, lasting effect on reproductive health across the lifespan. Exposure to environmental chemicals in the air, water, soil, food, and consumer products is ubiquitous. An analysis of the national health and nutrition survey found that virtually every pregnant woman in the United States is exposed to 43 different chemicals. These chemicals in pregnant women can cross the placenta, and in some cases, such as methyl mercury, can accumulate in the fetus, resulting in higher concentrations in the fetus than in the mom. Prenatal exposure to environmental chemicals is linked to a variety of adverse health consequences, and patient exposure at any point in time can lead to harmful reproductive outcomes. There's only so much a mom can do. Until and unless proven otherwise, ACOG considers potential exposures to chemicals in pregnancy an unreasonable list, so it's our position that if there's potential exposure to pregnant women in the fetus, infants, or children, it's high priority. In addition, as EPA seeks to develop procedural regulations, it's our hope that EPA will prioritize the development of the requested notification system for the disclosure of confidential business information. This will improve the physician's ability to speak freely and confidentially with our patients with factual information relevant to their health. The chemical prioritization process here before us sets the future course of chemicals and the ability for states to undertake their own actions. We urge EPA to place the utmost importance on the health of potentially exposed or susceptible populations, especially pregnant women, during this process. We look forward to working with you on the implementation to ensure the new era of chemical safety improves public health for future generations. Thank you for your time and attention.

Speaker 18: Bob Skoglund, Covestro
I'm Bob Skoglund with Covestro. As communicated yesterday, we are a world leading manufacturer of high tech polymer materials and products and application solutions that touch nearly every aspect of modern life. Our vision to make the world a brighter place is fulfilled through leading technological products that benefit society and the environment. Not only did we advocate for the modernization of TSCA, but we are now committed to the success of the Frank R. Lautenberg Chemical Safety for the 21st Century Act to increase both the confidence of the EPA's and our industry's chemical manufacturing practices. Fundamental to the success of the Frank R. Lautenberg Chemical Safety for the 21st Century Act is a robust, transparent, reproducible, and defensible prioritization process. The following are several key elements of such a process. First, it's important that the chemical selection process align with the overall prioritization process and be risk-based. As such, EPA needs to publish guidance on how hazard, use, and exposure criteria will be used in selecting chemicals for prioritization. In some cases, 90 days may not be enough to provide EPA the information needed to make a priority designation, particularly since this will now include more use and exposure information. While there is a provision for an extension of this period for information as the administration determines is necessary, we understand the timeline is tight and extensions are not always an option. Therefore, EPA should consider ways in which it might provide an early heads up to interested persons what the agency's contemplating, including the candidate list for prioritization, thus allowing more time to adequately prepare this information. The agency should look at what other governments, like the Canadian government, have done in this regard, and leverage their experience in this space. EPA should provide additional opportunities for interested persons to submit information that becomes available after the 90 day window has closed. If for nothing else, this data can be used in the scoping and the risk evaluation processes. The prioritization process will include a consideration for hazard and exposure potential of a chemical. However, there are no standardized protocols or frameworks for collecting and interpreting use and exposure information for prioritization, scoping, or even the risk evaluation. EPA needs to provide guidance on expectations for use and exposure information and how they will be interpreting this information to allow interested persons to adequately prepare this information. Finally, chemicals designated as low priority require no further action, but can move into high priority based on new information. In the event the administrator becomes aware of new information, will there be an opportunity for interested persons to again submit relevant information that may have become available otherwise? And how will this chemical be reinserted into the chemical selection process? 

Speaker 19: Nancy Beck, American Chemistry Council
I'm Dr. Nancy Beck with the American Chemistry Council. As you can imagine, ACC is pleased to be working with EPA and other stakeholders to implement a statute that's founded on the principles of risk evaluation, requiring due consideration of hazard and exposure. I want to make two points today. 

While prioritization is in itself a screening level assessment, it's important that this be conducted in a transparent and reproducible manner. Section 26 of the Frank R. Lautenberg Chemical Safety for the 21st Century Act includes not only scientific standards in section H, but other sections that ensure assessment has occurred using reasonably available information. This applies to the prioritization step. Clarity and completeness with regard to the data, assumptions, methods, quality assurance approaches, and analyses used to generate information are not just good science practices, they are requirements of the statute, and these elements must be incorporated into the rule making even for the screening step. Improving the clarity and transparency of the decision making process by not just articulating the general criteria, but also clearly articulating how those criteria have been used to prioritize individual chemicals, will go a long way toward increasing public confidence in EPA's activities. EPA often completes large levels of analyses before making a decision. The new act now gives the agency an opportunity to present that work to the public and get credit for all the behind-the-scenes considerations that the public often doesn't see. 

My second comment focuses on the section 26 requirement that EPA makes decisions based on the weight of the scientific evidence. Again, this requirement for use of the weight of the scientific evidence applies to the prioritization step. Under a weight of the evidence approach, EPA must evaluate whether the strengths, limitations, and relevance of the information used to designate chemicals is high or low priority and integrate the information as necessary or appropriate based on the relevance of that information. This means even for a screening type analysis, such as prioritization, EPA must consider the quality and the relevance of the information underlying the approach. EPA now has an obligation to ensure the methods, databases, and other information relied upon are of the highest quality and relevant to the prioritization decisions. Thank you very much for the opportunity to comment.

Speaker 20: Richard Denison, Environmental Defense Fund
I'm Richard Denison, a lead scientist at the Environmental Defense Fund. I want to make two comments that address issues that have been raised yesterday and today. The first has to do with this question of mandated standards in the law and the question of whether those necessarily need to be incorporated into a procedural rule or not. EDF fully acknowledges that Section 26 has a number of mandatory requirements with regard to science decisions that need to be incorporated in EPA decisions. However, those mandates are already in the law, and it does not require that they be in a procedural rule in order to be mandatory in EPA's application of that rule in making prioritization decisions or carrying out risk evaluations. It does not follow that because they are mandatory in the statute  -  indeed the mandatory nature of them in the statute makes it mandatory  -  and putting them in a rule does not alter that one way or another. 

The second point I want to make is to draw attention to attention that has been part of the TSCA debate from the beginning. Many of the stakeholders fought very hard to keep out requirements that involved minimum information sets, and a lot of angst and a lot of debate and a lot of compromise went into the new authority to get information against the absence of requirements for minimum data sets that were broadly applicable. Having said that, I do feel an obligation to draw attention to what I think is a significant contradiction in what I'm hearing from my industry colleagues here. On the one hand, they want EPA making prioritization decisions on the basis of existing information and not going out and requiring new information to be collected or generated. On the other hand, they want those decisions to be of the highest quality and absolutely certain before a chemical gets designated high priority. I don't understand how you square that circle in the absence of EPA exercising its authority to get good information in order to inform the prioritization process. 

One of the earlier speakers mischaracterized the position by saying that we were calling for minimum data sets. We are not, and we recognize the clear language of the law that precludes that, but that is different than saying that EPA can and should be clearly identifying information and needs for purposes of prioritization and then utilizing its clear authorities to ensure it gets that information in a timely manner to inform those prioritization decisions. Thank you.

Speaker 21: Scott Arnold, Dow Chemical Company
Thank you. I work in the environmental health and safety organization with about 20 years of experience in risk assessment. We look forward to a successful implementation of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, and we really appreciate this historic opportunity to help shape and improve chemical regulation within the United States. I was on this morning, and hearing the comments, there are certainly a number of key themes that have emerged. My comments will speak to a number of these themes, but will also propose additional items for EPA to consider. 

So first, comments on general prioritization: obviously EPA must establish a risk-based screening process for designating substances as high priority for risk evaluation or low priority for which evaluations are not warranted at this time. The chemical prioritization framework should be based on consistent application of specific hazard and exposure science elements that define risk potential and be employed in a manner consistent with the best available science. The screening approach should be simple and transparent. We recommend the prioritization framework be developed within the purview of an extra panel consisting of all interested stakeholders working in concert with EPA scientists. Once implemented, we recommend an open, iterative process that includes an opportunity for review, comment on initial rankings together with the information that led to the result, and an opportunity to update the rankings with improved information. 

Comments on the risk-based chemical prioritization framework: Exposure and use information is the key to prioritizing existing substances of concern or for establishing test programs for either existing chemicals or new chemicals being submitted for agency approval. The hazard only approach ignores the exposure side of the equation. For example, chemicals used as isolated intermediates or in closed systems or exist in a form in products with no exposure potential should not be characterized as high priority regardless of hazard. In addition, the inherent properties of a chemical should be taken into account as this will affect human health and ecological exposure potential. There are numerous screening models and frameworks that exist to accomplish this goal, but the framework should be open and iterative to accommodate higher tiered data, such as human and environmental exposure data, especially in the event modeled information is uncertain. For certain substances, human biomonitoring data gives information on actual human exposure, and combined with biomonitoring equivalents gives a powerful risk-based approach that can be used for prioritization. Evaluation of hazard of a chemical must use the best science that is grounded in a systematic review, evidence integration and certainty analysis, and peer review, as noted in a number of recent recommendations by the National Academy of Sciences and incorporated in EPA guidance such as the recent risk principles and practices. 

EPA has the opportunity to develop an inclusive process that engages stakeholders from NGOs, stakeholders, and scientists, and these combined resources unique perspectives and can be beneficial. Dow encourages the agency to leverage support from all offices. EPA ORD has demonstrated leading edge research that's inclusive and cross disciplinary. Scientists have been engaged with industry in developing tiered risk assessment approaches that highlight the use of exposure information and the new twenty first century approaches for predictive safety assessment, i.e. the Risk 21 process mentioned earlier and the approach presented by EPA's own Rusty Thomas in 2013. The framework should be flexible to incorporating the use of these technologies as they mature. 

In closing, Dow looks forward to working with the agency and interested stakeholders to ensure the chemical safety act is successful and to safely advance new chemical technologies that benefit the public. Thank you very much. 

Speaker 22: Kelly Moran, TDC Environmental
My name is Kelly Moran, and I'm with TDC Environmental, LLC. I'm commenting based largely on my experience serving as co-chair of the California Green Ribbon Science Panel. This panel advises the California Safer Consumer Products regulatory program, so my comments are my own but drawn from that experience. 

First, I want to agree and reiterate the recommendation that EPA can learn a great deal from California's experience in developing its prioritization process. The Science Advisory Panel played an important role in developing that California process. It was different than a stakeholder group. I understand that EPA is subject to FACA limitations that will preclude that kind of panel in this process, but perhaps EPA could consider an internal federal government expert group to capture some of that dialogue as you work through the issues here. There are quite a few. Here are just a couple of examples of the kinds of things that we have learned in the California process that I want to highlight for you. 

One of them is that most people working in this area are focused on human health, and they don't remember that they need to include their responsibility to protect the non-human environment. By that, I mean chemicals that occur in air, water, soil, plants, animals, and across all the nation's major ecosystems. Endangered species are affected, and aquatic organisms are very different than people in their responses. Plants, wildlife, and organisms crucial to the biological treatment process in treatment plants can all be affected by toxic chemicals in consumer products. There are many ways to address this in the prioritization process. I would include coordination with other EPA offices in consideration of the duties under the endangered species act for consultation with these services.

An important element of the entire process, not just prioritization, will be working to prevent regrettable substitutions. This has been happening, and basically, there's been a transition from chemicals harmful to human health to chemicals harmful to the environment. In pesticides, regulatory programs shifted from DDT to phosphates, and now to pyrethroids and the neonics. We've shifted from PBTs and human health hazard chemicals to chemicals that are harming aquatic and insect ecosystems. 

So the third thing that came up was that a strict ranking system that tries to compare all chemicals against each other just won't work very well in the context when you are trying to incorporate values to cancer or is important reproductive toxicity more important than salmon populations? No. So a system that has a different approach that does not try to deal with that will be more feasible. 

And finally, the group advises strongly that the process consider both severe and widespread exposures. Severe being someone dies, but not everyone has to die. Widespread being many, many people or large parts of the ecosystems are exposed. While the harm might be very small in the latter case, even a few IQ points lost has major societal consequences, and similarly, a small effect on reproductive toxicity can eventually wipe out an entire species. Thinking through these and the other lessons could be really helpful in the prioritization process, so I wish you the very best of luck as you work to the many challenges here, and I'd be happy to support it if there's any way I can. Thank you for the opportunity to speak.

Speaker 23: Linda Reinstein, Asbestos Disease Awareness Organization
I'm the President of the Asbestos Disease Awareness Organization, the largest independent nonprofit dedicated to eliminating asbestos caused diseases. Throughout the past 12 years, we have been a stakeholder on legislative discussions and actions to prevent exposure to asbestos, and that's why I'm calling today. Organizations, institutions, and trade unions agree that today's meeting is one of the most important discussions that the EPA has taken to begin the landmark step forward. I'd like to make five points about the prioritization. Asbestos has been the poster child for the failure of the 1976 TSCA for decades. It will now become the litmus test for the access and efficacy of the new Lautenberg Act. It's wonderful to know the agency has mandated the use of health based standards when prioritizing and evaluating existing and new chemicals rather than the economic cost of any regulations. The EPA is required to select 10 high risk chemicals from the chemical list, which has been screened and scored nearly 100 chemicals. According to the new law, we know that prioritizing these chemicals based on the persistence and bioaccumulation scores and also which chemicals are known human carcinogens and have high acute and chronic toxicities will allow the EPA to advance twenty first century safety. As we talk about asbestos, it's not a legacy issue. Imports continue today. USGS report alone in 2015 that we have consumed more than 400 metric tons of asbestos to meet manufacturing needs even though safe substitutes exist. In fact, the alkaline industry accounted for 90 percent of the U.S. consumption of asbestos. We urge the EPA to take a look at these studies and reports and prioritize asbestos in the first top 10 2016 chemicals. Consumers have lost trust in chemical safety, and that's why the task of bill is exciting to all of us. Prioritizing asbestos in the top 2016 10 list will lead not only to swift regulation, but consumer trust. Most importantly, it will send a powerful message that the EPA TSCA implementation effort is a landmark step forward to protect public health and the environment. Lastly, it's a somber reminder that 20,000 Americans have died from preventable asbestos caused diseases just in the three decades since the EPA failed to ban asbestos in 1989. ADAO urges the EPA to prioritize asbestos as one of the first 2016 high risk chemicals for evaluation and regulatory action to end the asbestos manmade disaster. Thank you. 

Speaker 24: Stuart Cagen, Shell
My name is Stuart Cagen, and I'm a human health toxicologist for Shell Health in Texas. My comments today pertain to elements of prioritization and are consistent with comments from the American Chemistry Council. These comments will be submitted in written form. Today I would like to emphasize the importance of best science when the EPA considers options for prioritizing chemicals for evaluation under the new Frank R. Lautenberg Chemical Safety for the 21st Century Act. This includes the use of best science for weighing information from various sources, including outreach to industry to devise relevant information. While important information from industries is often available in literature, additional information, very useful information, can be obtained from unpublished reports. Thus, ample opportunity should be provided for public comments. Further information should be weighed so as to assure appropriate emphasis is paid to individual sources of data. In doing so, a hopeful expectation is that a consensus prioritization arrangement will become clear. Alternatively, the EPA should avoid the temptation to always seek a piece of information that will provide the most conservative set of priorities. This can lead not only to an inappropriate commitment of resources to assess relatively lower risk materials, it can also lead to excluding chemicals of otherwise high importance. In the end, the EPA is urged to provide procedural guidelines for prioritization. This guidance should undergo external review including providing the opportunity for public comment. The EPA is encouraged to use multiple data sources including new tools for the assessments. The use of these twenty first century tools should be incorporated judiciously, and methods and evaluation criteria regarding the assignment of priorities based on these methods should be specifically provided for public comment. In addition, the use of data from in vitro studies can be calibrated for relevance using data and quantitative in vitro to in vivo extrapolation methods. Thank you for the opportunity to comment today. 

Speaker 25: Bill Greggs, Soleil Consulting
I'm Bill Greggs, Principal of Soleil Consulting and a chemical engineer by training. I've worked for the past 45 years in consumer product manufacturing and on product safety and product stewardship. These methods are good starting point and have a number of components that work well. The strong points are a two-step process. The first step identifies a set of candidate chemicals, and in step 2 screening and hazard exposure information is developed to score candidates. For hazard ranking, the use of readily available information. For exposure ranking the use of a combination of multiple readily available indicators of use and exposure. But there are several major concerns about the methodology that make it limited for longer term application. Those are the use of lists in step one to identify candidates and the lack of stakeholder consultation on candidates during the prioritization process. The step one use of lists underlies EPA's overall criteria for candidate identification. It may have been a useful shortcut to get the program started in 2012, and it may still be appropriate for the next few years in identifying the 10 initial priority chemicals for risk evaluation. However, a list based approach by definition narrows the field. It sets aside thousands of other substances that are not on the lists used. This may leave some risky substances not considered. The reverse is true if lists are used to identify the low priority end. It would be rightfully unsatisfying for stakeholders if the priority chemical program is based on lists ad infinitum. Of course, EPA could manually screen all chemicals not just listed substances, but only if there were unlimited funds, people, and time. That will never be the case. So how can the agency screen for all active chemicals and ensure stakeholders it's applying due diligence and priority setting? One possibility would be the application of the twenty first century high throughput methodology. These tools are being developed to address both hazard and exposure. There's increasing confidence in the capability and reach of the tools. For hazard, this means assessing bioactivity via Toxcast and mixed testing methods and applying quantitative in vitro and in vivo extrapolation. For exposure, it will be prediction by a high throughput exposure modeling. When these tools are ready they offer the only serious alternative that will allow screening of all active chemicals in an updated step one. In developing the prioritization process rule, EPA should ensure there is a placeholder for the application of these and other advanced methods. They should work closely with the National Center for Computational Toxicology and with stakeholders to monitor progress on these technologies, and when ready, quickly apply them to all active substances. Lastly on stakeholder consultation, it's good to hear that there will be two opportunities for comment in the prioritization process, which did not occur in the work plan. An important feature of Canada's prioritization efforts was the iteration between agency identification of chemical screening information and giving stakeholders the opportunity to provide information not readily available to the government. This worked to ensure Health and Environment Canada had the most complete and up to date information for finalizing priority setting decisions. Including comment periods in the process will improve EPA's priority chemical selection and better serve the needs and interest of EPA and stakeholders. Thank you for this opportunity.

Speaker 26: Aryenish Birdie, Physicians Committee for Responsible Medicine
Thank you. I'm the Regulatory Testing Policy Specialist at the Physicians Committee for Responsible Medicine. The Physician's Committee promotes relevant non-animal test methods over animal tests because these methods often provide more reliable information on how humans react to chemicals, and the authors of this new law agree. TSCA now requires EPA to replace vertebrate animals in testing of chemical substances or mixtures. This core principle must be included in prioritization decisions. Because of this, the EPA should adopt as a matter of policy, that only non-animal test methods be used in prioritizing chemicals. This will allow for quicker detection of the most dangerous chemicals at a lower cost. The agency must also apply a testing strategy in which the results of tests and available information are used to inform decisions on whether additional tests are necessary. EPA is aware that Toxcast and other in vitro tools provide information on chemicals quicker than animal tests. Therefore, these tools should be taken advantage of instead of requiring animal tests for chemicals that lack information. Chemical producers also have a responsibility to minimize animal testing. There's a mandate on any person developing information for submission on a voluntary basis to first test to develop information using non-animal testing methods when available. Many resources are currently available for companies to use to better understand potential effects of the chemicals such as the OECD QSAR toolbox, AOP wiki and many other tools including on EPA's website. We can also be a resource to any company looking for more information on these methods or that wishes to switch to non-animal methods. Getting away from animal tests allow us to better ensure protections for human health and the environment and we look forward to being part of this historic process as it unfolds. Thanks.

Speaker 27: Amy Kyle, University of California at Berkeley
This is Amy Kyle with the University of California at Berkeley, and again, I want to say how much I appreciate the opportunity to participate in this forum and talk to EPA, but also hear from the other participants. I have a couple of comments about the prioritization process as laid out in the statute and how that might compare to a scientifically based one and what some of the implications of that are and then a broader comment about the trajectory of this work. So to start with the first part of that, with the prioritization, EPA again has some challenges, I think, in trying to create a scientifically based process given the way this is written in the statute in that the statute basically provides almost for a triage, where you are selecting a few chemicals for further evaluation and then maybe you will identify a few low priority ones, and then it seems like the rest of them will end up, as many people have said, in some middle ground. This does not really reflect the kind of data we have about chemicals; there are much finer gradations. Most of the data is variations and can vary by orders of magnitude, so you are losing a lot by doing that, though I understand the point of it from a management point of view. 

The second issue is the low throughput. If EPA is going to designate a total of 20 chemicals to work on at any point in time and maybe do five of those a year, then if you think there are 1,000 that will need to be evaluated, that will take, I guess, 200 years. I think there are probably 5,000 and that will take 1,000 years, so the low throughput of this process is not fit for purpose at the outset. I recognize the EPA, of course, needs to start where it is and then work this out, but I think we should also keep an eye on what is really needed to provide a sound chemicals management system as you do this because there is an opportunity to get back to Congress and to kind of consider what the targets are and what else needs to be done, and I think we should be keeping that in mind in the design of all of this. 

A few things I would suggest are to consider methods that allow comparisons across chemicals not as a fixed ranking, but in the way data is captured and recorded. The second is to consider methods that would systematically seek out the best available data in different categories and trying to do that over time in a more systematic way and not just with regard to the action that you are taking in the immediate moment. And then the last one would be to consider working towards interoperability with other data systems at EPA and elsewhere to build more on what other people are doing. We focus on individual chemicals and you start with the chemical to figure data needs etc. but I think what we really need is more of a systems data approach that looks at the chemicals used as an ecosystem and pulls data more routinely from different sources and updates findings, etc. et cetera. I know that is not what we have right now, but that is really what we need, and I think as you work through these problems, perhaps we could think toward what that might involve. 

And then I guess the last comment I wanted to make is somewhat in response to some of the other comments that have been made by other parties here, and this is about transparency and confidential information. It is essential to have transparency on health and safety data to have a credible system. And I don't think we can continue to assert the health and safety data could be held as confidential because it has value. Of course, it has value, but a lot of things have value under the public domain, so I think that issue does not quite seem to be part of the - I'm not sure where that fits in the evolution of this process, but I think it's another really key thing that needs to be addressed for this system as a whole to work in a way that is credible and transparent. Thank you.

Speaker 28: Tony Schatz, Ashland Chemical Company
Good afternoon. My name is Tony Schatz. I'm the Director of Global Product Stewardship and Occupational Health at Ashland Chemical Company. We are a specialty chemical company and have supported the task of reform and worked with EPA and our trade associations along the way. Thank you for the opportunity to speak today. I have a few comments that I want to make. One is that EPA needs complete transparency  -  as we've heard a number of times  -  in the use of a weight of evidence approach and the best weight of science and existing data from other countries and registrations that have been submitted instead of relying on just chemical lists for prioritization methods. My second point is that EPA needs to ensure that the prioritization process is such that it does not dilute down actual prioritization by having such a wide net that most chemicals fall into high priority. Significant impacts to reducing exposures to truly highly hazardous chemicals based on their specific uses will pose a significant risk to consumers, workers, the community or the environment as well as the most efficient use of resources depends on this approach. Hazard does not equal risk and exposure does not equal risk. Therefore, we must consider both in a reasonable way for prioritization. So, for example, intermediates used in a closed system do not lead to significant exposure and therefore, should not be considered high priority even if they are hazardous. Regarding the requirement for inventory reset and 10 year look back where these chemicals are considered active, the EPA must figure out how to set this large list of active chemicals for prioritization review and remove those that are not currently in use for commerce and those that have been phased out to avoid wasting any time or resources on reviewing those chemicals not currently resulting in any significant or real exposures. This may be done using the latest reporting or other means of reporting mechanisms in order to have a more realistic look at what is considered active. And finally, EPA should consider how to deal with those chemicals that do not currently fall into high priority or low priority. We've heard a few times today about chemicals in between, which are not truly low priority chemicals but not sufficient to be high priority. A tiered approach or some medium level priority may need to be considered for a number of chemicals. Thank you for your time.