Summary of Public Comments
Risk Evaluation Process Rule for the Toxic Substances Control Act as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act
                                August 9, 2016

Speaker 1: Joe Manuppello, People for the Ethical Treatment of Animals
My name is Joe Manuppello. I'm with People for the Ethical Treatment of Animals. Thanks for the opportunity to come in today. Thanks to the tireless efforts of advocates, the Frank R. Lautenberg Chemical Safety for the 21st Century Act requires EPA to use the best available science to evaluate the risks to health and the environment presented by chemical substances.  As stakeholders in the process with this update, we intend to keep in close eye on the implementation. The agency is required to employ the processes that replaces and reduces invertebrate animal testing while providing information with equivalent or better scientific quality and relevance.  This screening and testing process begins by assessing available information on hazards and exposure for each substance specifically including toxicity information, computational toxicology in bioinformatics and throughput screening methods and models. In addition, when requesting the development of new information, the agency must facilitate the use of scientifically valid test methods and strategies that reduce or replace the use of vertebrate animals. The grouping of two or more substances into scientifically appropriate categories so information from one or more substance can be read across to others in the category and the formation of industry consortia to avoid duplication and tests. The agency must also explain the basis for any decision which requires the use of vertebrate animals.  Finally, the agency must promote the development and use of new scientifically valid test methods and strategies that are not based on vertebrate animals.  We wish to emphasize the importance of training in these methods for agency staff and we offer our assistance in organizing training by outside experts with expertise in the relevant fields.  The agency must develop a strategic plan no later than two years after the date of enactment of the act. However, we would appreciate interim progress report on the agency's efforts to implement the animal replacement provisions along with opportunities for discussion prior to commenting on a draft plan. In addition, the agency must prioritize performance assessments validation and translational studies. Notably, information generated from non-animal methods must be consistent with the intended use. It does not need to be identical to information produced by traditional animal methods which generally have failed to predict effects in humans. As the act requires the agency to make a determination that a substance or its uses do not present an unreasonable risk to health and the environment we remind industry representatives that the act also requires entities developing information on a voluntary basis to first attempt to do so by means of alternative test methods and strategies before conducting new vertebrate animal testing. We welcome the agency's publication of its first manufacture notice determinations under the act. Appropriately, the agency estimated human health hazard of these chemical substances based on their physical chemical properties which indicated they will not be observed or inhaled or ingested or by dermal contact and comparing them to structurally analogous substances for which there is information available on hazards.  The agency estimated the environmental hazard by comparing them to analogous substances using ecological structure activity relationships predictive model.  I suppose I should probably stop there. With time we are confident the act will facilitate the development and use of reliable non animal testing methods which will not only save animals from suffering, but better protect human health and our environment. Thank you.

Speaker 2: Manuel Gomez, Consultant
Good morning I'm Dr. Gomez, a concerned citizen and private consultant and I appreciate the opportunity to offer my comments. At the outset I must say that my overarching comment is that I would strongly encourage EPA to vigorously fulfill its responsibilities for workplace issues under the new TSCA and incidentally I was pleased to see how many mentions of those responsibilities were made earlier. These would include: obtaining and incorporating into all its actions exposure data and health effects information from occupational settings which are essential to evaluating risk, always considering occupational exposures in its data collection, prioritization, risk evaluation and risk management activities under the act, insuring that procedures for privatization, risk assessment and management include occupational exposures and risks and coordinating closely with OSHA and NIOSH including taking action when those agencies cannot do so in a timely manner to protect workers from toxic substances. The new TSCA requires EPA to include potentially exposed populations including workers for practically every action the legislation requires the agency to take. This requirement applies to expedited actions, testing and data collection, prioritization and risk evaluation. It also requires risk management for the workplace, although the exact manner in which this authority will be implemented is somewhat unclear from the language of the new TSCA and will probably need administrative and procedural clarification from EPA.  The legislation has a provision for EPA to consult with OSHA regarding risk management orders for workplace exposures for new substances, specifically any prohibition or other restriction to a chemical substance.  The EPA is authorized to take action if OSHA fails to do so; however, the agency should aggressively fulfill this requirement including instances where OSHA does not act in a timely fashion.  The legislation also addresses instances where another agency has authority over chemical under other Federal laws as would be the case with OSHA health standards.  This section requires EPA to issue a report to OSHA with the results of the risk assessment and risk management analyses presumably also including a specific recommendation for risk management.  OSHA is obligated to answer within a time period indicating what action, if any and plans to take to address the EPA report.  It is not clear, however, what actions EPA can take if OSHA rejects the report or its findings or proposes no action for the implementation of the OSHA action, such as setting and occupational health standard is excessively delayed.  It is therefore necessary that EPA clarify these authorities on how the agency would enforce any time limits for actions it requires or recommends to OSHA or other agencies.

Several facts relevant to EPA's workplace under the new standard are undeniable and deserve to be mentioned.  First, workers are almost always the first and worst exposed and the new TSCA unequivocally covers their toxic exposures.  Secondly, there is wide agreement that the deaths due to occupational disease are roughly 10 times those due to acute safety incidents not to mention the vast numbers of nonfatal and unreported occupational diseases. And, last, but not least, everyone agrees that OSHA health standards are badly outdated and that the agency unable to issue standards in a timely fashion.  In this context, it is critical that EPA vigorously discharge all its responsibilities about workplace risk in the new law.  In closing, in light of this reality and the authority the new TSCA gives EPA regarding workplace risk evaluation and management for chemicals, I would pose two questions for the agency to consider following this meeting:  First, how does EPA plan to fulfill these new responsibilities regarding workplace exposure prioritization and risk assessments under the new TSCA, and how does EPA interpret the consultation and relationship to other federal laws language in the law with regard to prioritization, risk assessment and especially risk management in particular? How does EPA plan to address a negative response by OSHA to the recommendations in the report as described earlier? How does OSHA plan to ensure that OSHA's responses, even if positive, are implemented in a timely fashion? Thank you.

Speaker 3: Lorenz Rhomberg, Gradient
Hello, I'm Lawrence Romberg I'm with a consulting firm in Cambridge, Mass. and my comments are my own.  Out of the many things I'd like to say, I'm going to focus on the question of coordination among the various kinds of assessments and judgments that need to be made here.  There are section six judgments about prioritizations, there are ones about acceptable uses and also section five things that now have to make affirmative judgments of safety and we have to remember there's also the IRIS process that's there in another part of the agency that is itself struggling to undergo a reform in its risk assessment process.  More than that, there's a whole world of free thinking going on so I'm urging as you do each one of these components to think not only about its larger world and specifically about the other components even within TSCA.  For instance, if you are just using these things to trigger actions and if you don't trigger the action, nothing happens the old way, that is okay, but if you are making affirmative statements of safety even if those statements mean somewhat different things for section five and section six and four prioritization and final actions and so on and so forth, nonetheless, those kinds of affirmations should mean the same things and yet the information available is very asymmetric with new chemicals and new uses or very little information.  If you make a low standard for making those affirmations, how do you make those consistent with things that happen under section six where there is more data?  It's going to be difficult to not find yourself in a situation where, say, something passes as a new chemical, passes its standards, becomes an existing chemical and where does it go in the prioritization list?  Does a jump to a good spot because it was affirmed under section five under those standards or is it the same set of standards that apply to other ones that have been existing chemicals?  Working through those kinds of potential pitfalls is important and so I guess the essence of my comment is think through how the various kinds of rules for these processes you make will interact with one another as you make them.  There are some real challenges there because of the asymmetry of information available, the time available to do things, the consequences both ways.  If you make everything the same the judgments mean the same thing but you have to base them on very different kinds and levels and amounts of data in the different situations and there are pitfalls there.  If you make them different you could have something to be this is okay under section five and it now has a problem under section six and that would be very awkward.  And as I say, think about the IRIS process and try to work with them I would hope to try to jointly make a risk assessment process with the wide assess ability aimed at these things.  This does mean putting down on paper some real criteria for how judgments are made.  There is a provision in the new TSCA for third parties to submit draft assessments and if those are going to be something that are really useful in the process, some criteria for what makes an assessment accessible there also needs to be made.  Another thing is that it needs to be coordinated with others because it would be important for the agency to obey the same rules for acceptability itself rather than have a different set for outside parties and for themselves.  That means putting a lot of these criteria for how to do these things on a much more specific footing than they've been before and again my suggestion is to coordinate these things across different judgments so we don't get awkward conflicts of recommendations arising.  Thank you.

Speaker 4: Derek Swick, American Petroleum Institute
Good morning my name is Derek Swick with the American Petroleum Institute.  We are a trade association representing the oil and natural gas industry.  We have over 650 member companies involved in all aspects of the industry from upstream to downstream to service and supply companies.  In terms of the topic of today's meeting, we support EPA's efforts to develop a risk based prioritization process for high priority chemicals involving evaluating hazard exposure for identified uses.  We would like to note that the Frank R. Lautenberg Chemical Safety for the 21st Century Act directs EPA to adopt the weight of evidence approach.  We feel EPA's rulemaking should explain in detail this approach in terms of how EPA will use it as opposed to relying on existing agency guidance.  Also we would like to note that TSCA section 26 provides scientific standards for EPA to follow in carrying out sections four, five, and six of the act.  EPA's role in this space should address all of these considerations and clearly explain how EPA will use the best available science.  We would like to offer a couple of points for the agency's consideration in developing the proposed rule.
One, studies used in risk evaluation to address hazards and exposures should be reliable, relevant and reproducible and conducted in accordance with good laboratory practices.  Two, EPA evaluation should identify information from all available reliable sources including domestic and global programs, both voluntary and mandatory.  Companies, agencies across the U.S. government, and other international bodies have significant experience in this space from the REACH program to Canada's chemical program to the other programs and we encourage EPA to work with these fears entities to obtain existing information and to use that information as opposed to requiring new data.  Third, risk evaluations need to use representative exposure scenarios focused on conditions of use.  In our view it's important EPA does not use inaccurate proxies or inappropriate default assumptions for exposure.  As two examples, one volume must not be used as a surrogate for exposure when determining risk and two, the presence of a chemical that humans or the environment should not be equated to risk or harm.  Continuing on the topic of exposure, an issue of particular importance to the oil and gas industry, EPA's risk evaluation should consider all existing controls preventing or at limiting chemical exposures or releases as an important aspect of this, a risk evaluation should take into account existing federal and state regulation of a chemical substance.  Controls in place for specific condition of use and other existing conditions that limit or mitigate relevant risk.  When EPA publishes the scope of a risk evaluation it should identify in scope those uses that meet the conditions for designating the chemical as a high priority than the risk evaluation process should allow for designated other uses of the chemical as a low priority use which should be counted as assessed but then need no further evaluation.  Finally, we really want to head home that EPA needs to be explicit in how it will conduct the risk evaluation in many aspects in the proposed rule and a few specifics include how EPA will gather and select the information to be used in risk evaluations, how the agency will incorporate systematic approaches and we've heard a little bit about that earlier, when and how EPA will use section 4 information gathering of authority.  How EPA will address articles and what the general template will be for risk evaluation process.  We feel this will be the heart of a modernized TSCA and look forward to participating with the agency in the rulemaking process.  Thank you.

Speaker 5: Jennifer McPartland, Environmental Defense Fund
Good morning my name is Jennifer McPartland and I'm a Senior Scientist with the Environmental Defense Fund.  We believe the final risk evaluation rule should establish basic workflows and processes relevant 10, 20, 30 years from now.  Rulemaking developed time- and resource-intensive processes are not the appropriate vehicle for tackling scientific laws that evolve overtime with advances in science as is the case with conducting individual chemical risk evaluations.  Risk evaluation related to science issues including those raised in section 6, 4 and 26 are better addressed and guidance documents and policy statements are more nimble. Tala mentioned some guidance is in her presentation.  We remind the agencies that all guidance necessary to implement the new law are to be developed within 2 years of enactment.  Transparency in the risk evaluation process from the outset is critical.  We urge EPA to provide for public comment on draft scopes of risk evaluation, as has been the recent practice with the work plan chemical assessment; however, it is imperative that the additional comment period in no way impinge on EPA's ability to meet its statutory deadline.  For efficiency where sufficient information exists the rule should authorize EPA to publish and take comment on a draft scope at the same time as it proposes a high priority designation.  After publishing a final scope, based on the information developed, EPA may determine the scope needs modification.  The risk evaluation rule should authorize EPA to modify the scope of the risk evaluation subject to full and transparent justification in the draft risk evaluation itself.  This would also allow for public comment on any changes.  EPA may also find in conducting a risk evaluation that there are certain uses where it had sufficient information to evaluate risk and other uses where more information is needed.  In these situations, especially where EPA finds certain uses present an unreasonable risk, we urge strongly that the rules provide for bifurcated process, allowing EPA to move forward and finalize risk evaluation for those uses where it has sufficient information to do so and secondly by explicitly requiring EPA to use its new authority to probably generate or collect information it needs to complete the full scope of the risk evaluation.  A major difference between past workplan chemical assessment and assessments that now will be occurring under the new law is that EPA now has new authority to gather the information it needs to complete the full scope of the risk evaluation and we strongly encourage the agency to use the new authority.  The limited scope of any partial risk evaluation must be made crystal clear and this bifurcated process should in no way alter EPA's a negation to meet the statutory deadline.  Finally, under the new law EPA is to consider the full range of uses and subpopulations in determining the scope of a risk evaluation.  We do not mean to compel the agency to always necessarily include all identified uses and subpopulation in the risk evaluation.  That being said the Risk Evaluation Rule should require full transparency as the uses and subpopulation is considered.  Science-based identified uses and subpopulations ensure protection of vulnerable populations at any time in the process of developing risk evaluation.  Lack of information is not sufficient for setting aside a use or specific population.  Thank you.

Speaker 6: Barbara Losey, Alkylphenols & Ethoxylates Research Council
I'm Barbara Losey, Director of the Alkylphenols & Ethoxylates Research Council which is a source based trade association. We appreciate the opportunity provided today to provide comments in advance of the rule.  My comments are drawn from experience with a listing of several chemicals on a 24 teamwork plan as well as our experience engaging in U.S. Canadian regulatory cooperation Council work groups that are evaluating various aspects of the risk assessment process.  I was glad to see recognition in Dr. Henry's talk this morning about the need for and work on a well-documented transparent approach to systematic review and risk evaluation of chemicals.  In addition, there should be sufficient flexibility in the Risk Evaluation Rule to allow for incorporation of new hazard and risk evaluation methods as they evolve, however, any methods added should be fully validated for the purpose.  We are currently engaged in the U.S. EPA environment climate change Canada U.S. regulatory cooperation Council case study on chemicals that is examining data sources for use and exposure used by the agencies.  The workgroup also includes several companies and trade associations representing the various levels in the supply chain as well as various NGO organizations.  Through this RCC process, limitations of the data sources that U.S. EPA currently uses to identify uses have become apparent.  Also apparent is a value of engaging with industry up and down the supply chain to fully understand use and exposure.  Another of the issues identified in the RCC case study is tools like the CDR do not consistently distinguish between intentional use of the chemical and its use of a chemical intermediate that may remain in the end product.  Reporting a chemical that is solely used as an intermediate as having a consumer use overstates the exposure to the public. Therefore, dialogue and input is necessary to clarify the exposure from chemical intermediates.  Since manufacturers, particularly of chemical intermediates, do not have full access to information about downstream users, we encourage EPA to develop a framework within the risk evaluation process to allow collection of information regarding volume use and exposure from downstream users.

On the topic of defining chemical categories, care should be taken when grouping chemicals for the purpose of prioritization and risk evaluation. While grouping based on structure can be useful in some situations, sometimes chemicals with similar structures have different hazards and use profiles.  For example, some are listed as a group in the 24 teamwork plan; however, this represents a wide range of compounds including polymers with very different technical and hazard properties.  Any chemical categories addressed under TSCA need to be clearly defined and scientifically justified.  We recommend referencing a guidance when using chemical categories.  The Frank R. Lautenberg Chemical Safety for the 21st Century Act recommends  -  it takes into consideration  -  risks for this process.  It's likely this process will identify certain uses or condition of use of a high priority chemical that do not result in exposures of concern.  We recommend that uses of low concern that are identified in the risk evaluation scoping process are sufficiently addressed in the final risk assessment for all significant uses such that there's no ambiguity in either the market or among the states as to their status.  Thank you.

Speaker 7: Jack Snyder, Styrene Information & Research Center
My name is Jack Snyder the Executive Director of the Styrene Information Research Center and appreciate the opportunity to speak this morning as EPA implements this important act.  We would like to congratulate EPA and the stakeholders for their work to secure the passage of the TSCA modernization act.  There is a strong need for federal programs to separate out and manage the unreasonable risk potentially exposed by various uses of chemicals from the majority of other uses that are safe.  My comments focus on two approaches that we hope EPA adopts in the implementation of the new TSCA: to make good use of crowdsourcing in the approach to public participation, and second a recommendation for the new TSCA the agency does not reinvent the wheel in terms of hazard and risk assessment options as well as risk management options.

Relative to crowdsourcing, we know the deadline defined in the new act proves challenging for the agency to meet in a timely fashion all that the act requires.  This means EPA will need to use common sense management skills to get the work done.  Some government programs may view public comment period as time consuming chores necessary because we live in a democracy but that encroaches on the time the agency needs to work on the real.  We suggest a more modern common sense approach to public participation is embodied in the popular concept of crowdsourcing.  If you ask the right questions the public including NGOs, and companies, trade associations in the scientific community can help you find relevant data you may not know about.  Crowdsourcing can help with early identification of key issues and potential concerns about the chemical or uses that will need to be addressed in the agency's work.  Issues you may not otherwise hear about until it's time for peer review.  In short, be innovative about and use public participation as a valuable resource to achieve quality work on time.

Secondly we urge EPA not to reinvent the wheel in implementing the new TSCA.  We know signs and processes of risk assessment and risk management have been around a long time and have evolved over the years.  As Dr. Henry noted, EPA has published many guidance documents including the 2005 Cancer guidelines, for example, which while not perfect are good place to start.  A good example is the national research decision support that emphasizes the importance of risk evaluators communicating to risk managers and the public the uncertainties associated with any risk evaluations and the reasons for stressing this are well summarized on page 98 of the report.  This recommendation along with the recommendation in the council's May 2014 report on the IRIS program that evaluator should present decision makers in public with a range of values should be invaluable with less than perfect choices with the approach to take.  EPA should not be afraid to communicate to the public both what it knows and what it does not know about a chemical thereby giving decision makers the broadest amount of information of which to make difficult risk management decisions.

In summary, we hope the agency will carefully provide for maximum public participation in the processes and also studies and adopts the best recommendations and policies that the NRC in the agency already have carefully defined in past years.  We hope the implementation of this important law will bring together the country's best minds and practices on science and environmental regulation in an outside of the Government.  Thank you for the opportunity to provide these comments.

Speaker 8: Christina Franz, American Chemistry Council
Good morning, I'm Christina Franz with the American Chemistry Council.  We have an important interest in EPA's risk evaluation process as well.  Risk evaluations will inform EPA's regulatory decision making which is EPA's fundamental responsibility under the act.  Therefore, the design and implementation of the risk evaluation role is critical to the success of this statute.  EPA has excellent existing guidance directly relevant to risk evaluation such as EPA's risk characterization handbook and its framework for human health assessment which align nicely with some of these scientific standards set for the sections six and 26 of the new statute and they should help serve as a foundation upon which to build a high quality risk evaluation process.  However, it is very significant that the scientific standards described in existing EPA guidance are now a statutory requirement under the act and must be consistently applied by EPA.

In order to successfully implement the risk evaluation process ACC believes EPA should use a tiered approach to its risk evaluation processes, one that includes a screening-level approach is step one in the scoping and problem formulation stage.  Screening level assessments are conservative and deterministic. When a screening assessment indicates an acceptable level of risk, the agency has a high degree of confidence that potential risks are much lower than the calculation and therefore, actual risks are lower and/or perhaps nonexistent.  However, when a screening level assessment indicates a potential concern for an adverse effect, this does not mean that actual risks are significant and warrant action.  Rather, it indicates the agency should take a second step in risk evaluation to refine the evaluation to use more realistic information in a probabilistic assessment from to quantify risk.  An example where EPA has used a screening level assessment approach that I am describing was in the problem formulation of TBBPA.  In that case, although EPA should have made public the relevant calculation and information supporting the conceptual model and analysis plan, it does appear that EPA used high end exposure and toxicity values in the initial assessment which maybe appropriate in a screening assessment.  Section six of the act uses the word "scoped" to describe exactly the process EPA used when it scoped and conducted a screening level problem formulation of TBBPA.  We encourage EPA to define "scope" in the risk evaluation process rule to include one, a clear description of the focus and degree of complexity of the evaluation and the conditions of use addressed including the uses that do not present a concern for further evaluation and why.  And two, identification of available information and data needs including a data and information call in to ensure that available information such as exposure read across mode of action etc. is identified properly and three, a description of overall evaluation process, the process for stakeholder engagement and the anticipated level of peer review required for the evaluation.  ACC believes there are opportunities for EPA to improve its approaches when refining initial assessment so they are in fact, fit for purpose.  For example, EPA should acknowledge that it will not continue using the lowest hazard and exposure values when it refines a risk evaluation so it is refined exposure in evaluations are probabilistic.  And I realize my time is up so with that I will thank you very much, for the opportunity to comment.

Speaker 9: Rebecca Reindel, AFL-CIO
Good afternoon.  My name is Rebecca Reindel. I'm a Senior Safety and Health Risk Specialist with the AFL CIO and appreciate the opportunity to comment today during these TSCA stakeholder meetings.  We are a federation of 56 national and international unions representing more than 12.5 million working people.  The recent reform to the Toxic Substances Control Act is overdue and we believe these provisions will reduce toxic chemical exposures with very serious health effects for millions of workers.  The new law gives EPA import new authority.  Under the new law EPA is directed to establish rules on setting priorities and conducting risk evaluations which protect potentially exposed populations that may be at greater risk of adverse health effects for exposure to a chemical substance or mixture.  One of these groups specifically covered in the law, workers and worker exposures, must be fully considered and evaluated throughout EPA prioritization and assessment processes for regulating chemicals.  Workers are susceptible subpopulation because they are exposed to chemicals early in the supply chain and also due to the nature of their jobs in handling, manufacturing, using and disposing of chemicals.  Evidence historically including the exposed risk characterization control and health effects studies have come from the study of worker populations.  Under the new law EPA is directed to rely on the 2014 TSCA workplan for priority setting and risk evaluation, the existing workplan characterizes 90 chemicals with potential risk to humans and environment and was developed by applying a consistent criteria for exposures and persistence in bioaccumulations.  Some chemicals have assessment and some others are ongoing.  Under the new law EPA is directed first to initiate risk evaluations on 10 chemicals drawn from this work plan.  We urge the EPA to examine the chemicals on the workplan that have serious risk factors and considerations in the initial selection.  Under the new law, EPA must ensure risk evaluations are conducted on at least 20 high priority substances and 20 chemicals have been designated as low priority substances.  Many, but not all substances have to come from the workplan and preference-setting priorities should be given to chemicals based on persistence and bioaccumulation, carcinogenicity and toxicity.  We urge the EPA to examine closely the chemicals on this workplan as well as other chemicals the EPA has the authority to include but also for evaluating risk to a chemical based on health factors.  Many unregulated chemicals toxic to working people are in alignment with the law prioritization criteria and are important to examine in the context of workplace exposures under the law criteria for susceptible populations.  The unique nature of occupational exposure should be carefully considered and fully evaluated as part of EPA's risk evaluation.  Under the new TSCA law EPA is required to consider exposure factors in setting priorities for risk evaluations and regulations.  We urge EPA to coordinate and collaborate closely with both OSHA and NIOSH on chemical selection and evaluation time with OSHA on regulating and controlling exposures.  The AFL CIO are happy to continue to dialogue on this.  This TSCA law provides important opportunities to reduce risk from worker exposure to chemicals. We look for to engaging with EPA in this matter moving forward.  Thank you very much.

Speaker 10: Kari Mavian, SI Group
Good morning I'm Kari Mavian. I'm a Senior Director of Global Regulatory Affairs at SI Group.  We are the local developer and manufacturer of chemical intermediates, specialty resins, and solutions critical to the quality of consumer goods.  We are headquartered in New York State with a local presence in 10 countries around the world with 2700 employees.  We are a member of the American Chemistry Council and the Research Council both with representatives here who are speaking today.  We support the new amendments to TSCA and appreciate the opportunity to provide comments today and are committed to working with EPA in making this a successful implementation.  I would like to make some brief comments.  First, as stated today, we support EPA making this a transparent process and emphasize the importance of opportunities for stakeholder engagement early on and throughout the risk evaluation process.  We request EPA to specifically include in the rulemaking, opportunities early in the scoping process to engage stakeholders and gathering information and determining the scope of a risk evaluation and include additional opportunities to the process for dialogue with stakeholders in public comment.  This will assist EPA in understanding the uses and identifying ways to obtain complete accurate information on exposures and hazards of the chemical substances under evaluation early on in the process.  Second, especially important is the engagement with industry up and down the supply chain to fully understand use and exposure patterns.  Manufacturers of chemicals, notably manufactures of chemical intermediates, do not always have full access to volume and exposure data of all downstream uses.  We encourage EPA to develop a framework within the risk evaluation process to allow EPA to collect proprietary information regarding the volume, use and exposure of chemical substances from downstream users and we welcome the opportunity to assist EPA in developing such a framework.  As part of the process it's critical for EPA to ensure protection of confidentiality of information it obtains throughout the supply chain.

Next, recognizing the importance and complexity of risk evaluation, we also encourage EPA to provide more than the minimum of 30 days to comment on the draft risk evaluation as currently stated in the act.  We suggest EPA align the common period with other mentioned in the act of at least 90 days.  And finally, the act requires the risk evaluation process take into consideration conditions of use which is appropriate for this risk based process.  It's likely this process will identify certain uses of a high priority chemical that do not result in exposures of concern such as the case with many chemical intermediates.  We supply a wide a range of chemical intermediates to our downstream partners and these substances are further reacted and consumed through industrial processing.  Such intermediates are not intended to enter into consumer products and there is low to know exposure.  We recommend these low exposure low priority intermediate applications are explicitly identified in the evaluation scoping process and the diversity of chemical applications as evaluated substances sufficiently addressed in the final risk assessment to ensure there are no questions in either the market or among the states as to their status.  Thank you very much.

Speaker 11: Tracey Woodruff, UCSF Program on Reproductive Health and the Environment
Good morning.  My name is Tracey Woodruff.  I'm a professor at the University of California San Francisco in the Department of Reproductive Sciences and I am here to make comments on the risk evaluation under the new TSCA law for EPA.  I have the following main points and will be following up with written comments and given time I will give detail on them.  The first is that we strongly advocate for using science to advance timely decision making about toxic chemicals and there will be lots of cases where there is insufficient data the use of defaults which are scientifically based.  We strongly advocate codifying only the most modern scientific methods and approaches.  I'll talk about that a little bit more briefly: That they match the burden of proof to the decision being made so when chemicals are decided as being not unreasonable risk that has a very strong standing in terms of scientific information.  That cancer and non-cancer health points should be treated as scientific equals.  Right now they are not treated in the same manner and they should be treated in the same manner both for evaluating what is termed in the law as "weighted evidence" as well as the risk evaluation.  Similarly there should not be requirement that knowing the mechanism by which a chemical disperses toxicity is necessary for that.  It should account for aggregate risk as well as cumulative risk also not mentioned in the law, but import to acknowledge multiple chemicals at the same time and that will influence the risk estimates.  Thirdly not to assume a threshold response for non-cancer outcomes and this is brought up in science and decisions inconsistent with unifying the approaches for cancer non-cancer and to use science based defaults that are recommended by the National Academy of Sciences in 2008 and finally, we recommend using systematic review methods for evidence evaluation.  And to follow up on some of the points, in terms of codifying the modern scientific methods and approaches there has been a number of reports that have been put out by the National Academy of Sciences and we recommend the recommendations in science and decisions as well as cumulative risk provide a very good blueprint for EPA to do their risk evaluations that both consider that move toward the approach of unifying approaches for non-cancer and cancer risk assessment.  The other area that I want to add more detail in terms of treating cancer non-cancer endpoints as scientific equals is that the risk assessment in addition recommends very strongly that the EPA not use margin of exposure approaches.  These are simply another version of the ERFD which the NAS is also recommended moving against and that EPA produce risk based numbers for non-cancer health effects which is completely doable under analytical protocols and also it's very important that risk assessments include the factors that are likely to influence and I know there's a lot of discussion in the bill about vulnerable subpopulations or developmental life stages, but there are also other factors that influence people for disease status external factors and life circumstances all which influence these and should be incorporated into EPA's assessments.  Thank you.

Speaker 12: Nancy Beck, American Chemistry Council
Okay, Good morning, I'm Nancy Beck with the American Chemistry Council and would like to use my few minutes to speak about high quality refined risk assessments. So, in order for EPA to conduct assessments consistent with the quality demanded in the time frames required we think you have to take a tiered approach to risk evaluation.  During the scoping phase, tools exist to allow EPA to conduct screening level analyses as appropriate for consumers, workers, and subpopulations and the environment.  This will allow EPA to have a more tailored focus on those populations and exposures of greatest concern during the refined risk evaluation process. So since the refined process looks to EPA directly for management decisions similar to the steps before, consistent with section 26 rely on the best available science protocols and models reasonable and consistent with the intended use of the information.  Since the remedy to control exposures for a particular use could be as rigorous as a band or a costly labeling requirement, the highest quality data and methodology must be used, so as was mentioned already, you have to use the weight of evidence and systematic review of approach.  This means among other steps, EPA must provide tiers for judging the quality and relevance of all information and integrate that information based on stringent limitations and relevance so systematic review is rigorous, but once these criteria are identified in the approach outlined the rigor, clarity, and transparency of the EPA assessment will be greatly improved and this will have tremendous cost and time savings likely during peer-reviewed and public comment.  EPA will likely be tempted particularly for hazard identification to rely on information from existing databases; however, I caution you the requirements of the new statute make this hard.  For and since it's well known that the EPA IRIS program has struggled to produce high quality assessments.  The National Academies have commented noting persistence problems and while the IRIS program is working to correct these problems the data has not finalized a single assessment that's fully consistent with the NAS recommendations. As the IRIS program releases a few assessments a year, this means the majority of information in the database may be not only outdated and not representative of today's best available science, but also the process being used to evaluate, judge, and assist the information are not consistent with the evaluation processes that exist today.  So while the margin of exposure approach you use does not require direct adoption of this I think you still must be extremely cautious when relying on studies, points of departure, and points that are identified by the IRIS assessment.  The justification that it's in IRIS won't suffice under the requirement of the new act.

Similarly, modeling approaches may not be fully informed by the weight of the evidence including mode of action and mechanistic data so grabbing studies from IRIS maybe appropriate for your screening level assessments, but for the refined hazard assessment we think you have to conduct a new way for the evidence review.  Picking the lowest value might be considered adequate, but really regardless of using the highest quality information will not be acceptable.  So we think when you address the science standards it allows the program to become a true leader not only within EPA, but within the Federal Government.  Much has been written already about what a quality risk assessment looks like for instance, the recent publication by Senator Crispin 2016 might be helpful.  We will provide distinct suggestions for guidance documents in a written comment so my final point is the standard should be incorporated into the planned rulemaking for risk evaluation as well as in the guidance for industry to inform submissions from industry.  Members stand ready to be held to the same high quality standards the agency will put in place for itself.  We believe the statute demands this of everyone.  Thank you.

Speaker 13: Katie Huffling, Alliance of Nurses for Healthy Environments
Good morning, my name is Katie and I address the Alliance of Nurses for Healthy Environments.  Thank you for the opportunity to provide comments.  We are the only national nursing organization focused solely on how the environment impacts human health. Besides directing the Alliance, I'm a nurse and a nurse midwife.  In 2015 and 2016 I had the honor to be part of a group of scientists and health professionals that wrote a public statement on toxic chemicals in brain development.  Based on our extensive review of the scientific evidence, the experts find early life exposures to toxic chemicals are increasing children's risk for developmental disorders including intellectual impairment, autism and ADHD.  During fetal development, in utero, and early childhood, children's brains are exclusively vulnerable to harmful exposures in toxic chemicals.  Even extremely low doses of toxic chemicals in utero can disrupt neurological processes with lasting effects on IQ, cognition, and behavior.  Due to the metabolism, size and hand-to-mouth behaviors, children are more highly exposed to chemicals and are more likely to suffer adverse health effects.  EPA's current risk assessment methods typically underestimate the risk to the developing fetus and young children thereby failing to protect our most vulnerable and precious population.  Moving forward it is critical that EPA's risk assessment fully account for in utero exposures and for the likelihood of higher exposures and greater impacts on infants and young children as well as pregnant women and use appropriate safety factors to take into account uncertainties and data gaps in developmental endpoints.  This is especially true for chemicals used in consumer products, but it's also true for other substances since TSCA requires EPA to protect children and pregnant women who live in communities where substances are manufactured or processed as well as exposed.  We cannot afford to continue with risk assessment methods that fail to protect children's developing brains and bodies from toxic chemicals and I as well as thousands of nurses who are members of the alliance urge you to use the most protective risk assessment methodology to protect the health of our future generations.  Thank you.

Speaker 14: Jennifer Lowry, American Academy of Pediatrics
Good morning.  My name is Dr. Jennifer Lowry and I'm here representing the American Academy of Pediatrics.  As you know, I also serve as chair to the Environmental Health Council.  As you know, children are not little adults.  They have unique developmental and behavioral differences that influence their responses to environmental exposures.  Because children are smaller than adults, the surface area to body ratio is greater which means they have more surface area to absorb potentially harmful substances.  Pound for pound, children also breathe more air, eat more food and drink more water than adults and tragic experience with children exposed to mercury poisoning in Japan, reproductive cancers and baby girls exposed to chemicals and fetal alcohol syndrome has taught us repeatedly that toxic chemical exposures in the earliest most vulnerable stages of human life can have devastating consequences on children's health that have no counterpart in adult life.  Children's behavior changes with age and with it the routes of exposure to chemicals change.  Infants are incapable of independent locomotion leaving them unable to escape from environmental hazards, heat and cold without assistance.  Children of all ages spend more time on the floor or ground than adults.  Therefore, children will come into more contact with contaminants on these surfaces.  As children grow and mature their bodies may have heightened vulnerability to chemical exposures during critical windows of development particularly in their nervous and hormonal systems.  These differences and risk for exposure and susceptibility to chemicals and children as compared to adults make clear the need for strong consideration of children and chemical policies.  This principle must underpin all of the steps to implement the amended TSCA including the analysis of what constitutes unreasonable risk of injury to child health.  We already know tremendous amount of how ubiquitous chemicals affect child health, but there also gaps in our knowledge and there is a need for ongoing study of the impacts of certain toxic substances and child health.  It is therefore imperative that EPA direct the development and regular updating of this body of information to close the gaps especially in areas of reproductive and developmental toxicity and protect children's health.  The long-term effectiveness of the Lautenberg Act will rest in part on the quality of data and analysis regarding the impact of substances on children and pregnant women and that research may be conducted by experts. It's important EPA evaluate the information and that EPA, through grants and cooperative agreements, creates incentives for the ongoing assessment of research on these vulnerable populations.  As industry manufactures more and different chemicals and as these substances are applied in new different ways, EPA must help ensure that the risk evaluations are contemporaneous.  EPA can and must monitor and incentivize the development of good science.  As EPA conducts the evaluation of risk as related to infants children and pregnant women it must develop, consider, and base decision on the following: data on reproductive toxicity, data on developmental toxicity including, but not limited to, narrow developmental toxicity and data on intracranial disruption as a relates to interruption and puberty.  EPA's decision should be based on information about hazard proposed use and potential exposures.  Hazard implies intrinsic properties of chemicals or classes based on molecular structure, for example, persistence, carcinogenicity, and neurotoxicity.  We strongly urge EPA to consider aggregate and cumulative exposures.  Lastly it's important to remember children are curious and while unintentional will have acute high dose exposures in homes, day cares, schools, places, and workplaces.  The short term effects from these exposures are better known, but largely they apply to adults in the workplace.  Additionally and where emphasis should be placed, the child unknowingly has chronic low dose exposures that may occur at significant times during their development.  Strategies to assess the implications of these exposures at critical endpoints in children's lives are imperative as the Lautenberg Act is implemented.  Thank you for the opportunity to provide comment here.

Speaker 15: Sarah Amick, Rubber Manufacturers Association
Good morning, I'm Sarah and I work for the Rubber Manufacturers Association. We represent 10 tire manufacturers that manufacture tires in the United States.  We've had experience with the 2012 workplan chemicals. We provided information to the agency and also participated in the Regulatory Cooperation Council work between the U.S. and Canada as well and we appreciate the opportunity to participate in the process and found it very valuable.  My comment today focuses on one key issue and that's uses identified during the problem formulation as Tala mentioned today. Problem formulation is the first step in the risk assessment and we ask that for uses identified during problem formulation that the determination of the uses be included in the final risk assessment.  EPA has outlined for workplan chemicals sometimes multiple uses of a chemical substance during formulation and in identifying uses of a substance EPA may identify uses of a high priority chemical that often don't result in exposure which would not warrant a full risk assessment and for uses of a chemical substance identified during problem formulation that don't result in an exposure concern we recommend EPA include in the final risk assessment a determination that these substances are safe for the intended condition of use.  To summarize again, we recommend for each use that EPA identifies on a problem formulation document that the agency make a safety determination and include that in the final risk assessment for each used to prevent any ambiguity.  Thank you.

Speaker 16: Eve Gartner, Earthjustice
Good morning, I'm Eve Gartner from Earthjustice we appreciate you giving the public the opportunity to weigh in on this important process and for making this hearing accessible to communities around the country remotely.  We hope this public participation is a key part of the ongoing risk evaluation process under TSCA even in circumstances where it's not mandated itself.  We hope EPA will include the public in decision making around which manufacturer nominated chemicals it accepts for risk evaluation and we also urge EPA to provide public comment on the scope of the risk evaluation.  Public input on the scoping is especially important to EPA's ability to fully identify sensitive and vulnerable subpopulations and to start the process of determining whether the chemical poses unreasonable risk to any of the subpopulations.  It's also important that the systematic review which has been talked about extensively today precede the final decisions on scoping.  There's been a lot of scope about fit for purpose and one thing we think is important is that EPA not predetermine what is the purpose.  We have to go through the systematic review to decide what is the purpose of the risk evaluation.  We are pleased there has been so much talk today about science and decisions and that the slide really reflected EPA's commitment to follow science and commitment.  I think it's important to point out that one of the key aspects of the risk evaluation under the NAS recommendation is aggregate exposure and the new TSCA law actually mandates somewhat obliquely actually mandates aggregate exposure, in particular in section six the law requires EPA to determine whether the manufacturing process distribution encompasses disposal. Disposal is the key language, for any combination of those activities presents an unreasonable risk and we read any combination requiring aggregate exposure, and I think one thing I noticed in the slides earlier is that disposal was not mentioned as one of the pathways, exposure pathways that EPA will be looking at and that's critical for communities.  Those are vulnerable subpopulations, people that live in the vicinity of where some of these chemicals are disposed of.  Also critical is if there is no data that does not mean there is no risk and in the slides earlier there was discussion that EPA will only attempt to quantify pathways of exposure where there is data.  We think EPA needs to attempt to take into account all known exposures even if there is not quantified data EPA can use qualitative measures and default assumptions, but no data doesn't mean no risk.  Finally, we hope that EPA, in developing the evaluation process, will look to the document it produced in the pesticide program, the policy paper on revised risk assessment methods for workers and children of workers where EPA agreed to use science under FIFRA even though it was not mandated under FIFRA.  It's not reasonable risk statute, but EPA agreed to use qualitative measures cumulative and aggregate and safety factors because in the words of EPA, that is consistent with this science and under FIFRA and we urge EPA to use the same science under TSCA and look forward to working with you on implementation.  Thank you very much.

Speaker 17: Katherine Tracy, Center for Progressive Reform
I am Katie Tracy, a Policy Analyst, and I have a few brief comments to share today and the rest will be followed up with comments to the docket.  The first point I would like to make is the way EPA treats the risk evaluation process is critically important.  It's inherently uncertain when variations in exposure pathways, responses, and other factors presented to researchers from chemical risk analysis derives shortcomings and data gaps.  Lack of certainty does not mean lack of risk. Given the EPA regulates uncertainty, EPA's risk assessment should favor a protective regulation not against it.  The second point is regarding judicial review.  As EPA develops a role for risk evaluation process it should be careful to avoid a highly prescriptive approach.  Doing so could open every risk evaluation EPA conducts to judges second guessing the scientific experts and the difficult job of variable and uncertain evidence.  Judicial review of EPA science on matters of chemical risk assessment would undermine the basic principles of rulemaking.  EPA should consider ways to protect against judicial review and especially over interpretation of scientific data.  EPA should look through schemes that exist under federal laws and assess whether they are written in a way that has led to appropriate judicial review or alternatively were written poorly and have led to breakdowns because of errors on the part of the agency.  The next point I'd like to make is on potentially exposed or susceptible subpopulations.  As the law defines it, this includes a group of individuals within the general population identified by the administrator who due to either greater susceptibility or exposure may be a greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture.  The law gives examples including infant children, pregnant women, workers, or elderly, but it's important to keep in mind this list is not exhaustive.  For example, another vulnerable population should be included is impoverished communities.  EPA should consider factoring economic and social factors into the subpopulations.  For example, if a chemical's critical health effect is a form of cancer that can be treated if detected early, EPA should take into account a greater susceptibility of the impoverished households that lack access to cancer screening.  Additionally the EPA administrator can identify susceptible subpopulations with regard to identifying whether workers are susceptible subpopulation EPA should consult with OSHA and NIOSH.  EPA should take into consideration OSHA capacity to initiate and complete a rulemaking.  It can take over a decade for OSHA to develop a role and there are certain cases EPA should act instead of OSHA.  It's important to consider what the agencies can require for worker protection.  Provisions may have benefits for workers that EPA restrictions under TSCA cannot achieve.  My final point is EPA must be careful not to take cost into account.  For instance, EPA needs to be vigilant about the cost considerations into the risk evaluation process through chemical uses.  This is to conclude and say thank you for the opportunity to comment.

Speaker 18: Tim Brown, Consumer Specialty Products Association
Good afternoon, my name is Tim Brown.  We are a trade association representing companies of more than 100 billion annually in the U.S. of consumer familiar products with cleaner and healthier environments.  Products include disinfectants that kill germs in homes, hospitals, restaurants, room deodorizers, candles, lawn and garden cleaning products, polishes and aerosols.  We've actively engaged in the work plan chemicals under TSCA and think there are important lessons to offer to assist the agency and the development of risk evaluation guidance.  First, prioritization is critical to allow agencies to focus resources where they provide the greatest benefit.  Second, given the risk assessment mandates we believe efficiency is key.  Our members provide exposure information necessary to allow narrowing the scope of risk assessment.  The critical questions are how and when to provide use of exposure information to generate benefit without overburdening industry or the agency.  Next, transparency of process directly impacts competence.  We are pleased with the level of detail and transparency of the notice to date and we encourage the agency to carry this forward.  The more transparent the process, the more competent stakeholders and the public will have with the process.  Next in light of transparency, EPA should identify uses considered that do not [inaudible] and finally, the EPA regulatory framework for TSCA must include a means by which EPA can obtain exposure information from downstream companies like those the EPA represents to better inform them prior to position decision making and subsequent risk evaluation work.  In sum, we look forward to continuing to engage EPA and promote the transparent risk evaluation process and provide relevant use and exposure information to better narrow the scope and promote efficiency within the process.  Thank you.

Speaker 19: Gina Solomon, California Environmental Protection Agency
I'm Gina Solomon, the Deputy Secretary for Science and Health at the California EPA and I'm very happy to be here today.  California very closely watched the legislation and weighed in numerous times as did other states in the interest of allowing states to continue to implement our own laws to protect our citizens.  And we will remain engaged in the implementation process and look forward to continuing to partner with EPA as we have done through the MOU's we already have in place between our agency and yours.  And we recognize that we may sometimes be overlapping as we move forward and the times when we do, we look forward to working to be value-added and to coordinating and being mutually supportive, but we also recognize that there are many, many targets out there and many chemicals that must be evaluated and so we are assuming that the overlap will be the exception rather than the rule.  As EPA moves forward with the proposed rule for chemical risk evaluation we urge you to give yourself maximum latitude and flexibility in the rule itself.  A lot of the details especially on these scientific issues that have been discussed today are best reserved for guidance documents.  In the rule itself you want to play out a process that will allow you to meet these ambitious deadlines, allow you to achieve the throughput you are mandated to achieve and that will allow it to be done in a consistent and transparent manner and that is really the goal here with this rule.  And so we are hoping you don't get bogged down into many of the details in the rule or narrow your own latitudes excessively as you think about this.  We do think that some of the things that you have been doing so far have been extremely well thought through in particular the grouping or a clustering of chemicals is something we also are doing in California and we founded to be a useful approach so we hope you will continue doing that.  We appreciate you are looking at eco toxicity although that tends to be the poor stepchild in many cases and people focus on human health but we think that looking at eco tox and keeping that very much a part of the issue and discussion is important.  We appreciated the increased focus on problem formulation and on aggregate and sensitive subpopulations that you are required to do including sensitive subpopulations beyond the obvious, kids; looking at some of the maybe less obvious, genetically susceptible, and so forth.  But we also are hoping that you will adopt more of a probabilistic approach to non-carcinogens as recommended in science and decisions and to very much avoid, be wary of, the no data no risk trap and try to avoid that.  And I think the only last thought is on the sentinel exposures, that along with the reasonably foreseeable language and the requirement to prioritize storage near sources of drinking water suggest to me that EPA should be looking at and thinking about upset conditions, not just regular expected conditions, but in other words, there is clear reference here in the legislation to the spill in the river so if you are looking at chemicals you need to be thinking about what is reasonably foreseeable and a potential sentinel event in an upset.  Thank you.

Speaker 20: Dr. Yolanda Whyte, Pediatric Practitioner
Hello.  Thank you for the opportunity to speak to you all today and thank you for having this comment session.  I'm urging the EPA to comply with the recommendations of the leading policies that under the safer chemical healthy families coalition and also urging the EPA to implement the cautionary principles and all known carcinogens and neurotoxins that contribute to the most devastating diseases that we are seeing in children being birth defects, cancer, autism and other developmental conditions.  The public at large and government officials don't see, don't regularly see or interact with these children because they can't live a normal life, going to the mall, department stores, playground, or public transportation.
But teachers, pediatricians, day care workers, therapist and others who work with children can attest to the health, education and financial burden that these families must deal with.  I'm also urging the EPA to work with Health and Human Services, health insurance companies, and healthcare providers to create entities that will create lab testing for the high risk chemicals available so that we can actually get to the root cause of these conditions and reverse the rising trajectory of chronic diseases that we are seeing.  Our only evidence that this exists is that the biomonitoring study that is only done on select populations however, the time that we prioritize the health of all Americans and focus on prevention which is primarily done through early screening and detection.  Thank you.

Speaker 21: Linda Reinstein, Asbestos Disease Awareness Organization
Thank you for giving me the opportunity to make a comment.  I am a widow and the president of the Asbestos Disease Awareness Organization and we are the largest nonprofit dedicated to eliminating asbestos caused diseases.  I want to congratulate the people sitting with you today and EPA signing into law this reform for the twenty-first century.  During the past 12 years it's important to recognize that as in so many other agencies have been stakeholders during these discussions to prevent exposure.  I want to make five points for the rulemaking process.  One: asbestos has been the poster child for the failure of TSCA 1970s for decades and it is not the litmus test for the success and efficacy of the new act.  We are excited; the key obstacles that previously stymied EPA to advance and regulate chemicals including the other 80,000 in the environment, this is a wonderful opportunity going forward. However the risk evaluation and prioritization rulemaking is essential for the success.  We urge the EPA during the rulemaking efforts to establish a transparent and collaborative review process to protect public health and the environment.  This would include making sure that the junk science that has been used with asbestos issues not be allowed into the record for consideration.  We've seen this far too many times including science that has actually -- where millions of dollars are spent to reshape science that is used within legislative efforts or agencies.  We urge the agency to collaborate with other NGOs, trade unions such as OSHA, NIOSH and of course, AFL-CIO and many others.  Decades have been spent on asbestos risk evaluation and regulatory action.  We feel we can serve as a model for success and failure and the time to recognize the overwhelming consensus about the dangers of asbestos and the need for ban has never been more apparent.  It's been ignored through legislative action since the World Health Organization and other agencies and all Surgeon Generals and recently reiterated by the president that asbestos is a carcinogen the EPA's failure to understand this carcinogen.  Looking back at history it's a wonderful playing field that gives EPA a unique opportunity, but most important to remember that during this time when EPA failed to ban asbestos in 1989, 200,000 Americans died from preventable asbestos-caused diseases and it's time to make sure this rulemaking process and the prioritization ensures public health and environment are indeed protected.  Thank you for allowing me to make these comments.

Speaker 22: Steve Risotto, American Chemistry Council
Yes, thank you.  Good afternoon.  Thanks for the opportunity to provide comments on the risk evaluation processes under the Frank R. Lautenberg Chemical Safety for the 21st Century Act. My name is Steve Risotto, a Senior Director at the American Chemistry Council.  In addition to risk evaluation that has already been noted, independent external peer review helps ensure the development of scientifically robust risk evaluations.  The American Chemistry Council and self-funded chemical groups in particular have been intimately involved in the review of many chemical assessments and based on our experience offer the following recommendations for ensuring robust peer review of evaluations under the new statute.  In selecting peer review panel members, the foremost consideration should be given to expertise.  Qualified scientists from industry should be given equal consideration for appointment based on the subject matter and in accordance with the applicable conflict of interest provisions.  Biases and perspective should be identified and balanced.  The charge questions posed to any peer review panel help determine not only the makeup of the panel, but the scope and depth of the peer review itself.  EPA should initiate development of charge questions at the problem formulation stage of a risk evaluation and then solicit public input on the draft charge questions concurrent with the public input on the draft risk evaluation.  EPA should strive to concurrently provide the peer review panel and the public with the risk evaluation and other draft materials.  Reviewers should focus on the scientific and technical aspects of a risk evaluation under review, rather than on policy or other considerations.  Peer review meeting should be restructured to encourage open scientific dialogue between both peer reviewers and the public and provide sufficient time for public commenters to present their remarks.  And the peer review report on the risk evaluation should provide responses to substantive public comments.  Peer reviewers also should have ample time to consider written public comments on the risk evaluations.  The peer review report should include a minority report if peer reviewers fail to reach consensus.  Thank you for your attention.

Speaker 23: Robert Budinsky, Dow Chemical Company
Thank you.  My name is Dr. Bob Budinsky.  I'm with the Dow Chemical Company.  The success of the Frank R. Lautenberg Chemical Safety for the 21st Century Act is essential for building safety and confidence.  We note that the agency has the expertise to meet the challenges of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, but it must leverage all of EPA's expertise. R&D under the leadership and collaboration with industry and academia have developed leading edge research for supporting risk assessment and exposure information and twenty-first century processes.  This will increase efficiency, decrease cost and limit animal testing.  EPA should also draw expertise from industry, academia, regulatory scientists and NGOs.  For example, industry is engaged with the EPA environmental health sciences and academia in developing and validating and applying methods that will be especially valuable for new chemical technologies.  The agency must also hold recommendations of its own repertoire of risk evaluation policy and guidances.  Dow was very supportive of a tiered process for screening level efforts and complex risk evaluations and systematic review integration and analysis on peer reviews incorporating quantitative screening evaluations should be performed early in the scoping and formulation stages and consistent with section 26  best science and evidence mandate including probabilistic approaches target exposure studies. Biomonitoring and environmental monitoring studies and evaluation will all be required with risk assessments that indicate potential concern.  It is strongly suggested the agency carefully define the assumptions and data needs for each risk evaluation tier.  Agreement between all stakeholders should be pursued on how higher tier exposure and hazard data should be used in the risk evaluation process.  The agency should engage industry to gain hazard information for the safety of chemical technology. We encourage the agency to utilize otherwise valuations and put forth a global consistency to reduce resource need and allow the agency to focus on higher priority assessments.  In closing, we look for to working with the agency and stakeholders to ensure the Frank R. Lautenberg Chemical Safety for the 21st Century Act is a success so that we can increase the trust of safety chemical technologies to benefit the public.  Thank you.

Speaker 24: Bill Greggs, Soleil Consulting
Good afternoon my name is Bill Greggs, principal of Soleil Consulting, chemical engineer by training, and worked for the past 45 years and consumer product manufacturing and product safety and product stewardship.  I will address exposure information and tools necessary for risk evaluation under the new law.  For risk evaluation we have two tasks, first scoping and problem formulation for selected priority chemicals.  In addition to developing data and conceptual models, scoping separates users presenting no concerns from those that will require targeted higher tier assessment.  Exposure assessment follows the same pattern, requiring approaches and tools appropriate for each task.  In an ideal world, EPA would have readily available measured exposure information representative, reproducible and reliable.  Such information should be preferred to model exposure information.  Recognizing this frequently is not possible.  There's a necessity for high-quality fit for purpose exposure models to inform scoping and risk evaluations.  Section 26 discusses the need for models to be used in the manner consistent with best available science.  Models must also be reasonable and consistent with the intended use of the information.  This means that lower-tier very conservative models that are useful for scoping and screening will not be sufficient for the refined risk assessments necessary to inform decisions about whether risk management is appropriate.  So the agency must closely evaluate the capability of exposure models in its toolbox.  Key currently available models are focused on worker, general population, and consumer environmental exposures.  These were developed as screening level models that may not be consistent with the standards for targeted risk evaluations.  In particular the EFAST consumer exposure model or CEM covers very few product categories.  The recent beta update for CEM is intended to address many more product categories, but that has yet to undergo peer review validation.  Separately ORD has developed an update covering product categories, but it requires evaluation and validation.  On the higher tier model front for environmental there are number of useful models for human exposure. EPA has three useful models for wall paint, indoor air, and migration exposures, but by definition they cover narrow product use patterns.  EPA has the challenge of quickly developing or getting access to models for higher tier human risk evaluation.  One source that the agency should explore is a set of exposure models used in Europe by member states and registrants.  The REACH exposure toolbox includes a component for scoping and screening exposures to workers general population, consumers and the environment.  Secondly the toolbox includes hire tier models like solvents react for cleaning products, test for plastic additives, other consumer products and other models.  For more refined workplace exposures the toolbox includes BAMA, manager and ART.  These models are publicly available and well documented and have been intensively reviewed by conferences, science advisory panels, scientific journals and many others.  Importantly, they have been utilized for the registration of 10,000 substances and have a very strong track record.  In closing, the deadline for the quick action by EPA to develop or get access and adequate approaches and tools for exposure assessment.  It will be important to collaborate with experts and stakeholders as this work proceeds.  Industry is willing to help EPA in making models workable for agency needs.  Lastly I would like to briefly comment on Dr. Henry's question about sentinel exposure.  This is not intended to mean that high and occupational exposure is sentinel for consumer exposure.  Rather it can be used in an overall product category context where subcategory with highest exposure can represent and be the sentinel for other categories.  If the sentinel subcategories are adequately protected then the rest are okay.  If not, a deeper dive is warranted.  Written comments will elaborate on this.  Thank you for the opportunity to speak today.

Speaker 25: Dr. Fred Reitman, Shell
Hello, I'm Dr. Fred Reitman I'm a Senior Toxicologist employed by Shell.  Thank you for allowing me a few minutes to provide these comments pertaining to the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  My career has been devoted to health and safety which is a top priority for Shell.  These comments addressed to topics, the first briefly describes the petroleum industry response to the EPA's high production volume challenge program.  The second pertains to risk assessment methodology as described by the staff.  HPV: on October 9, 1998 the U.S. EPA announced a challenge volume program.  In response, manufacturers and importers of petroleum substances in the United States for the HPV testing group sponsored approximately 400 petroleum process streams and related substances.  The testing group subsequently developed and submitted to EPA a considerable amount of information pertaining to physical chemical properties of these substances and potential hazards to human health and the environment.  Toxicity and/or eco toxicity testing was conducted on some of the substances and the contract laboratory final reports for all submitted to EPA.  Further the testing groups published program results in the peer-reviewed literature and may be available to the public cost-free online at petroleumHPV.org.  I ask that you consider this information developed for the petroleum screens under the program when undertaking risk evaluation for the substances.  Second topic is risk assessment.  With respect to risk assessment I note that the Lautenberg Act amends TSCA by adding new sections which read in part scientific standards.  In carrying out section four, five and six and to the extent that the administrator makes a decision based on science, the administrator shall use scientific information, technical procedures, methods, protocols, methodologies and models employed in a manner consistent with best available science and scientific evidence.  The administrator shall make decisions under section four, five, and six based on the scientific evidence.  I ask you to consider the statutory language when developing risk assessments, when considering risk assessments developed by other EPA program offices including IRIS or risk assessments developed by outside parties.  We should rely on the strongest science to ensure the strongest safety standards.  The standards and weight of evidence are important because adherence to these principles help to lead to risk assessments based on scientific evidence as opposed to unnecessary use of default assumptions and overly conservative assessments of risk.  Thank you.

Speaker 26: Dr. Stuart Cagen, Shell
My name is Dr. Stuart Cagen and I'm a human health toxicologist for Shell Health in Houston, Texas.  My comments cover risk evaluation and are consistent with comments from the American Chemistry Council.  In general terms these comments will be included in written comments to be submitted by the American Chemistry Council.  Today I would like to offer best science as the EPA considers the components of risk evaluation and assessments are prepared and reviewed.  The Lautenberg Act requires chemicals with exposure and hazard to determine whether a chemical poses an unreasonable risk under the act.  EPA is reminded to use best science to ensure that the technical elements are based on scientifically supportable assumptions and data.  EPA should use the best available science information from various sources including information collected during outreach to industry to provide relevant information.  Information from industries is often available in public literature. Additional information can be attained from unpublished reports many of which are submitted to the agency.  Ample opportunity should be provided for public comments.  EPA should also accommodate an effective mechanism to assess information that's assembled under the program.  A complicated and serious mandate of the act requires chemicals to be evaluated using the weight of the evidence approach to determine whether chemical poses an unreasonable risk.  I'll note three elements EPA should consider.  To understand, a more comprehensive set of comments will be provided by the American Chemistry Council in the written comments.  Note these elements are consistent with numerous EPA guidance documents and are now consistent with science standards in section 26 of the statute.  In practice, EPA assessments will now need to ensure additional rigor quality and transparency consistent with the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  Important new elements include importance of conducting the evaluation and need for EPA to avoid reliance on a piece of information that will provide the most conservative assessment regardless of its quality.  Reliance on conservative assumptions and the compounding of conservative assumptions individual assessments do not currently provide an accurate description of risk.  The EPA has an opportunity to assess studies, dose response methods and scientific standards clearly and specifically mandated in the act.  When hazards and risks are assessed EPA should seek a fair weighing of information based on the quality and relevance of the data.  Elements of their quality and value should be assessed using predetermined criteria.  This is consistent with systematic review practices.  Finally, those response models and ever increasing identification of biologically based pathways offer an opportunity to provide more sophisticated science based assessments than ever before.  We encourage EPA to rely on this information and cooperate in its hazard assessments to the extent feasible.  Thank you for the opportunity to comment today.

Speaker 27: Billy Maines, National Tribal Caucus
Good afternoon and thank you for the opportunity to speak this afternoon.  My name is Billy Maines. I'm with the Tribal Council and have the pleasure of serving as the chairman of the Tribal Caucus for EPA.  I'm providing comments on the risk evaluation as well as risk assessments.  When EPA talked about risk evaluations, you are including -- you need to include the close connection between the environment and Tribal populations across the country, Tribal lifeways are about an ongoing relationship we have with our interactions with Mother Nature, with the land, with the air, with the water.  We depend on this by continuing this. Tribal people have a higher and more frequent exposure to toxic chemicals or bio accumulating more toxic chemicals than the average American. Meaning that instead of being in an office 8-5 Monday through Friday, when I get off work here I go home and change my clothes and I'm out on the land looking for stuff to bring home to put on the table and feed my kids, my relatives and my family and self.  Those animals and berries and vegetables and herbs depend on what is going on in the air, the land, the water and I bring this up for one major reason is that when you are looking at things, when you are creating it, you also have to look at exposing it.  More times than not especially in the state of Alaska, these are open to all weather and more times than not, the weather tends to have a lot with the breaking up of whatever is put into that landfill.  Be it the water that goes through and then slows down to the ground water and stuff like that and in other ways people tend to burn either in the backyards or even at these landfills and it gets into the air that ends up down in the land and the water too.  So when you are thinking about anything when it comes to risk evaluation or risk assessment you have to really consider the Tribal folks across this nation because we are out there almost 24/7 except for the times we are indoor doing the work we need to do on behalf of our children and Tribal folks and on behalf of mother nature.  It's unacceptable that the significant increase hazards and risks around the Tribal communities because the manufacturing chemical use of a product that's discarded in a known manner.  The manufacturers must be held accountable for these chemicals that are not placed at a reasonable risk for people and to our lands, to our air, to our water.  I had the pleasure last year of providing with the administrator a report from the Tribal Science Council and over 10 years ago a white paper that talked about the relationship between Tribes and what goes on around us, the chemicals that are placed in the clothing and into everyday life and how it needs to be considered when you create and put it into practice that you also think about how you are going to get rid of it and it has to be in them.  But the main thing I said at that time and I'll say it again is that whatever EPA or any of its contractors look at doing risk evaluations are risk assessments of Tribal people it should be at the forefront and not an afterthought.  Thank you.

Speaker 28: Dr. Delina Lyon, Shell
Thank you and good afternoon.  My name is Dr. Delina Lyon and I'm an eco-toxicologist with Shell, one of the world's leading chemical suppliers.  The statements I make today will focus on the environmental risk evaluation and the statements will be reflected in written comments that the American Chemistry Council will be submitting to the docket.  I'm happy to see the commitment and energy the EPA is giving toward tackling the challenge of the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  As a scientist working at a chemical company I would like to see the regulated community and industry scientists working collaboratively with the EPA on the risk evaluation process to make it stronger and more relevant.  Industry scientists often have unique insight and experience with their companies' chemistry and collectively have a large body of knowledge globally.  I would encourage EPA to leverage that knowledge and engage early and frequently with industry.  I am not only speaking of the opportunity to refute the regulations but provide input on the costing of the risk evaluation process.  One area of risk evaluation that I would like to focus on is the use of computational approaches, models and predictive software.  As Tala Henry discussed this morning, models were used for both exposure and hazard assessment and these models are built on reliable data and provide week for week data sets or value on which the risk evaluation can be built.  In the hierarchy of input into risk evaluation hazards models should be the last resort coming after high quality test data, category identification and analogs.  There are many hazard prediction models available of varying quality and reliability some of which perform better for different types of chemicals.  The demand of applicability restricts which chemicals and chemical families can be reliably modeled in a certain program.  A model tailored for a specific category of chemicals may give a more accurate output than a more generic model.  I would encourage EPA to allow a greater range of tailored and externally sourced models into the risk evaluation provided the models undergo an assessment for acceptability.  The assessment process for predictive models needs to be as stringent and as transparent as the criteria for actual test data.  It would behoove both industry and EPA to agree upon a set of acceptance criteria for a few reasons.  First, this would permit and accelerate the acceptance of existing and externally sourced model for uses in risk evaluation.  Second, new models including those specific for certain chemical families to be constructed in accordance with the criteria and finally, the criteria could be used to generate a running list of pre- approved models. This imports a degree of flexibility and reliability that leads to timely and better risk evaluation.  We would welcome the opportunity to continue a dialogue with EPA to work together to develop these important criteria for model acceptance.  Thank you for the opportunity to share recommendations in this exciting time for chemical regulation.

Speaker 29: Pamela Miller, Alaska Community Action on Toxins
Good afternoon and thank you for the opportunity to provide comments today.  My name is Pamela Miller and I'm the Executive Director of Alaskan Community Action on Toxins, an environmental health research and advocacy organization.  We work with rural Alaskan native communities to prevent harmful chemical exposures deriving from military and industrial sources.  We will submit written comments with more detail.  The new law affords the opportunity to reduce and eliminate harmful exposures to particularly vulnerable populations.  Other speakers have addressed the importance and mandate that EPA has under the new law to protect vulnerable populations including workers, children, pregnant women, the elderly, and those with chronic illnesses.  I'm here to speak to the need of protecting vulnerable populations that might not be immediately obvious because they may be distant from most manufacturing centers, but are nevertheless highly and disproportionately exposed: people of the North and Arctic, especially indigenous people who rely on traditional diets of fish and marine mammals.  Northern and Arctic peoples bear a burden of health disparity including cancers, reproductive disorders, birth defects and learning and developmental disabilities.  The line of chemical manufacturing distribution and disposal extends to the Arctic because chemicals can travel hundreds and thousands of miles on atmospheric and ocean currents where they accumulate in the body of fish, wildlife and people of the North in a process known as global distillation.  Far and pristine, the Arctic contains some of the most contaminated animals and people in the world.  The traditional foods that northern peoples have relied on for generations for spiritual, cultural and physical health and well-being, fish, birds and marine mammals are now highly contaminated.  And indigenous leader for a village and a board members said we don't eat just one chemical, we eat the whole fish so the need to address cumulative exposures, chemical mixtures and synergistic effects.  Chemicals are passed through successive generations from mother to child and harm the ability of children to learn their languages, traditional lifeways, songs, stories, and knowledge.  Many chemicals are harming the brains and health of our future generation.  We urge EPA to consider the special vulnerability of northern and Arctic indigenous people and future generations when conducting risk evaluation.  People of the north are also more highly exposed to chemicals in the indoor environment because of longer winters and need to insulate against the cold and less insulation.  In addition to traditional foods, EPA must consider this exposure.  We also agree with others on the need for transparency, meaningful public involvement and prevention of undue industry influence, the need to assess aggregate and cumulative exposures consideration of neurodevelopmental and endocrine effects at critical windows of development, epidemiological data and scientific literature review as well as the importance of including comprehensive assessments of exposure routes and excluding the assumption of no data no risk.  Thank you again for the opportunity to speak today.

Speaker 30: Timothy Malloy, UCLA School of Law
Thank you.  Thank you for the opportunity to comment today.  I will follow these brief comments with a set of written comments providing more background on our recommendation.  Today I wanted to focus on the nature of risk evaluation and the relationship to the concept of unreasonable risk.  Thus far today most speakers including those from EPA have inflated the risk evaluation and risk assessment and I wanted to take a moment to emphasize the difference between the two.  I think it's fair to say that most of us have a pretty good sense of what risk assessment is and involves especially the things after that informative presentation by Dr. Henry this morning.  I think of risk assessment is characterized to the nature and extent of risk associated with particular scenarios of chemical use.  Clearly part of risk evaluation but it is not all of risk evaluation.  Under the statute, risk evaluation is a process I will quote here: "used to determine whether a chemical substance present an unreasonable risk to health or the environment under conditions of use."  Risk assessment tells the nature and extent of risk, risk evaluation goes beyond risk assessment to the determination of whether the identified risk is unreasonable.  This judgment as to whether risk is unreasonable is not scientific judgment.  It is normative judgment about what ought to be as we as a society are willing to accept.  To say that a judgment is not normative though is not to say it is standardless.  To the contrary the regulatory study is extremely poor and to establish standards to be used in determining whether a risk is reasonable or unreasonable.  It's important from a civic perspective to ensure the legitimacy, consistency, and objectivity of the decision-making process and it's important from a practical eco- standpoint to withstand judicial review later on in the regulatory process so I encourage you regarding the evaluation process to include consideration of the standards to be used in determining whether risk is unreasonable.  The term unreasonable risk has a long history toward an environmental law.  To some degree the statute alters the historical understanding by creating consideration of cost.  I don't have the time today to discuss the different standards used in the past.  I include the use of the future in making the call about unreasonableness.  I hope to do so in my written comment, but one consideration should be the availability of comparable meaningful safer alternatives.  The reason I say this apart from the historical significance that safer alternatives play in unreasonable risk is tasting common sense.  Other than California, let me give you an example.  Say I want to go surfing after the meeting.  There's a small risk of a shark attack at Ventura Beach, but it's reasonable for me to take on that risk, but if I discover another beach nearby that is identical in all respects to Ventura beach with the exception that it has a substantially lower risk of shark attack, surfing at Ventura Beach may now be unreasonable.  The point here is that reasonableness depends on context and the availability of meaningful safer substitute affects that determination.  Thank you very much, for your time today.

Speaker 31: Catherine Willett, Humane Society of the United States
Thank you for this early opportunity to comment on EPA's approach to adapting to the new provisions contained in the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  I am Catherine Willet from the Humane Society of the United States.  A main element in the new bill is the requirement to reduce and replace the use of vertebrate animals and testing.  The overarching principle must be considered when designing potential effects carried out to address this bill whether testing required by EPA or voluntary testing performed by industry.  Several possible approaches are mentioned specifically to address this requirement including the formation of industry consortia to avoid duplicate DIF testing, the use of existing information, chemical grouping and read across to avoid unnecessary testing, the use of available high throughput test platforms to provide fast efficient information about potential chemical activity and the application of predictive modeling to assist in determining safe exposure.  EPA has been successfully implementing several approaches under test the past four years.  Under the new provision EPA will have access to additional information that will improve predictive modeling and the resulting risk assessment and require an improved and more complex weight of evidence evaluation.  Consideration of biological pathway information in the form of adverse pathways and other related information will be increasingly helpful in supporting weight of evidence evaluation and in designing any further testing strategy that might be deemed necessary.  Pathway information can be used to support prioritization and evaluation information to improve certainty, not only in prioritization, but also in further hazard and risk assessment.  This information can add value in situations that are currently difficult to address.  For example, different developmental stages or combined exposures of chemicals that affects similar pathway profiles.  Pathway based approaches also involve an estimate of certainty in the individual pathway components as well as in the overall pathways further allowing increased transparency of the certainty of any resulting hazard or risk assessments.  Within two years of implementation, EPA must create a strategic plan to promote the development and implementation of alternative test methods and strategies and these must provide information of equivalent or better scientific quality for risk.  Several methods and strategies already exist.  EPA's implementing and developing some of these with pesticides particularly for acute and endocrine related endpoints and has been a defaulting this method and interpretation model to better address these various hazard influences.  We expect the required provisions will accelerate the efforts already underway and prioritize developments of alternative approaches for the OSHA to be developed.  Given the new mandate to cover chemicals quickly combined with the requirement to reduce animal testing we expect these efforts to accelerate and improve the quality of risk assessments. Consistent with EPA's previous approach, prioritization and evaluation of risk are not hazard based and others have been engaged in efforts to improve exposure information modeling including EPA's program and the risks 21 project.  Each of these projects is focused on improving estimates of potential hazard an exposure and to identify margins of safety to a prioritizing chemicals.  An added benefit of this approaches these models also include estimates of uncertainty.  When requesting any new information, EPA must employ a tiered screening and testing process under which the results of screening level test or assistance and available information can inform the decision as to whether one or more test is necessary.  This is consistent with EPA's current approach, but combined with requirements to identify the need for new information and described how the information reasonably available was used to inform the decision and to explain the basis of any decision that requires the use of vertebrate animals as well as reduce and replace the vertebrate animals we expect the tiered testing -- that tiered screening testing and assessment will continue to reduce animal testing while improving the speed efficiency and effectiveness of chemical evaluation.  In determining whether new chemicals or new uses of chemicals may or may not present an unreasonable risk prior to manufacture the EPA will necessarily rely on existing and improved tools as described above.  The additional requirements to reduce vertebrate testing and justify new testing will spur both EPA and industry to implement existing scientifically valid alternatives such of those already in use by EPA and those approved by the OECD as well as to develop new approaches.  EPA already issued determinations under the new provisions of TSCA.  These determinations follow the existing processes and resulted in a finding of not likely to prevent unreasonable risk.  Going forward this process is likely to involve more information and greater need for improved implementation of problem formulation, weight of evidence evaluation integration of existing and improving tools at already mentioned.  In addition, emphasis on tiered assessment process is critical for meeting deadlines and focusing resources as well as reducing animal testing.  And added benefit of the new approach is they are accompanied by an estimate of uncertainty in the underlying information, modeling and prediction of allowing a certainty estimate that can and should be included with any determination.  We look forward to working with EPA and other stakeholders to make sure the new provisions and TSCA result in better risk determination using few, if any animals in a timely fashion.  Thank you very much.

Speaker 32: Amy Kyle, University of California at Berkeley
Thank you and thank you all for this forum.  My name is Amy Kyle from the University of California at Berkeley and I have 4 points I wanted to raise at this time.  The first one is about some goals that seem important perhaps to consider for the evaluation process in addition to what you've talked about.  And one of them is about the throughput.  And I get a certain sense of maybe lower expectations from EPA and from the audience in completing the assessments and implementing actions.  I think EPA can do it.  I think EPA has a lot of smart and dedicated people and you can get this done, but it's going to be important to design this process with throughput as a key metric.  You want to get your 20 assessments in place down in a timely way etc. and the evaluation process has to be designed so it does not get bogged down so I really encourage EPA to take a very active posture in terms of setting this up in a way that it can be completed.  Various kinds of assessment and can be completed in a timely way and not allow yourself to get diverted into endless debate about everything.  The second thing I want to talk about is about the match between data and methods for assessment.  I think it's important to recognize right at the outset is that EPA is put in the position of having to reconcile competing realities from the legislation in that we all want to use good data, good assessment methods and incorporate modern approaches and the national science recommendations and produce quantifiable results.  Everyone can agree on that and the law requires that but that requires good data about a lot of things and the law leaves the burden for mandating data development and submission on EPA and that burden on the manufacturers and importers have breached it.  So it's illogical in a way to do that.  If you want to have the most highly scientific developed assessment then you need to have certain standards of data.  So EPA I think needs to face this squarely in designing the assessments that go into the evaluation and the process for that and develop a strategic approach that allows it to match its assessment to the kind of data it's going to be able to obtain.  And I'm concerned; I know that others have mentioned this that we don't want to revert to an approach that says no data is no problem.  If we don't have good enough data than we will leave something out of the assessment and there is some suggestion of that in the presentations and in the previous assessments that have been done but leaving things out because you don't have any data about it is certainly not good science so I think further thought needs to be given to how to reconcile those issues.  So my third issue is about the question of time.  Things change over time obviously and in this context exposure I think we need to recognize exchanges a lot more than hazard so when we put exposure and hazard on the diagram to equal risk, the hazard side is fairly consistent, you can do the testing or whatever method and you know that.  Exposure can change dramatically as a result of product changes, technology etc. and also as a result of catastrophic events such as fires, earthquakes, sea level rise and some thought needs to be given how to factor in deliberate or unintended changes that occur over time.  The methods that are being used were really intended for a point in time and you are going to do our assessments that are going to be applicable for a long period and it may require more meta- level of evaluation for this long term potential and exceptional events.  And my last comment is about the question of highly impacted populations including children and environmental justice communities including the Tribal communities mentioned before in that a lot of people have talked about the importance of protecting vulnerable populations including children and the law requires this but, this needs more focused attention with regard to how to pull together the data methods, consideration of the biological susceptibility, social vulnerability and cumulative impacts.  There are pieces of this out there, but I certainly have not seen an overall approach that brings this together in a way that I think will achieve the purposes set in the law so it seems this is another area that needs attention at the higher level.  Thank you for the opportunity to comment.

Speaker 33: Ansje Miller, Center for Environmental Health
Good afternoon.  My name is Ansje Miller and I'm the Center for Environmental Health we are committed to using the latest science to eliminate chemicals that pose the greatest risk to health of American families.  As a number of previous commenters noted, the law requires EPA to protect vulnerable populations and in the new safety standards the risk evaluation must consider highly exposed populations.  The term potentially exposed or subpopulations is defined as a group of individuals within the general population identified by the administrator who has greater susceptibility or greater exposure may be at greater risk of than the general population of adverse health effects from exposure to a chemical substance such as children, pregnant women, workers, or the elderly.  Members of communities often face additional burdens from social determinants of health.  These communities, often on the fence line of manufacturing, distribution, and transportation lines, must be included in the valuation of susceptible populations.  Moreover, accounting for cumulative risk should include measures of risk from both environmental sources as well as social determinants as those determinants have a significant impact on a population vulnerability to exposures and the ability to mitigate risk.  Also, as mentioned by previous speakers, transparency in the risk evaluation process is critical and this was touched on previously, so I won't go too much into that but I just want to note it's especially critical when it comes to the systematic review.  In the U.S. the cost of treating health conditions for which chemical exposure is implicated is over $1 trillion a year. An essential feature of this is it's found using low chemical concentration and effects of it at low concentration can be different than the effects at higher concentrations.  There are many types of vulnerability that can be particularly harmful.  The critical periods are early postnatal development and effects of one generation maybe transmitted to future generations through programming gene activity.  To date, no chemical in use has been thoroughly tested for these effects.  Traditional testing protocols were not designed to test for endocrine disruption at ambient and low exposure levels.  In this morning's presentation, the presenter noted EPA uses the process for evaluating chemicals.  When evaluating disrupting chemicals we recommend that the EPA utilize the secure protocol for endocrine disruption.  This has been created by a team of scientists and experts in a wide range of fields to lay out the necessary tools that a chemist would need to measure potential activities.  Endocrine disruption is something that has been inadequately addressed by industrial and regulatory science.  This testing protocol consists of five testing tiers ranging from broad evaluation through specific cell and whole organism based approaches.  The proposed protocol will not detect possible mechanisms and disruptions because scientific understanding is advancing rapidly.  To ensure the protocol remains current the protocol incorporates measures to incorporate new assays into the protocol as science advances.  I also wanted to add my appreciation for creating this opportunity for public input and provide the opportunity for remote participation.  This webinar was incredibly helpful and welcome the opportunity to participate and reduce my carbon footprint by not having to travel there.  I hope you will continue this practice in every step of the process.  In closing I'm looking forward to the implementation of the law in a way that protects all of us especially those who are disproportionately exposed as the new law requires and we work with you to make these a reality.

Speaker 34: Celeste Monforton, George Washington University
Good afternoon and this is Celeste Monforton and I'm speaking as an individual, someone actively involved with the American Public Health Association, specifically the Occupational Health & Safety section.  Workers are on the front lines of chemical production and most often they have the highest exposure and are at the greatest potential risk of harm.  They are exposed to chemicals along the production and supply chain across the whole lifecycle of chemicals and I want to say I appreciate EPA's historical efforts to incorporate exposure data and health effects information from occupational settings in its risk assessments.  And the new law formalizes that practice.  I know in the risk assessments that are already prepared for some of the workplace chemicals such as NMP paint strippers and methylene chloride data from occupational exposures were integrated into the assessments. Some of that was from peer-reviewed literature and others from data and evaluations by the National Institute for Occupational Safety and Health (NIOSH) and OSHA.  Some assessments note the limitations of OSHA exposure data particularly the paucity of it and that's a function of how OSHA is able to conduct these assessments each year and even be aware when they conduct exposure sampling.  Because occupational exposures must be considered as EPA moves forward with both the risk evaluation and chemical prioritization process, I see the new laws providing a great opportunity for EPA, NIOSH and OSHA to work together to fill those data gaps for both exposure and health effects information with respect to worker population.  And with respect to establishing criteria for risk assessment I urge EPA to collaborate closely with OSHA and NIOSH to establish such criteria.  I suggest collaboration be formalized in some manner such as a memorandum of agreement.  I know in some of the final risk assessments from the work plan chemicals do have listed OSHA staff reviewers, but some are risk assessments did not and one of the aspects of a formal collaboration or memorandum of agreement I would suggest would be ensuring that both OSHA and NIOSH are invited as peer reviewers for every risk assessment and if they decline it should be noted in the peer review acknowledgment page.  Finally, throughout much of the deliberation discussion about the legislation about toxic reform, asbestos was held up as a poster child for the law deficiency and I urge EPA to include asbestos and all of its forms as one of its first five chemicals for action.  Thousands of risk assessments have been conducted on asbestos and the risks are very well understood.  Asbestos is already on EPA's work plan because it is a known human carcinogen and one with significant occupational exposure and selecting asbestos is one of the first chemicals in completing the rulemaking promptly on it would demonstrate to the public the success of the new law.  Thank you so much.

Speaker 35: Caffey Norman, Squire Patton Boggs
Thank you for the opportunity to comment.  I represent ALJ.  The notice indicates that EPA is looking for input to inform a proposed rule on conducting risk evaluations.  I believe the best place for EPA to start would be with the assessment just completed for TCE and methylene chloride.  With regard to those work plan assessments that have been completed prior to passage of the Lautenberg Act, TSCA section 26 L4 provides the administrator may publish proposed and final rules under section six that are consistent with the scope of the completed risk assessment for the chemical substance consistent with applicable requirements of section six.  It's important to recognize that EPA may base regulation on the risk assessments only to the extent that they comply with the substantive requirements of the Lautenberg Act.  I'm not going to go through what section six and section 26 H require.  Those are spelled out and other commenters have mentioned.  There's weight of scientific evidence, use of best available science and importantly recognition that independent verification of peer review should be given careful consideration.  While this is not the place for an extensive analysis of the shortcomings of the completed assessments, a few examples may be helpful to EPA as it goes forward looking how to do risk evaluation in the future.  The TCE workplan assessment relies on hazard values derived from a single academic study to estimate non-cancer risk.  It does not take into account the findings of several other studies including two GLP compliant studies conducted under EPA guidelines which were unable to reproduce the effect seen in the academic study that EPA relies on.  That academic study has been heavily criticized in the public literature.  Other regulatory agencies including Cal EPA have declined to allow the academic study citing quality concerns.  The authors of the studies have published repeated corrections and a majority of EPA's own staff scientists have expressed, "low" confidence in its results.  In addition, both the assessments relied on out-of-date exposure scenarios, did not take into account changes in workplace submissions and exposures as a result of adoption and implementation of the Clean Air Act that already regulate these sources of those compounds.  Indeed, the methylene chloride assessment relies on data that preceded the 20 fold reduction in permitted levels when OSHA adopted workplace standards in 1997.  That's a significant change from 500 parts per million which is the data in the EPA assessment down 225 PPM which is the legal limit.  Also, both assessments are screening-level assessments and do not need OMB guidelines implementing the quality act.  They imported worst case or default assumptions.  These may be appropriate to support a decision of no further action needed because the competency potential risks will not be a concern but they are inappropriate to support regulations intended to reduce risk because they did not accurately estimate the risk of quantified exposures.  Finally, the report of the peer review of the assessment highlights these points, but EPA has so far chosen to ignore it.  The Assistant Administrator for Chemical Safety and Pollution Prevention wrote to the EPA Inspector General that it's notable that the external peer reviews assessments we have completed so far supported our methodologies in conclusion at the same time there was a contemporaneous report entitled EPA peer reviewer say trichloroethylene analysis is not ready for regulatory use.  So I will close with that but I urge EPA to begin implementation of the TSCA with credible risk evaluations that meet the substantive requirements of the Lautenberg Act.  Thank you.

Speaker 36: James Cooper, AFPM
Good afternoon, I'm Jim Cooper with the American Chemical Manufacturers.  Thank you for convening a public meeting.  I really hope this continues in the future.  I've always liked a good public dialogue even if there are various viewpoints expressed with which I may not agree, it's still good to have that conversation in public with everybody present so thank you for doing this.  One of the fundamental objectives when we were updating TSCA or thinking about it was that the public would have more confidence and would view this as a credible chemical law.  And really about the only way to achieve this is going to be true transparency and that's probably been the number one thing pointed to by every stakeholder is saying we need more transparency.  We think the agency has taken steps in the last couple of years to increase that.  We think the law is going to help bring that further down the road.  Really the way to achieve that is going to be through the weight of the evidence approach.  It makes things more transparent, but to even accomplish that one of the first tasks the agency's going to have to do is develop the criteria by which it judges the quality of the study.  Make that publicly available for comment.  It is many different stakeholders commenting and if we can all get hopefully some agreement in the future it will stop a lot of this side conversation about the quality of the studies the agency is taking into consideration especially when establishing the actual numbers in their assessments.  That being said don't reinvent risk assessment.  The agency's been doing this a long time.  It follows the science, the current science.  We know the science involved allow it to evolve.  Keep doing what you do well and you do many things well.  There are always going to be disagreements because of the art of toxicology and things of that nature, but still as long as it is a transparent process people are not going to have the heartburn they've had in the past over some of the results they've seen.  The last thing I really want to talk about was exposure and exposure assessment because I think that will be the most challenging thing for the agency and I've heard agency scientists saying that as well.  I used to be involved in that quite a few years ago and saw how challenging it can be trying to get together to talk about exposure.  It was not an easy process.  And first it should be limited only to the intended conditions of use.  That's where the focus of exposure has to live.  We can guess work all we want on all the scenarios that could occur but that is just going to lead the agencies down so many different paths it will never be able to reach a conclusion so really focusing on the exposures limited to those intended conditions of use will be key to getting work done.  Also EPA really needs to use section eight tools especially those that don't have to go through OMB review.  Those things are critical because then you can identify and use them in a targeted fashion to get the information from people most likely to have it.  That is really the intent of Congress is when they said also involve processors at certain points and that is why they are not requiring the agency to just do this blanket thing where processors have to report everything that they know because that's not going to be very productive and that is pretty much it.  Hopefully these dialogues will continue.  Thank you.

Speaker 37: Dr. Kimberly White, American Chemistry Council
Good afternoon, my name is Dr. Kimberly White. I'm with the American Chemical Council. You've heard from a number of colleagues here as well as a number of stakeholders about how important this risk evaluation process is.  Dr. Henry mentioned a couple of things in her comments I'd like to stress how important these particular elements are.  The first thing I'd like to talk about is the systematic review process and really three key elements in that systematic review process that are important for how we develop this risk evaluation.  The first is problem formulation.  Dr. Henry mentioned in her presentation that problem formulation and scoping is the critical first step in the risk evaluation process, but I want to emphasize when we are talking about the formulation steps we are talking about the formal plan the agency lays out for how it will address the key elements in the evaluation.  That includes how it will actually develop and identify the data acquisition plan, the literature strategy, how they will include and exclude criteria for the studies, the data evaluation procedures and the methods they will use for the hazard characterization and the response process and the framework to assess the weight of evidence.  You've heard from a number of speakers the importance of the weight of evidence process.  It's important it's included as part of the rule.  The next piece is, once you finish that scoping step the next critical step is pulling together the scientific information and that is transparent, objective criteria for the science literature and making sure you have clear and established criteria for including and excluding that data.  Specifically in the evaluation piece and integration of that data so we want to make sure once you have called in that important data that you look at the quality of that data.  I can't stress the importance of evaluating the data quality strengths and weaknesses of that and I want to stress that because I don't just mean qualitative assessment of whether or not this is a generally good quality study but taken that information into consideration of how that's integrated into the risk evaluation and the conclusion you reach so in the weight of the evaluation process we want to stress the difference between evaluation versus strength of evidence.  The strength of evidence process does not take into consideration that data quality and how we can impact the inclusion so you want to make sure there is a clear outline process for how you will be evaluating the data quality in these elements not only need to be delineated up front in the overall risk evaluation process, but need to be included as part of the overall portfolio because we need to be able to see and be held to that standard of how you will actually pull in data, evaluate the data for quality and use that information to reach a conclusion so it's really important that's part of the proposal not something left to guidance.  Thank you.

Speaker 38: Andy Igrejas, Safer Chemicals Healthy Families
I'm Andy with Safer Chemicals Healthy Families.  We are a coalition of groups that came together to push for toxics reform a while back and now going back to 2009.  Thank you for having this public process and just wanted to remind folks the TSCA reform is driven ultimately by evidence that toxic chemicals are contributing to the burden of chronic disease, disability in this country, burdening many millions of American families and the tools EPA has worked with in the past are insufficient for you to craft the needed public health intervention. So that's what this is about: getting the evaluation right and the public health intervention is adequate and makes a dent in that problem of disease and disability.  We are encouraged by a lot of what was said here and some of the other stakeholders, so depending on some, these terms and will go very well or maybe there is more conflict that is apparent.  In your presentation you had the unique opportunity to deal with the whole lifecycle of the chemical, production, distribution, commerce, uses and disposals, but that's a unique opportunity to deal with that and the vulnerable population that exist at the facility make it and the workers and the people disproportionally exposed whether by from small doses of chemicals to pregnant women, but that person might also be person who lives in a fence line community so you have a population with a double whammy.  We were encouraged by aggregate exposure and that's something the agency is pointed toward.  It's supported by organizations and it captures the real world of exposures that these populations and we share the skepticism that Sentinel exposure was brought up a lot in the debate.  The law requires you to publish which the approach you told took, but now we see that an aggregate exposure will be more than half of how you conduct evaluations.  To flag concerns based on the evaluations posted so far, we would be concerned the agency rely on studies and not some recent studies and that the studies if you can't get the actual study, use that order of authority. That's one of the key reforms in the bill to require the actual study.  We are concerned the absence of data on exposure will not be taken as exonerating, that the agency use both the tools that Jim mentioned in section eight to get exposure data, but also the default assumptions and safety factor that the national academies and others have encouraged the use of.  The scoping process is critical and the way you formulate it here is the problem formulation for the whole process.  It's clearly very critical and we would encourage you if it's not required by the law to have public process around the scoping process explicitly in the risk evaluations as they go forward so people have a chance to identify, raise their hand and if they are someone touched by this chemical along the supply chain or lifecycle of the chemical.  We agree with the comments made that it's a judgment call about how much science policy is included in this rural verses in guidance.  It's good to err on the side of guidance and it's a deliberate decision in the bill to cut down the amount of rules in favor of guidance and that's reflected in the final bill.  Finally, if you keep the public health intervention purpose of this reform in mind, really account for the real world exposures of people along the supply chain, fall back on the national Academy guidance where there's doubt the agency is a good chance of succeeding.  So, thank you, and we appreciate the public process.

Speaker 39: Dr. Deborah Lander, Chemours