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Scientific Understanding

The Scientific Understanding work group is focused on filling knowledge gaps on the health effects of chemicals. To review the group’s membership, charge, and past meeting summaries, visit the National Conversation work group page.

Next Steps
The National Conversation Council will consider public input received through web dialogues and public comment in revising the Action Agenda in the early spring 2011. Work group reports will be appended to the action agenda.

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20 Comments

  1. Ellen Silbergeld

    I appreciate the effort and thoughtfulness that has gone into preparing this interim document. However, as someone who has been at the bench and in the trenches on this issue, I think that without really innovative thinking we are not going to solve the problem of “so many chemicals [and more to come – nanotech], so little time.” This document could have been written at almost any point over the past 15 years. I don’t see anything that is going to move us forward in a real way, that preserves a connection to science and re-establishes the compact with the public that no untested agents will be present in food, water, air, breastmilk, etc.

    I urge you to convene a small group to think way outside the box.

  2. Frederic Pfaender

    UNC Chapel Hill SRP

    This is a really outstanding report that clearly recognizes many of the deficiencies in the current approachs and makes realistic and meaningful recommendations for action. Just a couple of suggestions.

    1. In relation to Recommendation 1. The agencies need to conduct a study using a few chemicals in which a complete integrated assessment is done, including collecting additional data if necessary. They then have a platform for testing the hypothesis that collecting a lot of data will necessarily result in a better assessment. It can also reveal how much data, or what kinds are actually needed. Is has been clearly shown for many environmental data sets that we have collected far more data than actually needed if we were clear about what we wanted to know or control.

    2. Recommendation 2- this is very similar to conclusions reached by the Monitoring Group. Integrating large data sets is not simple either conceptually or technically. It is not simple computer science.

    3. Recommendtion 8- Perhaps we need to develop some rationale for abandoning approaches that have been shown not to work well (PHA) rather than applying bandaids. It may be much more efficient and cost effective to move on to better methods.

  3. Eileen Senn

    Independent Industrial Hygiene Consultant

    In your view, what are the most important recommendations put forward by the work group?
    Recommendations 1, 2, 3, and 9.

    Do you have suggestions for strengthening the report or any of the recommendations?
    Recommendation 8 should be expanded to include the study of the methods of other agencies, particularly OSHA. Alternatively, a separate recommendation could be made on this.

    OSHA’s approach to controlling chemical hazards is completely broken. When workers complain about chemical exposures, staff slavishly follows the approach of collecting air samples for comparison with outdated PELs, despite the fact that over 95% of these samples are inevitably in compliance. The results of OSHA inspections are not transparent. The results of air sampling are not presented to employer and workers. Comparisons of sampling results are only made to outdated PELs, not with more protective criteria for evaluation. Staff lacks expertise in evaluating worker health complaints. No attempt is made to correlate health complaints with exposures. Letters of recommendations to lower exposures are rarely issued.

    Given that the work group was limited to 12 recommendations, are there issues that you think should be prioritized over those addressed in the report?
    Issues 5 and 7 could be combined to make room for the above recommendation dealing with occupational health.
    [file]http://resolv.org/site-nationalconversation/files/2011/02/The Case against OSHA PELs.doc[/file]

  4. Roger D. Masters

    Dartmouth College

    Enclosed manuscript is submitted for National Conversation Work Group Reports on “Scientific Understanding”. It contains substantive findings published over the last decade that have generally been ignored by neurotoxicologists. In addition to its important findings on an easily removed toxin that significantly increases rates of violent crime, It should be of particular interest to all researchers who use geographic data from the U.S. to study factors in human health and behavior.

    For a bibliography, see second enclosure.

    For the most recent publication of hs research on silicolfuorides with Myon J. Coplan, see
    http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6W81-4N5CX5D-1&_user=1
    0&_coverDate=09%2F30%2F2007&_rdoc=1&_fmt=high&_orig=search&_origin=search&_sort=
    d&_docanchor=&view=c&_searchStrId=1456202380&_rerunOrigin=scholar.google&_acct=C
    000050221&_version=1&_urlVersion=0&_userid=10&md5=75c1bec185cd80c9ffee68229ec07f
    88&searchtype=a

    For further information, contact:
    Prof. Roger D.Masters
    Research Professor and Nelson A. Rockefeller Professor Emeritus
    Department of Government
    Dartmouth College
    Hanover, NH 03755
    http://www.dartmouth.edu/~rmasters
    [file]http://resolv.org/site-nationalconversation/files/2011/02/Neurotoxicity and Violent Crime- Linking Brain Biochemistry, Toxins, and Violent Crime.rtf[/file]
    [file]http://resolv.org/site-nationalconversation/files/2011/02/Publications on Silicofluorides, Neurotoxicity, and Behavior.doc[/file]

  5. Richard Clapp

    B.U. School of Public Health and Lowell Center for Sustainable Production

    The Scientific Understanding Work Group draft has some useful recommendations. The reference to risk assessment seems wishy-washy and I would recommend adding the perspective articulated by David Kriebel in the attached article from Occupational and Environmental Medicine. Clearly, the chemical regulatory regime we currently have in the U.S. follows the “reactionary principle,” as Dr. Kriebel defines it, and we need to move toward the precautionary principle as the underlying rationale.

    Also, two colleagues and I have reviewed the current state of knowledge on occupational and environmental carcinogens and the evidence is much stronger than many believe. The attached article by the three of us may be worth adding to your bibliography.
    File: reactprinc.pdf
    File: ReviewonPubMed.pdf

  6. Mary Lamielle

    National Center for Environmental Health Strategies

    The goal of gaining a “better understanding of variations in individual susceptibility, factors that increase the vulnerability of certain communities, and the impacts of low-dose, multiple, and cumulative chemical exposures, including naturally occurring toxins,” is critical to the public health. Such a focus is long overdue.
    I strongly support Recommendation 7 Improve understanding of individual susceptibility to chemical exposures. For over twenty-five years I have worked with tens of thousands of individuals who have suffered greatly due to chemical intolerances/chemical sensitivities. These comprehensive research recommendations are essential to advance the science necessary to address the health and disability needs of these individuals and to prevent future illness and disability. I also support Recommendation 6 Define gene-environment interactions in chemical and other environmentally exposed groups, research that is relevant to those with chemical intolerances. I support Recommendation 4 Identify and improve scientific knowledge of adverse health effects from indoor air pollutants…. This is one area that has been examined in the context of chemical intolerances/sensitivities. The U. S. Access Board contracted with the National Institute of Building Sciences in a multidirectional project that involved government representatives, indoor air experts, professional associations, clinicians, patient advocates and others. NIBS issued the “Indoor Environmental Quality Project Report” (www.access-board.gov/research/ieq) which focuses on making public and commercial buildings healthier for everyone and more accessible for people with chemical and electrical sensitivities. This report is referenced in the recently released ASHRAE Indoor Air Quality Guide.

    I recommend rewriting p. 11, ll. 519-20 citing the NIBS report and including it in the references.

    Page 11, lines 519-20: “Indoor air quality [or indoor environmental quality] is affected by building design and construction; materials and furnishings; operations and maintenance products and practices including selection of cleaning agents and the use of scented products; and activities and personal care products of building occupants.” (NIBS, 2006.)

    I recommend an addition to p. 11, l. 499: “underlying respiratory, cardiovascular, and neurological diseases.”

    I recommend that the definition of “Community” p. 33, ll.1561-2 be broaden either by removing the reference to “living together” or expanding the definition of community to include individuals with commonality in “health or disability status” as in the Serving Communities Work Group Report, p. 3-4, ll. 138-141. A “community” can consist of individuals who have experienced a common exposure event such as Gulf War Veterans or those affected by the World Trade Center disaster. People with chemical intolerances rarely live in a geographical community but are clearly a “community” in the context of this paper.

    I’ve noticed the frequent use of “green”, “greener”, or “Green Chemistry” in this report. Because “green” can be ambiguous, perhaps it would be more accurate to refer to “healthier” or “safer” or “less toxic” or “no VOC, even for naturally occurring substances” depending on the reference. Many products marketed as “green” such as citrus or pine-scented cleaning agents are not healthier, safer or less toxic.

  7. Nancy Evans

    PLEASE NOTE: These comments were prepared in collaboration with Cindy Sage, Sage Associates, Santa Barbara, CA. sage@silcom.com

    The National Conversation on Public Health and Chemical Exposures needs to acknowledge that non-chemical environmental agents such as radiation, particularly non-ionizing radiation, called electromagnetic fields (EMF) can intensify the toxic effects of chemical exposures.

    A substantial body of evidence suggests that electromagnetic radiation (EMF) can potentiate the effects of chemical toxins and therefore needs to be considered in monitoring environmental exposure and in achieving a more complete understanding of chemicals and their health effects. For example, nursing staff and other healthcare workers may experience multiple, harmful exposures (chemicals, heavy metals, other toxicants) in combination with EMF exposures as wireless technologies proliferate in the healthcare environment. In a meta-analysis of 65 studies, Juutilainen et al (2006) reported that the combined effects of toxic agents and ELF magnetic fields enhanced toxic effects as compared to the toxic chemical exposure alone. Overall results showed that 91% of the in vivo studies and 68% of the in vitro studies had worse outcomes (were positive for changes indicating synergistic damage) with ELF exposure in combination with toxic agents. The percentage of 65 studies with positive effects was highest when the EMF exposure preceded the chemical exposure.

    Juutilainen J, Kumlin T, Naarala J. (2006). Do extremely low frequency magnetic fields enhance the effects of environmental carcinogens? A meta-analysis of experimental studies. International Journal of Radiation Biology 82:1-12.

    The Scientific Understanding Working Group report states (lines 92-93) “Chemicals are ubiquitous in our society; they are dispersed throughout our environment, in our water, air, soil, and food.” Electromagnetic radiation also is ubiquitous in our society, and arguably a more pervasive chronic exposure than many chemicals. The dramatic increase in the deployment of wireless technologies and the infrastructure that supports them has intensified the electromagnetic environment exponentially.

    The National Research Council has called for EPA to [lines 609-616] “develop databases and default approaches to allow for incorporation of key non-chemical stressors in cumulative risk assessments in the absence of population-specific data, considering exposure patterns, contributions to relevant background processes and interactions with chemical stressors.” EMF is a non-chemical stressor that interacts with chemical stressors.

    The Scientific Understanding work group recommendations are aimed at [lines 63-65] “gaining a better understanding of variations in individual susceptibility, factors that increase the vulnerabilities of certain communities, and the impact of low-dose, multiple, and cumulative chemical exposures, including exposures to naturally occurring toxins.” EMF is a major source of low-dose, multiple and chronic exposures.

    The Scientific Understanding report also [lines 224-227] points out the need for “further research into the connection between chemical exposures andmultiple health outcomes (including neurobehavioral, developmental and reproductive endpoints.” In other words, cancer should not be the only criterion for toxicity, and this also is true of EMF.

  8. Barbara Rubin

    To Whom it May Concern,

    I only received word last night of this project and that comments were due by five o’clock this afternoon. As there remains only one hour now before I can send you comments, please forgive this generic submission. Some of theses issues are crucial to the American health care system already stretched to the point of collapse as nearly a third of American adults (to age 64) and a quarter of our children are demonstrating chronic health conditions and disabilities. Our soaring rate of developmental disabilities which now affects one in six children according to Dr. Phillip Landrigan of the Mt. Sinai Hospital Center in NYC, is a good measure of our need for better management of chemicals.

    I am a clinician and special educator who was disabled with permanent central nervous system and metabolic damage at the age of 45, by toxic chemicals used in a school setting. I became a whistle-blower through calling in the EPA to investigate misuse of pesticides and began a decade of learning about your areas of study. I hope my discoveries regarding the large gaps in public policy will be of use. Please let me know if I can offer further detail of these major points to you after your deadline. My mild aphasia and acquired ADD as a result of pesticide poisoning does not make this an efficient process.

    1.Education: Citizens are generally referred to as consumers in this country. This has allowed us to become confused regarding a citizen’s right to safe drinking water, an unadulterated food supply, and clean air in our enclosed living and working spaces. Instead we are approached only in our role as good customers for the industry best able to advertise a quick answer to any of our needs. As we see in the larger economic picture, buying cheaper and more readily obtained products and services (e.g. construction, pest control, laundry services) can result in a far more costly cascade of events such the lost productivity and school attendance of children and adults suffering with asthma; reduction in achievements by children suffering losses of intellectual potential from lead, mercury, neuro-toxic pesticides; loss of a strong consumer base as disabled workers and those following the downward spiral to that end point (one third of the workforce) cannot use their discretionary income for anything but health care services. Citizens need to become more familiar with chemicals and that can only be done by altering a public policy which endorses ignorance. In fact, we are not permitted in may locales to know in advance when toxic chemicals will be introduced into our lives by employers, landlords and school administrators. Congress has yet to release the School Environment Protection Act from committee which would have mandated my advance notice of pesticide applications and possibly saved my health and career when such notice was denied me. Vendors selling toxic products are ignorant of their ingredients and hazards while proprietary formulas are permitted, eradicating freedom of choice on the basis of health related standards. Education in all subjects is, well, subject to public policy as follows.

    2.Public Policy:
    a) Full disclosure of ingredients in all products: Since patents protect industry formulas and exact proportions of ingredients are not released to the general public, mandates of full disclosure for 100% of a product’s contents is essential. Capitalism is a trickle up policy by which consumers control the marketplace according to demand. One cannot demand the best quality products when secrecy makes knowledge of what constitutes “best” from the process.
    b) Full disclosure (non-punitive) of all applications of toxic chemicals. Staff and parents need to know when schools are receiving insecticidal treatments. Communities ought to be able to go to the clerk’s office and know what is in use in farm fields so they can decide if living in a particular location is a good choice for themselves and their children. The EPA does not receive notice of farmer’s use of herbicides and pesticides which do not require a license to obtain. Numerous studies show drift is a serious issue for many miles in farming communities and has been seen to cause changes in central nervous system functions.

    c) Oversight of chemical use has long been a source of conflict of interest. The department of agriculture is intensely involved with a very specialized industry. Their involvement in the management and enforcement of pesticide laws (FIFRA) in our residential and non-farming industry practices is entirely inappropriate. People are not crops and the use of agricultural chemicals indoors completely alters their actions and efficacy as well as endangering a large group of non-targeted living beings. In schools, hospitals, and nursing homes that means our most vulnerable populations are exposed to chemicals which are not only going to act upon them differentially than healthy adult males (current reference group) but also interact with medications being taken (particularly cholinergically active medications) for a wide variety of normal developmental and abnormal health conditions. A body of scientists and citizens ought to be reviewing the use of industrial chemicals in non-industry settings. SEPA has not passed because the House Agriculture committee will never approve such measures. Notice of applications and restrictions in the class of chemicals applied in schools is counter to the wishes of agribusiness.

    3. Bio-monitoring: Recognition of chemically induced illness is very poor for a variety of reasons. This can only be overcome by increasing the ease of bio-monitoring for components in indoor air and of blood/urine metabolites for commonly encountered chemicals. As of this moment, there are no laboratories in the US which assess metabolites of the most commonly used pesticides in this country – pyrethroids and DEET. The fact that older use pesticides became regulated (and a number banned) as bio-monitoring for them became more accessible, one can only suppose such an absence of testing for pesticides, hormones and certain solvents are intentional. The CDC looked at 3,000 individuals in 2002 and found 70% of them positive for metabolites of current use pesticides. Yet they were unable to provide me with any lab facilities capable of measuring it in the population today.

    4. Enforcement: I have received two death threats in the past 13 months and had my residences and car sprayed with pesticides. Not one agency in this nation actually gets involved in crimes using common chemicals including Homeland Security, the EPA, FEMA or the CDC despite all groups being notified. They referred me to the local police who referred me back to them. Someone must take responsibility and quickly for investigating the misuse of chemicals for gain (I am a litigant and advocate for safer use of chemicals). I may not live to see my litigation to completion and have no recourse whatsoever.

    Specific to the scientific understanding group- poisons are only recognized by the public and many of our regulatory agencies for frank damage to organs or particular systems. As poisoning is also an applicable term to anything which impairs the ability of a catalyst to function means we need to be looking lower down in the chain of events. I suffered a gene mutation which impaired sulfation/methylation abilities which will significantly shorten my life-span and vulnerability to further chemical damage. I hope this type of research will increase.

    Barbara Rubin
    44489 Town Center Way 117
    Palm Desert, Ca 92260

  9. Elise Pechter

    Please forgive limited comments from a limited review. I was encouraged to look at the draft document for scientific understanding, after a brief review of the policies and practices report. Absent from the scientific understanding document is the appreciation of the workplace as a source of exposure and rich literature about the consequences of exposure. Occupational studies provide, unfortunately, the information about higher level exposures. Workers often serve as the guinea pigs for community based exposures. At best, these occupational studies evaluate sentinel health events and sentinel surveillance findings serve as a crucial piece of the scientific story about the harm chemicals can do.

    While arguing for a precautionary approach, the scientific understanding section also notes the inability to link community health outcomes to exposures to multiple low level chemicals. Occupational studies provide data about health effects linked to exposure.

    Nor does the report call for an end to proprietary protection that absolves companies of disclosing ingredients and findings. The report also absolves manufacturers of the responsibility for testing their chemicals prior to use. The burden for testing is all on government agencies, which allows the manufacturers to produce without precaution.
    I would like to see the incorporation of worker protection and occupational literature into overal scientific understanding of the impact of chemicals on human health.

  10. Mary S. Rivkin

    UMBC

    As a professor of early childhood education, I am profoundly concerned about the impact of chemicals on children. In child care settings, in schools, and in homes safety is the highest priority. “Precaution” is the watchword. It is imperative that the chemical environment conform to the overall standard of care. Accordingly, I wholeheartedly support the Draft Report in its making

    Recommendation 9. Develop scientific criteria for the application of the precautionary approach, in order to better protect human health and the environment (p.20)

    The history of regulation in the US makes apparent the difficulty of implementing the precautionary principle but ht experience of the European Union and the many regulatory, judicial, and scholarly proceedings provide guidance to such implementation. The need for the precautionary approach is urgent-indeed, with rising rates of autism, allergies, autoimmune diseases, and endocrine disruption in our children, all of us are truly “endangered species.”

    The Work Group should sustain and strengthen this recommendation.
    [file]http://resolv.org/site-nationalconversation/files/2011/02/Mary Rivkin – Comment-scan of original fax.pdf[/file]

  11. Claire Schlaff

    White Lake Area Cancer Mapping Project

    Our community, which is one of the Great Lakes Areas of Concern, is in the process of conducting a cancer mapping project. We are including anyone who has had cancer, who was born in 1910 or later, and who has ever lived or worked in the White Lake area (which consists of two small cities and four townships). We are asking participants for their diagnosis, the year they were diagnosed, their addresses while living in the area, what years they lived at each address, their workplaces, what years they worked at each workplace, and what their jobs were while working there. We have approximately 1,000 names on our list and have completed all the information we need for about 330 of them. We gather the information through phone interviews and email. We have found that people are eager to participate. They want to tell their stories. When we, the volunteers, have finished gathering the data we will present it to the epidemiologist at the health department for interpretation and mapping. She will be looking to see if there are any clusters, especially of any rare cancers.

    The point I would like to make in submitting this comment is that if health facilities gathered demographic information, including past addresses and workplaces, about patients when they were diagnosed with cancer, our cancer mapping project would have been unnecessary.

    My son died at the age of 35 in December 2008 from Ewing’s Sarcoma. During his 2 1/2 years of treatment at two major medical facilities, no one ever asked him any questions about his possible exposures to toxins. They had his home address in Manistee MI, but they didn’t know that he grew up in Montague MI, home of Hooker Chemical Co. and Dupont, and across the lake from a tannery and Howmet Corporation. They wouldn’t know if there were others with Ewing’s Sarcoma who had grown up in the White Lake area. How will researchers ever determine the cause of this (or any) rare cancer if they don’t have information about each person’s possible exposures to toxins?

    One thing I have learned while doing our cancer mapping project is that people want to share this information. They want someone to ask them these questions because they want to think that someone is going to look at this data and attempt to prevent this disease. They want to participate in sharing and prevention because they want their suffering to count for something.

  12. Stephanie Wozniak

    My general comment after briefly reviewing all of the draft reports and hearing that our nation has been officially declared the “fattest” nation on earth is this: clearly I believe the overwhelming presence of persistent, bio-accumulative, toxic, carcinogenic, mutagenic, reproductive system damaging and endocrine disruptive chemicals in our food supply, air, water and homes has made us not only the fattest, but also the most depressed, medicated, lethargic, apathetic and generally unhealthy people who are most likely to become extinct by our own actions and arrogance.

    I would like to say that without a doubt one of the most important decisions our nations leaders and scientists and industry leaders can make is to stop poisoning the population and the environment with wood preservatives and other known dangerous pesticides.

    Please see attachment for complete fax submission and work group specific comments.
    [file]http://resolv.org/site-nationalconversation/files/2011/02/Stephanie Wozniak – Scientific Understanding.pdf[/file]

  13. Rick Becker

    American Chemistry Council

    General Comments

    The National Conversation’s draft workgroup recommendations represent a good first step in increasing the dialog with the public health community about the important issue of public health and chemical exposures. The diversity of topics covered in the Conversation is extensive. Work Group members should be commended for expending so much time and effort addressing issues ranging from regulation of chemicals in commerce under the Toxic Substances Control Act to assessment of Superfund sites, consideration of environmental justice concerns, and chemical security issues.

    That said, ACC was disappointed with many of the process aspects of the National Conversation. It was never exactly clear for whom the recommendations were being developed, and for what purpose. It was never clear how the Leadership Council was supposed to treat the recommendations of the work groups. In retrospect, we think the National Conversation would have been more productive if it had been organized as a Federal Advisory Committee because that format would have provided greater discipline to the process. The process issues made it difficult for our organization to contribute to the Conversation in a comprehensive way.

    In addition, some of the specific draft action recommendations of the work groups reveal major gaps in understanding what information is already available on chemicals today, how chemicals are regulated and managed under a myriad of federal and state laws, the science of risk assessment and toxicology, the complexity of the chemical value chain, and the practical considerations that must be taken into account when regulating chemicals in commerce. ACC supports modernization of the Toxics Substances Control Act (TSCA). As we are certain the Working Groups understand, TSCA is a very complex issue and modernizing the statute is not a simple prospect. Not all of the recommendations of the work groups relate to TSCA modifications, but several reflect a basic lack of understanding of many of the complexities of chemical regulation. These comments do not address every recommendation, but our comments focus on ACC’s broader concerns about some of the work groups’ recommendations.

    Comments on the Scientific Understanding Work Group Report

    1. Discussion of the HPV program has been omitted from the Report
    The discussion of “Current Status” fails to include any mention of EPA’s or OECD’s High Production Volume (HPV) programs. Although the report cites the EPA 1998 finding of lack of data for HPV chemicals, it ignores the substantial effort EPA and industry made to implement the High Production Volume Challenge program. By failing to include a discussion of the HPV program, the report appears to be at best uninformed, and at worst, highly biased. The HPV program is well documented on EPA’s internet site. It is puzzling why the report included no mention at all of the data and information collected as a result of the HPV program. This major omission makes light of the substantial effort by US EPA and industry to bring forward and provide to the public hazard information on a substantial number of chemicals in U.S. commerce.
    The results of the HPV program have been summarized by EPA in a 2004 publication that is also publicly available on the EPA web site at http://www.epa.gov/hpv/pubs/general/hpvreport.pdf. In this report, EPA concludes:

    “In conclusion, EPA is very pleased with the overwhelming response from companies and consortia to the HPV Challenge Program. The extraordinary response to the Program has resulted in a tremendous amount of sponsor-submitted test plan / summary data being made publicly available. More than 400 companies and 100 consortia have sponsored over 2200 chemicals in the Program. In addition to the 851 chemicals sponsored indirectly through the ICCA HPV Initiative, 353 test plans have been submitted for 1,266 (92%) of the 1,371 chemicals sponsored directly in the HPV Challenge Program.”

    “The majority of the test information that addresses the SIDS endpoints was comprised of unpublished, existing data, which because of the HPV Challenge Program has now been made publicly available. In addition, category approaches and SAR techniques have been applied to extend the available data to other related chemicals, thereby reducing the need for new testing. The Agency has developed a strategy to address those from the original list of approximately 2800 chemicals that have either not been sponsored or have been sponsored but submission of test plans / data summaries are currently overdue. This strategy, plus efforts to develop the HPVIS while working with other governments in developing the Global HPV Portal, will help ensure that more data are accessible in the U.S. and internationally.”

    Furthermore, in a paper published in 2008, Plunkett and Becker[1] reported that as of August 2007, study summaries and other relevant information covering a total of 1,399 HPV Challenge chemicals had been submitted. This hazard information covers a range of endpoints, including studies assessing acute toxicity, subchronic toxicity, genotoxicity, and developmental and reproductive toxicity (the same set of hazard information for human health hazard assessment required international agreement of 30 nations under the OECD SIDS program). Nearly all of these approximately 1400 HPV chemicals had sufficient hazard information for each hazard endpoint; ranging from 92.4% for reproduction and developmental (combined) toxicity studies to 98.6% for acute toxicity studies.

    2. The recommendation to “fill data gaps” seems to suggest the need for a comprehensive toxicological data set for all chemicals, irrespective of volume of manufacture, uses in closed systems, and exposure potential.
    The Report recommends that “EPA and other regulatory agencies should identify a targeted data set for all chemicals.” It is unclear what this “targeted data set” is. The report does not mention or acknowledge the fact that both EPA and OECD have already identified such a “targeted data set” for HPV chemicals – the Screening Information Data Set (SIDS)[2]. The SIDS data set is:
    • Chemical Identity (CAS Number(s), Name (OECD name(s)), CAS Descriptor (Only required for inorganic chemicals), Structural Formula and Composition of the chemical(s) being assessed
    • Quantity (estimated production and/or import volume)
    • Use Pattern (categories and types of use)
    • Sources of Exposure
    • Physical-Chemical Properties (Melting Point, Boiling Point, Relative Density, Vapor Pressure, Partition Co-efficient: n-Octanol/Water, Water Solubility, Dissociation Constant (for substances normally capable of dissociation), Oxidation-reduction Potential)
    • Environmental Fate (Photodegradation, Stability in Water, Transport and Distribution between Environmental Compartments (including distribution pathways including Henry’s Law constant, aerosolisation, volatilisation, soil adsorption and desorption), Aerobic biodegradability)
    • Environmental Toxicology (Acute Toxicity to Fish, Acute Toxicity to Daphnia, Toxicity to Algae, Chronic Toxicity (necessity determined based on physical chemical properties of the chemical)
    • Mammalian Toxicology (Acute Toxicity (either by oral route, dermal route or inhalation; required only on the most relevant route of exposure), Repeated Dose Toxicity, Genetic Toxicity, Reproductive Toxicity (requires data to assess fertility and developmental toxicity) Experience with Human Exposure (if available).

    Furthermore, the Report uses the term “data gap” but falls well short in understanding and communicating that a “data gap” is not always a “data need.” EPA has publicly stated that it is important to make such distinctions[3].

    A hazard “data gap” is not necessarily a “data need” with respect to characterizing potential risks. A “data gap” indicates information that is lacking, and can refer to data, analyses or presentation. Most importantly, every “data gap” is not a “data need.”
    “Data needs” are those specific “data gaps” requiring additional work before potential risks can be adequately characterized. Devoting resources to toxicity “data gaps” irrespective of whether the specific information is actually needed (that is, data or information which is viewed as necessary to characterize risks with an adequate degree of scientific certainty), would be scientifically unjustifiable, require unnecessary animal testing and would impose unwarranted costs. Many substances can be adequately characterized with respect to potential hazards and risk to humans by use of a tiered testing and assessment framework, comprised of appropriate studies examining key endpoints and life stages, coupled with biologically-based decision criteria and exposure assessments.

    A single, “one size fits all” inflexible battery of tests with a specific checklist of studies does not fit all chemicals. Chemicals differ in physical/chemical characteristics and in many other ways that influence toxicity and risk. In particular, certain substances such as pesticides and pharmaceuticals are designed or developed to induce biological activity, while commodity chemicals and pesticide inert ingredients, with some exceptions, are generally not intended to have that characteristic.[4]

    Since risk is a function of both inherent toxicity and exposure, production processes and use patterns that influence exposure will ultimately influence potential risks to human health. Any single mandated battery of tests beyond the screening tier (e.g., OECD SIDS for HPV chemicals) would not permit flexibility to set rational testing priorities based on anticipated toxicity and exposure potential.

    3. The recommendation for improvement of databases and data dissemination makes no mention of the existing internet portals that provide free and fully public access to chemical hazard information. This failure to cite existing databases is perplexing. Indeed, the failure has lead ACC to wonder whether the review of existing resources conducted by the drafters was adequate. At a minimum, the failure suggests that an additional review of existing web-based databases should be undertaken before the Report’s recommendations on databases are made final. There is no need to duplicate on-going activities unless critical shortcomings in the current activities are identified.

    Examples of existing resources not cited in the Report include the National Library of Medicine’s (NLM) TOXNET, the NLM Environmental Health and Toxicology web site, EPA’s High Production Volume Information System (HPVIS) and the OECD eChemPortal.
    The National Library of Medicine’s TOXNET[5] is a fairly comprehensive collection of databases on toxicology, hazardous chemicals, environmental health, and toxic releases. The TOXNET program provides ready access via the internet at no charge to the following databases: HSDB®, IRIS, ITER, LactMed, TOXLINE®, TOXMAP®, TRI, ChemIDplus®, CCRIS, CPDB, DART®, GENE-TOX and Haz-Map® and the Household Products Database.

    The NLM Environmental Health and Toxicology web site also has a portal[6] that includes access to databases which focus on “Chemicals and Drugs,” “Diseases and the Environment,” “Environmental Health,” “Occupational Safety and Health,” “Poisoning,” “Risk Assessment and Regulations,” “Toxicology,” and “Pesticide Exposure.”

    The EPA HPVIS[7] is a database that provides access to health and environmental effects information obtained as part of the HPV Challenge program. The HPVIS contains data on up to 50 endpoints per substance organized into 1) Physical/chemical properties (e.g., melting point, vapor pressure); 2) Environmental fate and pathways (e.g., biodegradation, stability in soil); 3) Ecotoxicity (e.g., fish toxicity, toxicity to aquatic plants); and 4) Mammalian health effects (e.g., reproductive toxicity, developmental toxicity).

    The OECD eChemPortal[8] includes access to the following databases: ACToR, CESAR, CHRIP, EnviChem, ESIS, GHS-J, HPVIS, HSDB, HSNO CCID, INCHEM, JECDB, NICNAS PEC, OECD HPV, SIDS UNEP, UK CCRMP Outputs, US EPA IRIS, US EPA SRS. These are databases that include contributions from the U.S., Japan, Europe, United Kingdom, New Zealand, the World Health Organization, Australia, and the OECD.

    4. Improving Risk Assessment (Recommendation #9 and 11)
    The discussion of the concepts of incorporating a “precautionary approach” seems to miss the point that risk assessment, as currently practiced by federal agencies, has been specifically designed and implemented to be “precautionary” and to protect public health. The citation to the “Wingspread” definition (developed by a small group of non-governmental public interest groups)_and the failure to cite the United Nation’s Rio Declaration definition suggests that this section of the report is not reporting a mainstream or unbiased reference. In any case, the Report should include the full definition contained in the UN Rio Declaration on Environment and Development [9]:

    “In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation. “

    The Report does not recognize that EPA risks assessments are purposely designed so as not to underestimate potential health risks.

    “EPA risk assessments tend towards protecting public and environmental health by preferring an approach that does not underestimate risk in the face of uncertainty and variability. In other words, EPA seeks to adequately protect public and environmental health by ensuring that risk is not likely to be underestimated.”[10]

    In short, the report should acknowledge that EPA’s current practice is to overestimate risk through the application of multiple conservative assumptions that produce a high margin of safety in risk assessments.

    The Report seems to put forward the premise that more efforts should be devoted to a “precautionary approach.” In statements such as “the lack of toxicity data is often misunderstood as evidence of safety” the Report seems to completely ignore the fact that in the current practice of risk assessment, the lack of toxicity data is indeed addressed. For example, a database uncertainty factor[11] is routinely used by EPA[12] to address inadequate or incomplete toxicity datasets.

    By failing to acknowledge these fundamental practices of current regulatory risk assessments, the Report falls well short of an objective and unbiased review.

    There is certainly a need for risk assessment to be improved as new knowledge is obtained and new methods are developed and validated. However, it would be premature to have regulatory agencies blindly follow some of the recommendations put forward by the authors of the NRC report “Science and Decisions.” In particular the NRC report recommendation to assume low-dose linearity for quantitative risk assessment of systemic toxicities remains far from settled science.

    Currently, the existing regulatory approach for assessing risks for food additives, chemicals, pesticides and pharmaceuticals in U.S. agencies all follow a similar approach. In each case, for systemic toxicity the agencies assume that there are threshold exposure levels or doses of an agent above which toxicity or adverse health effects can occur, and below which toxicity or adverse health effects are unlikely. Regulatory risk assessments typically use health-protective approaches to develop exposure guidelines for systemic toxic effects in order to assure that human exposures are controlled to levels that will not lead to adverse health outcomes. For example, EPA follows this approach in setting Reference Doses[13] for systemic toxicities. These Reference Doses are defined as

    [a]n estimate of a daily oral exposure for a given duration to the human population (including susceptible subgroups) that is likely to be without an appreciable risk of adverse health effects over a lifetime. It is derived from a BMDL, a NOAEL, a LOAEL, or another suitable point of departure, with uncertainty/variability factors applied to reflect limitations of the data used.

    The approach for systemic toxicity risk assessment recommended by the authors of the NRC’s Science and Decisions report departs from the standard practice of using a threshold risk assessment approach for non-cancer toxic effects. Instead, a low-dose linear or non-threshold approach is advocated in the Science and Decisions report. This recommendation differs substantially with the decades of experience in observing exposure-response relationships in pharmacology and toxicology. The universality, or lack thereof, of assuming a low-dose linear extrapolation model for risk assessment of non-cancer chemical exposures at environmentally relevant concentrations remains to be shown. The examples cited by the authors of the Science and Decisions report were quite limited in both scope and breadth, and further examples and greater discourse by more scientists in the toxicology and risk assessment profession are warranted before such a recommendation is adopted and put into regulatory practice.

    [1] Laura Plunkett and Richard A. Becker, 2008. Does The Standard Toxicological Testing Paradigm for Industrial Chemicals Apply to Screening for Children’s Health Risks? The Open Toxicology Journal 2: 42-60.

    [2] http://www.oecd.org/dataoecd/60/43/1947477.pdf

    [3] http://www.epa.gov/fedrgstr/EPA-TOX/2008/June/Day-27/t14528.htm

    [4] USEPA, 2002. Guidance document on methodology for determining the data needed and the types of assessments necessary to make FFDCA Section 408 safety determinations for lower toxicity pesticide chemicals. Washington DC.

    [5] http://toxnet.nlm.nih.gov/

    [6] http://sis.nlm.nih.gov/enviro.html

    [7] http://www.epa.gov/hpvis/

    [8] http://webnet3.oecd.org/echemportal/

    [9] http://www.unep.org/Documents.Multilingual/Default.asp?documentid=78&articleid=1163

    [10] http://www.epa.gov/osa/pdfs/ratf-final.pdf

    [11] http://www.tera.org/publications/UF%20in%20Noncancer.pdf

    [12] http://www.epa.gov/pesticides/trac/science/determ.pdf

    [13] http://www.epa.gov/iris/rfd.htm

  14. Nsedu Witherspoon

    Children's Environmental Health Network

    Scientific Understanding:

    The Network was disappointed that no recommendation focuses on children, especially since a subsection of recommendations were developed “to gain a better understanding of variations in individual susceptibility, factors that increase the vulnerability of certain communities, and the impacts of low-dose, multiple, and cumulative chemical exposures, including exposures to naturally occurring toxins (e.g., mold and mycotoxins)” (p. 12)

    The Network urges supports the specific inclusion of this recommendation: “identify and define children’s unique vulnerabilities, susceptibilities and exposures.” If children and developmental stages are not considered, our “better understanding” will be severely limited and we cannot be assured that we are protecting children.

    Other comments:

    *The Network supports the mention and discussion of the precautionary approach and the recommendation calling for developing criteria for its application.

    *The Network supports the acknowledgement of the need to protect children and other vulnerable populations in various mentions in this report, such as:
    -”In the medium term, EPA should develop a prioritization method focused on chemical safety and health, with special emphasis on sensitive subpopulations. “ (p. 6)
    -One of the “Desired outcomes and implementation” (p. 9) is “Develop approaches that allow for the evaluation of susceptible subpopulations.”
    -Recognition of “growing concern over prenatal exposures and exposures to children, adults, pregnant women and the elderly” (p. 11)

    *On p. 3 (4 in pdf), the report says:
    “The challenge lies in coordinating observations within a community of exposures and health effects, identifying a chemical’s potential for toxicity, understanding the impacts of multiple and cumulative chemical exposures, developing test methods that will detect more subtle adverse effects or populations that may be more susceptible, translating such effects back to the human, acting upon that information for assessing risk, and communicating potential hazards to the community for action. “

    The Network believes that “the challenge” is to protect the health of our most vulnerable. Doing so includes the steps listed above, as well as taking health-protective actions in the absence of knowledge. We urge the paragraph to be changed to read:

    “The challenge lies in protecting our health and our environment, beginning with protecting our most vulnerable populations, including children. Steps to do so include: coordinating observations within a community of exposures and health effects, identifying a chemical’s potential for toxicity, understanding the impacts of multiple and cumulative chemical exposures, developing test methods that will detect more subtle adverse effects or populations that may be more susceptible, translating such effects back to the human, acting upon that information for assessing risk, communicating potential hazards to the community for action, and acting with caution to protect health. “

    *On p. 7, the report states: “At a minimum, manufacturers should provide a targeted set of information on the acute and chronic effects of the chemical necessary for a robust assessment of that chemical’s risk, which could include profiles for persistence/bio-accumulation/toxicity (PBT), carcinogenic/mutagenic/reproductive (CMR) effects and endocrine disruption, as necessary.”

    The Network urges that information on developmental effects, especially neurodevelopmental effects, be required. Studies conducted on mature systems will not necessarily capture impacts on developing systems.

    * In the “Recommendations to achieve a more complete understanding of chemicals and their health effects,” proposed roles are listed for a variety of government entities. The Network urges that entities with pediatric health expertise be included in these efforts, especially the activities under Executive Order 13045 on children’s environmental health and safety and the interagency task force it created.

  15. Barbara Warren

    Executive Director

    See attached Letter and Comments.
    [file]http://resolv.org/site-nationalconversation/files/2011/02/Scientific Understanding Workgroup Comments.docx.doc[/file]

  16. Mary Lamielle

    National Center for Environmental Health Strategies

    I would like to expand on my previous comment # 6 above which recommended in part rewriting the sentence at p. 11, ll. 519-20: “Indoor air quality [or indoor environmental quality] is affected by building design and construction; materials and furnishings; operations and maintenance products and practices including selection of cleaning agents and the use of scented products; and activities and personal care products of building occupants.” (NIBS, 2006.) I would recommend adding the following: “ Fragrances and fragranced products are significant indoor pollutants which have been linked to a myriad of health problems including chemical sensitivities, asthma, allergies, migraines, seizures, sinus infection, and bronchitis. Researchers should examine issues of individual susceptibility, the availability of safer, less toxic alternatives, and the need for full disclosure and labeling for ingredients that make up the mixtures that constitute individual fragrances or fragrance in a fragranced product whether it be an air freshener, deodorizer, cleaning agent, or similar item.” The number of individuals reporting mild to debilitating reactions to scents and scented products is substantial. The EEOC’s proposed rulemaking on the ADA Amendments Act of 2009 included (A) Example 1: An individual with asthma who is substantially limited in respiratory functions and breathing compared to most people, as indicated by the effects experienced when exposed to substances such as cleaning products, PERFUMES, and cigarette smoke. I would recommend that the Scientific Understanding and the Policies and Programs Work Group Reports and most importantly the Leadership Council encourage the CDC and other federal agencies as appropriate to promulgate CDC’s Fragrance-Free Policy across federal agencies and in the private sector to promote and protect the public health. (I had hoped to attach the CDC Indoor Environmental Quality Policy which includes the Fragrance-Free Policy but was not able to do so. Please contact me if you need a copy: (856)816-8820 or marylamielle@ncehs.org)

  17. Mari Eggers

    Crow Environmental Health Steering Committee

    The attached commentary is from our Steering Committee, composed of health and environmental professionals and cultural experts, all Crow Tribal members, from the Crow Reservation, in southcentral Montana. We compiled our responses to several reports into one document (not realizing this format for comments). Please see page 1 for a list of our members, and pages 6-8 for some comments on your work group’s report, which we thought was excellent. Thank you.
    [file]http://resolv.org/site-nationalconversation/files/2011/02/Community conversation summary.ppt[/file]
    File: CumminsEtAl_2010_CBPR_In_Indian_Country.pdf

  18. Diane VanDe Hei

    Association of Metropolitan Water Agencies

    Scientific Understanding Comments

    The Association of Metropolitan Water Agencies (AMWA) appreciates the opportunity to submit comment on the Scientific Understanding work group draft report. AMWA is an organization of the largest publicly owned drinking water systems in the United States. AMWA’s membership serves more than 130 million Americans with drinking water from Alaska to Puerto Rico.

    AMWA is the nation’s only policy-making organization solely for metropolitan drinking water suppliers. Member representatives to AMWA are the general managers and CEOs of these large water systems.

    The workgroup tasked with drafting the National Conversation on Public Health and Chemical Exposure section on “Scientific Understanding” identified several areas in which research is needed to inform public policy. The timing of this document is fortuitous because it comes at a time when EPA has engaged drinking water stakeholders in a national dialog about how to approach regulating drinking water contaminants by groups. The workgroup report is timely that the workgroup has identified exposure to multiple contaminants as a significant issue with numerous unresolved issues.

    We would hope that CDC and ASTRR continues to embrace the core values outlined by the current administration by dedicating and allocating the resources needed to address the numerous recommendations made by the workgroup. We would also hope that the recommendations from this workgroup are communicated with EPA as it affects the development and direction of public policy in drinking water.

    Specific Comments:
    1. Just as the workgroup points out that it is difficult to separate “scientific understanding” from “policies and practice,” it is equally difficult to separate “education and communication” from these topics. The ability to communicate the findings of science is key to “gaining community trust for government actions” or trust in the government development of public policy. Without the ability to clearly communicate, the strength the workgroup identifies in the risk assessment process and transparency will not be recognized. Some acknowledgement of this linkage would be useful in tying these three topics together.
    2. Recommend that the section in line 204-211 also mention the Safe Drinking Water Act (SDWA) established 1974, amended in 1986, and 1996, which gives EPA the authority to regulate contaminants found in drinking water.
    3. Lines 120 to 128 cover the issue of lead and mercury, but the bulk of the paragraph text pertains to lead specifically, although some of the discussion could be extrapolated to mercury.
    4. In Line 426 the term “validated” is used. A more thorough definition of what the workgroup means by this term would be useful. Does this mean establishing performance criteria for test precision and accuracy so alternative analytical techniques might be developed? Does this mean establishing minimum statistical power requirements to ensure the rigor of comparisons? Does this include establishing limits of detection and limits of quantitation?
    5. In line 223 the term “minimize” is used. To the general public this might mean “0” as in no consequences. We think that the interface of scientific understanding and public policy and practice needs to be “balanced” or the economic consequences could be severe. The balancing point need not be the same in all cases, but it needs to account for more than just science and minimum consequence. Society and the government agencies will have to weigh not only the health benefits of protecting society, with the benefits gained by the manufacture and use of the chemical(s) in question.
    6. We also agree with the workgroup comments (lines 351 to 358) regarding the collection of data and the establishment of databases. This problem was illustrated in the recent economic analysis conducted for the revisions of the Total Coliform Rule (TCR) under the SDWA. Although water utilities submit all compliance data to the states, the EPA only has “exceptions” data in their database, but not for all 50 states. The economic analysis and projection of economic and public health benefits is really a hypothesis, which, unless the proper metrics and data collection systems are in place, is never proven (or disproven) for veracity.
    7. We agree with recommendation 12, but believe it applies to regulatory programs other than just RCRA. There have been numerous “assumptions” made in the development of public policy that are practiced today without really knowing if they were correct (see previous comment regarding the Economic Analysis for the revised TCR under the SDWA). Before moving forward these past assumptions should be checked and verified to ensure that future public policy has a foundation in reality.

  19. Pamela Schnepper

    Dose Environmental

    I’d like to applaud ATSDR for recognizing the need for this effort, and for the manor with which it has been conducted thus far.

    In regard to Recommendation 8 (page 17), I support ATSDR’s open approach to improve the scientific basis of the Public Health Assessment (PHA) process. I think it is helpful to reiterate that the ATSDR PHA was developed as a screening tool to assist allocation of limited federal resources to existing Superfund sites. The PHA process is glaringly simplified in comparison to the chemical health risk assessment methodology utilized by EPA for chemical regulation.

    In my opinion, the PHA presents a danger to community trust in that environmental risk managers may make decisions based on the outcome of a PHA, as if a comprehensive chemical health risk analysis was performed. Chemical risk managers may inappropriately use the outcome of a PHA to demonstrate that they have satisfied their obligation to protect public health. A PHA is not a “mini” health risk assessment, but a screening level assessment. I would like to see ATSDR work to incorporate EPA health risk assessment methodology into the PHA process.

    Thank you for the opportunity to comment.

    Pamela Wadman Schnepper, MS
    Senior Toxicologist
    DoseEnvironmental.com

  20. Kathy Curtis

    Oregon Toxics Alliance...

    Oregon Toxics Alliance, Northwest Indiana Toxics Action Project, Alliance of Nurses for Healthy Environments, Alaska Community Action on Toxics, University of Alabama Hospital Highlands, Oregon Environmental Council, Clean New York, Environmental Health Fund, Citizens’ Environmental Coalition

    Comments to the Centers for Disease Control & Prevention regarding National Conversation on Public Health and Chemical Exposures
    Workgroup Reports

    General Comments:

    The Massachusetts TURI program should be made into a federal program, using a similar structure. It is funded by a user fee that companies pay based on the amount of hazardous materials they use. The fees are used to support programs that work with companies to help them reduce their use of hazardous chemicals, which then reduces the fees they have to pay to the program. In addition, companies that reduce their hazardous chemicals also reduce costs to store, ship, and dispose of them, which usually saves them money overall.

    Children are generally not called out in any of the work group reports, yet they are a specific vulnerable population: they cannot identify risks, remove themselves from harm, or describe exposures or events. Neither CDC’s Environmental Public Health Tracking nor the National Children’s Study collect information regarding children’s exposures in schools or child care centers, but they should be. When those are mentioned in various work group reports, it would be prudent to add that EPHT and NCS need to swiftly address these well-known data gaps with revised work plans. Children have exposures “on the job” in schools and child care centers and outnumber adults by about ten to one (depending on age group and health status) in those settings, but children/families have no recourse and no public services to intervene or to track or research those exposures.

    Scientific Understanding Work Group:

    Children are often described as a vulnerable subpopulation, but they are in fact an entire population of the future. There can be no adult without passing through childhood, and a healthy childhood can be a key determining factor of the adult’s future health and ability to function. Detoxification mechanisms in the adult are often not well-developed in a child. If a chemical is toxic in an adult, that same dose may be quite different to the child. The over 200 toxic chemicals a child is born with do not normally occur in blood, were not present 100 years ago, are not vitamins and nutrients, and many are known to be toxic. We should have a better understanding of a child’s exposure to multiple different neurotoxic chemicals and the effects on the still developing nervous system.

    We seek strong recommendations on the following issues of critical importance:

    1. Children’s exposure to chemicals from conception to childhood through adolescence,
    2. Total human exposure to a single chemical from all sources,
    3. Cumulative exposures and impacts,
    4. The evaluation of exposure to mixtures,
    5. Endocrine Disruption and mechanisms,
    6. The need for independent science not influenced by industry and their funding support,
    7. The promotion of green chemistry.

    Total human exposure to a single chemical from all sources: Total exposure is a sum of all sources of exposures. Efforts to assess human exposure to a single chemical from all possible sources are rare. Instead we have risk estimates of air pollutants or drinking water contaminants or skin absorption or food intake. Without understanding total exposures, it is impossible to achieve a margin of safety. Health effects may be occurring without sufficient assessments of their cause based on cumulative exposures (or mixtures) by any health or environmental agency.

    Endocrine disruption is a whole emerging field, with far more questions arising as we study more. Significantly, this involves extremely small signals yielding large effects and there are many mechanisms and interactions with the nervous system.

    There is a trend of private interest taking over scientific research endeavors. We recommend that government establish strong, independent scientific institutions that can conduct science related to health free from corporate influence.

    The goal of the National Conversation is to develop an action agenda with clear, achievable recommendations to protect the public from harmful chemical exposures. To accomplish that goal all of the topics listed above should have received major attention in a document from this important workgroup.

    Recommendation #4 Section B as written seems geared to identifying individual susceptibility and thereby the suggestion of responsibility for illness. The title of Section B suggests a discussion of multiple and cumulative chemical exposures, which should have been the focus, but none of the subsequent recommendations in this section address this issue.

    Recommendation #5 references NRC’s 2009 report that described better tools to support cumulative risk assessment. But the ensuing discussion fails to really talk about cumulative risk assessment, instead focusing on cultural and social factors, non-chemical stressors. The section following is poorly worded, seeks to blame the victims, and was not prepared by qualified scientists, such as sociologists or anthropologists. Environmental Justice Communities are often excessively burdened by environmental contaminants from multiple sources, and may be disproportionately burdened by other factors affecting disease, such as poor nutrition and stress. The report should highlight the importance of addressing cumulative impacts.

    We recommend the deletion of #5, as presented.

    Recommendation #6 regarding gene-environmental interactions while an appropriate area of research, has important ethical considerations. Chemical exposures can cause epigenetic effects as well as gene mutations, which should be studied. Inherited susceptibility needs to be approached with more caution. Identifying unique susceptibility based on race, ethnic or familial background, especially when coupled with biomonitoring results, could be used to restrict employment opportunities or affect health and life insurance rates or coverage. As a result, care needs to be taken to select multiple target populations representative of the full range of the US population, in order to study the full range of susceptibility present.

    Recommendation #7 relates largely to chemical intolerance. We support recommendation #7. Studies suggest that large percentages of the population when questioned in detail report reactions to particular chemical exposures. Most of these are mild reactions, but study of the prevalence of reactions to exposure in the overall population is important to our overall understanding of the range of responses.

    We fully support Recommendation #8.

    We also support Recommendation #9. We urge inclusion of a public health framework that utilizes professional judgment to take appropriate action to protect the public’s health from potential threats with the precautionary principle in this section. While the precautionary principle is relatively new, the principles and practice of public health are not. Public Health actions that could be taken based on the precautionary principle are absent from Recommendation #9.

    Recommendation #10 We caution against prescriptive standardized scientific protocols, because experiences with alternatives assessment are new, with different approaches depending on the chemical and the particular use being examined. We need to fund government entities to do this work and document what works and what doesn’t as well as emerging best practices.

    Recommendation #11 seeks to improve Risk Assessment, rather than transition to a Hazard Assessment approach. Risk Assessment has been a monumental failure in protecting the public and the environment from toxic chemicals:
    • Risk assessments take years to produce & are extremely expensive
    • RAs perfectly suit industry’s desire for regulatory delay
    • Industry is often invited to participate as stakeholders
    • Industry has full-time individuals to press their opinions
    • The NGO community and the public cannot afford this level of participation, even though they represent far more people.
    • Risk assessments cover adverse effects most studied and known, ignoring huge data gaps and failing to list them in the final report. For example, neurotoxicity -not studied, reproductive/developmental- not studied, etc.
    • Uncertainty regarding precise dose-effect relationship can limit actions even where exposures are very high and no margin of safety exists, ie., diesel exhaust RA
    • RAs hinder, rather than help, timely action to address public health threats.

    We support Recommendation #12.

    Respectfully submitted,

    Donna Hippert, President
    Oregon Toxics Alliance

    Lin Kaatz Chary
    Northwest Indiana Toxics Action Project

    Katie Huffling,
    Alliance of Nurses for Healthy Environments

    Pamela Miller, Executive Director
    Alaska Community Action on Toxics

    Elisa Mejia
    University of Alabama Hospital Highlands

    Renee Hackenmiller-Paradis, Program Director
    Oregon Environmental Council

    Kathleen A. Curtis, Policy Director
    Clean New York

    Judith Robinson, Associate Director
    Environmental Health Fund

    Barbara Warren, Executive Director
    Citizens’ Environmental Coalition

    Niaz Dorry, Director
    Northwest Atlantic Marine Alliance