Addressing systemic problems with exposure assessments to protect the public's health.

BACKGROUND: Understanding, characterizing, and quantifying human exposures to environmental chemicals is critical to protect public health. Exposure assessments are key to determining risks to the general population and for specific subpopulations given that exposures differ between groups. Exposure data are also important for understanding where interventions, including public policies, should be targeted and the extent to which interventions have been successful. In this review, we aim to show how inadequacies in exposure assessments conducted by polluting industries or regulatory agencies have led to downplaying or disregarding exposure concerns raised by communities; that underestimates of exposure can lead regulatory agencies to conclude that unacceptable risks are, instead, acceptable, allowing pollutants to go unregulated; and that researchers, risk assessors, and policy makers need to better understand the issues that have affected exposure assessments and how appropriate use of exposure data can contribute to health-protective decisions. METHODS: We describe current approaches used by regulatory agencies to estimate human exposures to environmental chemicals, including approaches to address limitations in exposure data. We then illustrate how some exposure assessments have been used to reach flawed conclusions about environmental chemicals and make recommendations for improvements. RESULTS: Exposure data are important for communities, public health advocates, scientists, policy makers, and other groups to understand the extent of environmental exposures in diverse populations. We identify four areas where exposure assessments need to be improved due to systemic sources of error or uncertainty in exposure assessments and illustrate these areas with examples. These include: (1) an inability of regulatory agencies to keep pace with the increasing number of chemicals registered for use or assess their exposures, as well as complications added by use of 'confidential business information' which reduce available exposure data; (2) the failure to keep assessments up-to-date; (3) how inadequate assumptions about human behaviors and co-exposures contribute to underestimates of exposure; and (4) that insufficient models of toxicokinetics similarly affect exposure estimates. CONCLUSION: We identified key issues that impact capacity to conduct scientifically robust exposure assessments. These issues must be addressed with scientific or policy approaches to improve estimates of exposure and protect public health.

A science-based agenda for health-protective chemical assessments and decisions: overview and consensus statement.

The manufacture and production of industrial chemicals continues to increase, with hundreds of thousands of chemicals and chemical mixtures used worldwide, leading to widespread population exposures and resultant health impacts. Low-wealth communities and communities of color often bear disproportionate burdens of exposure and impact; all compounded by regulatory delays to the detriment of public health. Multiple authoritative bodies and scientific consensus groups have called for actions to prevent harmful exposures via improved policy approaches. We worked across multiple disciplines to develop consensus recommendations for health-protective, scientific approaches to reduce harmful chemical exposures, which can be applied to current US policies governing industrial chemicals and environmental pollutants. This consensus identifies five principles and scientific recommendations for improving how agencies like the US Environmental Protection Agency (EPA) approach and conduct hazard and risk assessment and risk management analyses: (1) the financial burden of data generation for any given chemical on (or to be introduced to) the market should be on the chemical producers that benefit from their production and use; (2) lack of data does not equate to lack of hazard, exposure, or risk; (3) populations at greater risk, including those that are more susceptible or more highly exposed, must be better identified and protected to account for their real-world risks; (4) hazard and risk assessments should not assume existence of a "safe" or "no-risk" level of chemical exposure in the diverse general population; and (5) hazard and risk assessments must evaluate and account for financial conflicts of interest in the body of evidence. While many of these recommendations focus specifically on the EPA, they are general principles for environmental health that could be adopted by any agency or entity engaged in exposure, hazard, and risk assessment. We also detail recommendations for four priority areas in companion papers (exposure assessment methods, human variability assessment, methods for quantifying non-cancer health outcomes, and a framework for defining chemical classes). These recommendations constitute key steps for improved evidence-based environmental health decision-making and public health protection.

Dispelling Stem-Cell Ideology.

Week-old embryos are considered the richest source of stem cells usable in medical treatments. Because the embryos are destroyed when the stem cells are removed, the debate over the embryo's legal, moral, political, and scientific status has exploded. In this debate, Sheldon Krimsky's Stem Cell Dialogues: A Philosophical and Scientific Inquiry into Medical Frontiers (Columbia UP, 2015) is the single best book. Evenhanded, eminently readable, up to date, educational, scientifically precise, powerfully researched, and very entertaining, Krimsky's slim volume is one that no scientist, policy-maker, ethicist, or intelligent reader should miss.

Taking action on developmental toxicity: scientists' duties to protect children.

BACKGROUND: Although adaptation and proper biological functioning require developmental programming, pollutant interference can cause developmental toxicity or DT. OBJECTIVES: This commentary assesses whether it is ethical for citizens/physicians/scientists to allow avoidable DT. METHODS: Using conceptual, economic, ethical, and logical analysis, the commentary assesses what major ethical theories and objectors would say regarding the defensibility of allowing avoidable DT. RESULTS: The commentary argues that (1) none of the four major ethical theories (based, respectively, on virtue, natural law, utility, or equity) can consistently defend avoidable DT because it unjustifiably harms, respectively, individual human flourishing, human life, the greatest good, and equality. (2) Justice also requires leaving "as much and as good" biological resources for all, including future generations possibly harmed if epigenetic change is heritable. (3) Scientists/physicians have greater justice-based duties, than ordinary/average citizens, to help stop DT because they help cause it and have greater professional abilities/opportunities to help stop it. (4) Scientists/physicians likewise have greater justice-based duties, than ordinary/average citizens, to help stop DT because they benefit more from it, given their relatively greater education/consumption/income. The paper shows that major objections to (3)-(4) fail on logical, ethical, or scientific grounds, then closes with practical suggestions for implementing its proposals. CONCLUSIONS: Because allowing avoidable DT is ethically indefensible, citizens---and especially physicians/scientists---have justice-based duties to help stop DT.

Does Hazardous-Waste Testing Follow Technical Guidance, Thus Help Protect Environmental Justice and Health?

Does representative hazardous-waste-site testing tend to follow or to violate government technical guidance? This is an important question, because following such guidance promotes reliable risk analysis, adequate remediation, and environmental-justice and -health protection. Yet only government documents typically address this question, usually only when it is too late, when citizens have already exhibited health harm, allegedly from living or working near current/former hazardous-waste sites. Because no systematic, representative, scientific analyses have answered the preceding question, this article begins to investigate it by posing a narrower part of the question: Does representative US testing of volatile-organic-compound (VOC) waste sites tend to follow or to violate government technical requirements? The article (i) outlines US/state-government technical guidance for VOC testing; (ii) develops criteria for discovering representative US cases of VOC testing; (iii) uses the dominant US Environmental Protection Agency method to assess whether these representative cases follow such guidance; (iv) employs the results of (iii) to begin to answer the preceding question; then (v) discusses the degree to which, if any, these results suggest threats to environmental health or justice. Our initial, but representative, results show that almost all US VOC-waste-site testing (that we investigated) violates government technical requirements and systematically underestimates risks, and this may help justify less expensive, potentially health-threatening cleanups, mostly in environmental justice communities. We outline needed future research and suggest two strategies to promote following government technical guidance for hazardous-waste testing.

Climate change, nuclear economics, and conflicts of interest.

Merck suppressed data on harmful effects of its drug Vioxx, and Guidant suppressed data on electrical flaws in one of its heart-defibrillator models. Both cases reveal how financial conflicts of interest can skew biomedical research. Such conflicts also occur in electric-utility-related research. Attempting to show that increased atomic energy can help address climate change, some industry advocates claim nuclear power is an inexpensive way to generate low-carbon electricity. Surveying 30 recent nuclear analyses, this paper shows that industry-funded studies appear to fall into conflicts of interest and to illegitimately trim cost data in several main ways. They exclude costs of full-liability insurance, underestimate interest rates and construction times by using "overnight" costs, and overestimate load factors and reactor lifetimes. If these trimmed costs are included, nuclear-generated electricity can be shown roughly 6 times more expensive than most studies claim. After answering four objections, the paper concludes that, although there may be reasons to use reactors to address climate change, economics does not appear to be one of them.

Correction: Shrader-Frechette, K.; Biondo, A.M. Data-Quality Assessment Signals Toxic-Site Safety Threats and Environmental Injustices. Int. J. Environ. Res. Public Health 2021, 18, 2012.

The authors would like to make the following corrections (1 and 2) to this paper [...].

Correction: Shrader-Frechette, K.; Biondo, A.M. Health Misinformation about Toxic-Site Harm: The Case for Independent-Party Testing to Confirm Safety. Int. J. Environ. Res. Public Health 2021, 18, 3882.

Because part of the text was unintentionally omitted, the first paragraph under Section 2.2.4.3. on p. 13 was jumbled and incomplete when it was published [...].

Health Misinformation about Toxic-Site Harm: The Case for Independent-Party Testing to Confirm Safety.

Health misinformation can cause harm if regulators or private remediators falsely claim that a hazardous facility is safe. This misinformation especially threatens the health of children, minorities, and poor people, disproportionate numbers of whom live near toxic facilities. Yet, perhaps because of financial incentives, private remediators may use safety misinformation to justify reduced cleanup. Such incentives exist in nations like the United States, where most toxic-site testing/remediation is semi-privatized or voluntary, conducted by private parties, commercial redevelopers, who can increase profits by underestimating health harm, thus decreasing required testing/remediation. Our objective is to begin to determine whether or not interested parties misrepresent health harm (at hazardous facilities that they test/remediate/redevelop) when they use traditional and social media to claim that these sites are safe. Our hypothesis is that, contrary to the safety claims of the world's largest commercial developer, Coldwell Banker Real Estate/Trammell Crow (CBRE/TCC), the authors' screening assessment, especially its lab-certified, toxic-site, indoor-air tests, show violations of all three prominent government, cancer-safety benchmarks. If so, these facilities require additional testing/remediation, likely put site renters at risk, and may reveal problems with privatized hazardous cleanup. To our knowledge, we provide the first independent tests of privatized, toxic-site assessments before cancer reports occur. Our screening assessment of this hypothesis tests indoor air in rental units on a prominent former weapons-testing site (the US Naval Ordnance Testing Station, Pasadena, California (NOTSPA) that is subject to carcinogenic vapor intrusion by volatile organic compounds, VOCs), then compares test results to the redeveloper's site-safety claims, made to government officials and citizens through traditional and social media. Although NOTSPA toxic soil-gas concentrations are up to nearly a million times above allowed levels, and indoor air was never tested until now, both the regulator and the remediator (CBRE/TCC) have repeatedly claimed on social media that "the site is safe at this time." We used mainly Method TO-17 and two-week sampling with passive, sorbent tubes to assess indoor-air VOCs. Our results show that VOC levels at every location sampled-all in occupied site-rental units-violate all three government-mandated safety benchmarks: environmental screening levels (ESLs), No Significant Risk Levels (NSRLs), and inhalation risks based on the Inhalation Unit Risk (IUR); some violations are two orders of magnitude above multiple safety benchmarks. These results support our hypothesis and suggest a need for independent assessment of privatized cleanups and media-enhanced safety claims about them. If our results can be replicated at other sites, then preventing health misinformation and toxic-facility safety threats may require new strategies, one of which we outline.

Data-Quality Assessment Signals Toxic-Site Safety Threats and Environmental Injustices.

Most hazardous-waste sites are located in urban areas populated by disproportionate numbers of children, minorities, and poor people who, as a result, face more severe pollution threats and environmental-health inequalities. Partly to address this harm, in 2017 the United Nations unanimously endorsed the New Urban Agenda, which includes redeveloping urban-infill-toxic-waste sites. However, no systematic, independent analyses assess the public-health adequacy of such hazardous-facility redevelopments. Our objective is to provide a preliminary data-quality assessment (PDQA) of urban-infill-toxic-site testing, conducted by private redevelopers, including whether it adequately addresses pollution threats. To this end, we used two qualitative, weight-of-evidence methods. Method 1 employs nine criteria to select assessments for PDQA and help control for confounders. To conduct PDQA, Method 2 uses three US Environmental Protection Agency standards-the temporal, geographical, and technological representativeness of sampling. Our Method 1 results reveal four current toxic-site assessments (by CBRE/Trammell Crow, the world's largest commercial developer); at all of these sites the main risk drivers are solvents, volatile organic compounds, including trichloroethylene. Our Method 2 results indicate that all four assessments violate most PDQA standards and systematically underestimate health risk. These results reveal environmental injustice, disproportionate health threats to children/minorities/poor people at all four sites. Although preliminary, our conclusion is that alleviating harm and environmental-health inequalities posed by urban-infill-toxic-site pollution may require improving both the testing/cleanup/redevelopment requirements of the New Urban Agenda and the regulatory oversight of assessment and remediation performed by private redevelopers.

Using routine, independent, scientific-data audits as an early-warning for potentially fraudulent toxic-site cleanup: PCE, TCE, and other VOCs at the former Naval-Ordnance Test Station, Pasadena, California.

Two of the most prevalent Superfund-site contaminants are carcinogenic solvents PCE (perchloroethylene) and TCE (trichloroethylene). Because their cleanup is difficult and costly, remediators have repeatedly falsified site-cleanup data, as Tetra Tech apparently did recently in San Francisco. Especially for difficult-to-remediate toxins, this paper hypothesizes that scientific misrepresentations occur in toxic-site assessments, before remediation even begins. To begin to test this hypothesis, the paper (1) defines scientific-data audits (assessing whether published conclusions contradict source data), (2) performs a preliminary scientific-data audit of toxic-site assessments by consultants Ninyo and Moore for developer Trammell Crow. Trammel Crow wants to build 550 apartments on an unremediated Pasadena, California site - once a premier US Navy weapons-testing/development facility. The paper (3) examines four key Ninyo-and-Moore conclusions, that removing only localized metals-hotspots will (3.1) remediate TCE/PCE; (3.2) leave low levels of them; (3.3) clean the northern half of soil, making it usable for grading, and (3.4) ensure site residents have lifetime cancer risks no greater than 1 in 3,000. The paper (4) shows that source data contradict all four conclusions. After summarizing the benefits of routine, independent, scientific-data audits (RISDA), the paper (5) argues that, if these results are generalizable, RISDA might help prevent questionable toxic-site assessments, especially those of expensive-to-remediate toxins like PCE/TCE.

Trimming exposure data, putting radiation workers at risk: improving disclosure and consent through a national radiation dose-registry.

In the United States, regulatory standards allow workers to be exposed to ionizing radiation that can cause 1 additional cancer fatality per 400 workers per year. Because radiation-dose limits cover only single sources (e.g., a nuclear plant) or exposure classes (workplace, medical, or public) and are defined for average occupational exposure, workers typically do not know their precise cumulative, individual, and relative risks from radiation. Nevertheless, this information is necessary for informed consent, because most scientists say radiation effects are cumulative and linear with no risk threshold. To promote public health, informed consent, and better understanding of the effects of low-dose radiation, I argue for a multistage National Radiation-Dose Registry, beginning with cumulative, individual worker doses.

EPA's 2006 human-subjects rule for pesticide experiments.

Arguing that the 2006 Environmental Protection Agency (EPA) human-subjects rule allows use of unethical third-party research (on pregnant women and children) in setting pesticide regulations, this article first (a) provides a brief history of U.S. pesticide regulation, particularly regarding childhood safety. Next it (b) outlines ethical and scientific loopholes in the 2006 EPA rule; (c) shows how the Human Subjects Review Board, mandated by the 2006 rule, has been implemented in flawed ways; and (d) illustrates that one source of problems with the rule may be influence by those with conflicts of interest.

Pesticides, Neurodevelopmental Disagreement, and Bradford Hill's Guidelines.

Neurodevelopmental disorders such as autism affect one-eighth of all U.S. newborns. Yet scientists, accessing the same data and using Bradford-Hill guidelines, draw different conclusions about the causes of these disorders. They disagree about the pesticide-harm hypothesis, that typical United States prenatal pesticide exposure can cause neurodevelopmental damage. This article aims to discover whether apparent scientific disagreement about this hypothesis might be partly attributable to questionable interpretations of the Bradford-Hill causal guidelines. Key scientists, who claim to employ Bradford-Hill causal guidelines, yet fail to accept the pesticide-harm hypothesis, fall into errors of trimming the guidelines, requiring statistically-significant data, and ignoring semi-experimental evidence. However, the main scientists who accept the hypothesis appear to commit none of these errors. Although settling disagreement over the pesticide-harm hypothesis requires extensive analysis, this article suggests that at least some conflicts may arise because of questionable interpretations of the guidelines.

Commentary: Flawed scientific-evidence standards delay diesel regulations.

Of 188 government-monitored air toxics, diesel particulate matter (DPM) causes seven times more cancer than all the other 187 air toxics combined, including benzene, lead, and mercury. Yet, DPM is the only air toxic not regulated more stringently under the Clean Air Act, as a hazardous air pollutant (HAP). One reason is that regulators use flawed standards of scientific evidence. The article argues (1) that DPM meets all six specified evidentiary criteria, any one of which is sufficient for HAP regulation and (2) that regulators' standards of evidence for denying HAP status to DPM (no DPM unit-risk estimate, inadequate dose-response data, alleged weak mechanistic data) err logically and scientifically, set the evidence bar too high, delay regulation, and allow 21,000 avoidable DPM deaths annually in the U.S.

Commentary: flawed science delays smelter cleanup and worsens health.

For 6,000 years, humans have known about smelter hazards. Yet these metals threats continue. Why? This commentary provides one preliminary answer. It (1) summarizes the history of smelter pollution and (2) suggests that at least 3 problems-especially flawed smelter-polluter science-allow continuing health threats. It (3) illustrates this flawed science by using one of the most dangerous of U.S. former smelters, in DePue, Illinois. There polluters are avoiding violating the law yet trying to minimize smelter-caused health threats, thus clean-up costs, by using two questionable scientific claims. The causality-denial claim denies that smelter metals cause neurodegenerative diseases. The biomagnification-denial claim denies that food-chain biomagnification of smelter metals can put citizens at risk. The commentary shows both claims err, and (4) suggests ways to address flawed smelter science and resulting health harms.

Research integrity and conflicts of interest: the case of unethical research-misconduct charges filed by Edward Calabrese.

Special-interest polluters often file research-misconduct (RM) charges against scientists whose research suggests needed pollutant regulation. This article argues that U.S. RM regulations are flawed in requiring RM assessors/experts/accused, but not accusers, to reveal possible conflicts of interest (COI) that could affect RM allegations. It (1) summarizes U.S. RM regulatory history; (2) uses a case study about 2011 RM allegations, filed by chemical-industry-funded toxicologist Edward Calabrese, to illustrate problems with RM regulations; and (3) offers 4 arguments in favor of revising RM regulations so as to require RM-accuser revelation of possible COI and who funded preparation of the RM allegations.