Regulating Chemicals: Law, Science, and the Unbearable Burdens of Regulation

Silbergeld, Ellen K.; Mandrioli, Daniele; Cranor, Carl F.

doi:10.1146/annurev-publhealth-031914-122654

Cited by 45 publications

(39 citation statements)

References 36 publications

(24 reference statements)

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“…In contrast, the European Union's Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) legislation, uses precautionary principles, putting the burden of proof of safety on the industries that produce them (Silbergeld et al 2015). Under the precautionary principle, new substances and their derivatives are assumed to pose risk until proven otherwise, and the responsibility for proving the absence of risk is placed on both the producer and the regulator.…”

Section: Toxic Substances Policy In the United Statesmentioning

confidence: 99%

“…Although the courts can settle issues of human and environmental failures, this approach is, by definition, reactionary and can only interpret legislation to nullify or clarify obligations, or set appropriate enforcement actions, through slow, costly, and often adversarial means (Silbergeld et al 2015). Adjudication can preemptively affect policy as legislatures shy away from creating unenforceable policies.…”

Section: Toxic Substances Policy In the United Statesmentioning

confidence: 99%

“…It is clear from our case studies of lead, glyphosate, SOx, heavy metals, and BPA that many toxic chemical risks are persistent both in their sources and their biological consequences. These risks often only become known after enough harm has accrued to communities to elicit a social response (Mesnage et al 2015, Silbergeld et al 2015. Patterns of enforcement and adjudication indicate that present regulatory processes generally only mitigate or act retroactively, not preventatively.…”

Section: Paths Forwardmentioning

confidence: 99%

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Toxic Chemical Governance Failure in the United States: Key Lessons and Paths Forward

et al. 2019

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Abstract Over 40 years of regulations in the United States have failed to protect human and environmental health. We contend that these failures result from the flawed governance over the continued production, use, and disposal of toxic chemicals. To address this failure, we need to identify the broader social, political, and technological processes producing, knowing, and regulating toxic chemicals, collectively referred to as toxic chemical governance. To do so, we create a conceptual framework covering five key domains of governance: knowledge production, policy design, monitoring and enforcement, evaluation, and adjudication. Within each domain, social actors of varying power negotiate what constitutes acceptable risk, creating longer-term path dependencies in how they are addressed (or not). Using existing literature and five case studies, we discuss four paths for improving governance: evolving paradigms of harm, addressing bias in the knowledge base, making governance more equitable, and overcoming path dependency.

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Section: Toxic Substances Policy In the United Statesmentioning

confidence: 99%

Section: Toxic Substances Policy In the United Statesmentioning

confidence: 99%

Section: Paths Forwardmentioning

confidence: 99%

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Toxic Chemical Governance Failure in the United States: Key Lessons and Paths Forward

et al. 2019

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“…The same principle is applied for testing other chemicals developed for their toxic properties, such as pesticides. For other chemicals produced by industry, the situation is less consistent ( Silbergeld et al 2015 ). For the many chemicals that are already on the market, nonhuman toxicological evidence can support prudent actions to reduce exposures without the delays and human costs of awaiting evidence from observational studies.…”

Section: Introductionmentioning

confidence: 99%

Evidence from Toxicology: The Most Essential Science for Prevention

Mandrioli

Silbergeld

2016

Environ Health Perspect

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BackgroundThe most essential goal of medicine and public health is to prevent harm (primum non nocere). This goal is only fully achieved with primary prevention, which requires us to identify and prevent harms prior to human exposure through research and testing that does not involve human subjects. For that reason, public health policies place considerable reliance on nonhuman toxicological studies. However, toxicology as a field has often not produced efficient and timely evidence for decision making in public health. In response to this, the U.S. National Research Council called for the adoption of evidence-based methods and systematic reviews in regulatory decision making. The U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the European Food Safety Agency (EFSA) have recently endorsed these methods in their assessments of safety and risk.ObjectivesIn this commentary we summarize challenges and problems in current practices in toxicology as applied to decision making. We compare these practices with the principles and methods utilized in evidence-based medicine and health care, with emphasis on the record of the Cochrane Collaboration.DiscussionWe propose a stepwise strategy to support the development, validation, and application of evidence-based toxicology (EBT). We discuss current progresses in this field produced by the Office of Health Assessment and Translation (OHAT) of the National Toxicology Program and the Navigation Guide works. We propose that adherence to the Cochrane principles is a fundamental prerequisite for the development and implementation of EBT.ConclusionThe adoption of evidence-based principles and methods will enhance the validity, transparency, efficiency, and acceptance of toxicological evidence, with benefits in terms of reducing delays and costs for all stakeholders (researchers, consumers, regulators, and industry).CitationMandrioli D, Silbergeld EK. 2016. Evidence from toxicology: the most essential science for prevention. Environ Health Perspect 124:6–11; http://dx.doi.org/10.1289/ehp.1509880

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“…Environmental health researchers and government scientists in the United States typically encounter a paucity of information on both toxicity and exposure for most chemicals in commerce (Judson et al 2009; Egeghy et al 2012; Neltner et al 2013; Silbergeld et al 2015). Even if data are available, federal and state agencies have limited capacity for assessing health risks (GAO 2013).…”

Section: Introductionmentioning

confidence: 99%

Identifying Chemical Groups for Biomonitoring

Krowech

Hoover

Plummer

et al. 2016

Environ Health Perspect

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Summary:Regulatory agencies face daunting challenges identifying emerging chemical hazards because of the large number of chemicals in commerce and limited data on exposure and toxicology. Evaluating one chemical at a time is inefficient and can lead to replacement with uncharacterized chemicals or chemicals with structural features already linked to toxicity. The Office of Environmental Health Hazard Assessment (OEHHA) has developed a process for constructing and assessing chemical groups for potential biomonitoring in California. We screen for chemicals with significant exposure potential and propose possible chemical groups, based on structure and function. To support formal consideration of these groups by Biomonitoring California’s Scientific Guidance Panel, we conduct a detailed review of exposure and toxicity data and examine the likelihood of detection in biological samples. To date, 12 chemical groups have been constructed and added to the pool of chemicals that can be selected for Biomonitoring California studies, including p,p´-bisphenols, brominated and chlorinated organic compounds used as flame retardants, non-halogenated aromatic phosphates, and synthetic polycyclic musks. Evaluating chemical groups, rather than individual chemicals, is an efficient way to respond to shifts in chemical use and the emergence of new chemicals. This strategy can enable earlier identification of important chemicals for monitoring and intervention.

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Regulating Chemicals: Law, Science, and the Unbearable Burdens of Regulation

Cited by 45 publications

References 36 publications

Toxic Chemical Governance Failure in the United States: Key Lessons and Paths Forward

Toxic Chemical Governance Failure in the United States: Key Lessons and Paths Forward

Evidence from Toxicology: The Most Essential Science for Prevention

Identifying Chemical Groups for Biomonitoring

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