Megan R. Schwarzman

Toward a new U.S. chemicals policy: rebuilding the foundation to advance new science, green chemistry, and environmental health.

Objective We describe fundamental weaknesses in U.S. chemicals policy, present principles of chemicals policy reform, and articulate interdisciplinary research questions that should be addressed. With global chemical production projected to double over the next 24 years, federal policies that shape the priorities of the U.S. chemical enterprise will be a cornerstone of sustainability. To date, these policies have largely failed to adequately protect public health or the environment or motivate investment in or scientific exploration of cleaner chemical technologies, known collectively as green chemistry. On this trajectory, the United States will face growing health, environmental, and economic problems related to chemical exposures and pollution. Conclusions Existing policies have produced a U.S. chemicals market in which the safety of chemicals for human health and the environment is undervalued relative to chemical function, price, and performance. This market barrier to green chemistry is primarily a consequence of weaknesses in the Toxic Substances Control Act. These weaknesses have produced a chemical data gap, because producers are not required to investigate and disclose sufficient information on chemicals’ hazard traits to government, businesses that use chemicals, or the public; a safety gap, because government lacks the legal tools it needs to efficiently identify, prioritize, and take action to mitigate the potential health and environmental effects of hazardous chemicals; and a technology gap, because industry and government have invested only marginally in green chemistry research, development, and education. Policy reforms that close the three gaps—creating transparency and accountability in the market—are crucial for improving public and environmental health and reducing the barriers to green chemistry. The European Union’s REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulation has opened an opportunity for the United States to take this step; doing so will present the nation with new research questions in science, policy, law, and technology.

New Science for Chemicals Policy

U.S. regulation of chemicals is in need of an overhaul, informed by European legislation and guided by new thinking about risk. Over the last century, industrial chemicals have become ubiquitous in materials, products, and manufacturing processes used throughout society. In 2006, more than 34 million metric tons of chemical substances were produced in, or imported into, the United States every day (1). Over the next quarter-century, global chemical production is projected to double, rapidly outpacing the rate of population growth (2). These substances ultimately enter Earths environment; hundreds of chemicals are routinely detected in people and ecosystems worldwide (3, 4). Long-standing public policies governing chemical design, production, and use need deep restructuring in light of new science on the health and environmental effects of anthropogenic chemicals. Such reforms are essential to safeguard ecosystem integrity, human health, and economic sustainability.

Screening for Chemical Contributions to Breast Cancer Risk: A Case Study for Chemical Safety Evaluation

Background Current approaches to chemical screening, prioritization, and assessment are being reenvisioned, driven by innovations in chemical safety testing, new chemical regulations, and demand for information on human and environmental impacts of chemicals. To conceptualize these changes through the lens of a prevalent disease, the Breast Cancer and Chemicals Policy project convened an interdisciplinary expert panel to investigate methods for identifying chemicals that may increase breast cancer risk. Methods Based on a review of current evidence, the panel identified key biological processes whose perturbation may alter breast cancer risk. We identified corresponding assays to develop the Hazard Identification Approach for Breast Carcinogens (HIA-BC), a method for detecting chemicals that may raise breast cancer risk. Finally, we conducted a literature-based pilot test of the HIA-BC. Results The HIA-BC identifies assays capable of detecting alterations to biological processes relevant to breast cancer, including cellular and molecular events, tissue changes, and factors that alter susceptibility. In the pilot test of the HIA-BC, chemicals associated with breast cancer all demonstrated genotoxic or endocrine activity, but not necessarily both. Significant data gaps persist. Conclusions This approach could inform the development of toxicity testing that targets mechanisms relevant to breast cancer, providing a basis for identifying safer chemicals. The study identified important end points not currently evaluated by federal testing programs, including altered mammary gland development, Her2 activation, progesterone receptor activity, prolactin effects, and aspects of estrogen receptor β activity. This approach could be extended to identify the biological processes and screening methods relevant for other common diseases. Citation Schwarzman MR, Ackerman JM, Dairkee SH, Fenton SE, Johnson D, Navarro KM, Osborne G, Rudel RA, Solomon GM, Zeise L, Janssen S. 2015. Screening for chemical contributions to breast cancer risk: a case study for chemical safety evaluation. Environ Health Perspect 123:1255–1264; http://dx.doi.org/10.1289/ehp.1408337

Green Chemistry: Wilson and Schwarzman Respond

We commend O’Brien, Myers, and Warner for their pioneering work identifying chemical threats to human and ecosystem health and for advancing the field of green chemistry. In our article (Wilson and Schwarzman 2009), we discussed advancing green chemistry as an objective of chemicals policy and described existing policy barriers that, if lifted, would spur the scientific and commercial development of green chemistry. O’Brien et al. recognize that the science of green chemistry has a role in informing chemicals policies. We would add that public policy that accurately reflects current science—and the needs of the chemicals market—is instrumental to the widespread adoption of green chemistry, but dispute that green chemistry is integral to chemicals policy itself. Green chemistry’s potential is expanded when the science is embedded in a larger context. For example, in an introductory text on green chemistry, Lancaster (2002) stated that Green chemistry is not a new branch of science, but more a new philosophical approach that underpins all of chemistry and has technological, environmental and societal goals. Lancaster (2002) pointed out that “over the last ten years, green chemistry has gradually become recognized as both a culture and a methodology for achieving sustainability,” and that the “12 principles of green chemistry help show how this can be achieved” (Lancaster 2002). This book addresses technical aspects of green chemistry while acknowledging the economic, legal, and knowledge barriers to advancing green chemistry. California has adopted a similarly expansive approach. The state’s 2-year old Green Chemistry Initiative is rooted in the 12 principles of green chemistry, and it also embraces a range of tools to ensure the success of green chemistry in society. These include new regulatory strategies, economic incentives, technical assistance, research, and education, with the goal of “launch[ing] a new chemicals framework and a quantum shift in environmental protection” (Adams 2008). These are the same kinds of legislative and regulatory tools that California has used successfully to promote innovation in the energy sector, and which the empirical evidence has identified are the primary drivers for the adoption of cleaner technologies (Nameroff 2004). It is in this context that we see the broad potential of green chemistry. It is a credit to those who have established the field of green chemistry that multiple interests recognize its value in achieving environmental and economic sustainability, with benefits for worker health, resource conservation, environmental justice, public health, and global warming. As a result, green chemistry is reaching out from a core set of technical principles to inform broad societal goals. As the field of green chemistry garners increasing attention in the scientific community and in society, it is worth recognizing that the 12 principles of green chemistry will be put to use in many contexts. We welcome the opportunity to join others in engaging with this promising field, with its relationship to the environmental health sciences and its role in effective public policy.

The role of chemical policy in improving supply chain knowledge and product safety

Although the US government has made important improvements in chemical management since the 1970s, these advances have not kept pace with scientific knowledge about chemical hazards. While US federal chemical policy reform is being debated for the first time since 1976, some US businesses have voluntarily sought to improve their knowledge of chemical hazards in their supply chains, and several US states, the European Union, China, and other countries have moved forward with chemical policy reforms. Until policy reforms occur in the USA, the US chemical market will continue to experience problems associated with poor information on hazardous chemicals in supply chains. These market conditions make it difficult for consumer product companies to identify hazards and create safer products. Results from interviews with consumer product company representatives demonstrate that challenges in obtaining chemical-related information exist across sectors, and information on chemical hazards and uses can be conflicting, protected by trade secrets, lost in supply chains, or nonexistent. Interview results illustrate how some consumer product companies are exceeding regulatory requirements by voluntarily restricting from their products chemicals that could harm human health or the environment. Understanding the motivations behind—and barriers to—these actions could inform efforts to modernize US chemicals policies in ways that promote effective chemical management in supply chains. Using examples from the European Union and some US states, we introduce policy suggestions that would increase knowledge, market transparency, and information flows regarding hazardous chemicals and their uses; these would support the efforts of companies to develop and market safer products.

Reshaping Chemicals Policy on Two Sides of the Atlantic: The Promise of Improved Sustainability through International Collaboration

This well-documented book analyzes the possibilities and constraints of regulatory cooperation between the EU and the US (particularly California) with a specific focus on environmental protection, food safety and agriculture, biosafety and biodiversity.