The Critical Role of Commercial Analytical Reference Standards in the Control of Chemical Risks: The Case of PFAS and Ways Forward

Abstract

Background: Various countries have instituted risk governance measures to control and minimize the risks of chemicals at the national and international levels. Activities typically include risk assessment based on a) hazard and exposure assessments; b) setting limits on the production, use, and emissions of chemicals; c) enforcement of regulations; and d) monitoring the effectiveness of the measures taken. These steps largely depend on chemical analysis and access to pure chemical reference standards. However, except for specific highly regulated categories of chemicals, such reference standards often are not commercially available. This raises a critical question: Given the widespread lack of reference standards, is the current approach to governing chemicals adequate to protect humans and the environment from harm? If not, what measures could be taken to improve the situation?

Objective: We outline how current chemical risk governance is hampered by the widespread lack of reference standards to produce the required scientific evidence. We also provide a list of recommendations for controlling chemical risks in the absence of reference standards.

Discussion: We use per- and polyfluoroalkyl substances (PFASs), specifically the chemical C6O4 [perfluoro ([5-methoxy-1,3-dioxolan-4-yl]oxy) acetic acid], to illustrate how companies that produce chemicals can prevent access to reference standards. We argue that the very limited availability of reference standards undermines the ability of scientists to produce independent scientific evidence needed for chemical risk governance and, thereby, prevents society from protecting people and the environment against chemical pollution and its harms. Possible ways to improve the situation include a) guaranteeing access to chemical reference standards by creating a reference standards repository, b) redefining the level of confidence sufficient for regulatory action, c) providing alternative options for chemical identification and quantification when reference standards are not available, and d) considering, when no reference standards are available, regulation of chemicals by class rather than individually. https://doi.org/10.1289/EHP12331.

Figure 1.

Number of PFAS chemical reference standards available from commercial providers. The raw and curated data underlying this figure and references can be found in Excel Tables S2–S8. “Pesticides” and “pharmaceuticals” refer to active ingredients in pesticides and pharmaceuticals, respectively. Methodology and limitations underlying this data can be found in the Supplemental Excel file tab “About.”

Figure 2.

Examples of the uses for reference standards in scientific investigations.