The American Chemistry Council (ACC) Formaldehyde Panel (the Panel) believes increasing transparency and public confidence in government regulations, while protecting personal privacy, confidential business information, proprietary interest and intellectual property rights, is of utmost importance. Although some have argued this opens the door for industry to go after important studies that underpin public health protections, the Panel begs to differ. Changes happening at the EPA are bolstering this concept, ensuring independent experts can have access to the science supporting regulatory initiatives.
Predictably, we’ve seen an onslaught of various degrees from those that oppose Administrator Pruitt’s initiative. Scott Waldman of E&E News recently interpreted industry’s desire for open and transparent data—in his article “How Pruitt’s Science Plans Might Help Industry Fight Rules”—as an effort to discredit science that underlies regulations that protect public health. This is untrue. Industry does not seek access to research to discredit it nor to limit regulation; rather Americans deserve to know that high quality science is the foundation of government regulations.
Take for example the case of formaldehyde. There have been claims over the years that formaldehyde causes leukemia. However, the weight of scientific evidence does not support a causal association between formaldehyde exposure and leukemia. Yet since 2010, several government agencies, including the EPA, have used a study known as the Zhang Study, to support incorrect conclusions that formaldehyde causes leukemia.
The Zhang Study failed to meet its own data quality standards and the scientific standard of reproducibility. For these very reasons, Dr. Goldstein and other scientists have repeatedly called for researchers to attempt to replicate the Zhang Study. Following these findings, industry took multiple steps to advocate redoing the Zhang Study in a different group of workers exposed to formaldehyde, however no such occupational settings with exposures as high as the original Zhang Study exist. Even if such an occupational setting was found, the same cross-sectional approach that was used for the Zhang Study would not be recommended. Instead a study which includes validated outcomes more predictive of leukemia than less specific-specific blood measures would be of a higher standard. In addition, industry has sent multiple letters to both the National Institute of Environmental Health Sciences (NIEHS) and EPA to suggest partnering to replicate the Zhang Study, with no response to our proposals.
Notably, in order to access data from the study to conduct a reanalysis, it took multiple years of requests to the National Cancer Institute (NCI) for the release of relevant data. Once the data were made available and reanalysis conducted, the data were found to have significant scientific shortcomings that called into question the original findings—a fact that regulators today would not have known if it weren’t for the analysis of the raw data that pointed out the significant flaws of the study.
But Zhang is not the only example. There have been several examples in recent years where publicly-funded research data were not provided in a transparent or timely manner and erroneous evaluations and interpretations persisted. In one such instance, again after years of requests and negotiations, the underlying data from another NCI study were obtained and reanalyzed. In a publication by Checkoway et al. 2015, a fuller analysis and interpretations of the data determined that some of the original study conclusions were not supported and, most notable, that the study did not demonstrate a link between occupational formaldehyde exposure at any level and risk of acute myeloid leukemia (AML). The scientific quality of the Checkoway et al. reanalysis was acknowledged when the publication received the 2017 American College of Occupational and Environmental Medicine (ACOEM’s) Journal of Occupational and Environmental Medicine (JOEM) Kammer Merit in Authorship Award.
In another call for data transparency and availability, it took nearly two years and multiple requests to the National Toxicology Program (NTP) for the release of a full study report on a key government-conducted rodent study finding no association with leukemia. The delay in revealing and communicating accurate analyses and interpretations of these three studies materially contributed to the growing but erroneous belief that formaldehyde causes leukemia.
Dr. Goldstein of the University of Pittsburgh claims in Waldman’s article that industry does not fund “new science to see whether this thing is right or wrong.” He accuses industry of “waging a political and legal war, rather than focusing on research.” Contrary to this claim, industry has diligently worked to support research that improves the understanding of formaldehyde; adds to the scientific evidence demonstrating that formaldehyde does not cause leukemia; and supports that there are clearly defined safe thresholds for formaldehyde exposure. Using state-of-the-art technologies, it is clear that inhaled formaldehyde does not reach the bone marrow (nor does it move beyond the nose). In fact, formaldehyde is naturally occurring. All of this information has been shared with EPA and made available in dozens of peer reviewed scientific publications. Formaldehyde is one of the most-well studied substances, thanks, in part to industry’s commitment to generating new science.
Data availability and transparency are key components to ensuring that the best available and most relevant science underlies regulatory decision-making and protects public health. Yet many policymakers—not to mention the public at large—are left in the dark as to whether the science they are charged with interpreting to form public health regulations is sound.
Relying on the misleading findings as reported in the original Zhang Study for example has consequently led to flawed chemical assessment conclusions. Formaldehyde technologies however have broad roles in the economy, from the automotive to aerospace industries, providing thousands of jobs. The impact of poor science as the foundation for government regulation can be felt across the entire value chain, from manufacturer, to workers and finally the consumer.
In order to help improve public confidence in the decision-making process, it is critical data be made available in a timely and transparent way to ensure decisions are based on scientifically defensible information.
The ACC Formaldehyde Panel