Op-eds and Articles

Federal Agencies Should Investigate on Reasonable Fears, But Regulate on Science

By / 3.8.2016

In November, the Food & Drug Administration approved for the first time a modified, fast-growing salmon for human consumption. More than five years ago, FDA accepted a risk assessment’s conclusion that the modified fish was safe to eat and posed no threat to the environment. The FDA re-opened the process for additional comment because critics challenged the science, among other things. This landmark decision to go forward spotlights two key issues: the importance of assuring scientific integrity of government regulations, and a key difference between how North American regulators view science from their European counterparts.

Major enhancements in human and environmental health impact studies have allowed regulators to dive deeper into scientific determinations, but they also have given partisans tools to obfuscate the dialogue. In litigation, important causation decisions are expected to be based on battles of opposing experts, but the regulatory process is supposed to be less partisan where subjective agendas are set aside for real science. People must believe FDA, for example, when it approves a drug as safe and effective for its labeled indications. When the Environmental Protection Agency, Center for Disease Control or other agency issues exposure guidelines for potentially harmful substances, it should reflect the best scientific knowledge. Scientific understanding evolves, and these regulations and standards should reflect those advancements.

For progressives, the importance of this process is more than just assuring that regulations are appropriately tailored to known risks. It is essential for protecting the integrity of the government and the regulatory process itself. Thus, while competing viewpoints on the science may infect submissions to federal agencies, just like they do in court, it is the agencies’ responsibility to make decisions that are not unduly influenced by partisans on any side. Submissions from all stakeholders, including both for and against industry, should be treated with the same scrutiny so that agencies are not unduly influenced by anyone’s tainted lenses.

For modified salmon, reopening the investigation affirmed the initial results. A few years ago, the Canadian Environment Minister reversed course when reopening its rulemaking on siloxanes. Siloxanes have been used since the 1940s in a variety of household products, including deodorants, shampoos and cosmetics. It gives these products a smooth, non-greasy texture that helps in their applications. When the products are used, the siloxanes either evaporate into the air or wash off and go down the drain.

In the early 2000s, scientists in Norway developed computer modeling suggesting that siloxanes, namely those known as “Siloxane D5,” could have adverse environmental impacts. Computer modeling has become an increasingly useful tool in assessing health and environmental risks, but it has obvious limitations given that it is not based on actual results such as epidemiological studies. In 2006, Canadian officials began reassessing its rules for Siloxane D5. In 2009, Canada issued a proposed order to add Siloxane D5 to its Toxic Substances List, which much like California’s Proposition 65 leads to significant restrictions on product use.

Before the new rule took effect, the Silicones Environmental Health and Safety Council of North America filed a Notice of Objection requesting an expert Board of Review to investigate the integrity of the modeling. Canada’s Minister of the Environment appointed three independent, highly respected toxicologists to this review panel. This was the first time an official Board of Review was used in Canada since it adopted this process for potentially serious and irreversible threats in 1999. The panel conducted a multi-disciplinary evaluation of the nature and extent of any hazards posed by D5 to the environment and biological diversity.

In 2011, the Board of Review issued a report concluding that the modeling used to predict Siloxane D5 in the environment was wrong. What they found was that regardless of whether Siloxane D5 entered the environment in the ground or air, it migrates to the air and degrades rapidly. As a result, “it is virtually impossible for Siloxane D5 to occur in any environmental matrix at concentrations sufficient to produce harm to the environment,” and that “Siloxane D5 does not pose a danger to the environment or its biological diversity.”

The Board further found that a key error in the modeling was that it used other types of silicone as surrogates for the physical and chemical properties of Siloxane D5. It then recommended better transparency for how modeling is developed and that agencies have better means for reviewing regulations to make sure they reflect the best scientific knowledge. In 2012, the Canadian Minister of the Environment endorsed the findings and removed Siloxane D5 from its list of toxic substances.

Last summer, the Norwegian scientists at the center of the allegations reportedly acknowledged that field studies showed conflicting results. The article from the High North Center for International Climate and Environmental Research that included the scientists’ remarks ironically was published around the same time that European regulators decided to move forward with their own restrictions on siloxanes. European regulators should learn from Canada and look beyond modeling. Just last year, the U.S. Trade Representative called out European regulators on genetically modified foods and feed, saying they were “ignor[ing] science-based safety and environmental determinations.”

In the end, what matters most is getting the science right. With modified salmon and siloxanes, U.S. and Canadian officials demonstrated this point by re-opening an investigation to assure a thorough understanding of the science. Like the scientific process itself, this approach to regulation encourages good faith skepticism, honest debate, and confidence in the regulations themselves. Most people, whether in Canada, Europe or the United States, understand that government investigations may be based on suspicions, but regulations must be based on science.

This is cross-posted on the Huffington Post.